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As filed with the U.S. Securities and Exchange Commission on December 20, 2016

File No.001-37859


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



Amendment No. 4
to

FORM 10



GENERAL FORM FOR REGISTRATION OF SECURITIES
PURSUANT TO SECTION 12(b) OR 12(g) OF
THE SECURITIES EXCHANGE ACT OF 1934



Bioverativ Inc.
(Exact name of Registrant as specified in its charter)



Delaware
(State or other jurisdiction of
incorporation or organization)
  81-3461310
(I.R.S. Employer
Identification No.)

225 Binney Street, Cambridge, Massachusetts
(Address of principal executive offices)

 

02142
(Zip Code)

(617) 679-2000
(Registrant's telephone number, including area code)

Securities to be registered pursuant to Section 12(b) of the Act:

Title of Each Class to be so Registered   Name of Each Exchange on which
each class is to be registered
Common Stock, par value $0.001 per share   The Nasdaq Stock Market

Securities to be registered pursuant to Section 12(g) of the Act: None

        Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer  o   Accelerated filer  o   Non-accelerated filer  ý
(Do not check if a
smaller reporting company)
  Smaller reporting company  o

        The registrant is an "emerging growth company," as defined in Section 2(a) of the Securities Act. This registration statement complies with the requirements that apply to an issuer that is an emerging growth company.

   



BIOVERATIV INC.

INFORMATION REQUIRED IN REGISTRATION STATEMENT
CROSS-REFERENCE SHEET BETWEEN INFORMATION STATEMENT
AND ITEMS OF FORM 10

        Certain information required to be included in this Form 10 is incorporated by reference to specifically identified portions of the body of the information statement filed with this Form 10 as Exhibit 99.1. None of the information contained in the information statement shall be incorporated by reference in this Form 10 or deemed to be a part of this Form 10 unless such information is specifically incorporated by reference.

Item 1.    Business.

        The information required by this item is contained under the sections of the information statement entitled "Information Statement Summary," "Risk Factors," "Cautionary Statement Concerning Forward-Looking Statements," "Unaudited Pro Forma Combined Financial Statements," "Selected Historical Combined Financial Data," "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Business," "Certain Relationships and Related Person Transactions," "Where You Can Find More Information" and "Index to Financial Statements" and the financial statements referenced in the information statement. Those sections are incorporated herein by reference.

Item 1A.    Risk Factors.

        The information required by this item is contained under the section of the information statement entitled "Risk Factors." That section is incorporated herein by reference.

Item 2.    Financial Information.

        The information required by this item is contained under the sections of the information statement entitled "Unaudited Pro Forma Combined Financial Statements," "Selected Historical Combined Financial Data," "Capitalization" and "Management's Discussion and Analysis of Financial Condition and Results of Operations." Those sections are incorporated herein by reference.

Item 3.    Properties.

        The information required by this item is contained under the section of the information statement entitled "Business—Manufacturing and Facilities." That section is incorporated herein by reference.

Item 4.    Security Ownership of Certain Beneficial Owners and Management.

        The information required by this item is contained under the section of the information statement entitled "Security Ownership by Certain Beneficial Owners and Management." That section is incorporated herein by reference.

Item 5.    Directors and Executive Officers.

        The information required by this item is contained under the section of the information statement entitled "Management." That section is incorporated herein by reference.

Item 6.    Executive Compensation.

        The information required by this item is contained under the section of the information statement entitled "Executive Compensation." That section is incorporated herein by reference.


Item 7.    Certain Relationships and Related Transactions.

        The information required by this item is contained under the sections of the information statement entitled "Management," "Executive Compensation" and "Certain Relationships and Related Person Transactions." Those sections are incorporated herein by reference.

Item 8.    Legal Proceedings.

        The information required by this item is contained under the section of the information statement entitled "Business—Legal Proceedings." That section is incorporated herein by reference.

Item 9.    Market Price of, and Dividends on, the Registrant's Common Equity and Related Stockholder Matters.

        The information required by this item is contained under the sections of the information statement entitled "Risk Factors," "Dividend Policy," "Capitalization," "The Separation and Distribution" and "Description of Bioverativ's Capital Stock." Those sections are incorporated herein by reference.

Item 10.    Recent Sales of Unregistered Securities.

        The information required by this item is contained under the section of the information statement entitled "Description of Bioverativ's Capital Stock—Sale of Unregistered Securities." That section is incorporated herein by reference.

Item 11.    Description of Registrant's Securities to be Registered.

        The information required by this item is contained under the sections of the information statement entitled "Risk Factors," "Dividend Policy," "Capitalization," "The Separation and Distribution" and "Description of Bioverativ's Capital Stock." Those sections are incorporated herein by reference.

Item 12.    Indemnification of Directors and Officers.

        The information required by this item is contained under the section of the information statement entitled "Description of Bioverativ's Capital Stock—Limitations on Liability and Indemnification of Officers and Directors." That section is incorporated herein by reference.

Item 13.    Financial Statements and Supplementary Data.

        The information required by this item is contained under the section of the information statement entitled "Index to Financial Statements" and the financial statements referenced therein. That section is incorporated herein by reference.

Item 14.    Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

        None.

Item 15.    Financial Statements and Exhibits.

(a)
Financial Statements

        The information required by this item is contained under the section of the information statement entitled "Index to Financial Statements" and the financial statements referenced therein. That section is incorporated herein by reference.


(b)
Exhibits

        The following documents are filed as exhibits hereto:

Exhibit
Number
  Exhibit Description
  2.1   Form of Separation Agreement by and between Biogen Inc. and Bioverativ Inc.**^

 

2.2

 

Form of Transition Services Agreement by and between Biogen Inc. and Bioverativ Inc.**^

 

2.3

 

Form of Tax Matters Agreement by and between Biogen Inc. and Bioverativ Inc.***^

 

2.4

 

Form of Manufacturing and Supply Agreement by and between Biogen Inc. and Bioverativ Inc.**^

 

2.5

 

Form of Employee Matters Agreement by and between Biogen Inc. and Bioverativ Inc.**

 

2.6

 

Form of Intellectual Property License Agreement by and between Biogen Inc. and Bioverativ Inc.**^

 

3.1

 

Form of Amended and Restated Certificate of Incorporation of Bioverativ Inc.**

 

3.2

 

Form of Amended and Restated Bylaws of Bioverativ Inc.**

 

10.6

 

Second Amended and Restated Development and Commercialization Agreement between Bioverativ Therapeutics Inc. (formerly Biogen Idec Hemophilia Inc.) and Swedish Orphan Biovitrum AB (publ), dated April 10, 2014**#

 

10.7

 

Amendment No. 1 to Second Amended and Restated Development and Commercialization Agreement between Bioverativ Therapeutics Inc. (formerly Biogen Idec Hemophilia, Inc.) and Swedish Orphan Biovitrum AB (publ), dated August 13, 2014***

 

10.8

 

Amendment No. 2 to Second Amended and Restated Development and Commercialization Agreement between Bioverativ Therapeutics Inc. (formerly Biogen Idec Hemophilia, Inc.) and Swedish Orphan Biovitrum AB (publ), dated June 25, 2015***

 

10.9

 

Form of Indemnification Agreement between Bioverativ Inc. and individual directors and officers***+

 

10.10

 

Letter regarding employment arrangement of John G. Cox dated May 19, 2016***+

 

10.11

 

Letter regarding employment arrangement of John Greene dated October 28, 2016***+

 

10.12

 

Letter regarding employment arrangement of Rogério Vivaldi, M.D. dated September 28, 2016***+

 

21.1

 

Subsidiaries of Bioverativ Inc.**

 

99.1

 

Information Statement of Bioverativ Inc., preliminary and subject to completion, dated December 20, 2016**

 

99.2

 

Form of Notice of Internet Availability of Information Statement Materials***

**
Filed herewith.

***
Previously filed.

#
Certain provisions of this exhibit have been omitted pursuant to a request for confidential treatment.

+
Management contract or compensatory plan or arrangement.

^
Schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The registrant hereby undertakes to furnish copies of any of the omitted schedules and exhibits upon request by the U.S. Securities and Exchange Commission.


SIGNATURES

Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized.

    BIOVERATIV INC.

 

 

By:

 

/s/ JOHN G. COX

        Name:   John G. Cox
        Title:   Chief Executive Officer

Date: December 20, 2016




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BIOVERATIV INC. INFORMATION REQUIRED IN REGISTRATION STATEMENT CROSS-REFERENCE SHEET BETWEEN INFORMATION STATEMENT AND ITEMS OF FORM 10
SIGNATURES

Exhibit 2.1

 

Form of

 

SEPARATION AGREEMENT

 

by and between

 

BIOGEN INC.

 

and

 

BIOVERATIV INC.

 

Dated as of [ · ],[ · ]

 



 

TABLE OF CONTENTS

 

 

 

 

Page

 

 

 

 

Article I

 

DEFINITIONS AND INTERPRETATION

 

 

 

 

Section 1.1

General

 

2

Section 1.2

References; Interpretation

 

15

 

 

 

 

Article II

 

THE SEPARATION

 

 

 

 

Section 2.1

General

 

16

Section 2.2

Restructuring: Transfer of Assets; Assumption of Liabilities

 

16

Section 2.3

Treatment of Shared Contracts

 

18

Section 2.4

Intercompany Accounts

 

19

Section 2.5

Limitation of Liability

 

19

Section 2.6

Transfers Not Effected at or Prior to the Distribution Effective Time; Transfers Deemed Effective as of the Distribution Effective Time

 

20

Section 2.7

Further Assurances

 

22

Section 2.8

Novation of Biogen Retained Liabilities; Indemnification

 

23

Section 2.9

Novation of Bioverativ Liabilities; Indemnification

 

24

Section 2.10

Disclaimer of Representations and Warranties

 

25

Section 2.11

Cash Management

 

26

 

 

 

 

Article III

 

CERTAIN ACTIONS AT OR PRIOR TO THE DISTRIBUTION

 

 

 

 

Section 3.1

Transaction Agreements

 

26

 

 

 

 

Article IV

 

THE DISTRIBUTION

 

 

 

 

Section 4.1

Stock Dividend; Distribution

 

26

Section 4.2

Fractional Shares

 

27

Section 4.3

Actions in Connection with the Distribution

 

27

Section 4.4

Sole Discretion of Biogen

 

28

Section 4.5

Conditions to Distribution

 

28

 

i



 

Article V

 

CERTAIN COVENANTS

 

 

 

 

Section 5.1

Non-Solicit; Non-Hire

 

29

Section 5.2

Certain Restrictions

 

30

Section 5.3

No Right to Use Regulatory Information

 

31

Section 5.4

Use of Retained Names and Marks

 

32

 

 

 

 

Article VI

 

INDEMNIFICATION

 

 

 

 

Section 6.1

Release of Pre-Distribution Claims

 

34

Section 6.2

Indemnification by Biogen

 

37

Section 6.3

Indemnification by Bioverativ

 

37

Section 6.4

Procedures for Indemnification

 

37

Section 6.5

Indemnification Obligations Net of Insurance Proceeds and Other Amounts

 

40

Section 6.6

Contribution

 

41

Section 6.7

Additional Matters; Survival of Indemnities

 

41

 

 

 

 

Article VII

 

PRESERVATION OF RECORDS; ACCESS TO INFORMATION; CONFIDENTIALITY; PRIVILEGE

 

 

 

 

Section 7.1

Preservation of Information

 

42

Section 7.2

Financial Statements and Accounting

 

43

Section 7.3

Provision of Information

 

43

Section 7.4

Witness Services; Cooperation

 

45

Section 7.5

Reimbursement; Other Matters

 

45

Section 7.6

Confidentiality

 

45

Section 7.7

Privilege Matters

 

47

Section 7.8

Ownership of Information

 

50

Section 7.9

Other Agreements

 

50

 

 

 

 

Article VIII

 

DISPUTE RESOLUTION

 

 

 

 

Section 8.1

Negotiation

 

50

Section 8.2

Continuity of Service and Performance

 

51

 

ii



 

Article IX

 

INSURANCE MATTERS

 

 

 

 

Section 9.1

Rights to Biogen Policies

 

51

Section 9.2

Claims

 

52

 

 

 

 

Article X

 

MISCELLANEOUS

 

 

 

 

Section 10.1

Complete Agreement; Construction

 

52

Section 10.2

Transaction Agreements

 

53

Section 10.3

Counterparts

 

53

Section 10.4

Survival of Agreements

 

53

Section 10.5

Fees, Costs and Expenses

 

53

Section 10.6

Notices

 

54

Section 10.7

Waivers

 

54

Section 10.8

Assignment

 

54

Section 10.9

Successors and Assigns

 

54

Section 10.10

Termination and Amendment

 

54

Section 10.11

Payment Terms

 

55

Section 10.12

Specific Performance

 

55

Section 10.13

Subsidiaries

 

56

Section 10.14

Third Party Beneficiaries

 

56

Section 10.15

Titles and Headings

 

56

Section 10.16

Exhibits and Schedules

 

56

Section 10.17

Governing Law

 

56

Section 10.18

Consent to Jurisdiction

 

56

Section 10.19

Waiver of Jury Trial

 

57

Section 10.20

Severability

 

57

Section 10.21

Public Announcements

 

57

Section 10.22

Interpretation

 

58

Section 10.23

No Duplication; No Double Recovery

 

58

Section 10.24

No Waiver

 

58

Section 10.25

No Admission of Liability

 

58

 

List of Exhibits

 

Exhibit A

Employee Matters Agreement

Exhibit B

IP License Agreement

Exhibit C

Manufacturing and Supply Agreement

Exhibit D

Tax Matters Agreement

Exhibit E

Transition Services Agreement

 

iii



 

List of Schedules

 

Schedule 1.1(12)(ii)(1)

Registered Bioverativ Intellectual Property

Schedule 1.1(12)(ii)(2)

Other Bioverativ Intellectual Property

Schedule 1.1(12)(vii)

Bioverativ Contracts

Schedule 1.1(12)(xiii)

Other Bioverativ Assets

Schedule 1.1(12)(xiv)

Bioverativ Real Property

Schedule 1.1(12)(xv)

Bioverativ I/T Assets

Schedule 1.1(14)

Description of Bioverativ Discovery and Research and Development Projects

Schedule 1.1(19)(vii)

Other Bioverativ Liabilities

Schedule 1.1(19)(ix)

Bioverativ Actions

Schedule 1.1(20)

Bioverativ Products

Schedule 1.1(35)(i)

Excluded Manufacturing Related Assets

Schedule 1.1(35)(ii)

Excluded Intellectual Property

Schedule 1.1(35)(iii)

Excluded Contracts

Schedule 1.1(36)(i)

Excluded Liabilities

Schedule 1.1(36)(ii)

Biogen Distribution Disclosure Document Liabilities

Schedule 2.3(a)

Shared Contracts

Schedule 2.5

Contracts Surviving Separation

 

iv



 

Index of Defined Terms

 

Defined Term

 

Section

 

 

 

Action

 

1.1(1)

Affiliate

 

1.1(2)

Agreement

 

Preamble

Ancillary Agreements

 

1.1(3)

Assets

 

1.1(4)

Assume

 

2.2(b)(iii)

Biogen

 

Preamble

Biogen Claim

 

6.3

Biogen Common Stock

 

1.1(5)

Biogen Designees

 

1.1(6)

Biogen Group

 

1.1(7)

Biogen Indemnitees

 

1.1(8)

Biogen Released Liabilities

 

6.1(a)(i)

Biogen Retained Assets

 

1.1(9)

Biogen Retained Business

 

1.1(10)

Biogen Retained Liabilities

 

1.1(11)

Bioverativ

 

Preamble

Bioverativ Assets

 

1.1(12)

Bioverativ Balance Sheet

 

1.1(13)

Bioverativ Business

 

1.1(14)

Bioverativ Claim

 

6.2

Bioverativ Common Stock

 

1.1(15)

Bioverativ Designees

 

1.1(16)

Bioverativ Group

 

1.1(17)

Bioverativ Indemnitees

 

1.1(18)

Bioverativ Liabilities

 

1.1(19)

Bioverativ Records

 

1.1(12)(xii)

Bioverativ Released Liabilities

 

6.1(a)(ii)

Board

 

Recitals

Business Day

 

1.1(21)

Claiming Party

 

6.4(b)

Commission

 

1.1(22)

Confidential Information

 

1.1(23)

Consents

 

1.1(24)

Contract

 

1.1(25)

Conveyancing and Assumption Instruments

 

1.1(26)

Copyrights

 

1.1(48)

Delaware Courts

 

10.18

Direct Claim

 

6.4(b)

Dispute Notice

 

8.1

Disputes

 

8.1

Distribution

 

Recitals

Distribution Agent

 

1.1(27)

 

v



 

Distribution Date

 

1.1(28)

Distribution Disclosure Documents

 

1.1(29)

Distribution Effective Time

 

1.1(30)

Distribution Ratio

 

1.1(31)

DMF Business

 

1.1(32)

Employee Matters Agreement

 

1.1(33)

Exchange Act

 

1.1(34)

Excluded Assets

 

1.1(35)

Excluded Liabilities

 

1.1(36)

Field of MS

 

1.1(37)

Field of Non-Malignant Hematology

 

1.1(38)

Final Determination

 

1.1(39)

Form 10

 

1.1(40)

Governmental Entity

 

1.1(41)

Group

 

1.1(42)

Indemnifiable Losses

 

1.1(43)

Indemnifying Party

 

1.1(44)

Indemnitee

 

1.1(45)

Indemnity Payment

 

6.5(a)

Information Statement

 

1.1(46)

Insurance Proceeds

 

1.1(47)

Intellectual Property

 

1.1(48)

Intercompany Account

 

1.1(49)

Internal Reorganization

 

1.1(50)

IP License Agreement

 

1.1(51)

Know-How

 

1.1(48)

Law

 

1.1(52)

Liabilities

 

1.1(53)

Manufacturing and Supply Agreement

 

1.1(54)

NASDAQ

 

1.1(55)

Negotiation Period

 

8.1

Parties

 

Preamble

Party

 

Preamble

Patents

 

1.1(48)

Person

 

1.1(56)

Policies

 

1.1(57)

Prime Rate

 

1.1(58)

Privilege

 

1.1(59)

Privileged Information

 

8.17(b)

Products

 

1.1(20)

Record Date

 

1.1(60)

Registered

 

1.1(61)

Regulatory Authorization Date

 

1.1(62)

Representatives

 

1.1(63)

Securities Act

 

1.1(64)

Security Interest

 

1.1(65)

 

vi



 

Separation

 

Recitals

Shared Contract

 

1.1(64)

Shared Privileged Information

 

7.7(b)(i)

Subsidiary

 

1.1(67)

Tax

 

1.1(68)

Tax Contest

 

1.1(69)

Tax Matters Agreement

 

1.1(70)

Tax Opinion

 

4.5(c)

Tax Returns

 

1.1(71)

Taxing Authority

 

1.1(72)

Third Party

 

1.1(73)

Third Party Agreements

 

1.1(74)

Third Party Claim

 

6.4(b)

Third Party Proceeds

 

6.5(a)

Trademarks

 

1.1(48)

Transaction Agreement

 

1.1(75)

Transfer

 

2.2(b)(i)

Transition Services Agreement

 

1.1(76)

 

vii


 

SEPARATION AGREEMENT

 

This SEPARATION AGREEMENT (this “ Agreement ”), dated as of [ · ],[ · ], is entered into by and between Biogen Inc. (“ Biogen ”), a Delaware corporation, and Bioverativ Inc. (“ Bioverativ ”), a Delaware corporation and a wholly owned subsidiary of Biogen. “ Party ” or “ Parties ” means Biogen or Bioverativ, individually or collectively, as the case may be.  Each capitalized term used and not elsewhere defined herein has the meaning set forth in Section 1.1 .

 

W I T N E S S E T H:

 

WHEREAS, Biogen, acting together with its Subsidiaries, currently conducts the Biogen Retained Business and the Bioverativ Business;

 

WHEREAS, the Board of Directors of Biogen (the “ Board ”) has determined that it is appropriate, desirable and in the best interests of Biogen and its stockholders to separate Biogen into two separate, publicly traded companies, one for each of (i) the Biogen Retained Business, which shall be owned and conducted, directly or indirectly, by Biogen and its Subsidiaries and (ii) the Bioverativ Business, which shall be owned and conducted, directly or indirectly, by Bioverativ and its Subsidiaries (the “ Separation ”);

 

WHEREAS, as part of and to implement the Separation, Biogen shall cause the Distribution Agent to issue pro rata to the Record Holders pursuant to the Distribution Ratio, all of the issued and outstanding shares of Bioverativ Common Stock (such issuance, the “ Distribution ”) on the terms and conditions set forth in this Agreement;

 

WHEREAS, it is appropriate and desirable to set forth the principal corporate transactions required to effect the Separation and certain other agreements relating to the relationship of Biogen and Bioverativ and their respective Subsidiaries following the Distribution;

 

WHEREAS, (i) the Board has (x) determined that the Separation and the other transactions contemplated by this Agreement and the Ancillary Agreements (as defined below) have a valid business purpose, are in furtherance of and consistent with its business strategy and are in the best interests of Biogen and its stockholders and (y) approved this Agreement and each of the Ancillary Agreements and (ii) the board of directors of Bioverativ has approved this Agreement and each of the Ancillary Agreements to which Bioverativ is a party;

 

WHEREAS, it is the intention of the Parties that the Separation will qualify as a transaction that is tax-free for U.S. federal income tax purposes under Section 355 and Section 368(a)(1)(D) of the Internal Revenue Code of 1986; and

 

WHEREAS, this Agreement is intended to be a “plan of reorganization” within the meaning of Treas. Reg. Section 1.368-2(g);

 

NOW, THEREFORE, in consideration of the foregoing and the mutual agreements, provisions and covenants contained in this Agreement, the Parties hereby agree as follows:

 



 

ARTICLE I

 

DEFINITIONS AND INTERPRETATION

 

Section 1.1                                     General . As used in this Agreement, the following terms shall have the following meanings:

 

(1)                                  Action ” means any demand, action, claim, suit, countersuit, arbitration, inquiry, subpoena, case, litigation, proceeding or investigation (whether civil, criminal, administrative or investigative) by or before any court or grand jury, any Governmental Entity or any arbitration or mediation tribunal.

 

(2)                                  Affiliate ” means, when used with respect to a specified Person and at a point in, or with respect to a period of, time, a Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such specified Person at such point in or during such period of time.  For the purposes of this definition, “control”, when used with respect to any specified Person means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities or other interests, by Contract or otherwise.  It is expressly agreed that no Party or member of its Group shall be deemed to be an Affiliate of the other Party or a member of such other Party’s Group solely by reason of having common stockholders or one or more directors in common or by reason of having been under common control of Biogen prior to the Distribution Effective Time.

 

(3)                                  Ancillary Agreements ” means the Transaction Agreements other than this Agreement, all Conveyancing and Assumption Instruments and any and all other agreements entered into by the Parties or members of their respective Groups (but as to which no Third Party is a party) in connection with the Separation or the other transactions contemplated by the Transaction Agreements.

 

(4)                                  Assets ” means all rights, title and ownership interests in and to all rights, properties, claims, Contracts, businesses, or assets (including goodwill), wherever located (including in the possession of vendors or other third parties or elsewhere), of every kind, character and description, whether real, personal or mixed, tangible or intangible, whether accrued, contingent or otherwise, in each case, whether or not recorded or reflected on the books and records or financial statements of any Person.  Except as otherwise specifically set forth herein or in the Tax Matters Agreement, the rights and obligations of the Parties with respect to Taxes shall be governed by the Tax Matters Agreement and, therefore, Taxes (including any Tax items, attributes or rights to receive any Tax Refunds (as defined in the Tax Matters Agreement)) shall not be treated as Assets governed by this Agreement.

 

(5)                                  Biogen Common Stock ” means the common stock of Biogen, par value $0.0005 per share.

 

2



 

(6)                                  Biogen Designees ” shall mean any and all entities (including corporations, general or limited partnerships, trusts, joint ventures, unincorporated organizations, limited liability entities or other entities) designated by Biogen and that will be members of the Biogen Group as of immediately prior to the Distribution Effective Time.  For clarity, members of the Biogen Group party to any Conveyancing and Assumption Instrument shall be a Biogen Designee for purposes of this Agreement.

 

(7)                                  Biogen Group ” means (a) prior to the Distribution Effective Time, Biogen and each entity that will be a Subsidiary of Biogen immediately following the Distribution Effective Time and (b) from and after the Distribution Effective Time, Biogen and each entity that is a Subsidiary of Biogen.

 

(8)                                  Biogen Indemnitees ” means the members of the Biogen Group and their respective past, present and future directors, officers, employees and agents, in each case in their respective capacities as such, and each of the heirs, executors, administrators, successors and assigns of any of the foregoing.

 

(9)                                  Biogen Retained Assets ” means (i) any and all Assets of Biogen or any of its Subsidiaries that are not Bioverativ Assets and, after the Distribution Effective Time, any and all Assets that are acquired or otherwise become Assets of any member of the Biogen Group and (ii) any Assets that are held by the Bioverativ Group or the Biogen Group immediately prior to the Distribution Effective Time not exclusively related to the Bioverativ Business that were inadvertently omitted or assigned that, had the Parties given specific consideration to such Assets as of the date of this Agreement, would have otherwise been classified as a Biogen Retained Asset based on the principles set forth in this Section 1.1(9); provided , that no Asset shall be a Biogen Retained Asset solely as a result of this clause (ii) unless a claim with respect thereto is made by Biogen on or prior to the date that is fifteen (15) months after the Distribution Date.  For clarity, Biogen Retained Assets shall include all Excluded Assets.

 

(10)                           Biogen Retained Business ” means those businesses, operations and activities of Biogen or any of its Subsidiaries (whether or not such businesses, operations or activities are or have been terminated, divested or discontinued) other than the Bioverativ Business and, after the Distribution Effective Time, those entities or businesses acquired or established by or for any member of the Biogen Group.

 

(11)                           Biogen Retained Liabilities ” means (i) all Liabilities of Biogen or any of its Subsidiaries that are not Bioverativ Liabilities, and, after the Distribution Effective Time, all Liabilities of each member of the Biogen Group and (ii) any and all other Liabilities of Biogen or any of its Subsidiaries immediately prior to the Distribution Effective Time that were inadvertently omitted or assigned that, had the Parties given specific consideration to such Liabilities as of the date of this Agreement, would have otherwise been classified as a Biogen Retained Liability based on the principles set forth in this Section 1.1(11); provided , that no Liability shall be a Biogen Retained Liability solely as a result of this clause (ii) unless a claim with respect thereto is made by Biogen or Bioverativ on or prior to the date that is fifteen (15) months after the Distribution Date.  For clarity, Biogen Retained Liabilities shall include all Excluded Liabilities.

 

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(12)                           Bioverativ Assets ” means the following, but in each case excluding the Excluded Assets:

 

(i)                                      all interests in the capital stock of, or any other equity interests in, the members of the Bioverativ Group held, directly or indirectly, by Biogen immediately prior to the Distribution Effective Time (other than the capital stock of Bioverativ);

 

(ii)                                   all Intellectual Property that is exclusively related to the Bioverativ Business, including the Registered Intellectual Property identified on Schedule 1.1(12)(ii)(1) and all Intellectual Property identified on Schedule 1.1(12)(ii)(2) ;

 

(iii)                                any and all Assets that are expressly allocated by this Agreement or any Ancillary Agreement (or the Schedules hereto or thereto) as Assets which have been or are to be retained by, or Transferred to, any member of the Bioverativ Group, including any and all cash and cash equivalents expressly allocated to Bioverativ pursuant to Section 2.11 ;

 

(iv)                               any and all Assets reflected on the Bioverativ Balance Sheet (including accounts receivable outstanding as of the Distribution Date but excluding cash and cash equivalents, the allocation of which shall be governed by Section 2.11 ) or the accounting records supporting such balance sheet, subject to any dispositions of any of such Assets subsequent to the date of the Bioverativ Balance Sheet;

 

(v)                                  any and all Assets acquired by or for any member of the Bioverativ Group subsequent to the date of the Bioverativ Balance Sheet which, had they been so acquired on or before such date and owned as of such date, would have been reflected on the Bioverativ Balance Sheet if prepared on a consistent basis, subject to any dispositions of any of such Assets subsequent to the date of the Bioverativ Balance Sheet;

 

(vi)                               all rights and claims of either Party or any of its Subsidiaries as of the Distribution Effective Time to the Bioverativ Products, including all rights and claims of either Party or any of its Subsidiaries as of the Distribution Effective Time to all clinical study data, reports and analyses, product registrations and applications and marketing registrations and applications (which shall include all United States Food and Drug Administration and other similar regulatory approvals and licenses related to, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for, a Bioverativ Product) to the extent related to the Bioverativ Products;

 

(vii)                            all Contracts to which either Party or any member of its Group is a party or by which it or any member of its Group or any of their respective Assets is bound, in each case, as of immediately prior to the Distribution Effective Time

 

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exclusively related to the Bioverativ Business and any rights or claims arising thereunder, including the Contracts listed on Schedule 1.1(12)(vii) ;

 

(viii)                         the portion of any Shared Contract that relates to the Bioverativ Business;

 

(ix)                               all transferable licenses, permits, registrations, approvals and authorizations of either Party or any of the members of its Group as of immediately prior to the Distribution Effective Time which have been issued by any Governmental Entity and which relate exclusively to, or are used exclusively in, the Bioverativ Business or the Bioverativ Assets, and any rights or claims arising thereunder;

 

(x)                                  any and all Bioverativ Product Drug Product (as defined in the Manufacturing and Supply Agreement) and Finished Goods (as defined in the Manufacturing and Supply Agreement) inventory held by or for the account of Biogen or any of its Subsidiaries immediately prior to the Distribution Effective Time;

 

(xi)                               all rights, claims, credits, causes of action or rights of set-off against Persons other than members of the Biogen Group relating exclusively to the Bioverativ Business or the Bioverativ Assets, including unliquidated rights under Third Party manufacturers’ and vendors’ warranties;

 

(xii)                            to the extent in the possession of any member of the Biogen Group or the Bioverativ Group immediately prior to the Distribution Effective Time (and other than Intellectual Property) (A) all business records to the extent exclusively related to the Bioverativ Assets or Bioverativ Liabilities, including the company minute books and related equity or membership records of the members of the Bioverativ Group, information and records used to demonstrate compliance with applicable Law and any other compliance records related to the Bioverativ Business; (B) all of the separate financial and property Tax records of the members of the Bioverativ Group that do not form part of the general ledger of any member of the Biogen Group; and (C) all other books, records, ledgers, files, documents, correspondence, lists, plats, drawings, photographs, product literature, equipment test records, advertising and promotional materials, distribution lists, customer lists, supplier lists, studies, reports, operating, production and other manuals, manufacturing and quality control records and procedures, research and development files, accounting and business books, records, files, documentation and materials, in all cases whether in paper, microfilm, microfiche, computer tape or disc, magnetic tape or any other form, to the extent exclusively related to the Bioverativ Business (collectively, the “ Bioverativ Records ”); provided , however , that: (x) Biogen shall be entitled to retain a copy of any and all Bioverativ Records; (y) Biogen shall be entitled to retain any materials in clauses (A) and (C) that are not reasonably practicable to identify and extract subject to the right of access pursuant to Section 7.3 ; and (z) Biogen shall be entitled to redact any portion of the Bioverativ Records to the extent related to any matter other than the

 

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Bioverativ Business; provided , however , that such retained materials shall be deemed Confidential Information of Bioverativ and subject to the provisions of Section 7.6 ;

 

(xiii)                         the Assets listed or described on Schedule 1.1(12)(xiii) (which for the avoidance of doubt is not a comprehensive listing of all Bioverativ Assets and is not intended to limit other clauses of this definition of “Bioverativ Assets”);

 

(xiv)                        the facilities and other real property listed or described on Schedule 1.1(12)(xiv) ;

 

(xv)                           all tangible equipment (including information technology, equipment and machinery), infrastructure, wires, supplies and other tangible property that is owned by, leased to or licensed to Biogen or any of its Subsidiaries immediately prior to the Distribution Effective Time and exclusively related to the Bioverativ Business, including the information technology Assets listed or described on Schedule 1.1(12)(xv) ;

 

(xvi)                        any and all other Assets that relate exclusively to or are used exclusively in the Bioverativ Business or exclusively related to a Bioverativ Asset that are held by the Bioverativ Group or the Biogen Group immediately prior to the Distribution Effective Time; and

 

(xvii)                     any and all other Assets that were inadvertently omitted or assigned that, had the Parties given specific consideration to such Assets as of the date of this Agreement, would have otherwise been classified as Bioverativ Assets based on the principles set forth in this Section 1.1(12) ; provided , that no Asset shall be a Bioverativ Asset solely as a result of this clause (xvii) unless a claim with respect thereto is made by Bioverativ on or prior to the date that is fifteen (15) months after the Distribution Date.

 

Notwithstanding the foregoing or anything to the contrary herein, “Bioverativ Asset” shall not include any rights or interests in or to any Intellectual Property except to the extent set forth in clause (ii) of this Section 1.1(12) (including the Schedules referred to in Section 1.1(12)(ii)).

 

(13)                           Bioverativ Balance Sheet ” means the pro forma balance sheet of the Bioverativ Group, including the notes thereto, as of [ · ],[ · ], as included in the Information Statement.

 

(14)                           Bioverativ Business ” means: (i) the business, operations and activities conducted at any time prior to the Distribution Effective Time by either Party or any of its Subsidiaries to the extent relating to, arising out of or resulting from the Bioverativ Products (including the discovery, research, development, importation, exportation, marketing, distribution, promotion and sale of such Bioverativ Products worldwide); and (ii) the business, operations and activities conducted at any time prior to the Distribution Effective Time by or on behalf of either Party or any of its Subsidiaries to the extent related to the discovery, research and development projects listed and

 

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described on Schedule 1.1(14) , including the operations and activities of any member of the Bioverativ Group conducted prior to the Distribution Effective Time relating to the foregoing.

 

(15)                           Bioverativ Common Stock ” means the common stock of Bioverativ, par value $0.001 per share.

 

(16)                           Bioverativ Designees ” means any and all entities (including corporations, general or limited partnerships, trusts, joint ventures, unincorporated organizations, limited liability entities or other entities) designated by Bioverativ and that will be members of the Bioverativ Group as of immediately prior to the Distribution Effective Time.

 

(17)                           Bioverativ Group ” means (a) Bioverativ and each entity that is a Subsidiary of Bioverativ or will be a Subsidiary of Bioverativ immediately following the Distribution Effective Time and (b) on and after the Distribution Effective Time, Bioverativ and each entity that is a Subsidiary of Bioverativ.  For clarity, members of the Bioverativ Group party to any Conveyancing and Assumption Instrument shall be a Bioverativ Designee for purposes of this Agreement.

 

(18)                           Bioverativ Indemnitees ” means the members of the Bioverativ Group and their respective past, present and future directors, officers, employees and agents, in each case in their respective capacities as such, each of the heirs, executors, administrators, successors and assigns of any of the foregoing.

 

(19)                           Bioverativ Liabilities ” means, without duplication, but in each case excluding the Excluded Liabilities:

 

(i)                                      any and all Liabilities to the extent relating to, arising out of or resulting from the conduct of the Bioverativ Business, as conducted at any time, including prior to, at or after the Distribution Effective Time (including any Liability to the extent relating to, arising out of or resulting from any act or failure to act by any director, officer, employee, agent or representative (whether or not such act or failure to act is or was within such Person’s authority) of the Bioverativ Group or the Biogen Group);

 

(ii)                                   any and all Liabilities to the extent relating to, arising out of or resulting from the conduct of any business by any member of the Bioverativ Group at any time after the Distribution Effective Time (including any Liability to the extent relating to, arising out of or resulting from any act or failure to act by any director, officer, employee, agent or representative (whether or not such act or failure to act is or was within such Person’s authority) of the Bioverativ Group);

 

(iii)                                any and all Liabilities to the extent relating to, arising out of or resulting from any Bioverativ Asset, whether arising before, on or after the Distribution Effective Time;

 

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(iv)                               any and all Liabilities that are expressly contemplated by this Agreement or any Ancillary Agreement (or the Schedules hereto or thereto) as Liabilities to be Assumed or retired or satisfied by any member of the Bioverativ Group;

 

(v)                                  any and all Liabilities reflected on the Bioverativ Balance Sheet or the accounting records supporting such balance sheet (including all outstanding accounts payable as of the Distribution Date) and any and all Liabilities incurred by or for Bioverativ or any member of the Bioverativ Group or Biogen Group subsequent to the date of the Bioverativ Balance Sheet which, had they been so incurred on or before such date, would have been reflected on the Bioverativ Balance Sheet if prepared on a consistent basis, subject to any discharge of any of such Liabilities subsequent to the date of the Bioverativ Balance Sheet; it being understood that (A) the Bioverativ Balance Sheet shall be used to determine the types of, and methodologies used to determine, those Liabilities that are included in the definition of Bioverativ Liabilities pursuant to this clause (v) ; and (B) the amounts set forth on the Bioverativ Balance Sheet with respect to any Liabilities shall not be treated as minimum amounts or limitations on the amount of such Liabilities that are included in the definition of Bioverativ Liabilities pursuant to this clause (v) ;

 

(vi)                               any and all Liabilities to the extent relating to, arising out of or resulting from the manufacture of Bioverativ Products prior to the Distribution Effective Time by any member of the Bioverativ Group or the Biogen Group;

 

(vii)                            the Liabilities listed or described on Schedule 1.1(19)(vii) ;

 

(viii)                         any and all Liabilities relating to, arising out of or resulting from any untrue statement or alleged untrue statement of a material fact or omission or alleged omission to state a material fact required to be stated therein or necessary to make the statement therein not misleading, with respect to all information contained in the Distribution Disclosure Documents, except to the extent specifically enumerated in clause (ii) of the definition of “Excluded Liabilities”;

 

(ix)                               any and all Liabilities arising directly or indirectly from Actions to the extent relating to the Bioverativ Assets, the Bioverativ Business or any Bioverativ Liability, including in respect of any alleged tort, breach of Contract, violation or noncompliance with Law or any licenses, permits, registrations, approvals and authorizations, whether arising prior to, on or after the Distribution Date, including the Actions listed on Schedule 1.1(19)(ix) ;

 

(x)                                  any and all other Liabilities that are held by the Bioverativ Group or the Biogen Group immediately prior to the Distribution Effective Time that were inadvertently omitted or assigned that, had the Parties given specific consideration to such Liabilities as of the date of this Agreement, would have otherwise been classified as a Bioverativ Liability based on the principles set forth in this Section 1.1(19) ; provided , that no Liability shall be a Bioverativ Liability

 

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solely as a result of this clause (x) unless a claim with respect thereto is made by Biogen or Bioverativ on or prior to the date that is fifteen (15) months after the Distribution Date.

 

(20)                           Bioverativ Products ” means the products described on Schedule 1.1(20) .

 

(21)                           Business Day ” means any day other than Saturday or Sunday and any other day on which commercial banking institutions located in New York, New York are required, or authorized by Law, to remain closed.

 

(22)                           Commission ” means the U.S. Securities and Exchange Commission.

 

(23)                           Confidential Information ” means, with respect to a Party, all confidential or proprietary information to the extent concerning: (i) such Party or any of its Subsidiaries, (ii) with respect to Bioverativ, the Bioverativ Business, any Bioverativ Assets or any Bioverativ Liabilities and (iii) with respect to Biogen, the Biogen Retained Business, any Biogen Retained Assets or any Biogen Retained Liabilities, in each case including any such information furnished pursuant to Article VII or otherwise pursuant to this Agreement or any Ancillary Agreement; provided , however , that “Confidential Information” shall not include any Information that is (i) in the public domain or known to the public through no fault of the receiving Party or any of its Subsidiaries, (ii) lawfully acquired after the Distribution Effective Time by the receiving Party or any of its Subsidiaries from Third Parties not known to be subject to confidentiality obligations with respect to such information or (iii) independently developed by the receiving Party or any of its Subsidiaries after the Distribution Effective Time without reference to any Confidential Information of the disclosing Party or any of its Subsidiaries.  For the avoidance of doubt, subject to the foregoing proviso, any information that Bioverativ receives from any Third Party Manufacturer (as defined in the Manufacturing and Supply Agreement) or other third party contractor retained by any member of the Biogen Group regarding its technology, products, business or objectives shall be deemed to be Confidential Information of Biogen, and any pricing or other information relating to the Drug Product (as defined in the Manufacturing and Supply Agreement) or Finished Goods (as defined in the Manufacturing and Supply Agreement) shall be deemed to be the Confidential Information of both Parties.

 

(24)                           Consents ” means any consents, waivers, notices, reports or other filings to be obtained from or made, including with respect to any Contract, or any registrations, licenses, permits, authorizations to be obtained from, or approvals from, or notification requirements to, any Third Parties, including any Governmental Entity.

 

(25)                           Contract ” means any agreement, contract, subcontract, obligation, binding understanding, note, indenture, instrument, option, lease, promise, arrangement, release, warranty, license, sublicense, insurance policy, benefit plan, purchase order or legally binding commitment or undertaking of any nature (whether written or oral and whether express or implied).

 

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(26)                           Conveyancing and Assumption Instruments ” means, collectively, the various Contracts (other than any Transaction Agreement) by and between or among any member(s) of the Biogen Group, on one hand, and any member(s) of the Bioverativ Group, on the other hand, including related local asset transfer agreements or intellectual property assignment agreements and other documents entered into prior to the Distribution Effective Time and to be entered into, in each case to effect the Transfer of Assets and the Assumption of Liabilities in the manner contemplated by the Transaction Agreements, in such form or forms as the applicable parties thereto agree.

 

(27)                           Distribution Agent ” means Computershare Trust Company, N.A.

 

(28)                           Distribution Date ” means the date, as shall be determined by the Board, on which the Distribution occurs.

 

(29)                           Distribution Disclosure Documents ” means the Form 10 and all exhibits thereto (including the Information Statement), any current reports on Form 8-K and the registration statement on Form S-8 related to securities to be offered under Bioverativ’s employee benefit plans, in each case as filed or furnished by Bioverativ with or to the Commission in connection with the Distribution and including any amendments or supplements thereto.

 

(30)                           Distribution Effective Time ” means [ · ], Eastern time, on the Distribution Date.

 

(31)                           Distribution Ratio ” means [ · ] share(s) of Bioverativ Common Stock for every [ · ] share(s) of Biogen Common Stock.

 

(32)                           DMF Business ” means discovering, researching, developing, importing, exporting, manufacturing, marketing, distributing, promoting or selling anywhere in the world any pharmaceutical product that contains dimethyl fumarate.

 

(33)                           Employee Matters Agreement ” means the Employee Matters Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit A .

 

(34)                           Exchange Act ” means the Securities Exchange Act of 1934.

 

(35)                           Excluded Assets ” means: (i) the manufacturing related Assets listed or described on Schedule 1.1(35)(i) ; (ii) the Intellectual Property listed or described on Schedule 1.1(35)(ii) ; (iii) the Contracts listed or described on Schedule 1.1(35)(iii) ; (iv) all cash and cash equivalents, except to the extent expressly allocated to the Bioverativ Group pursuant to Section 2.11 ; (v) any and all Bioverativ Product Drug Substance (as defined in the Manufacturing and Supply Agreement) inventory and other raw materials used in the manufacture of Bioverativ Product Drug Product (as defined in the Manufacturing and Supply Agreement) held by or for the account of Biogen or any of its Subsidiaries immediately prior to the Distribution Effective Time; (vi) subject to the rights of the Bioverativ Group pursuant to Article IX , all Policies binders and claims and rights thereunder and all prepaid insurance premiums (other than any insurance policies

 

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acquired prior to the Distribution Effective Time directly by and in the name of Bioverativ or a member of the Bioverativ Group); (vii) any and all work papers of Biogen’s auditors and any other Tax records (including accounting records) of any Biogen Group member (which will be addressed in the Tax Matters Agreement); and (viii) any and all Assets that are expressly contemplated by this Agreement or any Ancillary Agreement (or the Schedules hereto or thereto) as Assets which have been or are to be retained by, or Transferred to, any member of the Biogen Group.

 

(36)                           Excluded Liabilities ” means (i) the Liabilities listed or described on Schedule 1.1(36)(i) , (ii) with respect to all information contained in the Distribution Disclosure Documents, any and all Liabilities relating to, arising out of or resulting from any untrue statement or alleged untrue statement of a material fact or omission or alleged omission to state a material fact required to be stated therein or necessary to make the statement therein not misleading described in the sections of the Distribution Disclosure Documents referenced in Schedule 1.1(36)(ii) that is expressly related to the Biogen Group and not related to the Bioverativ Group or the Bioverativ Business and (iii) any and all Liabilities to the extent expressly contemplated by this Agreement or by any Ancillary Agreement (or the Schedules hereto or thereto) as Liabilities to be Assumed or discharged by any member of the Biogen Group.

 

(37)                           Field of Hemoglobinopathies ” means the diagnosis, prevention, or treatment of any of the following indications: hemoglobinopathies, hemophilia, sickle cell, thalassemia, anemias, myelodysplastic syndrome, myelofibrosis, agranulocytosis, Von Willebrand disease and Wiskott-Aldrich syndrome.

 

(38)                           Field of MS ” means the diagnosis, prevention, or treatment of multiple sclerosis.

 

(39)                           Final Determination ” has the meaning set forth in the Tax Matters Agreement.

 

(40)                           Form 10 ” means the registration statement on Form 10 (Registration No. 001-37859) filed by Bioverativ with the Commission under the Exchange Act in connection with the Distribution, including any amendment or supplement thereto.

 

(41)                           Governmental Entity ” means any nation or government, any state, municipality or other political subdivision thereof and any entity, body, agency, commission, department, board, bureau or court, whether domestic, foreign, multinational, or supranational exercising executive, legislative, judicial, regulatory, self-regulatory or administrative functions of or pertaining to government and any executive official thereof.

 

(42)                           Group ” means (a) with respect to Biogen, the Biogen Group and (b) with respect to Bioverativ, the Bioverativ Group, as the context requires.

 

(43)                           Indemnifiable Losses ” means any and all Liabilities, including damages, losses, deficiencies, obligations, penalties, judgments, settlements, claims,

 

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payments, fines and other costs and expenses of any and all Actions and demands, assessments, judgments, settlements and compromises relating thereto and the reasonable fees and expenses of attorneys’, accountants’, consultants’ and other professionals’ incurred in the investigation or defense thereof or the enforcement of rights hereunder.

 

(44)                           Indemnifying Party ” means, with respect to any Direct Claim or Third Party Claim, the Party which is or may be required pursuant to Article VI to provide indemnification pursuant to such claim.

 

(45)                           Indemnitee ” means, with respect to any Direct Claim or Third Party Claim, the Biogen Indemnitee or Bioverativ Indemnitee, as the case may be, that may be entitled to indemnification hereunder with respect to such claim.

 

(46)                           Information Statement ” means the Information Statement attached as Exhibit 99.1 to the Form 10, to be distributed or made available to the holders of shares of Biogen Common Stock in connection with the Distribution, including any amendment or supplement thereto.

 

(47)                           Insurance Proceeds ” means those monies (a) received by an insured from a Third Party insurance carrier or (b) paid by a Third Party insurance carrier on behalf of an insured, in either case net of any applicable deductible or retention.

 

(48)                           Intellectual Property ” means all intellectual property, whether registered or unregistered, of every kind and description throughout the world, including all U.S. and non-U.S.: (i) trademarks, trade dress, service marks, certification marks, logos, slogans, design rights, names, corporate names, trade names, Internet domain names, social media accounts and addresses and other similar designations of source or origin, together with the goodwill symbolized by any of the foregoing (collectively, “ Trademarks ”); (ii) patents and patent applications, and any and all related national or international counterparts thereto and utility models, including any divisionals, continuations, continuations-in-part, reissues, reexaminations, substitutions and extensions thereof (including supplementary protection certificates) (collectively, “ Patents ”); (iii) copyrights and copyrightable subject matter, excluding Know-How (collectively, “ Copyrights ”); (iv) rights in Software; (v) trade secrets, and all other confidential or proprietary information, know-how, clinical data, non-clinical data, pre-clinical data, in-vitro data, inventions, processes, formulae and methodologies, excluding Patents (collectively, “ Know-How ”); (vi) all applications and registrations for the foregoing; and (vii) all rights and remedies against past, present, and future infringement, misappropriation, or other violation thereof.

 

(49)                           Intercompany Account ” means any receivable, payable or loan between any member of the Biogen Group, on the one hand, and any member of the Bioverativ Group, on the other hand, except for any such receivable, payable or loan that arises pursuant to this Agreement or any Ancillary Agreement.

 

(50)                           Internal Reorganization ” means the allocation and transfer or assignment of Assets and Liabilities, including by means of the Conveyance and

 

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Assumption Instruments, resulting in (a) the Bioverativ Group owning and operating the Bioverativ Business, and (b) the Biogen Group continuing to own and operate the Biogen Retained Business, as described in the steps plan provided to Bioverativ by Biogen prior to the date hereof, as updated from time to time by Biogen at its sole discretion prior to the Distribution.

 

(51)                           IP License Agreement ” means the Intellectual Property License Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit B .

 

(52)                           Law ” means any applicable U.S. or non-U.S. federal, national, supranational, state, provincial, local or similar statute, law, ordinance, regulation, rule, code, income tax treaty, order, requirement or rule of law (including common law) or other binding directives promulgated, issued, entered into or taken by any Governmental Entity.

 

(53)                           Liabilities ” means any and all indebtedness, liabilities, costs, expenses, interest and obligations, whether accrued or fixed, absolute or contingent, matured or unmatured, known or unknown, reserved or unreserved, or determined or determinable, including those arising under any Law, Action, or in connection with any dispute, whether asserted or unasserted, or order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Entity and those arising under any Contract or any fines, damages or equitable relief which may be imposed and including all costs and expenses related thereto.  Except as otherwise specifically set forth herein or in the Tax Matters Agreement, the rights and obligations of the Parties with respect to Taxes shall be governed by the Tax Matters Agreement and, therefore, Taxes shall not be treated as Liabilities governed by this Agreement.

 

(54)                           Manufacturing and Supply Agreement ” means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C .

 

(55)                           NASDAQ ” means the Nasdaq Stock Market LLC.

 

(56)                           Person ” mean an individual, a general or limited partnership, a corporation, a trust, a joint venture, an unincorporated organization, a limited liability entity, any other entity and any Governmental Entity.

 

(57)                           Policies ” means insurance policies and insurance contracts of any kind (other than life and benefits policies or contracts), including primary, excess and umbrella policies, commercial general liability policies, fiduciary liability, directors and officers liability, product liability, automobile, property and casualty, workers’ compensation and employee dishonesty insurance policies and bonds, together with the rights, benefits and privileges thereunder.

 

(58)                           Prime Rate ” means the “prime rate” as published in The Wall Street Journal , Eastern Edition.

 

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(59)                           Privilege ” means all privileges, immunities or other protections from disclosure which may be asserted under applicable Law, including attorney-client privilege, business strategy privilege, joint defense privilege, common interest privilege and protection under the work-product doctrine.

 

(60)                           Record Date ” means [ · ],[ · ], as determined by the Board as the record date for determining the holders of record of Biogen Common Stock entitled to receive Bioverativ Common Stock in the Distribution.

 

(61)                           Registered ” means issued by, registered or filed with, renewed by or the subject of a pending application before any Governmental Authority or Internet domain name registrar.

 

(62)                           Regulatory Authorization Date ” means the date of receipt by the Bioverativ Group of all of the US Required Regulatory Authorizations and the Canadian Required Regulatory Authorization, each as defined in the Transition Services Agreement.

 

(63)                           Representatives ” means with respect to any Person, any of such Person’s directors, officers, employees, agents, consultants, advisors, accountants, attorneys or other representatives.

 

(64)                           Securities Act ” means the Securities Act of 1933.

 

(65)                           Security Interest ” means any mortgage, security interest, pledge, lien, charge, claim, option, right to acquire, voting or other restriction, right-of-entry, covenant, condition, easement, encroachment, restriction on transfer, or other encumbrance of any nature whatsoever, excluding restrictions on transfer under securities Laws.

 

(66)                           Shared Contract ” means the Contracts listed or described on Schedule 2.3(a) .

 

(67)                           Subsidiary ” means with respect to any Person (i) a corporation, fifty percent (50%) or more of the voting or capital stock of which is, as of the time in question, directly or indirectly owned by such Person and (ii) any other Person in which such Person, directly or indirectly, owns fifty percent (50%) or more of the equity or economic interest thereof or has the power to elect or direct the election of fifty percent (50%) or more of the members of the governing body of such Person.

 

(68)                           Tax ” or “ Taxes ” has the meaning set forth in the Tax Matters Agreement.

 

(69)                           Tax Contest ” has the meaning as set forth in the Tax Matters Agreement.

 

(70)                           Tax Matters Agreement ” means the Tax Matters Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit D .

 

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(71)                           Tax Returns ” has the meaning set forth in the Tax Matters Agreement.

 

(72)                           Taxing Authority ” has the meaning set forth in the Tax Matters Agreement.

 

(73)                           Third Party ” means any Person other than the Parties or any of their respective Subsidiaries.

 

(74)                           Third Party Agreements ” means any Contract between or among a Party (or any member of its Group) and any Third Party (it being understood that to the extent that the rights and obligations of the Parties and the members of their respective Groups under any such Contracts constitute Bioverativ Assets or Bioverativ Liabilities, or Biogen Retained Assets or Biogen Retained Liabilities, such Contracts shall be assigned or retained pursuant to Article II ).

 

(75)                           Transaction Agreement ” means any of this Agreement, the Employee Matters Agreement, the IP License Agreement, the Manufacturing and Supply Agreement, the Tax Matters Agreement and the Transition Services Agreement.

 

(76)                           Transition Services Agreement ” means the Transition Services Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit E .

 

Section 1.2                                     References; Interpretation . References in this Agreement to any gender include references to all genders, and references to the singular include references to the plural and vice versa.  Unless the context otherwise requires, the words “include”, “includes” and “including” when used in this Agreement shall be deemed to be followed by the phrase “without limitation”.  Unless the context otherwise requires, references in this Agreement to Articles, Sections, Exhibits and Schedules shall be deemed references to Articles and Sections of, and Exhibits and Schedules to, this Agreement.  Unless the context otherwise requires, the words “hereof”, “hereby” and “herein” and words of similar meaning when used in this Agreement refer to this Agreement in its entirety and not to any particular Article, Section or provision of this Agreement.  The words “written request” when used in this Agreement shall include email.  Reference in this Agreement to any time shall be to Eastern time unless otherwise expressly provided herein.  Unless the context requires otherwise, references in this Agreement to “Biogen” shall also be deemed to refer to the applicable member of the Biogen Group, references to “Bioverativ” shall also be deemed to refer to the applicable member of the Bioverativ Group and, in connection therewith, any references to actions or omissions to be taken, or refrained from being taken, as the case may be, by Biogen or Bioverativ shall be deemed to require Biogen or Bioverativ, as the case may be, to cause the applicable members of the Biogen Group or the Bioverativ Group, respectively, to take, or refrain from taking, any such action.  The word “or” shall not be exclusive.  References to any “statute” or “regulation” are to such statute or regulation as amended, modified, supplemented or replaced from time to time (and, in the case of any statute, include any rules and regulations promulgated under such statute) and to any “section of any statute or regulation” include any successor to such section.  References to any Governmental Entity include any successor to such Governmental Entity, and references to any

 

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Affiliate include any successor to such Affiliate.  Whenever the last day for the exercise of any right or the discharge of any duty under this Agreement falls on other than a Business Day, the Party having such right or duty shall have until the next Business Day to exercise such right or discharge such duty.  Unless otherwise indicated, the word “day” shall be interpreted as a calendar day.

 

ARTICLE II

 

THE SEPARATION

 

Section 2.1                                     General . Subject to the terms and conditions of this Agreement, the Parties shall use, and shall cause their respective Subsidiaries to use, commercially reasonable efforts to consummate the transactions contemplated hereby, a portion of which may have already been implemented prior to the date hereof, including the completion of the Internal Reorganization.

 

Section 2.2                                     Restructuring: Transfer of Assets; Assumption of Liabilities .

 

(a)                        Internal Reorganization . Prior to the Distribution Effective Time, the Parties shall complete the Internal Reorganization, except for such steps (if any) as Biogen in its sole discretion shall have determined need not be completed or may be completed after the Distribution Effective Time; provided , however , that any such determination shall not limit the Parties’ respective obligations under Section 2.2(b) .

 

(b)                        Transfer of Assets and Assumption of Liabilities .  Unless otherwise provided in this Agreement or in any Ancillary Agreement, on or prior to the Distribution Effective Time and to the extent not previously effected pursuant to the Internal Reorganization:

 

(i)              Biogen shall, and shall cause the applicable members of the Biogen Group to, contribute, assign, transfer, convey and deliver (“ Transfer ”) to Bioverativ, or the applicable Bioverativ Designees, and Bioverativ or such Bioverativ Designees shall accept from Biogen and the applicable members of the Biogen Group, all of Biogen’s and such Biogen Group member’s respective direct or indirect right, title and interest in and to all Bioverativ Assets held by Biogen or a member of the Biogen Group (it being understood that if any Bioverativ Asset shall be held by a Person all of the outstanding equity of which is included in the Bioverativ Assets to be Transferred pursuant to this Section 2.2(b)(i) , such Bioverativ Asset may be considered to be so Transferred to Bioverativ or the applicable Bioverativ Designee as a result of the Transfer of all of the equity interests in such Person from Biogen or the applicable member(s) of the Biogen Group to Bioverativ or the applicable Bioverativ Designee); and

 

(ii)           Bioverativ shall, and shall cause the applicable members of the Bioverativ Group to, Transfer to Biogen or the applicable Biogen Designees, and Biogen or such Biogen Designees shall accept from Bioverativ and the applicable members of the Bioverativ Group, all of Bioverativ’s and such Bioverativ Group member’s respective direct or indirect right, title and interest in

 

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and to all Biogen Retained Assets held by Bioverativ or a member of the Bioverativ Group (it being understood that if any Biogen Retained Asset shall be held by a Person all of the outstanding equity of which is included in the Biogen Retained Assets to be Transferred pursuant to this Section 2.2(b)(ii) , such Biogen Retained Asset may be considered to be so Transferred to Biogen or the applicable Biogen Designee as a result of the Transfer of all of the equity interests in such Person from Bioverativ or the applicable member(s) of the Bioverativ Group to Biogen or the applicable Biogen Designee).

 

(iii)        Assumption of Liabilities . (i) Biogen shall, or shall cause another member of the Biogen Group to, accept, assume (or, as applicable, retain) and perform, discharge and fulfill, in accordance with their respective terms (“ Assume ”; and “ Assumption ” shall have the correlative meaning), all of the Biogen Retained Liabilities and (ii) Bioverativ shall, or shall cause another member of the Bioverativ Group to Assume all the Bioverativ Liabilities, in each case regardless of (A) when or where such Liabilities arose or arise, (B) where or against whom such Liabilities are asserted or determined, (C) whether such Liabilities arise from or are alleged to arise from negligence, gross negligence, recklessness, violation of law, willful misconduct, bad faith, fraud or misrepresentation by any member of the Biogen Group or the Bioverativ Group, as the case may be, or any of their past or present respective directors, officers, employees, or agents, (D) which entity is named in any action associated with any Liability and (E) whether the facts on which such Liabilities are based occurred prior to, on or after the date hereof.

 

(c)                         The Parties shall use their respective commercially reasonable efforts to obtain the Consents required to Transfer any Contracts, licenses, permits, authorizations and other Assets as contemplated by this Agreement.  Notwithstanding anything herein to the contrary, no Contract or other Asset shall be Transferred if it would violate applicable Law or, in the case of a Contract, the rights of any Third Party to such Contract; provided , that Section 2.6 , to the extent provided therein, shall apply to such Asset or Contract.

 

(d)                        It is understood and agreed by the Parties that certain of the Transfers or Assumptions referenced in Section 2.2(b) have heretofore occurred and, as a result, no additional Transfers or Assumptions by any member of the Biogen Group or Bioverativ Group, as applicable, shall be deemed to occur upon the execution of this Agreement with respect thereto.  Moreover, to the extent that any member of the Biogen Group or Bioverativ Group, as applicable, is liable for any Biogen Retained Liability or Bioverativ Liability, respectively, by operation of Law immediately following any Transfer in accordance with this Agreement or any Conveyancing and Assumption Instruments, there shall be no need for any other member of the Biogen Group or Bioverativ Group, as applicable, to Assume such Liability in connection with the operation of Section 2.2(b) and, accordingly, no other member of such Group shall Assume such Liability in connection with Section 2.2(b) .

 

(e)                         In connection with, and in furtherance of, the Transfers of Assets and the Assumptions of Liabilities contemplated by this Agreement, the Parties shall execute or cause to be executed, on or after the date hereof by the appropriate entities to the extent not

 

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executed prior to the date hereof, any Conveyancing and Assumption Instruments necessary to evidence the valid Transfer to the applicable Party or member of such Party’s Group of all right, title and interest in and to its accepted Assets and the valid and effective Assumption by the applicable Party or member of such Party’s Group of its respective Liabilities for Transfers and Assumptions to be effected pursuant to Delaware Law or the Laws of one of the other states of the United States or, if not appropriate for a given Transfer or Assumption, and for Transfers or Assumptions to be effected pursuant to non-U.S. Laws, in such form as the Parties shall reasonably agree.

 

(f)                          Biogen hereby waives compliance by itself and each and every member of the Biogen Group with the requirements and provisions of any “bulk-sale” or “bulk transfer” Laws of any jurisdiction that may otherwise be applicable with respect to the transfer or sale of any or all of the Biogen Retained Assets to Biogen or any member of the Biogen Group.

 

(g)                         Bioverativ hereby waives compliance by itself and each and every member of the Bioverativ Group with the requirements and provisions of any “bulk-sale” or “bulk transfer” Laws of any jurisdiction that may otherwise be applicable with respect to the transfer or sale of any or all of the Bioverativ Assets to Bioverativ or any member of the Bioverativ Group.

 

(h)                        Notwithstanding anything in this Section 2.2 to the contrary, no Biogen Group member shall be required to undertake any action or arrangement contemplated by this Section 2.2 that would result in, or could reasonably be expected to result in, Tax treatment that is inconsistent with the conclusions set forth in the Tax Opinion.

 

Section 2.3                                     Treatment of Shared Contracts .

 

(a)                        Unless the Parties otherwise agree or the benefits of any Contract described in this Section 2.3 are expressly conveyed to the applicable Party pursuant to an Ancillary Agreement, in the case of a Shared Contract, the Parties shall use commercially reasonable efforts to cause such Shared Contract to be: (i) assigned in relevant part to a member of the Bioverativ Group (or to a member of the Biogen Group if the contracting party is a member of the Bioverativ Group) if so assignable; (ii) appropriately amended, prior to, on or after the Distribution Effective Time; or (iii) replaced or otherwise addressed with suitable arrangements, in each case so that each Party or their respective Subsidiaries shall be entitled to the rights and benefits and shall assume the related portion of any obligations and Liabilities inuring to their respective businesses; provided , however , that in no event shall either Party or its respective Subsidiaries be required to assign or amend any Shared Contract in its entirety or to assign a portion of any Shared Contract that is not assignable or cannot be amended by its terms (including any terms imposing Consents or conditions on an assignment where such Consents or conditions have not been obtained or fulfilled). If any Shared Contract cannot be so partially assigned, or cannot be amended, or if such assignment or amendment would impair the benefit the parties thereto derive from such Shared Contract and such Shared Contract is not replaced or otherwise addressed with suitable arrangements, Biogen and Bioverativ shall, and shall cause each member of their respective Groups to, take such other reasonable and permissible actions to cause (with the costs and expenses of any such actions following the Distribution to be shared equally between the Parties): (A) the Assets associated with that portion of each Shared Contract

 

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that relates to the Bioverativ Business to be enjoyed by a member of the Bioverativ Group; (B) the Liabilities associated with that portion of each Shared Contract that relates to the Bioverativ Business to be borne by a member of the Bioverativ Group; (C) the Assets associated with that portion of each Shared Contract that relates to the Biogen Retained Business to be enjoyed by a member of the Biogen Group; and (D) the Liabilities associated with that portion of each Shared Contract that relates to the Biogen Retained Business to be borne by a member of the Biogen Group.

 

(b)                        Except for payments required in accordance with the performance of the applicable Shared Contract, nothing in this Section 2.3 shall obligate either Party or any of member of its Group to make any payment, incur any Liability or offer or grant any accommodation for the benefit of the other Party or any member of the other Party’s Group, in each case, in order to effect any transaction (other than the pass-through of rewards and burdens of the applicable portions of the Shared Contracts in accordance with this Section 2.3 ) (except to the extent advanced, assumed or agreed in advance to be reimbursed by the other Party or any member of the other Party’s Group).

 

(c)                         Each of Biogen and Bioverativ shall, and shall cause the members of its Group to, (A) treat for all Tax purposes the portion of each Shared Contract inuring to its respective Businesses as Assets owned by, and/or Liabilities of, as applicable, such Party as of the Distribution Effective Time and (B) neither report nor take any Tax position (on a Tax Return or otherwise) inconsistent with such treatment (unless required by applicable Tax Law or good faith resolution of a Tax Contest).

 

Section 2.4                                     Intercompany Accounts .  Each Intercompany Account which exists and is reflected immediately prior to the Distribution Effective Time in any general ledger account or other records of Biogen, Bioverativ or any of their respective Affiliates, shall be: (a) closed as of the Distribution Effective Time and satisfied or settled within thirty (30) days following the Distribution Date by the relevant members of the Biogen Group and the Bioverativ Group by (i) one or a related series of distributions of or contributions to capital, (ii) payment by the relevant obligor to the relevant obligee or (iii) dividends or a combination of the foregoing, in each case as determined by Biogen or (b) otherwise terminated effective as of the Distribution Effective Time.  For the avoidance of doubt, the obligation to satisfy, settle or terminate Intercompany Accounts shall survive the Distribution Effective Time.

 

Section 2.5                                     Limitation of Liability .  Except as provided in this Section 2.5 and in Article VI , neither Biogen nor Bioverativ nor any member of their respective Groups shall have any Liability to the other or any member of the other Party’s Group based upon, arising out of or resulting from any agreement, arrangement, course of dealing or understanding existing on or prior to the Distribution Effective Time other than pursuant to (i) this Agreement or any Ancillary Agreement, (ii) any Contract listed or described on Schedule 2.5 ; (iii) any Third Party Agreement or (iv) any other Contract or agreement entered into in connection with the consummation of the transactions contemplated by the Transaction Agreements, and any such Liability, whether or not in writing, that is not reflected in any of the foregoing, is hereby irrevocably cancelled, released and waived effective as of the Distribution Effective Time.  No such terminated agreement, arrangement, course of dealing or understanding (including any

 

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provision thereof that purports to survive termination) shall be of any further force or effect after the Distribution Effective Time.

 

Section 2.6                                     Transfers Not Effected at or Prior to the Distribution Effective Time; Transfers Deemed Effective as of the Distribution Effective Time .

 

(a)                        If and to the extent that the valid, complete and perfected Transfer to the Bioverativ Group of any Bioverativ Asset or Assumption by the Bioverativ Group of any Bioverativ Liability, in each case contemplated hereby, would be a violation of applicable Law or require any Consent in connection with the Separation that has not been obtained or made by the Distribution Effective Time then, unless the Parties mutually shall otherwise agree, the Transfer to the Bioverativ Group of such Bioverativ Assets or the Assumption by the Bioverativ Group of such Bioverativ Liabilities, as the case may be, shall be automatically deemed deferred and any such purported Transfer or Assumption shall be null and void until such time as all legal impediments are removed or such Consent has been obtained or made.  Notwithstanding the foregoing, any such Bioverativ Asset or Bioverativ Liability shall continue to constitute a Bioverativ Asset or Bioverativ Liability, as applicable, for all other purposes of this Agreement.

 

(b)                        If and to the extent that the valid, complete and perfected Transfer to the Biogen Group of any Biogen Retained Asset or Assumption by the Biogen Group of any Biogen Retained Liability, in each case contemplated hereby, would be a violation of applicable Law or require any Consent in connection with the Separation that has not been obtained or made by the Distribution Effective Time then, unless the Parties mutually shall otherwise agree, the Transfer to the Biogen Group of such Biogen Retained Assets or the Assumption by the Biogen Group of such Biogen Retained Liabilities, as the case may be, shall be automatically deemed deferred and any such purported Transfer or Assumption shall be null and void until such time as all legal impediments are removed or such Consent has been obtained or made.  Notwithstanding the foregoing, any such Biogen Retained Assets or Biogen Retained Liabilities shall continue to constitute Biogen Retained Assets and Biogen Retained Liabilities for all other purposes of this Agreement.

 

(c)                         With respect to Assets and Liabilities described in Section 2.6(a) and Section 2.6(b) , taking into account any applicable restrictions or considerations relating to the contemplated Tax treatment of the transactions contemplated hereby, each of Biogen and Bioverativ shall, and shall cause the members of its respective Group to, (i) treat for all Tax purposes (A) the deferred Assets as assets having been Transferred to and owned by the Person entitled to such Assets not later than the Distribution Effective Time and (B) the deferred Liabilities as having been Assumed by the Person intended to be subject to such Liabilities not later than the Distribution Effective Time and (ii) neither report nor take any Tax position (on a Tax Return or otherwise) inconsistent with such treatment (unless required by a change in applicable Tax Law or good faith resolution of a Tax Contest).

 

(d)                        In the event that any Transfer of Assets or Assumption of Liabilities intended to be effected hereunder has not been consummated at or prior to the Distribution Effective Time, whether as a result of the provisions of Section 2.6(a) or Section 2.6(b) or for any other reason (other than with respect to Shared Contracts, which shall be governed solely by Section 2.3 ):

 

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(i)                                      unless the Parties shall otherwise agree, the Parties and their respective Group members shall cooperate and use commercially reasonable efforts to seek to obtain, in accordance with applicable Law, any necessary Consents for the Transfer of all Assets and the Assumption of all Liabilities contemplated to be Transferred or Assumed, as applicable, pursuant to this Article II to the fullest extent permitted by applicable Law; provided , however , that, except to the extent expressly provided in this Agreement or any of the Ancillary Agreements or as otherwise agreed between Biogen and Bioverativ, neither Biogen nor Bioverativ shall be obligated to make any payment, incur any Liability or offer or grant any accommodation (financial or otherwise, regardless of any provision to the contrary in any underlying Contract, including any requirements for the securing or posting of any bonds, letters of credit or similar instruments, or the furnishing of any guarantees) to any Third Party to obtain or make such Consent; and

 

(ii)                                   (A) the Party (or the applicable member of its Group) retaining such Asset shall thereafter hold (or shall cause such member in its Group to hold) such Asset in trust for the use and benefit of the Party entitled thereto (at the expense of the Party entitled thereto) and (B) the Party intended to Assume such Liability shall, or shall cause the applicable member of its Group to, pay or reimburse the Party retaining such Liability for all amounts paid or incurred in connection with the retention of such Liability.  To the extent the foregoing applies to any Contracts to be assigned for which any necessary Consents are not received prior to the Distribution Effective Time, the treatment of such Contracts shall, for the avoidance of doubt, be subject to Section 2.8 and Section 2.9 , to the extent applicable.  In addition, the Party (or the applicable member of its Group) retaining such Asset or Liability shall (or shall cause such member in its Group to) treat, insofar as reasonably possible and to the extent permitted by applicable Law, such Asset or Liability in the ordinary course of business in accordance with past practice and take such other actions as may be reasonably requested by the Party to which such Asset is to be Transferred or by the Party Assuming such Liability in order to place such Party, insofar as reasonably possible and to the extent permitted by applicable Law, in the same position as if such Asset or Liability had been Transferred or Assumed as contemplated hereby, and so that all the benefits and burdens relating to such Asset or Liability, including possession, use, risk of loss, potential for income and gain, and dominion, control and command over such Asset or Liability, are to inure from and after the Distribution Effective Time to the applicable member or members of the Biogen Group or the Bioverativ Group entitled to the receipt of such Asset or required to Assume such Liability.  In furtherance of the foregoing, the Parties agree that, as of the Distribution Effective Time, each Party shall be deemed to have acquired complete and sole beneficial ownership over all such Assets, together with all rights, powers and privileges incident thereto, and shall be deemed to have Assumed in accordance with the terms of this Agreement all such Liabilities, and all duties, obligations and responsibilities incident thereto, which such Party is entitled to acquire or required to Assume pursuant to the terms of the Transaction Agreements.

 

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(e)                         If and when the Consents or conditions, the absence or non-satisfaction of which caused the deferral of Transfer of any Asset or deferral of the Assumption of any Liability pursuant to Section 2.6(a)  or Section 2.6(b) , are obtained or satisfied, the Transfer or Assumption of the applicable Asset or Liability shall be effected without further consideration in accordance with and subject to the terms of this Agreement (including Section 2.2 ) or the applicable Ancillary Agreement, and shall, to the extent possible without the imposition of any undue cost on any Party, be deemed to have become effective as of the Distribution Effective Time.

 

(f)                          The Party (or the applicable member of its Group) retaining any Asset or Liability due to the deferral of the Transfer of such Asset or the deferral of the Assumption of such Liability pursuant to Section 2.6(a)  or Section 2.6(b)  or otherwise shall (i) not be obligated, in connection with the foregoing, to expend any money unless the necessary funds are advanced, assumed, or agreed in advance to be reimbursed by the Party (or the applicable member of its Group) entitled to such Asset or the Person intended to be subject to such Liability, other than reasonable attorneys’ fees and recording or similar or other incidental fees, all of which shall be promptly reimbursed by the Party (or the applicable member of its Group) entitled to such Asset or the Person intended to be subject to such Liability and (ii) be indemnified for all Indemnifiable Losses or other Liabilities arising out of any actions (or omissions to act) of such retaining Party taken (or not taken) at the written direction of the other Party (or the applicable member of its Group) in connection with and relating to such retained Asset or Liability, as the case may be.

 

Section 2.7                                     Further Assurances .

 

(a)                        In addition to and without limiting the actions specifically provided for elsewhere in this Agreement and subject to the limitations expressly set forth in this Agreement, including Section 2.6 , each of the Parties shall cooperate with each other and shall use (and shall cause its respective Subsidiaries to use) commercially reasonable efforts, from and after the Distribution Effective Time, to take, or to cause to be taken, all actions, and to do, or to cause to be done, all things reasonably necessary on its part under applicable Law or contractual obligations to consummate and make effective the transactions contemplated by this Agreement and the Ancillary Agreements as promptly as reasonably practicable.

 

(b)                        Without limiting the foregoing, from and after the Distribution Effective Time:

 

(i)                        each Party shall cooperate with the other Party to execute and deliver, and use commercially reasonable efforts to cause to be executed and delivered, all instruments, including instruments of Transfer or title, and to make all filings with, and to obtain all Consents, and to take or cause to be taken all such other actions as such Party may reasonably be requested to take by any other Party from time to time, as promptly as reasonably practicable, consistent with the terms of this Agreement and the Ancillary Agreements, in order to effectuate the provisions and purposes of this Agreement and the Ancillary Agreements and the Transfers of the applicable Assets and the

 

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assignment and Assumption of the applicable Liabilities and the other transactions contemplated hereby and thereby; and

 

(ii)                     in the event that any Party (or member of such Party’s Group) receives any Assets (including the receipt of payments made pursuant to Contracts and proceeds from accounts receivable with respect to such Asset) or is liable for any Liability that is otherwise allocated to any Person that is a member of the other Group pursuant to this Agreement or the Ancillary Agreements, such Party agrees to promptly Transfer, or cause to be Transferred, without further consideration such Asset or Liability to the other Party so entitled thereto (or to a member of such other Party’s Group as designated by such other Party) and, prior to any such Transfer, such Asset or Liability, as the case may be, shall be held in accordance with the provisions of Section 2.6 ; provided , that the provisions of this Section 2.7(b)(ii)  are not intended to, and shall not, be deemed to constitute an authorization by any Party to permit the other to accept service of process on its behalf and no Party is or shall be deemed to be the agent of any other Party for service of process purposes.

 

(c)                         From and after the Distribution Effective Time, with respect to any Action where any Party hereto is a defendant, when and if requested by such Party, the other Party shall use commercially reasonable efforts to petition the applicable court to remove the requesting Party as a defendant to the extent that such Action relates solely to Assets or Liabilities that the other Party (or any member of such other Party’s Group) has been allocated pursuant to this Article II , and the other Party shall cooperate and assist in any required communication with any plaintiff or other related Third Party.

 

Section 2.8                                     Novation of Biogen Retained Liabilities; Indemnification .

 

(a)                        Other than with respect to Shared Contracts, which shall be governed solely by Section 2.3 , each of Biogen and Bioverativ, at the request of the other Party, shall use its commercially reasonable efforts to obtain, or to cause to be obtained, as soon as reasonably practicable, any Consent, substitution or amendment required to novate or assign all obligations and other Liabilities for which a member of the Biogen Group and a member of the Bioverativ Group are jointly or severally liable and that constitute Biogen Retained Liabilities, or to obtain in writing the unconditional release of all members of the Bioverativ Group to such arrangements, so that, in any such case, the members of the Biogen Group will be solely responsible for such Liabilities; provided , however , that except as expressly provided in any of the Ancillary Agreements, any Third Party Agreement, or as otherwise agreed between Biogen and Bioverativ, neither Biogen nor Bioverativ shall be obligated to make any payment, incur any Liability or offer or grant any accommodation (financial or otherwise, regardless of any provision to the contrary in any underlying Contract, including any requirements for the securing or posting of any bonds, letters of credit or similar instruments, or the furnishing of any guarantees) to any Third Party from whom any such Consent, substitution, amendment or release is requested.

 

(b)                        If Biogen or Bioverativ, as applicable, is unable to obtain, or to cause to be obtained, any such required Consent, substitution, amendment or release with respect

 

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to any such Liability, the applicable member of the Bioverativ Group shall from and after the Distribution Effective Time continue to be bound by such obligation or other Liability and, unless not permitted by the terms thereof or by Law, from and after the Distribution Effective Time, Biogen shall or shall cause a member of the Biogen Group to, as agent or subcontractor for such member of the Bioverativ Group pay, perform and discharge fully such Liability to the extent that it does not constitute a Bioverativ Liability.  Bioverativ shall cause each member of the Bioverativ Group without further consideration to promptly pay and remit, or cause to be paid or remitted, to Biogen or to another member of the Biogen Group specified by Biogen, all money, rights and other consideration received by Bioverativ or any member of the Bioverativ Group in respect of such performance (unless any such consideration is a Bioverativ Asset).  If and when any such Consent, substitution, amendment or release shall be obtained or the Liability shall otherwise become assignable or able to be novated, without payment of further consideration, Bioverativ shall promptly assign, or cause to be assigned, such Liability to Biogen or to another member of the Biogen Group specified by Biogen, and Biogen shall, or shall cause such other member of the Biogen Group to, Assume such Liability.

 

Section 2.9                                     Novation of Bioverativ Liabilities; Indemnification .

 

(a)                        Other than with respect to Shared Contracts, which shall be governed solely by Section 2.3 , each of Biogen and Bioverativ, at the request of the other party, shall use its commercially reasonable efforts to obtain, or to cause to be obtained, as soon as reasonably practicable, any Consent, substitution or amendment required to novate or assign all obligations or other Liabilities for which a member of the Biogen Group and a member of the Bioverativ Group are jointly or severally liable and that constitute Bioverativ Liabilities, or to obtain in writing the unconditional release of all parties to such arrangements other than any member of the Bioverativ Group, so that, in any such case, the members of the Bioverativ Group will be solely responsible for such Liabilities; provided , however , that except as expressly provided in any of the Ancillary Agreements, any Third Party Agreement, or as otherwise agreed between Biogen and Bioverativ, neither Biogen nor Bioverativ shall be obligated to make any payment, incur any Liability or offer or grant any accommodation (financial or otherwise, regardless of any provision to the contrary in any underlying Contract, including any requirements for the securing or posting of any bonds, letters of credit or similar instruments, or the furnishing of any guarantees) to any Third Party from whom any such Consent, substitution, amendment or release is requested.

 

(b)                        If Biogen or Bioverativ, as applicable, is unable to obtain, or to cause to be obtained, any such required Consent, substitution, amendment or release with respect to any such Liability, the applicable member of the Biogen Group shall from and after the Distribution Effective Time continue to be bound by such obligation or other Liability and, unless not permitted by the terms thereof or by Law, from and after the Distribution Effective Time, Bioverativ shall or shall cause a member of the Bioverativ Group to, as agent or subcontractor for such member of the Biogen Group pay, perform and discharge fully such Liability to the extent that it does not constitute a Biogen Retained Liability.  Biogen shall cause each member of the Biogen Group without further consideration to promptly pay and remit, or cause to be paid or remitted, to Bioverativ or to another member of the Bioverativ Group specified by Bioverativ, all money, rights and other consideration received by Biogen or any member of the Biogen Group in respect of such performance (unless any such consideration is a

 

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Biogen Retained Asset).  If and when any such Consent, substitution, amendment or release shall be obtained or the Liability shall otherwise become assignable or able to be novated, without payment of further consideration, Biogen shall promptly assign, or cause to be assigned, such Liability to Bioverativ or to another member of the Bioverativ Group specified by Bioverativ, and Bioverativ shall, or shall cause such other member of the Bioverativ Group to, Assume such Liability.

 

Section 2.10                              Disclaimer of Representations and Warranties .

 

(a)                        EACH OF BIOGEN (ON BEHALF OF ITSELF AND EACH MEMBER OF THE BIOGEN GROUP) AND BIOVERATIV (ON BEHALF OF ITSELF AND EACH MEMBER OF THE BIOVERATIV GROUP) UNDERSTANDS AND AGREES THAT, EXCEPT AS EXPRESSLY SET FORTH HEREIN, IN ANY ANCILLARY AGREEMENT, NO PARTY TO THIS AGREEMENT, ANY ANCILLARY AGREEMENT OR ANY OTHER AGREEMENT OR DOCUMENT CONTEMPLATED BY THIS AGREEMENT, ANY ANCILLARY AGREEMENTS OR OTHERWISE, IS REPRESENTING OR WARRANTING IN ANY WAY, AND HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, AS TO THE ASSETS, BUSINESSES OR LIABILITIES CONTRIBUTED, TRANSFERRED OR ASSUMED AS CONTEMPLATED HEREBY OR THEREBY, AS TO ANY CONSENTS REQUIRED IN CONNECTION HEREWITH OR THEREWITH, AS TO THE VALUE OR FREEDOM FROM ANY SECURITY INTERESTS OF, AS TO NONINFRINGEMENT, VALIDITY OR ENFORCEABILITY OR ANY OTHER MATTER CONCERNING, ANY ASSETS OR BUSINESS OF SUCH PARTY, OR AS TO THE ABSENCE OF ANY DEFENSES OR RIGHT OF SETOFF OR FREEDOM FROM COUNTERCLAIM WITH RESPECT TO ANY ACTION OR OTHER ASSET, INCLUDING ACCOUNTS RECEIVABLE, OF ANY PARTY, OR AS TO THE LEGAL SUFFICIENCY OF ANY CONTRIBUTION, ASSIGNMENT, DOCUMENT, CERTIFICATE OR INSTRUMENT DELIVERED HEREUNDER TO CONVEY TITLE TO ANY ASSET OR THING OF VALUE UPON THE EXECUTION, DELIVERY AND FILING HEREOF OR THEREOF.  EXCEPT AS MAY EXPRESSLY BE SET FORTH HEREIN OR IN ANY ANCILLARY AGREEMENT, ALL SUCH ASSETS ARE BEING TRANSFERRED ON AN “AS IS, WHERE IS” BASIS (AND, IN THE CASE OF ANY REAL PROPERTY, BY MEANS OF A QUITCLAIM OR SIMILAR FORM DEED OR CONVEYANCE) AND THE RESPECTIVE TRANSFEREES SHALL BEAR THE ECONOMIC AND LEGAL RISKS THAT (I) ANY CONVEYANCE SHALL PROVE TO BE INSUFFICIENT TO VEST IN THE TRANSFEREE GOOD TITLE, FREE AND CLEAR OF ANY SECURITY INTEREST AND (II) ANY NECESSARY CONSENTS OR GOVERNMENTAL APPROVALS ARE NOT OBTAINED OR THAT ANY REQUIREMENTS OF LAWS OR JUDGMENTS ARE NOT COMPLIED WITH.

 

(b)                        Each of Biogen (on behalf of itself and each member of the Biogen Group) and Bioverativ (on behalf of itself and each member of the Bioverativ Group) further understands and agrees that if the disclaimer of express or implied representations and warranties contained in Section 2.10(a)  is held unenforceable or is unavailable for any reason under the Laws of any jurisdiction outside the United States or if, under the Laws of a jurisdiction outside the United States, both Biogen or any member of the Biogen Group, on the one hand, and Bioverativ or any member of the Bioverativ Group, on the other hand, are jointly or severally liable for any Biogen Retained Liability or any Bioverativ Liability, then the Parties intend that,

 

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notwithstanding any provision to the contrary under the Laws of such non-U.S. jurisdictions, the provisions of this Agreement and the Ancillary Agreements (including the disclaimer of all representations and warranties, allocation of Liabilities among the Parties and their respective Subsidiaries, releases, indemnification and contribution of Liabilities) shall prevail for any and all purposes among the Parties and their respective Subsidiaries.

 

Section 2.11                              Cash Management .  From the date of this Agreement until the Distribution, Biogen and its Subsidiaries shall be entitled to use, retain or otherwise dispose of all cash generated by the Bioverativ Business and the Bioverativ Assets in accordance with the ordinary course operation of Biogen’s cash management systems.  Prior to the Distribution Date, in connection with the intended capitalization of the Bioverativ Group, Biogen shall cause to be contributed to Bioverativ an amount in cash and cash equivalents, as Biogen may determine in its sole discretion.  All cash and cash equivalents held by any member of the Bioverativ Group as of the Distribution shall be a Bioverativ Asset and all cash and cash equivalents held by any member of the Biogen Group as of the Distribution shall be a Biogen Retained Asset.

 

ARTICLE III

 

CERTAIN ACTIONS AT OR PRIOR TO THE DISTRIBUTION

 

Section 3.1                                     Transaction Agreements . At or prior to the Distribution Effective Time, Biogen and Bioverativ shall enter into, or (where applicable) shall cause a member or members of their respective Groups to enter into each Transaction Agreement (other than this Agreement).

 

ARTICLE IV

 

THE DISTRIBUTION

 

Section 4.1                                     Stock Dividend; Distribution . On or prior to the Distribution Effective Time, in furtherance of the Separation, Bioverativ shall issue to Biogen as a stock dividend such number of shares of Bioverativ Common Stock as may be requested by Biogen after consultation with Bioverativ in order to effect the Distribution (or Biogen and Bioverativ shall take or cause to be taken such other appropriate actions to ensure that Biogen has the requisite number of shares of Bioverativ Common Stock), which shares as of the date of issuance shall represent (together with such shares previously held by Biogen) all of the issued and outstanding shares of Bioverativ Common Stock.  Subject to the conditions and other terms set forth in this Article IV , Biogen shall cause the Distribution Agent on the Distribution Date to make the Distribution, including by crediting the appropriate number of shares of Bioverativ Common Stock to book entry accounts for each Record Holder or designated transferee or transferees of such Record Holder.  For stockholders who own Biogen Common Stock through a broker or other nominee, their shares of Bioverativ Common Stock will be credited to their respective accounts by such broker or nominee.  No action by any stockholder (or such stockholder’s designated transferee or transferees) shall be necessary to receive the applicable number of shares of Bioverativ Common Stock (and, if applicable, cash in lieu of any fractional shares) to which such stockholder is entitled in the Distribution.

 

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Section 4.2                                     Fractional Shares .  Biogen registered stockholders who, after aggregating the number of shares of Bioverativ Common Stock (or fractions thereof) to which such stockholder would be entitled on the Record Date, would be entitled to receive a fraction of a share of Bioverativ Common Stock in the Distribution, will be entitled to receive cash in lieu of fractional shares.  Fractional shares of Bioverativ Common Stock will not be distributed by Biogen in the Distribution.  The Distribution Agent shall, as soon as practicable after the Distribution Date, (a) determine the number of whole shares and fractional shares of Bioverativ Common Stock allocable to each such Biogen stockholder, (b) aggregate all such fractional shares into whole shares and sell the whole shares obtained thereby in open market transactions at then prevailing trading prices on behalf of holders who would otherwise be entitled to fractional share interests, and (c) distribute to each such holder, or for the benefit of each such beneficial owner, such holder’s or owner’s pro rata share of the aggregate net cash proceeds of these sales, after making appropriate deductions for any amount required to be withheld for U.S. federal income tax purposes.  Biogen shall bear the cost of brokerage fees and transfer Taxes incurred in connection with these sales of fractional shares, which such sales shall occur as soon after the Distribution Date as practicable and as determined by the Distribution Agent.  None of Biogen, Bioverativ or the Distribution Agent will guarantee any minimum sale price for the fractional shares of Bioverativ Common Stock.  Neither Biogen nor Bioverativ will pay any interest on the proceeds from the sale of fractional shares.  The Distribution Agent will have the sole discretion to select the broker-dealers through which to sell the aggregated fractional shares and to determine when, how and at what price to sell such shares.  Neither the Distribution Agent nor the selected broker-dealers will be Affiliates of Biogen or Bioverativ.

 

Section 4.3                                     Actions in Connection with the Distribution .

 

(a)                        Prior to the Distribution Date, Bioverativ shall file such amendments and supplements to its Form 10 as Biogen may reasonably request, and such amendments as may be necessary in order to cause the same to become and remain effective as required by Law, including filing such amendments and supplements to its Form 10 as may be required by the Commission or federal, state or non-U.S. securities Laws. Biogen shall, or at Biogen’s election, Bioverativ shall, mail (or deliver by electronic means where not prohibited by Law) to the holders of Biogen Common Stock, at such time on or prior to the Distribution Date as Biogen shall determine, the Information Statement included in its Form 10 (or a Notice of Internet Availability of the Information Statement), as well as any other information concerning Bioverativ, its business, operations and management, the transaction contemplated herein and such other matters as Biogen shall reasonably determine are necessary and as may be required by Law.  Promptly after receiving a request from Biogen, Bioverativ shall prepare and, in accordance with applicable Law, file with the Commission any such documentation that Biogen reasonably determines is necessary or desirable to effectuate the Distribution, and Biogen and Bioverativ shall each use commercially reasonable efforts to obtain all necessary approvals from the Commission with respect thereto as soon as practicable.

 

(b)                        Bioverativ shall use commercially reasonable efforts in preparing, filing with the Commission and causing to become effective, as soon as reasonably practicable (but in any case prior to the Distribution Effective Time), an effective registration statement or amendments thereof which are required in connection with the establishment of, or amendments to, any employee benefit plans of Bioverativ.

 

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(c)                         To the extent not already approved and effective, Bioverativ shall use commercially reasonable efforts to have approved and made effective, the application for the original listing on NASDAQ of the Bioverativ Common Stock to be distributed in the Distribution, subject to official notice of distribution.

 

(d)                        Nothing in this Section 4.3 shall be deemed to shift or otherwise impose Liability for any portion of the Form 10 or Information Statement to Biogen.

 

Section 4.4                                     Sole Discretion of Biogen . Biogen, in its sole discretion, shall determine the Distribution Date, the Distribution Effective Time and all other terms of the Distribution, including the form, structure and terms of any transactions or offerings to effect the Distribution and the timing of and conditions to the consummation thereof.  In addition, Biogen may, in accordance with Section 10.10 , at any time and from time to time until the completion of the Distribution decide to abandon the Distribution or modify or change the terms of the Distribution, including by accelerating or delaying the timing of the consummation of all or part of the Distribution.  Without limiting the foregoing, Biogen shall have the right not to complete the Distribution if, at any time prior to the Distribution Effective Time, the Board shall have determined, in its sole discretion, that the Distribution is not in the best interests of Biogen or its stockholders, that a sale or other alternative is in the best interests of Biogen or its stockholders or that it is not advisable at that time for the Bioverativ Business to separate from Biogen.

 

Section 4.5                                     Conditions to Distribution . Subject to Section 4.4 , the obligation of Biogen to consummate the Distribution is subject to the prior or simultaneous satisfaction, or, to the extent permitted by applicable Law, waiver by Biogen, in its sole discretion, of the following conditions.  None of Bioverativ, any other member of the Bioverativ Group, or any Third Party shall have any right or claim to require the consummation of the Distribution, which shall be effected at the sole discretion of the Board.  Any determination by Biogen, and any subsequent amendment, revision, withdrawal or change thereto made by Biogen prior to the Distribution and concerning the satisfaction or waiver of any or all of the conditions set forth in this Section 4.5 shall be conclusive and binding on the Parties.  The conditions are for the sole benefit of Biogen and shall not give rise to or create any duty on the part of Biogen or the Board to waive or not waive any such condition.  Each Party will use its commercially reasonable efforts to keep the other Party apprised of its efforts with respect to, and the status of, each of the following conditions:

 

(a)                        the Commission shall have declared effective the Form 10, no stop order relating thereto will be in effect, no proceedings seeking any such stop order shall be pending before or threatened by the Commission, and the Information Statement (or the Notice of Internet Availability of the Information Statement) shall have been distributed to holders of Biogen Common Stock;

 

(b)                        the shares of Bioverativ Common Stock to be distributed shall have been approved and accepted for listing by NASDAQ, subject to official notice of distribution;

 

(c)                         the receipt and continuing validity of an opinion (the “ Tax Opinion ”) from tax counsel or other Third Party advisor, that is in form and substance acceptable to Biogen, substantially to the effect that, among other things, the Separation will, based upon

 

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and subject to the assumptions, representations and qualifications set forth therein, qualify as a transaction that is tax-free for U.S. federal income tax purposes under Section 355 and Section 368(a)(1)(D) of the Internal Revenue Code of 1986;

 

(d)                        the receipt and continuing validity of an opinion from an independent appraisal firm to the Board, that is in form and substance acceptable to Biogen in its sole discretion, confirming the solvency of Bioverativ after the Distribution and, as to the compliance by Biogen in declaring to pay the Distribution, with surplus requirements under Delaware corporate law;

 

(e)                         all permits, registrations and Consents required under the securities or blue sky laws of states or other political subdivisions of the United States or of other foreign jurisdictions in connection with the Distribution shall have been received;

 

(f)                          no order, injunction, or decree issued by any Governmental Entity of competent jurisdiction,  or other legal restraint or prohibition preventing the consummation of the Distribution or any of the related transactions shall be pending, threatened, issued or in effect, and no other event outside the control of Biogen shall have occurred or failed to occur that prevents the consummation of all or any portion of the Distribution;

 

(g)                         the Internal Reorganization shall have been effectuated prior to the Distribution, except for such steps (if any) as Biogen in its sole discretion shall have determined need not be completed or may be completed after the Distribution Effective Time;

 

(h)                        the Board shall have declared the Distribution and approved all related transactions (and such declaration or approval shall not have been withdrawn);

 

(i)                            Bioverativ shall have executed and delivered each of the other Transaction Agreements; and

 

(j)                           no events or developments shall have occurred or shall exist that, in the sole and absolute judgment of the Board, make it inadvisable to effect the Distribution or would result in the Distribution and related transactions not being in the best interest of Biogen or its stockholders.

 

ARTICLE V

 

CERTAIN COVENANTS

 

Section 5.1                                     Non-Solicit; Non-Hire .  Commencing on and for a period of nine (9) months following the Distribution Date, neither Party nor any of its Subsidiaries will: (a) without the prior written consent of the other Party, directly or indirectly, on their own behalf or in the service or on behalf of others, solicit, aid, induce or encourage any employee of the other Party to terminate or breach an employment, contractual or other relationship with the other Party (or any of its Subsidiaries), or (b) hire or otherwise employ any employee of the other Party (or any of its Subsidiaries); provided , however , that nothing in this Section 5.1 shall be deemed to prohibit (i) any general solicitation for employment through advertisements and search firms not specifically directed at employees of such other Party (or any of its

 

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Subsidiaries ), provided that the soliciting Person has not encouraged or advised such firm to approach any such employee, (ii) the solicitation or hiring of an individual whose employment was terminated by such other Party (or any of its Subsidiaries), (iii) the solicitation or hiring of an individual formerly employed by a Party (or any of its Subsidiaries) at any time after six (6) months following such individual’s termination of his or her employment with such other Party or (iv) the hiring by any Party of any individual (y) not solicited by such Party in breach of this Section 5.1 and (x) with the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned or delayed), it being understood that the Party whose consent is requested may take into account, among other things, its own hiring needs and competitive considerations.

 

Section 5.2                                     Certain Restrictions .

 

(a)                        Biogen Restricted Business . From the Distribution Effective Time through the second (2nd) anniversary of the Distribution Date (the “ Restricted Period ”), Biogen shall not, and shall cause the other members of its Group not to, engage in the Biogen Restricted Business or own, operate, control, share any revenues of or have any profit or other equity interest in any business engaged in the Biogen Restricted Business. “ Biogen Restricted Business ” shall mean discovering, researching, developing, importing, exporting, manufacturing, marketing, distributing, promoting or selling anywhere in the world any product in the Field of Hemoglobinopathies.

 

(b)                        Bioverativ Restricted Business . During the Restricted Period, Bioverativ shall not, and shall the other members of its Group not to, engage in the Bioverativ Restricted Business or own, operate, control, share any revenues of or have any profit or other equity interest in any business engaged in the Bioverativ Restricted Business. “ Bioverativ Restricted Business ” shall mean, collectively, (x) discovering, researching, developing, importing, exporting, manufacturing, marketing, distributing, promoting or selling anywhere in the world any product in the Field of MS and (y) the DMF Business.

 

(c)                         Exceptions . Notwithstanding anything to the contrary set forth in this Section 5.2 , nothing in this Agreement shall prohibit, preclude or in any way restrict either of the Biogen Group or the Bioverativ Group from:

 

(i)                        undertaking any activity expressly contemplated by this Agreement, the Transition Services Agreement or any other Ancillary Agreement;

 

(ii)                     purchasing or acquiring, or being the holder or beneficial owner for passive investment purposes of, equity securities of a Person that, directly or indirectly, engages in (x) with respect to the Biogen Group, the Biogen Restricted Business and (y) with respect to the Bioverativ Group, the Bioverativ Restricted Business; provided that, in the case of this clause (ii), the aggregate holdings of such Group of such equity securities in such Person during the Restricted Period shall not exceed five percent (5%) of the outstanding equity securities of such Person;

 

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(iii)                  purchasing or acquiring or forming a joint venture (whether by merger, an asset, stock or equity acquisition, contribution or otherwise), and thereafter being the holder or beneficial owner of, at least fifty percent (50%) or more of the equity securities or consolidated assets of a Person that, directly or indirectly, engages in (x) with respect to the Biogen Group, the Biogen Restricted Business and (y) with respect to the Bioverativ Group, the Bioverativ Restricted Business; provided that, in the case of this clause (iii), (x) with respect to the Biogen Group, Biogen and (y) with respect to the Bioverativ Group, Bioverativ, shall cause such Person, as promptly as practicable following such purchase or acquisition (and in no event later than twelve (12) months after such purchase or acquisition), to cease engaging in (x) with respect to the Biogen Group, the Biogen Restricted Business and (y) with respect to the Bioverativ Group, the Bioverativ Restricted Business, during the Restricted Period, whether by divestiture or otherwise, for as long as such Person shall remain a member of the Biogen Group or the Bioverativ Group, as the case may be.

 

(d)                        Dispositions .  If Biogen or Bioverativ undergoes a Change of Control after the Distribution Effective Time and prior to the end of the Restricted Period, then the restrictions in this Section 5.2 shall terminate.  “ Change of Control ” shall mean, with respect to Biogen or Bioverativ, as applicable, the occurrence after the Distribution Effective Time of any of the following: (A) the sale, conveyance, transfer or other disposition (however accomplished), in one or a series of related transactions, of all or substantially all of the assets of such Party’s Group to a Third Party that is not an Affiliate of such Party; (B) the consolidation, merger or other business combination of such Party with or into any other to a Third Party that is not an Affiliate of such Party, immediately following which the stockholders of such Party immediately prior to such transaction fail to own in the aggregate at least a majority of the voting power in the election of directors of all the outstanding voting securities of the surviving Person in such consolidation, merger or business combination or of its ultimate publicly traded parent entity; (C) a transaction or series of transactions in which any Person or “group” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) acquires at least thirty-five (35%) of the outstanding voting securities of such Party and effective control of such Party (other than a reincorporation, holding company merger or similar corporate transaction in which each of such Party’s stockholders owns, immediately thereafter, interests in the new parent company in substantially the same percentage as such stockholder owned in such party immediately prior to such transaction); or (D) a majority of the board of directors of such Party ceasing to consist of Continuing Directors.  “ Continuing Directors ” shall mean, with respect to a Party, any member of the Board of Directors of the Party who (a) was a member of such Board of Directors on the Distribution Date or (b) was nominated for election or elected to such Board of Directors with the approval of a majority of the Continuing Directors who were members of such Board of Directors at the time of such nomination or election.

 

Section 5.3                                     No Right to Use Regulatory Information . Except as the Parties may otherwise agree in writing or as would otherwise be permitted by Law: (a) no member of the Biogen Group shall have a right of reference to or otherwise be entitled to use any regulatory filings or other regulatory information owned or controlled by any member of the Bioverativ Group for any products or product candidates in the Bioverativ Business; and (b) no member of the Bioverativ Group shall have a right of reference to or otherwise be entitled to use any

 

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regulatory filings or other regulatory information owned or controlled by any member of the Biogen Group for any products or product candidates in the Biogen Retained Business.

 

Section 5.4                                     Use of Retained Names and Marks .

 

(a)                        Bioverativ hereby acknowledges that Biogen or its Affiliates or its or their licensors own all right, title and interest in and to the company names (including “Biogen” and “Biogen Hemophilia”), trade names, logos, trade dress and other Trademarks, together with all variations, translations, transliterations and acronyms thereof and all company names, Trademarks, Internet domain names, social media accounts, addresses and all other identifiers and other identifiers of source or goodwill containing, incorporating or associated with any of the foregoing, excluding, on and after the Distribution Date, Intellectual Property included in the Bioverativ Assets (collectively, the “ Retained Names and Marks ”), and that, except as expressly provided below, any and all right of Bioverativ to use the Retained Names and Marks shall terminate as of the Distribution Date and shall immediately revert to Biogen or its Affiliates, along with any and all goodwill associated therewith.  Bioverativ further acknowledges that it has no rights in any of the Retained Names and Marks, and that it is not acquiring any rights, directly or indirectly, to use the Retained Names and Marks, except as expressly provided herein.

 

(b)                        Bioverativ shall, during the six (6) months following the Regulatory Authorization Date (the “ Applicable Transition Period ”), be entitled to use (and shall have a limited non-exclusive, non-transferable license to use, without the right to sublicense, the Retained Names and Marks used therein or thereon), solely in connection with the operation of the Bioverativ Business as operated immediately prior to the Distribution Date, all of the Bioverativ Business’s existing stocks of signs, letterheads, invoices, advertisements and promotional materials and all website content and other documents and materials in existence and used by Biogen or its Affiliates in the Bioverativ Business as of the Distribution Effective Time, and contained in the Bioverativ Assets (collectively, the “ Existing Stock ”), in each case, containing the Retained Names and Marks, after which Applicable Transition Period Bioverativ shall cause the removal or obliteration of all Retained Names and Marks from such Existing Stock or cease using such Existing Stock; provided , however , that the Applicable Transition Period shall be twelve (12) months following the Regulatory Authorization Date for (A) all Existing Stock to the extent related to Bioverativ Products and (B) Bioverativ’s use of “formerly Biogen Hemophilia” as a tag line or in any Bioverativ logo. Notwithstanding the foregoing, with respect to any and all Existing Stock related to Bioverativ Products, Bioverativ shall be permitted to use Retained Names and Marks in or on such Existing Stock following the Applicable Transition Period to the extent required or permitted by any applicable Governmental Entity; provided, that Bioverativ shall use commercially reasonable efforts to cease using Retained Names and Marks as soon as practicable following the expiration of the Applicable Transition Period. Upon Biogen’s request, Bioverativ shall promptly execute all assignment, transfer and other documents, and, at Biogen’s sole cost and expense, take all steps, in each case, that are necessary to confirm, effectuate or otherwise evidence Biogen’s and its Affiliates’ or any of its or their licensors’ rights, title and interests in and to, and control over, the Retained Names and Marks, including any registration or application thereof.

 

(c)                         Except as expressly provided in this Section 5.3 or to the extent contemplated in the IP License Agreement, no other right to use the Retained Names and Marks,  any other rights in the Trademarks of Biogen or its Affiliates (or any of its or their licensors) is granted by Biogen or its Affiliates to Bioverativ, its Affiliates or, after the Distribution Date, the Bioverativ Business, whether by implication or otherwise, and nothing hereunder permits Bioverativ, its Affiliates or, after the Distribution Date, the Bioverativ Business to use the

 

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Retained Names and Marks in any manner, other than in connection with the Existing Stock as set forth in this Section 5.4 , or to register or seek to register, or to permit any Third Party to register or to seek to register, any of the Retained Names and Marks or any other rights in Trademarks of Biogen or its Affiliates not transferred to Bioverativ or Bioverativ’s Affiliates pursuant to this Agreement in any jurisdiction.  Bioverativ shall ensure that all use of the Retained Names and Marks in connection with the Bioverativ Business, after the Distribution Date, as provided in this Section 5.4 , shall (i) be only with respect to goods and services of a level of quality equal to or greater than the quality of goods and services with respect to which Biogen and its Affiliates used the Retained Names and Marks immediately prior to the Distribution Date, (ii) comply with all reasonable trademark usage restrictions or other guidelines furnished by Biogen or its Affiliates, as applicable, to Bioverativ with respect to the use of such Retained Names and Marks and (iii) comply with all applicable Laws.  Any and all goodwill generated by the use of the Retained Names and Marks as permitted under this Section 5.4 shall inure solely to the benefit of Biogen and its Affiliates (or its or their licensors), and if Bioverativ obtains any goodwill, right, title or interest in or to any of the Retained Names and Marks, Bioverativ shall assign and hereby irrevocably assigns to Biogen or its Affiliates all such goodwill, rights, title and interests.  In any event, Bioverativ shall not, and shall cause its Affiliates not to, and, after the Distribution Date, the Bioverativ Business not to, use the Retained Names and Marks in any manner that would damage or tarnish the reputation of Biogen or its Affiliates or the goodwill associated with the Retained Names and Marks, or take any action that would adversely affect Biogen’s or its Affiliates’ (or its or their licensor(s)’) rights in any of the Retained Names and Marks or the validity, enforceability or distinctiveness of any of the Retained Names and Marks or any registrations or applications therefor.  Following the Applicable Transition Period, Bioverativ shall cease all use of any of the Retained Names and Marks and it shall not, and shall cause its Affiliates not to, adopt, use, register or seek to register any rights in Trademarks that are substantially similar to, confusingly similar to or dilutive of any of the Retained Names and Marks (including the trade dress used with the Bioverativ Products prior to the Distribution Date).

 

(d)                        Bioverativ agrees that none of Biogen or its Affiliates (or any of its or their licensors) shall have any responsibility for claims by Third Parties arising out of, or relating to, the use by Bioverativ or any of its Affiliates of any Retained Names and Marks after the Distribution Date, other than such claims that the use of the Retained Names and Marks in connection with the Bioverativ Business in accordance with the terms and conditions of this Section 5.4 or the IP License Agreement infringes the Intellectual Property rights of any Third Party.  Bioverativ hereby acknowledges and agrees that in the event of any breach or threatened breach of this Section 5.4 , Biogen shall have the right to specific performance and injunctive or other equitable relief in accordance with Section 10.12 , in addition to any and all other rights and remedies at law or in equity, and all such rights and remedies shall be cumulative.

 

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ARTICLE VI

 

INDEMNIFICATION

 

Section 6.1                                     Release of Pre-Distribution Claims .

 

(a)                        Except (x) as provided in Section 6.1(b) , (y) as may be otherwise expressly provided in this Agreement or in any Ancillary Agreement and (z) for any matter for which either Party is entitled to indemnification pursuant to this Article VI :

 

(i)                        Biogen, for itself and each member of the Biogen Group and, to the extent permitted by Law, all Persons who at any time prior to the Distribution Effective Time were directors, officers, agents or employees of any member of the Biogen Group (in their respective capacities as such), in each case, together with their respective heirs, executors, administrators, successors and assigns, does hereby remise, release and forever discharge Bioverativ and the other members of the Bioverativ Group and all Persons who at any time prior to the Distribution Effective Time were stockholders, directors, officers, agents or employees of any member of the Bioverativ Group (in their respective capacities as such), in each case, together with their respective heirs, executors, administrators, successors and assigns, from any and all (A) Biogen Retained Liabilities and (B) Liabilities existing or arising: (1) in connection with the implementation of the Separation (including the Distribution); or (2) from actions, inactions, events, omissions, conditions, facts or circumstances occurring or existing prior to the Distribution Effective Time (whether or not such Liabilities cease being contingent, mature, become known, are asserted or foreseen, or accrue, in each case before, at or after the Distribution Effective Time), in each case to the extent relating to, arising out of or resulting from the Biogen Retained Business, the Biogen Retained Assets or the Biogen Retained Liabilities, whether at Law or in equity (including any right of contribution), whether arising under any Contract, by operation of Law or otherwise, in each case, existing or arising from any acts or events occurring or failing to occur or alleged to have occurred or to have failed to occur or any conditions existing or alleged to have existed on or before the Distribution Effective Time, including in connection with the Separation and any of the other transactions contemplated hereunder and under the Ancillary Agreements (such liabilities, the “ Biogen Released Liabilities ”) and in any event shall not, and shall cause its respective Subsidiaries not to, bring any Action against any member of the Bioverativ Group in respect of any Biogen Released Liabilities; provided , however , that nothing in this Section 6.1(a)(i)  shall relieve any Person released in this Section 6.1(a)(i) who, after the Distribution Effective Time, is a director, officer or employee of any member of the Bioverativ Group and is no longer a director, officer or employee of any member of the Biogen Group from Liabilities arising out of, relating to or resulting from his or her service as a director, officer or employee of any member of the Bioverativ Group after the Distribution Effective Time.  Notwithstanding the foregoing, nothing in this Agreement shall be deemed to limit Biogen, any member of the Biogen Group, or their respective Affiliates from commencing any Actions against any Bioverativ officer, director, agent or employee, or their respective heirs, executors, administrators, successors and assigns with regard to matters arising from, or relating to criminal acts by any such officers, directors, agents or employees.

 

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(ii)                     Bioverativ, for itself and each member of the Bioverativ Group and, to the extent permitted by Law, all Persons who at any time prior to the Distribution Effective Time were directors, officers, agents or employees of any member of the Bioverativ Group (in their respective capacities as such), in each case, together with their respective heirs, executors, administrators, successors and assigns, does hereby remise, release and forever discharge Biogen and the other members of the Biogen Group and all Persons who at any time prior to the Distribution Effective Time were stockholders, directors, officers, agents or employees of any member of the Biogen Group (in their respective capacities as such), in each case, together with their respective heirs, executors, administrators, successors and assigns, from any and all (A) Bioverativ Liabilities and (B) Liabilities existing or arising: (1) in connection with the implementation of the Separation (including the Distribution); or (2) from actions, inactions, events, omissions, conditions, facts or circumstances occurring or existing prior to the Distribution Effective Time (whether or not such Liabilities cease being contingent, mature, become known, are asserted or foreseen, or accrue, in each case before, at or after the Distribution Effective Time), in each case to the extent relating to, arising out of or resulting from the Bioverativ Business, the Bioverativ Assets or the Bioverativ Liabilities, whether at Law or in equity (including any right of contribution), whether arising under any Contract, by operation of Law or otherwise, in each case, existing or arising from any acts or events occurring or failing to occur or alleged to have occurred or to have failed to occur or any conditions existing or alleged to have existed on or before the Distribution Effective Time, including in connection with the Separation and any of the other transactions contemplated hereunder and under the Ancillary Agreements (such liabilities, the “ Bioverativ Released Liabilities ”) and in any event shall not, and shall cause its respective Subsidiaries not to, bring any Action against any member of the Biogen Group in respect of any Bioverativ Released Liabilities; provided , however , that for purposes of this Section 6.1(a)(ii) , the members of the Bioverativ Group shall also release and discharge any officers or other employees of any member of the Biogen Group, to the extent any such officers or employees served as directors or officers of any member of the Bioverativ Group prior to the Distribution, from any and all Liabilities or responsibilities for any and all past actions or failures to take action, in each case in their respective capacities as directors or officers, as the case may be, of any such member of the Bioverativ Group, prior to the date of the Distribution.  Notwithstanding the foregoing, nothing in this Agreement shall be deemed to limit Bioverativ, any member of the Bioverativ Group, or their respective Affiliates from commencing any Actions against any Biogen officer, director, agent or employee, or their respective heirs, executors, administrators, successors and assigns with regard to matters arising from, or relating to criminal acts by any such officers, directors, agents or employees.

 

(b)                        Nothing contained in this Agreement, including Section 6.1(a)  or Section 2.5 , shall impair or otherwise affect any right of any Party and, as applicable, a member of such Party’s Group, as well as their respective heirs, executors,  administrators, successors and assigns, to enforce this Agreement, any Ancillary Agreement or any agreements, arrangements,

 

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commitments or understandings contemplated in this Agreement or in any Ancillary Agreement to continue in effect after the Distribution Effective Time.  In addition, nothing contained in Section 6.1(a)  shall:

 

(i)                        release any Person from any Liability Assumed, Transferred or expressly allocated to a Party or a member of such Party’s Group pursuant to or as contemplated by, or any other Liability of any member of such Group under, this Agreement or any Ancillary Agreement including (A) with respect to Biogen, any Biogen Retained Liability, (B) with respect to Bioverativ, any Bioverativ Liability, (C) any Liability expressly preserved pursuant to Section 2.5 and (D) any Liability that the Parties may have with respect to indemnification or contribution pursuant to this Agreement or otherwise for Actions brought against the Parties by Third Parties, which Liability shall be governed by the provisions of this Agreement and, in particular, this Article VI and, if applicable, the appropriate provisions of the Ancillary Agreements;

 

(ii)                     release any Person from any Liability provided for in or resulting from any other Contract or understanding that is entered into after the Distribution Effective Time between any Party (and/or a member of such Party’s Group), on the one hand, and the other Party (and/or a member of such Party’s Group), on the other hand;

 

(iii)                  release any Person other than the Persons released in Section 6.1(a) ; provided , that the Parties agree not to bring any Action or permit any other member of their respective Group to bring any Action against a Person released in Section 6.1(a)  with respect to such Liability; and

 

(iv)                 release any Bioverativ Employee from any Contract with any member of the Biogen Group to the extent related to the Biogen Retained Assets, Biogen Retained Liabilities or Biogen Retained Business.

 

In addition, nothing contained in Section 6.1(a)  shall release Biogen from indemnifying any director, officer or employee of Bioverativ who was a director, officer or employee of Biogen or any of its Affiliates prior to the Distribution Effective Time, as the case may be, with respect to which he or she was entitled to such indemnification pursuant to an obligation existing immediately prior to the Distribution Effective Time; it being understood that if the underlying obligation giving rise to such Action is established by a court of competent jurisdiction to be a Bioverativ Liability, Bioverativ shall indemnify Biogen for such Liability (including Biogen’s costs to indemnify the director, officer or employee) in accordance with the provisions set forth in this Article VI .

 

(c)                         Each Party shall not, and shall not permit any member of its Group to, make any claim for offset, or commence any Action, including any claim of contribution or any indemnification, against any other Party or any member of any other Party’s Group, or any other Person released pursuant to Section 6.1(a) , with respect to any Liabilities released pursuant to Section 6.1(a) .

 

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(d)                        If any Person associated with a Party (including any director, officer or employee of a Party) initiates any Action with respect to claims released by this Section 6.1 , the Party with which such Person is associated shall be responsible for the reasonable fees and expenses of counsel of the other Party and/or the members of such Party’s Group, as applicable, and such other Party shall be indemnified for all Liabilities incurred in connection with such Action in accordance with the provisions set forth in this Article VI .

 

Section 6.2                                     Indemnification by Biogen . In addition to any other provisions of this Agreement requiring indemnification and except as otherwise specifically set forth in any provision of this Agreement or of any Ancillary Agreement, following the Distribution Effective Time, Biogen shall and shall cause the other members of the Biogen Group to indemnify, hold harmless and defend the Bioverativ Indemnitees from and against any and all Indemnifiable Losses of the Bioverativ Indemnitees to the extent relating to, arising out of, by reason of or otherwise in connection with (a) the Biogen Retained Liabilities, including the failure of any member of the Biogen Group or any other Person to pay, perform or otherwise discharge any Biogen Retained Liability in accordance with its respective terms, whether arising prior to, on or after the Distribution Effective Time, or (b) any breach by Biogen of any provision of this Agreement or any Ancillary Agreement unless such Ancillary Agreement expressly provides for separate indemnification therein, in which case any such indemnification claims shall be made thereunder (each, a “ Bioverativ Claim ”).

 

Section 6.3                                     Indemnification by Bioverativ . In addition to any other provisions of this Agreement requiring indemnification and except as otherwise specifically set forth in any provision of this Agreement or of any Ancillary Agreement, following the Distribution Effective Time, Bioverativ shall and shall cause the other members of the Bioverativ Group to indemnify, hold harmless and defend the Biogen Indemnitees from and against any and all Indemnifiable Losses of the Biogen Indemnitees to the extent relating to, arising out of, by reason of or otherwise in connection with (a) the Bioverativ Liabilities, including the failure of any member of the Bioverativ Group or any other Person to pay, perform or otherwise discharge any Bioverativ Liability in accordance with its respective terms, whether prior to, on or after the Distribution Effective Time, or (b) any breach by Bioverativ of any provision of this Agreement or any Ancillary Agreement unless such Ancillary Agreement expressly provides for separate indemnification therein, in which case any such indemnification claims shall be made thereunder (each, a “ Biogen Claim ”).

 

Section 6.4                                     Procedures for Indemnification .

 

(a)                        Direct Claims . Other than with respect to Third Party Claims, which shall be governed by Section 6.4(b) :

 

(i)                        if a Bioverativ Indemnitee has made a determination that it is or may be entitled to indemnification in respect of any Bioverativ Claim, the Bioverativ Indemnitee shall so notify Biogen as promptly as reasonably possible after becoming aware of the existence of such Bioverativ Claim; and

 

(ii)                     if a Biogen Indemnitee has made a determination that it is or may be entitled to indemnification in respect of any Biogen Claim, the

 

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Biogen Indemnitee shall so notify Bioverativ as promptly as reasonably possible after becoming aware of the existence of such Biogen Claim

 

(any such claim made pursuant to Section 6.4(a)(i)  or this Section 6.4(a)(ii) , a “ Direct Claim ”).

 

Each such notice shall be in writing and shall describe in reasonable detail the basis for the claim for indemnification hereunder and set forth, to the extent known, the estimated amount of Indemnifiable Losses for which indemnification may be sought hereunder relating to such claim (including, to the extent practicable, the method of computation thereof); provided , however , that the failure to provide such written notice shall not release the Indemnifying Party from any of its obligations except and solely to the extent the Indemnifying Party shall have been actually materially prejudiced as a result of such failure.  The Indemnifying Party will have a period of forty-five (45) days after receipt of any such notice under this Section 6.4(a)  to respond to the claimant thereto.  If the Indemnifying Party fails to respond within such period, the claim specified in such notice from the Indemnitee shall be conclusively determined to be a indemnifiable claim for which the Indemnifying Party shall be liable to the applicable Indemnitee(s) hereunder.

 

(b)                        Third Party Claims . If a claim or demand is made against an Indemnitee by any Third Party (a “ Third Party Claim ”) as to which such Indemnitee is or may be entitled to indemnification pursuant to this Agreement, Biogen (on behalf of the Biogen Indemnitees) or Bioverativ (on behalf of the Bioverativ Indemnitees), as applicable (such claimant, the “ Claiming Party ”), shall notify the Indemnifying Party of the Third Party Claim in writing and in reasonable detail describing the basis for any claim for indemnification hereunder, referring to the provisions of this Agreement or any Ancillary Agreement in respect of which such right of indemnification is claimed by such Indemnitee or arises and including copies of all Third Party written notices and documents received by the Claiming Party (and any or all of its Indemnitees) relating to the Third Party Claim promptly (and in any event within twenty (20) days) after receipt by such Indemnitee of written notice of the Third Party Claim; provided , however , that the failure to provide notice of any such Third Party Claim pursuant to this sentence shall not release the Indemnifying Party from any of its obligations except and solely to the extent the Indemnifying Party shall have been actually materially prejudiced as a result of such failure.  Thereafter, the Claiming Party shall deliver to the Indemnifying Party, promptly (and in any event within five (5) Business Days) after the receipt thereof by the Claiming Party (or any of its Indemnitees), copies of any and all additional Third Party written notices and documents (including court papers) received by the Claiming Party (or any of its Indemnitees) relating to the Third Party Claim.  For all purposes of this Section 6.4(b) , each Party shall be deemed to have notice of the matters listed or described on Schedule 1.1(19)(ix) .

 

(c)                         Subject to the provisions of this Section 6.4(c) , the Indemnifying Party has the right, exercisable by written notice to the Claiming Party within thirty (30) days after receipt of notice from the Claiming Party pursuant to Section 6.4(b) , to assume and conduct the defense (including, subject to the conditions of this Section 6.4(c) , settlement) of such Third Party Claim in accordance with the limits set forth in this Agreement with counsel selected by the Indemnifying Party and reasonably acceptable to the applicable Indemnitees.  If the Indemnifying Party does not assume the defense of a Third Party Claim in accordance with this

 

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Section 6.4(c) , the Indemnitee may defend the Third Party Claim.  If the Indemnifying Party has assumed the defense of a Third Party Claim as provided in this Section 6.4(c) , the Indemnifying Party shall not be liable for any legal expenses subsequently incurred by the Indemnitee in connection with the defense of the Third Party Claim; provided , however , that if (w) in the reasonable judgment of the Indemnitee, after consultation with outside counsel, there exists a conflict of interest between the Indemnifying Party and the applicable Indemnitee(s) in the defense of such Third Party Claim by the Indemnifying Party, (x) the party making such Third Party Claim is a Governmental Authority with regulatory or other authority over the Indemnitee or any of its material assets, (y) the Third Party Claim seeks injunctive or other nonmonetary relief that, if granted, would reasonably be expected to have a material and adverse effect on the Indemnitee’s business or (z) the Indemnifying Party fails to take reasonable steps necessary to defend diligently such Third Party Claim, the Indemnitee may assume its own defense, and the Indemnifying Party shall be liable for all reasonable costs or expenses paid or incurred in connection with such defense.  The Indemnifying Party or the Indemnitee, as the case may be, has the right to participate in (but, subject to the prior sentence, not control), at its own expense, the defense of any Third Party Claim that the other Person is defending as provided in this Agreement.  The Indemnifying Party, if it has assumed the defense of any Third Party Claim as provided in this Agreement, may not, without the prior written consent of the Indemnitee (not to be unreasonably withheld, conditioned or delayed), consent to a settlement or compromise of, or the entry of any judgment arising from, any such Third Party Claim.  The Indemnitee may consent to a settlement or compromise of, or the entry of any judgment arising from, any Third Party Claim, the defense of which has not been assumed by the Indemnifying Party, only with the prior written consent of the Indemnifying Party, not to be unreasonably withheld, conditioned or delayed.

 

(d)                        The Claiming Party and the Indemnifying Party shall (and the Claiming Party shall cause the applicable Indemnitee(s) to) make reasonably available to each other and their respective agents and representatives all relevant records available to them that are necessary or appropriate for the defense of any Third Party Claim, subject to any bona fide claims of attorney-client privilege, and each of the Indemnifying Party and the Claiming Party shall use its reasonable efforts to assist, and to cause the employees and counsel of such party to assist, in the defense of such Third Party Claim.  If a Party asserts its right to participate in the defense and investigation of any Third Party Claim, the Party controlling the defense and investigation of such Third Party Claim shall act in good faith and reasonably consult and cooperate with the Indemnified Party or the Indemnifying Party, as the case may be, in connection with any appearances, briefs, arguments and proposals made or submitted by or on behalf of any party in connection with the Third Party Claim (including considering in good faith all reasonable additions, deletions or changes suggested by the Indemnified Party or the Indemnifying Party, as the case may be, in connection any filings made with any Governmental Entity or proposals to the Third Party claimant in connection therewith).  With respect to any Third Party Claim that implicates both Parties in any material respect due to the allocation of Liabilities, responsibilities for management of defense and related indemnities pursuant to this Agreement or any of the Ancillary Agreements, the Parties agree to use commercially reasonable efforts to cooperate fully and maintain a joint defense (in a manner that, to the extent reasonably practicable, will preserve for all Parties any Privilege with respect thereto). The Party that is not responsible for managing the defense of any such Third Party Claim shall, upon reasonable request, be consulted with respect to significant matters relating thereto and may, if necessary or

 

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helpful, retain counsel to assist in the defense of such claims. Notwithstanding the foregoing, nothing in this Section 6.4(d)  shall derogate from a Party’s right to control the defense of any Action in accordance with Section 6.4 .

 

(e)                         Each of the Parties agrees that at all times from and after the Distribution Effective Time, if an Action is commenced by a Third Party naming two (2) or more Parties (or any member of such Parties’ respective Groups) as defendants and with respect to which one or more named Parties (or any member of such Party’s Group) is a nominal defendant and/or such Action is related solely to an Asset or Liability that the other Party has been allocated under this Agreement, any Ancillary Agreement or any Third Party Agreement, then the other Party or Parties shall use commercially reasonable efforts to cause such nominal defendant to be removed from such Action, as soon as reasonably practicable.

 

(f)                          The provisions of this Section 6.4 (other than this Section 6.4(f) ) and Section 6.7 (other than Section 6.7(g) ) shall not apply to Taxes (Taxes being governed by the Tax Matters Agreement).

 

Section 6.5                                     Indemnification Obligations Net of Insurance Proceeds and Other Amounts .

 

(a)                        Any recovery by any Party (including any of its Indemnitees) for any Indemnifiable Loss subject to indemnification pursuant to this Article VI shall be calculated (i) net of Insurance Proceeds actually received by such Party (or any of its Indemnitees) with respect to any Indemnifiable Loss and (ii) net of any proceeds actually received by such Party (or any of its Indemnitees) from any Third Party with respect to any such Liability corresponding to the Indemnifiable Loss (“ Third Party Proceeds ”), in the case of (i) and (ii) net of the costs of collection thereof and any increase in premium attributable thereto under applicable Third Party Policies.  Accordingly, the amount which any Indemnifying Party is required to pay pursuant to this Article VI to any Indemnitee pursuant to this Article VI shall be reduced by any Insurance Proceeds or Third Party Proceeds theretofore actually recovered by or on behalf of the Indemnitee corresponding to the related Indemnifiable Loss.  If an Indemnitee receives a payment required by this Agreement from an Indemnifying Party corresponding to any Indemnifiable Loss (an “ Indemnity Payment ”) and subsequently receives Insurance Proceeds or Third Party Proceeds, then the Indemnitee shall pay to the Indemnifying Party an amount equal to the excess of the Indemnity Payment received over the amount of the Indemnity Payment that would have been due if the Insurance Proceeds or Third Party Proceeds had been received, realized or recovered before the Indemnity Payment was made.

 

(b)                        Insurers and Other Third Parties Not Relieved . The Parties hereby agree that an insurer or other Third Party that would otherwise be obligated to pay any amount shall not be relieved of the responsibility with respect thereto or have any subrogation rights with respect thereto by virtue of any provision contained in this Agreement or any Ancillary Agreement, and that no insurer or any other Third Party shall be entitled to a “windfall” (e.g., a benefit they would not otherwise be entitled to receive, or the reduction or elimination of an insurance coverage obligation that they would otherwise have, in the absence of the indemnification or release provisions) by virtue of any provision contained in this Agreement or any Ancillary Agreement.  Each Party shall, and shall cause its Subsidiaries to, use commercially

 

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reasonable efforts to collect or recover, or allow the Indemnifying Party to collect or recover, or cooperate with each other in collecting or recovering, any Insurance Proceeds that may be collectible or recoverable respecting the Liabilities for which indemnification may be available under this Article VI .  Notwithstanding the foregoing, an Indemnifying Party may not delay making any indemnification payment required under the terms of this Agreement, or otherwise satisfying any indemnification obligation, pending the outcome of any Actions to collect or recover Insurance Proceeds, and an Indemnitee need not attempt to collect any Insurance Proceeds prior to making a claim for indemnification or receiving any Indemnity Payment otherwise owed to it under this Agreement or any Ancillary Agreement.

 

Section 6.6                                     Contribution . If the indemnification provided for in this Article VI is unavailable for any reason to an Indemnitee (other than failure to provide notice with respect to any Third Party Claims in accordance with Section 6.4(b) ) in respect of any Indemnifiable Loss, then the Indemnifying Party shall, in accordance with this Section 6.6 , contribute to the Indemnifiable Losses incurred, paid or payable by such Indemnitee as a result of such Indemnifiable Loss in such proportion as is appropriate to reflect the relative fault of Bioverativ and each other member of the Bioverativ Group, on the one hand, and Biogen and each other member of the Biogen Group, on the other hand, in connection with the circumstances which resulted in such Indemnifiable Loss.  Solely for purposes of determining relative fault pursuant to this Section 6.6 : (i) any fault associated with information contained in the Distribution Disclosure Documents shall be deemed to be allocated to Bioverativ and the other members of the Bioverativ Group; (ii) any fault associated with the conduct of the Biogen Retained Business prior to the Distribution Effective Time shall be deemed to be allocated to Biogen and the other members of the Biogen Group, and no such fault shall be deemed to be the fault of Bioverativ or any other member of the Bioverativ Group; and (iii) any fault associated with the conduct of the Bioverativ Business prior to the Distribution Effective Time shall be deemed to be the fault of Bioverativ and the other members of the Bioverativ Group, and no such fault shall be deemed to be the fault of Biogen or any other member of the Biogen Group.

 

Section 6.7                                     Additional Matters; Survival of Indemnities .

 

(a)                        The agreements contained in this Article VI shall remain operative and in full force and effect, regardless of (i) any investigation made by or on behalf of any Indemnitee; and (ii) the knowledge by the Indemnitee of Indemnifiable Losses for which it might be entitled hereunder.  The agreements contained in this Article VI shall survive the Distribution.

 

(b)                        The rights and obligations of each Party and their respective Indemnitees under this Article VI shall survive (i) the sale or other Transfer by any Party or its respective Subsidiaries of any Assets or businesses or the assignment by it of any Liabilities and (ii) any merger, consolidation, business combination, sale of all or substantially all of the Assets, restructuring, recapitalization, reorganization or similar transaction involving either Party or any of its Subsidiaries.

 

(c)                         Except to the extent set forth in any Ancillary Agreement, absent fraud or willful misconduct by an Indemnifying Party, the provisions of this Article VI shall be the sole and exclusive remedy of an Indemnitee for any monetary or compensatory damages or losses resulting from any breach of this Agreement or any Ancillary Agreement and each Indemnitee

 

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expressly waives and relinquishes any and all rights, claims or remedies such Person may have with respect to the foregoing other than under this Article VI against any Indemnifying Party.

 

(d)                        Notwithstanding the foregoing, to the extent any Ancillary Agreement provides procedures for indemnification or contribution that differ from the provisions set forth in this Article VI , the terms of the Ancillary Agreement will govern.

 

(e)                         Any amounts payable pursuant to this Article VI shall be paid without duplication, and in no event shall any Party receive any payment in respect of an Indemnifiable Loss or receive contribution under different provisions of any Ancillary Agreement in respect of the same Liabilities.

 

(f)                          Any amount to be paid or reimbursed by an Indemnifying Party (or a member of such Party’s Group) to an Indemnitee pursuant to this Article VI shall be paid in accordance with the procedures set forth in Section 10.11 .

 

(g)                         The Parties shall report for all Tax purposes any amounts payable pursuant to this Article VI in accordance with Section 13.01 of the Tax Matters Agreement.

 

ARTICLE VII

 

PRESERVATION OF RECORDS; ACCESS TO INFORMATION; CONFIDENTIALITY; PRIVILEGE

 

Section 7.1                                     Preservation of Information .

 

(a)                        Except as otherwise required or agreed in writing, or as otherwise provided in any Ancillary Agreement, with regard to any information referenced in Section 7.3 , each Party shall use its commercially reasonable efforts, at its sole cost and expense, to retain, until the latest of, as applicable, (i) the date on which such Information is no longer required to be retained pursuant to Biogen’s applicable record retention policy as in effect immediately prior to the Distribution, including, without limitation, pursuant to any “Litigation Hold” issued by Biogen or any of its Subsidiaries prior to the Distribution, (ii) the concluding date of any period as may be required by any applicable Law, (iii) the concluding date of any period during which such Information relates to a pending or threatened Action which is known to the members of the Biogen Group or Bioverativ Group, as applicable, in possession of such Information at the time any retention obligation with regard to such Information would otherwise expire, and (iv) the concluding date of any period during which the destruction of such Information could interfere with a pending or threatened investigation by a Governmental Entity which is known to the members of the Biogen Group or Bioverativ Group, as applicable, in possession of such Information at the time any retention obligation with regard to such Information would otherwise expire; provided , that with respect to any pending or threatened Action arising after the Distribution, clause (iii) of this sentence applies only to the extent that whichever member of the Biogen Group or Bioverativ Group, as applicable, is in possession of such Information has been notified in writing pursuant to a “Litigation Hold” by the other Party of the relevant pending or threatened Action.  The Parties agree that upon written request from either Party that certain Information relating to the Bioverativ Business, the Biogen Retained Business or the transactions

 

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contemplated hereby be retained in connection with an Action, the other Party shall use reasonable efforts to preserve and not to destroy or dispose of such Information without the consent of the requesting Party.

 

(b)                        Biogen and Bioverativ intend that any transfer of information that would otherwise be within the attorney-client or attorney work product privileges not operate as a waiver of any potentially applicable privilege.

 

Section 7.2                                     Financial Statements and Accounting .

 

(a)                        From the Distribution Effective Time until the completion of each Party’s audit for the fiscal year ending December 31, 2017, each Party agrees to provide reasonable assistance and, subject to Section 7.6 , reasonable access to its properties, books and records, other information in its possession and control and personnel, and to use its commercially reasonable efforts to cooperate with the other Party’s requests, in each case to enable (i) such other Party to meet its timetable for dissemination of its earnings releases, financial statements and management’s assessment of the effectiveness of its disclosure controls and procedures and its internal control over financial reporting in accordance with Items 307 and 308, respectively, of Regulation S-K, (ii) such other Party’s accountants to timely complete their review of the quarterly financial statements and audit of the annual financial statements of such other Party, including, to the extent applicable to such Party, its auditor’s audit of its internal control over financial reporting and management’s assessment thereof in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 and the Commission’s and Public Company Accounting Oversight Board’s rules and auditing standards thereunder and (iii) such other Party to respond to any written request or official comment from a Governmental Entity, including in connection with responding to a comment letter from the Commission; provided , that in connection with this clause (iii), each Party shall provide reasonable access on the terms set forth in this Section 7.2 for a period of three (3) years following the Distribution Date.

 

(b)                        Nothing in this Article VII shall require any Party to violate any agreement with any Third Party regarding the confidentiality of Information relating to that Third Party or its business; provided , however , that in the event that a Party is required under this Section 7.2 to disclose any such Information, such Party shall use commercially reasonable efforts to seek to obtain such Third Party’s written consent to the disclosure of such Information.

 

Section 7.3                                     Provision of Information . Other than in circumstances in which indemnification is sought pursuant to Article VI (in which event the provisions of such Article VI shall govern) or for matters related to provision of Tax records (in which event the provisions of the Tax Matters Agreement shall govern), and subject to appropriate restrictions for Privileged Information or Confidential Information:

 

(a)                        From and after the Distribution Effective Time, and subject to compliance with the terms of the Ancillary Agreements, upon the prior written reasonable request by, and at the expense of, Bioverativ for specific and identified information that: (i) primarily relates to Bioverativ or the Bioverativ Business, as the case may be, prior to the Distribution Effective Time; (ii) is necessary for Bioverativ to comply with the terms of, or otherwise perform under, any Shared Contract or Ancillary Agreement to which Biogen and/or

 

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Bioverativ are parties; (iii) is otherwise required by Bioverativ with regard to reasonable compliance with reporting, disclosure, filing or other requirements imposed on Bioverativ (including under applicable securities laws) by a Governmental Entity having jurisdiction over Bioverativ; or (iv) is otherwise for use in any other judicial, regulatory, administrative or other proceeding or in order to satisfy audit, accounting, claims, regulatory, Action or other similar requirements, as applicable, Biogen shall provide, as soon as reasonably practicable following the receipt of such request, appropriate access or, to the extent such information is reasonably practicable to identify and extract, copies of such information (or the originals thereof if Bioverativ has a reasonable need for such originals) in the possession or control of Biogen or any of its Subsidiaries, but only to the extent such items so relate and are not already in the possession or control of Bioverativ or any of its Subsidiaries; provided , that, to the extent any originals are delivered to Bioverativ pursuant to this Agreement, a Shared Contract or the Ancillary Agreements, Bioverativ shall, at its own expense, return them to Biogen within a reasonable time after the need to retain such originals has ceased; provided further , that, in the event that Biogen, in its sole discretion, determines that any such access or the provision of any such information (including information requested under Section 7.2 ) would violate any Law or Contract with a Third Party or waive any attorney-client privilege, rights under the work product doctrine or other applicable privilege, Biogen shall not be obligated to provide such information requested by Bioverativ.  Notwithstanding the foregoing, Biogen shall not be obligated to provide any requested information pursuant to clause (iii) or (iv) above following the date that is eighteen (18) months from the date of this Agreement (or such later time or times as the Parties may agree).

 

(b)                        From and after the Distribution Effective Time, and subject to compliance with the terms of the Ancillary Agreements, upon the prior written reasonable request by, and at the expense of, Biogen for specific and identified information that: (i) primarily relates to Biogen or the Biogen Retained Business, as the case may be, prior to the Distribution Effective Time; (ii) is necessary for Biogen to comply with the terms of, or otherwise perform under, any Shared Contract or Ancillary Agreement to which Biogen and/or Bioverativ are parties; (iii) is otherwise required by Biogen with regard to reasonable compliance with reporting, disclosure, filing or other requirements imposed on Biogen (including under applicable securities laws) by a Governmental Entity having jurisdiction over Biogen; or (iv) is otherwise for use in any other judicial, regulatory, administrative or other proceeding or in order to satisfy audit, accounting, claims, regulatory, Action or other similar requirements, as applicable, Bioverativ shall provide, as soon as reasonably practicable following the receipt of such request, appropriate access or, to the extent such information is reasonably practicable to identify and extract, copies of such information (or the originals thereof if Biogen has a reasonable need for such originals) in the possession or control of Bioverativ or any of its Subsidiaries, but only to the extent such items so relate and are not already in the possession or control of Biogen or any of its Subsidiaries; provided that, to the extent any originals are delivered to Biogen pursuant to this Agreement, a Shared Contract or the Ancillary Agreements, Biogen shall, at its own expense, return them to Bioverativ within a reasonable time after the need to retain such originals has ceased; provided further , that, in the event that Bioverativ, in its sole discretion, determines that any such access or the provision of any such information (including information requested under Section 7.2 ) would violate any Law or Contract with a Third Party or waive any attorney-client privilege, the work product doctrine or other applicable privilege, Bioverativ shall not be obligated to provide such information requested by Biogen.

 

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Notwithstanding the foregoing, Bioverativ shall not be obligated to provide any requested information pursuant to clause (iii) or (iv) above following the date that is eighteen (18) months from the date of this Agreement (or such later time or times as the Parties may agree).

 

(c)                         In connection with the provision of information under this Section 7.3 , the providing Party shall be entitled to redact any portion of the information to the extent related to any matter other than the receiving Party’s business.  Each of Biogen and Bioverativ agree to make their respective personnel available during regular business hours to discuss the information exchanged pursuant to this Section 7.3 .

 

Section 7.4                                     Witness Services; Cooperation . At all times from and after the Distribution Effective Time, each of Biogen and Bioverativ shall use its commercially reasonable efforts to make available to the other Party, upon reasonable written request, its and its Subsidiaries’ officers, directors, employees and agents (taking into account the business demands of such individuals) as witnesses to the extent that (i) such Persons may reasonably be required to testify in connection with the prosecution or defense of any Action in which the requesting Party may from time to time be involved (except for claims, demands or Actions in which one or more members of one Group is adverse to one or more members of the other Group) and (ii) there is no conflict in the Action between the requesting Party and the other Party.  Notwithstanding any provisions of Article VII to the contrary, after the Distribution Effective Time, each Party shall use commercially reasonable efforts to assist (or cause the other members of its Group to assist) the other with respect to any Action or potential Action upon the request of such other Party, provided that any such expenses incurred in connection therewith shall be at such other Party’s sole expense.

 

Section 7.5                                     Reimbursement; Other Matters . Except to the extent otherwise contemplated by this Agreement or any Ancillary Agreement, a Party providing information, access to information or services to the other Party pursuant to this Article VII shall be entitled to receive from the recipient, upon the presentation of invoices therefor, payments for such amounts, relating to supplies, disbursements and other out-of-pocket expenses (which shall not include the costs of salaries and benefits of employees of such Party or any pro rata portion of overhead or other costs of employing such employees which would have been incurred by such employees’ employer regardless of the employees’ service with respect to the foregoing), as may be reasonably incurred and properly paid under applicable Law in providing such information, access to such information or services.

 

Section 7.6                                     Confidentiality .

 

(a)                        Except as otherwise provided herein, in any Ancillary Agreement, or in any Contract between a Party or its Subsidiaries, on the one hand, and their respective employees, on the other hand, each of Biogen and Bioverativ shall hold, and shall cause the other members of their respective Groups and their respective Representatives to hold, in strict confidence, with at least the same degree of care that applies to Biogen’s Confidential Information pursuant to policies and procedures in effect as of the Distribution Effective Time, and not disclose or release, or permit to be disclosed or released, all Confidential Information of the other Party that is either in the first Party’s  possession (including Confidential Information in its possession prior to the Distribution Effective Time) or furnished by the other Party or any

 

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member of its Group or their respective Representatives at any time pursuant to this Agreement or any Ancillary Agreement, and shall not use any such Confidential Information other than for such purposes as may be expressly permitted hereunder or under any Ancillary Agreement.  If any Confidential Information is disclosed to any member of the other Party’s Group in connection with providing services to any member of such first Party’s Group under this Agreement or any Ancillary Agreement, then such disclosed Confidential Information shall be used by the applicable member of such other Party’s Group only as required to provide such services.

 

(b)                        Notwithstanding anything the contrary in this Section 7.6 , each Party may disclose, or may permit disclosure of, the other Party’s Confidential Information: (i) to its Representatives who have a need to know such information for non-commercial purposes and are informed of the obligation to hold such information confidential and in respect of whose failure to comply with such obligations, the first Party will be responsible or (ii) if any Party or any other member of its Group is required or requested to disclose any such Confidential Information by judicial or administrative process or by other requirements of Law or stock exchange rule or is advised by outside counsel in connection with an Action brought by a Governmental Entity that it is advisable to do so.  Notwithstanding the foregoing, in the event that any demand or request for disclosure of Confidential Information is made by a Third Party pursuant to clause (ii) above, each Party, as applicable, shall promptly notify (to the extent permissible by Law) the Party to whom the Confidential Information relates of the existence of such requirement or request and shall provide such affected Party a reasonable opportunity to seek an appropriate protective order or other remedy, which such Party will cooperate in obtaining to the extent reasonably practicable.  In the event that such appropriate protective order or other remedy is not obtained, the Party which faces the disclosure requirement shall furnish only that portion of the Confidential Information that is required to be disclosed and shall take commercially reasonable steps to ensure that confidential treatment is accorded such Confidential Information.

 

(c)                         Each of Biogen and Bioverativ shall inform their respective Representatives who have or have access to the other Party’s Confidential Information of their obligation to hold such information confidential in accordance with the provisions of this Agreement.

 

(d)                        Without limiting the foregoing, when any Confidential Information is no longer needed for the purposes contemplated by this Agreement or any Ancillary Agreement, each Party shall, at its option and as promptly as practicable after receiving a written request from the other Party, either (i) return to such other Party all such information in a tangible form (including all copies thereof and all notes, extracts or summaries based thereon) or (ii) certify to such other Party that the first Party has destroyed such information (and such copies thereof and such notes, extracts or summaries based thereon); provided , that such first Party’s Representatives may retain one (1) copy of such information to the extent required by applicable Law or professional standards, and shall not be required to destroy any such information located in back-up, archival electronic storage.

 

(e)                         Each Party acknowledges that it and its respective Subsidiaries may presently have and, following the Distribution Effective Time, may gain access to or possession

 

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of confidential or proprietary information of, or personal information relating to, Third Parties (i) that was received under confidentiality or non-disclosure agreements entered into between such Third Parties, on the one hand, and the other Party (or another member of its Group), on the other hand, prior to the Distribution Effective Time; or (ii) that, as between the two Parties, was originally collected by the other Party (or another member of its Group) and that may be subject to and protected by privacy, data protection or other applicable Laws. As may be provided in more detail in an applicable Ancillary Agreement, each Party agrees that it shall hold, protect and use, and shall cause the other members of its Group and its and their respective Representatives to hold, protect and use, in strict confidence the confidential and proprietary information of, or personal information relating to, Third Parties in accordance with privacy, data protection or other applicable Laws and the terms of any agreements that were either entered into before the Distribution Effective Time or affirmative commitments or representations that were made before the Distribution Effective Time by, between or among the other Party (or other member(s) of its Group), on the one hand, and such Third Parties, on the other hand.

 

(f)                          The Parties agree that irreparable damage may occur in the event that the provisions of this Section 7.6 were not performed in accordance with their specific terms.  Accordingly, it is hereby agreed that the Parties shall have the right to seek specific performance and injunctive or other equitable relief in accordance with Section 10.12 , in addition to any and all other rights and remedies at law or in equity, and all such rights and remedies shall be cumulative.

 

(g)                         For the avoidance of doubt and notwithstanding any other provision of this Section 7.6 , (i) the sharing of Privileged Information shall be governed solely by Section 7.7 , and (ii) information that is subject to any confidentiality provision or other disclosure restriction in any Ancillary Agreement shall be governed by the terms of such Ancillary Agreement.

 

Section 7.7                                     Privilege Matters .

 

(a)                        Pre-Distribution Services . The Parties recognize that legal and other professional services that have been and will be provided prior to the Distribution Effective Time have been and will be rendered for benefit of Biogen and its Subsidiaries, including the members of the Bioverativ Group.  Accordingly, with respect to such pre-Distribution services, the Parties agree as follows:

 

(i)                        (A) Biogen shall be entitled, in perpetuity, to control the assertion or waiver of all privileges and immunities in connection with any Privileged Information that relates solely to the Biogen Retained Business, whether or not the Privileged Information is in the possession or under the control of a member of the Biogen Group or the Bioverativ Group and (B) Biogen shall also be entitled, in perpetuity, to control the assertion or waiver of all privileges and immunities in connection with any Privileged Information that relates solely to any Biogen Retained Liabilities resulting from any Actions that are now pending or may be asserted in the future, whether or not the Privileged Information is in the possession or under the control of a member of the Biogen Group or the Bioverativ Group;

 

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(ii)                     (A) Bioverativ shall be entitled, in perpetuity, to control the assertion or waiver of all privileges and immunities in connection with any Privileged Information that relates solely to the Bioverativ Business, whether or not the Privileged Information is in the possession or under the control of a member of the Bioverativ Group or the Biogen Group and (B) Bioverativ shall also be entitled, in perpetuity, to control the assertion or waiver of all privileges and immunities in connection with any Privileged Information that relates solely to any Bioverativ Liabilities resulting from any Actions that are now pending or may be asserted in the future, whether or not the Privileged Information is in the possession or under the control of a member of the Bioverativ Group or the Biogen Group;

 

(iii)                  If Biogen and Bioverativ do not agree as to whether certain information is Privileged Information, then the information shall be treated as Privileged Information, and the Party who believes such information is Privileged Information shall be entitled to control the assertion or waiver of all privileges and immunities in connection with any such information unless the Parties otherwise agree;

 

(iv)                 Bioverativ agrees that it shall not (and shall cause the members of its Group not to) waive, or allege or purport to waive, any Privilege which could be asserted under any applicable Law, and in which Biogen (or any member of its Group) has a Privilege, without the written consent of Biogen; and

 

(v)                    Biogen agrees that it shall not (and shall cause the members of its Group not to) waive, or allege or purport to waive, any Privilege which could be asserted under any applicable Law, and in which Bioverativ (or any member of its Group) has a Privilege, without the written consent of Bioverativ.

 

(b)                        Post-Distribution Services . The Parties recognize that legal and other professional services will be provided following the Distribution Effective Time to each of Biogen (or any member of its Group) and Bioverativ (or any member of its Group).  The Parties further recognize that certain of such post-Distribution services will be rendered solely for the benefit of Biogen (or any member of its Group) or Bioverativ (or any member of its Group), as the case may be, while other such post-Distribution services may be rendered jointly to both Biogen (or any member of its Group) and Bioverativ (or any member of its Group) with respect to claims, proceedings, litigation, disputes, or other matters which involve one or more members of both the Biogen Group and the Bioverativ Group.  With respect to such post- Distribution services and related information subject to Privilege (“ Privileged Information ”), the Parties agree as follows:

 

(i)                        All Privileged Information based on post-Distribution services rendered jointly to both one or more members of the Biogen Group and Bioverativ Group relating to any claims, proceedings, litigation, disputes or other matters which involve both the Biogen Group and the Bioverativ Group (“ Shared Privileged Information ”) shall be subject to a shared Privilege among such parties

 

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involved in the claims, proceedings, litigation, disputes or other matters at issue; and

 

(ii)                     Privileged Information relating to post-Distribution services provided solely to one of Biogen (or any member of its Group) or Bioverativ (or any member of its Group) shall not be deemed shared between the Parties (or among the members of their respective Groups).

 

(iii)                  No Party may (or cause or permit any member of its Group to) waive, or allege or purport to waive, any Privilege which could be asserted under any applicable Law with respect to Shared Privileged Information, without the written consent of the other Party, which shall not be unreasonably withheld or delayed;

 

(iv)                 If a dispute arises between or among the Parties or their respective Group members regarding whether a Privilege should be waived to protect or advance the interest of any Party (or members of its Group) with respect to Shared Privileged Information, each Party agrees that it shall negotiate in good faith, shall endeavor to minimize any prejudice to the rights of the other Party’s Group, and shall not unreasonably withhold consent to any request for waiver by the other Party, and each Party specifically agrees that it shall not withhold consent to waive for any purpose except to protect the legitimate interests of its Group; and

 

(v)                    If, within fifteen (15) days of receipt by the requesting Party of written objection, the Parties have not succeeded in negotiating a resolution to any dispute regarding whether a Privilege should be waived with respect to Shared Privileged Information, and the requesting Party determines that a Privilege should nonetheless be waived to protect or advance the legitimate interests of its Group, the requesting Party shall provide the objecting Party fifteen (15) days’ written notice prior to effecting such waiver.  Each Party specifically agrees that failure within fifteen (15) days of receipt of such notice to commence proceedings to enjoin such waiver under applicable Law shall be deemed full and effective consent to such waiver.  In the event proceedings are commenced as described above, the Parties agree that any such Privilege shall not be waived by either Party until the final determination of such dispute.

 

(c)                         The Parties agree that Shared Privileged Information shall continue to be held subject to Privilege even if adversity of interest may subsequently be discerned or arise between Parties or their respective Group members.  Further, in the event a Party or any member of its Group becomes adverse to the other Party or any member of its Group, each Party agrees that it shall not (and shall not cause or permit any member of its Group to) seek to disqualify any law firms who have or have had access to Shared Privileged Information from continuing to represent members of the other Party’s Group, as applicable, solely by having, or having had access to such Shared Privileged Information.

 

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(d)                        Nothing in this Section 7.7 shall be construed or interpreted to restrict the right or authority of the Parties to enter into any further agreement, not otherwise inconsistent with the terms of this Agreement, concerning the sharing of Privileged Information.

 

(e)                         The transfer of all information pursuant to this Agreement is made in reliance on the agreement of Biogen or Bioverativ as set forth in Section 7.6 and this Section 7.7 , to maintain the confidentiality of Privileged Information, and to assert and maintain any applicable Privilege.  The access to information being granted pursuant to Section 7.2 and Section 7.3 , the agreement to provide witnesses and individuals pursuant to Section 7.4 , the furnishing of notices and documents and other cooperative efforts contemplated by Section 6.4 and the transfer of Privileged Information between the Parties and the members of their respective Groups pursuant to this Agreement shall not be deemed a waiver of any Privilege that has been or may be asserted under this Agreement or otherwise.

 

Section 7.8                                     Ownership of Information . Any information owned by one Party or any of its Subsidiaries that is provided to a requesting Party pursuant to this Article VII shall be deemed to remain the property of the providing Party.  Unless expressly set forth herein, nothing contained in this Agreement shall be construed as granting a license or other rights to any Party with respect to any such information, whether by implication, estoppel or otherwise.

 

Section 7.9                                     Other Agreements . The rights and obligations granted under this Article VII are subject to any specific limitations, qualifications or additional provisions on the sharing, exchange or confidential treatment of information set forth in any Ancillary Agreement.

 

ARTICLE VIII

 

DISPUTE RESOLUTION

 

Section 8.1                                     Negotiation . In the event of (i) a controversy, dispute or Action arising out of, in connection with, or in relation to the interpretation, performance, nonperformance, validity or breach of this Agreement or the Ancillary Agreements or otherwise arising out of, or in any way related to, this Agreement or the Ancillary Agreements or the transactions contemplated hereby or thereby, including any Action based on contract, tort, statute or constitution, or (ii) a claim with respect to the inadvertent transfer or omission of an Asset or Liability as contemplated by the definition of “Biogen Retained Asset”, “Biogen Retained Liability”, “Bioverativ Asset” or “Bioverativ Liability”, respectively (collectively, “ Disputes ”), the appropriate executives of the Parties who have authority to settle the Dispute (or such other individuals designated by the respective executives) shall negotiate for a reasonable period of time to settle such Dispute; provided , that such reasonable period shall not, unless otherwise agreed by the Parties in writing, exceed fifteen (15) Business Days from the time of receipt by a Party of written notice of such Dispute (“ Dispute Notice ”).  If the Dispute has not been resolved within fifteen (15) Business Days after receipt of the Dispute Notice, the respective Chief Executive Officers or their respective designees (with full settlement authority) of Biogen and Bioverativ shall meet in person (or where necessary, by phone) at a mutually acceptable time and, if applicable, place, and thereafter as often as they reasonably deem necessary, to attempt in good faith to resolve the Dispute.  If the Dispute has not been resolved within forty-five (45) days after receipt of the Dispute Notice (“ Negotiation Period ”), the Parties shall be permitted to

 

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seek any and all remedies pursuant to this Agreement or the Ancillary Agreements in addition to any and all other rights and remedies at law or in equity.  The Parties shall not assert the defenses of statute of limitations and laches arising during the period beginning after the date of receipt of the Dispute Notice, and, other than with respect to this Article VIII , any contractual time period or deadline under this Agreement or any Ancillary Agreement to which such Dispute relates occurring after the Dispute Notice is received shall not be deemed to have passed until such Dispute has been resolved.  Notwithstanding anything in this Section 8.1 to the contrary, nothing in this Section 8.1 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, prior to the expiration of the Negotiation Period, if necessary to protect the interests of such Party.

 

Section 8.2                                     Continuity of Service and Performance . Unless otherwise agreed in writing, the Parties shall continue to provide service and honor all other commitments under this Agreement, any Shared Contract and each Ancillary Agreement during the course of a Dispute with respect to all matters not subject to such Dispute.

 

ARTICLE IX

 

INSURANCE MATTERS

 

Section 9.1                                     Rights to Biogen Policies .

 

(a)                        Bioverativ acknowledges and agrees that, from and after the Distribution Effective Time, except as expressly provided in this Agreement or any Ancillary Agreement, neither Bioverativ nor any member of the Bioverativ Group shall have any rights to or under any Policies of Biogen, other than any insurance Policies acquired prior to the Distribution Effective Time, including any renewal thereof, directly by and in the name of Bioverativ or a member of the Bioverativ Group or as expressly provided in Section 6.5 or this Article IX .  For the avoidance of doubt, Bioverativ acknowledges and agrees that the Bioverativ Group and not any member of the Biogen Group shall be responsible for establishing any and all insurance programs required to comply with the Bioverativ Group’s contractual obligations and such other insurance Policies required by Law or as necessary or appropriate to operate the Bioverativ Business, including with respect to general liability, product liability, workers’ compensation, directors’ and officers’ liability and fiduciary liability.

 

(b)                        The Parties acknowledge that, as of the Distribution Date, Biogen’s director and officer liability insurance policies will provide insurance coverage for directors and officers of Bioverativ who served as directors, officers or employees of Biogen or any of its Subsidairies prior to the Distribution Effective Time, for (i) wrongful acts occurring prior to the Distribution Effective Time related to the Biogen Retained Business and (ii) certain non-indemnifiable wrongful acts occurring prior to the Distribution Effective Time related to the Bioverativ Business. Biogen agrees not to terminate or amend this coverage in a manner materially adverse to these individuals.

 

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(c)                         This Agreement shall not be considered as an attempted assignment of any insurance Policy or as a contract of insurance and shall not be construed to waive any right or remedy of any member of the Biogen Group in respect of any of the Biogen insurance Policies and programs or any other contract or policy of insurance.  The Biogen Group may, at any time, without liability or obligation to any member of the Bioverativ Group, amend, commute, terminate, buy-out, extinguish liability under or otherwise modify any insurance Policies (and claims of the Bioverativ Group pursuant to this Article IX shall be subject to any such amendments, commutations, terminations, buy-outs, extinguishments and modifications).

 

(d)                        No member of the Biogen Group shall have any obligation to secure extended reporting for any claims under any member of the Biogen Group’s claims-made or occurrence-reported liability policies for any acts or omissions by any member of the Bioverativ Group incurred prior to the Distribution Effective Time.

 

Section 9.2                                     Claims .  Nothing in this Article IX will be construed to limit or otherwise alter in any way the indemnity obligations of the Parties, including (i) with respect to the Bioverativ Group, Bioverativ Liabilities, (ii) with respect to the Biogen Group, Biogen Retained Liabilities and (iii) those created by this Agreement, by operation of law or otherwise.  The Parties acknowledge that Biogen has used its commercially reasonable efforts to structure its director and officer insurance Policies consistent with such indemnity obligations.

 

ARTICLE X

 

MISCELLANEOUS

 

Section 10.1                              Complete Agreement; Construction . This Agreement, including the Exhibits and Schedules, and the Ancillary Agreements shall constitute the entire agreement between the Parties with respect to the subject matter hereof and shall supersede all previous negotiations, commitments, course of dealings and writings with respect to such subject matter.  In the event of any inconsistency between this Agreement and any Schedule hereto, the Schedule shall prevail.  In the event and to the extent that there shall be a conflict between the provisions of this Agreement and the provisions of any Ancillary Agreement, this Agreement shall control (except with respect to the Tax Matters Agreement, the IP License Agreement and the Employee Matters Agreement, in which case such Ancillary Agreement shall control).  Except as expressly set forth in this Agreement or any Ancillary Agreement: (i) all matters to the extent relating to Taxes and Tax Returns of the Parties and their respective Subsidiaries shall be governed exclusively by the Tax Matters Agreement and (ii) for the avoidance of doubt, in the event of any conflict between this Agreement or any Ancillary Agreement, on the one hand, and the Tax Matters Agreement, on the other hand, with respect to such matters, the terms and conditions of the Tax Matters Agreement shall govern, except to the extent expressly provided herein or therein.

 

Section 10.2                              Transaction Agreements . Except as expressly set forth herein, this Agreement is not intended to address, and should not be interpreted to address, the matters specifically and expressly covered by the other Transaction Agreements.

 

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Section 10.3                              Counterparts . This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become effective when one or more such counterparts have been signed by each of the Parties and delivered to each of the Parties.

 

Section 10.4                              Survival of Agreements . Except as otherwise contemplated by this Agreement or any Ancillary Agreement, all covenants and agreements of the Parties contained in this Agreement and each Ancillary Agreement shall survive the Distribution Effective Time and remain in full force and effect in accordance with their applicable terms.

 

Section 10.5                              Fees, Costs and Expenses .

 

(a)                        Except as otherwise agreed to in writing by the Parties, all out-of-pocket fees, costs and expenses incurred at or prior to the Distribution Effective Time in connection with, and as required by, the preparation, execution, delivery and implementation of this Agreement and any Ancillary Agreement, the Distribution Disclosure Documents and the consummation of the transactions contemplated hereby and thereby, including the Separation, shall be borne and paid by Biogen; provided , however , that Biogen shall bear the expense of all recordation of Intellectual Property Transferred at or prior to the Distribution Effective Time pursuant to this Agreement, whether such recordation occurs prior to or after the Distribution Effective Time.

 

(b)                        Except as otherwise expressly provided in this Agreement (including this Section 10.5 ) or any Ancillary Agreement, or as otherwise agreed to in writing by the Parties, each Party shall bear its own out-of-pocket fees, costs and expenses incurred or accrued after the Distribution Effective Time; provided , however , that, except as otherwise expressly provided in this Agreement, any fees, costs and expenses incurred in obtaining any Consents or novation from a Third Party in connection with the Transfer to or Assumption by a Party or its Subsidiary of any Assets or Liabilities in connection with the Separation shall be borne by the Party or its Subsidiary to which such Assets are being Transferred or which is Assuming such Liabilities.

 

(c)                         With respect to any post-Distribution expenses incurred pursuant to a request for further assurances granted under Section 2.7 , the Parties agree that any and all fees, costs and expenses incurred by either Party shall be borne and paid by the requesting Party; it being understood that no Party shall be obliged to incur any Third Party accounting, consulting, advisor, banking or legal fees, costs or expenses, and the requesting Party shall not be obligated to pay such fees, costs or expenses, unless such fee, cost or expense shall have had the prior written approval of the requesting Party.

 

(d)                        Notwithstanding the foregoing, each Party shall be responsible for paying its own internal fees, costs and expenses (e.g., salaries of personnel).

 

Section 10.6                              Notices . All notices, requests, claims, demands and other communications under this Agreement and, to the extent applicable and unless otherwise provided therein, under each of the Ancillary Agreements shall be in English, shall be in writing and shall be given or made (and shall be deemed to have been duly given or made upon receipt)

 

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by delivery in person, by overnight courier service, by facsimile with receipt confirmed (followed by delivery of an original via overnight courier service) or by registered or certified mail (postage prepaid, return receipt requested) to the respective Parties at the following addresses (or at such other address for a Party as shall be specified in a notice given in accordance with this Section 10.6 ):

 

To Biogen:

 

Biogen Inc.

225 Binney Street

Cambridge, MA 02142

Attn: Chief Legal Officer
Facsimile: [
· ]

 

To Bioverativ:

 

Bioverativ Inc.

225 Second Avenue

Waltham, MA 02451

Attn: Chief Legal Officer
Facsimile: [
· ]

 

Section 10.7                              Waivers . Any consent required or permitted to be given by any Party to the other Party under this Agreement shall be in writing and signed by the Party giving such consent and shall be effective only against such Party (and its Group).

 

Section 10.8                              Assignment . No party may assign any rights or delegate any obligations arising under Agreement, in whole or in part, directly or indirectly, without the prior written consent of the other Party, and any attempt to so assign any rights or delegate any obligations arising under this Agreement without such consent shall be void.  Notwithstanding the foregoing, no such consent shall be required for any such assignment or delegation (i) with respect to Biogen, to a Subsidiary of Biogen (so long as such Subsidiary remains a Subsidiary of Biogen), (ii) with respect to Bioverativ, to a Subsidiary of Bioverativ (so long as such Subsidiary remains a Subsidiary of Bioverativ) or (iii) to a bona fide Third Party in connection with a merger, reorganization, consolidation or the sale of all or substantially all the assets of a Party so long as the resulting, surviving or transferee entity assumes all the obligations of the assigning Party by operation of Law or pursuant to an agreement in form and substance reasonably satisfactory to the non-assigning Party; provided , however , that in the case of each of the preceding clauses (i) and (ii), no assignment permitted by this Section 10.8 shall release the assigning Party from liability for the full performance of its obligations under this Agreement.

 

Section 10.9                              Successors and Assigns . The provisions of this Agreement and the obligations and rights hereunder shall be binding upon, inure to the benefit of and be enforceable by (and against) the Parties and their respective successors and permitted assigns.

 

Section 10.10                       Termination and Amendment . This Agreement (including Article VI hereof) may be terminated, modified or amended, and the Distribution may be amended,

 

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modified or abandoned, at any time prior to the Distribution Effective Time by and in the sole discretion of Biogen without the approval of Bioverativ or the stockholders of Biogen.  In the event of such termination, no Party shall have any liability of any kind to the other Party or any other Person by reason of such termination.  After the Distribution Effective Time, this Agreement may not be terminated, modified or amended except by an agreement in writing signed by Biogen and Bioverativ.

 

Section 10.11                       Payment Terms .

 

(a)                        Except as set forth in Article VI or as otherwise expressly provided to the contrary in this Agreement or in any Ancillary Agreement, any amount to be paid or reimbursed by a Party (and/or a member of such Party’s Group) to the other Party (and/or a member of such other Party’s Group) under this Agreement shall be paid or reimbursed hereunder within sixty (60) days after presentation of an invoice or a written demand therefor, in either case setting forth, or accompanied by, reasonable documentation or other reasonable explanation supporting such amount.

 

(b)                        Except as set forth in Article VI or as expressly provided to the contrary in this Agreement or in any Ancillary Agreement, any amount not paid when due pursuant to this Agreement (and any amount billed or otherwise invoiced or demanded and properly payable that is not paid within sixty (60) days of such bill, invoice or other demand) shall bear interest at a rate per annum equal to the Prime Rate, from time to time in effect, plus two percent (2%), calculated for the actual number of days elapsed, accrued from the date on which such payment was due up to the date of the actual receipt of payment.

 

(c)                         Without the consent of the party receiving any payment under this Agreement specifying otherwise, all payments to be made by either Biogen or Bioverativ under this Agreement shall be made in U.S. dollars.  Except as expressly provided herein, any amount which is not expressed in U.S. dollars shall be converted into U.S. dollars by using the exchange rate published on Bloomberg at 5:00 p.m., Eastern time, on the day before the relevant date, or in The Wall Street Journal , Eastern Edition, on such date if not so published on Bloomberg.  Except as expressly provided herein, in the event that any indemnification payment required to be made hereunder or under any Ancillary Agreement may be denominated in a currency other than U.S. dollars, the amount of such payment shall be converted into U.S. dollars on the date notice of the claim is given to the Indemnifying Party.

 

Section 10.12                       Specific Performance . From and after the Distribution, in the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement or any Ancillary Agreement, the Parties agree that the Party or Parties to this Agreement or such Ancillary Agreement who are or are to be thereby aggrieved shall, subject to the terms of Article VIII , have the right to seek specific performance and injunctive or other equitable relief of its or their rights under this Agreement or such Ancillary Agreement, in addition to any and all other rights and remedies at law or in equity, and all such rights and remedies shall be cumulative.  The Parties agree that, from and after the Distribution, the remedies at law for any breach or threatened breach of this Agreement or any Ancillary Agreement, including monetary damages, are inadequate compensation for any Indemnifiable Loss, that any defense in any Action for specific performance that a remedy at law would be

 

55



 

adequate is hereby waived, and that any requirements for the securing or posting of any bond with such remedy are hereby waived.

 

Section 10.13                       Subsidiaries . Each of the Parties shall cause to be performed, and hereby guarantees the performance of, all actions, agreements and obligations set forth herein to be performed by any Subsidiary of such Party or by any entity that becomes a Subsidiary of such Party at or after the Distribution Effective Time, in each case to the extent such Subsidiary remains a Subsidiary of the applicable Party.

 

Section 10.14                       Third Party Beneficiaries . Except (i) as provided in Article VI relating to Indemnitees and for the releases under Section 6.1 of any Person as provided therein and (ii) as specifically provided in any Ancillary Agreement, this Agreement is solely for the benefit of the Parties and shall not be deemed to confer upon Person other than the Parties any remedy, claim, liability, reimbursement, cause of Action or other right beyond any that exist without reference to this Agreement.

 

Section 10.15                       Titles and Headings . Titles and headings to sections herein are inserted for the convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

 

Section 10.16                       Exhibits and Schedules .

 

(a)                        The Exhibits and Schedules shall be construed with and as an integral part of this Agreement to the same extent as if the same had been set forth verbatim herein.

 

(b)                        Subject to the prior written consent of the other Party (not to be unreasonably withheld or delayed), each Party shall be entitled to update the Schedules from and after the date hereof until the Distribution Effective Time.

 

Section 10.17                       Governing Law . This Agreement and any Dispute shall be governed by and construed in accordance with the Laws of the State of Delaware, without giving effect to the conflicts of laws principles thereof that might lead to the application of laws other than the Laws of the State of Delaware.

 

Section 10.18                       Consent to Jurisdiction . All Actions that, directly or indirectly, arise out of or relate to this Agreement shall be heard and determined exclusively in the Court of Chancery of the State of Delaware; provided , however , that if such court does not have jurisdiction over such Action, such Action shall be heard and determined exclusively in any Delaware state court or United States federal court sitting in the State of Delaware (such courts, “ Delaware Courts ”).  Each of the Parties further agrees that service of any process, summons, notice or document by U.S. registered mail to such Party’s respective address set forth in Section 10.6 shall be effective service of process for any Action in the Delaware Courts with respect to any matters to which it has submitted to jurisdiction in this Section 10.18 .  Consistent with the foregoing in this Section 10.18 , each of the Parties hereby (a) submits to the exclusive jurisdiction of any federal or state court sitting in the State of Delaware for the purpose of any Action brought by any party hereto that, directly or indirectly, arises out of or relates to this Agreement; (b) irrevocably waives and releases, and agrees not to assert by way of motion,

 

56



 

defense, or otherwise, in or with respect to any such Action, any claim that (i) such Action is not subject to the subject matter jurisdiction of at least one of the above-named courts; (ii) its property is exempt or immune from attachment or execution in the State of Delaware; (iii) such Action is brought in an inconvenient forum; (iv) that the venue of such Action is improper; or (v) this Agreement or the transactions contemplated by this Agreement may not be enforced in or by any of the above-named courts; and (d) agrees not to move to transfer any such Action to a court other than any of the above-named courts.

 

Section 10.19                       Waiver of Jury Trial . EACH OF THE PARTIES HEREBY IRREVOCABLY WAIVES TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY WITH RESPECT TO ANY ACTION OR LIABILITY, DIRECTLY OR INDIRECTLY, ARISING OUT OF, RELATING TO, OR IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT.  EACH OF THE PARTIES HEREBY (A) CERTIFIES THAT NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF ANY SUCH ACTION OR LIABILITY, SEEK TO ENFORCE THE FOREGOING WAIVER; AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT AND THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, AS APPLICABLE, BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 10.19 .

 

Section 10.20                       Severability . In the event any one or more of the provisions contained in this Agreement should be held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein and therein shall not in any way be affected or impaired thereby.  The Parties shall endeavor in good-faith negotiations to replace the invalid, illegal or unenforceable provisions with valid provisions, the economic effect of which comes as close as possible to that of the invalid, illegal or unenforceable provisions.

 

Section 10.21                       Public Announcements . From and after the Distribution Effective Time, Biogen and Bioverativ shall consult with each other before issuing, and each shall give the other the opportunity to review and comment upon, that portion of any press release or other public statement, including a statement made to its investors, that relates to the transactions contemplated by this Agreement or the Ancillary Agreements, and shall not issue any such press release or make any such public statement prior to such consultation, except (a) as may be required by applicable Law, court process or obligations pursuant to any listing agreement with any national securities exchange or national securities quotation system; (b) for disclosures made that are substantially identical to disclosure contained in any Distribution Disclosure Document or any prior written public statement not made in violation of this Section 10.21 ; or (c) with respect to a Party, for disclosure concerning the ordinary course operation of such Party’s business (other than any Dispute), notwithstanding that the disclosure may relate to arrangements under the Manufacturing and Supply Agreement or Transition Services Agreement (including the exhibits and schedules thereto).

 

57



 

Section 10.22                       Interpretation . The Parties have participated jointly in the negotiation and drafting of this Agreement.  This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the Party drafting or causing any instrument to be drafted.

 

Section 10.23                       No Duplication; No Double Recovery . Nothing in this Agreement or any Ancillary Agreement is intended to confer to or impose upon any Party a duplicative right, entitlement, obligation or recovery with respect to any matter arising out of the same facts and circumstances (including with respect to the rights, entitlements, obligations and recoveries that may arise out of one or more of Section 6.2 , Section 6.3 , Section 6.4 , Section 6.5 and Section 6.6 ).

 

Section 10.24                       No Waiver . No failure to exercise and no delay in exercising, on the part of any Party, any right, remedy, power or privilege hereunder or under the other Ancillary Agreements shall operate as a waiver hereof or thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder or thereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

 

Section 10.25                       No Admission of Liability . The allocation of Assets and Liabilities herein (including on the Schedules hereto) is solely for the purpose of allocating such Assets and Liabilities between Biogen and Bioverativ and is not intended as an admission of liability or responsibility for any alleged Liabilities vis-à-vis any Third Party, including with respect to the Liabilities of any non-wholly owned subsidiary of Biogen or Bioverativ.

 

[ Signature Page Follows ]

 

58



 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed as of the day and year first above written.

 

 

BIOGEN INC.

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

 

 

 

 

BIOVERATIV INC.

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

[ Signature Page to Separation Agreement ]

 




Exhibit 2.2

 

Form of

 

TRANSITION SERVICES AGREEMENT

 

by and between

 

BIOGEN INC.

 

and

 

BIOVERATIV INC.

 

Dated as of [ · ],[ · ]

 



 

TABLE OF CONTENTS

 

 

 

Page

 

Article I

 

Definitions; Interpretation

 

 

 

Section 1.1

General

1

 

 

 

Article II

 

Services

 

Section 2.1

General

2

Section 2.2

Standard for Services

2

Section 2.3

Transitional Nature of the Services

3

Section 2.4

Omitted Services

3

Section 2.5

Additional Services

4

Section 2.6

Transition Support

4

Section 2.7

Use of Third Parties

5

Section 2.8

Cooperation

5

Section 2.9

Access

5

Section 2.10

Performance

5

Section 2.11

Intellectual Property

5

 

 

 

Article III

 

FEES AND Payment

 

Section 3.1

Fees

5

Section 3.2

Expense

6

Section 3.3

Invoice

6

Section 3.4

Late Payments

6

Section 3.5

Service Taxes

6

Section 3.6

Withholding

7

Section 3.7

No Right to Set-Off

7

 

Article IV

 

Service Management

 

Section 4.1

Service Managers

7

Section 4.2

Service Coordinators

7

 

Article V

 

Sub-Contracting; Third Party Agreements

 

Section 5.1

Sub-Contractors

7

 



 

Section 5.2

Third Party Agreements

8

Section 5.3

Consents

8

 

Article VI

 

Term and Termination and Effects of Termination

 

Section 6.1

Termination

8

Section 6.2

Termination for Breach

8

Section 6.3

Early Termination of a Service

8

Section 6.4

Termination Upon Insolvency

9

Section 6.5

Effect of Termination

9

 

Article VII

 

Limitation of Liability; Indemnification

 

Section 7.1

Limited Liability

10

Section 7.2

Services Provided “As-Is”

10

Section 7.3

Indemnification

10

 

Article VIII

 

Insurance Matters

 

Section 8.1

Insurance

11

 

Article IX

 

PRESERVATION OF RECORDS; ACCESS TO INFORMATION; CONFIDENTIALITY; PRIVILEGE

 

Section 9.1

Confidentiality

11

 

Article X

 

Miscellaneous

 

Section 10.1

Inconsistencies

12

Section 10.2

Counterparts

12

Section 10.3

Entire Agreement

12

Section 10.4

Dispute Resolution

12

Section 10.5

Notices

12

Section 10.6

Waivers

13

Section 10.7

Force Majeure

13

Section 10.8

Assignment

14

Section 10.9

Successors and Assigns

14

Section 10.10

Third Party Beneficiaries

14

Section 10.11

Exhibits and Schedules

14

Section 10.12

Titles and Headings

14

 



 

Section 10.13

Governing Law

14

Section 10.14

Consent to Jurisdiction

14

Section 10.15

Waiver of Jury Trial

15

Section 10.16

Severability

15

Section 10.17

Interpretation

15

Section 10.18

No Waiver

15

Section 10.19

Independent Contractor Status

16

 

 

 

List of Exhibits and Schedules

 

 

 

Schedule I

Biogen Services

 

Exhibit A

Fees

 

Exhibit B

TSA Service Definitions

 

Exhibit C

Initial Service Managers

 

 



 

INDEX OF DEFINED TERMS

 

Defined Term

 

Page

 

 

 

Additional Service

 

1, 3, 4

Agreement

 

1

Biogen

 

1

Bioverativ

 

1

Delaware Courts

 

10.14

Force Majeure

 

1, 13

Parties

 

1

Party

 

1

Prior Period

 

2, 3

Separation Agreement

 

1

Service Provider

 

2

Services

 

2

Term

 

2

 



 

TRANSITION SERVICES AGREEMENT

 

This TRANSITION SERVICES AGREEMENT (this “ Agreement ”), dated as of [ · ],[ · ], is entered into by and between Biogen Inc. (“ Biogen ”), a Delaware corporation, and Bioverativ Inc. (“ Bioverativ ”), a Delaware corporation. “ Party ” or “ Parties ” means Biogen or Bioverativ, individually or collectively, as the case may be.

 

W   I   T   N   E   S   S   E   T   H :

 

WHEREAS, in conjunction with a Separation Agreement between Biogen and Bioverativ of even date hereof (the “ Separation Agreement ”), Bioverativ desires to obtain certain transition services from Biogen, and Biogen is willing to provide such services to Bioverativ on the terms and conditions set forth.

 

NOW, THEREFORE, in consideration of the foregoing and the respective warranties, covenants and agreements hereinafter set forth, and intending to be legally bound hereby, the Parties hereto agree as follows:

 

ARTICLE I

 

DEFINITIONS; INTERPRETATION

 

Section 1.1                                     General .  Capitalized terms not defined in this Agreement have the meanings assigned to them in the Separation Agreement. As used herein, the following terms have the following meanings:

 

(1)                                  Additional Service ” shall have the meaning set forth in Section 2.5.

 

(2)                                  Force Majeure ” shall have the meaning set forth in Section 10.7.

 

(3)                                  FTE Rate ” means, with respect to employees of Biogen or its Affiliates, the applicable rate per FTE to be applied by the Parties under this Agreement as set forth in Exhibit A , prorated on an hourly basis based on a total of one thousand seven hundred eighty (1,780) hours worked per year, subject to annual adjustment on each anniversary of the Distribution Effective Time by the change in the rate of the Employment Cost Index for total compensation for the “management, professional and related” occupational group, as published by the United States Department of Labor, Bureau of Labor Statistics (or any similar index agreed upon by the Parties if such index ceases to be compiled and published).

 

(4)                                  Internal Costs ” shall mean (i) the costs, determined at the FTE Rate, in respect of time spent by Biogen personnel with respect to the provision of Services hereunder,  and (ii) and other costs directly related to the provision of Services under this Agreement, as agreed upon between the two parties.  For the avoidance of doubt, Internal Costs shall not include Third Party Costs.

 

(5)                                  Omitted Service ” shall have the meaning set forth in Section 2.4.

 



 

(6)                                  Service Provider ” means, as the context may require, Biogen or, if not Biogen, the Person providing the Services on behalf of Biogen, including any of its Affiliates (it being agreed and understood that for purposes of this Agreement Biogen shall cause each such Person to comply with the provisions of this Agreement applicable to such Person in such Person’s capacity as a “Service Provider”).

 

(7)                                  Services ” means all of the services to be provided by or on behalf of the Service Provider under this Agreement and described on Schedule I hereto, as such Schedule may be updated and supplemented from time to time in accordance with the provisions of this Agreement, along with any Omitted Services and any Additional Services.  For purposes of clarity, Services shall not be deemed to include any advisory services to Bioverativ or its Affiliates (including consulting, decision making or advising with respect to the daily operations, goals or strategies of Bioverativ or legal, risk management/insurance, health care compliance financial, accounting, insurance, regulatory or tax advice), except in each case as may be expressly specified on Schedule I hereto.

 

(8)                                  Term ” means the period commencing on the date hereof and ending on the date of the last to expire Service as set forth in Schedule I .

 

(9)                                  Third Party Costs ” means the price paid by Biogen or its Affiliates to a Third Party for all applicable Services provided by such Third Party to Biogen or its Affiliates that are directly allocable to the provision of Services hereunder.

 

ARTICLE II

 

SERVICES

 

Section 2.1                                     General .  During the Term, subject to Section 2.2, Biogen shall (and shall cause each Service Provider providing Services to) provide to Bioverativ and, to the extent directed by Bioverativ, its Affiliates, the Services, in each case subject to the terms and conditions set forth herein.  The Services provided hereunder may be only those that were provided in connection with the Bioverativ Business (other than those services expressly excluded hereunder) during the twelve (12) months immediately prior to the date hereof (the “ Prior Period ”), or which are reasonably anticipated as of the date hereof to be necessary to continue to support the Bioverativ Business during the Term.  The Parties agree to negotiate in good faith any proposed changes to the Services, including pricing related thereto, during the Term.  Such proposed changes shall become effective only upon mutual agreement of the Parties as reflected in an addendum to Schedule I .  The Parties acknowledge and agree that the Services are generally intended to facilitate the transactions contemplated by the Separation Agreement, and to the extent Services described in Schedule I are general in nature, are intended to support the continued operation of the Bioverativ Business and the Bioverativ Products.  The Services are generally intended to achieve the overarching goals set forth on Exhibit B hereto.  In this Agreement, references to Biogen shall include Biogen’s Affiliates, and references to Bioverativ shall include Bioverativ’s Affiliates.

 

Section 2.2                                     Standard for Services . The Services shall be provided hereunder (i) in accordance with the terms and conditions of this Agreement and in a manner generally consistent with the provision of the Services provided during the Prior Period, (ii) in a manner at least as

 

2



 

complete in all material respects as the manner in which such Services have been provided during the Prior Period, (iii) with the same degree of skill, care and diligence as provided during the Prior Period, and (iv) giving substantially equal priority and substantially equal treatment that such Services received during the Prior Period; provided that if Service Provider has not previously provided any such Service to another Person, Service Provider will provide such Service in a manner substantially similar to similar services provided to its Affiliates or businesses. To the extent a more specific standard of care is specified in Schedule I with respect to any Service, Service Provider shall use its commercially reasonable efforts to comply with such more specific standard.  It is the Parties’ shared objective to transition responsibility for the performance of Services from Service Provider to Bioverativ and its Affiliates in a manner that minimizes, to the extent reasonably possible, disruption to the business operations of Service Provider and its Affiliates and the business operations of Bioverativ and its Affiliates.  Notwithstanding any provision of this Agreement or the Separation Agreement to the contrary, Service Provider shall not be required to (a) perform any Service in any manner that violates or contravenes any restrictions imposed on Service Provider by applicable Law or (b) perform any Service in any manner that breaches or contravenes any contractual obligations owed by Service Provider to any Third Party(ies).

 

Section 2.3                                     Transitional Nature of the Services .  Bioverativ understands that the Services provided hereunder are transitional in nature and are furnished by the Service Provider as an accommodation and for the purpose of facilitating the transactions contemplated by the Separation Agreement.  Bioverativ agrees to use, and shall cause its Affiliates to use, commercially reasonable efforts to transition from the Services as provided by Service Provider to services furnished by another Party as soon as practically possible, but in no case later than the expiration of the Term.  Bioverativ further understands that the Service Provider is not in the business of providing Services to Third Parties and will not provide the Services beyond the Term.

 

Section 2.4                                     Omitted Services .  If, during the forty-five (45) day period immediately following the date of this Agreement, Bioverativ identifies a service that was provided in connection with the Bioverativ Business (other than those services expressly excluded hereunder) during the Prior Period, or which are reasonably anticipated as of the date hereof to be necessary to continue to support the Bioverativ Business during the Term, but such services were inadvertently omitted from the list of Services in Schedule I hereto (each, to the extent included in the Services pursuant to this Section, an “ Omitted Service ”), then Service Provider shall use commercially reasonable efforts to cooperate with Bioverativ to amend Schedule I to add such Omitted Service as a Service, provided that Service Provider shall not be obligated to provide any Omitted Service if it does not, in its reasonable judgment, have adequate resources to provide such Omitted Service or if the provision of such Omitted Service would significantly disrupt the operation of its business.  In the event that the Parties agree that Service Provider should provide any such Omitted Service, the Parties shall execute amendments for such Omitted Service to (A)  Exhibit A , to the extent necessary to reflect any additional FTE Rates for such Omitted Service and (B)  Schedule I for such Omitted Service that shall set forth, among other things, (i) the time period during which such Omitted Service shall be provided, (ii) a description of such Omitted Service in reasonable detail, (iii) primary points of contact for each of the Parties with respect to the Service and (iv) any additional terms and conditions specific to such Omitted Service.  Service Provider’s obligations with respect to providing any such

 

3


 

Omitted Service shall become effective only upon mutual agreement of the Parties as reflected in an amendment to Schedule I and Exhibit A being duly executed and delivered by each Party.  Notwithstanding the foregoing, the time period for any such Omitted Service shall expire not later than the expiration of the Term as calculated prior to the addition of such Omitted Service unless the Parties agree otherwise.

 

Section 2.5                                     Additional Services . The Parties hereto acknowledge that Schedule I might not identify all of the Services that may be necessary or appropriate to affect the understanding set forth in this Agreement.  Bioverativ may request such additional Services from Service Provider (each, to the extent included in the Services pursuant to this Section, an “ Additional Service ”) in writing during the Term.  Service Provider will consider any such request for Additional Services promptly and in good faith.  In the event that the Parties agree that Service Provider should provide any such Additional Service, the Parties shall execute amendments for such Additional Service to (A)  Exhibit A , to the extent necessary to reflect any additional FTE Rates for such Additional Service and (B)  Schedule I that shall set forth, among other things, (i) the time period during which such Additional Service shall be provided, (ii) a description of such Additional Service in reasonable detail, (iii) primary points of contact for each of the Parties with respect to the Service and (iv) any additional terms and conditions specific to such Additional Service.  Service Provider’s obligations with respect to providing any such Additional Service shall become effective only upon mutual agreement of the Parties as reflected in an amendment to Schedule I and Exhibit A being duly executed and delivered by each Party.  Notwithstanding the foregoing, the time period for any such Additional Service shall expire not later than the expiration of the Term as calculated prior to addition of such Additional Service unless the Parties agree otherwise.

 

Section 2.6                                     Transition Support .  Notwithstanding anything to the contrary in this Article II, Service Provider shall provide (or cause to be provided) to Bioverativ and its Affiliates, at Bioverativ’s sole cost and expense, any reasonable cooperation and assistance requested by Bioverativ for the transition from Services to replacement services, whether such replacement services are to be provided by Bioverativ or any other Person, including without limitation allocating and providing commercially reasonable access to appropriate personnel and making available (or having made available) on a timely basis to Bioverativ all non-privileged and non-confidential information and materials reasonably requested by Bioverativ about the Services and the information technology systems used in connection with the provision of such Services.  Prior to the termination or expiration of this Agreement (or any Services provided hereunder) and subject to the last sentence of this Section 2.6, Service Provider shall deliver to Bioverativ such non-privileged and non-confidential documents, records and information as are reasonably necessary to achieve such transition.  Immediately upon the termination or expiration of this Agreement, at Bioverativ’s reasonable cost and expense, (i) Service Provider shall promptly deliver to Bioverativ copies of any and all such remaining documents, records and information in Service Provider’s possession and owned by Bioverativ or to which Bioverativ is otherwise entitled pursuant to this Agreement or the Separation Agreement and (ii) Bioverativ shall promptly return to Service Provider all such non-privileged and non-confidential documents, records and information in Bioverativ’s possession or under its control, other than those non-privileged and non-confidential documents, records and information that Bioverativ is entitled to retain pursuant to the Separation Agreement.

 

4



 

Section 2.7                                     Use of Third Parties .  Bioverativ understands that certain Services may be provided to it by the Service Provider in accordance with this Section 2.7 and pursuant to agreements between the Service Provider and various Third Parties.  To the extent not prohibited by a Third Party and with Bioverativ’s consent not to be unreasonably withheld, conditioned, or delayed, the Service Provider will coordinate the provision of Services by the Third Party to Bioverativ and Bioverativ will reasonably cooperate with any Third Party providing Services on behalf of the Service Provider in order to facilitate the provision and receipt of such Services.

 

Section 2.8                                     Cooperation .  Bioverativ and its Affiliates who are recipients of the Services will reasonably cooperate with the Service Provider in order to facilitate the provision and receipt of the Services.  Bioverativ acknowledges that such Services are dependent on such reasonable cooperation, and that its or its Affiliates’ failure to so cooperate, if not reasonable, shall relieve the Service Provider of its obligation to provide the related Services to the extent such failure renders such provision impractical or impossible.  Bioverativ and its Affiliates who are recipients of the Services will comply in all material respects with all applicable policies and procedures of the Service Provider.

 

Section 2.9                                     Access .  Each Party shall allow the other Party and its Affiliates and Representatives reasonable access to the facilities of such Party and its Affiliates that is necessary for Service Provider to provide the Services or for Bioverativ and its Affiliates to receive the Services. Each Party agrees that all of its and its Affiliates’ employees shall, and that it shall use commercially reasonable efforts to cause its Representatives’ employees to, when on the property of the other Party or any of its Affiliates, or when given access to any facilities, information, systems, infrastructure or personnel of the other Party or any of its Affiliates, conform to the policies and procedures of such other Party and any of its Subsidiaries, as applicable, concerning health, safety, conduct and security which are made known to the Party receiving such access from time to time.

 

Section 2.10                              Performance .  It is understood and agreed that any Party may cause any of its Subsidiaries to perform any or all of its obligations hereunder, and may designate any of its Subsidiaries to receive any of its entitlements hereunder.  Each of the Parties shall cause to be performed, and hereby guarantees the performance of, all actions, agreements and obligations set forth herein to be performed by any Subsidiary of such Party or by any entity that becomes a Subsidiary of such Party at or after the Distribution Effective Time, in each case to the extent such Subsidiary remains a Subsidiary of the applicable Party.

 

Section 2.11                              Intellectual Property .  Neither Party will gain, by virtue of this Agreement, any rights of ownership or use of copyrights, patents, trade secrets, trademarks or any other intellectual property rights (“ Intellectual Property Rights ”) owned by the other Party or its Affiliates.  To the extent any Intellectual Property Rights are developed by Biogen or its Affiliates solely specifically and exclusively for Bioverativ in the course of the performance of the Services, all right, title and interest in and to any such Intellectual Property Rights shall be the sole and exclusive property of Bioverativ, and Biogen shall (and shall cause its Affiliates to) assign, and does hereby assign, to Bioverativ all right, title and interest in and to any such Intellectual Property Rights.  Except as expressly specified in the foregoing, as between the Parties, all right, title and interest in any Intellectual Property Rights developed by or on behalf of Biogen in the course of providing the Services shall be owned by Biogen.

 

ARTICLE III

 

FEES AND PAYMENT

 

Section 3.1                                     Fees .  The fees payable hereunder for the Services (the “ Fees ”) shall be equal to (i) the Service Provider’s Internal Costs (plus a mark-up as provided in Exhibit A) plus (ii) the Service Provider’s Third Party Costs.  Bioverativ shall also pay the Service Provider for all of the reasonable, documented one-time costs and expenses, if any, incurred by

 

5



 

Service Provider in order to enable the Service Provider to provide and to terminate the Services as contemplated hereby, including costs for adapting the Service Provider’s systems to be able to interface with Bioverativ’s systems, if reasonably required.

 

Section 3.2                                     Expense .  The Fees are exclusive of expenses related to travel (including long-distance and local transportation, accommodation and meal expenses and other incidental expenses) by the Service Provider’s personnel or any subcontractor in connection with performing the Services.  All of the costs and expenses described in this Section 3.2 (“ Expenses ”) shall be charged by the Service Provider to the Service Recipient on a pass-through basis.  For the avoidance of doubt, the Expenses described in this Section 3.2 shall be consistent with the Service Provider’s general approach with respect to such types of costs and expenses; provided , that with respect to any Service, the Service Recipient’s prior written approval shall be required to the extent that Expenses exceed fifteen percent (15%) of the Fees paid and payable to the Service Provider for such Service in any calendar quarter.

 

Section 3.3                                     Invoice .  Not later than twenty-five (25) days after the last day of each calendar quarter (or, if such date is not a Business Day, then on the immediately succeeding Business Day), the Service Provider shall provide to Bioverativ an invoice for the preceding calendar quarter’s Services, which shall list (i) the Services provided by the Service Provider to Bioverativ during such calendar quarter, (ii) the Fees payable for such Services (and reasonable documentation supporting such Fees, to the extent requested by Bioverativ) and (iii) any one-time costs and expenses, out-of-pocket expenses and pass-through costs and expenses and reasonable documentation verifying such costs and expenses for such calendar quarter.  The amount stated in such invoices shall be paid by Bioverativ in full within fourty-five (45) days of the issuance of the invoices (or, if such date is not a Business Day, then on the immediately succeeding Business Day) to an account designated by the Service Provider, except to the extent such amount shall be the subject of a good faith dispute between the Service Provider and Bioverativ.

 

Section 3.4                                     Late Payments .  Without prejudice to the Service Provider’s other rights and remedies, where any sum remains unpaid sixty (60) Business Days after the applicable due date, it shall carry interest, which shall accrue daily, from the due date until the date of actual payment, at a rate based on the prime rate listed in the Wall Street Journal (Bond Yields and Rates) on the date such sum is due and payable plus two percent (2%).

 

Section 3.5                                     Service Taxes .  All payments due to the Service Provider under this Agreement shall be exclusive of any sales, use, value added, transfer, service, service use or other similar or analogous Tax (“ Service Taxes ”).  Bioverativ will pay, and hold Service Provider harmless against, any Service Taxes applicable to the provision of the Services. Each Party agrees to provide to the other Party such information and data as reasonably requested from time to time, and to fully cooperate with the other Party, in connection with (a) the reporting of any Service Taxes payable pursuant to this Agreement, (b) any audit relating to any such Service Taxes, or (c) any assessment, refund, claim or proceeding relating to any such Service Taxes. To the extent any such reporting, audit, assessment, refund, claim, or proceeding is in relation to Service Taxes owed or claimed to be owed by Service Provider or any of its Affiliates by a Governmental Entity, Biogen shall direct and control such reporting, audit, assessment, refund, claim, or proceeding.

 

6



 

Section 3.6                                     Withholding .  Bioverativ or any applicable Affiliate of Bioverativ, as the case may be, shall be entitled to duly and timely deduct or withhold from any payment otherwise payable pursuant to this Agreement such amounts as are required to be deducted and withheld with respect to such payment under applicable Law, and to the extent such amounts are duly and timely remitted to the appropriate Governmental Entity such amounts shall be treated for all purposes of this Agreement as having been paid to the person in respect of which such deduction and withholding was made; provided , however , that Bioverativ shall notify the Service Provider in writing of any anticipated withholding at least fifteen (15) Business Days prior to making any such deduction or withholding and will cooperate with the Service Provider in obtaining any available exemption from or reduction of such deduction or withholding. Bioverativ shall provide the Service Provider with evidence of payment to, or receipts from, the relevant Governmental Entity evidencing timely payment of such Taxes.

 

Section 3.7                                     No Right to Set-Off .  Each Party hereto acknowledges and agrees that it shall not be permitted to set-off any amount owed by such Party pursuant to this Agreement against any amount or obligation owed to such Party or an Affiliate hereunder or pursuant to the Separation Agreement or any other Ancillary Agreement.

 

ARTICLE IV

 

SERVICE MANAGEMENT

 

Section 4.1                                     Service Managers .  The Service Provider and Bioverativ shall each appoint an employee to have overall responsibility for managing and coordinating the delivery of Services in accordance with this Agreement (such employee, a “ Service Manager ”).  The initial Service Managers shall be identified on Exhibit C hereto or otherwise designated by each of the Parties prior to the Distribution Effective Time, and may thereafter be replaced from time to time upon written notice to the other Party.  Service Managers shall consult and coordinate with one another regarding the provision of Services hereunder.

 

Section 4.2                                     Service Coordinators .  Each Party has designated an employee or title as the principal point of contact for the day-to-day implementation or monitoring of each Service as specified in Schedule I (each, a “ Service Coordinator ”).  Communications relating to specific Services shall be directed to the applicable Service Coordinators.  The Service Coordinators will report to the applicable Service Manager from time to time, as directed by the Service Manager.

 

ARTICLE V

 

SUB-CONTRACTING; THIRD PARTY AGREEMENTS

 

Section 5.1                                     Sub-Contractors .  Upon Bioverativ’s consent, not to be unreasonably withheld, conditioned, or delayed, Service Provider may delegate or sub-contract its duties under this Agreement to a qualified Third Party, provided that, notwithstanding such delegation or sub-contracting, the Service Provider shall remain liable for the performance of its duties hereunder and shall ensure and guaranty that any Services provided by a subcontractor shall meet Service Provider’s obligations set forth in Section 2.2(i), (ii), (iii) and (iv).  For the avoidance of doubt, Service Provider will not be liable with respect to any agreement entered

 

7



 

into directly by Bioverativ (or its Affiliates) and a subcontractor, other than as mutually agreed in writing by the Parties hereto.

 

Section 5.2                                     Third Party Agreements .  Bioverativ acknowledges that the Services that were provided through Third Parties prior to the date hereof are subject to the terms and conditions of any applicable agreements between the Service Provider and such Third Parties, and Bioverativ agrees to comply with such terms and conditions to the extent applicable to Bioverativ and necessary for purposes of receiving such Services by Bioverativ.  For any Service to be delegated to a Third Party after the date hereof, and so long as any such Service is provided solely to Bioverativ and not to Service Provider or any Affiliates of Service Provider, Service Provider shall provide Bioverativ with a copy of any agreement contemplated to be entered into with such Third Party in relation to such Service and seek Bioverativ’s consent to such delegation, which consent may not be unreasonably withheld, delayed, or conditioned.  In the event any such consent is not granted, Service Provider shall not have any liability resulting from any delay in providing any such Service.

 

Section 5.3                                     Consents .  Notwithstanding anything to the contrary contained herein, the Service Provider shall use commercially reasonable efforts to obtain all consents from vendors that are necessary in order to provide any of the Services to Bioverativ under this Agreement; provided , however , that the Service Provider shall not be required to pay any out-of-pocket fees to any vendor in order to obtain such consent, but shall, instead, request that Bioverativ pay such out-of-pocket fees.  In the event that the Service Provider is unable to obtain any such consent, the Parties hereto will work together to agree upon a commercially reasonable alternative arrangement.  Any costs specified in the second sentence of Section 3.1 and any actual out-of-pocket fees levied on the Service Provider (i) in connection with its efforts to obtain and implement such consents and (ii) in connection with the implementation of any such commercially reasonable alternative arrangement, shall be borne by Bioverativ.  For the avoidance of doubt, any costs incurred by Biogen in connection with obtaining consents prior to the Distribution Effective Time shall be borne by Biogen.

 

ARTICLE VI

 

TERM AND TERMINATION AND EFFECTS OF TERMINATION

 

Section 6.1                                     Termination .  Except as otherwise provided herein or unless otherwise agreed in writing by the Parties hereto, Service Provider’s obligation to provide or procure, and Bioverativ’s obligation to purchase, each Service shall cease as of the end of the term specified for such Service in Schedule I hereto, and the Agreement shall terminate in its entirety at the end of the Term.

 

Section 6.2                                     Termination for Breach .  In the event that a Party hereto commits a material breach with respect to any of the Services, the other Party may terminate this Agreement with respect to such Service only, unless such breach is cured not later than thirty (30) days after receipt by the breaching Party of written notice of such breach.

 

Section 6.3                                     Early Termination of a Service .  Subject to the restrictions set forth herein, if Bioverativ should wish to terminate a Service (in whole, but not in part), Bioverativ shall provide written notice to the Service Provider not later than forty-five (45) days prior to the

 

8



 

requested termination date for such Service; provided , however , that no such notice of termination may be delivered to the Service Provider during the forty-five (45) day period immediately following the date hereof.  Notwithstanding the foregoing provisions, the Parties hereto acknowledge and agree that, in certain instances, terminating certain Services may require time periods longer than the forty-five (45) day period specified in this Section 6.3.  In any such event, the Parties agree to negotiate in good faith a longer period of time for any and all such transfers following the termination notice.  Bioverativ shall remain liable for any Fees or other amounts payable hereunder in connection with the terminated Service(s) incurred prior to the effective date of termination of such Service(s), including in the event that such terminated Services contemplated a deliverable that was not provided due to such early termination.  Bioverativ acknowledges and agrees that (a) Services provided by Third Parties may be subject to term-limited licenses and contracts between Service Provider and applicable Third Parties (collectively, “ Provider Third Party Contracts ”), (b) the renewal periods under the Provider Third Party Contracts may be for fixed periods, and (c) Service Provider may not have the right to renew certain Provider Third Party Contracts.  As a result, Bioverativ agrees that (i) if Service Provider is required to extend any Provider Third Party Contract in order to continue to provide any Service during the Term, then Bioverativ shall be required to pay Service Provider the amount of any renewal fees or purchase commitments applicable to the relevant Service for the full renewal period specified in the applicable Provider Third Party Contract, regardless of whether the Term or Service Provider’s provision of the relevant Service ends prior to the end of the relevant renewal period, and (ii) Service Provider will not be required to provide any Service to the extent it is unable to renew any applicable Provider Third Party Contract.

 

Section 6.4                                     Termination Upon Insolvency .  Either Party may terminate this Agreement immediately in the event the other Party (i) becomes insolvent, (ii) is generally unable to pay, or fails to pay, its debts as they become due, (iii) files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, (iv) makes or seeks to make a general assignment for the benefit of its creditors, or (v) applies for, or consents to, the appointment of a trustee, receiver or custodian for a substantial part of its property or business.

 

Section 6.5                                     Effect of Termination .  Not later than thirty (30) days following the date it receives a final invoice from the Service Provider following termination or expiration of any Services or this Agreement, Bioverativ shall pay to the Service Provider all remaining monies due to the Service Provider hereunder in respect of Services provided prior to such termination or expiration except for any amounts then the subject of a good faith dispute.  In addition, at the end of the Term, each Party hereto shall, at the disclosing Party’s option, return or destroy the Confidential Information of the disclosing Party.  In the event that the disclosing Party elects destruction, the other Party shall furnish to the disclosing Party a written certificate of destruction signed by an officer of the certifying Party. Any provision which by its nature should survive, including the provisions of this Section 6.5 (Effect of Termination), and Section 2.11 (Intellectual Property), Article III (Fees and Payment), Article VII (Limitation of Liability; Indemnification),  Article IX (Preservation of Records; Access to Information; Confidentiality; Privilege), and Article X (Miscellaneous), shall survive the termination of this Agreement.

 

9



 

ARTICLE VII

 

LIMITATION OF LIABILITY; INDEMNIFICATION

 

Section 7.1                                     Limited Liability .

 

(a)                                  The Liabilities of Service Provider and its Affiliates and Representatives, collectively, under this Agreement for any act or failure to act in connection herewith (including the performance or breach of this Agreement), or from the sale, delivery, provision or use of any Services provided under or contemplated by this Agreement, whether in contract, tort (including negligence and strict liability) or otherwise, at law or equity, shall not exceed the amount of Service charges received (and not previously paid back as a Liability hereunder) by the Service Provider (or its Affiliates) prior to the date on which the Service Provider’s (or its applicable Affiliate’s or Representative’s) action or inaction (or, prior to the one-year anniversary of this Agreement if such action or inaction occurs during the first year of this Agreement) giving rise to the Liability arises or occurs.

 

(b)                                  Notwithstanding anything to the contrary contained in the Separation Agreement or this Agreement, the Service Provider shall not be liable to Bioverativ or any of its Affiliates or Representatives, whether in contract, tort (including negligence and strict liability) or otherwise, at law or equity, for any special, indirect, incidental, punitive or consequential damages whatsoever (including lost profits or damages calculated on multiples of earnings approaches), which in any way arise out of, relate to or are a consequence of, the performance or nonperformance by the Service Provider (including any Affiliates and Representatives of the Service Provider and any unaffiliated third party providers, in each case, providing the applicable Services) under this Agreement or the provision of, or failure to provide, any Services under this Agreement, including with respect to loss of profits, business interruptions or claims of customers.

 

(c)                                   The limitations in Section 7.1 shall not apply with respect to any Liability arising out of or in connection with the gross negligence, willful misconduct, or fraud of or by the Party to be charged.

 

Section 7.2                                     Services Provided “As-Is” .  THE SERVICE PROVIDER PROVIDES ANY AND ALL SERVICES ON AN “AS-IS” BASIS AND, EXCEPT AS SET FORTH IN SECTION 2.2, MAKES NO REPRESENTATIONS OR WARRANTIES AS TO THE SERVICES PROVIDED.  THE SERVICE PROVIDER DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IN CONNECTION WITH THIS AGREEMENT.

 

Section 7.3                                     Indemnification .

 

(a)                                  Subject to Section 7.1, Bioverativ hereby agrees to indemnify, defend and hold harmless each such Service Provider and its Affiliates and Representatives from and against any and all Liabilities arising from, relating to or in connection with the use of any Services by such Bioverativ or any of its Affiliates, Representatives or other Persons using such Services, except to the extent that such Liabilities arise out of, relate to or are a consequence of Service Provider’s or its Affiliates’ or Representatives’ gross negligence, willful misconduct or fraud.

 

10



 

(b)                                  Subject to Section 7.1, Service Provider hereby agrees to indemnify, defend and hold harmless Bioverativ and its Affiliates and Representatives from and against any and all Liabilities arising from, relating to or in connection with  the provision of any Services by such Service Provider or any of its Affiliates, Representatives, except to the extent that such Liabilities arise out of, relate to or are a consequence of Bioverativ’s gross negligence, willful misconduct or fraud.

 

(c)                                   Indemnification pursuant to this Section 7.3 represents the Parties’ sole and exclusive remedy under this Agreement, provided that, if Service Provider commits an error with respect to, incorrectly performs or fails to perform any Service, at Bioverativ’s request, without prejudice to any other rights or remedies Bioverativ may have, Service Provider shall use commercially reasonable efforts to correct such error, re-perform such Service or perform such Service, as applicable, at no additional cost to Bioverativ.  To the extent the Service Provider is unable to provide in its entirety a Service because of a partial delay which excuses performance pursuant to Section 10.7, the Service Provider shall allocate such resources and/or products as are then currently available to it and necessary for the performance of such Service ratably between the Service Provider for its own account and Bioverativ for the performance of such Services hereunder.

 

ARTICLE VIII

 

INSURANCE MATTERS

 

Section 8.1                                     Insurance .  Each Party hereto shall, throughout the term of this Agreement, carry appropriate insurance with a reputable insurance company covering property damage, business interruptions, automobile and general liability insurance (including contractual liability) to protect its own business and property interests; provided, that each Party shall be permitted to reasonably self-insure against the liabilities specified in Article VII.

 

ARTICLE IX

 

PRESERVATION OF RECORDS; ACCESS TO INFORMATION; CONFIDENTIALITY; PRIVILEGE

 

Section 9.1                                     Confidentiality .  The provisions of ARTICLE VII (PRESERVATION OF RECORDS; ACCESS TO INFORMATION; CONFIDENTIALITY; PRIVILEGE) of the Separation Agreement shall apply to disclosures of information made pursuant to this Agreement mutatis mutandis .

 

11


 

ARTICLE X

 

MISCELLANEOUS

 

Section 10.1          Inconsistencies .  Nothing contained in this Agreement (or any Annex, Schedule or Exhibit) shall be deemed to supersede or change any of the agreements, obligations, representations or warranties of the Parties to the Separation Agreement or any other Ancillary Agreement.  To the extent that any provision in this Agreement (or any Annex, Schedule or Exhibit) is inconsistent or conflicts with any provision of the Separation Agreement or any other Ancillary Agreement, the provisions of the Separation Agreement or such other Ancillary Agreement, as the case may be, shall control.  To the extent that any provision of any Schedule or Exhibit is inconsistent or conflicts with any other provision of this Agreement, such other provision of this Agreement shall control.

 

Section 10.2          Counterparts .  This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become effective when one or more such counterparts have been signed by each of the Parties and delivered to each of the Parties.

 

Section 10.3          Entire Agreement; Amendments .  This Agreement, including the Exhibits and Schedules, together with the Separation Agreement and the other Ancillary Agreements, shall constitute the entire agreement between the Parties with respect to the subject matter hereof and shall supersede all previous negotiations, commitments, course of dealings and writings with respect to such subject matter.  No amendment, modification or supplement of any provision of this Agreement will be valid or effective unless made in writing and signed by a duly authorized officer of each Party.

 

Section 10.4          Dispute Resolution .  The provisions in Article VIII (DISPUTE RESOLUTION) of the Separation Agreement shall apply to any Dispute related to this Agreement, mutatis mutandis .

 

Section 10.5          Notices .

 

All notices, requests, claims, demands and other communications under this Agreement shall be in English, shall be in writing and shall be given or made (and shall be deemed to have been duly given or made upon receipt) by delivery in person, by overnight courier service, by facsimile with receipt confirmed (followed by delivery of an original via overnight courier service) or by registered or certified mail (postage prepaid, return receipt requested) to the respective Parties at the following addresses (or at such other address for a Party as shall be specified in a notice given in accordance with this Section 10.5):

 

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To Biogen:

 

Biogen Inc.
225 Binney Street
Cambridge, MA 02142
Attn: Chief Legal Officer
Facsimile: [
· ]

 

To Bioverativ:

 

Bioverativ Inc.

225 Second Avenue

Waltham, MA 02451
Attn: Chief Legal Officer
Facsimile: [ · ]

 

Section 10.6          Waivers .  Any consent required or permitted to be given by any Party to the other Party under this Agreement shall be in writing and signed by the Party giving such consent and shall be effective only against such Party.

 

Section 10.7          Force Majeure .

 

(a)           Neither Party hereto shall be liable for delay in performance (other than the payment of money) of its obligations to the extent caused by events which could not have been foreseen and are beyond the reasonable control of the Party affected (an event of “ Force Majeure ”), including but not limited to (i) acts of God, the elements, epidemics, explosions, accidents, landslides, lightning, earthquakes, fires, storms (including but not limited to tornadoes and hurricanes or tornado and hurricane warnings), sinkholes, floods, or washouts; (ii) labor shortage or trouble including strikes or injunctions (whether or not within the reasonable control of such Party and provided that the settlement of strikes and other labor disputes shall be entirely within the discretion of the Party experiencing the difficulty); (iii) inability to obtain material, equipment or transportation; (iv) national defense requirements, war, blockades, insurrections, sabotage, terrorism, riots, arrests and restraints of the government, either federal or state, civil or military (including any governmental taking by eminent domain or otherwise); or (v) any changes in applicable Law, regulation or rule or the enforcement thereof by any governmental or regulatory agency having jurisdiction, that limits or prevents a Party from performing its obligations hereunder or any notice from any such agency of its intention to fine or penalize such Party or otherwise impede or limit such Party’s ability to perform its obligations hereunder.

 

(b)           The Service Provider will endeavor to provide to Bioverativ uninterrupted Services through the Term.  In the event, however, that (i) the Service Provider is wholly or partially prevented from providing a Service or Services either temporarily or permanently by reason of any Force Majeure event, or (ii) the Service Provider, in the exercise of its reasonable good faith judgment, deems it necessary to suspend delivery of a Service hereunder for purposes of inspection, maintenance, repair, replacement of equipment parts or structures, or similar activities consistent with past practices, the Service Provider shall not be obligated to deliver such Service during such periods, and, in the case of the immediately preceding clause (ii), the

 

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Service Provider shall cooperate with Bioverativ with respect to the timing of such interruption.  Notices provided under this Section 10.7 shall be provided to Bioverativ’s Service Manager (or other executive designated in writing by Bioverativ in accordance with Article IV) and may be provided in accordance with Article IV.

 

Section 10.8          Assignment .  Neither Party may assign any rights or delegate any obligations arising under Agreement, in whole or in part, directly or indirectly, without the prior written consent of the other Party, and any attempt to so assign any rights or delegate any obligations arising under this Agreement without such consent shall be void.  Notwithstanding the foregoing, no such consent shall be required for any such assignment or delegation (i) with respect to Biogen, to a Subsidiary of Biogen (so long as such Subsidiary remains a Subsidiary of Biogen), (ii) with respect to Bioverativ, to a Subsidiary of Bioverativ (so long as such Subsidiary remains a Subsidiary of Bioverativ) or (iii) to a bona fide Third Party in connection with a merger, reorganization, consolidation or the sale of all or substantially all the assets of a Party so long as the resulting, surviving or transferee entity assumes all the obligations of the assigning Party by operation of Law or pursuant to an agreement in form and substance reasonably satisfactory to the non-assigning Party; provided , however , that in the case of each of the preceding clauses (i) and (ii), no assignment permitted by this Section 10.8 shall release the assigning Party from liability for the full performance of its obligations under this Agreement.

 

Section 10.9          Successors and Assigns .  The provisions of this Agreement and the obligations and rights hereunder shall be binding upon, inure to the benefit of and be enforceable by (and against) the Parties and their respective successors and permitted assigns.

 

Section 10.10       Third Party Beneficiaries .  Except as provided in Section 7.3 with respect to Persons entitled to claim indemnification hereunder, this Agreement is solely for the benefit of the Parties and shall not be deemed to confer upon Person other than the Parties any remedy, claim, liability, reimbursement, cause of Action or other right beyond any that exist without reference to this Agreement.

 

Section 10.11       Exhibits and Schedules .  The Exhibits and Schedules shall be construed with and as an integral part of this Agreement to the same extent as if the same had been set forth verbatim herein.

 

Section 10.12       Titles and Headings .  Titles and headings to sections herein are inserted for the convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

 

Section 10.13       Governing Law .  This Agreement and any Dispute shall be governed by and construed in accordance with the Laws of the State of Delaware, without giving effect to the conflicts of laws principles thereof that might lead to the application of laws other than the Laws of the State of Delaware.

 

Section 10.14       Consent to Jurisdiction .  All Actions that, directly or indirectly, arise out of or relate to this Agreement shall be heard and determined exclusively in the Court of Chancery of the State of Delaware; provided , however , that if such court does not have jurisdiction over such Action, such Action shall be heard and determined exclusively in any

 

14



 

Delaware state court or United States federal court sitting in the State of Delaware (such courts, “ Delaware Courts ”).  Each of the Parties further agrees that service of any process, summons, notice or document by U.S. registered mail to such Party’s respective address set forth in Section 10.5 shall be effective service of process for any Action in the Delaware Courts with respect to any matters to which it has submitted to jurisdiction in this Section 10.14 .  Consistent with the foregoing in this Section 10.14 , each of the Parties hereby (a) submits to the exclusive jurisdiction of any federal or state court sitting in the State of Delaware for the purpose of any Action brought by any party hereto that, directly or indirectly, arises out of or relates to this Agreement; (b) irrevocably waives and releases, and agrees not to assert by way of motion, defense, or otherwise, in or with respect to any such Action, any claim that (i) such Action is not subject to the subject matter jurisdiction of at least one of the above-named courts; (ii) its property is exempt or immune from attachment or execution in the State of Delaware; (iii) such Action is brought in an inconvenient forum; (iv) that the venue of such Action is improper; or (v) this Agreement or the transactions contemplated by this Agreement may not be enforced in or by any of the above-named courts; and (d) agrees not to move to transfer any such Action to a court other than any of the above-named courts.

 

Section 10.15       Waiver of Jury Trial .  EACH OF THE PARTIES HEREBY IRREVOCABLY WAIVES TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY WITH RESPECT TO ANY ACTION OR LIABILITY, DIRECTLY OR INDIRECTLY, ARISING OUT OF, RELATING TO, OR IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT.  EACH OF THE PARTIES HEREBY (A) CERTIFIES THAT NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF ANY SUCH ACTION OR LIABILITY, SEEK TO ENFORCE THE FOREGOING WAIVER; AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT AND THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, AS APPLICABLE, BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 10.15 .

 

Section 10.16       Severability .  In the event any one or more of the provisions contained in this Agreement should be held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein and therein shall not in any way be affected or impaired thereby.  The Parties shall endeavor in good-faith negotiations to replace the invalid, illegal or unenforceable provisions with valid provisions, the economic effect of which comes as close as possible to that of the invalid, illegal or unenforceable provisions.

 

Section 10.17       Interpretation .  The Parties have participated jointly in the negotiation and drafting of this Agreement.  This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the Party drafting or causing any instrument to be drafted.

 

Section 10.18       No Waiver .  No failure to exercise and no delay in exercising, on the part of any Party, any right, remedy, power or privilege hereunder shall operate as a waiver hereof or thereof; nor shall any single or partial exercise of any right, remedy, power or privilege

 

15



 

hereunder or thereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

 

Section 10.19       Independent Contractor Status .  The Service Provider shall be deemed to be an independent contractor to Bioverativ.  Nothing contained in this Agreement shall create or be deemed to create the relationship of employer and employee between the Service Provider and Bioverativ.  The relationship created between the Service Provider and Bioverativ pursuant to or by this Agreement is not and shall not be one of partnership or joint venture.  No Party to this Agreement shall, by reason hereof, be deemed to be a partner or a joint venture of the other Party hereto in the conduct of their respective businesses and/or the conduct of the activities contemplated by this Agreement.  Except as specifically and explicitly provided in this Agreement, and subject to and in accordance with the provisions hereof, no Party to this Agreement is now, shall become, or shall be deemed to be an agent or representative of the other Party.  Except as herein explicitly and specifically provided, neither Party shall have any authority or authorization, of any nature whatsoever, to speak for or bind the other Party to this Agreement.

 

[Remainder of this page intentionally left blank]

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed as of the day and year first above written.

 

 

BIOGEN INC.

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

 

 

 

 

 

BIOVERATIV INC.

 

 

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

[Signature Page to Transition Services Agreement]

 




Exhibit 2.4

 

Form of

 

MANUFACTURING AND SUPPLY AGREEMENT

 

by and between

 

BIOGEN INC.

 

and

 

BIOVERATIV INC.

 

Dated as of [ · ],[ · ]

 



 

TABLE OF CONTENTS

 

ARTICLE 1 DEFINITIONS

3

ARTICLE 2 MANUFACTURING — GENERAL PROVISIONS

10

ARTICLE 3 [RESERVED]

11

ARTICLE 4 PHASES

11

ARTICLE 5 MANUFACTURING, FORECASTS, ORDERS AND INVENTORY

13

ARTICLE 6 TESTING AND QUALITY ASSURANCE

17

ARTICLE 7 COST ALLOCATION, PRICING, AND PAYMENT

18

ARTICLE 8 AUDITS

18

ARTICLE 9 RELEASE, STORAGE AND SHIPMENT

19

ARTICLE 10 MANAGEMENT OF THE ALLIANCE

29

ARTICLE 11 MANUFACTURE SERVICES

30

ARTICLE 12 REGULATORY MATTERS

35

ARTICLE 13 TERM AND TERMINATION

36

ARTICLE 14 INTELLECTUAL PROPERTY

39

ARTICLE 15 CONFIDENTIALITY

40

ARTICLE 16 REPRESENTATIONS AND WARRANTIES; COVENANTS

40

ARTICLE 17 LIABILITY LIMITATION

43

ARTICLE 18 INDEMNITY

44

ARTICLE 19 INSURANCE

44

ARTICLE 20 DISPUTE RESOLUTION

45

ARTICLE 21 MISCELLANEOUS

46

 

Schedules

 

Schedule 1

 

Clinical Products

Schedule 2A

 

Drug Substance Specifications

Schedule 2B

 

Drug Product Specifications

Schedule 2C

 

Finished Goods Specifications

Schedule 3

 

Presentations

Schedule 4

 

Intended Timeline

Schedule 5

 

Forecast and Purchase Order Template

Schedule 6

 

Pricing; Invoicing and Payment; Batch Failure Treatment

Schedule 7

 

Determination of Latent Defects

Schedule 8

 

Technology Transfer Cost Schedule

Schedule 9

 

Management of the Alliance

Schedule 10

 

Initial Forecast

 


 

MANUFACTURING AND SUPPLY AGREEMENT

 

This Manufacturing and Supply Agreement (the “ Agreement ”) is made and entered into as of [ · ], [ · ], by and between Biogen Inc., a Delaware corporation (“ Biogen ”), and Bioverativ Inc., a Delaware corporation (“ Bioverativ ”). Each of the parties hereto are referred to collectively as the “ Parties ” and individually as a “ Party ”.

 

WHEREAS, Biogen is pursuing a plan to separate (the “ Separation” ) into two separate, publicly traded companies and, in furtherance thereof, Biogen and its subsidiary, Bioverativ, propose to enter into a Separation Agreement (the “ Separation Agreement ”) and the other Transaction Agreements (as defined in the Separation Agreement), including the IP License Agreement (as defined in the Separation Agreement), that will govern and provide a framework for the Separation;

 

WHEREAS, pursuant to the Transaction Agreements the Parties have agreed that Biogen will manufacture and supply certain products, including drug substance, active drug product and finished goods to Bioverativ in accordance with the terms and conditions of this Agreement;

 

WHEREAS , pursuant to the IP License Agreement, Biogen has licensed to Bioverativ intellectual property rights controlled by Biogen and used in the manufacture of the products hereunder and Bioverativ has licensed to Biogen intellectual property rights controlled by Bioverativ and used in the manufacture of products hereunder.

 

NOW, THEREFORE, in consideration of the promises and the mutual covenants and agreements herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:

 

ARTICLE 1

 

DEFINITIONS

 

Capitalized terms used herein have the definitions given in this Article 1 or elsewhere in this Agreement; provided that if any capitalized term used herein is not listed in Article 1 or defined elsewhere in this Agreement, such term shall have the definition provided in the Separation Agreement, as it may be amended from time to time.

 

Active Drug Product ” means drug product manufactured using the Drug Substance.

 

Additional Cure Period ” is defined in Section 13.3(b).

 

ADP Certificate of Analysis ” is defined in Section 6.1.

 

ADP Certificate of Conformance ” is defined in Section 6.1.

 

ADP Certificates ” means the ADP Certificate of Analysis and ADP Certificate of Conformance collectively.

 

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ADP Lot ” means the Active Drug Product output for one Active Drug Product manufacturing unit operation.

 

Advisory Forecast ” is defined in Section 5.2(a)(iii).

 

Affiliate ” has the meaning set forth in the Separation Agreement.

 

Agreement ” is defined in the Preamble.

 

Alliance ” will mean the relationship of the Parties as established by this Agreement.

 

Applicable Law ” means the applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other governmental authority regulating or otherwise exercising authority, that may be in effect from time to time and applicable to the Parties in relation to the activities and products hereunder.  For the avoidance of doubt, cGMPs shall be considered to be a part of Applicable Laws.

 

Audited Party ” is defined in Section 8.3.

 

Auditing Party ” is defined in Section 8.3.

 

Batch Documentation ” means all batch specific information included in a release decision, including but not limited to executed batch records, testing results and deviation investigations, in each instance based on Biogen’s applicable standard operating procedures.

 

Binding Forecast ” is defined in Section 5.2(a)(i).

 

Binding Purchase Order ” is defined in Section 5.2(b) .

 

Biogen ” is defined in the Preamble.

 

Biogen Background IP ” is defined in Section 14.1.

 

Biogen Broader Change ” is defined in Section 11.3(d).

 

Biogen Indemnified Parties ” means Biogen and its Indemnified Parties.

 

Biogen Marks ” is defined in Section 4.2(b).

 

Bioverativ ” is defined in the Preamble.

 

Bioverativ Background IP ” is defined in Section 14.1.

 

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Bioverativ Indemnified Parties ” means Bioverativ and its Indemnified Parties.

 

Breaching Party ” is defined in Section 13.3(a).

 

Campaign ” means a series of batches or lots of the same product that are produced in parallel or consecutively at the same manufacturing site.

 

cGMP Consultant ” is defined in Section 9.1(c)(ii)(C).

 

cGMPs ” means current good manufacturing practices as provided for (and as amended from time to time) in European Community Directive 91/356/EEC (Principles and Guidelines of Good Manufacturing Practice for Medicinal Products) and in the Current Good Manufacturing Practice Regulations of the United States Code of Federal Regulations Title 21 (21 CFR Parts 210-211) in relation to the production of pharmaceutical intermediates and active pharmaceutical ingredients, as interpreted by ICH Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

 

Compliance Issue ” means an issue as to whether Finished Goods, Drug Product or Drug Substance was manufactured in accordance with cGMPs in effect when such product is shipped to Bioverativ or upon the applicable product release.

 

Confidential Information ” has the meaning set forth in the Separation Agreement.

 

Diluent ” means the pre-filled syringe of sterile water for injection used to reconstitute the Active Drug Product or Finished Goods for intravenous delivery.

 

Diluent Certificate of Analysis ” is defined in Section 6.1.

 

Diluent Certificate of Conformance ” is defined in Section 6.1.

 

Diluent Certificates ” means the Diluent Certificate of Analysis and Diluent Certificate of Conformance collectively.

 

Diluent Lots ” means the quantity of Diluent prepared or required for one unit operation.

 

Distribution Date ” has the meaning set forth in the Separation Agreement.

 

Distribution Effective Time ” has the meaning set forth in the Separation Agreement.

 

DP Release ” means, with respect to Active Drug Product, the date on which Bioverativ receives the ADP Certificate of Analysis and the ADP Certificate of Conformance, and with respect to Diluent, the date on which Bioverativ receives the Diluent Certificate of Analysis and the Diluent Certificate of Conformance.

 

DP/FG Testing Laboratory ” is defined in Section 9.2(c)(i)(B).

 

Drug Product ” means Active Drug Product and Diluent, whether separately or collectively.

 

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Drug Product Specifications ” means the Specifications for the Active Drug Product or Diluent, as applicable, the current versions of which (as of the Effective Date) are set forth in Schedule 2B attached hereto .

 

Drug Substance ” (or “ DS ”) means, as applicable, the bulk drug substance containing (i) that certain Factor VIII: Fc Construct that is the subject of BLA 125487, or (ii) that certain Factor IX Fc Construct that is the subject of BLA 125444, in each case as such biologics license application may be amended or revised from time to time, or (iii) those certain clinical products that are specified on Schedule 1 attached hereto or as agreed to by the parties from time to time.

 

Drug Substance Specifications ” means the Specifications for the Drug Substance, the current version of which (as of the Effective Date) is set forth in Schedule 2A attached hereto.

 

DS Batch ” means the quantity of Drug Substance from a single formulation operation produced under cGMP and in accordance with a defined set of release criteria, using 1,000 liter, 2,000 liter, 15,000 liter or 18,000 liter working volume bioreactor, and as a result of a series of sequential inoculation cell culture, harvest and purification steps for manufacture of Drug Substance for inclusion in (i) products intended for commercial sale and (ii) products intended for use in clinical development.

 

DS Certificate of Analysis ” is defined in Section 6.1.

 

DS Certificate of Conformance ” is defined in Section 6.1.

 

DS Certificates ” means the DS Certificate of Analysis and DS Certificate of Conformance collectively.

 

DS Release ” is defined in Section 9.1(a).

 

DS Testing Laboratory ” is defined in Section 9.1(c)(i)(B).

 

Effective Date ” is means the Distribution Date (as defined in the Separation Agreement).

 

Engineering Batch ” shall mean one (1) test batch or lot, as applicable, of product manufactured at scale in accordance with its applicable Specifications, excluding completion of all release test results.

 

“Facility” shall mean a Biogen manufacturing facility and/or any other facility operated by Biogen or a Third Party Manufacturer in connection with the manufacture of the product.

 

Finished Goods ” means Drug Product in finished dosage form, packaged and labeled for distribution or sale, for donation or for use in clinical trials.

 

Finished Goods Certificate of Analysis ” is defined in Section 6.1.

 

“Finished Goods Certificate of Conformance ” is defined in Section 6.1.

 

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“Finished Goods Certificates ” means the Finished Goods Certificate of Analysis and Finished Goods Certificate of Conformance collectively.

 

Finished Goods Release ” means the date on which Bioverativ receives the Finished Goods Certificates.

 

Finished Goods Specifications ” means the Specifications for the Finished Goods, the current versions of which (as of the Effective Date) are set forth in Schedule 2C attached hereto .

 

First Phase ” means, with respect to a particular jurisdiction, the period from the Effective Date until the date that Bioverativ has obtained appropriate licenses in such jurisdiction such that Bioverativ is enabled under Applicable Law to take title to, and sell, Finished Goods and Drug Product.

 

Force Majeure Event ” is defined in Section 21.2.

 

Forecast ” means the Binding Forecast, the Semi-Binding Forecast or the Advisory Forecast.

 

FTE Rate ” means, with respect to Biogen’s employees, the full-time equivalent rate then used by Biogen for its internal accounting purposes, prorated on an hourly basis based on a total of one thousand six hundred (1,600) hours worked per year.

 

Indemnified Parties ” means, with respect to a Party, such Party and such Party’s Affiliates and licensors of intellectual property sublicensed under this Agreement, and its and their respective officers, directors, shareholders, successors, assigns, agents, employees and insurers to the extent the same become subject to a claim in such capacity.

 

Initial Cure Period ” is defined in Section 13.3(a).

 

Initial Term ” is defined in Section 13.1(a).

 

Joint IP ” is defined in Section 14.3.

 

Joint Manufacturing and Supply Committee ” or “ JMSC ” is defined in Section 10.1.

 

Latent Defect ” means (i) with respect to Drug Substance, a Non-Conformity or a Compliance Issue that was not reasonably discoverable within the forty-five (45) day period referenced in Section 9.1(c)(i)(A)) and which failure is confirmed by the procedure set forth on Schedule 7 attached hereto; and (ii) with respect to Drug Product or Finished Goods, a Non-Conformity or a Compliance Issue that was not reasonably discoverable within the forty-five (45) day period referenced in Section 9.2(c)(i)(A) and which failure is confirmed by the procedure set forth on Schedule 7 attached hereto.

 

“Lot” shall refer to a Drug Product lot or a Diluent lot.

 

Manufacture ” or “ Manufacturing ” means, with respect to a product for which an Order is made under this Agreement, the process scale-up, validation, clinical and commercial

 

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manufacturing (including bulk manufacturing, finished pharmaceutical product manufacturing, and label-pack); provided , that Manufacturing excludes development and commercialization of such product.

 

“MFC” means projected months forward coverage of inventory calculated against the most recent unit demand Forecasts by stage of Manufacture.  Finished Goods will be calculated as independent demand and drug product and drug substance will be calculated as dependent demand.

 

NDC ” means National Drug Code.

 

Non-Conformity ” means (i) with respect to any Drug Substance, a failure of such Drug Substance to conform to the Drug Substance Specifications in effect at the time of the DS Release, (ii) with respect to any Drug Product or Finished Goods, a failure of such Drug Product or Finished Goods, or the Drug Substance used to Manufacture such Drug Product or Finished Goods, to conform to the Drug Product Specifications or Finished Goods Specifications in effect at the time of the DP Release; and (iii) with respect to any Finished Goods, a failure of such Finished Goods to comply with the Finished Goods Specifications in effect at the time of Finished Goods Release, and the adjective “ Non-Conforming ” shall have the correlative meaning.

 

Notifying Party ” is defined in Section 13.3(a).

 

Order ” means (i) a Purchase Order or (ii) a service order for commitment of Finished Goods as transacted in the First Phase.

 

Party ” and “ Parties ” are defined in the first paragraph of this Agreement.

 

Presentation ” means the presentations set forth in Schedule 3 attached hereto, as it may be updated from time to time by the JMSC.

 

Process ” shall mean a process for the manufacture of product in accordance with the terms of this Agreement, comprising all intellectual property and other technical information relating to the process of manufacture and testing reasonably required to produce a product including, without limitation, any associated documentation, as set forth in the applicable Specification for such product.

 

Proposed Change ” is defined in Section 11.3(a).

 

Purchase Order ” is defined in Section 5.2(b).

 

Quality Agreement ” means the quality agreement between the Parties relating to Drug Substance, Drug Product and Finished Goods, as such agreement is amended from time to time.  As of the Effective Date, the Parties anticipate that the Quality Agreement will be executed within 60 days of the Effective Date.

 

Regulatory Approva l” means, with respect to a product and a country, any and all approvals (including any applicable governmental price and reimbursement approvals), licenses,

 

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registrations or authorizations of the applicable Regulatory Authority necessary for the use, storage, import, promotion, marketing and sale of such product in such country, including approval of all relevant regulatory filings.

 

Regulatory Authority ” means, with respect to a country, any governmental authority (whether federal, state, provincial, municipal or other) regulating the exportation, importation, use, manufacture, distribution, marketing and/or sale of pharmaceuticals, which, in the U.S., shall include the U.S. Food and Drug Administration (or any successor agency thereto) and, in Europe, shall include the European Medicines Agency (or any successor agency thereto).

 

Renewal Term ” is defined in Section 13.1(b).

 

Representing Party ” is defined in Section 16.1(a).

 

Required Change ” is defined in Section 11.2.

 

Second Phase” means, with respect to a particular jurisdiction, the period from the end of the First Phase until the date that is 18 months after the date of this Agreement, or as may be mutually agreed by the parties.

 

Semi-Binding Forecast ” is defined in Section 5.2(a)(ii).

 

Senior Executives ” means, with respect to Biogen, [      ], and with respect to Bioverativ, [     ].

 

Separation ” is defined in the Recitals.

 

Separation Agreement ” is defined in the Recitals.

 

Severed Clause ” is defined in Section 21.7.

 

Specifications ” shall mean, with respect to any product, all specifications for the Process of manufacture of product, including required materials, approved suppliers, manufacturing, analytical and testing procedures, release, packaging, labeling, storage and other processes relating to the manufacture, shipping and handling of the product, all as set forth in the applicable Appendix, in each case including the Quality Agreement and test methods referred to therein.

 

“Term” means collectively the Initial Term and (if any) the Renewal Term(s).

 

Third Party ” means any Person other than Biogen, Bioverativ or their respective Affiliates.

 

Third Party Carrier ” means any carrier selected or approved by Bioverativ or its Affiliates to (i) transport Drug Substance (pursuant to Section 9.1(e)), or (ii) transport Drug Product or Finished Goods from the Manufacturing Facility to Bioverativ or Bioverativ’s designee.

 

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Third Party Manufacturer ” is defined in Section 2.3.

 

Third Phase” means, with respect to a particular jurisdiction, the period from the end of the Second Phase to the end of the Term.

 

Transaction Agreements ” is defined in the Separation Agreement.

 

Transferred Agreements ” means that certain amended and restated FVIII: FC Lead Product Commercial Manufacturing and Supply Agreement between Swedish Orphan Biovitrum AB (Publ) and Biogen Hemophilia Inc., dated as of 20 November 2014, and that certain amended and restated FIX: Fc Lead Product Commercial Manufacturing and Supply Agreement between Swedish Orphan Biovitrum AB (Publ) and Biogen Hemophilia Inc., dated as of December 22, 2014, in each case, as the same may be amended or supplemented from time to time.

 

ARTICLE 2

 

MANUFACTURING — GENERAL PROVISIONS

 

2.1                                Manufacturing Authority .  Except as otherwise expressly set forth in this Agreement, Biogen shall retain full decision-making authority with respect to Drug Substance, Drug Product and Finished Goods manufacturing operations.

 

2.2                                Exclusivity .  Except as expressly contemplated by this Agreement, Biogen shall not manufacture or supply the Drug Substance, Drug Product or Finished Goods contemplated by this Agreement, or any biosimilar of any of the foregoing, to any Person other than Bioverativ until the date that is one year after the expiration or termination of this Agreement.

 

2.3                                Affiliates and Third Party Manufacturers .  Notwithstanding anything to the contrary in this Agreement, Biogen may use one or more Third Party manufacturers (each a “ Third Party Manufacturer ”) or Affiliates to (a) manufacture the Drug Substance, Active Drug Product and/or Diluent and/or to (b) pack and label and perform other activities necessary for the provision of the Finished Goods, in each case solely to the extent Bioverativ, in its reasonable judgment, has consented in writing to the use of such Third Party Manufacturers; provided that Bioverativ shall be deemed to be have consented hereunder to the continued use of Third Party Manufacturers used by Biogen prior to the date of this Agreement.

 

2.4                                Technology Transfer .  Either Party may request during the Term a technology transfer from the Facility to another facility in accordance with this Section 2.4.   Biogen may request, and Bioverativ may approve (such approval not to be unreasonably withheld, conditioned or delayed; for the avoidance of doubt, a material increase in the resulting cost of goods to Bioverativ shall be a reasonable basis for objection) a technology transfer from a Facility to another Biogen Facility, provided that Biogen shall bear all costs associated therewith.  Bioverativ may request a technology transfer to its own facility or that of a Third Party, provided that Bioverativ shall bear all costs associated therewith, including any costs set forth on the cost schedule included in Schedule 8 attached hereto.  Scale technology transfers requested by Biogen shall be approved by Bioverativ (with such approval not to be unreasonably withheld, conditioned or delayed) and Biogen shall bear all costs associated therewith. Scale

 

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technology transfers requested by Bioverativ shall adhere to the technology transfer cost schedule included in Schedule 8 attached hereto.

 

2.5                                Invoicing by Biogen’s Affiliates .  Where this Agreement refers to invoices being issued by Biogen to Bioverativ, Biogen may, at its discretion, have one or more of its Affiliates issue such invoices. If an Affiliate of Biogen issues such an invoice to Bioverativ, Bioverativ shall pay such Affiliate in accordance with the payment instructions on such invoice, and Bioverativ’s payment of a given amount against such invoice shall be deemed to satisfy its obligation hereunder to pay such amount to Biogen.

 

2.6                                IRC Section 199 .  The Parties agree that the mutual intent is for Bioverativ to be considered as having the IRC Section 199 benefits and burdens, pursuant to Treasury Regulation 1.199-3(f)(1), of any Drug Substance manufacturing activity occurring within the United States on or after the Effective Date.

 

ARTICLE 3

 

[RESERVED]

 

ARTICLE 4

 

PHASES

 

4.1                                First Phase .  During the First Phase, with respect to a particular jurisdiction, Bioverativ shall forecast Drug Substance, Drug Product and Finished Goods that are packaged and labelled for sale by Biogen or by a Third Party designated by Biogen as agreed by the Parties.  Biogen or such designated Third Party will distribute, sell and have sold such Finished Goods under Biogen’s or such Third Party’s necessary authorizations and licenses for the marketing of prescription biopharmaceutical products in any applicable territory.  For the avoidance of doubt, during the First Phase, title to such Finished Goods shall not transfer from Biogen to Bioverativ.

 

4.2                                Second Phase .

 

(a)                                  During the Second Phase, with respect to a particular jurisdiction, Bioverativ shall forecast Drug Substance, Drug Product and Finished Goods and order Drug Product or Finished Goods that are packaged and labelled for sale by Bioverativ or by a Third Party designated by Bioverativ, which shall include, for the avoidance of doubt, any product remaining unsold following the end of the First Phase that was forecasted by Bioverativ during the First Phase and that bears Biogen’s or a Biogen designated Third Party’s NDC numbers (or any equivalent non-U.S. designation of responsible party).  Bioverativ shall take title to all such Drug Product or Finished Goods in accordance with Section 9.2(d) in order to enable Bioverativ or such designated Third Party to distribute, sell and have sold such products under Bioverativ’s or such Third Party’s necessary authorizations

 

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and licenses for the marketing of prescription biopharmaceutical products in any applicable territory.

 

(b)                                  Effective as of the beginning of the Second Phase on a territory-by-territory basis, Biogen, on behalf of itself and its Affiliates, hereby grants to Bioverativ and its Affiliates, until the earlier of (i) the sale of the last Finished Goods bearing the trade marks and trade dress of Biogen as provided on Finished Goods manufactured by Biogen for Bioverativ (the “ Biogen Marks ”) in the applicable territory or (ii) the expiration of the usable shelf life of the last Finished Goods in such territory bearing the Biogen Marks, a non-exclusive, sublicenseable, worldwide, and royalty-free license to use the Biogen Marks to facilitate the transition by Bioverativ and its Affiliates to the sale of Finished Goods bearing new names and marks.  All goodwill associated with the Biogen Marks generated by Bioverativ or its Affiliates’ use of the Biogen Marks pursuant to the foregoing license in this Section 4.2(b) shall inure to the benefit of Biogen and its Affiliates.  Bioverativ and its Affiliates shall use the Biogen Marks at a level of quality equivalent in all material respects to that in effect as of the beginning of the Second Phase in the applicable territory.  For purposes of clarity, nothing in this Section 4.2(b) shall preclude any uses of the Biogen Marks by Bioverativ and its Affiliates that are required or otherwise not prohibited under Applicable Law, including uses of the Biogen Marks not in commerce, uses that would not cause confusion as to the origin of a good or service, and references to the Biogen Marks in historical, tax, and similar records.

 

4.3                                Third Phase .  During the Third Phase, with respect to a particular jurisdiction, Bioverativ shall forecast and order Drug Substance from Biogen.  Bioverativ shall take title to all such Drug Substance and arrange shipments in accordance with Sections 9.1(d) and 9.1(e), respectively.  The parties shall in good faith work together to determine the duration and terms for storage of any Drug Substance in a Biogen Facility. For the avoidance of doubt, the Parties intend that Bioverativ enter the Third Phase in each jurisdiction as expeditiously as possible and and not later than eighteen (18) months from the Distribution Effective Time unless otherwise agreed.  The Parties agree to cooperate in good faith to enable Bioverativ to further such objective.

 

4.4                                Phase Timeline .  The Parties currently intend that the timeline for the applicability of the First Phase, Second Phase and Third Phase to certain jurisdictions shall be as set forth on Schedule 4.4 attached hereto.  For the avoidance of doubt, upon execution of this Agreement, Japan and jurisdictions included in the Transferred Agreements shall begin in the Second Phase and the United States and Canada shall begin in the First Phase. The Parties will work together in good faith to address supply for the humanitarian aid program and other jurisdictions to adjust the timeline as appropriate in response to circumstances to achieve the aims of this Agreement.

 

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ARTICLE 5

 

MANUFACTURING, FORECASTS, ORDERS AND INVENTORY

 

5.1                                Manufacture and Supply .  Subject to the terms of this Agreement, Biogen shall manufacture (or cause to be manufactured) and/or supply, as applicable, Drug Substance, Active Drug Product, Diluent and Finished Goods, in each case in accordance with the Binding Forecast.

 

5.2                                Forecasting, Planning, Ordering, and Inventory .

 

(a)                                  Forecast and Planning . Bioverativ shall submit to Biogen written, rolling forecasts for planning and purchase of Drug Substance, Drug Product and Finished Goods supply needs, in accordance with the template attached on Schedule 5 attached hereto, itemized as follows:

 

FORECAST

 

“Binding
Forecast”
Months

 

“Semi-
Binding
Forecast”
Months

 

“Advisory
Forecast”
Months

 

Minimum Update
Frequency

Clinical Drug Substance

 

1-7

 

8-19

 

20–60

 

Quarterly

Commercial Drug Substance

 

1-13

 

14-25

 

26-60

 

Quarterly

Clinical and Commercial Active Drug Product & Diluent

 

1-7

 

8-16

 

17-60

 

Monthly

Finished Goods

 

1-4

 

N/A

 

5-24

 

Monthly

 

(i)                                      The “Binding Forecast” shall be binding per the terms noted above for the quantities of clinical and commercial DS Batches or Active Drug Product and Diluent or Finished Goods, respectively, by Presentation forecasted for future orders by Bioverativ for release in the months specified above, with “month-one” of such Binding Forecast representing the month during which such Forecast is submitted.

 

(1)                                  Drug Substance : The aggregate quantities forecasted in a Binding Forecast for the months in any quarter may not be more than fifty percent (50%) above or fifty percent (50%) below the number of DS Batches for such quarter when it first appeared in the Semi-Binding Forecast, and the quantities forecasted for any month of the Binding Forecast may not be changed from the quantities forecasted for such month in the first Binding Forecast to include such month, without the prior written consent of Biogen on a case-by-case basis.

 

(2)                                  Drug Product : The Binding Forecast for any month (i) may not be more than fifty percent (50%) above or fifty percent (50%) below the number of Lots respectively by Presentation for such month when it first appeared in the Semi-

 

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Binding Forecast and (ii) may not be changed from the quantities forecasted for such month in the first Binding Forecast to include such month, without the prior written consent of Biogen on a case-by-case basis.

 

(ii)                                   The “Semi-Binding Forecast ” shall specify the quantities of DS Batches or Active Drug Product and Diluent, respectively, by Presentation forecasted for future orders by Bioverativ for release in the months specified above, with “month-one” representing the month during which such Forecast is submitted.

 

(1)                                  Drug Substance : The amounts forecasted by Bioverativ for each quarter within the Semi-Binding Forecast period may not be changed by Bioverativ to be more than fifty percent (50%) above or fifty percent (50%) below the number of DS Batches for such quarter when it first appeared in the Semi-Binding Forecast.

 

(2)                                  Drug Product : The amounts forecasted by Bioverativ for each month within the Semi-Binding Forecast period may not be changed by Bioverativ to be more than fifty percent (50%) above or fifty percent (50%) below the number of Lots by Presentation for such month when it first appeared in the Semi-Binding Forecast.

 

(iii)                                The “Advisory Forecast ” shall be non-binding and specify for each month noted above the quantities of DS Batches or Active Drug Product and Diluent or Finished Goods, respectively, by Presentation forecasted for future order by Bioverativ for release in the months specified above, with “month-one” representing the month during which such Forecast is submitted.

 

(iv)                               Biogen will provide Bioverativ a 24 month forecast of planned Facility outages and overall Facility utilization for Drug Substance Manufacture in conjunction with Bioverativ’s quarterly Drug Substance forecast.

 

(b)                                  Orders .  Bioverativ shall place Orders for the number of batches or units of Drug Substance, Active Drug Product, Diluent and Finished Goods by Presentation (a “ Purchase Order ”), in accordance with the amounts, procedures and timelines set forth on Schedule 5 attached hereto. Such Purchase Order shall become binding in accordance with the procedures and timelines set forth on Schedule 5 attached hereto, and thereafter shall be deemed to be a “ Binding Purchase Order.”

 

(c)                                   Subject to the foregoing conditions, Biogen shall give such response of acceptance of the Purchase Order within ten (10) Business Days from receipt of a Purchase Order and such response shall include confirmation of the shipment date.  Biogen shall be committed to use commercially reasonable efforts to produce and deliver the quantities of Drug Substance, Active Drug Product, Diluent and Finished Goods, by Presentation, set forth in such Binding Purchase

 

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Order; provided , however , that if Biogen conditionally agrees to supply any quantities of Drug Substance, Active Drug Product, Diluent and Finished Goods in excess of the quantities for such item set forth in the applicable Binding Forecast, Biogen’s efforts to supply such quantities shall be at its discretion. If Bioverativ does not place such a Purchase Order, or places a Purchase Order for a lesser quantity than the quantities specified in the Binding Forecast, in any case without Biogen’s prior written approval, then (i) Bioverativ shall nevertheless be deemed to have submitted such Purchase Order for the forecasted quantities of Drug Substance, Active Drug Product, Diluent and Finished Goods, (ii) Biogen may, but is not obligated to, produce the quantities of Drug Substance, Active Drug Product, Diluent or Finished Goods by Presentation that exceed the quantities in the applicable Binding Purchase Order if one was actually placed by Bioverativ, or any quantities of Drug Substance, Active Drug Product, Diluent or Finished Goods by Presentation if Bioverativ failed to timely place a Binding Purchase Order, (iii) Biogen shall be entitled to invoice Bioverativ for such Drug Substance, Active Drug Product, Diluent and Finished Goods pursuant to Section Article 7, (iv) Bioverativ shall be obligated to pay Biogen for such Drug Substance, Active Drug Product, Diluent and Finished Goods, and (v) such quantities of Drug Substance, Active Drug Product, Diluent and Finished Goods shall be deemed produced pursuant to a Binding Purchase Order.  When scheduling Drug Substance production of Bioverativ Orders, and giving consideration to delivery schedules as per accepted Purchase Orders, Biogen will use commercially reasonable efforts to plan and conduct cost efficient manufacturing campaigns.

 

(d)                                  Inventory .  The Parties shall manage inventory levels, including minimum levels of critical materials and components and safety stock of Drug Substance, Drug Product and Finished Goods, in accordance with the following.

 

(i)                                      Specifically, Biogen and Bioverativ, as appropriate depending on Phase, shall use commercially reasonable efforts to maintain safety stock (released and unreleased) inventories of twelve months Drug Substance MFCs, nine months Drug Product MFCs and 3 months Finished Goods MFCs.

 

(ii)                                   Biogen will maintain all incoming materials including raw materials and components at safety stock levels appropriate to ensure uninterrupted market supply.

 

(iii)                                Inventory deemed excess or obsolete by Bioverativ due to any reason, including but not limited to changes in demand, inventory transitions, production scheduling, campaign and lot sizing or batch yield will be charged to Bioverativ per pricing schedule.

 

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5.3                                Manufacturing Difficulties and Shortages .

 

(a)                                  DS Batch Failure.

 

(i)                                      During each calendar year, Biogen is expected to maintain the production success rates for commercial DS Batches as included in Schedule 6 attached hereto.  If during such time less than 10 commercial batches are produced, then the time period will be extended until 10 or greater commercial batches have been produced.  The costs of commercial batch failures will be borne by the parties based on the production success rates and as set forth on Schedule 6 attached hereto.

 

(ii)                                   The cost of clinical batch failures will be borne by the parties as set forth in Schedule 6 attached hereto.

 

(iii)                                To the extent Bioverativ is responsible for any costs related to batch failures as set forth in Schedule 6, it will pay Biogen the cost incurred by Biogen, including the cost of raw materials. To the extent Biogen is responsible for any costs related to batch failures as set forth in Schedule 6, it will be responsible for its cost incurred, except for failures resulting from incoming raw materials which were properly inspected upon receipt or due to product process changes initiated at the request of Bioverativ.

 

(iv)                               Any batch failures resulting from incoming raw material or process failures due to product process changes initiated at the request of Bioverativ will not be factored into the success rate calculations and will be paid for according to Schedule 6, including raw materials, by Bioverativ. In the case of gross negligence, Biogen will be financially responsible for any costs related to batch failures, including raw materials.

 

(v)                                  For batch failures, Bioverativ may elect to:

 

(1)                                  not request replacement of the failed batches, with no impact to the requirements of the Binding Forecast or Semi-Binding Forecast and without financial impact to Bioverativ;

 

(2)                                  cause Biogen to manufacture, at Biogen’s cost and expense, a new DS Batch that conforms to the Specifications as soon as practicable using commercially reasonable efforts, taking into account the availability of materials; or

 

(3)                                  cause Biogen to reprocess, at a cost and expense per pre-defined success rate criteria set forth on Schedule 6 attached hereto, the DS Batch (if reasonably possible), with the goal that the reprocessed DS Batch conforms to the Specifications as soon as practicable using commercially reasonable efforts.

 

(vi)                               Notwithstanding any provision herein to the contrary: (i) Biogen will be responsible for any loss of resin or similar high value material resulting from gross negligence or willful misconduct by Biogen or its agents or contractors, and (ii) for any loss of resin or similar high value material at each production scale resulting from unrecoverable and assignable failure of Biogen or its agents or contractors that is not

 

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considered gross negligence or willful misconduct, Biogen will be responsible for 25% of the loss connected with the first occurrence, 75% of the loss connected with the second occurrence and 100% for the third and all subsequent loss occurrences; (iii) the number of resin and high value material losses described in this Section shall not be resin specific, and shall be reset on each fifth anniversary of the Effective Date; and (iv) in the event that resins or similar high value materials are not expected to be used in the manufacture of product within 12 months of the expected receipt date of such resins or high value materials.

 

(vii)                            No credit will be allowed and no relief from any payment obligation will result under Section 5.3(a) for any loss or production of any Engineering Batch.

 

(b)                                  Shortages Allocation .  In the case of a shortage of Drug Substance, Drug Product or components of Finished Goods or manufacturing capacity issues, including shortages due to a Force Majeure Event that is not caused by Biogen, Biogen shall produce and allocate to Bioverativ, with respect to each relevant Purchase Order, a portion of the product that is the subject of such shortage equal to the percentage of Bioverativ’s requirements for such product (based on the anticipated average annual production from the most recent twenty-four (24) month Forecast) bears to the overall product requirements of Biogen to produce all Biogen products, Third Party drug products and Bioverativ products, provided , however , that (i) unmet medical needs are prioritized first and foremost across all Biogen, Bioverativ and non-Biogen products manufactured; (ii) appropriate safety stock inventories (as set forth in Section 5.2(d) above ) are adhered to; and (iii) unless (and only to the extent) not permitted by the terms of any agreements with Biogen’s other customers in effect on the date hereof (or any subsequent renewals on substantially the same terms), Biogen shall produce and allocate to Bioverativ the subject of the Purchase Order for which there is a shortage on an equal basis as Biogen products to the extent produced over all other non-Biogen products.  Notwithstanding the foregoing, Biogen shall not prioritize the production of any Biogen products or any Third Party drug products that use the same materials or components that are subject to the shortage over the production of any Bioverativ products.

 

ARTICLE 6

 

TESTING AND QUALITY ASSURANCE

 

6.1                                Finished Goods, Drug Product and Drug Substance Testing .  Subject to the Quality Agreement and prior to the release and delivery of a DS Batch, a ADP Lot or a Diluent Lot, Biogen shall manage the testing and release of such Drug Substance, Active Drug Product, Diluent or Finished Goods, as applicable, and supply to Bioverativ the applicable certificates setting forth the analytical test results for such Drug Substance, Drug Product or Finished Goods, as applicable (the “ DS Certificate of Analysis ,” “ ADP Certificate of Analysis, ” “ Diluent Certificate of Analysis ”  and “ Finished Goods Certificate of Analysis ” respectively) and (b)

 

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stating whether such Drug Substance, Drug Product or Finished Goods, as applicable, is manufactured in accordance with cGMPs and conforms with Drug Substance Specifications, Drug Product Specifications or Finished Goods Specifications, as applicable (the “ DS Certificate of Conformance ,” “ ADP Certificate of Conformance, ” “ Diluent Certificate of Conformance ” and “ Finished Goods Certificate of Conformance ” respectively).

 

ARTICLE 7

 

COST ALLOCATION, PRICING, AND PAYMENT

 

7.1                                Pricing .  Bioverativ shall pay Biogen for Drug Substance, Drug Product and Finished Goods on a cost-plus markup basis in accordance with Schedule 6 attached hereto.

 

7.2                                Invoicing and Payment . Biogen will submit or cause to be submitted to Bioverativ for payment invoices of amounts due under this Agreement in accordance with Schedule 6 attached hereto.

 

7.3                                Payment Denominations .  All payments to be made under this Agreement shall be made in United States dollars.

 

7.4                                Taxes .

 

(a)                                  Bioverativ shall pay and otherwise be responsible for all applicable sales taxes, VAT, goods and services taxes and transfer taxes in connection with any payment made by Bioverativ pursuant to this Agreement.

 

(b)                                  Any income or other tax that one Party hereunder is required to withhold and pay on behalf of the other Party hereunder with respect to amounts payable under this Agreement shall be deducted from and offset against said amounts prior to payment to the other Party; provided , however , that in regard to any tax so deducted, the Party making the withholding shall give or cause to be given to the other Party such reasonable assistance as may reasonably be necessary to enable that other Party to claim exemption therefrom or credit therefor, and in each case shall furnish the Party on whose behalf amounts were withheld, proper evidence of the taxes paid on its behalf.  Each Party shall comply with reasonable requests of the other Party to take any proper actions that may minimize any withholding obligation.

 

ARTICLE 8

 

AUDITS

 

8.1                                Drug Substance Facility .  Subject to the terms of the Quality Agreement, reasonable advance notice to Biogen and confidentiality considerations, Bioverativ, at its cost (excluding, however, Biogen’s internal costs), shall have the right to audit Biogen’s Drug Substance manufacturing Facility one (1) time per every calendar year, unless legitimate quality concerns warrant additional visits or the Parties mutually agree otherwise, during normal business hours. The Parties agree that Biogen may refuse any Bioverativ employee or agent

 

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access to the Facility (or eject such person from the Facility) where it reasonably believes, and can reasonably demonstrate to Bioverativ that it has grounds for such belief, that such employee or agent is or may be a security risk to Biogen or does not meet Biogen’s safety or security requirements. Biogen shall have no liability under this Agreement for refusing access to or ejecting such individual(s). Bioverativ further agrees to protect, defend, indemnify, and hold harmless Biogen and its Affiliates from all demands, claims, actions, liability, loss, damage, costs and expenses, including reasonable attorneys’ fees arising out of any claims for personal injury or property damage caused by, or sustained by, a Bioverativ employee or agent while visiting Biogen’s Drug Substance manufacturing Facility.

 

8.2                                Facilities for Manufacture of Drug Product and Finished Goods .  Biogen shall, on its own and on Bioverativ’s behalf, audit the Third Party Manufacturer’s Facilities for the Manufacture of Drug Product and Finished Goods in accordance with the provisions of the agreement between Biogen and the Third Party Manufacturer and shall furnish to Bioverativ the reports from such audits. Bioverativ shall not accrue any costs for such audit.

 

8.3                                Financial Audits .  Each Party (the “ Auditing Party ”) shall have the right during the Term and for a period of three (3) years thereafter, to have an independent certified public accountant reasonably acceptable to the other Party (the “ Audited Party ”) examine the relevant books and records of the Audited Party and its Affiliates during normal business hours, not more than once each calendar year, to verify that appropriate accounting and payments have been made under this Agreement.  In the event a determination is made that the Auditing Party has been underpaid or overcharged, the Audited Party shall promptly pay to the Auditing Party the amount by which the Auditing Party was underpaid or overcharged. The fees and expenses of the accountant performing any verification pursuant to this Section 8.3 shall be paid by the Auditing Party; provided , however , that, if a determination is made that the amount paid to the Auditing Party with respect to any calendar year was less than ninety-five percent (95%) of the amount properly due to the Auditing Party, the Audited Party shall promptly reimburse the Auditing Party for the costs of such verification.  Any accountant who examines the books and records of the Audited Party pursuant to this Section 8.3 shall sign a confidentiality agreement reasonably satisfactory to the Audited Party.

 

ARTICLE 9

 

RELEASE, STORAGE AND SHIPMENT

 

9.1                                Drug Substance .  Subject to the Quality Agreement, this Section 9.1 shall apply to Drug Substance manufactured and supplied by Biogen under this Agreement in the Second Phase and the Third Phase. For the avoidance of doubt, this Section 9.1 shall not apply to the First Phase.

 

(a)                                  Biogen Release .  Biogen shall perform release testing in accordance with the Drug Substance Specifications of all DS Batches to ensure compliance with the Drug Substance Specifications and cGMPs.  With respect to each DS Batch produced by Biogen under a Binding Purchase Order (or under Binding Forecast with respect to Drug Substance produced by Biogen under Section 5.2) and subject to Sections 5.2, 9.1(c) and 9.1(f), Biogen will release such Drug Substance

 

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to Bioverativ at the delivery date upon Biogen forwarding to Bioverativ by electronic transmission (as specified in the quality agreement) the DS Certificate of Analysis and the DS Certificate of Conformance (the “ DS Release ”).  If Bioverativ submits to Biogen a written request for a copy of the related Batch Documentation, Biogen shall furnish a copy of such Batch Documentation to Bioverativ within five (5) Business Days.

 

(b)                                  Biogen Refusal to Release .  Without limiting Biogen’s obligation to supply Drug Substance hereunder, Biogen has the right to disqualify any quantity of Drug Substance for failure to comply with the Drug Substance Specifications, cGMPs or with other requirements (as determined in Biogen’s sole discretion) and to decide not to release such Drug Substance.

 

(c)                                   Bioverativ Rejection .

 

(i)                                      Specifications .

 

(A)                                If, based on its review of the DS Certificates and/or Batch Documentation, Bioverativ claims that any Drug Substance released by Biogen does not meet the Drug Substance Specifications, then Bioverativ shall notify Biogen in writing of its intent to reject such Drug Substance within forty-five (45) days of its receipt of the DS Certificate of Analysis and DS Certificate of Conformance for such Drug Substance, which notice shall describe in reasonable detail the reasons for rejection (e.g., the specific Drug Substance Specification failure and the deviation of reported numbers from required Drug Substance Specifications).

 

(B)                                If the Parties, through the JMSC, are unable to agree as to whether such Drug Substance meets the Drug Substance Specifications, then (i) the Parties shall jointly select an independent testing laboratory to test such disputed Drug Substance (the “ DS Testing Laboratory ”), (ii) Biogen shall send a sample of the disputed Drug Substance, along with the DS Certificates, to the DS Testing Laboratory within ten (10) Business Days of joint selection of the DS Testing Laboratory, (iii) within a mutually agreed period after receipt of the test sample, the DS Testing Laboratory shall test such sample for compliance with the Drug Substance Specifications using methods validated and approved by Biogen, and shall forward such test results to Biogen and Bioverativ, and (iv) such test results shall be binding on Biogen and Bioverativ on the issue of compliance of the Drug Substance with the Drug Substance Specifications.

 

(C)                                If the parties agree, or if the DS Testing Laboratory concludes, that the disputed Drug Substance meets the Drug Substance Specifications, then (i) such Drug Substance shall be

 

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deemed to be accepted under this Agreement and the DS Release shall be deemed effective as of the original release date as determined pursuant to Section 9.1(a), (ii) all payment and other terms of this Agreement shall apply as of such effective date of the DS Release and (iii) Bioverativ shall bear the cost of such laboratory testing.

 

(D)                                If the parties agree, or the DS Testing Laboratory concludes, that the disputed Drug Substance does not meet the Drug Substance Specifications, then (i) such Drug Substance shall be deemed to have been rejected under this Agreement and no DS Release with respect to such rejected Drug Substance shall be deemed to have occurred, (ii) Biogen shall use commercially reasonable efforts to replace the rejected DS Batch as soon as reasonably practicable but in no event later than six (6) months from the conclusion of the DS Testing Laboratory, and Bioverativ shall pay for such replacement DS Batch only if it has not paid for the DS Batch being replaced and (iii) Biogen shall bear the cost of such laboratory testing.

 

(E)                                 For the avoidance of doubt and without limiting other remedies provided hereunder for any Non-Conformity, Bioverativ shall not have a right to reject Drug Substance where it does not provide its rejection notice within the forty-five (45) day period referenced in Section 9.1(c)(i)(A); provided that if Bioverativ discovers, or otherwise becomes aware of, a  Latent Defect relating to a Non-Conformity with respect to any Drug Substance, Bioverativ shall be entitled to the same remedies set forth above in this Section 9.1(c)(i) so long as Bioverativ notifies Biogen promptly after the discovery of such Latent Defect and in any event prior to the documented or labeled expiration date of the shelf life of the applicable quantity of Drug Substance.

 

(F)                                  Without prejudice to Bioverativ’s rights pursuant to Sections 11.8, 11.10, 16.1(c) and 18.2, the remedies set forth in Section 9.1(c)(i) shall be the sole and exclusive remedies for Biogen’s failure to deliver Drug Substance in accordance with the Drug Substance Specifications.

 

(ii)                                   Compliance .

 

(A)                                If, based on its review of the DS Certificates, Bioverativ claims that any Drug Substance released by Biogen is subject to a Compliance Issue, then Bioverativ shall notify Biogen in writing of its rejection of such Drug Substance within forty-five (45) days of its receipt of the DS Certificate of Analysis and DS Certificate of Conformance for such Drug Substance, which notice shall describe

 

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in reasonable detail the reasons for rejection (e.g., the specific Compliance Issue failure).

 

(B)                                If the Parties agree that a Compliance Issue exists with respect to such Drug Substance, then Biogen shall, at its election, replace such Drug Substance as soon as reasonably practicable, but in no event later than six (6) months from the conclusion of the DS Testing Laboratory, and Bioverativ shall pay for such replacement DS Batch only if it has not paid for the DS Batch being replaced.

 

(C)                                If the Parties, through the JMSC, are unable to agree as to whether a Compliance Issue exists with respect to such Drug Substance, then (i) the Parties shall jointly select an independent consultant with expertise in cGMPs applicable to the manufacturing of  biological drug products to test such disputed Drug Substance (the “ cGMP Consultant ”), (ii) Biogen shall send a sample of the disputed Drug Substance, along with the applicable DS Certificate of Analysis, DS Certificate of Conformance, Batch Documentation and any other information requested by the cGMP Consultant, to the cGMP Consultant within ten (10) Business Days of joint selection of the cGMP Consultant, (iii) within a mutually agreed period after receipt of the test sample and the foregoing documentation, the cGMP Consultant shall assess and make a determination as to the existence and nature of the alleged Compliance Issue, and shall forward the results of its assessment and determination (along with a detailed statement of the basis for its determination) to Biogen and Bioverativ, and (iv) such determination shall be binding on Biogen and Bioverativ on the issue of the alleged Compliance Issue.

 

(D)                                If the parties agree, or if the cGMP Consultant concludes, that the disputed Drug Substance was manufactured in accordance with cGMPs in effect when such Drug Substance was released, then (i) such Drug Substance shall be deemed to be accepted under this Agreement and the DS Release shall be deemed effective as of the original release date as determined pursuant to Section 9.1(a), (ii) all payment and other terms of this Agreement shall apply as of such effective date of the DS Release and (iii) Bioverativ shall bear the cost of the cGMP Consultant’s assessment and determination.

 

(E)                                 If the parties agree, or the cGMP Consultant concludes, that the disputed Drug Substance is subject to a Compliance Issue, then (i) such Drug Substance shall be deemed to have been rejected under this Agreement and no DS Release with respect to such rejected Drug Substance shall be deemed to have occurred, (ii) Biogen shall replace the rejected DS Batch as soon as reasonably practicable but in no event later than six (6) months from the

 

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conclusion of the DS Testing Laboratory, and Bioverativ shall pay for such replacement DS Batch, and (iii) Biogen shall bear the cost of the cGMP Consultant.

 

(F)                                  For the avoidance of doubt and without limiting other remedies provided hereunder for any Compliance Issue, Bioverativ shall not have a right to reject Drug Substance where it does not provide its rejection notice within the forty-five (45) day period referenced in Section 9.1(c)(ii)(A); provided that if Bioverativ discovers, or otherwise becomes aware of, a Latent Defect relating to a Compliance Issue with respect to any Drug Substance, Bioverativ shall be entitled to the same remedies set forth above in this Section 9.1(c)(ii) so long as Bioverativ notifies Biogen promptly after the discovery of such Latent Defect and in any event prior to the documented or labeled expiration date of the shelf life of the applicable quantity of Drug Substance.

 

(G)                                Without prejudice to Bioverativ’s rights pursuant to Sections 11.8, 11.10, 16.1(c) and 18.2, the remedies set forth in Section 9.1(c)(ii) shall be the sole and exclusive remedies for any Compliance Issue.

 

(d)                                  Delivery . Upon DS Release in the Third Phase, delivery of the corresponding Drug Substance to Bioverativ shall be deemed to have occurred and title and risk of loss with respect to such Drug Substance shall transfer to Bioverativ.  Upon Bioverativ’s request, Biogen shall sign any reasonable documents and take such other actions required for Bioverativ to perfect its title in such Drug Substance and, to the fullest extent permitted by law, Biogen hereby expressly grants Bioverativ authority and a limited power of attorney to file financing statements and other documents to record and otherwise perfect such title.

 

(e)                                   Shipment .  Unless otherwise agreed, delivery terms for Drug Substance shall be FCA (Incoterms 2010) to the applicable storage or manufacturing facility for the Drug Product and Finished Goods following receipt of a written authorization letter from Bioverativ in accordance with the reasonable shipping instructions provided therein and using a Third Party Carrier selected by Bioverativ for such the shipment.  Bioverativ shall be responsible for all payments due to such Third Party Carrier with respect to such shipments of Drug Substance. Biogen shall be responsible for all packaging required for the proper shipment of Drug Substance, which shall be reimbursed by Bioverativ in accordance with Schedule 6.

 

(f)                                    Drug Substance Shortfalls and Shelf Life .  In the event that Biogen fails to deliver a DS Batch under a Binding Purchase Order, Biogen shall remedy such shortfall as soon as commercially reasonable, but in no event later than six (6)

 

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months after the delivery date under such Binding Purchase Order.  Unless agreed in advance, DS Batches shall have no more than 18 months shelf life consumed.

 

9.2                                Drug Product and Finished Goods .  Subject to the Quality Agreement, this Section 9.2 shall apply to Drug Product and Finished Goods supplied by Biogen under this Agreement in the Second Phase. For the avoidance of doubt, this Section 9.2 shall not apply to the First Phase or the Third Phase.

 

(a)                                  Biogen Release .  With respect to each order of Drug Product or Finished Goods by Bioverativ under a Binding Purchase Order, Biogen shall perform manufacturer’s release of such order and provide Bioverativ by email the ADP Certificate of Analysis and the ADP Certificate of Conformance, Finished Goods Certificate of Analysis and the Finished Goods Certificate of Conformance, or the Diluent Certificate of Analysis and the Diluent Certificate of Conformance, as applicable. If Bioverativ submits to Biogen a written request for a copy of the related Batch Documentation, Biogen shall furnish a copy of such Batch Documentation to Bioverativ within three (3) Business Days.

 

(b)                                  Biogen Refusal to Release .  Biogen has the right to disqualify any quantity of Drug Product or Finished Goods for failure to comply with the Drug Product Specifications or Finished Goods Specifications, cGMPs or with other requirements (as determined in Biogen’s sole discretion) and to decide not to release such Drug Product or Finished Goods.

 

(c)                                   Bioverativ Rejection .

 

(i)                                      Specifications .

 

(A)                                If, based on its review of the ADP Certificates, Diluent Certificates and/or Batch Documentation, Bioverativ claims that any Drug Product or Finished Goods released by Biogen was not compliant with the Drug Product Specifications or Finished Goods Specifications at the time of DP Release by Biogen pursuant to Section 9.2(a), Bioverativ shall notify Biogen of its rejection of such Drug Product or Finished Goods within forty-five (45) days of its receipt of the ADP Certificates, Diluent Certificates or Finished Goods Certificates, as applicable, for such Drug Product or Finished Goods, which notice shall describe in reasonable detail the reasons for rejection (e.g., the specific Drug Product Specifications or Finished Goods Specification failure and the deviation of reported numbers from required Drug Product Specifications or Finished Goods Specifications).

 

(B)                                If the Parties, through the JMSC, are unable to agree as to whether such Drug Product or Finished Goods meets the Drug Product Specifications or Finished Goods Specifications, then (i) the Parties shall jointly select an independent testing laboratory to

 

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test such disputed Drug Product or Finished Goods (the “ DP/FG Testing Laboratory ”), (ii) Biogen shall send a sample of the disputed Drug Product or Finished Goods, along with the applicable ADP Certificates or Diluent Certificates, to the DP/FG Testing Laboratory within ten (10) Business Days of joint selection of the DP/FG Testing Laboratory, (iii) within a mutually agreed period after receipt of the test sample, the DP/FG Testing Laboratory shall test such sample for compliance with the Drug Product Specifications or Finished Goods Specifications using methods validated and approved by Biogen, and shall forward such test results to Biogen and Bioverativ and (iv) such test results shall be binding on Biogen and Bioverativ on the issue of compliance of the Drug Product or Finished Goods with the Drug Product Specifications or Finished Goods Specifications.

 

(C)                                If the Parties agree, or if the DP/FG Testing Laboratory concludes, that the disputed Drug Product or Finished Goods meets the Drug Product Specifications or Finished Goods Specifications, then (i) such Drug Product or Finished Goods shall be deemed to be accepted under this Agreement and the DP Release shall be deemed effective as of Biogen’s original issuance of the applicable ADP Certificates or Diluent Certificates to Bioverativ under Section 9.2(a), (ii) all payment and other terms of this Agreement shall apply as of such effective date of the DP Release and (iii) Bioverativ shall bear the cost of such laboratory testing.

 

(D)                                If the parties agree, or the DP/FG Testing Laboratory concludes, that the disputed Drug Product or Finished Goods does not meet the Drug Product Specifications or Finished Goods Specifications, then (i) such Drug Product or Finished Goods shall be deemed to have been rejected under this Agreement and no DP Release with respect to such rejected Drug Product or Finished Goods shall be deemed to have occurred, (ii) Biogen shall use commercially reasonable efforts to replace the rejected Drug Product or Finished Goods as soon as reasonably practicable but in no event later than six (6) months from the conclusion of the DP/FG Testing Laboratory, and Bioverativ shall pay for such replacement Drug Product or Finished Goods only to the extent it has not paid for the Drug Product or Finished Goods being replaced; provided that (1) to the extent that any such failure to meet the Drug Product Specifications or Finished Goods Specifications was caused by the Third Party Manufacturer, Bioverativ’s sole remedy from Biogen shall be limited to the same remedy to which Biogen is entitled from its Third Party Manufacturer as further specified under Section 11.7, and (2) Biogen shall have no obligation to replace rejected Drug Product or Finished Goods, nor any other liability to Bioverativ, if the

 

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failure to meet the Drug Product Specifications or Finished Goods Specifications was caused by the Third Party Carrier; and (iii) Biogen shall bear the cost of such laboratory testing.

 

(E)                                 With respect to Drug Product or Finished Goods during Second Phase only, notwithstanding anything to the contrary in this Agreement, but except to the extent Biogen is entitled to compensation from its Third Party Manufacturer, Biogen shall not be required to replace Drug Substance (or to bear the cost of replacement of Drug Substance) contained in any rejected Drug Product or Finished Goods, which cost shall be borne by Bioverativ, and Biogen shall be relieved of any obligation to replace Drug Product or Finished Goods if Bioverativ fails to provide adequate replacement Drug Substance for use in manufacturing the replacement Drug Product or Finished Goods.

 

(F)                                  For the avoidance of doubt, Bioverativ shall not have a right to reject Drug Product or Finished Goods where it does not provide its rejection notice within the forty-five (45) day period referenced in Section 9.2(c)(i)(A); provided that if Bioverativ discovers, or otherwise becomes aware of, a Latent Defect relating to Non-Conformity with respect to any Drug Product or Finished Goods, Bioverativ shall be entitled to the same remedies, subject to the same limitations, set forth above in this Section 9.2(c)(i) so long as Bioverativ notifies Biogen promptly after the discovery of such Latent Defect and in any event prior to the documented or labeled expiration date of the shelf life of the applicable quantity of Drug Product or Finished Goods.

 

(G)                                Without prejudice to Bioverativ’s rights pursuant to Sections 11.8, 11.10, 16.1(c) and 18.2, the remedies set forth in Section 9.2(c)(i) shall be the sole and exclusive remedies for Biogen’s failure to deliver Drug Product or Finished Goods in accordance with the Drug Product Specifications or Finished Goods Specifications.

 

(ii)                                   Compliance .

 

(A)                                If, based on its review of the ADP Certificates, Diluent Certificates, Finished Goods Certificates and/or Batch Documentation, as applicable, Bioverativ claims that any Drug Product or Finished Goods released by Biogen is subject to a Compliance Issue, then Bioverativ shall notify Biogen in writing of its rejection of such Drug Product or Finished Goods within forty-five (45) days of its receipt of the ADP Certificate of Analysis and ADP Certificate of Conformance, or Diluent Certificate of Analysis and Diluent Certificate of Conformance, as applicable,

 

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which notice shall describe in reasonable detail the reasons for rejection (e.g., the specific Compliance Issue failure).

 

(B)                                If the Parties, through the JMSC, are unable to agree as to whether a Compliance Issue exists with respect to such Drug Product or Finished Goods, then (i) the Parties shall refer the issue to the cGMP Consultant, (ii) Biogen shall send a sample of the disputed Drug Product or Finished Goods, along with the applicable Finished Goods Certificates or ADP Certificates, Diluent Certificates, Batch Documentation and any other information requested by the cGMP Consultant, to the cGMP Consultant within ten (10) Business Days of joint selection of the cGMP Consultant, (iii) within a mutually agreed period after receipt of the test sample and the foregoing documentation, the cGMP Consultant shall assess and make a determination as to the existence and nature of the alleged Compliance Issue, and shall forward the results of its assessment and determination (along with a detailed statement of the basis for its determination) to Biogen and Bioverativ and (iv) such determination shall be binding on Biogen and Bioverativ on the issue of the alleged Compliance Issue.

 

(C)                                If the parties agree, or if the cGMP Consultant concludes, that the disputed Drug Product or Finished Goods was manufactured in accordance with cGMPs in effect when such Drug Product or Finished Goods was released, then (i) such Drug Product or Finished Goods shall be deemed to be accepted under this Agreement and the DP Release shall be deemed effective as of the original release date as determined pursuant to Section 9.2(a), (ii) all payment and other terms of this Agreement shall apply as of such effective date of such release and (iii) Bioverativ shall bear the cost of the cGMP Consultant’s assessment and determination.

 

(D)                                If the parties agree, or the cGMP Consultant concludes, that the disputed Drug Product or Finished Goods is subject to a Compliance Issue, then (i) such Drug Product or Finished Goods shall be deemed to have been rejected under this Agreement and no DP Release with respect to such rejected Drug Product or Finished Goods shall be deemed to have occurred, (ii) Biogen shall replace the rejected batch of Drug Product or Finished Goods as soon as reasonably practicable but in no event later than six (6) months from the determination by the cGMP Consultant, and Bioverativ shall pay for such replacement Batch; provided that (1) to the extent that any Compliance Issue was caused by the Third Party Manufacturer, Bioverativ’s sole remedy from Biogen shall be limited to the same remedy to which Biogen is entitled from its Third Party Manufacturer as further specified under Section 11.7,

 

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and (2) Biogen shall have no obligation to replace rejected Drug Product or Finished Goods, nor any other liability to Bioverativ, if the Compliance Issue was caused by the Third Party Carrier; and (iii) Biogen shall bear the cost of such laboratory testing.

 

(E)                                 Notwithstanding anything to the contrary in this Agreement, but except to the extent Biogen is entitled to compensation from its Third Party Manufacturer, Biogen shall not be required to replace Drug Substance (or to bear the cost of replacement of Drug Substance) contained in any rejected Drug Product or Finished Goods, which cost shall be borne by Bioverativ, and Biogen shall be relieved of any obligation to replace Drug Product or Finished Goods if Bioverativ fails to provide adequate replacement Drug Substance for use in manufacturing the replacement Drug Product or Finished Goods.

 

(F)                                  For the avoidance of doubt, Bioverativ shall not have a right to reject Drug Product or Finished Goods where it does not provide its rejection notice within the forty-five (45) day period referenced in this Section 9.2(c)(ii)(A); provided that if Bioverativ discovers, or otherwise becomes aware of, a Latent Defect relating to a Compliance Issue with respect to any Drug Product or Finished Goods, Bioverativ shall be entitled to the same remedies, subject to the same limitations, set forth above in this Section 9.2(c)(ii) so long as Bioverativ notifies Biogen promptly after the discovery of such Latent Defect and in any event prior to the documented or labeled expiration date of the shelf life of the applicable quantity of Drug Product or Finished Goods.

 

(G)                                Without prejudice to Bioverativ’s rights pursuant to Sections 11.8, 11.10, 16.1(c) and 18.2, the remedies set forth in this Section 9.2(c)(ii) shall be the sole and exclusive remedies for a Compliance Issue.

 

(d)                                  Shipment and Delivery .  Bioverativ shall arrange the shipment of each order of Drug Product or Finished Goods via a Third Party Carrier it selects to the location designated in the Binding Purchase Order no later than (i) upon the expiration of the forty-five (45) day review period set forth in Section 9.2(c)(ii)(A) if Bioverativ has not furnished to Biogen a rejection notice within such period, or (ii) in the case of disputed Drug Product or Finished Goods, the date the DP/FG Testing Laboratory determines that the Drug Product or Finished Goods complies with the Drug Product or Finished Goods Specifications.  If Bioverativ fails to arrange for timely shipment, Biogen shall have the right to arrange for such shipment and invoice Bioverativ for the shipment costs.  If Bioverativ fails to specify a delivery location in any Binding Purchase Order, Biogen shall be entitled to either ship to the location last specified in any Binding Purchase Order and invoice Bioverativ for the shipment costs or to store or

 

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arrange for a Third Party to store such Drug Product or Finished Goods at Bioverativ’s expense, which storage costs shall be invoiced to and payable by Bioverativ on a monthly basis within ten days after the date of invoice.  Unless agreed prior, the delivery terms shall be FCA (Incoterms 2010) Facility for Drug Product or Finished Goods, as applicable.  For clarity, title to and risk of loss in the Drug Product or Finished Goods (as distinct from title and risk of loss in the Drug Substance, which is governed by Section 9.1(d)) shall transfer to Bioverativ upon the Drug Product or Finished Goods being made available to the Third Party Carrier at the Facility for Drug Product or Finished Goods, as applicable, and Bioverativ shall be responsible for obtaining insurance for the Drug Product from that time onward.  Bioverativ shall be responsible for all delivery charges, duties or other export or import fees or charges, and any other costs associated with the export, import or carriage of the Drug Product.  Biogen shall comply with Bioverativ’s written specifications for packaging for the shipment of Drug Product.

 

(e)                                   Drug Product Batch Size and Number Shortfalls .  If any Lot of Drug Product or amount of Finished Goods produced for Bioverativ by the Third Party Manufacturer is of a quantity that is lower than the expected yield range but otherwise meets the Drug Product Specifications or Finished Goods Specifications, Bioverativ shall accept such Lot or amount and Bioverativ’s sole remedy from Biogen shall be limited to the same remedy to which Biogen is entitled from its Third Party Manufacturer for such Lot or amount size shortfall.  If Biogen is unable to supply to Bioverativ the number of Lots of Drug Product or amount of Finished Goods properly ordered by Bioverativ under this Agreement, Bioverativ will be entitled to any remedy for a shortfall in the number of Lots or amount that Biogen may be entitled to under Biogen’s supply agreement with the Third Party Manufacturer.  For clarity, Bioverativ shall not be entitled to recover from Biogen for any shortfall in Drug Product or Finished Goods quantity or size any more than Biogen is entitled to recover from its Third Party Manufacturer for such shortfall.

 

ARTICLE 10

 

MANAGEMENT OF THE ALLIANCE

 

10.1                         In connection with managing the Alliance, including the management of the Parties’ efforts hereunder, the exchange of Forecasts and other communications and certain other related matters, Bioverativ and Biogen will establish a joint steering committee (the “ Joint Manufacturing and Supply Committee ” or “ JMSC ”) and certain procedures related to the operation thereto, in each case in accordance with Schedule 9 attached hereto.

 

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ARTICLE 11

 

MANUFACTURE SERVICES

 

11.1                         General .  Biogen shall manufacture or cause to be manufacture by a Third Party Manufacturer in accordance with the Specifications, cGMPs, Applicable Law and the Quality Agreement. Nothing in this Agreement shall be deemed to restrict in any way Biogen’s right to make changes in any Facility in its sole discretion, provided that such Facility remains in compliance with all requirements of this Agreement and the Parties shall discuss and reasonably agree upon a plan to provide Bioverativ with sufficient supply of product manufactured according to the then current Specifications and allow Biogen to implement such Facility changes within a commercially reasonable time. Biogen shall inform Bioverativ of any Facility changes impacting facility process equipment or infrastructure to ensure regulatory impact is assessed. If any changes could have a material effect on Bioverativ or its Affiliates’ product filing requirements or requirements for product, Biogen shall provide at least twelve (12) months’ notice of any such proposed changes and shall not proceed without Bioverativ’s prior written consent, such consent not to be unreasonably withheld.

 

11.2                         Required Changes in Specifications or Process . If Bioverativ or Biogen is required to change the Facility, any Specifications or the Process (i) in order to comply with any requirement of any Regulatory Authority, (ii) in response to the order or request of any Regulatory Authority, (iii) due to the loss of a validated source of a material, or (iv) in order to avoid infringing any third-party patent (each of the foregoing, a “ Required Change ”), all of the following provisions shall apply:

 

(a)                                  The Party receiving the order or request from the Regulatory Authority shall promptly advise the other Party in writing of any such Required Change(s) to Specifications or the Process and each Party shall promptly advise the other as to scheduling adjustments that may result from such Required Change(s), if any.

 

(b)                                  Biogen shall exercise commercially reasonable efforts to implement all such Required Changes and to resume production schedules to Specifications and the Process as soon as reasonably possible after implementing such Required Changes notice thereof, but in any event shall do so within the time required by any Regulatory Authority.

 

(c)                                   Bioverativ shall reimburse Biogen for all costs reasonable incurred arising out of Biogen’s efforts to implement any Required Changes relating to Bioverativ products within forty-five (45) days of receipt, upon delivery by Biogen to Bioverativ of an itemized invoice for the same, including but not limited to: (i) all Third Party costs or expenses, to the extent incurred by Biogen or arising as part of Biogen’s efforts to implement any such Required Changes of Bioverativ to Specifications or the Process, (ii) Biogen’s reasonable actual costs of all supplies provided by Biogen, and (iii) time spent by Biogen personnel at the FTE Rate to the extent not already included in the pricing for Drug Substance, Drug Product and Finished Goods.

 

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(d)                                  The JMSC may adjust pricing for product supplied under this Agreement to reflect the change in the incremental cost arising out of any Required Change.  Biogen shall provide to Bioverativ such documentation as is reasonably necessary to verify such cost changes, and the price increase or decrease shall be negotiated in good faith between the Parties.

 

(e)                                   Bioverativ shall prepare for submission, and Biogen shall review and provide comments upon, any regulatory filings or portions thereof related to the Process or the product required in relation to implementation of any Required Change.

 

(f)                                    Biogen shall prepare for submission, and Bioverativ shall review and provide comments upon, any regulatory filings or portions thereof related to the Facility or the equipment required in relation to implementation of any Required Change.

 

11.3                         Discretionary Changes to Specifications, Process or Suppliers.

 

(a)                                  If either Party desires to change Specifications or the Process in a way that does not involve a Required Change, it shall notify the other Party in writing of the proposed change (a “ Proposed Change” ), and the Parties shall review and discuss such Proposed Change, including whether the implementation of such Proposed Change is expected to result in material changes to costs compared to what Biogen is then incurring to manufacture product.

 

(b)                                  Biogen shall be entitled to propose, as Proposed Changes, any changes to the Process or Specifications, for batches or lots of product resulting from a particular Campaign, due to events or circumstances which arise following the start of such Campaign and are, for Biogen, reasonably unexpected with respect to such Campaign.

 

(c)                                   Neither Party shall have any obligation to give effect to any Proposed Change that is not a Biogen Broader Change (as defined below) unless the Parties agree in writing to effect the Proposed Change.

 

(d)                                  Biogen shall be entitled to implement, and Bioverativ shall have an obligation to give effect to, changes to or within Biogen manufacturing facilities, including changes to general equipment, any facility-wide standard operating procedures, or any other general change to or within the Facility, (each a “ Biogen Broader Change ”) that are intended by Biogen to address matters other than the Process or Specifications but which may have an effect on the same on reasonable advance notice to Bioverativ and subject to Biogen providing, at no cost to Bioverativ, all reasonable assistance to Bioverativ to make any regulatory filings required in relation to implementation of any such change within any applicable time periods required by law. Should any such Proposed Change affect filing requirements with governmental agencies, the parties shall discuss and reasonably agree upon a plan to provide Bioverativ with sufficient supply of product

 

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manufactured according to the then current Specifications and allow Biogen to implement such Facility changes within a commercially reasonable time. Notwithstanding the foregoing, Biogen cannot make any changes without Bioverativ’s prior written consent, such consent not to be unreasonably withheld, if any such changes would affect Biogen’s supply of product as set forth herein or affect any requirements, such as filing requirements with governmental agencies, that Bioverativ or its Affiliates may have for the product.

 

(e)                                   Each Party shall reimburse the other Party for the reasonable out-of-pocket expenses incurred by the other Party as a result of any Proposed Change by such Party that is implemented, in each case as approved by the JMSC prior to either party incurring any costs. In addition, either Party may condition its consent to any Proposed Change on the implementation of satisfactory reimbursement arrangements to cover its costs and expenses, including ongoing costs and expenses, which are beyond reasonable out-of-pocket expenses.

 

(f)                                    Notwithstanding the other provisions of this Section 11.3: (i) Biogen shall not propose any Proposed Change if the implementation of such Proposed Change would, itself, infringe any third party intellectual property rights; and (ii) any Proposed Change in respect of the Process of manufacturing for product shall require Bioverativ’s prior written consent, which may be withheld in its sole discretion, and (iii) all costs associated with a Biogen Broader Change shall be the sole responsibility of Biogen .

 

(g)                                   For the avoidance of doubt, Proposed Changes shall include but not be limited to changes in the type or model of equipment used in the Process, but not the substitution of a new piece of equipment of the same make and model in replacement of an older piece of equipment, and shall also include proposed substitution (other than in the context of a Required Change) of any assay, process validation procedure, vendor or contract supplier of materials or other components used in providing manufacturing services of the product.

 

(h)                                  The JMSC may adjust the pricing for product under this Agreement to reflect any change in ongoing cost of manufacturing of product resulting from any Proposed Change.

 

(i)                                      For any Proposed Changes, Bioverativ shall prepare for submission, and Biogen shall review and provide comments upon, any regulatory filings required in relation to implementation of any such Proposed Change.

 

(j)                                     Biogen shall devote commercially reasonable efforts to implement any Proposed Changes in a manner that is orderly and avoids any supply interruption to Bioverativ.

 

11.4                         Facility Validation . Except as expressly provided in this Agreement, and excluding process validation and validation of Bioverativ-owned equipment, Biogen shall perform at no additional cost to Bioverativ and on an on-going basis the necessary Facility

 

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validation activities required by cGMPs or Applicable Law in connection with the regular course of manufacturing the product.

 

11.5                         Other Manufacturing Process Change .  During the First Phase, subject to obtaining any required Regulatory Approval, Biogen has authority to change the manufacturing Process if Biogen provides Bioverativ advance written notice of such change and copies of any regulatory filings prepared by Biogen in connection with such proposed change and Bioverativ consents in writing to such change.  In the event that a change of the manufacturing Process results in significant change of the yield or manufacturing cost, the Parties shall negotiate in good faith to change the corresponding batch or unit price to reflect such change.

 

11.6                         Capital Expenditures .  All capital expenditures, to the extent arising out of any Required Change specific to a Bioverativ product, shall be the sole responsibility of Bioverativ.  General facility or process related capital changes required to meet cGMP’s, age of life or any other non-specific Bioverativ product requirement will be the responsibility of Biogen.  For expenditures related to Bioverativ area of responsibility, Biogen will invoice such expenditures as incurred by Biogen.  To the extent that any such capital expenditures have not been fully reimbursed upon termination or expiration of the Agreement, Bioverativ shall pay any such unreimbursed amounts to Biogen prior to any such termination or expiration.

 

11.7                         Drug Product and Finished Goods Failures .  If Biogen or Bioverativ determines that an ADP Lot or Diluent Lot or Finished Goods manufactured for Bioverativ is Non-Conforming or is subject to a Compliance Issue that, in each case, is caused by the Third Party Manufacturer, then Biogen shall be responsible to Bioverativ to the same extent that Biogen’s Third Party Manufacturer is responsible to Biogen with respect to the portion of the loss caused by the Third Party Manufacturer. For the avoidance of doubt, Biogen’s liability for damages or loss with respect to any rejected ADP Lot or Diluent Lot or Finished Goods that is caused by the Third Party Manufacturer shall be limited to the extent of the Third Party Manufacturer’s liability for damages or loss to Biogen under Biogen’s agreement with the Third Party Manufacturer, except as provided in this Section 11.7 or in Section 11.10 below, as limited in each case by Article 17.   Biogen shall have no liability with respect to any damages or loss with respect to any Compliance Issue, Non-Conformity or failure to comply with Applicable Law that is caused by a Third Party Carrier.

 

11.8                         Product Complaints .  If, after the release of Finished Goods or Drug Product, either Party becomes aware that any such Finished Goods are, or Drug Product is, Non-Conforming or is subject to a Compliance Issue, or that such Finished Goods are, or Drug Product is, the subject of a complaint, then such Party shall immediately notify the other Party. The Parties shall then confer and coordinate as to the actions required, if any, to comply with Applicable Law, and Bioverativ shall have responsibility for responding and taking the action required by Applicable Law. Nothing herein is intended to preclude either Party from acting as required under Applicable Law.

 

11.9                         Recalls, Product Withdrawals and Field Corrections .  If any governmental entity issues a request, directive or order to a Party (or its Affiliate) requiring that any of the Finished Goods or Drug Product be recalled, or detains or destroys or prevents the release of any of the Finished Goods or Drug Product, or if either Party becomes aware of any other facts or

 

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circumstances that suggest a recall, withdrawal or field correction may be warranted, such Party shall give the other Party telephonic notice within twenty-four (24) hours (to be confirmed in writing within one (1) Business Day) of the occurrence of such event. In the Second Phase and Third Phase, Bioverativ shall have the sole right to determine whether to implement a recall, product withdrawal or field correction of the Finished Goods or Drug Product, but shall make such decision in accordance with the instructions of the Regulatory Authority of the country where such Finished Goods or Drug Product was distributed and shall reasonably take into consideration Biogen’s comments and concerns in relation to any proposed recall, withdrawal or field correction. If Bioverativ decides that there shall be a recall, withdrawal or field correction, Bioverativ shall have the sole right to control the implementation of such recall, withdrawal or field correction, but shall keep Biogen informed on a regular basis of its progress in planning and implementing the recall, withdrawal or field correction. Biogen shall cooperate with Bioverativ in connection with, and the provisions of Section 11.10 below shall be applicable to, any such action, and Bioverativ shall provide to Biogen all documentation reasonably requested by such other Party.

 

11.10                  Cost of Recalls, Product Withdrawals and Field Corrections .  If any of the Finished Goods are, or Drug Product is, quarantined, recalled, withdrawn, or subject to a field correction (whether voluntary or by governmental action), any direct costs and expenses incurred and paid by Bioverativ (including government fines or penalties related to such quarantine, recall, withdrawal or field correction) shall be (a) reimbursed by Biogen, if such corrective action is demonstrated to be due to the negligence or willful misconduct of Biogen (or its Third Party Manufacturer)  or (b) borne by Bioverativ, for all other corrective actions.  Where such corrective action is due to a Latent Defect or Biogen’s (or its Third Party Manufacturer’s) negligence or willful misconduct, Biogen shall use commercially reasonable efforts to schedule manufacturing Campaigns to replace the quantities of Finished Goods or Drug Product affected by the corrective action. Notwithstanding anything to the contrary in this Agreement, in the case of any such actions caused by the negligence of Third Party Manufacturer, Biogen shall not be required to reimburse Bioverativ in an amount that exceeds the reimbursement to which it is entitled from its Third Party Manufacturer or beyond the limitations set forth in Article 17.

 

11.11                  Record-Keeping .  Each Party (as applicable) shall maintain, in accordance with and for the period required under cGMPs and all other Applicable Laws, complete and accurate records pertaining to its manufacture, processing, testing, packing, labeling, holding, marketing, and distribution activities of the Finished Goods, Drug Substance and Drug Product, as applicable. Each Party shall provide the other Party with reasonable access to and the right to copy, at the requesting Party’s expense, such documentation maintained by the other Party during normal business hours and upon reasonable advance notice.

 

11.12                  Person In Plant .  Bioverativ shall have the right but not the obligation to establish its employees or up to three (3) outside consultants, in each case under strict confidentiality and non-use provisions at least as stringent as those applicable to Bioverativ employees with respect to Confidential Information of Biogen, as resident in Biogen’s Drug Substance manufacturing facility in order to observe operations relevant to products and to facilitate communications between the Parties regarding same.  For avoidance of doubt, any such resident employee or consultant shall not have authority to direct or interfere with the operations at such facility and Biogen shall have the right to exclude any such employee or consultant from

 

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areas of the facility deemed in Biogen’s reasonable judgment to be particularly commercially sensitive or as reasonably required by any agreement with a Third Party having a bona fide interest in confidentiality at the facility.  Bioverativ shall in all cases remain responsible for any equipment, salary, benefits and insurance associated with any such employee or consultant, who shall under no circumstances be deemed in the employment of or under contract to Biogen.  Biogen’s sole obligation with respect to any such employee or consultant shall be to provide reasonable working space at or near the facility and to grant the agreed access to the facility to such employee or consultant.

 

11.13                  Facility Access .  Biogen shall use commercially reasonable efforts to accommodate a request from Bioverativ, upon reasonable notice, for facility tours with external patient groups, key opinion leaders and other key scientific and leaders. All such tours shall be conducted by Biogen during normal business hours and follow all site protocols, procedures and confidentiality requirements.

 

ARTICLE 12

 

REGULATORY MATTERS

 

12.1                         Regulatory Support .  Bioverativ may request regulatory support that is related to the Manufacture of Drug Substance.  Biogen shall use commercially reasonable efforts to provide the following support services and shall be reimbursed by Bioverativ for reasonable costs incurred in connection therewith and in accordance with Schedule 6 attached hereto: (a) providing regulatory information, drafts and filings that Biogen already has in its possession and (b) answering questions reasonably necessary for the preparation of regulatory filings for the products.  For purposes of clarity, Biogen shall not be required to hire and/or transfer from other projects any regulatory full-time equivalents in order to meet the regulatory support needs described in this Section 12.1.  In any event, Biogen will provide to Bioverativ free of charge copies of any regulatory filings prepared by Biogen relating to changes to Regulatory Approvals that arise from CMC-related changes for the products.

 

12.2                         Inspection by Regulatory Authority .  The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of Biogen’s Drug Substance manufacturing facility and/or the Third Party Manufacturer’s Drug Product and Finished Goods manufacturing facility. Biogen shall give Bioverativ notice of, and Bioverativ shall have the right to be on site during the portion of, any such regulatory inspection conducted by a Regulatory Authority that relates to the Drug Substance or the Drug Product or Finished Goods, except to the extent (a) not permitted by applicable law of the Regulatory Authority conducting the inspection, (b) any such attendance would result in the disclosure of Confidential Information or trade secrets unrelated to the Drug Substance, Drug Product or Finished Goods (where Biogen shall have taken reasonable measures to seek to avoid disclosure of Confidential Information and such trade secrets, provided , however , that in no event shall such reasonable measures be deemed to include any measures under which Biogen would incur unreasonable additional costs), or (c) the Third Party Manufacturer’s contract with Biogen does not permit such attendance.  If in Biogen’s reasonable judgment Bioverativ’s presence on site is required, Biogen will notify Bioverativ and may require Bioverativ to attend such inspection (or answer questions of the Regulatory Authority).

 

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ARTICLE 13

 

TERM AND TERMINATION

 

13.1                         Term .

 

(a)                                  Term .  Unless earlier terminated in accordance with Section 13.2, this Agreement will remain in force for the period commencing on the Effective Date and continuing through the day immediately prior to the fifth (5 th ) anniversary (the “ Initial Term ”).

 

(b)                                  Renewals . Bioverativ may, in its sole discretion, renew this Agreement for a five year term and the Parties may further renew this Agreement an additional five (5) year term thereafter (but are not obligated to do so) (each, a “ Renewal Term ”). If Bioverativ intends to renew the Agreement, it shall give such notice of intent to renew at least two (2) years prior to the expiration of the Initial Term.  If either Party intends to further renew this Agreement, such Party shall give notice of intent to renew at least three (3) years prior to the expiration of the first Renewal Term.  The Parties shall use good faith efforts, for a period not to exceed ninety (90) days after receipt of the renewal notice for the second Renewal Term, unless a longer negotiation period is agreed to in writing by the Parties, to agree in writing to the terms applicable to the second Renewal Term.  If no such notice of intent to renew is issued by Bioverativ, with respect to the first Renewal Term, or by Bioverativ or Biogen, with respect to the second Renewal Term, in each case prior to the applicable deadline for such renewal or if, in the case of the second Renewal Term, such notice is issued but the Parties fail to agree to a new Renewal Term and the terms thereof within the permitted negotiation period, then, if Bioverativ wishes to assume manufacturing of Drug Substance and Drug Product and Finished Goods upon the expiration of this Agreement, the Parties shall use good faith efforts to agree upon and implement a technology transfer plan in accordance with Section 13.4(e) within a reasonable timeframe to enable Bioverativ to assume manufacturing of Drug Substance, Drug Product and Finished Goods as of the date of expiration of this Agreement.  To the extent that any Forecast for Drug Substance, Drug Product or Finished Goods extends after the Initial Term or, if applicable, a Renewal Term, no Binding Forecast contained therein shall be made for applicable months following the anticipated expiration of this Agreement unless mutually agreed by the Parties.

 

13.2                         Termination .

 

(a)                                  Debarment or Exclusion .  Either Party, at its sole option, may immediately terminate this Agreement upon written notice, but without prior advance notice, to the other Party in the event that the other Party has been debarred under 21 U.S.C. Section 335a or  excluded  under Section 1128 of the Social Security Act of 1935.

 

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(b)                                  Bankruptcy; Insolvency .  To the extent allowable under Applicable Law, either Party at its sole option may immediately terminate this Agreement upon written notice, but without prior advance notice, to the other Party in the event that (i) the other Party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by such other Party; or (iii) this Agreement (or a Party’s other assets) is (are) assigned by such other Party for the benefit of creditors.

 

13.3                         Termination for Material Breach .

 

(a)                                  Notice and Cure .  If one Party commits a material breach of this Agreement (the “ Breaching Party ”), the other Party (the “ Notifying Party ”) may provide fifty-nine (59) days’ advance written notice to the Breaching Party of its intent to terminate this Agreement, which notice shall identify the material breach and the actions or conduct that it considers to be an acceptable cure of such material breach, which shall be in accordance with the terms of this Agreement.  During such fifty-nine (59) day period, the Breaching Party may seek to cure such material breach (the “ Initial Cure Period ”).  If the material breach is not cured within such fifty-nine (59) day period, the Notifying Party may terminate this Agreement upon twenty (20) days written notice; provided , that if the Breaching Party disputes such material breach as provided in subsection (b) below, such termination shall be effective only as provided in such subsection (b).

 

(b)                                  Disputed Breach .  If the Notifying Party gives notice of material breach under this Section 13.3 and the Breaching Party disputes whether there is a material breach, then the issue of whether the Notifying Party may properly terminate this Agreement on expiration of such Initial Cure Period shall be resolved in accordance with Article 20 (Dispute Resolution), and the Agreement shall not terminate except as provided in this Section 13.3(b).  Such dispute resolution proceeding does not suspend either Party’s obligations hereunder and each Party shall use reasonable efforts to mitigate all damages prior to the conclusion of the dispute resolution proceeding.  If, as a result of such dispute resolution proceeding, it is determined that the Breaching Party did not commit a material breach (or that such material breach was cured within the Initial Cure Period) then no termination shall be effective and this Agreement shall remain in effect as it was prior to such notice by the Notifying Party for the remaining duration of the Term. If, as a result of such dispute resolution process, it is determined that the Breaching Party committed a material breach and the Breaching Party does not cure such breach within sixty (60) days after the date of the arbitration award (the “ Additional Cure Period ”), then such termination shall be effective upon the expiration of the Additional Cure Period.

 

13.4                         Effect of Termination or Expiration .

 

(a)                                  Upon expiration of this Agreement, Biogen will, upon Bioverativ’s request, perform a technology transfer in accordance with Section 13.4(e).

 

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(b)                                  Upon termination of this Agreement by Biogen under Sections 13.2(a) (Debarment or Exclusion), 13.2(b) (Bankruptcy; Insolvency) or 13.3 (Termination for Material Breach): Bioverativ shall be obligated to purchase and pay Biogen for the Finished Goods, Drug Substance and Drug Product (and all starting materials and components necessary to produce the Finished Goods, Drug Substance and Drug Product) pursuant to the quantities contained in its Binding Forecast.  For avoidance of doubt, Biogen shall have no obligation to conduct technology transfer activities under this Section 13.4(b).

 

(c)                                   Upon termination of this Agreement by Bioverativ under Sections 13.2(a) (Debarment or Exclusion), 13.2(b) (Bankruptcy; Insolvency) or 13.3 (Termination for Material Breach):  (i) the Parties will conduct the technology transfer activities in accordance with Section 13.4(e); and (ii) Biogen shall, unless otherwise notified by Bioverativ to halt such production, continue to produce Drug Substance and Drug Product and Finished Goods in accordance with the Binding Forecast in effect as of the date of notice of termination and Bioverativ shall purchase and pay Biogen for such Drug Substance and Drug Product and Finished Goods in accordance with Article 7.

 

(d)                                  Upon any expiration or termination of this Agreement, remedies for breach, rights to accrued payments and Articles and Sections 1 (Definitions), 7.1 (Pricing), 7.2 (Invoicing and Payment), 7.3 (Payment Denominations), 7.4 (Taxes), 9.1(c) (Bioverativ Rejection) (solely with regard to Latent Defects and the entire sub-section with regard to any Drug Substance supplied after the date of termination), 9.2(c) (Bioverativ Rejection) (solely with regard to Latent Defects and the entire sub-section with regard to any Drug Product and Finished Goods supplied after the date of termination), 11.7 (Drug Product and Finished Goods Failures) (solely with regard to any Drug Product and Finished Goods supplied after the date of termination), 11.8 (Product Complaints), 11.9 (Recalls, Product Withdrawals and Field Corrections), 11.10 (Cost of Recalls, Product Withdrawals and Field Corrections), 11.11 (Record-Keeping), 13.4 (Effect of Termination or Expiration), 13.5 (Quality Agreement), Article 14 (Intellectual Property), Article 15 (Confidentiality), 16.1(c), 16.2 (Warranty Limitations and Disclaimer), 17 (Liability Limitation), 18 (Indemnity), 19 (Insurance Coverage), Article 20 (Dispute Resolution), Article 21 (Miscellaneous) and Schedule 7 attached hereto shall survive.

 

(e)                                   In the event that a provision of this Article 13 specifies that the Parties will conduct technology transfer activities, Biogen will assist Bioverativ and be reimbursed in accordance with Schedule 8, and at Bioverativ’s cost (provided that upon termination by Bioverativ according to Section 13.3 or upon certain sale or transfers with respect to Biogen as specified in Section 21.3, there shall be no such reimbursement), with technology transfer and validation activities in connection with transferring Drug Substance manufacturing and Drug Product and Finished Goods manufacturing (as applicable) to another manufacturer, except that it shall be solely Bioverativ’s responsibility and obligation to secure and make arrangements with any such replacement manufacturer as well as any

 

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other vendors Bioverativ deems necessary, subject to a technology transfer plan or agreement to be negotiated in good faith by the Parties and the relevant manufacturers and/or other vendors within six (6) months of the event triggering the technology transfer obligation, and in all events prior to commencing such technology transfer, and provided that each such manufacturer and vendor is reasonably acceptable to Biogen and has executed a confidentiality and limited use agreement with Biogen to protect Biogen’s rights in its intellectual and proprietary or Confidential Information.

 

13.5        Quality Agreement .  For the avoidance of doubt, a breach of the Quality Agreement shall not constitute a breach of this Agreement.

 

ARTICLE 14

 

INTELLECTUAL PROPERTY

 

14.1        Background IP .   As between Bioverativ and Biogen, Biogen shall exclusively own all right, title and interest in and to any Intellectual Property owned by Biogen as of immediately following the Distribution Effective Time (collectively, the “ Biogen Background IP ”).  As between the Parties, Bioverativ shall exclusively own all right, title and interest in and to any Intellectual Property owned by Bioverativ as of immediately following the Distribution Effective Time (collectively, the “ Bioverativ Background IP ”).  Except for the license rights expressly provided for herein, nothing herein shall be construed as granting any rights (ownership, licensed or otherwise) to Bioverativ in any such Biogen Background IP or to Biogen in any such Bioverativ Background IP.

 

14.2        Foreground IP .

 

(a)           As between the Parties, Biogen shall own and retain the entire right, title and interest in and to all Intellectual Property made solely by the employee(s) or agent(s) of Biogen or any of its Affiliates, including  all Patents and Copyrights arising from such Intellectual Property subject only to the rights expressly granted to Bioverativ under this Agreement.

 

(b)           As between the Parties, Bioverativ shall own and retain the entire right, title and interest in and to all Intellectual Property made solely by the employee(s) or agent(s) of Bioverativ or any of its Affiliates, including all Patents arising from such Intellectual Property subject only to the rights expressly granted to Biogen under this Agreement.

 

14.3        Joint IP Each Party shall own and retain an undivided equal ownership interest in all Intellectual Property made jointly by the employee(s) or agent(s) of one Party or any of its Affiliates and the employee(s) or agent(s) of the other Party or any of its Affiliates, including all Patents arising from such Intellectual Property (the “ Joint IP ”), subject only to the rights expressly granted by the Parties under this Agreement.  For purposes of control of the prosecution, maintenance, defense and assertion of Joint IP arising under this Agreement, the

 

39



 

applicable provisions of the IP License Agreement as related to the Biogen Shared Intellectual Property (as defined in the IP License Agreement) shall apply.  Except as expressly permitted under this Agreement or the IP License Agreement, neither Party shall have the right to license or sublicense any Joint IP to any Third Party without the prior written consent of the other Party.

 

14.4        Ownership of Intellectual Property and Patents arising from the activities under this Agreement will be determined in accordance with U.S. laws of inventorship.  Each Party agrees to take all actions that are reasonably necessary to give effect to the ownership interests set forth in this Article 14.

 

14.5        This Agreement shall be understood to be a joint research agreement in accordance with 35 U.S.C. §103(c) or 35 U.S.C. §102(c), as applicable, provided that neither Party shall (i) unilaterally invoke the protections of or (ii) be required by this reference to have any Patent take advantage of or become subject to, such §103(c)(3) or 35 U.S.C. §102(c), as applicable, except with the prior written consent of the other Party.

 

ARTICLE 15

 

CONFIDENTIALITY

 

15.1        Confidential Information . The provisions of Article VII (PRESERVATION OF RECORDS; ACCESS TO INFORMATION; CONFIDENTIALITY; PRIVILEGE) of the Separation Agreement shall apply to disclosures of information made pursuant to this Agreement mutatis mutandis .  In addition,  Biogen shall have the right to provide to each Third Party Manufacturer and other third party contractors retained by Biogen such Confidential Information of Bioverativ as is reasonably necessary for such Third Party Manufacturer to perform its services with respect to the manufacture of Drug Substance, Drug Product or Finished Goods, subject to a confidentiality and limited use agreement containing appropriate restrictions and Bioverativ shall have the right to provide to Third Party contractors retained by Bioverativ such Confidential Information of Biogen as is reasonably necessary for such Third Party to perform its services with respect to manufacture of finished product from the Drug Product or of Drug Product, distribution of Finished Goods, or for enabling Bioverativ’s marketing, sale and distribution of the Drug Product or Finished Goods, in each case in accordance with the terms of this Agreement, subject to a confidentiality and limited use agreement containing appropriate restrictions.

 

ARTICLE 16

 

REPRESENTATIONS AND WARRANTIES; COVENANTS

 

16.1        Representations and Warranties .

 

(a)           Each Party (the “ Representing Party ”) represents and warrants to the other Party that, as of the Effective Date: (i) the Representing Party is a corporation duly organized and in good standing under the laws of the jurisdiction of its incorporation, and it has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being

 

40



 

conducted and as it is contemplated to be conducted by this Agreement; (ii) the Representing Party has the full right, power and authority to enter into this Agreement and to perform as required under this Agreement; (iii) there are no existing or, to the Representing Party’s knowledge, threatened actions, suits or claims pending with respect to the subject matter of this Agreement or the Representing Party’s right to enter into and perform its obligations under this Agreement; (iv) the Representing Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement; (v) this Agreement has been duly executed and delivered on behalf of the Representing Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof, subject to the general principles of equity and to bankruptcy, insolvency, moratorium and other similar laws affecting the enforcement of creditors’ rights generally; (vi) all necessary consents, approvals and authorizations of all regulatory and governmental authorities and other persons required to be obtained by the Representing Party in connection with the execution and delivery of this Agreement have been obtained; (vii) the execution and delivery of this Agreement by the Representing Party and the performance of the Representing Party’s obligations hereunder do not conflict with, or constitute a default under, any of its contractual obligations; and (viii) the Representing Party has not been debarred  under 21 U.S.C. Section 335a, excluded  under Section 1128 of the Social Security Act of 1935, convicted of any crime or engaged in any conduct for which such Representing Party could be so debarred or excluded,  is not under investigation for any debarment or exclusion action, has not been disqualified as an investigator pursuant to 21 C.F.R. §312.70, does not have a disqualification hearing pending and is not currently employing any person or entity that has been so debarred, excluded  or disqualified to perform any of the Representing Party’s obligations under this Agreement.

 

(b)           The Representing Party shall promptly notify the other Party if it is debarred, excluded or disqualified as described in Section 16.1(a)(viii) and shall terminate any so debarred, excluded or disqualified individual’s or entity’s participation in the performance of any of the Representing Party’s obligations under this Agreement promptly upon the Representing Party’s awareness of such debarment, exclusion or disqualification.

 

(c)           Biogen represents and warrants to Bioverativ that the Finished Goods supplied to Bioverativ under this Agreement shall be Manufactured in accordance with the Finished Goods Specifications and cGMPs, the Drug Substance released under this Agreement shall be in accordance with the Drug Substance Specifications and cGMPs, and the Drug Product (either directly or through the Third Party Manufacturer) supplied to Bioverativ under this Agreement shall be Manufactured in accordance with the Drug Product Specifications and cGMPs.  The Parties agree that a breach of the foregoing warranty (i) shall, without prejudice to Bioverativ’s rights pursuant to Sections 11.8, 11.10 and 18.2, be subject to the sole remedy, as applicable, set forth in Sections 9.1(c)(i) with respect to Non-Conforming Drug Substance, 9.1(c)(ii) with respect to Drug

 

41



 

Substance Compliance Issues, 9.2(c)(i) with respect to Non-Conforming Drug Product or Non-Conforming Finished Goods, or 9.2(c)(ii) with respect to Drug Product Compliance Issues or Finished Goods Compliance Issues, (ii) shall not be deemed a breach of this Agreement giving rise to a right of termination by Bioverativ under Section 13.3, unless such breach is based on the third consecutive Campaign of Drug Substance or Drug Product or Finished Goods, as the case may be, containing a Batch that fails the foregoing warranty; provided , for avoidance of doubt, that any failure to replace any Batch of such non-compliant Drug Substance or Drug Product or Finished Goods in accordance with Sections 9.1(c)(i), 9.1(c)(ii), 9.2(c)(i) or 9.2(c)(ii), as applicable, may give rise to a right of termination, subject to Section 13.3.

 

16.2        Warranty Limitations and Disclaimer .  EXCEPT AS EXPRESSLY SET FORTH IN THE REPRESENTATIONS AND WARRANTIES INCORPORATED UNDER SECTION 16.1 HEREOF, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND UNDER THIS AGREEMENT (INCLUDING WITH RESPECT TO ANY FINISHED GOODS, DRUG SUBSTANCE OR DRUG PRODUCT PROVIDED UNDER THIS AGREEMENT), EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, QUALITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR VALIDITY OF PATENT CLAIMS, WHETHER ISSUED OR PENDING.

 

16.3        Covenants .

 

(a)           Each Party has (or will timely obtain) and will maintain and comply with at all relevant times throughout the term of this Agreement in all respects, all material applicable supra-national, federal, regional, state, provincial, and local permits, licenses, registrations and other governmental authorizations and approvals as may be required by Applicable Law in order for it to perform its obligations under this Agreement.

 

(b)           Bioverativ shall make its Forecasts in good faith based on information reasonably available to it at such time.

 

(c)           Biogen shall take all reasonable and necessary steps to:

 

(i)            Ensure the manufacture of the initial order of rFIIIFc-VWF-XTEN batches in a timely manner and as otherwise set forth in the initial Forecast under the Agreement (as set forth on Schedule 10 attached hereto); and

 

(ii)           Expand the visual inspection capacity for Drug Product intended for distribution and use in Japan in cooperation with Bioverativ.

 

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ARTICLE 17

 

LIABILITY LIMITATION

 

17.1        EXCEPT WITH RESPECT TO A BREACH OF THE CONFIDENTIALITY PROVISIONS INCORPORATED IN ARTICLE 15 (CONFIDENTIALITY) OR A PARTY’S LIABILITY UNDER ARTICLE 18 (INDEMNITY), IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY OTHER PERSON FOR INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, PUNITIVE, MULTIPLE OR OTHER INDIRECT DAMAGES, OR FOR LOSS OF PROFITS, LOSS OF DATA OR LOSS OF USE DAMAGES ARISING OUT OF THIS AGREEMENT, WHETHER BASED UPON WARRANTY, CONTRACT, TORT, STATUTE, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR LOSSES.

 

17.2        NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, EXCEPT WITH RESPECT TO A BREACH OF THE CONFIDENTIALITY PROVISIONS INCORPORATED IN ARTICLE 15 (CONFIDENTIALITY) OR TO THE EXTENT THE SAME ARE AWARDED TO A THIRD PARTY IN ANY JUDGMENT OR SETTLEMENT IN A CLAIM AGAINST WHICH A PARTY IS OBLIGATED TO INDEMNIFY ANY OF THE INDEMNIFIED PARTIES PURSUANT TO ARTICLE 18 (INDEMNITY), (A) BIOGEN’S LIABILITY FOR ANY LOSS OR DAMAGES SUFFERED BY BIOVERATIV IN CONNECTION WITH THIS AGREEMENT SHALL NOT EXCEED (I) $150 MILLION IF INCURRED ON OR PRIOR TO THE THIRD ANNIVERSARY OF THE DATE OF THIS AGREEMENT OR (II) $10 MILLION IF INCURRED AFTER THE THIRD ANNIVERSARY OF THE DATE OF THIS AGREEMENT, PROVIDED THAT IF SUCH LOSS IS DUE TO THE ACTS OR OMISSIONS OF A THIRD PARTY MANUFACTURER, BIOGEN’S LIABILITY SHALL NOT EXCEED THE AMOUNT THAT BIOGEN IS ENTITLED TO RECEIVE FROM ITS THIRD PARTY MANUFACTURER AS DAMAGES OR IN SETTLEMENT OF SUCH CLAIM, AND (B) BIOVERATIV’S LIABILITY FOR ANY LOSS OR DAMAGES SUFFERED BY BIOGEN IN CONNECTION WITH THIS AGREEMENT SHALL NOT EXCEED THE GREATER OF $10 MILLION OR THE TOTAL AMOUNT OF UNPAID INVOICES DUE FROM BIOVERATIV TO BIOGEN UNDER THIS AGREEMENT. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, THE LIMITATIONS IN CLAUSE (A) OF THIS SECTION 17.2 SHALL NOT APPLY WITH RESPECT TO ANY LOSS OR DAMAGES SUFFERED BY BIOVERATIV ARISING OUT OF OR IN CONNECTION WITH A WILLFUL BREACH OF THIS AGREEMENT BY BIOGEN.

 

17.3        For avoidance of doubt, either Party’s liability with respect to its activities under this Agreement, including the supply to Bioverativ of Finished Goods and the commercial manufacture and supply of Drug Substance and Drug Product, shall be limited to claims under this Agreement, and neither Party shall have any liability under any other Transaction Agreement with respect to the activities under this Agreement, including the supply of Finished Goods or the commercial manufacture or supply of Drug Substance or Drug Product.

 

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ARTICLE 18

 

INDEMNITY

 

18.1        Bioverativ Indemnification .  Bioverativ shall indemnify, defend, and hold harmless the Biogen Indemnified Parties from and against all liability, claims, damages, loss, or expense (including reasonable attorneys’ fees) resulting from any Third Party claims made or legal proceedings instituted against the Biogen Indemnified Parties to the extent such claims arise out of or result from: (a) death or bodily injury based on the Manufacture by or for Bioverativ (other than by Biogen or its Affiliates) or its sublicensees of Drug Substance or Drug Product or Finished Goods, but, for clarity, excluding any claim that is subject to Section 18.2(a); (b) infringement, or alleged infringement, of any patents due to the Manufacture of Drug Substance or Drug Product or Finished Goods by or for Bioverativ or its sublicensees; (c) Bioverativ’s breach of its representations and warranties in Sections 16.1(a) or 16.1(b); or (d) Bioverativ’s gross negligence or intentional misconduct in connection with this Agreement, except, in each case, to the extent Biogen is obligated to indemnify and hold harmless the Bioverativ Indemnified Parties therefrom pursuant to Section 18.2 below.

 

18.2        Biogen Indemnification .  Biogen shall indemnify, defend, and hold harmless the Bioverativ Indemnified Parties from and against all liability, claims, damages, loss, or expense (including reasonable attorneys’ fees) resulting from any Third Party claims made or legal proceedings instituted against the Bioverativ Indemnified Parties to the extent such claims arise out of or result from: (a) death or bodily injury arising out any Non-Conformity or Compliance Issue of any Finished Goods, Drug Substance or Drug Product provided by Biogen under this Agreement; (b) Biogen’s breach of its representations and warranties in Sections 16.1(a) or 16.1(b); or (c) Biogen’s gross negligence or intentional misconduct in connection with this Agreement, except to the extent Bioverativ is obligated to indemnify and hold harmless the Biogen Indemnified Parties therefrom pursuant to Section 18.1 above. Notwithstanding anything to the contrary in this Agreement, Biogen’s obligation to indemnify with respect to any Non-Conformity or Compliance Issue to the extent that such claim is caused by the Third Party Manufacturer shall not exceed the amounts Biogen is entitled to receive from its Third Party Manufacturer (where claims by Bioverativ under this Section 18.2 shall be deemed claims of a third party under Biogen’s agreement with the Third Party Manufacturer), and Biogen shall have no obligation to indemnify with respect to any Non-Conformity or Compliance Issue caused by any Third Party Carrier, which shall be a matter solely between Bioverativ and such Third Party Carrier.

 

ARTICLE 19

 

INSURANCE

 

19.1        Insurance Coverage .  Without limiting either Party’s undertaking to defend, indemnify, and hold the other Party harmless as set forth in Article 18, each Party shall obtain and maintain during the Term either a commercially reasonable self-insurance program or a Commercial General Liability policy including coverage for Commercial General Liability claims and coverage for products liability claims, in an amount and coverage reasonably

 

44



 

determined by each Party on a country-by-country basis.  The foregoing coverage shall continue with respect to product liability claims, for a period of five (5) years after the Term.

 

ARTICLE 20

 

DISPUTE RESOLUTION

 

20.1        Initial Disputes Procedure .  Within ten (10) days after delivery of a notice of dispute from one Party to the other Party, the JMSC shall attempt in good faith to resolve the dispute. If the JMSC does not resolve the dispute, either Party may present a notice of dispute to the Senior Executives.

 

20.2        Senior Executives Resolution .  Within seven (7) days after delivery of the notice of dispute pursuant to Section 20.1 (Initial Disputes Procedure), the Senior Executives shall meet or converse by telephone at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, to attempt to resolve the dispute. Each Party shall honor all reasonable requests for information made by the other Party, and the Parties shall treat all negotiations pursuant to this clause as confidential and as compromise and settlement negotiations for purposes of applicable rules of evidence. If the Senior Executives do not resolve the dispute within twenty-five (25) days after the delivery of the notice to the Senior Executives under Section 20.1 (or such shorter or longer period as the Parties may agree), then either Party may institute a formal arbitration of such matter pursuant to Section 20.3; provided , however , that to the extent such dispute relates to day-to-day operational decisions regarding the implementation and the conduct of process development and manufacturing activities, including managing (i) sources of raw materials, (ii) the inventory of raw materials, (iii) the staffing of manufacturing facilit(ies), (iv) manufacturing run rates, (v) choice of manufacturing facility(ies), (vi) choice of sub-contractors and Third Party Manufacturers and (vii) choice of which manufacturing processes should be utilized in manufacturing, Biogen shall have the final authority to resolve such dispute in its reasonable discretion, subject to Article 10, and the Parties shall have no recourse to arbitration with respect thereto.

 

20.3        Arbitration .

 

(a)           Any dispute, controversy or claim arising out of or relating to this Agreement, or the breach, termination or invalidity thereof, which has not been resolved pursuant to Sections 20.1 or 20.2 shall be finally settled by binding arbitration conducted in the English language in Boston, Massachusetts under the commercial arbitration rules of the American Arbitration Association.  Each Party shall appoint an arbitrator and the two (2) arbitrators so appointed shall jointly appoint a third arbitrator; provided , however , that if they cannot agree (or if one Party refuses to appoint an arbitrator) within thirty (30) days after the initiation of the arbitration, then such unappointed arbitrator(s) shall be appointed by the American Arbitration Association.  Disputes about arbitration procedure shall be resolved by the arbitrators or failing agreement, by the American Arbitration Association.  The arbitrators may proceed to an award notwithstanding the failure of the other Party to participate in the proceedings.  Discovery shall be limited to

 

45



 

mutual exchange of documents relevant to the dispute, controversy or claim; depositions shall not be permitted unless agreed to by both Parties.

 

(b)           The arbitrators shall be authorized to grant interim relief, including to prevent the destruction of goods or documents involved in the dispute, protect trade secrets and provide for security for a prospective monetary award.  The limitations on liability set out in Article 17 shall apply to any award of the arbitrators.  Specifically, but without limitation, under no circumstances shall the arbitrators be authorized to award punitive or multiple damages.  Any purported award of punitive or multiple damages or of other damages not permitted under Article 17 shall be beyond the arbitrators’ authority, void, and unenforceable.

 

(c)           If the dispute subject to such arbitration proceeding arises under Section 13.3(b), the arbitral tribunal shall be directed to first determine whether the applicable Party is entitled to terminate under Section 13.3(b).  The arbitral tribunal’s decision on such issue shall be the arbitration award referred to in Section 13.3(b) for the purpose of commencing the Breaching Party’s final right to cure during the Additional Cure Period.  The same tribunal shall then continue such proceeding for the purpose of determining all damages and other remedies, including a monetary amount to compensate the Notifying Party for all damages and other losses incurred or suffered as a result of a material breach and any failure to cure such breach while dispute resolution proceeding is pending and the Additional Cure Period (subject to the limitations of Article 17).

 

20.4        Award .  The prevailing Party shall be entitled to an award of reasonable attorney fees incurred in connection with the arbitration in such amount as may be determined by the arbitrators.  The award of the arbitrators shall be the sole and exclusive remedy of the Parties and shall be enforceable in any court of competent jurisdiction, subject only to revocation on grounds of fraud or clear bias on the part of the arbitrators.  Notwithstanding anything contained in this Article 20 to the contrary, each Party shall have the right to institute judicial proceedings against the other Party or anyone acting by, through or under such other Party, in order to enforce the instituting Party’s rights hereunder through reformation of contract, specific performance, injunction or similar equitable relief.

 

ARTICLE 21

 

MISCELLANEOUS

 

21.1        Notice .

 

(a)           All notices, requests, consents and other communications required or permitted under this Agreement shall be in writing and shall be sent by hand, delivered by messenger or courier service, or mailed by registered or certified mail (postage prepaid), return receipt requested, or delivered by reputable international air courier delivery service, addressed to:

 

46


 

If to Bioverativ:

 

 

 

 

Bioverativ Inc.

 

225 Second Avenue

 

Waltham, MA 02451

 

Attn: [ · ]

 

Facsimile: [ · ]

 

 

with a copy to:

 

 

 

 

Bioverativ Inc.

 

225 Second Avenue

 

Waltham, MA 02451

 

Attn: Chief Legal Officer

 

Facsimile: [ · ]

 

 

 

If to Biogen:

 

 

 

 

 

SVP, Global Operations Biogen

 

 225 Binney Street

 

Cambridge, MA 02142

 

USA

 

 

 

with a copy to:

 

 

 

 

 

Executive VP and Chief Legal Officer

 

Biogen Inc.

 

225 Binney Street

 

Cambridge, MA 02142

 

USA

 

E-mail: legaldepartment@biogen.com

 

(b)           Each such notice shall be deemed delivered (i) on the date delivered if by personal or overnight delivery, (ii) on the date upon which the return receipt is signed or delivery is refused or the notice is designated by the postal authorities as not deliverable, as the case may be, if mailed, or (iii) four (4) calendar days after delivery to the applicable air courier.

 

(c)           Either Party may from time to time to change its address upon written notice to the other Party in accordance with this Section 21.1.

 

21.2        Force Majeure .  No failure or omission by a Party in the performance of any obligation of this Agreement shall be deemed a breach of this Agreement or create any liability if the same shall arise from any cause or causes beyond the reasonable control of such Party (a “ Force Majeure Event ”), which may include, but are not limited to, the following: acts of God; acts or omissions of any government; any rules, regulations or orders issued by any governmental authority or by any officer, department, agency or instrumentality thereof; fire; flood; storm; earthquake; accident; war; rebellion; insurrection; riot; and invasion; and provided

 

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that such failure or omission resulting from one of the foregoing causes is cured as soon as is practicable after its occurrence.

 

21.3        Assignment; Binding Effect .

 

(a)           Neither this Agreement nor any of the rights or obligations hereunder may be assigned by either Party without the prior written consent of the other Party, except to a single Third Party that acquires, by merger, sale of assets or otherwise, all or substantially all of the business of the assigning Party to which the subject matter of this Agreement relates.  Notwithstanding anything to the contrary in this Agreement, (i) Biogen may not assign this Agreement nor any of the rights or obligations hereunder to and for the benefit of creditors without Bioverativ’s prior written consent and (ii) each Party shall have the right to assign this Agreement, in whole or in part, to an Affiliate of such Party, or to procure the performance by an Affiliate of some or all of such Party’s obligations hereunder, without the prior written consent of the other Party, provided that such Party guarantees the performance of such Affiliate of its obligations hereunder.  Any assignment not in accordance with the foregoing shall be void.

 

(b)           Each Party agrees that, notwithstanding any provisions of this Agreement to the contrary, in the event that this Agreement is assigned by either Party in connection with the sale or transfer (by merger, sale of assets or otherwise) of all or substantially all of the business and assets of such Party to which the subject matter of this Agreement pertains, (i) such assignment shall not provide the non-assigning Party with rights or access to intellectual property or technology of the acquirer of such Party, and (ii) in the case of an sale or transfer to a competitor of the other Party, the transferring Party shall ensure that (A) the Confidential Information of such other Party is maintained in a manner that makes it unavailable to the competitor company, and (B) any employees or agents of the transferring Party who have had or gain access to the other Party’s Confidential Information through the transferring Party do not become involved in any capacity for the competitor business (other than the business of  the transferring Party as it was practiced immediately prior to the transfer) that could reasonably be expected to benefit from knowledge of such Confidential Information.

 

(c)           In addition, in the case of a sale or transfer (by merger, sale of assets or otherwise) of all or substantially all of the business and assets of Biogen to which the subject matter of this Agreement pertains, Biogen will, upon Bioverativ’s request, perform a technology transfer in accordance with Section 13.4(e).

 

21.4        Modifications; Waivers .  No change, modification, extension, termination or waiver of any obligation, term or provision contained herein shall be valid or enforceable unless same is reduced to writing and signed by a duly authorized representative of each of the Parties

 

48



 

to be bound thereby.  No waiver of any right in any one instance shall constitute a waiver of that right or of any other right in other instances under this Agreement.

 

21.5        Transferred Agreement Support .   To the extent Bioverativ is required to satisfy obligations under the Transferred Agreement for matters not specifically addressed herein, Biogen shall ensure that Bioverativ is able to meet such obligations under the Transferred Agreement.

 

21.6        Entire Agreement .  This Agreement and the Schedules attached hereto, together with the Transaction Agreements (including the Quality Agreement), contain every obligation and understanding between the Parties relating to the subject matter hereof and supersedes all prior discussions, negotiations and agreements, if any, between them relating to the subject matter hereof, and neither of the Parties shall be bound by any conditions, definitions, understandings, warranties or representations other than as expressly provided or referred to herein.

 

21.7        Severability .  If, under Applicable Law or regulation, any provision of this Agreement is invalid or unenforceable, or otherwise directly or indirectly affects the validity of any other material provision(s) of this Agreement (“ Severed Clause ”), it is mutually agreed that this Agreement shall endure except for the Severed Clause.  The Parties shall consult and use their best efforts to agree upon a valid and enforceable provision which shall be a reasonable substitute for such Severed Clause in light of the intent of this Agreement.

 

21.8        Section Headings .  The section headings in this Agreement are for convenience of reference only and shall not be deemed to affect the interpretation of any provision of this Agreement.

 

21.9        Relationship of Parties .  This Agreement shall not constitute or be construed as creating a partnership, employer-employee or joint venture relationship between the Parties, and neither Party shall be liable for any debts or obligations of the other Party.  Neither Party shall have any power to enter into any contracts or commitments in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever.

 

21.10      Construction .  Each Party acknowledges that it has been advised by counsel during the course of negotiation of this Agreement and, therefore, that this Agreement shall be interpreted without regard to any presumption or rule requiring construction against the Party causing this Agreement to be drafted.  Except where the context otherwise requires, wherever used, the use of any gender will be applicable to all genders and the word “or” is used in the inclusive sense (and/or).  The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement.  The terms “include” and “including,” in all their forms, as used herein mean including, without limiting the generality of any description preceding such term.  Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document refers 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 or therein), (b) any reference to any laws refer to such laws as from time to time enacted, repealed or amended,

 

49



 

(c) the words “herein”, “hereof” and “hereunder”, and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof, and (d) all references herein to Articles, Sections and Schedules, unless otherwise specifically provided, refer to the Articles, Sections and Schedules of this Agreement.

 

21.11      Governing Law .  The rights and obligations of the Parties to this Agreement shall not be governed by the provisions of the U.N. Convention on Contracts for the International Sale of Goods, 1980; rather this Agreement has been entered into and shall be construed and enforced in accordance with the laws of the State of Delaware, without reference to the choice of law principles thereof.

 

21.12      Conflicting Terms .  To the extent the terms of an Order conflict with terms of this Agreement, the terms of this Agreement shall govern, unless otherwise agreed in writing by the Parties.

 

21.13      Injunctive Relief .  Unless otherwise expressly stated under this Agreement, the Parties agree that each will have, in addition to any other rights or remedies available to it at law, the right to seek injunctive relief, including specific performance, in the event of any threatened or actual violation of any or all of the provisions of this Agreement.

 

21.14      Counterparts .  This Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

 

[Signature Page Follows]

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed as of the day and year first above written.

 

 

BIOGEN INC.

 

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

 

 

 

 

 

 

BIOVERATIV INC.

 

 

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

[ Signature Page to Manufacturing and Supply Agreement ]

 

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Exhibit 2.5

 

Form of

 

EMPLOYEE MATTERS AGREEMENT

 

 

by and between

 

 

BIOGEN INC.

 

 

and

 

 

BIOVERATIV INC.

 

 

Dated as of [ · ],[ · ]

 



 

TABLE OF CONTENTS

 

 

 

PAGE

 

 

 

ARTICLE I

 

DEFINITIONS

 

 

 

Section 1.1

General

1

 

 

 

ARTICLE II

 

TRANSFER OF BIOVERATIV EMPLOYEES; GENERAL PRINCIPLES

 

 

 

Section 2.1

Transfer of Employment to Bioverativ of Additional Employees; Post-Effective Time Transfers; Independent Contractors

4

Section 2.2

Assumption and Retention of Liabilities

5

Section 2.3

Bioverativ Participation in the Biogen Plans

5

Section 2.4

Sponsorship of the Bioverativ Plans

6

Section 2.5

No Duplication of Benefits; Service and Other Credit

6

Section 2.6

Reimbursements

6

Section 2.7

Approval of Plans

6

Section 2.8

Delivery of Shares; Registration Statement

6

Section 2.9

Labor Relations

7

 

 

 

ARTICLE III

 

DEFINED CONTRIBUTION AND NON-QUALIFIED DEFERRED COMPENSATION PLANS

 

 

 

Section 3.1

401(k) Plan

7

Section 3.2

Supplemental Savings Plan; Grantor Trusts

8

Section 3.3

Cash Retention Agreements

9

 

 

 

ARTICLE IV

 

HEALTH AND WELFARE PLANS; PAYROLL; COBRA AND VACATION

 

 

 

Section 4.1

Cessation of Participation in Biogen Health and Welfare Plans

9

Section 4.2

Allocation of Health and Welfare Plan Liabilities

9

Section 4.3

Flexible Spending Plan Treatment

10

Section 4.4

Workers’ Compensation Liabilities

10

Section 4.5

Payroll Taxes and Reporting

11

Section 4.6

COBRA and HIPAA Compliance

11

Section 4.7

Vacation and Paid Time Off

11

 



 

ARTICLE V

 

INCENTIVE COMPENSATION, EQUITY COMPENSATION AND OTHER BENEFITS

 

 

 

Section 5.1

Annual Cash-Based Incentive Plans

11

Section 5.2

Awards under the Biogen Equity-Based Plans

12

Section 5.3

Biogen ESPP

15

 

 

 

ARTICLE VI

 

NON-U.S. EMPLOYEES

 

 

 

Section 6.1

Special Provisions for Employees Outside of the United States

15

 

 

 

ARTICLE VII

 

GENERAL AND ADMINISTRATIVE

 

 

 

Section 7.1

Sharing of Participant Information

16

Section 7.2

No Third Party Beneficiaries

16

Section 7.3

Audit Rights with Respect to Information Provided

17

Section 7.4

Fiduciary Matters

17

Section 7.5

Consent of Third Parties

17

Section 7.6

Assignment of “Claw-Back” or Recoupment Rights

17

Section 7.7

Proprietary Information and Inventions Agreements

17

 

 

 

ARTICLE VIII

 

DISPUTE RESOLUTION

 

 

 

Section 8.1

General

18

 

 

 

ARTICLE IX

 

MISCELLANEOUS

 

 

 

Section 9.1

Complete Agreement; Construction

18

Section 9.2

Counterparts

18

Section 9.3

Survival of Agreements

18

Section 9.4

Expenses

18

Section 9.5

Notices

19

Section 9.6

Waivers

19

Section 9.7

Assignment

19

Section 9.8

Successors and Assigns

20

Section 9.9

Termination and Amendment

20

Section 9.10

Payment Terms

20

Section 9.11

Specific Performance

20

Section 9.12

Subsidiaries

21

 



 

Section 9.13

Third Party Beneficiaries

21

Section 9.14

Titles and Headings

21

Section 9.15

Governing Law

21

Section 9.16

Consent to Jurisdiction

21

Section 9.17

Waiver of Jury Trial

21

Section 9.18

Severability

22

Section 9.19

Interpretation

22

Section 9.20

No Duplication; No Double Recovery

22

Section 9.21

No Waiver

22

Section 9.22

No Admission of Liability

22

Section 9.23

Transfer of Records and Information

22

Section 9.24

Cooperation

23

 



 

EMPLOYEE MATTERS AGREEMENT

 

This EMPLOYEE MATTERS AGREEMENT (this “ Agreement ”), dated as of [ · ],[ · ], is entered into by and between Biogen Inc. (“ Biogen ”), a Delaware corporation, and Bioverativ Inc. (“ Bioverativ ”), a Delaware corporation and a wholly owned subsidiary of Biogen.  Capitalized terms used and not defined herein shall have the meaning set forth in the Separation Agreement between the Parties, dated as of [ · ], [ · ] (the “ Separation Agreement ”).

 

WHEREAS, as contemplated by the Separation Agreement, Biogen and Bioverativ desire to enter into this Agreement to provide for the allocation of assets, Liabilities, and responsibilities with respect to certain matters relating to employees and other individual service providers (including employee compensation and benefit plans and programs) between them.

 

NOW, THEREFORE, the Parties, intending to be legally bound, agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

Section 1.1                                     General .  For purposes of this Agreement the following terms shall have the meaning ascribed to them in this Article I.

 

1.1                                Adjustment Fraction ” means a fraction, the numerator of which is the volume-weighted average trading price of Biogen Common Stock (trading “regular way”) on the ten (10) trading days immediately prior to the date upon which the Distribution Effective Time occurs and the denominator of which is the volume-weighted average trading price of Biogen Common Stock on the ten (10) trading days immediately following the date upon which the Distribution Effective Time occurs, each as reported on Bloomberg.

 

1.2                                Biogen Cash-Settled Performance Unit ” means a unit granted by Biogen prior to the Effective Date pursuant to a Biogen Equity-Based Plan that vests in whole or in part based on the achievement of a specified performance objective and represents a general unsecured promise by Biogen to deliver an amount in cash.

 

1.3                                Biogen Defined Contribution Plan ” means the Biogen 401(k) Savings Plan.

 

1.4                                Biogen Employee ” means any individual who, as of the Distribution Effective Time, is either receiving compensation from a member of the Biogen Group which is to be reported on IRS Form W-2 (in the case of individuals employed in the United States) or who is on the payroll of a Biogen Group member (in the case of individuals outside the United States), but does not include any Bioverativ Employee.

 

1.5                                Biogen ESPP ” means the Biogen 2015 Employee Stock Purchase Plan.

 



 

1.6                                Biogen Equity-Based Plans ” means the Biogen 2008 Amended and Restated Omnibus Equity Plan and the Biogen 2005 Omnibus Equity Plan.

 

1.7                                Biogen FSAs ” has the meaning set forth in Section 4.3 .

 

1.8                                Biogen Health and Welfare Plans ” means the health and welfare plans sponsored and maintained by Biogen or any Biogen Group member immediately prior to the Distribution Effective Time which provide group health, life, dental, accidental death and dismemberment, health care reimbursements, dependent care assistance and disability benefits.

 

1.9                                Biogen Market Stock Unit ” means a unit granted by Biogen prior to the Effective Date pursuant to a Biogen Equity-Based Plan representing a general unsecured promise by Biogen to deliver a share of Biogen Common Stock or an amount in cash that vests in whole or in part based on the achievement of specified performance objectives in respect of the fair market value of Biogen Common Stock.

 

1.10                         Biogen Participant ” means any individual who is a Biogen Employee or a Former Biogen Employee, and any beneficiary, dependent, or alternate payee of such individual, as the context requires.

 

1.11                         Biogen Supplemental Savings Plan ” means the Biogen Supplemental Savings Plan.

 

1.12                         Biogen Grantor Trust ” means the Biogen Grantor Trust established by the Grantor Trust Agreement by and between Biogen and Wells Fargo Bank, National Association, as amended from time to time.

 

1.13                         Biogen Units ” means the Biogen Cash-Settled Performance Units, the Biogen Market Stock Units, and the Biogen Time-Based Restricted Stock Units.

 

1.14                         Bioverativ 401(k) Plan ” means the tax-qualified defined contribution savings plan with a cash or deferred arrangement under Section 401(k) of the Code adopted by Bioverativ or a Bioverativ Group member prior to the Distribution Effective Time.

 

1.15                         Bioverativ Employee ” means any individual who, as of the Distribution Effective Time, is either actively employed by or then on a leave of absence from Bioverativ or a Bioverativ Group member (including maternity, paternity, family, sick, disability leave, qualified military service under the Uniformed Services Employment and Reemployment Rights Act of 1994, and leave under the Family Medical Leave Act and other approved leaves) or who is employed by Biogen or a Biogen Group member and who becomes a Bioverativ Employee pursuant to the operation of this Agreement.

 

1.16                         Bioverativ FSAs ” has the meaning set forth in Section 4.3 .

 

1.17                         Bioverativ Health and Welfare Plans ” has the meaning set forth in Section 4.1 .

 

2



 

1.18                         Bioverativ Omnibus Equity Plan ” means the Bioverativ Omnibus Equity Plan adopted by Bioverativ prior to the Distribution Effective Time.

 

1.19                         Bioverativ Participant ” means any individual who is a Bioverativ Employee or a Former Bioverativ Employee, and any beneficiary, dependent, or alternate payee of such individual, as the context requires.

 

1.20                         Bioverativ Supplemental Savings Plan ” means the Bioverativ Supplemental Savings Plan adopted by Bioverativ prior to the Distribution Effective Time.

 

1.21                         Bioverativ Grantor Trust ” means the Bioverativ Grantor Trust established by Bioverativ prior to the Distribution Effective Time.

 

1.22                         COBRA ” means the continuation coverage requirements for “group health plans” under Title X of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended, and as codified in Code Section 4980B and ERISA Sections 601 through 608.

 

1.23                         Code ” means the Internal Revenue Code of 1986, as amended, or any successor federal income tax law.  Reference to a specific Code provision also includes any proposed, temporary, or final regulation in force under that provision.

 

1.24                         Conversion Fraction ” means a fraction, the numerator of which is the volume-weighted average trading price of Biogen Common Stock (trading “regular way”) on the ten (10) trading days immediately prior to the date upon which the Distribution Effective Time occurs and the denominator of which is volume-weighted average trading price of Bioverativ Common Stock on the ten (10) trading days immediately following the date upon which the Distribution Effective Time occurs, each as reported on Bloomberg.

 

1.25                         ERISA ” means the Employee Retirement Income Security Act of 1974, as amended.  Reference to a specific provision of ERISA also includes any proposed, temporary, or final regulation in force under that provision.

 

1.26                         Former Biogen Employee ” means any individual whose employment with a Biogen Group member terminated for any reason before the Distribution Effective Time, other than a Former Bioverativ Employee.

 

1.27                         Former Bioverativ Employee ” means any individual whose employment with either Party or any of its respective Subsidiaries and Affiliates terminated for any reason before the Distribution Effective Time, and who was primarily engaged in providing services to the Bioverativ Business as of the date of his or her termination of employment.

 

1.28                         HIPAA ” means the health insurance portability and accountability requirements for “group health plans” under the Health Insurance Portability and Accountability Act of 1996, as amended.

 

1.29                         Incentive Stock Option ” means an option which qualifies as an incentive stock option under the provisions of Section 422 of the Code.

 

3



 

1.30                         Option ” when immediately preceded by “Biogen,” means an option (either nonqualified or an Incentive Stock Option) to purchase Biogen Common Stock granted by Biogen prior to the Effective Date pursuant to a Biogen Equity-Based Plan and when immediately preceded by “Bioverativ” means an option (either nonqualified or an Incentive Stock Option) to purchase Bioverativ Common Stock, which option is granted pursuant to the Bioverativ Omnibus Equity Plan as part of the adjustment to Biogen Options as set forth in Section 5.2(a) .

 

1.31                         Plan ,” when immediately preceded by “Biogen,” means any plan, policy, program, payroll practice, on-going arrangement, contract, trust, insurance policy or other agreement or funding vehicle (including a Biogen Health and Welfare Plan) for which the eligible classes of participants include employees or former employees of Biogen or a Biogen Group member (which may include employees of Bioverativ Group members prior to the Distribution Effective Time), and when immediately preceded by “Bioverativ,” means any plan, policy, program, payroll practice, on-going arrangement, contract, trust, insurance policy or other agreement or funding vehicle (including a Bioverativ Health and Welfare Plan) for which the eligible classes of participants are limited to employees or former employees (and their eligible dependents) of Bioverativ or a Bioverativ Group member, but no other Biogen Group member.

 

1.32                         Time-Based Restricted Stock Unit ,” when immediately preceded by “Biogen,” means a unit granted by Biogen prior to the Effective Date pursuant to a Biogen Equity-Based Plan that vests solely based on the continued employment or service of the recipient and represents a general unsecured promise by Biogen to deliver a share of Biogen Common Stock or an amount in cash (determined by reference to the value of a share of Biogen Common Stock) and when immediately preceded by “Bioverativ,” means a unit granted by Bioverativ that vests solely based on the continued employment or service of the recipient and represents a general unsecured promise by Bioverativ to deliver a share of Bioverativ Common Stock, which unit is granted as part of the adjustment to Biogen Units as set forth in Section 5.2(b) .

 

ARTICLE II

 

TRANSFER OF BIOVERATIV EMPLOYEES; GENERAL PRINCIPLES

 

Section 2.1                                     Transfer of Employment to Bioverativ of Additional Employees; Post-Effective Time Transfers; Independent Contractors .

 

(a)                                  Following the date hereof and prior to the Distribution Effective Time, Biogen and Bioverativ may cause the employment of individuals designated by Biogen who are not employed by a Bioverativ Group member as of the date hereof to be transferred to a Bioverativ Group member.

 

(b)                                  Reserved.

 

(c)                                   In the event that Biogen determines following the Distribution Effective Time that any individual employed outside the United States (other than an individual who the Parties intend to be a Bioverativ Employee) has inadvertently become employed by a member of the Bioverativ Group (due to the operation of transfer of undertakings or similar law or regulation),

 

4


 

the Parties shall cooperate and take such actions as may be reasonably necessary in order to cause the employment of such individuals to be promptly transferred to a member of the Biogen Group.

 

(d)                                  The Parties shall cooperate and take such actions as may be reasonably necessary in order to minimize potential statutory, contractual, plan-based or other severance or similar obligations to the Parties or their Affiliates in connection with any transfers of employment described in this Section 2.1 .

 

(e)                                   Bioverativ will determine which, if any, temporary workers, individual consultants or independent contractors who are performing service primarily related to the Bioverativ Business, it wishes to transfer to Bioverativ and, the Parties shall use reasonable efforts to transfer the individual or to assign the applicable Contract to a member of the Bioverativ Group and Bioverativ shall, or shall cause a member of the Bioverativ Group to, assume and perform such Contract.  In the event that a transfer fee is required to be paid in order to effect such transfer, Bioverativ shall be responsible for and pay the full amount of such fee.

 

Section 2.2                                     Assumption and Retention of Liabilities .  Biogen and Bioverativ intend that employment-related Liabilities associated with Biogen Participants are to be retained or assumed by Biogen or a Biogen Group member, and employment-related Liabilities associated with Bioverativ Participants are to be assumed by Bioverativ or a Bioverativ Group member, in each case, except as specifically set forth herein.  Accordingly, as of the Distribution Effective Time:

 

(a)                                  Biogen or the applicable member of the Biogen Group hereby retains or assumes and agrees to pay, perform, fulfill, and discharge, except as expressly provided in this Agreement, (i) all Liabilities arising under or related to Biogen Plans, (ii) all employment or service-related Liabilities with respect to (A) all Biogen Participants and (B) any individual who is, or was, an independent contractor, temporary employee, temporary service worker, consultant, freelancer, agency employee, leased employee, on-call worker, incidental worker, or non-payroll worker or in any other employment or similar relationship primarily connected to Biogen or a Biogen Group member and (iii) any Liabilities expressly transferred or allocated to Biogen or a Biogen Group member under this Agreement (it being understood and agreed that the provisions of this Agreement do not create or constitute a source of any such Liability); and

 

(b)                                  Bioverativ hereby retains or assumes and agrees to pay, perform, fulfill, and discharge, except as expressly provided in this Agreement, (i) all Liabilities arising under or related to Bioverativ Plans, (ii) all employment or service-related Liabilities with respect to (A) all Bioverativ Participants and (B) any individual who is, or was, an independent contractor, temporary employee, temporary service worker, consultant, freelancer, agency employee, leased employee, on-call worker, incidental worker, or non-payroll worker or in any other employment or similar relationship primarily connected to Bioverativ or a Bioverativ Group member and (iii) any Liabilities expressly transferred or allocated to Bioverativ or a Bioverativ Group member under this Agreement.

 

Section 2.3                                     Bioverativ Participation in the Biogen Plans .  Effective not later than the Distribution Effective Time, Bioverativ and each Bioverativ Group member shall cease to be a participating company in each Biogen Plan, and Biogen and Bioverativ shall take all necessary

 

5



 

action before the Distribution Effective Time to effectuate such cessation as a participating company.

 

Section 2.4                                     Sponsorship of the Bioverativ Plans .  Effective no later than immediately prior to the Distribution Effective Time, Biogen and Bioverativ shall take such actions (if any) as are required to cause Bioverativ or a Bioverativ Group member to assume, sole sponsorship of, and all Liabilities with respect to, each Bioverativ Plan.

 

Section 2.5                                     No Duplication of Benefits; Service and Other Credit .  Biogen and Bioverativ shall adopt, or cause to be adopted, all reasonable and necessary amendments and procedures to prevent Bioverativ Participants from receiving duplicative benefits from the Biogen Plans and the Bioverativ Plans. With respect to Bioverativ Employees, each Bioverativ Plan shall provide that for purposes of determining eligibility to participate, vesting, and entitlement to benefits, service prior to the Distribution Effective Time with Biogen or a Biogen Group member shall be treated as service with Bioverativ or the applicable Bioverativ Group member.  Such service also shall apply for purposes of satisfying any waiting periods, evidence of insurability requirements, or the application of any preexisting condition limitations under any Bioverativ Plan.  Each Bioverativ Plan shall, to the extent practicable, waive pre-existing condition limitations with respect to Bioverativ Employees.   Bioverativ shall honor any deductible, co-payment and out-of-pocket maximums incurred by the Bioverativ Employees and their eligible dependents under the Biogen Plans in which they participated immediately prior to the Distribution Effective Time during the then-elapsed portion of the calendar year prior to the Distribution Effective Time in satisfying any deductibles, co-payments or out-of-pocket maximums under the Bioverativ Plans in which they are eligible to participate after the Distribution Effective Time in the same plan year in which such deductibles, co-payments or out-of-pocket maximums were incurred.

 

Section 2.6                                     Reimbursements .  From time to time after the Distribution Effective Time, the Parties shall promptly reimburse one another, upon reasonable request of the Party requesting reimbursement and the presentation by such Party of such substantiating documentation as the other Party shall reasonably request, for the cost of any Liabilities satisfied or assumed by the Party requesting reimbursement or its Affiliates that are made pursuant to this Agreement, the responsibility of the other Party or any of its Affiliates.

 

Section 2.7                                     Approval of Plans .  Prior to the Distribution Effective Time, Biogen shall cause Bioverativ to adopt the Bioverativ Omnibus Equity Plan and an employee stock purchase plan intended to meet the requirements of Section 423 of the Code and the regulations promulgated thereunder (the “ Bioverativ ESPP ”) and take all actions as may be necessary to approve the Bioverativ Omnibus Equity Plan and the Bioverativ ESPP in order to satisfy the applicable requirements of the Code and the applicable rules and regulations of the NASDAQ.

 

Section 2.8                                     Delivery of Shares; Registration Statement .  From and after the Distribution Effective Time, Bioverativ shall have sole responsibility for delivery of shares of Bioverativ Common Stock pursuant to awards issued under a Bioverativ Plan in satisfaction of any obligations to deliver such shares under the Bioverativ and/or Biogen Plans (including delivery to Biogen Employees and Former Biogen Employees) and shall do so without compensation from any Biogen Group member.  Bioverativ shall cause a registration statement on Form S-8 (or other appropriate form) to be filed with respect to such issued or issuable shares prior to the Distribution

 

6



 

Effective Time and shall cause such registration to remain in effect for so long as there may be an obligation to deliver Bioverativ shares under such Bioverativ and/or Biogen Plans.  Biogen shall use commercially reasonable efforts to assist Bioverativ in completing such registration.

 

Section 2.9                                     Labor Relations .  To the extent required by applicable Law or any agreement with a labor union, works council or similar employee organization, the Parties shall cooperate to provide notice, engage in consultation and take any similar action which may be required on its part in connection with the Distribution.

 

ARTICLE III

 

DEFINED CONTRIBUTION AND NON-QUALIFIED DEFERRED COMPENSATION PLANS

 

Section 3.1                                     401(k) Plan .

 

(a)                                  Establishment of Plan and Trust .  Prior to the Distribution Effective Time, Biogen shall cause Bioverativ or a Bioverativ Group Member to adopt the Bioverativ 401(k) Plan, which shall be substantially similar in all material respects to the Biogen Defined Contribution Plan, and any trust agreements, other plan documents, summary plan descriptions, notices and enrollment materials reasonably necessary to implement the Bioverativ 401(k) Plan, and shall cause trustees to be appointed for such plan.  Each Bioverativ Employee who was eligible to participate in the Biogen Defined Contribution Plan immediately prior to the effective date of the Bioverativ 401(k) Plan (or prior to the Distribution Effective Time, if later) shall be eligible to participate in the Bioverativ 401(k) Plan as of its effective date, and the participation of each Bioverativ Employee in the Biogen Defined Contribution Plan shall cease as of such date.  All other Bioverativ Employees shall become eligible to participate in the Bioverativ 401(k) Plan as provided under the terms of such plan.

 

(b)                                  Assumption of Liabilities and Transfer of Assets .  In accordance with applicable Law, Biogen and Bioverativ shall cause, in the manner described herein, the accounts under the Biogen Defined Contribution Plan of each Bioverativ Employee to be transferred to the Bioverativ 401(k) Plan on, as soon as practicable after, the effective date of the Bioverativ 401(k) Plan.  On, or as soon as practicable after, the effective date of the Bioverativ 401(k) Plan: (i) Biogen shall cause the accounts (including any outstanding loan balances) of each Bioverativ Employee in the Biogen Defined Contribution Plan to be transferred from the trust established under the Biogen Defined Contribution Plan to the trust established under the Bioverativ 401(k) Plan ; (ii) the Bioverativ 401(k) Plan shall assume and be solely responsible for all Liabilities under the Bioverativ 401(k) Plan relating to the accounts that are so transferred as of the time of such transfer; and (iii) Bioverativ shall cause such transferred accounts to be accepted by the Bioverativ 401(k) Plan and its related trust and shall cause the Bioverativ 401(k) Plan to satisfy all protected benefit requirements under Section 411(d)(6) of Code and applicable Law with respect to the transferred accounts.

 

(c)                                   Service Crediting .  In determining whether a Bioverativ Employee is vested in his or her account under the Bioverativ 401(k) Plan, the Bioverativ 401(k) Plan shall credit each

 

7



 

Bioverativ Employee with all the individual’s service credited under the Biogen Defined Contribution Plan.  Participants in the Biogen Defined Contribution Plan will not be treated as having experienced a severance from employment, within the meaning of Section 401(k)(2)(B)(i) of the Code, for purposes of such plans as a result of the Distribution or the occurrence of the Distribution Effective Time.

 

(d)                                  Post-Distribution Effective Time Contributions .  If any Bioverativ Employees are entitled to true-up matching contributions under Section 5.1(b) of the Biogen Defined Contribution Plan (or any other employer contributions under such plan) with respect to the 2016 plan year, and such contributions have not yet been deposited into the Bioverativ Employees’ accounts under the Biogen Defined Contribution Plan as of the date such accounts are transferred from the trust established under the Biogen Defined Contribution Plan to the trust established under the Bioverativ 401(k) Plan as set forth in Section 3.1(a), then Biogen shall contribute the amount of such true-up matching contributions (and other employer contributions, if any) into the applicable Bioverativ Employees’ accounts under the Biogen Defined Contribution Plan as soon as practicable following the end of the 2016 plan year.  Biogen shall then cause the amount of such true up matching contributions (and other employer contributions, if any) to be transferred to the Bioverativ 401(k) Plan in the manner set forth in Section 3.1(b) as soon as practicable following their deposit into the Biogen Defined Contribution Plan, and Bioverativ shall cause such transferred amounts to be accepted by the Bioverativ 401(k) Plan.

 

Section 3.2                                     Supplemental Savings Plan; Grantor Trusts .

 

(a)                                  Establishment of Plan and Trust; Assumption of Liabilities and Transfer of Assets .   Prior to the Distribution Effective Time, Biogen and Bioverativ shall (i) adopt or cause to be adopted the Bioverativ Supplemental Savings Plan and (ii) establish the Bioverativ Grantor Trust, each of which shall be substantially identical to the Biogen Savings Plan and Biogen Grantor Trust, respectively.  Prior to or upon the Distribution Effective Time, Biogen and Bioverativ shall cause the accounts under the Biogen Supplemental Savings Plan of each Bioverativ Employee to be transferred to the Bioverativ Supplemental Savings Plan and, upon such transfer, Bioverativ and the Bioverativ Supplemental Savings Plan shall assume all Liabilities with respect to each Bioverativ Employee who participates the Biogen Supplemental Savings Plan.  Prior to or upon the Distribution Effective Time, Biogen shall cause the assets of the Biogen Grantor Trust in respect of Bioverativ Employees to be transferred to the Bioverativ Grantor Trust, which assets will be expressly assumed by Bioverativ under the Bioverativ Grantor Trust.  For purposes of determining when a distribution is required from the Bioverativ Supplemental Savings Plan described in this Section 3.2 , Bioverativ Employees who were participants in such plan will be treated as not having experienced a separation from service until such employees have separated from service from all Bioverativ Group members.

 

(b)                                  Post-Distribution Effective Time Contributions .  To the extent that Biogen has, immediately prior to the Distribution Effective Time, an accrual in respect of contributions to the Biogen Supplemental Savings Plan for Bioverativ Employees who participated in such plan during 2016 (which accrual, absent the Distribution, would have resulted in a contribution to the Biogen Grantor Trust for 2016 in respect of such employees and the crediting of an amount under the Biogen Supplemental Savings Plan to the account of such Bioverativ Employees), Bioverativ

 

8



 

shall, following the Distribution Effective Time, credit the account of each such Bioverativ Employee under the Bioverativ Supplemental Savings Plan an amount equal to such employee’s portion of such Biogen accrual.

 

Section 3.3                                     Cash Retention Agreements .  Upon the Distribution Effective Time, any cash retention arrangements in place with a Bioverativ Employee (together with the rights and obligations thereunder) shall be assigned to Bioverativ by the applicable Biogen Group member.  Continued employment with Bioverativ following the Distribution Effective Time shall constitute continued employment for all purposes under any such agreement.

 

ARTICLE IV

 

HEALTH AND WELFARE PLANS; PAYROLL; COBRA AND VACATION

 

Section 4.1                                     Cessation of Participation in Biogen Health and Welfare Plans .  Prior to the Distribution Effective Time, Bioverativ shall establish health and welfare plans (the “ Bioverativ Health and Welfare Plans ”) which generally correspond to the Biogen Health and Welfare Plans in which Bioverativ Employees participate immediately prior to the Distribution Effective Time.  As of the Distribution Effective Time Bioverativ Employees shall cease to participate in the Biogen Health and Welfare Plans and shall, as applicable, commence participation in the corresponding Bioverativ Health and Welfare Plan for which they have enrolled.  Bioverativ shall cause Bioverativ Employees and their covered dependents who participate in Biogen Health and Welfare Plans immediately before the Distribution Effective Time to be given the opportunity to enroll as of the Distribution Effective Time in such Bioverativ Health and Welfare Plans as are made available to the Bioverativ Employee.  The transfer of employment from Biogen or a Biogen Group member to Bioverativ or a Bioverativ Group member prior to or as of the Distribution Effective Time shall not be treated as a “status change” with respect to any Bioverativ Employee under the Biogen Health and Welfare Plans or the Bioverativ Health and Welfare Plans.

 

Section 4.2                                     Allocation of Health and Welfare Plan Liabilities .  All outstanding Liabilities relating to, arising out of, or resulting from health and welfare coverage or claims incurred by or on behalf of Bioverativ Employees or their covered dependents under the Biogen Health and Welfare Plans on or before the Distribution Effective Time shall be assumed by Bioverativ upon the Distribution Effective Time; provided , however , that to the extent that (1) such a Liability is covered under an insurance policy maintained with respect to a Biogen Health and Welfare Plan (which, for the avoidance of doubt, consists only of a stop-loss policy) or (2) Biogen has received prior to the Distribution Effective Time an invoice from the service provider billing Biogen for the service or product, Bioverativ shall not in either case assume such Liability.  For purposes of this Agreement, a claim shall be incurred upon the date upon which service or product giving rise to the Liability was provided. Any payments, repayments, reimbursements or credits consisting of, or representing, dividends, demutualizations, premium refunds, rebates, subrogation or similar reimbursements, overpayments, class action recoveries, or like payments under, or relating to, any Biogen Health or Welfare Plan whenever occurring shall remain the property solely of Biogen and neither Bioverativ, any Bioverativ Group member nor any Bioverativ Participant shall have any interest in or right to such Biogen property.

 

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Section 4.3                                     Flexible Spending Plan Treatment .  Prior to the Distribution Effective Time, Bioverativ shall establish a dependent care spending account and a medical care spending account (the “ Bioverativ FSAs ”) effective as of the Distribution Effective Time, which Bioverativ FSAs shall have terms that are substantially identical to the analogous Biogen dependent care and medical care flexible spending accounts (the “ Biogen FSAs ”) as in effect immediately prior to the Distribution Effective Time.  Bioverativ and Biogen shall take all steps necessary or appropriate so that the account balances (positive or negative) under the Biogen FSAs of each Bioverativ Employee who has elected to participate therein in the year in which the Distribution Effective Time occurs shall be transferred on, or as soon as practicable after, the Distribution Effective Time from the Biogen FSAs to the corresponding Bioverativ FSAs.  The Bioverativ FSAs shall assume responsibility as of the Distribution Effective Time for all outstanding dependent care and medical care claims under the Biogen FSAs of each Bioverativ Employee for the year in which the Distribution Effective Time occurs and shall assume the rights of and agree to perform the obligations of the analogous Biogen FSA from and after the Distribution Effective Time.  Bioverativ shall take all steps necessary or appropriate so that the contribution elections of each such Bioverativ Employee as in effect immediately before the Distribution Effective Time remain in effect under the Bioverativ FSAs following the Distribution Effective Time. As soon as practicable, after the Distribution Effective Time, Biogen shall transfer to Bioverativ an amount equal to the total contributions made to the Biogen FSAs by Bioverativ Employees in respect of the plan year in which the Distribution Effective Time occurs, reduced by an amount equal to the total claims already paid to Bioverativ Employees in respect of such plan year. From and after the Distribution Effective Time, Biogen shall provide Bioverativ with such information such entity may reasonably request to enable it to verify any claims information pertaining to a Biogen FSA.

 

Section 4.4                                     Workers’ Compensation Liabilities .  All workers’ compensation Liabilities relating to, arising out of, or resulting from any claim by Bioverativ Employees or Former Bioverativ Employees that result from an accident or from an occupational disease which is incurred or becomes manifest, as the case may be, on or before the Distribution Effective Time and while such individual was employed by Biogen or a Biogen Group member shall be assumed by Bioverativ as of the Distribution Effective Time; provided , however , that to the extent that either (1) such a Liability is covered under an workers compensation insurance policy of Biogen or a Biogen Group member or (2) Biogen has received an invoice for a covered expense prior to the Distribution Effective Time, Bioverativ shall not assume such Liability.  Notwithstanding the foregoing, Bioverativ shall assume worker’s compensation Liabilities to the extent they are imposed on Bioverativ under applicable law or where the injury or illness related to the Liability is aggravated or subject to further injury after the Distribution Effective Time.  A Liability which must be paid due to the existence of a deductible shall not be deemed to be covered by a workers compensation insurance policy for purposes of this Section 4.4.  Subject to the foregoing, Bioverativ and each Bioverativ Group member shall also be solely responsible for all workers’ compensation Liabilities relating to, arising out of, or resulting from any claim incurred for a compensable injury sustained by a Bioverativ Employee that results from an accident or from an occupational disease which is incurred or becomes manifest, as the case may be, after the Distribution Effective Time.  Biogen, each Biogen Group member, Bioverativ and each Bioverativ Group member shall cooperate with respect to processing of claims, any notification to appropriate governmental agencies of the disposition and the issuance of new, or the transfer of existing, workers’ compensation insurance policies and claims handling contracts.

 

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Section 4.5                                     Payroll Taxes and Reporting .  Biogen and Bioverativ (i) shall, to the extent practicable, treat Bioverativ (or a Bioverativ Group member designated by Bioverativ) as a “successor employer” and Biogen (or the appropriate Biogen Group member) as a “predecessor,” within the meaning of Sections 3121(a)(1) and 3306(b)(1) of the Code, with respect to Bioverativ Employees for purposes of taxes imposed under the United States Federal Unemployment Tax Act or the United States Federal Insurance Contributions Act, and (ii) hereby agree to use commercially reasonable efforts to implement the alternate procedure described in Section 5 of Revenue Procedure 2004-53.  Without limiting in any manner the obligations and Liabilities of the Parties under the Tax Matters Agreement, including all withholding obligations otherwise set forth therein, Biogen, each Biogen Group member, Bioverativ and each Bioverativ Group member shall each bear its responsibility for payroll tax obligations and for the proper reporting to the appropriate governmental authorities of compensation earned by their respective employees after the Distribution Effective Time, including compensation related to the exercise of Options or the vesting or exercise of other equity awards, including in instances where such equity awards are with respect to the equity of the other Party.

 

Section 4.6                                     COBRA and HIPAA Compliance .  Biogen or a Biogen Group member shall retain the responsibility for administering compliance with the health care continuation requirements of COBRA for any COBRA qualified beneficiaries who incur a COBRA qualifying event or loss of coverage under the Biogen Health and Welfare Plans at any time before the Distribution Effective Time.  Bioverativ shall be responsible for administering compliance with the health care continuation requirements of COBRA, and the corresponding provisions of the Bioverativ Health and Welfare Plans with respect to Bioverativ Participants who incur a COBRA qualifying event or loss of coverage under the Bioverativ Health and Welfare Plans at any time upon or after the Distribution Effective Time.

 

Section 4.7                                     Vacation and Paid Time Off .  As of the Distribution Effective Time, the applicable Bioverativ Group member shall credit each Bioverativ Employee with the vacation and earned sick time that such individual has accrued immediately prior to the Distribution Effective Time in accordance with the vacation and personnel policies applicable to such employee immediately prior to the Distribution Effective Time, except to the extent that such Bioverativ Employee prior to the Distribution Effective Time has elected to be paid with respect to such accrued vacation.

 

ARTICLE V

 

INCENTIVE COMPENSATION, EQUITY COMPENSATION AND OTHER BENEFITS

 

Section 5.1                                     Annual Cash-Based Incentive Plans .  As of the Distribution Effective Time, Bioverativ shall assume the obligation, if any, to pay each Bioverativ Employee who is participating in a Biogen 2016 annual cash incentive bonus program, including a sales incentive compensation plan, of Biogen or a Biogen Group member such Bioverativ Employee’s incentive or sales bonus under such plan, based upon the amount accrued by Biogen in respect of such obligations.  Bioverativ shall cause such payments to be made to the applicable Bioverativ Employees at the time such payments are made under the corresponding Biogen incentive bonus program.

 

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Section 5.2                                     Awards under the Biogen Equity-Based Plans .  Biogen and, where applicable, Bioverativ shall take all actions necessary or appropriate so that each outstanding Biogen Option and Unit outstanding immediately prior to the Distribution Effective Time shall be adjusted as set forth in this Section 5.2 .

 

(a)                                  Options .

 

(i)                                      Biogen Options held by Biogen Employees .  Upon the Distribution Effective Time, each Biogen Option held by a Biogen Employee will be equitably adjusted solely into an adjusted Biogen Option.  The number of shares of Biogen Common Stock subject to the adjusted Biogen Option will be equal to the number of shares of Biogen Common Stock subject to the option immediately prior to the Distribution Effective Time multiplied by the Adjustment Fraction, with the result being rounded down to the nearest whole share.  The per share exercise price of the adjusted Biogen Option will be equal to the per share exercise price of the original Biogen Option divided by the Adjustment Fraction, with the result being rounded up to the nearest whole cent.  Each adjusted Biogen Option shall be subject to the same terms and conditions regarding term, vesting, and other provisions regarding exercise as set forth in the original Biogen Option.

 

(ii)                                   Biogen Options held by Bioverativ Employees .   Upon the Distribution Effective Time, each Biogen Option held by a Bioverativ Employee will be converted into an adjusted Bioverativ Option.  The number of shares of Biogen Common Stock subject to the adjusted Biogen Option will be equal to the number of shares of Biogen Common Stock subject to the option immediately prior to the Distribution Effective Time multiplied by the Conversion Fraction, with the result being rounded down to the nearest whole share.  The per share exercise price of the adjusted Biogen Option will be equal to the per share exercise price of the original Biogen Option divided by the Conversion Fraction, with the result being rounded up to the nearest whole cent.  Each adjusted Bioverativ Option shall be subject to the same terms and conditions regarding term, vesting, and other provisions regarding exercise as set forth in the original Biogen Option.

 

(b)                                  Biogen Units .

 

(i)                                      Biogen Units held by Biogen Employees .  Upon the Distribution Effective Time, each Biogen Unit held by a Biogen Employee will be converted into an adjusted Biogen Unit.  The number of shares of Biogen Common Stock subject to the adjusted Biogen Unit will be equal to the number of shares of Biogen Common Stock subject to the Biogen Unit immediately prior to the Distribution Effective Time, multiplied by the Adjustment Fraction, rounded down to the nearest whole share.

 

(1)                                  The Biogen Units described in Section 5.2(b)(i)  shall continue to be subject to the same terms and conditions as were applicable to such awards prior to the Distribution Effective Time, including with respect to vesting; provided , that in the case of adjusted Biogen Units which are Biogen Cash-Settled Performance Stock Units

 

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(“CSPUs”) and Biogen Market Stock Units (“MSUs”), the following additional provisions shall apply:

 

(A)                                For CSPUs the vesting of which is conditioned upon the attainment of goals with respect to revenue and adjusted free cash flow targets for 2016 (in addition to service based vesting requirements),the attainment of such targets will be determined based on full 2016 year results, without giving effect to the consummation of the transactions contemplated by the Separation Agreement; and

 

(B)                                For MSUs, the share price goals upon which vesting is based shall be adjusted, as of the Distribution Effective Time, by multiplying such share price goals by the Adjustment Fraction and such goals, as adjusted, will apply from and after the Distribution Effective Time.

 

(ii)                                   Biogen Units held by Bioverativ Employees (other than those in Japan) .  Each Biogen Time-Based Restricted Stock Unit that is outstanding and held by a Bioverativ Employee (other than one employed in Japan) immediately prior to the Distribution Effective Time will be converted into a Bioverativ Time-Based Restricted Stock Unit.  The number of shares of Bioverativ Common Stock subject to the Bioverativ Time-Based Restricted Stock Unit will be equal to the number of shares of Biogen Common Stock subject to the Biogen Time-Based Restricted Stock Unit immediately prior to the Distribution Effective Time multiplied by the Conversion Fraction.

 

(iii)                                Biogen Units held by Bioverativ Employees in Japan .  Notwithstanding the provisions of subparagraph (ii) above, each Biogen Time-Based Restricted Stock Unit that is outstanding and held by a Bioverativ Employee employed in Japan immediately prior to the Distribution Effective Time will be cancelled upon the Distribution Effective Time.  In replacement of such cancelled units, Bioverativ shall grant each such employee a replacement Bioverativ Time-Based Restricted Stock Unit award.  The number of shares of Bioverativ Common Stock subject to the replacement Bioverativ Time-Based Restricted Stock Unit will be equal to the number of shares of Biogen Common Stock subject to the Biogen Time-Based Restricted Stock Unit immediately prior to the Distribution Effective Time multiplied by the Conversion Fraction.

 

(1)                                  The Bioverativ Time-Based Restricted Stock Units described in Section 5.2(b)(ii)  and Section 5.2(b)(iii)  shall continue to be subject to the same terms and conditions as were applicable to such awards prior to the Distribution Effective Time, including with respect to vesting; provided , that for purposes of vesting, continued employment with a Bioverativ Group member shall be treated as continued employment for all purposes of such Bioverativ Time-Based Restricted Stock Unit and further provided that:

 

(A)                                For Bioverativ Time-Based Restricted Stock Units that are attributable to CSPUs, (i) such Bioverativ Time-Based Restricted Stock

 

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Units shall be settled in shares of Bioverativ Common Stock upon vesting, rather than in cash, and (ii) the number of shares of Bioverativ Common Stock deliverable pursuant to such awards shall be determined by measuring the attainment of the applicable performance goals for the respective performance periods, without giving effect to the consummation of the transactions contemplated by the Separation Agreement; and

 

(B)                                For Bioverativ Time-Based Restricted Stock Units that are attributable to MSUs, the number of shares of Bioverativ Common Stock deliverable pursuant to such awards shall be determined by measuring the attainment of the applicable share price goals against the trading price of the Biogen Common Stock immediately prior to the Distribution Effective Time.

 

(iv)                               Delivery; Withholding . Bioverativ shall be solely responsible for the issuance of Bioverativ Common Stock in respect of Bioverativ Time-Based Restricted Stock Units (regardless of the holder thereof), for ensuring the withholding of all applicable employment tax on behalf of the employing entity of such holder, and for ensuring the remittance of such employment taxes to the employing entity of such holder.  Biogen shall be solely responsible for the issuance of Biogen Common Stock in respect of Biogen Units (regardless of the holder thereof), for ensuring the withholding of all applicable employment tax on behalf of the employing entity of such holder, and for ensuring the remittance of such employment taxes to the employing entity of such holder.

 

(c)                                   Allocation of Tax Deduction .  The allocation of any deduction in respect of equity based awards held by Biogen or Bioverativ Employees will be governed by the Tax Matters Agreement.

 

(d)                                  Partial Interests in Shares .  To the extent that any adjustment described in this Section 5.2 results in any fractional interest in shares, such fractional interest shall be rounded down to the nearest whole share and Biogen or Bioverativ, as the case may be, shall pay to their respective employees as soon as practicable following the Distribution Effective Time a payment in cash equal to such fractional share interest multiplied by the volume-weighted average trading price of the Bioverativ Common Stock or Biogen Common Stock, as the case may be, on the ten (10) trading days immediately following the date upon which the Distribution Effective Time occurs.

 

(e)                                   Administration .  Each of Biogen and Bioverativ shall establish an appropriate administration system (expected to be through Fidelity) in order to handle exercises and delivery of shares in an orderly manner and provide reasonable levels of service for equity award holders.  Upon the Distribution Effective Time, Bioverativ shall succeed to all administrative and interpretive and other rights of Biogen with respect to awards converted into awards with respect to Bioverativ hereunder.

 

(f)                                    No Effect on Subsequent Awards .  The provisions of this Section 5.2 shall have no effect on the terms and conditions of equity and equity-based awards granted following the Effective Date by Biogen or Bioverativ.

 

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(g)                                   No Termination of Employment or Service .  Holders of equity or equity-based awards described in this Section 5.2 will not be treated as having experienced a termination of employment or service for purposes of such awards as a result of the Distribution or the occurrence of the Distribution Effective Time.

 

(h)                                  Bioverativ Change in Control; Assumption of Administrative Authority . If an award with respect to Bioverativ Common Stock resulting from an adjustment provided for under this Section 5.2 had, prior to such adjustment, a provision providing for the actual or contingent acceleration of vesting upon the occurrence of a “Corporate Transaction” or “Corporate Change in Control” of Biogen (as such terms are defined in the instruments governing the applicable award), such provision shall remain in effect following the adjustment; provided , that the definitions of “Corporate Transaction” or “Corporate Change in Control” (and certain related definitions) shall be equitably adjusted as of the Separation so that such definitions shall thereafter relate to Bioverativ.  The applicable definitions are set forth on Exhibit A hereto.   The administrative authority of the Board of Directors of Biogen (or a committee thereof) with respect to such awards (including with respect to the potential treatment of awards upon a “Corporate Transaction” or “Corporate Change in Control”) shall be held by the Board of Directors Of Bioverativ (or a committee thereof) following the Separation.  The consummation of the transactions contemplated by the Separation Agreement shall not constitute a corporate Change in Control or Corporate Transaction with respect to Bioverativ.

 

Section 5.3                                     Biogen ESPP .  As of the Distribution Effective Time, the participation of Bioverativ Employees in the Biogen ESPP shall terminate and, as soon as practicable following the Distribution Effective Time, the Bioverativ Employees shall receive a lump sum amount in respect of their payroll deductions not previously used to purchase Biogen Common Stock in accordance with the terms of the Biogen ESPP.

 

ARTICLE VI

 

NON-U.S. EMPLOYEES

 

Section 6.1                                     Special Provisions for Employees Outside of the United States .

 

(a)                                  Canadian Deferred Profit Sharing Plan .  Prior to the Distribution Effective Time, Biogen and Bioverativ shall cooperate to establish a registered retirement savings plan for Bioverativ Employees employed in Canada the terms of which shall comply with applicable Law and which shall, immediately prior to the Distribution Effective Time, be sponsored by a Bioverativ Group member (the “Bioverativ RRSP”).  The other terms and conditions of the Bioverativ RRSP shall be reasonably determined by Biogen.  Bioverativ Employees who, prior to the Distribution Effective Time, participated in the Biogen Deferred Profit Sharing Plan (the “Biogen DPSP”) and the Biogen Registered Retirement Savings Plan (the “Biogen RRSP”) shall, following the Distribution Effective Time, have the ability to (but shall not be required to) transfer balances in the Biogen DPSP and the Biogen RRSP to the Bioverativ RRSP in accordance with the terms of such plans and applicable Law.  Upon the Distribution Effective Time, such Bioverativ Employees shall cease to participate in the Biogen DPSP and Biogen RRSP.

 

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(b)                                  Japanese Retirement Plan .  Prior to the Distribution Effective Time, Biogen and Bioverativ shall cooperate to establish a retirement savings plan for Bioverativ Employees employed in Japan the terms of which shall comply with applicable Law and which shall, to the extent such plan is established immediately prior to the Distribution Effective Time, be sponsored by a Bioverativ Group member (the “Bioverativ Japanese Retirement Plan”).  The other terms and conditions of the Bioverativ Japanese Retirement shall be reasonably determined by Biogen.  Bioverativ Employees who, prior to the Distribution Effective Time, participated in the Biogen Japanese Retirement Plan (the “Biogen Japanese Retirement Plan”) shall, following the Distribution Effective Time and without further action by the participant, have their balances in the Biogen Japanese Retirement Plan transferred to the Bioverativ Japanese Retirement Plan accordance with applicable Law.  Upon the Distribution Effective Time, such Bioverativ Employees shall cease to participate in the Biogen Japanese Retirement Plan.  In the event that the Bioverativ Japanese Retirement Plan is not established at or prior to the Distribution Effective Time, Bioverativ shall establish such plan as soon as practicable following the Distribution Effective Time.

 

(c)                                   Cooperation .  From and after the date hereof, the Parties agree to reasonably cooperate to effect the provisions of this Agreement (including but not limited to those of this Section 6.1) with respect to employees and employee-related matters outside of the United States, in accordance with applicable Law.

 

ARTICLE VII

 

GENERAL AND ADMINISTRATIVE

 

Section 7.1                                     Sharing of Participant Information .  To the maximum extent permitted under applicable Law, Biogen and Bioverativ shall share, and shall cause each member of its respective Group to share, with each other and their respective agents and vendors all participant information reasonably necessary for the efficient and accurate administration of each of the Biogen Plans and the Bioverativ Plans. Biogen and Bioverativ and their respective authorized agents shall, subject to applicable laws on confidentiality, be given reasonable and timely access to, and may make copies of, all information relating to the subjects of this Agreement in the custody of the other Party, to the extent necessary for such administration.

 

Section 7.2                                     No Third Party Beneficiaries .  No provision of this Agreement or the Separation Agreement shall be construed to create any right, or accelerate entitlement, to any compensation or benefit whatsoever on the part of any future, present, or former employee of Biogen, a Biogen Group member, Bioverativ, or a Bioverativ Group member under this Agreement, the Separation Agreement, any Biogen Plan or Bioverativ Plan or otherwise.  Except as expressly provided in this Agreement, nothing in this Agreement shall preclude Bioverativ or any Bioverativ Group member, at any time after the Distribution Effective Time, from amending, merging, modifying, terminating, eliminating, reducing, or otherwise altering in any respect any Bioverativ Plan, any benefit under any Bioverativ Plan or any trust, insurance policy or funding vehicle related to any Bioverativ Plan; and (iii) except as expressly provided in this Agreement, nothing in this Agreement shall preclude Biogen or any Biogen Group member, at any time after the Distribution Effective Time, from amending, merging, modifying, terminating, eliminating,

 

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reducing, or otherwise altering in any respect any Biogen Plan, any benefit under any Biogen Plan or any trust, insurance policy or funding vehicle related to any Biogen Plan.

 

Section 7.3                                     Audit Rights with Respect to Information Provided .  Each of Biogen and Bioverativ, and their duly authorized representatives, shall have the right to conduct reasonable audits with respect to all information provided to it by the other Party pursuant to this Agreement.  The Parties shall cooperate to determine the procedures and guidelines for conducting audits under this Section 7.3 , which shall require reasonable advance notice by the auditing Party.  The auditing Party shall have the right to make copies of any records at its expense, subject to applicable Law.  Failure of a third party service provider to provide information shall not constitute a breach of this Section 7.3 ; provided , that the applicable Party has timely requested the information from such service provider

 

Section 7.4                                     Fiduciary Matters .  Biogen and Bioverativ each acknowledge that actions required to be taken pursuant to this Agreement may be subject to fiduciary duties or standards of conduct under ERISA or other applicable Law, and no Party shall be deemed to be in violation of this Agreement if it fails to comply with any provisions hereof based upon its good faith determination (as supported by advice from counsel experienced in such matters) that to do so would violate such a fiduciary duty or standard. Each Party shall be responsible for taking such actions as are deemed necessary and appropriate to comply with its own fiduciary responsibilities and shall fully release and indemnify the other Party for any Liabilities caused by the failure to satisfy any such responsibility.

 

Section 7.5                                     Consent of Third Parties .  If any provision of this Agreement is dependent on the consent of any third party (such as a vendor or Governmental Authority), Biogen and Bioverativ shall use commercially reasonable efforts to obtain such consent, and if such consent is not obtained, to implement the applicable provisions of this Agreement to the full extent practicable.  If any provision of this Agreement cannot be implemented due to the failure of such third party to consent, Biogen and Bioverativ shall negotiate in good faith to implement the provision in a mutually satisfactory manner.  The phrase “commercially reasonable efforts” as used herein shall not be construed to require the incurrence of any non-routine or unreasonable expense or liability or the waiver of any right.

 

Section 7.6                                     Assignment of “Claw-Back” or Recoupment Rights .  To the extent a member of the Biogen Group holds any repayment “claw-back” or recoupment rights with respect to remuneration paid or provided to Bioverativ Employees (e.g., the right to require repayment of compensation upon a termination of employment or misconduct by the employee) in connection with any relocation benefit, sign-on bonus, tuition benefit or otherwise, such rights are hereby assigned to Bioverativ upon the Distribution Effective Time, it being agreed that the transactions contemplated by the Separation Agreement shall not, in and of themselves, trigger any such repayment or recoupment right.  The Parties shall cooperate to execute any further documentation as may be necessary to evidence such assignment.

 

Section 7.7                                     Proprietary Information and Inventions Agreements .  Effective as of the Distribution Effective Time, Biogen shall, or shall cause the appropriate member of the Biogen Group to, waive such rights under any proprietary information, confidentiality, inventions, restrictive covenant or similar agreement between any Bioverativ Employee and any Biogen

 

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Group member as Biogen determines in its discretion to be necessary or appropriate to permit such Bioverativ Employee to perform her services to Bioverativ or a Bioverativ Group member from and after the Distribution Effective Time.

 

ARTICLE VIII

 

DISPUTE RESOLUTION

 

Section 8.1                                     General .  The provisions of Article VIII of the Separation Agreement shall apply, mutatis mutandis, to all disputes, controversies or claims (whether arising in contract, tort or otherwise) between the Parties that may arise out of or relate to, or arise under or in connection with this Agreement or the transactions contemplated hereby.

 

ARTICLE IX

 

MISCELLANEOUS

 

Section 9.1                                     Complete Agreement; Construction . This Agreement shall constitute the entire agreement between the Parties with respect to the subject matter hereof and shall supersede all previous negotiations, commitments, course of dealings and writings with respect to such subject matter.  In the event and to the extent that there shall be a conflict between the provisions of this Agreement and the provisions of the Separation Agreement or any other Ancillary Agreement, this Agreement shall prevail.

 

Section 9.2                                     Counterparts . This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become effective when one or more such counterparts have been signed by each of the Parties and delivered to each of the Parties.

 

Section 9.3                                     Survival of Agreements . Except as otherwise contemplated by this Agreement, all covenants and agreements of the Parties contained in this Agreement shall survive the Distribution Effective Time and remain in full force and effect in accordance with their applicable terms.

 

Section 9.4                                     Expenses .

 

(a)                                  Except as otherwise expressly provided in this Agreement, or as otherwise agreed to in writing by the Parties, all out-of-pocket fees and expenses incurred at or prior to the Distribution Effective Time in connection with, and as required by, the preparation, execution, delivery and implementation of this Agreement shall be borne and paid by Biogen.

 

(b)                                  Except as otherwise expressly provided in this Agreement (including this Section 9.4), or as otherwise agreed to in writing by the Parties, each Party shall bear its own costs and expenses incurred or accrued after the Distribution Effective Time; provided , however , that, except as otherwise expressly provided in this Agreement, any fees, costs and expenses incurred in

 

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obtaining any Consents or novation from a Third Party in connection with the Transfer to or Assumption by a Party or its Subsidiary of any Assets or Liabilities in connection with the Separation shall be borne by the Party or its Subsidiary to which such Assets are being Transferred or which is Assuming such Liabilities.

 

Section 9.5                                     Notices .  All notices, requests, claims, demands and other communications under this Agreement and, to the extent applicable and unless otherwise provided therein, under each of the Ancillary Agreements shall be in English, shall be in writing and shall be given or made (and shall be deemed to have been duly given or made upon receipt) by delivery in person, by overnight courier service, by facsimile with receipt confirmed (followed by delivery of an original via overnight courier service) or by registered or certified mail (postage prepaid, return receipt requested) to the respective Parties at the following addresses (or at such other address for a Party as shall be specified in a notice given in accordance with this Section 9.5 ):

 

To Biogen:

 

225 Binney Street

Cambridge, MA 02142

Attn: Chief Legal Officer

Facsimile: [ · ]

 

To Bioverativ:

 

Bioverativ Inc.

225 Second Avenue

Waltham, MA 02451

Attn: Chief Legal Officer

Facsimile: [ · ]

 

Section 9.6                                     Waivers .  Any consent required or permitted to be given by any Party to the other Party under this Agreement shall be in writing and signed by the Party giving such consent and shall be effective only against such Party (and its Group).

 

Section 9.7                                     Assignment .  No party may assign any rights or delegate any obligations arising under Agreement, in whole or in part, directly or indirectly, without the prior written consent of the other Party, and any attempt to so assign any rights or delegate any obligations arising under this Agreement without such consent shall be void.  Notwithstanding the foregoing, no such consent shall be required for any such assignment or delegation (i) with respect to Biogen, to a Subsidiary of Biogen (so long as such Subsidiary remains a Subsidiary of Biogen), (ii) with respect to Bioverativ, to a Subsidiary of Bioverativ (so long as such Subsidiary remains a Subsidiary of Bioverativ) or (iii) to a bona fide Third Party in connection with a merger, reorganization, consolidation or the sale of all or substantially all the assets of a Party so long as the resulting, surviving or transferee entity assumes all the obligations of the assigning Party by operation of Law or pursuant to an agreement in form and substance reasonably satisfactory to the non-assigning Party; provided , however , that in the case of each of the preceding clauses (i) and (ii), no assignment permitted by this Section 9.7 shall release the assigning Party from liability for the full performance of its obligations under this Agreement.  It is understood and agreed that any Party may cause any of its Subsidiaries to perform any or all of its obligations hereunder, and may designate any of its Subsidiaries to receive any of its entitlements hereunder.

 

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Section 9.8                                     Successors and Assigns .  The provisions of this Agreement and the obligations and rights hereunder shall be binding upon, inure to the benefit of and be enforceable by (and against) the Parties and their respective successors and permitted assigns.

 

Section 9.9                                     Termination and Amendment .  This Agreement may be terminated, modified or amended, and the Distribution may be amended, modified or abandoned, at any time prior to the Distribution Effective Time by and in the sole discretion of Biogen without the approval of Bioverativ or the stockholders of Biogen.  In the event of such termination, no Party shall have any liability of any kind to the other Party or any other Person by reason of such termination.  After the Distribution Effective Time, this Agreement may not be terminated, modified or amended except by an agreement in writing signed by Biogen and Bioverativ.

 

Section 9.10                              Payment Terms .

 

(a)                                  Except as otherwise expressly provided to the contrary in this Agreement, any amount to be paid or reimbursed by a Party (and/or a member of such Party’s Group) to the other Party (and/or a member of such other Party’s Group) under this Agreement shall be paid or reimbursed hereunder within sixty (60) days after presentation of an invoice or a written demand therefor, in either case setting forth, or accompanied by, reasonable documentation or other reasonable explanation supporting such amount.

 

(b)                                  Except as expressly provided to the contrary in this Agreement, any amount not paid when due pursuant to this Agreement (and any amount billed or otherwise invoiced or demanded and properly payable that is not paid within sixty (60) days of such bill, invoice or other demand) shall bear interest at a rate per annum equal to the Prime Rate, from time to time in effect, plus two percent (2%), calculated for the actual number of days elapsed, accrued from the date on which such payment was due up to the date of the actual receipt of payment.

 

(c)                                   Without the consent of the party receiving any payment under this Agreement specifying otherwise, all payments to be made by either Biogen or Bioverativ under this Agreement shall be made in U.S. dollars.  Except as expressly provided herein, any amount which is not expressed in U.S. dollars shall be converted into U.S. dollars by using the exchange rate published on Bloomberg at 5:00 p.m., Eastern time, on the day before the relevant date, or in The Wall Street Journal, Eastern Edition, on such date if not so published on Bloomberg.  Except as expressly provided herein, in the event that any indemnification payment required to be made hereunder may be denominated in a currency other than U.S. dollars, the amount of such payment shall be converted into U.S. dollars on the date notice of the claim is given to the Indemnifying Party.

 

Section 9.11                              Specific Performance .  From and after the Distribution, in the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the Parties agree that the Party or Parties to this Agreement who are or are to be thereby aggrieved shall, subject and pursuant to the terms of ARTICLE VIII of the Separation Agreement, have the right to seek specific performance and injunctive or other equitable relief of its or their rights under this Agreement, in addition to any and all other rights and remedies at law or in equity, and all such rights and remedies shall be cumulative.  The Parties agree that, from and after the Distribution, the remedies at law for any breach or threatened breach of this Agreement,

 

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including monetary damages, are inadequate compensation for any Indemnifiable Loss, that any defense in any Action for specific performance that a remedy at law would be adequate is hereby waived, and that any requirements for the securing or posting of any bond with such remedy are hereby waived.

 

Section 9.12                              Subsidiaries .  Each of the Parties shall cause to be performed, and hereby guarantees the performance of, all actions, agreements and obligations set forth herein to be performed by any Subsidiary of such Party or by any entity that becomes a Subsidiary of such Party at or after the Distribution Effective Time, in each case to the extent such Subsidiary remains a Subsidiary of the applicable Party.

 

Section 9.13                              Third Party Beneficiaries .  This Agreement is solely for the benefit of the Parties and shall not be deemed to confer upon Person other than the Parties any remedy, claim, liability, reimbursement, cause of Action or other right beyond any that exist without reference to this Agreement.

 

Section 9.14                              Titles and Headings .  Titles and headings to sections herein are inserted for the convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

 

Section 9.15                              Governing Law .  This Agreement and any Dispute shall be governed by and construed in accordance with the Laws of the State of Delaware, without giving effect to the conflicts of laws principles thereof that might lead to the application of laws other than the Laws of the State of Delaware.

 

Section 9.16                              Consent to Jurisdiction .  Subject to the provisions of ARTICLE VIII of the Separation Agreement, all Actions that, directly or indirectly, arise out of or relate to this Agreement shall be heard and determined exclusively in the Court of Chancery of the State of Delaware; provided , however , that if such court does not have jurisdiction over such Action, such Action shall be heard and determined exclusively in the Delaware Courts.  Each of the Parties further agrees that service of any process, summons, notice or document by U.S. registered mail to such Party’s respective address set forth in Section 9.5 shall be effective service of process for any Action in the Delaware Courts with respect to any matters to which it has submitted to jurisdiction in this Section 9.16 .  Subject to the provisions of ARTICLE VIII of the Separation Agreement, each of the Parties hereby (a) submits to the exclusive jurisdiction of any federal or state court sitting in the State of Delaware for the purpose of any Action brought by any party hereto that, directly or indirectly, arises out of or relates to this Agreement; (b) irrevocably waives and releases, and agrees not to assert by way of motion, defense, or otherwise, in or with respect to any such Action, any claim that (i) such Action is not subject to the subject matter jurisdiction of at least one of the above-named courts; (ii) its property is exempt or immune from attachment or execution in the State of Delaware; (iii) such Action is brought in an inconvenient forum; (iv) that the venue of such Action is improper; or (v) this Agreement or the transactions contemplated by this Agreement may not be enforced in or by any of the above-named courts; and (d) agrees not to move to transfer any such Action to a court other than any of the above-named courts.

 

Section 9.17                              Waiver of Jury Trial . EACH OF THE PARTIES HEREBY IRREVOCABLY WAIVES TO THE FULLEST EXTENT PERMITTED BY APPLICABLE

 

21



 

LAW ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY WITH RESPECT TO ANY ACTION OR LIABILITY, DIRECTLY OR INDIRECTLY, ARISING OUT OF, RELATING TO, OR IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT.  EACH OF THE PARTIES HEREBY (A) CERTIFIES THAT NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF ANY SUCH ACTION OR LIABILITY, SEEK TO ENFORCE THE FOREGOING WAIVER; AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT AND THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, AS APPLICABLE, BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 9.17 .

 

Section 9.18                              Severability .  In the event any one or more of the provisions contained in this Agreement should be held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein and therein shall not in any way be affected or impaired thereby.  The Parties shall endeavor in good-faith negotiations to replace the invalid, illegal or unenforceable provisions with valid provisions, the economic effect of which comes as close as possible to that of the invalid, illegal or unenforceable provisions.

 

Section 9.19                              Interpretation .  The Parties have participated jointly in the negotiation and drafting of this Agreement.  This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the Party drafting or causing any instrument to be drafted.

 

Section 9.20                              No Duplication; No Double Recovery .  Nothing in this Agreement is intended to confer to or impose upon any Party a duplicative right, entitlement, obligation or recovery with respect to any matter arising out of the same facts and circumstances.

 

Section 9.21                              No Waiver .  No failure to exercise and no delay in exercising, on the part of any Party, any right, remedy, power or privilege hereunder shall operate as a waiver hereof or thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder or thereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

 

Section 9.22                              No Admission of Liability .  The allocation of Assets and Liabilities herein is solely for the purpose of allocating such Assets and Liabilities between Biogen and Bioverativ and is not intended as an admission of liability or responsibility for any alleged Liabilities vis-à-vis any Third Party, including with respect to the Liabilities of any non-wholly owned subsidiary of Biogen or Bioverativ.

 

Section 9.23                              Transfer of Records and Information .  Subject to applicable law, Biogen shall transfer to Bioverativ any and all employment records and information (including, but not limited to, any Form I-9, Form W-2 or other Internal Revenue Service forms) with respect to Bioverativ Employees and other records reasonably required by Bioverativ to enable Bioverativ properly to carry out its obligations under this Agreement. Such transfer of records and information generally shall occur as soon as administratively practicable on or after the Distribution Effective Time. Each Party will permit the other Party reasonable access to employee

 

22



 

records and information, to the extent reasonably necessary for such accessing Party to carry out its obligations hereunder (subject to applicable law).

 

Section 9.24                              Cooperation .  The Parties agree to reasonably cooperate to effect the terms and conditions of this Agreement, from and after the date hereof.

 

[The remainder of this page is intentionally left blank.]

 

23



 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed as of the day and year first above written.

 

 

BIOGEN INC.

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

 

 

BIOVERATIV INC.

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

[Signature Page to Employee Matters Agreement]

 



 

EXHIBIT A

 

Adjusted Definitions

 

“Affiliate” shall have the meaning set forth in Rule 12b-2 under Section 12 of the Securities Exchange Act of 1934, as amended.

 

**********************************************************************

 

“Beneficial Owner” shall have the meaning set forth in Rule 13d-3 under the Securities Exchange Act of 1934, as amended, except that a Person shall not be deemed to be the Beneficial Owner of any securities with respect to which such Person has properly filed an effective Schedule 13G

 

**********************************************************************

 

“Board of Directors” shall mean the Board of Directors of Bioverativ Inc.

 

**********************************************************************

 

“Company” shall mean Bioverativ Inc.

 

**********************************************************************

 

A “Corporate Change in Control” shall be deemed to have occurred upon the first of the following events following the Distribution Date:

 

(i) any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Company (not including in the securities beneficially owned by such Person any securities acquired directly from the Company or its subsidiaries) representing 50% or more of the combined voting power of the Company’s then outstanding securities, excluding any Person who becomes such a Beneficial Owner in connection with a transaction which is a merger or consolidation;

 

(ii) the election to the Board of Directors, without the recommendation or approval of a majority of the incumbent Board of Directors (as of the Effective Date), of directors constituting a majority of the number of directors of the Company then in office, provided, however, that directors whose election or appointment following the Effective Date is approved by a majority of the members of the incumbent Board of Directors shall be deemed to be members of the incumbent Board of Directors for purposes hereof, provided further that directors whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of directors of the Company will not be considered as members of the incumbent Board of Directors for purposes of this paragraph (ii); or

 

(iii) the occurrence of any other event which the incumbent Board of Directors in its sole discretion determines should be considered a Corporate Change in Control.

 

**********************************************************************

 



 

A “Corporate Transaction” shall be deemed to have occurred upon the first of the following to occur following the Distribution Date:

 

(i) there is consummated a merger or consolidation of the Company or any direct or indirect subsidiary of the Company with any other company, other than (A) a merger or consolidation which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving or parent entity) at least 50% of the combined voting power of the voting securities of the Company or such surviving or parent entity outstanding immediately after such merger or consolidation (unless following such merger or consolidation the voting securities of the Company outstanding immediately prior thereto represent less than 60% of the combined voting power of the voting securities of the Company or such surviving or parent entity outstanding immediately after such merger or consolidation and the transaction results in those persons who are members of the incumbent Board of Directors immediately prior to such merger or consolidation constituting less than 50% of the membership of the Board of Directors or the board of directors of such surviving or parent entity immediately after, or subsequently at any time as contemplated by such merger or consolidation (in which case the transaction shall be a Corporate Transaction)) or (B) a merger or consolidation effected to implement a recapitalization of the Company (or similar transaction) in which no Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Company (not including in the securities Beneficially Owned by such Person any securities acquired directly from the Company or its subsidiaries) representing 30% or more of the combined voting power of the Company’s then outstanding securities; or

 

(ii) the stockholders of the Company approve a plan of complete liquidation or dissolution of the Company or there is consummated an agreement for the sale or disposition by the Company of all or substantially all of the Company’s assets, other than a sale or disposition by the Company of all or substantially all of the Company’s assets to an entity, at least 50% of the combined voting power of the voting securities of which are owned by stockholders of the Company in substantially the same proportions as their ownership of the Company immediately prior to such sale.

 

**********************************************************************

 

“Effective Date” shall mean the Distribution Date.

 

**********************************************************************

 

“Person” shall mean shall have the meaning given in Section 3(a)(9) of the Securities Exchange Act of 1934, as amended, as modified and used in Sections 13(d) and 14(d) thereof, except that such term shall not include (i) the Company or any of its Affiliates, (ii) a trustee or other fiduciary holding securities under an employee benefits plan of the Company or any of its Affiliates, (iii) an underwriter temporarily holding securities pursuant to an offering of such securities or (iv) a corporation or other business entity owned, directly or indirectly, by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company.

 

**********************************************************************

 




Exhibit 2.6

 

Form of

 

INTELLECTUAL PROPERTY LICENSE AGREEMENT

 

between

 

BIOGEN INC.

 

and

 

BIOVERATIV INC.

 

Dated as of [ · ],[ · ]

 



 

TABLE OF CONTENTS

 

 

 

 

Page

 

 

 

 

Article I

 

DEFINITIONS

 

 

 

 

Section 1.1

General

 

1

 

 

 

 

Article II

 

LICENSE RIGHTS AND LIMITATIONS, RESTRICTIONS AND OWNERSHIP

 

 

 

 

Section 2.1

Non-Exclusive License to Biogen of Bioverativ Shared Intellectual Property

 

4

Section 2.2

Non-Exclusive License to Bioverativ of Biogen Shared Intellectual Property

 

4

Section 2.3

Non-Exclusive License to Bioverativ of Biogen Manufacturing Technology

 

4

Section 2.4

Non-Exclusive License to Biogen of Bioverativ Manufacturing Technology

 

4

Section 2.5

Sublicensing

 

5

Section 2.6

Right of Reference

 

5

Section 2.7

Performance

 

5

Section 2.8

No Implied Licenses

 

5

Section 2.9

Sublicensing Third Party Contracts

 

5

 

 

 

 

Article III

 

INTELLECTUAL PROPERTY OWNERSHIP AND MAINTENANCE

 

 

 

 

Section 3.1

Intellectual Property Ownership

 

5

Section 3.2

Patent Prosecution and Maintenance

 

5

Section 3.3

Infringement by Third Parties

 

6

 

 

 

 

Article IV

 

TERM AND TERMINATION

 

 

 

 

Section 4.1

Term

 

7

Section 4.2

Termination

 

7

Section 4.3

Consequences of Termination

 

7

 

 

 

 

Article V

PRESERVATION OF RECORDS; ACCESS TO INFORMATION; CONFIDENTIALITY; PRIVILEGE

 

 

 

 

Section 5.1

Confidentiality

 

8

 



 

Article VI

MISCELLANEOUS

 

 

 

 

Section 6.1

Complete Agreement; Construction

 

8

Section 6.2

Counterparts

 

8

Section 6.3

Survival of Agreements

 

8

Section 6.4

Expenses

 

8

Section 6.5

Notices

 

9

Section 6.6

Interpretation

 

10

Section 6.7

Waivers

 

10

Section 6.8

Assignment

 

10

Section 6.9

Successors and Assigns

 

10

Section 6.10

Third Party Beneficiaries

 

10

Section 6.11

Titles and Headings

 

10

Section 6.12

Exhibits and Schedules

 

10

Section 6.13

Governing Law

 

11

Section 6.14

Consent to Jurisdiction

 

11

Section 6.15

Waiver of Jury Trial

 

11

Section 6.16

Severability

 

11

Section 6.17

Dispute Resolution

 

12

Section 6.18

No Waiver

 

12

Section 6.19

Specific Performance

 

12

 

List of Exhibits and Schedules

 

Schedule A

Biogen Shared Patents

Schedule B

Bioverativ Shared Patent

Schedule C

Biogen Manufacturing Patents

Appendix A

Bioverativ Invention Disclosures

 



 

INDEX OF DEFINED TERMS

 

Defined Term

 

Page

 

 

 

Affiliate

 

1

Agreement

 

1

Biogen

 

1

Biogen Field

 

1

Biogen Manufacturing Technology

 

2

Biogen Shared Intellectual Property

 

2

Biogen Shared Know-How

 

2

Biogen Shared Patent

 

2

Bioverativ

 

1, 2

Bioverativ Field

 

2

Bioverativ Field Manufacturing Technology

 

2

Bioverativ Shared Intellectual Property

 

2

Bioverativ Shared Know-How

 

2

Bioverativ Shared Patent

 

2

Business Day

 

2

Contract

 

3

Controlled

 

3

Controlling Party

 

7

Delaware Courts

 

11

Effective Date

 

1, 3

FDA

 

3

Initiating Party

 

3, 7

Intellectual Property

 

3

Law

 

3

Manufacturing and Supply Agreement

 

3

Material Shared Patent

 

7

Non-Controlling Party

 

7

Non-Initiating Party

 

3, 7

Parties

 

1, 3

Party

 

1, 3

Person

 

4

Proposed Enforcement Action

 

7

Regulatory Authority

 

4

Regulatory Submissions

 

4

RemainCo

 

1

Separation Agreement

 

1

Term

 

4, 8

Third Party

 

4

Transaction

 

1

Veto Option

 

7

 



 

INTELLECTUAL PROPERTY LICENSE AGREEMENT

 

This INTELLECTUAL PROPERTY LICENSE AGREEMENT (this “ Agreement ”) is made and effective as of [            ], 2017 (the “ Effective Date ”) by and between Bioverativ Inc. (“ Bioverativ ”), a Delaware corporation, and Biogen Inc. (“ Biogen ”), a Delaware corporation (each of Bioverativ and Biogen being a “ Party ,” and collectively, the “ Parties ”).

 

WHEREAS, in conjunction with a Separation Agreement (the “ Separation Agreement ”) between Biogen and Bioverativ of even date hereof (the “ Transaction ”), Bioverativ desires to obtain a license under certain intellectual property and technology of Biogen for use in connection with the Bioverativ Field (as defined below), and Biogen desires to obtain a license under certain intellectual property and technology of Bioverativ for use in the Biogen Field, and each Party is willing to grant a license to the other on the terms and conditions set forth below; and

 

NOW THEREFORE, in consideration of the mutual promises and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

Section 1.1                                     General .  Any capitalized term not defined herein shall have the meaning ascribed to such term in the Separation Agreement.  The following terms, whether used in the singular or the plural, shall have the meanings designated to them under this Article unless otherwise specifically indicated.

 

(1)                                  Affiliate ”  means, when used with respect to a specified Person and at a point in, or with respect to a period of, time, a Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such specified Person at such point in or during such period of time.  For the purposes of this definition, “control”, when used with respect to any specified Person means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities or other interests, by Contract or otherwise.  It is expressly agreed that no Party or member of its Group shall be deemed to be an Affiliate of the other Party or a member of such other Party’s Group solely by reason of having common stockholders or one or more directors in common or by reason of having been under common control of Biogen prior to the Distribution Effective Time.

 

(2)                                  Agreement ” has the meaning set forth in the Preamble.

 

(3)                                  Biogen ” has the meaning set forth in the Preamble.

 

(4)                                  Biogen Field ” means all uses outside the Bioverativ Field.

 

1



 

(5)                                  Biogen Manufacturing Patents ” means those Patents set forth on Schedule C .

 

(6)                                  Biogen Manufacturing Technology ” means the Biogen Manufacturing Patents and the technology Controlled by Biogen, to the extent used by Biogen for the manufacture of products in the Bioverativ Field during the Term of the Manufacturing and Supply Agreement.

 

(7)                                  Biogen Shared Intellectual Property ” means the Biogen Shared Patents and Biogen Shared Know-How.

 

(8)                                  Biogen Shared Know-How ” means Know-How owned or Controlled by Biogen as of the Effective Date to the extent related to the Bioverativ Field, after giving effect to the transfer to Bioverativ of the acquired Assets pursuant to the Separation Agreement.

 

(9)                                  Biogen Shared Patent ” means any Patent owned or Controlled by Biogen as of the Effective Date, after giving effect to the transfer to Bioverativ of the acquired Assets pursuant to the Separation Agreement, to the extent related to the Bioverativ Field, and any provisional, continuation, divisional, continuation in part application, reissue, renewal, reexamination, extension, and registration of any such patent or patent application, including such Patents set forth on Schedule A.

 

(10)                           Bioverativ ” has the meaning set forth in the Preamble.

 

(11)                           Bioverativ Field ” means all activities conducted in connection with the discovery, research, development, and commercialization of therapies for the treatment of hemophilia and other blood disorders.

 

(12)                           Bioverativ Manufacturing Technology ” means the technology Controlled by Bioverativ, to the extent used by Biogen to manufacture products in the Bioverativ Field at any time during the Term of the Manufacturing and Supply Agreement.

 

(13)                           Bioverativ Shared Intellectual Property ” means the Bioverativ Shared Patents and Bioverativ Shared Know-How, in each case to the extent related to use in the Biogen Field.

 

(14)                           Bioverativ Shared Know-How ” means Know-How acquired by Bioverativ in the Transaction to the extent related to products in the Biogen Field.

 

(15)                           Bioverativ Shared Patent ” means any Patent Controlled by Bioverativ as of the Effective Date to the extent related to the Biogen Field, including such Patents set forth on Schedule B .

 

(16)                           Business Day ” means any day other than Saturday or Sunday and any other day on which commercial banking institutions located in New York, New York are required, or authorized by Law, to remain closed.

 

2



 

(17)                           Contract ”  means any agreement, contract, subcontract, obligation, binding understanding, note, indenture, instrument, option, lease, promise, arrangement, release, warranty, license, sublicense, insurance policy, benefit plan, purchase order or legally binding commitment or undertaking of any nature (whether written or oral and whether express or implied).

 

(18)                           Controlled ” means, with respect to any item of Know-How or any intellectual property right, that a Party owns or has a license to such item or right and has the ability to grant to the other Party a license or sublicense under such item or right as provided for in this Agreement without violating the terms of any agreement or other arrangement with any Third Party in existence, as applicable.

 

(19)                           Copyrights ” means copyrights and copyrightable subject matter, excluding Know-How, and any registrations and applications for the foregoing.

 

(20)                           Effective Date ” has the meaning set forth in the Preamble.

 

(21)                           FDA ” shall mean the United States Food and Drug Administration, or any successor agency thereto.

 

(22)                           Initiating Party ” has the meaning set forth in Section 3.3(d) .

 

(23)                           Intellectual Property ” shall mean all intellectual property of every kind and description throughout the world, including all U.S. and non-U.S (a) Trademarks, (b) Patents, (c) Copyrights, (d) rights in software, (e) Know-How, and (g) all rights and remedies against past, present, and future infringement, misappropriation, or other violation thereof.

 

(24)                           Know-How ” means trade secrets, and all other confidential or proprietary information, know-how, clinical data, non-clinical data, pre-clinical data, in-vitro data, inventions, processes, formulae and methodologies, excluding Patents.

 

(25)                           Law ” means any applicable U.S. or non-U.S. federal, national, supranational, state, provincial, local or similar statute, law, ordinance, regulation, rule, code, income tax treaty, order, requirement or rule of law (including common law) or other binding directives promulgated, issued, entered into or taken by any Governmental Entity.

 

(26)                           Manufacturing and Supply Agreement ” means that Manufacturing and Supply Agreement, dated as of [ · ], by and between Biogen and Bioverativ.

 

(27)                           Non-Initiating Party ” has the meaning set forth in Section 3.3(d) .

 

(28)                           Party ” or “ Parties ” has the meaning set forth in the Preamble.

 

(29)                           Patents ” means patents and patent applications, design patents and applications, utility models and any and all related national or international counterparts thereto, including any divisionals, continuations, continuations-in-part, reissues, reexaminations, substitutions and extensions thereof (including supplementary protection certificates).

 

3



 

(30)                           Person ” means an individual, a general or limited partnership, a corporation, a trust, a joint venture, an unincorporated organization, a limited liability entity, any other entity and any Governmental Entity.

 

(31)                           Regulatory Authority ” shall mean any domestic (federal or state) or foreign court, commission or governmental, regulatory or administrative body, board, bureau, agency, instrumentality, authority or tribunal or any subdivision thereof, including the FDA and the authorities in the world that are comparable to the FDA.

 

(32)                           Regulatory Submissions ” means all applications, filings, dossiers and the like submitted to a Regulatory Authority for the purpose of obtaining regulatory approval from that Regulatory Authority, including INDs, NDAs, sNDAs, and foreign equivalents thereof.

 

(33)                           Term ” has the meaning set forth in Section 4.1 .

 

(34)                           Third Party ” means any Person other than Bioverativ, Biogen and their respective Affiliates.

 

(35)                           Trademarks ” means any trademarks, trade dress, service marks, certification marks, logos, slogans, design rights, names, corporate names, trade names, Internet domain names, social media accounts and addresses and other similar designations of source or origin, and any applications or registrations for the foregoing, together with the goodwill symbolized by any of the foregoing.

 

ARTICLE II

 

LICENSE RIGHTS AND LIMITATIONS, RESTRICTIONS AND OWNERSHIP

 

Section 2.1                                     Non-Exclusive License to Biogen of Bioverativ Shared Intellectual Property . Subject to the terms and conditions of this Agreement, Bioverativ hereby grants to Biogen a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license in and to the Bioverativ Shared Intellectual Property for any use in the Biogen Field.

 

Section 2.2                                     Non-Exclusive License to Bioverativ of Biogen Shared Intellectual Property . Subject to the terms and conditions of this Agreement, Biogen hereby grants to Bioverativ a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license to the Biogen Shared Intellectual Property for any use in the Bioverativ Field.

 

Section 2.3                                     Non-Exclusive License to Bioverativ of Biogen Manufacturing Technology .  Subject to the terms and conditions of this Agreement, Biogen hereby grants to Bioverativ a perpetual, non-exclusive, worldwide license to the Biogen Manufacturing Technology in connection with the manufacturing of products manufactured by Biogen under the Manufacturing and Supply Agreement for the Bioverativ Field.

 

Section 2.4                                     Non-Exclusive License to Biogen of Bioverativ Manufacturing Technology .  Subject to the terms and conditions of this Agreement, Bioverativ hereby grants to Biogen a non-exclusive, worldwide license to the Bioverativ Manufacturing Technology and sublicense to the Biogen Manufacturing Technology for the term of the Manufacturing and Supply

 

4



 

Agreement, solely for the purpose of fulfilling Biogen’s obligations under the Manufacturing and Supply Agreement or as otherwise agreed-upon by the Parties.

 

Section 2.5                                     Sublicensing .  A Party may sublicense some or all of its rights in this Article II to a Third Party, provided that such Party and Third Party enter into a written binding contract wherein such Third Party agrees to abide by the terms and conditions of this Agreement.

 

Section 2.6                                     Right of Reference .  Biogen hereby grants to Bioverativ a fully-transferable and fully sub-licensable (in each case, in whole or in part) perpetual and irrevocable right of reference to all Regulatory Submissions (including all data and information contained therein) made, prior to or on or after the Separation, by or on behalf of Bioverativ or Biogen (or any Affiliate or permitted successor in interest or sub-licensee of Bioverativ or Biogen) in connection with Regulatory Submissions for the Bioverativ Field.

 

Section 2.7                                     Performance .  It is understood and agreed that any Party may cause any of its Subsidiaries to perform any or all of its obligations hereunder, and may designate any of its Subsidiaries to receive any of its entitlements hereunder.

 

Section 2.8                                     No Implied Licenses .  Neither Party grants (or agrees to grant) to the other Party any right or license to use any of its Intellectual Property, Know-How or other proprietary information, materials or technology, or to practice any of its Patent or Trademark, or trade dress rights, except as expressly set forth in this Agreement.

 

Section 2.9                                  Sublicensing Third Party Contracts . To the extent either (a) Biogen identifies any inbound Intellectual Property license that would fall within the scope of Biogen Shared Intellectual Property or (b) Bioverativ identifies any inbound Intellectual Property license that would fall within the scope of Bioverativ Shared Intellectual Property, such Party shall provide a non-exclusive sublicense to the other party under such agreement in accordance with the terms of such agreement, provided, that such sublicense (x) is not prohibited by the applicable agreement, and (y) would not give rise to additional costs to the sublicensing party, unless the sublicensed party agrees to pay for any such additional costs.

 

5



 

ARTICLE III

 

INTELLECTUAL PROPERTY OWNERSHIP AND MAINTENANCE

 

Section 3.1                                     Intellectual Property Ownership .  Except as expressly set forth herein, as between the Parties, each Party is and shall remain the owner of all intellectual property that it owns or controls as of the Effective Date or that it develops or acquires thereafter.

 

Section 3.2                                     Patent Prosecution and Maintenance .

 

(a)                                  Bioverativ shall have the sole right to prosecute and maintain the Bioverativ Shared Patents.  Bioverativ shall provide Biogen with a reasonable opportunity to comment on all draft filings for the Bioverativ Shared Patents prior to their submission to the relevant patent authority.  Should Bioverativ decide that it is no longer interested in maintaining or prosecuting a particular Bioverativ Shared Patent, it shall promptly advise Biogen, and Biogen may assume such prosecution and maintenance at its sole expense.  If Biogen assumes prosecution or maintenance of any Bioverativ Shared Patent pursuant to the immediately preceding sentence, then Bioverativ shall promptly assign all of its right, title and interest therein to Biogen for no further consideration and such patent shall thereafter not be considered a Bioverativ Shared Patent for purposes hereunder.  Biogen shall list Bioverativ Shared Patents applicable to any products on the packaging therefor, subject in all respects to all applicable Laws and regulations and requirements of any applicable Regulatory Authority.

 

(b)                                  Biogen shall have the sole right to prosecute and maintain the Biogen Shared Patents, to the extent it has the rights to do so.  Biogen shall provide Bioverativ with a reasonable opportunity to comment on all draft filings for the Biogen Shared Patents prior to their submission to the relevant patent authority.  Should Biogen decide that it is no longer interested in maintaining or prosecuting a particular Biogen Shared Patent, it shall promptly advise Bioverativ, and Bioverativ may assume such prosecution and maintenance at its sole expense.  If Bioverativ assumes prosecution or maintenance of any Biogen Shared Patent pursuant to the immediately preceding sentence, then Biogen shall promptly assign all of its right, title and interest therein to Bioverativ for no further consideration and such patent shall thereafter not be considered a Biogen Shared Patent for purposes hereunder.  Bioverativ shall list Biogen Shared Patents applicable to Bioverativ Products on the packaging therefor, subject in all respects to all applicable Laws and regulations and requirements of any applicable Regulatory Authority.

 

(c)                                   All the prosecution expenses related to Bioverativ Shared Patents shall be borne by Bioverativ, and all the prosecution expenses related to Biogen Shared Patents shall be borne by Biogen.

 

(d)                                  At the reasonable request of the Party responsible for prosecution as set forth under this Section 3.2 (“ Prosecuting Party ”), the non-Prosecuting Party shall provide such Prosecuting Party with reasonable assistance and cooperation, including from such non-Prosecuting Party’s employees, with respect to such prosecuting activities as set forth in this Section 3.2 of the Biogen Shared Patents or Bioverativ Shared Patent, as applicable, including

 

6


 

providing any necessary powers of attorney, filings and any other assignment documents or instruments for such prosecution.

 

Section 3.3                                     Infringement by Third Parties .

 

(a)                                  Notice .  Each of Biogen and Bioverativ shall promptly notify the other Party in writing of any alleged or threatened infringement of any Bioverativ Shared Patent or Biogen Shared Patent by a Third Party, of which the Party becomes aware.

 

(b)                                  Right to Bring Suit .  Except as provided below, each Party shall have the sole and exclusive right, but not the obligation, on behalf of itself and in its name, to bring and control any action or proceeding with respect to any actual, alleged or threatened infringement of a Patent owned or Controlled by such Party.

 

(c)                                   Veto Right .  In the event that a Party Controls a Patent (the “ Controlling Party ”) that is reasonably material to the other Party’s business (such Patent, a “ Material Shared Patent ”) and decides to assert such Material Shared Patent against an alleged infringing use by a Third Party (“ Proposed Enforcement Action ”), the Controlling Party must notify the other Party (the “ Non-Controlling Party ”) as promptly as reasonably practical of such intention.  If the Non-Controlling Party reasonably believes that such Proposed Enforcement Action will negatively impact the Non-Controlling Party’s business and so notifies the Controlling Party, the Controlling Party shall refrain from commencing the Proposed Enforcement Action while the Parties consult in good faith to reach a resolution.  The Parties agree that, should such consultation fail to result in a resolution, the Non-Controlling Party has the right to veto the Proposed Enforcement Action (the “ Veto Option ”) by informing the Controlling Party in writing that it is exercising the Veto Option under this Section 3.3 .

 

(d)                                  Cooperation .  For any action or proceeding brought by a Party under this Section 3.3 (the “ Initiating Party ”), regardless of which Party brings such action or proceeding, the other Party (the “ Non-Initiating Party ”) shall cooperate reasonably in any such effort, all at the Initiating Party’s expense, including any of the Non-Initiating Party’s reasonable out-of-pocket costs (excluding any of the Non-Initiating attorneys’ fees and expenses), and the Parties shall reasonably cooperate to address new facts or circumstances that come to light during the course of any such action or proceeding that may affect the need for one Party or the other to participate in such action.  The Non-Initiating Party agrees to be joined as a plaintiff, at the Initiating Party’s expense, in any such action if needed for the Initiating Party to bring or continue an infringement action hereunder.  The Non-Initiating Party shall, at its own expense and with its own counsel, have the right to advise and provide comments with respect to any action brought by the Initiating Party under this Section 3.3 .

 

(e)                                   Recoveries .  Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any recovery realized as a result of any litigation under this Section 3.3 shall be retained by the Party that brought and controlled such litigation for purposes of this Agreement.

 

7



 

ARTICLE IV

 

TERM AND TERMINATION

 

Section 4.1                                     Term .  The term of this Agreement shall commence on the Effective Date and continue in full force and effect unless terminated in accordance with Section 4.2 (the “ Term ”).

 

Section 4.2                                     Termination .

 

(a)                                  Mutual Agreement .  This Agreement may be terminated in its entirety at any time upon mutual written agreement between the Parties.

 

(b)                                  Material Breach . Except as provided below, neither Party may terminate this Agreement absent mutual consent to termination even if the other Party is in material default or breach of this Agreement.  A Party’s sole remedies in relation to a default or breach shall be to sue for damages or equitable relief or both.

 

Section 4.3                                     Consequences of Termination .

 

(a)                                  Licenses .  Upon the expiration of this Agreement, or upon termination of this Agreement, all rights and licenses granted hereunder shall immediately terminate.

 

(b)                                  Technology Transfer .  Upon termination of any rights or licenses granted hereunder in accordance with this Article IV , such termination shall allow the non-terminating Party a sixty (60) day transition period to cease all use of such rights and licenses.

 

(c)                                   Remedies .  Termination of this Agreement in accordance with and fulfillment of all obligations set forth in this Article IV shall not affect any other rights or remedies that may be available to a Party in law or equity, all remedies being cumulative and not exclusive.

 

ARTICLE V
PRESERVATION OF RECORDS; ACCESS TO INFORMATION; CONFIDENTIALITY; PRIVILEGE

 

Section 5.1                                     Confidentiality .  The provisions of [Article VII] (PRESERVATION OF RECORDS; ACCESS TO INFORMATION; CONFIDENTIALITY; PRIVILEGE) of the Separation Agreement shall apply to disclosures of information made pursuant to this Agreement mutatis mutandis .

 

8



 

ARTICLE VI
MISCELLANEOUS

 

Section 6.1                                     Complete Agreement; Construction . This Agreement, including the Schedules, and the Separation Agreement shall constitute the entire agreement between the Parties with respect to the subject matter hereof and shall supersede all previous negotiations, commitments, course of dealings and writings with respect to such subject matter.  In the event of any inconsistency between this Agreement and any Schedule hereto, the Schedule shall prevail.  Except as expressly set forth in this Agreement or the Separation Agreement: (i) all matters to the extent relating to Taxes and Tax Returns of the Parties and their respective Subsidiaries shall be governed exclusively by the Tax Matters Agreement and (ii) for the avoidance of doubt, in the event of any conflict between this Agreement or the Separation Agreement, on the one hand, and the Tax Matters Agreement, on the other hand, with respect to such matters, the terms and conditions of the Tax Matters Agreement shall govern.

 

Section 6.2                                     Counterparts .  This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become effective when one or more such counterparts have been signed by each of the Parties and delivered to each of the Parties.

 

Section 6.3                                     Survival of Agreements .  Except as otherwise contemplated by this Agreement or the Separation Agreement, all covenants and agreements of the Parties contained in this Agreement and the Separation Agreement shall survive the Distribution Effective Time and remain in full force and effect in accordance with their applicable terms.

 

Section 6.4                                     Expenses .

 

(a)                                  Except as otherwise expressly provided in this Agreement (including this Section 6.4) or the Separation Agreement, or as otherwise agreed to in writing by the Parties, all out-of-pocket fees, costs and expenses incurred at or prior to the Distribution Effective Time in connection with, and as required by, the preparation, execution, delivery and implementation of this Agreement and the Separation Agreement, the Distribution Disclosure Documents and the consummation of the transactions contemplated hereby and thereby, including the Separation, shall be borne and paid by Biogen.

 

(b)                                  Except as otherwise expressly provided in this Agreement (including this Section 6.4) or the Separation Agreement, or as otherwise agreed to in writing by the Parties, each Party shall bear its own out-of-pocket fees, costs and expenses incurred or accrued after the Distribution Effective Time; provided , however , that, except as otherwise expressly provided in this Agreement, any fees, costs and expenses incurred in obtaining any Consents or novation from a Third Party in connection with the Transfer to or Assumption by a Party or its Subsidiary of any Assets or Liabilities in connection with the Separation shall be borne by the Party or its Subsidiary to which such Assets are being Transferred or which is Assuming such Liabilities.

 

9



 

(c)                                   With respect to any post-Distribution expenses incurred pursuant to a request for further assurances granted under Section 2.7 of the Separation Agreement, the Parties agree that any and all fees, costs and expenses incurred by either Party shall be borne and paid by the requesting Party; it being understood that no Party shall be obliged to incur any Third Party accounting, consulting, advisor, banking or legal fees, costs or expenses, and the requesting Party shall not be obligated to pay such fees, costs or expenses, unless such fee, cost or expense shall have had the prior written approval of the requesting Party.  Notwithstanding the foregoing, each Party shall be responsible for paying its own internal fees, costs and expenses (e.g., salaries of personnel).

 

Section 6.5                                     Notices .  All notices, requests, claims, demands and other communications under this Agreement and, to the extent applicable and unless otherwise provided therein, under each of the Ancillary Agreements shall be in English, shall be in writing and shall be given or made (and shall be deemed to have been duly given or made upon receipt) by delivery in person, by overnight courier service, by facsimile with receipt confirmed (followed by delivery of an original via overnight courier service) or by registered or certified mail (postage prepaid, return receipt requested) to the respective Parties at the following addresses (or at such other address for a Party as shall be specified in a notice given in accordance with this Section 6.5):

 

To Biogen:

 

Biogen Inc.

225 Binney Street

Cambridge, MA 02142

Attn: Chief Legal Officer
Facsimile: [
· ]

 

To Bioverativ:

 

Bioverativ Inc.

225 Second Avenue

Waltham, MA 02451

Attn: Chief Legal Officer
Facsimile: [
· ]

 

Section 6.6                                     Interpretation .  The Parties have participated jointly in the negotiation and drafting of this Agreement.  This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the Party drafting or causing any instrument to be drafted.

 

Section 6.7                                     Waivers .  Any consent required or permitted to be given by any Party to the other Party under this Agreement shall be in writing and signed by the Party giving such consent and shall be effective only against such Party (and its Group).

 

Section 6.8                                     Assignment .  This Agreement shall not be assignable, in whole or in part, directly or indirectly, by either Party without the prior written consent of the other Party (such

 

10



 

consent not to be unreasonably withheld, conditioned or delayed), and any attempt to assign any rights or obligations arising under this Agreement without such consent shall be void.  Notwithstanding the foregoing, this Agreement shall be assignable (i) with respect to Biogen, to an Affiliate of Biogen, (ii) with respect to Bioverativ, to an Affiliate of Bioverativ or (iii) to a Third Party in connection with a merger, reorganization, consolidation or the sale of all or substantially all the assets of a Party so long as the resulting, surviving or transferee entity assumes all the obligations of the assigning Party by operation of Law or pursuant to an agreement in form and substance reasonably satisfactory to the non-assigning Party; provided , however , that in the case of each of the preceding clauses (i), (ii) and (iii), no assignment permitted by this Section 6.8 shall release the assigning Party from liability for the full performance of its obligations under this Agreement.

 

Section 6.9                                     Successors and Assigns .  The provisions of this Agreement and the obligations and rights hereunder shall be binding upon, inure to the benefit of and be enforceable by (and against) the Parties and their respective successors and permitted assigns.

 

Section 6.10                              Third Party Beneficiaries .  This Agreement is solely for the benefit of the Parties and shall not be deemed to confer upon Person other than the Parties any remedy, claim, liability, reimbursement, cause of Action or other right beyond any that exist without reference to this Agreement.

 

Section 6.11                              Titles and Headings .  Titles and headings to sections herein are inserted for the convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

 

Section 6.12                              Exhibits and Schedules .  The Exhibits and Schedules shall be construed with and as an integral part of this Agreement to the same extent as if the same had been set forth verbatim herein.

 

Section 6.13                              Governing Law .  This Agreement and any Dispute shall be governed by and construed in accordance with the Laws of the State of Delaware, without giving effect to the conflicts of laws principles thereof that might lead to the application of laws other than the Laws of the State of Delaware.

 

Section 6.14                              Consent to Jurisdiction .  All Actions that, directly or indirectly, arise out of or relate to this Agreement shall be heard and determined exclusively in the Court of Chancery of the State of Delaware; provided , however , that if such court does not have jurisdiction over such Action, such Action shall be heard and determined exclusively in any Delaware state court or United States federal court sitting in the State of Delaware (such courts, “ Delaware Courts ”).  Each of the Parties further agrees that service of any process, summons, notice or document by U.S. registered mail to such Party’s respective address set forth in Section 6.5 shall be effective service of process for any Action in the Delaware Courts with respect to any matters to which it has submitted to jurisdiction in this Section 6.14 .  Consistent with the foregoing in this Section 6.14 , each of the Parties hereby (a) submits to the exclusive jurisdiction of any federal or state court sitting in the State of Delaware for the purpose of any Action brought by any party hereto that, directly or indirectly, arises out of or relates to this Agreement; (b) irrevocably waives and releases, and agrees not to assert by way of motion, defense, or

 

11



 

otherwise, in or with respect to any such Action, any claim that (i) such Action is not subject to the subject matter jurisdiction of at least one of the above-named courts; (ii) its property is exempt or immune from attachment or execution in the State of Delaware; (iii) such Action is brought in an inconvenient forum; (iv) that the venue of such Action is improper; or (v) this Agreement or the transactions contemplated by this Agreement may not be enforced in or by any of the above-named courts; and (d) agrees not to move to transfer any such Action to a court other than any of the above-named courts.

 

Section 6.15                              Waiver of Jury Trial .  EACH OF THE PARTIES HEREBY IRREVOCABLY WAIVES TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY WITH RESPECT TO ANY ACTION OR LIABILITY, DIRECTLY OR INDIRECTLY, ARISING OUT OF, RELATING TO, OR IN CONNECTION WITH THIS AGREEMENT.  EACH OF THE PARTIES HEREBY (A) CERTIFIES THAT NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF ANY SUCH ACTION OR LIABILITY, SEEK TO ENFORCE THE FOREGOING WAIVER; AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 6.15 .

 

Section 6.16                              Severability .  In the event any one or more of the provisions contained in this Agreement should be held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein and therein shall not in any way be affected or impaired thereby.  The Parties shall endeavor in good-faith negotiations to replace the invalid, illegal or unenforceable provisions with valid provisions, the economic effect of which comes as close as possible to that of the invalid, illegal or unenforceable provisions.

 

Section 6.17                              Dispute Resolution .  The provisions in Article VIII of the Separation Agreement shall apply to any Dispute related to this Agreement, mutatis mutandis .

 

Section 6.18                              No Waiver .  No failure to exercise and no delay in exercising, on the part of any Party, any right, remedy, power or privilege hereunder or under the Separation Agreement shall operate as a waiver hereof or thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder or thereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

 

Section 6.19                              Specific Performance . From and after the Effective Date, in the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the Parties agree that the Party or Parties to this Agreement who are or are to be thereby aggrieved shall, subject and pursuant to the terms of this Section 6.19 , have the right to seek specific performance and injunctive or other equitable relief of its or their rights under this Agreement, in addition to any and all other rights and remedies at law or in equity, and all such rights and remedies shall be cumulative.  The Parties agree that, from and after the Effective Date, the remedies at law for any breach or threatened breach of this Agreement, including monetary damages, are inadequate compensation for any Indemnifiable Loss, that any defense in

 

12



 

any Action for specific performance that a remedy at law would be adequate is hereby waived, and that any requirements for the securing or posting of any bond with such remedy are hereby waived.

 

[SIGNATURES FOLLOW ON NEXT PAGE]

 

13



 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the date first written above by their respective duly authorized officers.

 

 

 

BIOGEN INC.

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

 

 

 

 

BIOVERATIV INC.

 

 

 

 

 

By:

 

 

 

Name:

 

 

Title:

 

[ Signature Page to Intellectual Property License Agreement ]

 




Exhibit 3.1

 

AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
BIOVERATIV INC.

 

Pursuant to the General Corporation Law
of the State of Delaware

 

Bioverativ Inc. (the “Corporation”), a corporation organized and existing under the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify as follows:

 

FIRST: The original Certificate of Incorporation of Bioverativ Inc. was filed with the Secretary of State of Delaware on August 4, 2016.

 

SECOND: This Amended and Restated Certificate of Incorporation has been duly adopted in accordance with the provisions of Sections 242 and 245 of the DGCL and has been duly approved by the written consent of the stockholders of the Corporation in accordance with Section 228 of the DGCL, and amends and restates the provisions of the Corporation’s Certificate of Incorporation.

 

THIRD: The text of the Corporation’s Certificate of Incorporation so adopted is hereby amended and restated in its entirety to read as follows:

 

ARTICLE I

 

The name of this Corporation is Bioverativ Inc.

 

ARTICLE II

 

The address of the registered office of the Corporation in the State of Delaware is 2711 Centerville Road, Suite 400, Wilmington, New Castle County, 19808.  The name of its registered agent at that address is Corporation Service Company.

 

ARTICLE III

 

The nature of the business or purposes to be conducted or promoted is to engage in any lawful act or activity for which corporations may be organized under the DGCL.

 

ARTICLE IV

 

(A)          Classes of Stock . This Corporation is authorized to issue two classes of capital stock of the Company to be designated, respectively, “Common Stock” and “Preferred Stock.” The total number of shares which the Corporation is authorized to issue is Eight Hundred Fifty Million (850,000,000) shares. Eight Hundred Million (800,000,000) shares shall be Common Stock, par value $0.001 per share, and Fifty Million (50,000,000) shares shall be Preferred Stock, par value $0.001 per share.

 



 

(B)          Common Stock .

 

1.             Ranking .  The voting, dividend and liquidation rights of the holders of Common Stock are subject to and qualified by the rights of the holders of Preferred Stock of any series as may be designated by the board of directors upon any issuance of Preferred Stock of any series.

 

2.             Voting .  Each share of Common Stock shall entitle the holder thereof to one vote in person or by proxy for each share on all matters on which such stockholders are entitled to vote.  Except as expressly set forth in the applicable Certificate of Designations with respect to any such series of Preferred Stock or as otherwise is required by applicable law, the holders of Common Stock shall not be entitled to vote on any amendment to this Certificate of Incorporation (including any Certificate of Designations) that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together as a class with the holders of one or more other such series, to vote thereon.

 

3.             Dividend Rights .  The holders of shares of Common Stock shall be entitled to receive ratably such dividends and other distributions in cash, stock or property of the Corporation when, as and if declared thereon by the board of directors in its sole discretion from time to time out of assets or funds of the Corporation legally available therefor, subject to any preferential rights of any then outstanding Preferred Stock and any other provisions of this Certificate of Incorporation, as may be amended from time to time.

 

4.             Liquidation Rights . Upon the liquidation, dissolution or winding up of the Corporation, whether voluntary or involuntary, after payment or provision for payment of the debts and other liabilities of the Corporation, holders of Common Stock shall be entitled to receive all remaining assets of the Corporation available for distribution to its stockholders, ratably in proportion to the number of shares of Common Stock held by them and subject to any preferential rights of any then outstanding Preferred Stock.

 

5.             No Preemptive or Subscription Rights . No holder of shares of Common Stock shall be entitled to preemptive or subscription rights.

 

6.             No Cumulative Voting . The holders of shares of Common Stock shall not have cumulative voting rights.

 

7.             Recapitalization .  Upon this Certificate of Incorporation of the Corporation becoming effective at [ · ] on [ · ],[ · ], the date of filing with the Secretary of State of the State of Delaware, pursuant to the DGCL (the “Effective Time”), the One Thousand (1,000) shares of Common Stock, par value $0.001 per share, issued and outstanding immediately prior to the Effective Time, shall be reclassified by subdividing and thereafter constitute [ · ] shares of Common Stock.

 



 

(C)          Preferred Stock .

 

The board of directors is hereby expressly authorized to provide for the issuance of all or any shares of Preferred Stock in one or more classes or series, and to fix for each such class or series such voting powers, full or limited, or no voting powers, and such designations, preferences and relative, participating, optional or other special rights and such qualifications, limitations or restrictions thereof, as shall be stated and expressed in the resolution or resolutions adopted by the board of directors providing for the issuance of such class or series, including, without limitation, the authority to provide that any such class or series may be (a) subject to redemption at such time or times and at such price or prices; (b) entitled to receive dividends (which may be cumulative or non-cumulative) at such rates, on such conditions, and at such times, and payable in preference to, or in such relation to, the dividends payable on any other class or classes or any other series; (c) entitled to such rights upon the dissolution of, or upon any distribution of the assets of, the Corporation; or (d) convertible into, or exchangeable for, shares of any other class or classes of stock, or of any other series of the same or any other class or classes of stock, of the Corporation at such price or prices or at such rates of exchange and with such adjustments, all as may be stated in such resolution or resolutions.

 

ARTICLE V

 

In furtherance and not in limitation of the powers conferred by law, the board of directors is expressly authorized and empowered, without the assent or vote of the stockholders of the Corporation, to amend, supplement or repeal the bylaws of the Corporation by the requisite affirmative vote of directors as set forth in the bylaws of the Corporation; provided , however , that the stockholders may change or repeal any bylaw adopted by the board of directors by the requisite affirmative vote of stockholders as set forth in the bylaws of the Corporation; and, provided further , that no amendment or supplement to the bylaws of the Corporation adopted by the board of directors shall vary or conflict with any amendment or supplement thus adopted by the stockholders.

 

ARTICLE VI

 

The business and affairs of the Corporation shall be managed by or under the direction of the board of directors.  Subject to the rights of any series of Preferred Stock then outstanding, the number of directors of the Corporation shall be fixed exclusively by, or in the manner provided in, the bylaws of the Corporation.  In addition to the powers and authority hereinbefore or by statute expressly conferred upon them, the board of directors is hereby empowered to exercise all such powers and do all such acts and things as may be exercised or done by the Corporation, subject to the provisions of the DGCL, this Certificate of Incorporation and any bylaws of the Corporation; provided , however , that no bylaws of the Corporation hereafter adopted shall invalidate any prior act of the board of directors which would have been valid if such bylaws had not been adopted.

 

ARTICLE VII

 

Elections of directors need not be by written ballot unless the bylaws of the Corporation shall so provide. Directors shall hold office for a term ending on the date of the next annual meeting of stockholders following their election and until their successors shall have been

 



 

elected and qualified, subject to their earlier resignation, removal from office, death or incapacity.

 

ARTICLE VIII

 

The Corporation is to have perpetual existence.

 

ARTICLE IX

 

Meetings of stockholders may be held within or without the State of Delaware, as the bylaws of the Corporation may provide. The books of the Corporation may be kept (subject to any provision contained in the statutes) outside the State of Delaware at such place or places as may be designated from time to time by the board of directors or in the bylaws of the Corporation.

 

ARTICLE X

 

Any action required or permitted to be taken by the stockholders of the Corporation must be effected at a duly called annual or special meeting of stockholders of the Corporation, and the ability of the stockholders to consent in writing to the taking of any action is hereby specifically denied.

 

ARTICLE XI

 

A director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for any breach of fiduciary duty as a director, except for liability as a director (i) for any breach of the director’s duty of loyalty to the Corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) under Section 174 of the DGCL or (iv) for any transaction from which the director derived an improper personal benefit. If the DGCL is amended after approval of this Article to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director shall be eliminated or limited to the fullest extent permitted by the DGCL, as so amended. Any repeal or modification of the foregoing provisions of this Article XI shall not adversely affect any right or protection of a director of the Corporation with respect to any acts or omissions of such director occurring prior to such repeal or modification.

 

ARTICLE XII

 

To the fullest extent permitted by applicable law, the Corporation is also authorized to provide indemnification of (and advancement of expenses to) such agents (and any other persons to which Delaware law permits the Corporation to provide indemnification) through bylaw provisions, agreements with such agents or other persons, vote of stockholders or disinterested directors or otherwise, in excess of the indemnification and advancement otherwise permitted by Section 145 of the DGCL, subject only to limits created by applicable Delaware law (statutory or non-statutory), with respect to actions for breach of duty to the Corporation, its stockholders and others. Any repeal or modification of any of the foregoing provisions of this Article XII shall not adversely affect any right or protection of a director, officer, agent or other

 



 

person existing at the time of, or increase the liability of any director of the Corporation with respect to any acts or omissions of such director, officer or agent occurring prior to such repeal or modification.

 

ARTICLE XIII

 

Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall, to the fullest extent permitted by law, be the sole and exclusive forum for: (a) any derivative action or proceeding brought on behalf of the Corporation, (b) any action asserting a claim for breach of a fiduciary duty owed by any director, officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders, (c) any action asserting a claim arising pursuant to any provision of the DGCL or (d) any action asserting a claim governed by the internal affairs doctrine; provided, however, that, in the event that the Court of Chancery of the State of Delaware lacks subject matter jurisdiction over any such action or proceeding, the sole and exclusive forum for such action or proceeding shall be another state or federal court located within the State of Delaware, in each such case, unless the Court of Chancery (or such other state or federal court located within the State of Delaware, as applicable) has dismissed a prior action by the same plaintiff asserting the same claims because such court lacked personal jurisdiction over an indispensable party named as a defendant therein. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation shall be deemed to have notice of and consented to the provisions of this Article XIII. Failure to enforce the foregoing provisions would cause the Corporation irreparable harm and the Corporation shall be entitled to equitable relief, including injunction and specific performance, to enforce the forgoing provisions.

 

ARTICLE XIV

 

The Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, in the manner now or hereafter prescribed by statute, and all rights conferred upon stockholders herein are granted subject to this reservation.

 

[Signature Page Follows]

 



 

IN WITNESS WHEREOF , the undersigned has executed this Amended and Restated Certificate of Incorporation as of this [ · ] day of [ · ], [ · ].

 

 

BIOVERATIV INC.

 

 

 

 

 

 

By:

 

 

 

Name:

John G. Cox

 

 

Title:

Chief Executive Officer

 




Exhibit 3.2

 

AMENDED AND RESTATED

 

BYLAWS

 

OF

 

BIOVERATIV INC.

 

A Delaware Corporation

 



 

TABLE OF CONTENTS

 

 

 

Page

 

 

 

ARTICLE 1 Offices

1

 

 

 

1.1

Registered Office

1

1.2

Other Offices

1

 

 

 

ARTICLE 2 Meeting of Stockholders

1

 

 

 

2.1

Place of Meeting

1

2.2

Annual Meeting

1

2.3

Special Meetings Called by Directors or Officers

4

2.3A

Special Meetings Called by Stockholders

4

2.4

Notice of Meetings

6

2.5

List of Stockholders

7

2.6

Organization and Conduct of Business

7

2.7

Quorum

7

2.8

Adjournments

8

2.9

Voting Rights

8

2.10

Voting

8

2.11

Record Date for Stockholder Notice, Voting and Payment

8

2.12

Proxies

9

2.13

Inspectors of Election

9

 

 

 

ARTICLE 3 Directors

9

 

 

 

3.1

Number, Election, Tenure and Qualifications

9

3.1A

Proxy Access for Director Nominations

13

3.2

Enlargement and Vacancies

16

3.3

Resignation and Removal

17

3.4

Powers

17

3.5

Place of Meetings

17

3.6

Organizational Meetings

17

3.7

Regular Meetings

17

3.8

Special Meetings

17

3.9

Quorum, Action at Meeting, Adjournments

18

3.10

Action Without Meeting

18

3.11

Telephone Meetings

18

3.12

Committees

18

3.13

Fees and Compensation of Directors

19

3.14

Rights of Inspection

19

3.15

Lead Director

19

3.16

Conditional Resignation

19

 

 

 

ARTICLE 4 Officers

20

 

 

 

4.1

Officers Designated

20

4.2

Appointment

20

4.3

Tenure

20

4.4

Chairman and Vice Chairman

20

 

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4.5

The Chief Executive Officer

20

4.6

The President

21

4.7

The Vice President

21

4.8

The Secretary

21

4.9

The Assistant Secretary

21

4.10

The Chief Financial Officer

22

4.11

The Treasurer and Assistant Treasurers

22

4.12

Other Officers

22

 

 

 

ARTICLE 5 Notices

22

 

 

 

5.1

Delivery

22

5.2

Waiver of Notice

23

 

 

 

ARTICLE 6 Indemnification and Insurance

23

 

 

 

6.1

Indemnification

23

6.2

Advance Payment

26

6.3

Non-Exclusivity and Survival of Rights; Amendments

27

6.4

Insurance

27

6.5

Severability

27

6.6

Definitions

27

6.7

Notices

29

 

 

 

ARTICLE 7 Capital Stock

29

 

 

 

7.1

Certificates for Shares

29

7.2

Signatures on Certificates

30

7.3

Transfer of Stock

30

7.4

Registered Stockholders

30

7.5

Lost, Stolen or Destroyed Certificates

30

7.6

Transfer and Registry Agents

31

 

 

 

ARTICLE 8 General Provisions

31

 

 

 

8.1

Dividends

31

8.2

Dividend Reserve

31

8.3

Checks

31

8.4

Fiscal Year

31

8.5

Corporate Seal

31

8.6

Execution of Corporate Contracts and Instruments

32

8.7

Representation of Shares of Other Corporations

32

 

 

 

ARTICLE 9 Amendments

32

 

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AMENDED AND RESTATED

 

BYLAWS

 

OF

 

BIOVERATIV INC.

 

(Adopted as of August 4, 2016; as amended through [ · ], [ · ])

 

ARTICLE 1

 

Offices

 

1.1                                Registered Office

 

The registered office of the corporation shall be set forth in the certificate of incorporation of the corporation (as may be amended and restated from time to time, the “ Certificate of Incorporation ”).

 

1.2                                Other Offices

 

The corporation may also have offices at such other places, either within or without the State of Delaware, as the Board of Directors of the corporation (the “ Board ”) may from time to time designate or the business of the corporation may require.

 

ARTICLE 2

 

Meeting of Stockholders

 

2.1                                Place of Meeting

 

Meetings of stockholders of the corporation (the “ Stockholders ”) may be held at such place, either within or without of the State of Delaware, as may be designated by or in the manner provided in these bylaws, or, if not so designated, as determined by the Board.  The Board may, in its sole discretion, determine that a meeting of the Stockholders shall not be held at any place, but may instead be held solely by means of remote communication in the manner authorized by the General Corporation Law of the State of Delaware (the “ DGCL ”).

 

2.2                                Annual Meeting

 

Annual meetings of Stockholders shall be held each year at such place, date and time as shall be designated from time to time by the Board and stated in the notice of the meeting.  At each such annual meeting, the Stockholders shall elect directors to the Board to hold office until the next annual meeting of Stockholders after their election and until their successors are duly elected and qualified or until their earlier resignation, removal from office, death or incapacity.  The Stockholders shall also transact such other business as may properly be brought before the meeting.

 

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To be properly brought before the annual meeting, nominations of persons for election as directors must be made in accordance with the procedures set forth in Section 3.1 or 3.1A .

 

Subject to the last paragraph of this Section 2.2 , to be properly brought before the annual meeting, business other than nominations of persons for election to the Board must be (a) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the Board (or any duly authorized committee thereof) or the Chairman of the Board or the Chief Executive Officer, (b) otherwise properly brought before the meeting by or at the direction of the Board (or any duly authorized committee thereof) or the Chairman of the Board or the Chief Executive Officer, or (c) otherwise properly brought before the meeting by a Stockholder of record of the corporation at the time of giving of notice of meeting pursuant to Section 2.4 and at the time of the meeting, who is entitled to vote at the meeting and who otherwise complies with this Section 2.2 .  For any proposed business to be properly brought before an annual meeting by a Stockholder pursuant to clause (c) above of this paragraph, the proposed business must constitute a proper matter for Stockholder action.  Any such Stockholder may propose business to be brought before a meeting only if such Stockholder has given timely notice to the Secretary of the corporation in proper written form of the Stockholder’s intent to propose such business.

 

To be timely, the Stockholder’s notice must be delivered by a nationally recognized courier service or mailed by first class United States mail, postage or delivery charges prepaid, or other method of delivery approved by the Board, and received at the principal executive offices of the corporation addressed to the attention of the Secretary of the corporation not less than ninety (90) days nor more than one hundred twenty (120) days in advance of the first anniversary of the date of the previous year’s annual meeting of Stockholders; provided, however , that in respect of the corporation’s first annual meeting of Stockholders after its shares of common stock are first publicly traded (the “ First Public Annual Meeting ”), notice by the Stockholder must be received by the Secretary of the corporation not later than the close of business on the thirtieth (30 th ) day following the day on which notice of the date of the First Public Annual Meeting was mailed or public announcement of the date of the First Public Annual Meeting was first made, whichever first occurs; provided, further , that, other than in respect of the First Public Annual Meeting, in the event that no annual meeting was held in the previous year or the date of the annual meeting is more than thirty (30) days before or more than sixty (60) days after the first anniversary of the previous year’s annual meeting of Stockholders, notice by the Stockholder must be received by the Secretary of the corporation not earlier than the close of business on the one hundred twentieth (120 th ) day prior to such annual meeting and not later than the close of business on the later of (x) the ninetieth (90 th ) day prior to such annual meeting and (y) the tenth (10th) day following the day on which public announcement of the date of such meeting is first made. For the purposes of these bylaws, “ public announcement ” shall mean disclosure in a press release reported by the Dow Jones News Service, Associated Press or a comparable national news service or in a document publicly filed by the corporation with the Securities and Exchange Commission.  In no event shall the public announcement of an adjournment or postponement of an annual meeting commence a new time period (or extend any time period) for the giving of Stockholder’s notice as described above.

 

To be in proper form, a Stockholder’s notice to the Secretary must set forth as to each matter the Stockholder proposes to bring before the annual meeting: (i) a brief description of the business desired to be brought before the annual meeting, the text of the proposal or business (including the text of any resolutions proposed for consideration and in the event that such business includes a proposal to amend these bylaws, the language of the proposed amendment), and the reasons for conducting such business at the annual meeting, (ii) the name and record address of the Stockholder proposing such

 

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business and the beneficial owner, if any, on whose behalf the proposal is made, (iii) the class, series and number of shares of capital stock of the corporation that are owned beneficially and of record by the Stockholder and such beneficial owner, (iv) any option, warrant, convertible security, stock appreciation right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any class or series of shares of capital stock of the corporation or with a value derived in whole or in part from the value of any class or series of shares of capital stock of the corporation, whether or not such instrument or right shall be subject to settlement in the underlying class or series of capital stock of the corporation or otherwise (a “ Derivative Instrument ”) directly or indirectly owned beneficially by such Stockholder and any other direct or indirect opportunity to profit or share in any profit derived from any increase or decrease in the value of shares of capital stock of the corporation, (v) a description of any agreement, arrangement or understanding with respect to the proposal of business between or among such Stockholder and such beneficial owner, any of their respective affiliates or associates, and any others acting in concert with any of the foregoing, (vi) a description of any material interest of the Stockholder and the beneficial owner, if any, on whose behalf the proposal is made, in such business, (vii) a representation that the Stockholder is a holder of record of stock of the corporation entitled to vote at such meeting and intends to appear in person or by proxy at the meeting to propose such business, (viii) a representation whether the Stockholder or the beneficial owner, if any, intends or is part of a group which intends (a) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the corporation’s outstanding capital stock required to approve or adopt the proposal and/or (b) otherwise to solicit proxies from Stockholders in support of such proposal and (ix) any other information that is required to be provided by the Stockholder pursuant to Section 14 of the Securities Exchange Act of 1934 and the rules and regulations promulgated thereunder as amended from time to time (collectively, the “ 1934 Act ”) in such Stockholder’s capacity as a proponent of a Stockholder proposal.

 

A Stockholder providing notice of business proposed to be brought before an annual meeting shall further update and supplement such notice, if necessary, so that the information provided or required to be provided in such notice pursuant to this Section 2.2 shall be true and correct as of the record date for determining the Stockholders entitled to receive notice of the annual meeting and such update or supplement shall be delivered to, and received by, the Secretary at the principal executive offices of the corporation not later than five (5) business days after the later of (i) the record date for determining the Stockholders entitled to receive notice of the annual meeting and (ii) the date notice of such record date is first publicly disclosed.

 

Except as otherwise provided by applicable law, if the Chairman of the Board (or such other person presiding at the meeting in accordance with these bylaws) determines in good faith that business was not properly brought before the meeting in accordance with the provisions of this Section 2.2 (including whether the Stockholder or beneficial owner, if any, on whose behalf the proposal is made solicited (or is part of a group which solicited) or did not so solicit, as the case may be, proxies in support of such Stockholder’s proposal in compliance with such Stockholder’s representation as required by clause (viii) above of this Section 2.2 ), he or she may so declare to the meeting and any such business shall not be transacted.  Notwithstanding the foregoing provisions of this Section 2.2 , unless otherwise required by applicable law, if the Stockholder (or a qualified representative of the Stockholder) does not appear at the meeting to present proposed business, such proposed business shall not be transacted, notwithstanding that proxies in respect of such proposed business may have been received by the corporation.  For purposes of this provision, to be considered a qualified representative of the Stockholder, a person must be a duly authorized officer, manager or partner of such Stockholder or must be authorized by a writing executed by such Stockholder or an electronic transmission delivered by such Stockholder to act for such Stockholder as proxy at the meeting of Stockholders and

 

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such person must produce such writing or electronic transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of Stockholders.

 

Compliance with this Section 2.2 and Sections 3.1 and 3.1A shall be the exclusive means for a Stockholder to make nominations for director or submit other business to the Stockholders at an annual meeting (other than matters brought properly under and in compliance with Rule 14a-8 or other applicable rules and regulations under the 1934 Act).

 

2.3                                Special Meetings Called by Directors or Officers

 

Unless otherwise prescribed by statute or by the Certificate of Incorporation, special meetings of the Stockholders shall be called for any purpose or purposes by the Secretary at the request of the Chairman of the Board, the Chief Executive Officer or by a resolution duly adopted by the affirmative vote of a majority of the Board.  Such request shall state the purpose or purposes of the proposed meeting.  Business transacted at any such special meeting shall be limited to matters relating to the purpose or purposes stated in the notice of meeting.

 

2.3A                       Special Meetings Called by Stockholders

 

(a)                                  Special meetings of the Stockholders (each a “ Stockholder Requested Special Meeting ”) shall also be called by the Secretary upon the written request of a Stockholder (or a group of Stockholders formed for the purpose of making such request) who or which has Net Long Beneficial Ownership (as defined below) of 25% or more of the outstanding shares of common stock of the corporation (the “ Requisite Percent ”) as of the date of submission of the request, subject to Section 2.3A(b)  below.  Compliance by the requesting Stockholder or group of Stockholders with the requirements of this section and related provisions of these bylaws shall be determined in good faith by the Board, which determination shall be conclusive and binding on the corporation and the Stockholders.

 

Net Long Beneficial Ownership ” (and its correlative terms), when used to describe the nature of a Stockholder’s ownership of shares of common stock of the corporation, shall mean those shares of common stock of the corporation as to which the Stockholder in question possesses (a) the sole power to vote or direct the voting, (b) the sole economic incidents of ownership (including the sole right to profits and the sole risk of loss), and (c) the sole power to dispose of or direct the disposition. The number of shares calculated in accordance with clauses (a), (b) and (c) shall not include any shares (i) sold by such Stockholder in any transaction that has not been settled or closed, (ii) borrowed by such Stockholder for any purposes or purchased by such Stockholder pursuant to an agreement to resell or (iii) subject to any option, warrant, derivative or other agreement or understanding, whether any such arrangement is to be settled with shares of common stock of the corporation or with cash based on the notional amount of shares subject thereto, in any such case which has, or is intended to have, the purpose or effect of (A) reducing in any manner, to any extent or at any time in the future, such Stockholder’s rights to vote or direct the voting and full rights to dispose or direct the disposition of any of such shares or (B) offsetting to any degree gain or loss arising from the sole economic ownership of such shares by such Stockholder.

 

(b)                                  A request for a Stockholder Requested Special Meeting must be signed by Stockholders (or their duly authorized agents) having Net Long Beneficial Ownership of the Requisite Percent and be delivered to the Secretary at the principal executive offices of the corporation by a nationally recognized courier service or mailed by first class United States mail, postage or delivery charges

 

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prepaid, or other method of delivery approved by the Board.  Such request shall (i) set forth a statement of the specific purpose or purposes of the meeting and the matters proposed to be acted on at such special meeting, (ii) bear the date of signature of each such Stockholder (or duly authorized agent) signing the request, (iii) as to each Stockholder signing such request (or on whose behalf the request is signed) (A) set forth the name and address, as it appears in the corporation’s stock ledger, (B) set forth the class, if applicable, and the number of shares of common stock of the corporation as to which such Stockholder has Net Long Beneficial Ownership, (C) include evidence of the fact of such Stockholder’s beneficial ownership of such stock consistent with that which is required under Regulation 14A under the 1934 Act and (D) include a certification that the Stockholder satisfies the Net Long Beneficial Ownership requirement of these bylaws, and (iv) include an acknowledgment by each Stockholder signing such request (or on whose behalf the request is signed) and any duly authorized agent that any disposition of shares of common stock of the corporation as to which such Stockholder has Net Long Beneficial Ownership as of the date of delivery of the special meeting request and prior to the record date for the proposed meeting requested by such Stockholder shall constitute a revocation of such request with respect to such shares.  In addition, the Stockholder and any duly authorized agent shall promptly provide any other information reasonably requested by the corporation to allow it to satisfy its obligations under applicable law.  Any requesting Stockholder may revoke such Stockholder’s request for a special meeting at any time by written revocation delivered to the Secretary at the principal executive offices of the corporation.  If, following such revocation at any time before the date of the Stockholder Requested Special Meeting, the remaining Stockholders signing such request (or on whose behalf the request is signed) have Net Long Beneficial Ownership in the aggregate of less than the Requisite Percent, the Board, in its sole discretion, may cancel the Stockholder Requested Special Meeting or the Stockholder(s’) proposed business at the meeting.

 

(c)                                   Notwithstanding the foregoing, the Secretary shall not be required to call a special meeting of Stockholders if (i) the Board has called or calls an annual or special meeting of Stockholders to be held not later than sixty (60) days after the date on which a valid request has been delivered to the Secretary (the “ Delivery Date ”) where the request contains the same item as any item on the agenda for such annual or special meeting; or (ii) the request (A) is received by the Secretary during the period commencing one hundred twenty (120) days prior to the first anniversary of the date of the previous year’s annual meeting (or, solely in respect of the First Public Annual Meeting, one hundred twenty (120) prior to the date of such meeting) and ending on the date of the next annual meeting, (B) contains an identical or substantially similar item (a “ Similar Item ”) to an item that was presented at any meeting of Stockholders held within thirty (30) days prior to the Delivery Date (and, for purposes of this clause (B) the election of directors shall be deemed a “Similar Item” with respect to all items of business involving the election or removal of directors), excluding, for purposes of determining what constitutes a Similar Item, ancillary items that are contained in the request solely to support the primary item(s) of such request, (C) relates to an item of business that is not a proper subject for action by the Stockholders under applicable law or (D) was made in a manner that involved a violation of applicable law.

 

(d)                                  Any Stockholder Requested Special Meeting shall be held at such date, time and place within or without the State of Delaware as may be fixed by the Board; provided , however , that the date of any Stockholder Requested Special Meeting shall be not more than sixty (60) days after the record date for such meeting (the “ Meeting Record Date ”).  If the Board fails to designate a date and time for the meeting within ten (10) days after the Delivery Date, then such meeting shall be held at 9:00 a.m. local time on the sixtieth (60th) day after the Meeting Record Date (or, if that day shall not be a business day, then on the next preceding business day); provided further , that in the event that the

 

5



 

Board fails to designate a place for a Stockholder Requested Special Meeting within ten (10) days after the Delivery Date, then such meeting shall be held at the corporation’s principal executive offices.  The Meeting Record Date shall be fixed in accordance with Section 2.11 of these bylaws and if the Board fails to designate a Meeting Record Date within ten (10) days after the Delivery Date, then such Meeting Record Date shall be twenty (20) days after the Delivery Date.  In fixing a date and time for any Stockholder Requested Special Meeting, the Board may consider such factors as it deems relevant within the good faith exercise of business judgment, including, without limitation, the nature of the matters to be considered, the facts and circumstances surrounding any request for meeting and any plan of the Board to call an annual meeting or a special meeting.

 

(e)                                   Business transacted at any Stockholder Requested Special Meeting shall be limited to the purpose(s) stated in the request; provided , however , that nothing herein shall prohibit the corporation from submitting matters to a vote of the Stockholders at any Stockholder Requested Special Meeting.

 

A Stockholder providing notice of business proposed to be brought before a special meeting shall further update and supplement such notice, if necessary, so that the information provided or required to be provided in such notice pursuant to this Section 2.3A shall be true and correct as of the record date for determining the Stockholders entitled to receive notice of the special meeting and such update or supplement shall be delivered to, and received by, the Secretary at the principal executive offices of the corporation not later than five (5) business days after the later of (i) the record date for determining the Stockholders entitled to receive notice of the special meeting and (ii) the date notice of such record date is first publicly disclosed.

 

Except as otherwise provided by applicable law, if the Chairman of the Board (or such other person presiding at the meeting in accordance with these bylaws) determines in good faith that business was not properly brought before the meeting in accordance with the provisions of this Section 2.3A (including whether the Stockholder or beneficial owner, if any, on whose behalf the proposal is made solicited (or is part of a group which solicited) or did not so solicit, as the case may be, proxies in support of such Stockholder’s proposal in compliance with such Stockholder’s representation as required by clause (viii) above of Section 2.2 ), he or she shall so declare to the meeting and any such business shall not be transacted.  Notwithstanding the foregoing provisions of this Section 2.3A , unless otherwise required by applicable law, if the Stockholder (or a qualified representative of the Stockholder) does not appear at the meeting to present proposed business, such proposed business shall not be transacted, notwithstanding that proxies in respect of such proposed business may have been received by the corporation.  For purposes of this provision, to be considered a qualified representative of the Stockholder, a person must be a duly authorized officer, manager or partner of such Stockholder or must be authorized by a writing executed by such Stockholder or an electronic transmission delivered by such Stockholder to act for such Stockholder as proxy at the meeting of Stockholders and such person must produce such writing or electronic transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of Stockholders.

 

2.4                                Notice of Meetings

 

Except as otherwise provided by law, written notice of each meeting of Stockholders, annual or special, stating the place, if any, date and time of the meeting, the means of remote communications, if any, by which Stockholders and proxy holders may be deemed to be present in person and vote at such meeting, and, in the case of a special meeting, the purpose or purposes for which such special meeting

 

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is called, shall be given to each Stockholder entitled to vote at such meeting not less than ten (10) nor more than sixty (60) days before the date of the meeting.

 

When a meeting is adjourned to another place, date or time, notice need not be given of the adjourned meeting if the place, date and time thereof are announced at the meeting at which the adjournment is taken; provided, however , that if the date of any adjourned meeting is more than thirty (30) days after the date for which the meeting was originally noticed, or if a new record date is fixed for the adjourned meeting, written notice of the place, if any, date, time and means of remote communications, if any, of the adjourned meeting shall be given in conformity herewith.  At any adjourned meeting, any business may be transacted that might have been transacted at the original meeting.

 

2.5                                List of Stockholders

 

The officer in charge of the stock ledger of the corporation or the transfer agent shall prepare and make, at least ten (10) days before every meeting of Stockholders, a complete list of the Stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each Stockholder and the number of shares registered in the name of each Stockholder.  Such list shall be open to the examination of any Stockholder, for any purpose germane to the meeting, for a period of at least ten (10) days prior to the meeting, (i) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with the notice of the meeting, or (ii) during ordinary business hours, at the principal place of business of the corporation.  If the meeting is to be held at a place, then the list shall also be produced and kept at the time and place of the meeting during the whole time thereof, and may be inspected by any Stockholder who is present.  If the meeting is to be held solely by means of remote communication, then the list shall also be open to the examination of any Stockholder during the whole time of the meeting on a reasonably accessible electronic network, and the information required to gain access to such list shall be provided with the notice of the meeting.

 

2.6                                Organization and Conduct of Business

 

The Chairman of the Board or, in his or her absence, the Chief Executive Officer or President or, in their absence, such person as the Board may have designated or, in the absence of such a person, such person as may be chosen by the holders of a majority of the shares entitled to vote who are present, in person or by proxy, shall call to order any meeting of the Stockholders and act as chairman of the meeting.  In the absence of the Secretary, the secretary of the meeting shall be such person as the chairman of the meeting appoints.

 

The chairman of any meeting of Stockholders shall determine the order of business and the procedure at the meeting, including such regulation of the manner of voting and the conduct of discussion as seems to him or her in order.

 

2.7                                Quorum

 

Except where otherwise provided by applicable law or the Certificate of Incorporation or these bylaws, the holders of a majority of the shares of capital stock of the corporation issued and outstanding and entitled to vote, present in person or represented in proxy, shall constitute a quorum at all meetings of the Stockholders.

 

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2.8                                Adjournments

 

Any meeting of Stockholders may be adjourned from time to time to any other time and to any other place at which a meeting of Stockholders may be held under these bylaws, which time and place shall be announced at the meeting, by either the Chairman of the Board or the holders of a majority of the shares of capital stock of the corporation present in person or represented by proxy at the meeting and entitled to vote, whether or not a quorum is present, without notice other than announcement at the meeting.  At such adjourned meeting at which a quorum shall be present or represented, any business may be transacted which might have been transacted at the original meeting.  If the adjournment is for more than thirty (30) days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each Stockholder of record entitled to vote at the meeting.

 

2.9                                Voting Rights

 

Unless otherwise provided in the Certificate of Incorporation, each Stockholder represented at a meeting of the Stockholders shall be entitled to cast one vote for each share of capital stock of the corporation entitled to vote thereat held by such Stockholder.  For purposes of these bylaws, “votes cast” do not include abstentions or shares as to which a stockholder gives no authority or discretion, including “broker non-votes.”

 

2.10                         Voting

 

When a quorum is present at any meeting, other than with regard to the election of directors, a majority of the total number of votes of the corporation’s capital stock having voting power present in person or represented by proxy at the meeting and entitled to vote on such question shall decide any question brought before such meeting, unless the question is one upon which by express provision of statute or of the Certificate of Incorporation or of these bylaws a different vote is required in which case such express provision shall govern and control the decision of such question. With respect to the election of directors, the voting standard shall be as set forth in Section 3.1 of these bylaws.

 

2.11                         Record Date for Stockholder Notice, Voting and Payment

 

For purposes of determining the Stockholders entitled to notice of, or to vote at, any meeting of stockholders or any adjournment thereof, or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any right in respect of any change, conversion or exchange of shares of capital stock of the corporation or for the purpose of any other lawful action, the Board may fix, in advance, a record date, which shall not be more than sixty (60) days nor less than ten (10) days before the date of any such meeting nor more than sixty (60) days before any other action to which the record date relates. A determination of Stockholders of record entitled to notice of or to vote at a meeting of Stockholders shall apply to any adjournment of the meeting; provided , however , that the Board may fix a new record date for the adjourned meeting.  If the Board does not so fix a record date, then: (i) the record date for determining Stockholders entitled to notice of or to vote at a meeting of Stockholders shall be at the close of business on the business day next preceding the day on which notice is given or, if notice is waived, at the close of business on the business day next preceding the day on which the meeting is held; and (ii) the record date for determining Stockholders for any other purpose shall be at the close of business on the day on which the Board adopts the resolution relating to such purpose.

 

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2.12                         Proxies

 

Each Stockholder entitled to vote at a meeting of Stockholders may authorize another person or persons to act for such Stockholder by proxy, but no such proxy shall be voted or acted upon after three (3) years from its date unless the proxy provides for a longer period.  Subject to the limitation set forth in the last clause of the first sentence of this Section 2.12 , a duly executed proxy that does not state that it is irrevocable shall continue in full force and effect unless (i) revoked by the person executing it, before the vote pursuant to that proxy, by a writing delivered to the corporation stating that the proxy is revoked or by a subsequent proxy executed by, or attendance at the meeting and voting in person by, the person executing the proxy, or (ii) written notice of the death or incapacity of the maker of that proxy is received by the corporation before the vote pursuant to that proxy is counted.

 

2.13                         Inspectors of Election

 

The corporation shall, in advance of any meeting of Stockholders, appoint one or more inspectors of election to act at the meeting and make a written report thereof.  The corporation may designate one or more persons to act as alternate inspectors to replace any inspector who fails to act.  If no inspector or alternate is able to act at a meeting of Stockholders, the person presiding at the meeting shall appoint one or more inspectors to act at the meeting.  Each inspector, before entering upon the discharge of his or her duties, shall take and sign an oath faithfully to execute the duties of inspector with strict impartiality and according to the best of his or her ability.

 

ARTICLE 3

 

Directors

 

3.1                                Number, Election, Tenure and Qualifications

 

The number of directors that constitute the entire Board shall be fixed from time to time by resolution adopted by a majority of the entire Board.

 

Except as otherwise provided in Section 3.2 below or at a special meeting of Stockholders held for the purpose of electing directors, directors shall be elected at each annual meeting of Stockholders and each director elected shall hold office until the next annual meeting of Stockholders and until such director’s successor is duly elected and qualified, or until such director’s earlier resignation, removal from office, death or incapacity.  Except in a contested election, the vote required for the election of a director by the Stockholders shall be a majority of the votes cast in favor of the nominee.  In a contested election, a director shall be elected by a plurality of the votes so cast in favor of the nominee.  A contested election shall be one in which there are more nominees than positions on the Board to be filled at the meeting as of the fifth (5th) day prior to the date on which the corporation files its definitive proxy statement with the Securities and Exchange Commission.  Any subsequent amendment or supplement of the definitive proxy statement shall not affect the status of the election.

 

Subject to the last paragraph of this Section 3.1 , and subject to the rights of holders of any class or series of preferred stock of the corporation, if any, to nominate and elect a specified number of directors in certain circumstances, nominations of persons for election to the Board may be made (a) by or at the direction of the Board, (b) by any Stockholder (A) who was a Stockholder of record at the time of giving of notice of meeting pursuant to Section 2.4 and at the time of the meeting, (B) who is

 

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entitled to vote for the election of directors at the applicable meeting and (C) who complies with the notice procedures set forth in this Section 3.1 or (c) any person who meets the requirements of and complies with the procedures set forth in Section 3.1A .  Such nominations, other than those made by or at the direction of the Board or pursuant to Section 3.1A , shall be made pursuant to timely notice in proper written form to the Secretary.

 

To be timely, a Stockholder’s notice shall be delivered by a nationally recognized courier service or mailed by first class United States mail, postage or delivery charges prepaid, or other method of delivery approved by the Board, and received at the principal executive offices of the corporation addressed to the attention of the Secretary of the corporation in the case of an annual meeting not less than ninety (90) days nor more than one hundred twenty (120) days in advance of the first anniversary of the date of the previous year’s annual meeting of Stockholders; provided, however , that in respect of the First Public Annual Meeting, notice by the Stockholder must be received by the Secretary of the corporation not later than the close of business on the thirtieth (30 th ) day following the day on which notice of the date of the First Public Annual Meeting was mailed or public announcement of the date of the First Public Annual Meeting was first made, whichever first occurs; provided, further , that, other than in respect of the First Public Annual Meeting, in the event that no annual meeting was held in the previous year or the date of the annual meeting is more than thirty (30) days before or more than sixty (60) days after the first anniversary of the previous year’s annual meeting of Stockholders, notice by the Stockholder must be received by the Secretary of the corporation not earlier than the close of business on the one hundred twentieth (120 th ) day prior to such annual meeting and not later than the close of business on the later of (x) the ninetieth (90 th ) day prior to such annual meeting and (y) the tenth (10th) day following the day on which public announcement of the date of such meeting is first made. In no event shall the public announcement of an adjournment or postponement of an annual meeting commence a new time period (or extend any time period) for the giving of a Stockholder’s notice as described above.

 

To be in proper form, a Stockholder’s notice to the Secretary must set forth (a) as to each person whom the Stockholder proposes to nominate for election or reelection as a director, (i) the name, age, business address and residence address of the person, (ii) the principal occupation or employment of the person, (iii) the class, series and number of shares of capital stock of the corporation that are owned beneficially and of record by the person, (iv) a statement as to the person’s citizenship, (v) the completed and signed representation and agreement described below, (vi) any other information relating to the person that is required to be disclosed in solicitations for proxies for election of directors pursuant to Section 14 of the 1934 Act, and (vii) such person’s written consent to being named in the proxy statement as a nominee and to serving as a director if elected, and (b) as to the Stockholder giving the notice and the beneficial owner, if any, on whose behalf the nomination is made, (i) the name and record address of the Stockholder and of such beneficial owner, if any, (ii) the class, series and number of shares of capital stock of the corporation that are owned beneficially and of record by the Stockholder and such beneficial owner, (iii) any Derivative Instrument directly or indirectly owned beneficially by such Stockholder and any other direct or indirect opportunity to profit or share in any profit derived from any increase or decrease in the value of shares of capital stock of the corporation, (iv) a description of any agreement, arrangement or understanding with respect to the nomination between or among such Stockholder and such beneficial owner, any of their respective affiliates or associates, and any others acting in concert with any of the foregoing, (v) a representation that the Stockholder is a holder of record of stock of the corporation entitled to vote at such meeting and intends to appear in person or by proxy at the meeting to propose such nomination, and (vi) a representation whether the Stockholder or the beneficial owner, if any, (a “ Stockholder’s Representation ”) intends or is part of a group which intends (A) to deliver a proxy statement and/or

 

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form of proxy to holders of at least the percentage of the corporation’s outstanding shares of capital stock required to elect the nominee and/or (B) otherwise to solicit proxies from Stockholders in support of such nomination. The corporation may require any proposed nominee to furnish such other information as may reasonably be required by the corporation to determine the eligibility of such proposed nominee to serve as director of the corporation.

 

To be eligible to be a nominee for election or reelection as a director of the corporation, a person must deliver (in accordance with the time periods prescribed for delivery of notice under this Section 3.1 ) to the Secretary at the principal executive offices of the corporation a written representation and agreement that such person (i) is not and will not become a party to (A) any agreement, arrangement or understanding (whether written or oral) with, and has not given any commitment or assurance to, any person or entity as to how such person, if elected as a director of the corporation, will act or vote on any issue or question (a “ Voting Commitment ”) that has not been disclosed to the corporation or (B) any Voting Commitment that could limit or interfere with such person’s ability to comply, if elected as a director of the corporation, with such person’s fiduciary duties under applicable law, (ii) is not, and has not agreed to, become a party to any agreement, arrangement or understanding (whether written or oral) with any person or entity other than the corporation with respect to any direct or indirect compensation, reimbursement or indemnification in connection with service or action as a director that has not been disclosed in such written representation and agreement and agrees to promptly disclose to the Board any such agreement, arrangement or understanding (whether written or oral) with any person or entity other than the corporation with respect to any direct or indirect compensation, reimbursement or indemnification in connection with service or action as a director that such person becomes a party to at any time after the delivery of such written representation and agreement, and (iii) in such person’s individual capacity and on behalf of any person or entity on whose behalf the nomination is being made, would be in compliance, if elected as a director of the corporation, and will comply with, applicable law and all applicable rules of the securities exchanges upon which the securities of the corporation are listed and publicly disclosed corporate governance, conflict of interest, confidentiality and stock ownership and trading policies and guidelines of the corporation.  At the request of the corporation, each nominee for election as a director of the corporation must submit to the Secretary all completed and signed questionnaires required of directors and officers. With respect to any nominee for election as a director of the corporation, such nominee shall agree to the conditional resignation policy as set forth in Section 3.16 of these bylaws.

 

Notwithstanding anything in the fourth paragraph of this Section 3.1  to the contrary, in the event that the number of directors to be elected to the Board is increased effective at the annual meeting and there is no public announcement by the corporation naming the nominees for the additional directorships at least one hundred twenty (120) days prior to the first anniversary of the date of the previous year’s annual meeting of Stockholders, a Stockholder’s notice required by this Section 3.1 shall also be considered timely, but only with respect to nominees for the additional directorships, if it shall be received by the Secretary at the principal executive offices of the corporation not later than the close of business on the tenth (10th) day following the day on which such public announcement is first made by the corporation.

 

Nominations of persons for election to the Board may be made at a special meeting of Stockholders at which directors are to be elected pursuant to the corporation’s notice of meeting (i) by or at the direction of the Board or any committee thereof or (ii) provided that the Board has determined that directors shall be elected at such meeting, by any Stockholder of the corporation who is a Stockholder of record at the time of giving of notice of meeting pursuant to Section 2.4 and at the time

 

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of the meeting, who is entitled to vote at the meeting and upon such election and who complies with the notice procedures set forth in this Section 3.1 .  In the event the corporation calls a special meeting of Stockholders for the purpose of electing one or more directors to the Board, any such Stockholder entitled to vote in such election of directors may nominate a person or persons (as the case may be) for election to such position(s) as specified in the corporation’s notice of meeting, if the Stockholder’s notice required by the third paragraph of this Section 3.1 shall be received by the Secretary at the principal executive offices of the corporation not earlier than the close of business on the one hundred twentieth (120th) day prior to such special meeting and not later than the close of business on the later of the ninetieth (90th) day prior to such special meeting or the tenth (10th) day following the day on which public announcement is first made of the date of the special meeting and of the nominees proposed by the Board to be elected at such meeting.  In no event shall the public announcement of an adjournment or postponement of a special meeting commence a new time period (or extend any time period) for the giving of a Stockholder’s notice as described above.  Nominations pursuant to Section 3.1A of these bylaws may not be made in connection with a special meeting of Stockholders.

 

A Stockholder providing notice of any nomination proposed to be made at an annual meeting or special meeting of Stockholders shall further update and supplement such notice, if necessary, so that the information provided or required to be provided in such notice pursuant to this Section 3.1 shall be true and correct as of the record date for determining the Stockholders entitled to receive notice of the annual meeting or special meeting and such update or supplement shall be delivered to, and received by, the Secretary at the principal executive offices of the corporation not later than five (5) business days after the later of (i) the record date for determining the Stockholders entitled to receive notice of the annual meeting or special meeting and (ii) the date notice of such record date is first publicly disclosed.

 

In connection with any annual meeting of Stockholders (or, if and as applicable, any special meeting of the Stockholders), if the Chairman of the Board (or such other person presiding at such meeting in accordance with these bylaws) determines in good faith that a nomination was not made in accordance with the foregoing procedure (including whether the Stockholder or beneficial owner, if any, on whose behalf the nomination is made solicited (or is part of a group which solicited) or did not so solicit, as the case may be, proxies in support of such Stockholder’s nominee in compliance with such Stockholder’s Representation as required by this Section 3.1 ), he or she shall so declare to the meeting and the defective nomination may be disregarded by the Board.  Notwithstanding the foregoing provisions of this Section 3.1 , unless otherwise required by applicable law, if the Stockholder (or a qualified representative of the Stockholder) does not appear at the annual or special meeting of Stockholders of the corporation to present a nomination, such nomination shall be disregarded, notwithstanding that proxies in respect of such vote may have been received by the corporation.  For purposes of this Section 3.1 , to be considered a qualified representative of the Stockholder, a person must be a duly authorized officer, manager or partner of such Stockholder or must be authorized by a writing executed by such Stockholder or an electronic transmission delivered by such Stockholder to act for such Stockholder as proxy at the meeting of Stockholders and such person must produce such writing or electronic transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of Stockholders.

 

Compliance with Section 2.2 and this Section 3.1 shall be the exclusive means for a Stockholder to make nominations for director or submit other business to the Stockholders at an annual meeting (other than matters brought properly under and in compliance with Section 3.1A or Rule 14a-8 or other applicable rules and regulations under the 1934 Act).

 

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3.1A                       Proxy Access for Director Nominations.

 

(a)                            Proxy Access .  Whenever the Board solicits proxies with respect to the election of directors at an annual meeting of Stockholders, subject to the provisions of this Section 3.1A , the corporation shall include in its proxy statement for such annual meeting, in addition to any persons nominated for election by the Board, the name, together with the Required Information (defined below), of any person nominated for election (the “ Stockholder Nominee ”) to the Board by any Stockholder or group of Stockholders that satisfies the requirements of this Section 3.1A (such Stockholder or Stockholders, and any person on whose behalf they are acting, the “ Eligible Stockholder ”), and who expressly elects at the time of providing the notice required by this Section 3.1A (the “ Notice of Proxy Access Nomination ”) to have its nominee included in the corporation’s proxy materials (including the proxy card) pursuant to this Section 3.1A . For purposes of this Section 3.1A , the “ Required Information ” that the corporation will include in its proxy statement is the information provided to the Secretary of the corporation concerning each Stockholder Nominee and Eligible Stockholder that is required to be disclosed in the corporation’s proxy statement pursuant to Section 14 of the 1934 Act, and if the Eligible Stockholder so elects, a written statement, not to exceed 500 words, in support of the Stockholder Nominee(s)’ candidacy (the “ Statement ”). Notwithstanding anything to the contrary contained in this Section 3.1A , the corporation may omit from its proxy materials any information or Statement (or portion thereof) that it, in good faith, believes would violate any applicable law or regulation.

 

(b)                            Timeliness of Notice .  To be timely, the Notice of Proxy Access Nomination must be delivered to, and received by, the Secretary of the corporation no earlier than one hundred fifty (150) days and no later than one hundred twenty (120) days before the anniversary of the date that the corporation filed its proxy statement for the previous year’s annual meeting of Stockholders, or, solely in respect of the First Annual Meeting, not later than the close of business on the thirtieth (30 th ) day following the day on which notice of the date of the First Public Annual Meeting was mailed or public announcement of the date of the First Public Annual Meeting was first made, whichever first occurs; provided, however , that other than in respect of the First Public Annual Meeting, if the date of the annual meeting of Stockholders is called for more than thirty (30) days earlier or later than the anniversary date of the most recent annual meeting of Stockholders, then not later than the close of business on the earlier of (i) the tenth (10th) day after public announcement of the meeting date, or (ii) the sixtieth (60th) day prior to the date the corporation files its proxy statement in connection with the annual meeting of Stockholders. In no event shall the public announcement of an adjournment or postponement of an annual meeting of Stockholders commence a new time period (or extend any time period) for the giving of a Stockholder’s notice as described above.

 

(c)                             Maximum Number of Stockholder Nominees .

 

(i)                                      Maximum Number of Stockholder Nominees .  The maximum number of Stockholder Nominees nominated by all Eligible Stockholders that will be included in the corporation’s proxy materials with respect to an annual meeting of Stockholders shall not exceed 25% of the number of directors in office as of the last day on which a Notice of Proxy Access Nomination may be delivered pursuant to and in accordance with this Section 3.1A (the “ Final Proxy Access Nomination Date ”), or if such amount is not a whole number, the closest whole number below 25%, but not less than one. In the event that one or more vacancies for any reason occurs on the Board after the Final Proxy Access Nomination Date but before the date of the annual meeting and the Board resolves to reduce the size of the Board in connection therewith, the maximum number of Stockholder Nominees included in the corporation’s proxy

 

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materials shall be calculated based on the number of directors in office as so reduced.

 

(ii)                                   Persons Considered in Calculation of Maximum Number of Stockholder Nominees .  The following persons shall be considered Stockholder Nominees for purposes of determining when the maximum number of Stockholder Nominees provided for in this Section 3.1A has been reached: (1) any Stockholder Nominee whom the Board decides to nominate as a Board nominee, (2) with respect to any Stockholder meeting, any individual with respect to whom the Company receives notice pursuant to Section 3.1 of these bylaws that a Stockholder intends to nominate for election at such meeting, (3) any Stockholder Nominee who is subsequently withdrawn and (4) any director who had been a Stockholder Nominee at any of the preceding three annual meetings and whose reelection at the upcoming annual meeting is being recommended by the Board.

 

(iii)                                Ranking Stockholder Nominees .  Any Eligible Stockholder submitting more than one Stockholder Nominee for inclusion in the corporation’s proxy materials pursuant to this Section 3.1A shall rank such Stockholder Nominees based on the order that the Eligible Stockholder desires such Stockholder Nominees to be selected for inclusion in the corporation’s proxy statement. In the event that the number of Stockholder Nominees submitted by Eligible Stockholders pursuant to this Section 3.1A exceeds the maximum number of nominees provided for in this Section 3.1A , the highest ranking Stockholder Nominee who meets the requirements of this Section 3.1A from each Eligible Stockholder will be selected for inclusion in the corporation’s proxy materials until the maximum number is reached, whereby Eligible Stockholders disclosing the largest ownership of shares of common stock of the corporation in their respective Notice of Proxy Access Nomination submitted to the corporation receive priority based on the number of shares of common stock each Eligible Stockholder so disclosed as owned.  If the maximum number is not reached after the highest ranking Stockholder Nominee who meets the requirements of this Section 3.1A from each Eligible Stockholder has been selected, this process will continue as many times as necessary, following the same order each time, until the maximum number is reached.

 

(d)                            Ownership .  For purposes of this Section 3.1A , an Eligible Stockholder shall be deemed to “own” only those outstanding shares of common stock of the corporation as to which the Stockholder possesses Net Long Beneficial Ownership, as computed pursuant to the second paragraph of Section 2.3A(a)  of these bylaws.

 

(e)                             Required Ownership Percentage; Minimum Holding Period .  In order to make a nomination pursuant to this Section 3.1A , an Eligible Stockholder must have owned the Required Ownership Percentage (as defined below) of the corporation’s outstanding shares of common stock (the “ Required Shares ”) continuously for the Minimum Holding Period (as defined below) as of both the date the Notice of Proxy Access Nomination is received by the Secretary of the corporation in accordance with this Section 3.1A and the record date for determining the Stockholders entitled to vote at the annual meeting and must continue to own the Required Shares through the meeting date. For purposes of this Section 3.1A , the “ Required Ownership Percentage ” is 3% or more, and the “ Minimum Holding Period ” is three (3) years.

 

(f)                              Information to be Provided .

 

(i)                                      Information to be Provided by Eligible Stockholder . Within the time period specified in this Section 3.1A for delivering the Notice of Proxy Access Nomination, an

 

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Eligible Stockholder must provide the following information in writing to the Secretary:

 

(A)        one or more written statements from the record holder of the shares (and from each intermediary through which the shares are or have been held during the Minimum Holding Period) verifying that, as of a date within seven (7) calendar days prior to the date the Notice of Proxy Access Nomination is delivered to, and received by, the Secretary, the Eligible Stockholder owns, and has owned continuously for the Minimum Holding Period, the Required Shares, and the Eligible Stockholder’s agreement to provide, within five (5) business days after the record date for the annual meeting, written statements from the record holder and intermediaries verifying the Eligible Stockholder’s continuous ownership of the Required Shares through the record date;

 

(B)        a copy of the Schedule 14N that has been filed with the Securities and Exchange Commission as required by Rule 14a-18 under the 1934 Act;

 

(C)        the information, representations and agreements that are the same as those that would be required to be set forth in a Stockholder’s notice of nomination pursuant to Section 3.1 of these bylaws;

 

(D)        the consent of each Stockholder Nominee to being named in the proxy statement as a nominee and to serving as a director if elected;

 

(E)         a representation that the Eligible Stockholder (1) presently intends to maintain qualifying ownership of the Required Shares through the date of the annual meeting, (2) has not engaged and will not engage in, and has not and will not be a “participant” in another person’s, “solicitation” within the meaning of Rule 14a-1(l) under the 1934 Act in support of the election of any individual as a director at the annual meeting other than its Stockholder Nominee(s) or a nominee of the Board, and (3) agrees to comply with all applicable laws and regulations applicable to the use, if any, of soliciting material.

 

(F)          a representation as to the Eligible Stockholder’s intentions with respect to maintaining qualifying ownership of the Required Shares for at least one year following the annual meeting;

 

(G)        an undertaking that the Eligible Stockholder agrees to (1) assume all liability stemming from any legal or regulatory violation arising out of the Eligible Stockholder’s communications with the Stockholders of the corporation or out of the information that the Eligible Stockholder provided to the corporation and (2) indemnify and hold harmless the corporation and each of its directors, officers and employees individually against any liability, loss or damages in connection with any threatened or pending action, suit or proceeding, whether legal, administrative or investigative, against the corporation or any of its directors, officers or employees arising out of any nomination submitted by the Eligible Stockholder pursuant to this Section 3.1A .

 

(ii)                                   Information to be Provided by Stockholder Nominee .  Within the time period specified in this Section 3.1A for delivering the Notice of Proxy Access Nomination, each Stockholder Nominee must deliver to the Secretary of the corporation the representations, agreements and other information required by the sixth paragraph of Section 3.1 of these bylaws.

 

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(g)                             Notice of Defect .  In the event that any information or communications provided by the Eligible Stockholder or the Stockholder Nominee to the corporation or its Stockholders ceases to be true and correct in all material respects or omits a material fact necessary to make the statements made, in light of the circumstances under which they were made, not misleading, each Eligible Stockholder or Stockholder Nominee, as the case may be, shall promptly notify the Secretary of any defect in such previously provided information and of the information that is required to correct any such defect.

 

(h)                            Exclusions .  The corporation shall not be required to include in its proxy materials for any meeting of Stockholders, pursuant to this Section 3.1A , a Stockholder Nominee (i) for which the Secretary of the corporation receives a notice that a Stockholder has nominated such Stockholder Nominee for election to the Board pursuant to the advance notice requirements for Stockholder Nominees for director set forth in Section 3.1 of these bylaws, (ii) whose election as a member of the Board would cause the corporation to be in violation of the rules and listing standards of the principal securities exchanges upon which the shares of common stock of the corporation is traded, or any applicable state or federal law, rule or regulation, (iii) who is an officer or director of a competitor, as defined in Section 8 of the Clayton Antitrust Act of 1914, (iv) who is a named subject of a pending criminal proceeding (excluding traffic violations and other minor offenses) or has been convicted in such a criminal proceeding within the past ten (10) years, (v) if such Stockholder Nominee or the applicable Eligible Stockholder shall have provided information to the corporation in respect to such nomination that was untrue in any material respect or omitted to state a material fact necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading, as determined by the Board or any committee thereof, or (vi) the Eligible Stockholder or applicable Stockholder Nominee fails to comply with its obligations pursuant to this Section 3.1A in all material respects.

 

(i)                                Invalidity .  Notwithstanding anything to the contrary set forth herein, the Board or the chairman of the meeting of Stockholders shall declare a nomination by an Eligible Stockholder to be invalid, and such nomination shall be disregarded notwithstanding that proxies in respect of such vote may have been received by the corporation, if (i) the Stockholder Nominee(s) and/or the applicable Eligible Stockholder shall have breached its or their obligations under this Section 3.1A , as determined by the Board or the chairman of the meeting or (ii) the Eligible Stockholder (or a qualified representative thereof) does not appear at the meeting of Stockholders to present any nomination pursuant to this Section 3.1A .

 

(j)                               Group Membership .  No person may be a member of more than one group of persons constituting an Eligible Stockholder under this Section 3.1A .

 

(k)                            Restrictions on Successive Nominations .  Any Stockholder Nominee who is included in the corporation’s proxy materials for a particular annual meeting of Stockholders but either (i) withdraws from or becomes ineligible or unavailable for election at the annual meeting, or (ii) does not receive at least 25% of the votes cast in favor of such Stockholder Nominee’s election, will be ineligible to be a Stockholder Nominee pursuant to this Section 3.1A for the next two annual meetings. For the avoidance of doubt, this Section 3.1A(k)  shall not prevent any Stockholder from nominating any person to the Board pursuant to and in accordance with Section 3.1 of these bylaws.

 

3.2                                Enlargement and Vacancies

 

The number of members of the Board may be increased at any time as provided in Section 3.1 above.  Sole power to fill vacancies and newly created directorships resulting from any increase in the

 

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authorized number of directors shall be vested in the Board, and any directors so elected shall hold office until the next annual meeting of Stockholders after their election and until their successors are duly elected and qualified or until their earlier resignation, removal from office, death or incapacity; provided, however , that either the Board or the Stockholders may fill any vacancy resulting from Stockholder removal of a director.  If there are no directors in office, then an election of directors may be held in the manner provided by statute.  In the event of one or more vacancies in the Board, the remaining directors, except as otherwise provided by law or these bylaws, may exercise the powers of the full board until the vacancies are filled.

 

3.3                                Resignation and Removal

 

Any director may resign at any time upon written notice to the corporation at its principal place of business or to the Chief Executive Officer or the Secretary.  Such resignation shall be effective upon receipt of such notice unless the notice specifies such resignation to be effective at some other time or upon the happening of some other event.  Any director or the entire Board may be removed, with or without cause, by the holders of a majority of the shares then entitled to vote at an election of directors, unless otherwise specified in the Certificate of Incorporation.

 

3.4                                Powers

 

The business of the corporation shall be managed by or under the direction of the Board, which may exercise all such powers of the corporation and do all such lawful acts and things as are not by statute or by the Certificate of Incorporation or by these bylaws directed or required to be exercised or done by the Stockholders.

 

3.5                                Place of Meetings

 

The Board may hold meetings, both regular and special, either within or without the State of Delaware.

 

3.6                                Organizational Meetings

 

There shall be an organizational meeting of the Board each year for the purposes of organization, the appointment of officers and the transaction of other business.  Organizational meetings shall be held at such time and place as may be determined from time to time by the Board.

 

3.7                                Regular Meetings

 

Regular meetings of the Board may be held without notice at such time and place as may be determined from time to time by the Board; provided , however , that any director who is absent when such a determination is made shall be given prompt notice of such determination.

 

3.8                                Special Meetings

 

Special meetings of the Board may be called by the Chairman of the Board, the Lead Director (if any), the Chief Executive Officer or the President, or by the Secretary on the written request of two or more directors, or by one director in the event that there is only one director in office.  Notice of the time and place, if any, of special meetings shall be delivered personally or by telephone to each director, or sent by first-class mail or commercial delivery service, or by electronic mail or other electronic means, charges prepaid, to such director’s business or home address as they appear upon the

 

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records of the corporation.  In case such notice is mailed, at least two (2) days’ notice shall be provided to each director prior to the time of holding of the meeting.  In case such notice is delivered personally or by telephone or by commercial delivery service, or electronic mail or other electronic means, at least twenty-four (24) hours’ notice shall be provided to each director prior to the time of the holding of the meeting.  A notice or waiver of notice of a meeting of the Board need not specify the purposes of the meeting.

 

3.9                                Quorum, Action at Meeting, Adjournments

 

At all meetings of the Board, a majority of directors then in office, but in no event less than one-third (1/3) of the entire Board, shall constitute a quorum for the transaction of business and the act of a majority of the directors present at any meeting at which there is a quorum shall be the act of the Board, except as may be otherwise specifically provided by law or by the Certificate of Incorporation.  For purposes of this Section 3.9 , the term “ entire Board ” shall mean the number of directors last fixed by directors in accordance with these bylaws.  If a quorum shall not be present at any meeting of the Board, a majority of the directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum shall be present.

 

3.10                         Action Without Meeting

 

Unless otherwise restricted by the Certificate of Incorporation or these bylaws, any action required or permitted to be taken at any meeting of the Board may be taken without a meeting, if all members of the Board consent thereto in writing or by electronic transmission, and the writings or electronic transmissions are filed with the minutes of proceedings of the Board.

 

3.11                         Telephone Meetings

 

Unless otherwise restricted by the Certificate of Incorporation or these bylaws, any member of the Board may participate in a meeting of the Board, as the case may be, by means of conference telephone or by any form of communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting shall constitute presence in person at the meeting.

 

3.12                         Committees

 

The Board may, by resolution, designate one or more committees, each committee to consist of one or more of the directors of the corporation.  The Board may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee.  In the absence or disqualification of a member of a committee, the member or members present at any meeting and not disqualified from voting, whether or not the member or members present constitute a quorum, may unanimously appoint another member of the Board to act at the meeting in the place of any such absent or disqualified member.  Any such committee, to the extent provided in the resolution of the Board, shall have and may exercise all the powers and authority of the Board in the management of the business and affairs of the corporation, and may authorize the seal of the corporation to be affixed to all papers which may require it; but no such committee shall have the power or authority in reference to (i) approving or adopting, or recommending to the Stockholders, any action or matter expressly required by the DGCL to be submitted to Stockholders for approval or (ii) adopting, amending or repealing any of these bylaws.  Any such committee shall have such name as may be determined from time to time by resolution adopted by the Board.  Each committee shall keep

 

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regular minutes of its meetings and make such reports to the Board as the Board may request.  Except as the Board may otherwise determine, any committee may make rules for the conduct of its business, but unless otherwise provided by the directors or in such rules, its business shall be conducted as nearly as possible in the same manner as is provided in these bylaws for the conduct of its business by the Board.

 

3.13                         Fees and Compensation of Directors

 

Unless otherwise restricted by the Certificate of Incorporation or these bylaws, the Board shall have the authority to fix the compensation of directors.  The directors may be paid their expenses, if any, of attendance at each meeting of the Board and may be paid a fixed sum for attendance at each meeting of the Board or a stated salary as director, or such other compensation as may be determined by the Board.  No such payment shall preclude any director from serving the corporation in any other capacity and receiving compensation therefor.  Members of special or standing committees may be allowed like compensation for attending committee meetings.

 

3.14                         Rights of Inspection

 

Any director shall have the right to examine the corporation’s stock ledger, a list of its Stockholders and its other books and records.

 

3.15                         Lead Director

 

The Board may designate a Lead Director from among its members from time to time, who shall be an independent director, with such duties and authority as determined by the Board.

 

3.16                         Conditional Resignation

 

The Board shall not nominate for election as director any candidate who has not agreed to tender, promptly following the annual meeting at which he or she is elected as director, an irrevocable resignation that will be effective upon (a) the failure to receive the required number of votes for reelection at the next annual meeting of Stockholders at which he or she faces reelection, and (b) acceptance of such resignation by the Board. In addition, the Board shall not fill a director vacancy or newly created directorship with any candidate who has not agreed to tender, promptly following his or her appointment to the Board, the same form of resignation.

 

If an incumbent director fails to receive the number of votes required for reelection, the Board (excluding the director in question) shall, within ninety (90) days after certification of the election results, decide whether to accept the director’s resignation, taking into account such factors as it deems relevant. Such factors may include, without limitation, the stated reason or reasons why Stockholders voted against such director’s reelection, the qualifications of the director (including, for example, whether the director is an “audit committee financial expert”), and whether accepting the resignation would cause the Company to fail to meet any applicable listing standards or would violate applicable state law. The Board shall promptly disclose its decision and, if applicable, the reasons for rejecting the resignation in a filing with the Securities and Exchange Commission.

 

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ARTICLE 4

 

Officers

 

4.1                                Officers Designated

 

The officers of the corporation shall be chosen by the Board and shall include a Chief Executive Officer, a Secretary and a Chief Financial Officer or Treasurer.  The Board may elect from among its members a Chairman of the Board and a Vice Chairman of the Board.  The Board may also choose a President, one or more Vice Presidents, one or more assistant Secretaries or assistant Treasurers and such other officers as the Board deems appropriate from time to time.  Any number of offices may be held by the same person, unless the Certificate of Incorporation or these bylaws otherwise provide.

 

4.2                                Appointment

 

The Board at its annual organizational meeting shall choose a Chief Executive Officer, a Secretary and a Chief Financial Officer or Treasurer.  Other officers may be appointed by the Board at such meeting, at any other meeting, or by written consent, or in such other manner as is determined by the Board.

 

4.3                                Tenure

 

Each officer of the corporation shall hold office until such officer’s successor is appointed and qualified, unless a different term is specified in the vote choosing or appointing such officer, or until such officer’s earlier death, resignation, removal or incapacity.  Any officer may be removed with or without cause at any time by the Board.  Any vacancy occurring in any office of the corporation may be filled by the Board, at its sole discretion.  Any officer may resign by delivering such officer’s written resignation to the corporation at its principal place of business or to the Chief Executive Officer or the Secretary.  Such resignation shall be effective upon receipt unless it is specified to be effective at some other time or upon the happening of some other event.

 

4.4                                Chairman and Vice Chairman

 

The Chairman of the Board, if any, shall preside at all meetings of the Board and of the Stockholders at which he or she shall be present.  The Chairman of the Board shall have and may exercise such powers as are, from time to time, assigned to him or her by the Board and as may be provided by law.  In the absence of the Chairman of the Board, the Vice Chairman of the Board, if any, shall preside at all meetings of the Board and of the Stockholders at which he or she shall be present.  The Vice Chairman of the Board shall have and may exercise such powers as are, from time to time, assigned to him or her by the Board and as may be provided by law.

 

4.5                                The Chief Executive Officer

 

Subject to such supervisory powers, if any, as may be given by the Board to the Chairman of the Board, the Chief Executive Officer (who may also be designated by the title of “President” unless a separate President shall be appointed) shall preside at all meetings of the Stockholders and the Board in the absence of the Chairman and Vice Chairman of the Board or if there be none, shall have general and active management of the business of the corporation and shall see that all orders and resolutions of the Board are carried into effect.  He or she shall execute bonds, mortgages and other contracts

 

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requiring a seal, under the seal of the corporation, except where required or permitted by law to be otherwise signed and executed and except to the extent that the other officers of the corporation may sign and execute documents when so authorized by these bylaws, the Board or the Chief Executive Officer.

 

4.6                                The President

 

The President, if any, shall, in the event there be no Chief Executive Officer or in the absence of the Chief Executive Officer or in the event of his or her disability or refusal to act, perform the duties of the Chief Executive Officer, and when so acting, shall have the powers of and be subject to all the restrictions upon the Chief Executive Officer.  The President shall perform such other duties and have such other powers as may from time to time be prescribed for such person by the Board, the Chairman of the Board, the Chief Executive Officer or these bylaws.

 

4.7                                The Vice President

 

The Vice President (or in the event there be more than one, the Vice Presidents in the order designated by the directors, or in the absence of any designation, in the order of their appointment), shall, in the absence of the President or in the event of his or her disability or refusal to act, perform the duties of the President, and when so acting, shall have the powers of and be subject to all the restrictions upon the President.  The Vice President(s) shall perform such other duties and have such other powers as may from time to time be prescribed for them by the Board, the Chairman of the Board, the Chief Executive Officer, the President or these bylaws.

 

4.8                                The Secretary

 

The Secretary shall attend all meetings of the Board and the Stockholders and record all votes and the proceedings of the meetings in a book to be kept for that purpose and shall perform like duties for the standing committees of the Board, when required.  The Secretary shall give, or cause to be given, notice of all meetings of Stockholders and special meetings of the Board, and shall perform such other duties as may from time to time be prescribed by the Board, the Chairman of the Board, the Chief Executive Officer, the President or these bylaws.  The Secretary shall have custody of the seal of the corporation, and the Secretary, or an Assistant Secretary, shall have authority to affix the same to any instrument requiring it, and, when so affixed, the seal may be attested by his or her signature or by the signature of such Assistant Secretary.  The Board may give general authority to any other officer to affix the seal of the corporation and to attest the affixing thereof by his or her signature.  The Secretary shall keep, or cause to be kept, at the principal executive office or at the office of the corporation’s transfer agent or registrar, as determined by resolution of the Board, a share register, or a duplicate share register, showing the names of all Stockholders and their addresses, the number and classes of shares held by each, the number and date of certificates, if any, issued for the same and the number and date of cancellation of every certificate surrendered for cancellation.

 

4.9                                The Assistant Secretary

 

The Assistant Secretary, or if there be more than one, any Assistant Secretaries in the order designated by the Board (or in the absence of any designation, in the order of their appointment) shall assist the Secretary in the performance of his or her duties and, in the absence of the Secretary or in the event of his or her inability or refusal to act, perform the duties and exercise the powers of the Secretary and shall perform such other duties and have such other powers as may from time to time be

 

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prescribed by the Board, the Chairman of the Board, the Chief Executive Officer, the President or these bylaws.

 

4.10                         The Chief Financial Officer

 

The Chief Financial Officer (who may also be designated by the separate title of “Treasurer” unless a separate Treasurer is appointed) shall consider the adequacy of, and make recommendations concerning, the capital resources available to the corporation to meet it projected obligations and business plans; report periodically to the Chief Executive Officer and the Board on financial results and trends affecting the business; have custody of the corporate funds and deposit and pay out such funds from time to time in such manner as may be prescribed by, or in accordance with the direction of, the Board; and shall perform such other duties and have such other powers as may from time to time be prescribed by the Board, the Chairman of the Board, the Chief Executive Officer, the President or these bylaws.

 

4.11                         The Treasurer and Assistant Treasurers

 

The Treasurer (if one is appointed) shall, (i) if a Chief Financial Officer is appointed, have such duties as may be specified by the Chief Financial Officer to assist the Chief Financial Officer in the performance of his or her duties, and (ii) otherwise perform such duties and have other powers as may from time to time be prescribed by the Board, the Chairman of the Board, the Chief Executive Officer, the President or these bylaws.  It shall be the duty of any Assistant Treasurers to assist the Treasurer in the performance of his or her duties and to perform such other duties and have other powers as may from time to time be prescribed by the Board, the Chairman of the Board, the Chief Executive Officer, the President or these bylaws.   If required by the Board, the Treasurer or the Assistant Treasurer shall give the corporation a bond in such sum and with such surety or sureties as shall be satisfactory to the Board, including without limitation a bond for the faithful performance of the duties of the office of the Treasurer, or Assistant Treasurer, and for the restoration to the corporation of all books, papers, vouchers, money and other property of whatever kind in the Treasurer’s or Assistant Treasurer’s possession or under the Treasurer’s or Assistant Treasurer’s control and belonging to the corporation.

 

4.12                         Other Officers

 

Such other officers as the Board may choose shall perform such duties and have such powers as from time to time may be assigned to them by the Board.  The Board may delegate to any other officer of the corporation the power to choose such other officers and to prescribe their respective duties and powers.

 

ARTICLE 5

 

Notices

 

5.1                                Delivery

 

Whenever, under the provisions of applicable law, or of the Certificate of Incorporation or these bylaws, written notice is required to be given to any director or Stockholder, it shall not be construed to mean personal notice, but: (a) such notice may be given by mail, addressed to such director or Stockholder, at such person’s address as it appears on the records of the corporation, with postage thereon prepaid, and such notice shall be deemed to be given at the time when the same shall

 

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be deposited in the United States mail or delivered to a nationally recognized courier service; and (b) unless written notice by mail is required by applicable law, such notice may also be given by commercial delivery service, electronic means or similar means addressed to such director or Stockholder at such person’s address as it appears on the records of the corporation, in which case such notice shall be deemed to be given when delivered into the control of the persons charged with effecting such transmission, the transmission charge to be paid by the corporation or the person sending such notice and not by the addressee.  Oral notice or other in-hand delivery, in person or by telephone, shall be deemed given at the time it is actually given.

 

5.2                                Waiver of Notice

 

Whenever any notice is required to be given under the provisions of applicable law or of the Certificate of Incorporation or of these bylaws, a waiver thereof in writing, signed by the person or persons entitled to said notice, whether before or after the time stated therein, shall be deemed equivalent thereto.  In addition to the foregoing, notice of a meeting need not be given to any director who signs a waiver of notice or a consent, or electronically transmits the same, to holding the meeting or an approval of the minutes thereof, whether before or after the meeting, or who attends the meeting without protesting, prior thereto or at its commencement, the lack of notice to such director.  All such waivers, consents and approvals shall be filed with the corporate records or made a part of the minutes of the meeting.

 

ARTICLE 6

 

Indemnification and Insurance

 

6.1                                Indemnification

 

(a)                            Each person who was or is made a party or is threatened to be made a party to or is involved in (as a witness or otherwise) any action, suit, arbitration, alternate dispute resolution mechanism, investigation, inquiry, administrative hearing or any other proceeding, whether civil, criminal, administrative or investigative in nature (hereinafter a “ proceeding ”), by reason of the fact that he or she or a person of whom he or she is the legal representative (in the event of death or disability of such person) is or was a director or officer of the corporation (or any predecessor) or is or was serving at the request of the corporation (or any predecessor) as a director, officer, employee, fiduciary, representative, partner or agent of another corporation or of a partnership, joint venture, trust, employee benefit plan sponsored or maintained by the corporation, or other enterprise (or any predecessor of any of such entities), whether the basis of such proceeding is alleged action or inaction in an official capacity as a director, officer, employee, fiduciary, representative, partner or agent or in any other capacity while serving as a director, officer, employee, fiduciary, representative, partner or agent, shall be indemnified and held harmless by the corporation to the fullest extent authorized by the DGCL, as the same exists or may hereafter be amended (but, in the case of any such amendment, only to the extent that such amendment permits the corporation to provide broader indemnification rights than said law permitted the corporation to provide prior to such amendment), against all expense, liability and loss (including attorneys’ fees, judgments, fines, ERISA excise taxes or penalties, and amounts paid or to be paid in settlement) reasonably incurred or suffered by such person in connection with such proceeding; provided, however , that except as provided in Section 6.1(c)  below, the corporation shall indemnify any such person seeking indemnification in connection with a proceeding (or part thereof) initiated by such person only if such proceeding (or part thereof) was authorized by

 

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the Board.  The right to indemnification conferred in this Section 6.1 shall be a contract right subject to the terms and conditions of this Article 6 .

 

(b)                            To obtain indemnification under this Section 6.1 , a claimant shall submit to the corporation a written request, including therein or therewith such documentation and information as is reasonably available to the claimant and is reasonably necessary to determine whether and to what extent the claimant is entitled to indemnification; provided , however , that the failure of a claimant to so notify the corporation shall not relieve the corporation of any obligation which it may have to the claimant under this Section 6.1 or otherwise except to the extent that any delay in such notification actually and materially prejudices the corporation.  Upon written request by a claimant for indemnification pursuant to the preceding sentence, a determination, if required by applicable law, with respect to the claimant’s entitlement thereto shall be made as follows: (i) if requested by the claimant, by “Independent Counsel” (as hereinafter defined), or (ii) if no request is made by the claimant for a determination by Independent Counsel, (A) by the Board by a majority vote of the “Disinterested Directors” (as hereinafter defined), even though less than a quorum, or (B) by a committee of Disinterested Directors designated by majority vote of the Disinterested Directors, even though less than a quorum, or (C) if there are no Disinterested Directors or the Disinterested Directors so direct, by Independent Counsel in a written opinion to the Board, a copy of which shall be delivered to the claimant, or (D) if a quorum of Disinterested Directors so directs, by the Stockholders.

 

In the event the determination of entitlement to indemnification is to be made by Independent Counsel at the request of the claimant, the Independent Counsel shall be selected by the Board unless there shall have occurred within two (2) years prior to the date of the commencement of the proceeding for which indemnification is claimed a “Change of Control” (as hereinafter defined), in which case Independent Counsel shall be selected by the claimant unless the claimant shall request that such selection be made by the Board.  In either event, the claimant or the corporation, as the case may be, shall give written notice to the other advising it of the identity of the Independent Counsel so selected.  The party so notified may, within ten (10) days after such written notice of selection shall have been given, deliver to the corporation or to the claimant, as the case may be, a written objection to such selection; provided , however , that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of “Independent Counsel” as defined in Section 6.6 , and the objection shall set forth with particularity the factual basis of such assertion.  If such written objection is so made and substantiated, the Independent Counsel so selected may not serve as Independent Counsel unless and until such objection is withdrawn or a court has determined that such objection is without merit.  If, within thirty (30) days after submission by the claimant of a written request for indemnification pursuant to Section 6.1(b) , no Independent Counsel shall have been selected and not objected to, either the corporation or the claimant may petition the Court of Chancery of the State of Delaware for resolution of any objection which shall have been made by the corporation or the claimant to the other’s selection of Independent Counsel or for the appointment as Independent Counsel of a person selected by the Court or by such other person as the Court shall designate, and the person with respect to whom all objections are so resolved or the person so appointed shall act as Independent Counsel hereunder.  The corporation shall pay any and all fees and expenses of Independent Counsel reasonably incurred in connection with acting pursuant to Section 6.1(b) , and the corporation shall pay all reasonable fees and expenses incident to the procedures of Section 6.1(b) , regardless of the manner in which such Independent Counsel was selected or appointed.  Upon the due commencement of any judicial proceeding pursuant to Section 6.1(c) , Independent Counsel shall be discharged and relieved of any further responsibility in such capacity (subject to the applicable standards of professional conduct then prevailing).

 

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If the person, persons or entity empowered or selected under this Section 6.1(b)  to determine whether the claimant is entitled to indemnification shall not have made a determination within ninety (90) days after receipt by the corporation of the request therefor, the requisite determination of entitlement to indemnification shall be deemed to have been made and the claimant shall be entitled to such indemnification, absent (i) a misstatement by the claimant of a material fact, or an omission of a material fact necessary to make the claimant’s statement(s) not materially misleading, in connection with the request for indemnification or (ii) a prohibition of such indemnification under applicable law.

 

If it is determined that the claimant is entitled to indemnification, the corporation shall pay the claimant within twenty (20) business days after such determination any then known amounts with respect to which it has been so determined that the claimant is entitled to indemnification hereunder and will pay any other amounts thereafter incurred for which Indemnitee is entitled to indemnification within twenty (20) business days of the corporation’s receipt of reasonably detailed invoices for such amounts.

 

(c)                             In the event that (i) a determination is made pursuant to Section 6.1(b)  that the claimant is not entitled to indemnification, (ii) advancement of expenses is not timely made pursuant to Section 6.2 or (iii) a claim for indemnification under Section 6.1 is not paid in full by the corporation within twenty (20) business days after a determination has been made that the claimant is entitled to indemnification, the claimant may at any time thereafter bring suit against the corporation to determine his or her entitlement to such indemnification or advancement of expenses and, if successful in whole or in part, the claimant shall be entitled to be paid also the expense of prosecuting such claim.  If a Change of Control shall have occurred, in any judicial proceeding commenced pursuant to this Section 6.1(c) , the corporation shall have the burden of proving that the claimant is not entitled to indemnification.  It shall be a defense to any such action (other than an action brought to enforce a claim for expenses incurred in defending any proceeding in advance of its final disposition where the required undertaking, if any is required, has been tendered to the corporation) that the claimant has not met the standard of conduct that makes it permissible under the DGCL for the corporation to indemnify the claimant for the amount claimed, but the burden of proving such defense shall be on the corporation.  Neither the failure of the corporation (including the Board, Independent Counsel or Stockholders) to have made a determination prior to the commencement of such action that indemnification of the claimant is proper in the circumstances because he or she has met the applicable standard of conduct set forth in the DGCL, nor the fact that the corporation (including the Board, Independent Counsel or Stockholders) has determined that the claimant has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that the claimant has not met the applicable standard of conduct.  The termination of any action, suit or proceeding by judgment, order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the claimant has not met the applicable standard of conduct.

 

(d)                            If a determination shall have been made pursuant to this Section 6.1 that the claimant is entitled to indemnification, the corporation shall be bound by such determination in any judicial proceeding commenced pursuant to Section 6.1(c)  above, absent (i) a misstatement by the claimant of a material fact, or an omission of a material fact necessary to make the claimant’s statements not materially misleading in connection with a request for indemnification or (ii) a prohibition of such indemnification under applicable law.  The corporation shall be precluded from asserting in any judicial proceeding commenced pursuant to Section 6.1(c)  above that the procedures and presumptions of this Article 6 are not valid, binding and enforceable and shall stipulate in such proceeding that the corporation is bound by all the provisions of this Article 6 .

 

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(e)                             With respect to any proceeding for which indemnification is sought hereunder, so long as there shall not have occurred a Change of Control, the corporation, in its sole discretion, will be entitled to participate in such proceeding at its own expense and, except as provided below, to assume the defense of, and to settle, such proceeding.  After notice from the corporation to the claimant of its election so to assume the defense thereof, the corporation will not be liable to the claimant under this Article 6 for any legal or other expenses subsequently incurred by the claimant in connection with the defense thereof other than reasonable costs of investigation or as otherwise provided below.  The claimant shall have the right to employ its counsel in such proceeding but the fees and expenses of such counsel incurred after notice from the corporation of its assumption of the defense thereof shall be at the expense of the claimant unless (i) the employment of counsel by the claimant has been authorized by the corporation, (ii) the claimant shall have reasonably concluded that there may be a conflict of interest between the corporation and the claimant in the conduct of the defense of such proceeding or (iii) the corporation shall not in fact have employed counsel to assume the defense of such proceeding, in each of which cases the fees and expenses of counsel shall be at the expense of the corporation.  The corporation shall not be entitled to assume the defense of any proceeding brought by or on behalf of the corporation or as to which the claimant shall have made the conclusion provided for in clause (ii) of the immediately preceding sentence.  The claimant shall not compromise or settle any claim or proceeding, release any claim, or make any admission of fact, law, liability or damages with respect to any losses for which indemnification is sought hereunder without the prior written consent of the corporation, which consent shall not be unreasonably withheld (subject to the terms and conditions of this Article 6 , including any determination required by Section 6.1(b)  or by applicable law).  The corporation shall not be liable for any amount paid by the claimant in settlement of any proceeding or any claim therein, unless the corporation has consented to such settlement or unreasonably withholds consent to such settlement.

 

(f)                              If the claimant is a party to or involved in a proceeding with any other person(s) for whom the corporation is required to indemnify or advance expenses with respect to such proceeding, the corporation shall not be required to indemnify against or advance expenses for more than one law firm to represent collectively the claimant and such other person(s) in respect of the same matter unless the representation of the claimant and such other person(s) gives rise to an actual or potential conflict of interest.

 

6.2                                Advance Payment

 

The right to indemnification under this Article 6 shall include the right to be paid by the corporation the expenses incurred in defending any such proceeding in advance of its final disposition, such advances to be paid by the corporation within twenty (20) business days after the receipt by the corporation of a statement or statements from the claimant requesting and reasonably evidencing such advance or advances from time to time; provided, however , that if the DGCL requires, the payment of such expenses incurred by a director or officer in his or her capacity as a director or officer (and not in any other capacity in which service was or is rendered by such person while a director or officer, including, without limitation, service to an employee benefit plan) in advance of the final disposition of a proceeding, shall be made only upon delivery to the corporation of an undertaking by or on behalf of such director or officer to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified under Section 6.1 above or otherwise.

 

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6.3                                Non-Exclusivity and Survival of Rights; Amendments

 

The right to indemnification and the payment of expenses incurred in defending a proceeding in advance of its final disposition conferred in this Article 6 shall not be deemed exclusive of any other right which any person may have or hereafter acquire under any statute, provision of the Certificate of Incorporation, these bylaws, agreement, vote of Stockholders or Disinterested Directors or otherwise, both as to actions in such person’s official capacity and as to actions in another capacity while holding such office.  The indemnification and advancement of expenses provided by, or granted pursuant to, this Article 6 shall, unless otherwise provided when authorized or ratified, continue as to a person who has ceased to be a director, officer, employee or agent of the corporation and shall inure to the benefit of the heirs, executors and administrators of such a person.  Any repeal or modification of the provisions of this Article 6 shall not in any way diminish or adversely affect the rights or protections of any director, officer, employee or agent of the corporation hereunder in respect of any proceeding (regardless of when such proceeding is first threatened, commenced or completed) arising out of, or related to, any act or omission occurring prior to the time of such repeal or modification.

 

6.4                                Insurance

 

The corporation may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee, fiduciary, representative, partner or agent of another corporation or of a partnership, joint venture, trust, employee benefit plan sponsored or maintained by the corporation, or other enterprise (or any predecessor of any of such entities) against any expense, liability or loss asserted against such person and incurred by such person in any such capacity, or arising out of such person’s status as such, whether or not the corporation would have the power to indemnify such person against such liability under the provisions of the DGCL.

 

6.5                                Severability

 

If any word, clause, provision or provisions of this Article 6 shall be held to be invalid, illegal or unenforceable for any reason whatsoever: (i) the validity, legality and enforceability of the remaining provisions of this Article 6 (including, without limitation, each portion of any section or paragraph of this Article 6 containing any such provision held to be invalid, illegal or unenforceable, that is not itself held to be invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby; and (ii) to the fullest extent possible, the provisions of this Article 6 (including, without limitation, each such portion of any section or paragraph of this Article 6 containing any such provision held to be invalid, illegal or unenforceable) shall be construed so as to give effect to the intent manifested by the provision held invalid, illegal or unenforceable.

 

6.6                                Definitions

 

For the purpose of this Article 6 :

 

Change of Control ” shall mean:

 

(1)                                  the acquisition by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the 1934 Act (a “ Person ”)), directly or indirectly, of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the 1934 Act) of 20% or more of either (i) the then outstanding shares of common stock of the corporation (the “ Outstanding Corporation Common Stock ”) or (ii) the combined voting power of the then outstanding voting securities of the corporation entitled to vote generally in the election of

 

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directors (the “ Outstanding Corporation Voting Securities ”); provided, however , that for purposes of this part (1), the following acquisitions shall not constitute a Change of Control: (i) any acquisition directly from the corporation or any acquisition from other Stockholders where (A) such acquisition was approved in advance by the Board and (B) such acquisition would not constitute a Change of Control under part (2) or part (4) of this definition, (ii) any acquisition by the corporation, (iii) any acquisition by any employee benefit plan (or related trust) sponsored or maintained by the corporation or any corporation controlled by the corporation, or (iv) any acquisition by any corporation pursuant to a transaction that complies with clauses (i), (ii) and (iii) of part (4) of this definition; or

 

(2)                                  the acquisition by any Person, directly or indirectly, of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the 1934 Act) of 50% or more of either (i) the Outstanding Corporation Common Stock or (ii) the Outstanding Corporation Voting Securities; or

 

(3)                                  individuals who, as of the date hereof, constitute the Board (the “ Incumbent Board ”) cease for any reason to constitute at least a majority of the Board; provided, however , that any individual becoming a director subsequent to the date hereof whose election, or nomination for election by the Stockholders, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board (or such committee thereof that shall then have the authority to nominate persons for election as directors) shall be considered as though such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies of consents by or on behalf of a person other than the Board; or

 

(4)                                  consummation of a reorganization, merger or consolidation or sale or other disposition of all or substantially all of the assets of the corporation (a “ Business Combination ”), in each case, unless, immediately following such Business Combination, (i) all or substantially all of the individuals and entities who were the beneficial owners, respectively, of the Outstanding Corporation Common Stock and Outstanding Corporation Voting Securities immediately prior to such Business Combination beneficially own, directly or indirectly, more than 50% of, respectively, the then outstanding shares of common stock of the corporation and the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors, as the case may be, of the corporation resulting from such Business Combination (including, without limitation, a corporation that as a result of such transaction owns the corporation or all or substantially all of the corporation’s assets either directly or through one or more subsidiaries) in substantially the same proportions as their ownership, immediately prior to such Business Combination of the Outstanding Corporation Common Stock and Outstanding Corporation Voting Securities, as the case may be, (ii) no Person (excluding any corporation resulting from such Business Combination or any employee benefit plan (or related trust) of the corporation or such corporation resulting from such Business Combination) beneficially owns, directly or indirectly, 20% or more of, respectively, the then outstanding shares of common stock of the corporation resulting from such Business Combination or the combined voting power of the then outstanding voting securities of such corporation except to the extent that such ownership existed prior to the Business Combination, and (iii) at least a majority of the members of the board of directors of the corporation resulting from such Business Combination were members of the Incumbent Board at the time of the

 

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execution of the initial agreement, or of the action of the Board, providing for such Business Combination; or

 

(5)                                  approval by the Stockholders of a complete liquidation or dissolution of the corporation.

 

Disinterested Director ” shall mean a director of the corporation who is not and was not a party to the proceeding in respect of which indemnification is sought by the claimant.

 

Independent Counsel ” shall mean a law firm, a member of a law firm, or an independent practitioner, that is experienced in matters of corporation law and neither presently is, nor in the past five (5) years has been, retained to represent:  (i) the corporation or the claimant in any matter material to any such party, or (ii) any other party to the proceeding giving rise to a claim for indemnification hereunder.  Notwithstanding the foregoing, the term “Independent Counsel” shall not shall include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the corporation or the claimant in an action to determine the claimant’s rights under this Article 6 .

 

6.7                                Notices

 

Any notice, request or other communication required or permitted to be given to the corporation under this Article 6 shall be in writing and either delivered in person or sent by telecopy or other electronic transmission, overnight mail or courier service, or certified or registered mail, postage or charges prepaid, return copy requested, to the Secretary of the corporation and shall be effective only upon receipt by the Secretary.

 

ARTICLE 7

 

Capital Stock

 

7.1                                Certificates for Shares

 

The shares of capital stock of the corporation shall be represented by certificates or, where approved by the Board and permitted by law, shall be uncertificated.  Certificates representing shares of capital stock of the corporation shall be signed by, or in the name of the corporation by, the Chairman of the Board, the Chief Executive Officer, the President or a Vice President and by the Chief Financial Officer, the Treasurer or an Assistant Treasurer, or the Secretary or an Assistant Secretary of the corporation.  Certificates or uncertificated shares may be issued for partly paid shares and in the case of certificated shares, upon the face or back of the certificates issued to represent any such partly paid shares, the total amount of the consideration to be paid therefor, and the amount paid thereon shall be specified.

 

If the corporation shall be authorized to issue more than one class of capital stock of the corporation or more than one series of any class, the powers, designations, preferences and relative, participating, optional or other special rights of each class of stock or series thereof of the corporation and the qualifications, limitations or restrictions of such preferences or rights shall be set forth in full or summarized on the face or back of the certificate which the corporation shall issue to represent such class or series of stock, provided , however , that, except as otherwise provided in Section 202 of the DGCL, in lieu of the foregoing requirements, there may be set forth on the face or back of the certificate which the corporation shall issue to represent such class or series of stock, a statement that

 

29



 

the corporation will furnish without charge to each Stockholder who so requests the powers, designations, preferences and relative, participating, optional or other special rights of each class of capital stock of the corporation or series thereof and the qualifications, limitations or restrictions of such preferences or rights.

 

Within a reasonable time after the issuance or transfer of uncertificated stock, the corporation shall send to the registered owner thereof a written notice containing the information required by the DGCL or a statement that the corporation will furnish without charge to each Stockholder who so requests the powers, designations, preferences and relative participating, optional or other special rights of each class of capital stock of the corporation or series thereof and the qualifications, limitations or restrictions of such preferences or rights.

 

7.2                                Signatures on Certificates

 

Any or all of the signatures on a certificate may be a facsimile.  In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the corporation with the same effect as if he or she were such officer, transfer agent or registrar at the date of issue.

 

7.3                                Transfer of Stock

 

Shares of capital s tock of the corporation shall be transferable in the manner prescribed by applicable law and in these bylaws.  Transfers of stock shall be made on the books of the corporation only by the person named in the certificate or by such person’s attorney lawfully constituted in writing and upon the surrender of the certificate therefor, properly endorsed for transfer and payment of all necessary transfer taxes; provided, however, that such surrender and endorsement or payment of taxes shall not be required in any case in which the officers of the corporation shall determine to waive such requirement.  Every certificate exchanged, returned or surrendered to the corporation shall be marked “cancelled,” with the date of cancellation, by the Secretary or Assistant Secretary of the corporation or the transfer agent thereof.  No transfer of stock shall be valid as against the corporation for any purpose until it shall have been entered in the stock records of the corporation by an entry showing from and to whom transferred.

 

7.4                                Registered Stockholders

 

The corporation shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares to receive dividends, and to vote as such owner, and to hold liable for calls and assessments a person registered on its books as the owner of shares, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of any other person, whether or not it shall have express or other notice thereof, except as otherwise provided by the applicable laws of Delaware.

 

7.5                                Lost, Stolen or Destroyed Certificates

 

The corporation may direct that a new certificate or certificates or uncertificated shares be issued to replace any certificate or certificates theretofore issued by the corporation alleged to have been lost, stolen or destroyed, upon the making of an affidavit of that fact by the person claiming the certificate of stock to be lost, stolen or destroyed and on such terms and conditions as the corporation

 

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may require.  When authorizing the issue of a new certificate or certificates, the Board may, in its sole discretion and as a condition precedent to the issuance thereof, require the owner of the lost, stolen or destroyed certificate or certificates, or his or her legal representative, to advertise the same in such manner as it shall require, to indemnify the corporation in such manner as it may require, and to give the corporation a bond or other adequate security in such sum as it may direct as indemnity against any claim that may be made against the corporation with respect to the certificate alleged to have been lost, stolen or destroyed.

 

7.6                                Transfer and Registry Agents

 

The corporation may from time to time maintain one or more transfer offices or agencies and registry offices or agencies at such place or places as may be determined from time to time by the Board.

 

ARTICLE 8

 

General Provisions

 

8.1                                Dividends

 

Dividends upon the shares of capital stock of the corporation, subject to any restrictions contained in the DGCL or the provisions of the Certificate of Incorporation, if any, may be declared by the Board at any regular or special meeting or by unanimous written consent.  Dividends may be paid in cash, in property or in shares of capital stock of the corporation, subject to the provisions of the Certificate of Incorporation.  The Board may fix any record date for purposes of determining the Stockholders entitled to receive payment of any dividend as set forth in Section 2.11 above.

 

8.2                                Dividend Reserve

 

Before payment of any dividend, there may be set aside out of any funds of the corporation available for dividends such sum or sums as the Board from time to time, in its sole discretion, deems proper as a reserve or reserves to meet contingencies, equalizing dividends, or for repairing or maintaining any property of the corporation, or for such other purpose as the Board shall determine conducive to the interest of the corporation, and the directors may modify or abolish any such reserve in the manner in which it was created.

 

8.3                                Checks

 

Except as otherwise permitted in these bylaws, all checks or demands for money and notes of the corporation shall be signed by such officer or officers or such other person or persons as the Board may from time to time designate.

 

8.4                                Fiscal Year

 

The fiscal year of the corporation shall be fixed by resolution of the Board.

 

8.5                                Corporate Seal

 

The Board may, by resolution, adopt a corporate seal.  The corporate seal shall have inscribed thereon the name of the corporation, the year of its organization and the words “Corporate Seal,

 

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Delaware.”  The seal may be used by causing it or a facsimile thereof to be impressed or affixed or otherwise reproduced.  The seal may be altered from time to time by the Board.

 

8.6                                Execution of Corporate Contracts and Instruments

 

The Board, except as otherwise provided in these bylaws, may authorize any officer or officers, or agent or agents, to enter into any contract or execute any instrument in the name of and on behalf of the corporation; such authority may be general or confined to specific instances.  Unless so authorized or ratified by the Board or within the agency power of an officer, no officer, agent or employee shall have any power or authority to bind the corporation by any contract or engagement or to pledge its credit or to render it liable for any purpose or for any amount.

 

8.7                                Representation of Shares of Other Corporations

 

Each of the Chief Executive Officer, the President or any Vice President, the Chief Financial Officer or the Treasurer or any Assistant Treasurer, or the Secretary or any Assistant Secretary of the corporation is authorized to vote, represent and exercise on behalf of the corporation all rights incident to any and all shares of any corporation or corporations standing in the name of the corporation.  The authority herein granted to said officers to vote or represent on behalf of the corporation any and all shares held by the corporation in any other corporation or corporations may be exercised either by such officers in person or by any other person authorized so to do by proxy or power of attorney duly executed by said officers.

 

ARTICLE 9

 

Amendments

 

These bylaws may be altered, amended or repealed, in whole or in part, or new bylaws may be adopted by the Stockholders or by the Board.  Any such alteration, amendment, repeal or adoption must be approved by either the vote of the holders of a majority of the shares of capital stock of the corporation issued and outstanding and entitled to vote thereon or by the Board.

 

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Exhibit 10.6

 

 

Execution Version

 

 

Confidential Materials omitted and filed separately with the

 

 

Securities and Exchange Commission. Double asterisks denote omissions.

 

 

SECOND AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

between

 

Swedish Orphan Biovitrum AB (publ)

 

and

 

Biogen Idec Hemophilia Inc.

 

CONFIDENTIAL TREATMENT REQUESTED

FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE

 



 

 

Execution Version

 

TABLE OF CONTENTS

 

SECTIONS

 

1.

Definitions

2

2.

Management of Collaboration

26

3.

Product Selection, Development and Manufacture

30

4.

Sobi Opt-In; Post Opt-In Rights

43

5.

Names and Trademarks

62

6.

Additional Obligations

63

7.

Intellectual Property

64

8.

Payments

87

9.

Confidentiality

96

10.

Indemnification

101

11.

Insurance

104

12.

Representations and Warranties

104

13.

Limitation of Liability

106

14.

Term and Termination

106

15.

Dispute Resolution

114

16.

Miscellaneous

117

 

 

 

SCHEDULES

 

 

 

1.12

BIOGEN IDEC BACKGROUND PATENT RIGHTS

123

1.16

BIOGEN IDEC IMPROVEMENT PATENT RIGHTS

124

1.25

BIOGEN IDEC SOLE COLLABORATION PATENT RIGHTS

125

1.49

CORE COUNTRIES

126

1.66

FTE RATES

127

1.76

JOINTLY-OWNED PATENT RIGHTS

128

1.104

SOBI BACKGROUND PATENT RIGHTS

129

1.108

SOBI IMPROVEMENT PATENT RIGHTS

130

1.114

SOBI SOLE COLLABORATION PATENT RIGHTS

131

1.115

SOBI TERRITORY

132

3.3(A)

HIGH LEVEL DEVELOPMENT PLAN FOR THE LEAD PRODUCTS

133

 

APPENDIX A - TIMELINE OF PROPOSED LEAD PRODUCT DEVELOPMENT ACTIVITIES

134

 

APPENDIX B - OUTLINE BUDGETS FOR LEAD PRODUCTS

135

3.5

CERTAIN ADDITIONAL AGREED ACTIVITIES FOR THE LEAD PRODUCTS

136

4.1

REQUIREMENTS TO MAINTAIN SALES TERRITORY

137

4.2(J)

DISTRIBUTION TERMS

138

4.4(C)

SHARED SYSTEMS AND INFRASTRUCTURE EXPENSES

139

6

CERTAIN EXPORT PROVISIONS

140

8.1(F)(II)

ALLOCATION OF ROYALTIES TO AMUNIX

141

 

CONFIDENTIAL TREATMENT REQUESTED

FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE

 



 

 

Execution Version

 

THIS SECOND AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “ Agreement ”), dated as of April 10, 2014 (the “ Effective Date ”) is entered into between Swedish Orphan Biovitrum AB (publ), a Swedish corporation having a place of business at Tomtebodavägen 23A, Solna, Stockholm, SE-112 76, Sweden (“ Sobi ”) and Biogen Idec Hemophilia Inc., a Delaware corporation having a place of business at 14 Cambridge Center, Cambridge, MA 02142 USA (“ Biogen Idec ”).  Each of Sobi and Biogen Idec shall be referred to herein as a “ Party ,” and collectively as the “ Parties ”.

 

Recitals

 

A.             Biovitrum AB (“ Biovitrum ”), and Syntonix Pharmaceuticals, Inc. (“ Syntonix ”)  entered into that certain Development and Commercialization Agreement, dated January 6, 2006,  as amended as of December 30, 2006 (the “ Original Agreement ”), to collaborate on the development and commercialization of mutually agreed-upon recombinant coagulation factors incorporating Fc-fusion protein technology (the “ Collaboration ”).

 

B.             Biovitrum and Syntonix entered into that certain Amended and Restated Development and Commercialization Agreement, dated as of February 17, 2010 (the “ 2010 Restated Agreement ”), which replaced the Original Agreement in its entirety.

 

C.             The 2010 Restated Agreement was amended by that certain Amendment No. 1, dated August 24, 2011 (the “ First Amendment ”), and that certain Amendment No. 2, dated October 23,  2011 (the “ Second Amendment ,” and collectively with the First Amendment, the “ Amendments ”).

 

D.             Following the execution of the Original Agreement, Biogen Idec Inc. acquired Syntonix and later renamed Syntonix as Biogen Idec Hemophilia Inc.  Following the 2010 Restated Agreement, Biovitrum merged with Swedish Orphan International Holding AB, changed Biovitrum’s name to Swedish Orphan Biovitrum AB (publ) and retained Swedish Orphan Biovitrum International AB (“ SOI ”) as a wholly-owned subsidiary.

 

E.              The Parties entered into a letter agreement dated December 30, 2011 concerning the assignment and delegation by Sobi to its subsidiary SOI of certain rights and obligations relating to Factor

 

CONFIDENTIAL TREATMENT REQUESTED

FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE

 

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Execution Version

 

IX under the 2010 Restated Agreement and providing for certain guaranties by Sobi to Biogen Idec relating thereto  (collectively, the “ SOI FIX Assignment and Guaranty ”). Pursuant to the SOI FIX Assignment and Guaranty, Sobi is appointed as SOI’s agent for the negotiation of amendments to the 2010 Restated Agreement relating to Factor IX, and SOI is bound by any such amendments negotiated by Sobi.

 

F.               The Parties desire to restate in one agreement the 2010 Restated Agreement and the Amendments and to make further amendments to simplify decision making, improve efficiency and better reflect the current situations of both Parties as set forth herein.

 

Agreement

 

In consideration of the Recitals and the mutual covenants set forth in this Agreement and other good and valuable consideration, the receipt of which is hereby acknowledged, the Parties hereby amend and restate the 2010 Restated Agreement, as amended by the Amendments, in its entirety as set forth below:

 

1.                                      Definitions.

 

1.1                                Additional Agreed Activities ” means, with respect to a Product, activities that the Parties have agreed pursuant to Section 3.5 or 4.3 to conduct on a shared-cost basis.   For the avoidance of doubt, Additional Agreed Activities may include activities that fall within the definitions of Commercialization, Development, Post Opt-In Development or Final Development, as well as other medical and post-approval development activities, Manufacturing and, to the extent initiated after Opt-In for such Product, life cycle management activities (such as additional vial strengths, improved transfer device, improved delivery device and new formulations).

 

1.2                                Additional Agreed Activities Expenses ” means, with respect to a Product, all expenses incurred by Biogen Idec or Sobi, as the case may be, in accordance with the Joint Development Plan, Joint Commercialization Plan, or Schedule 3.5 (with respect to the Lead Products), or as

 

CONFIDENTIAL TREATMENT REQUESTED

FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE

 

2



 

 

Execution Version

 

otherwise expressly agreed in writing by the Parties prior to Opt-In for such Product and set forth in the approved minutes of the JSC, with respect to the Additional Agreed Activities for such Product, measured as follows: [**].

 

1.3                                Affiliate ” means any corporation, company, partnership, joint venture and/or firm which controls, is controlled by, or is under common control with a specified person or entity.  For purposes of this Section 1.3, “ control ” shall mean (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity or voting interest with the power to direct the management and policies of such non-corporate entities.  The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entity.

 

1.4                                Amunix ” means Amunix Operating, Inc., along with its Affiliates.

 

1.5                                Amunix Agreements ” means, collectively, the Amunix Research Agreement and any Amunix License Agreement(s) in effect from time to time.

 

1.6                                Amunix License Agreement ” means an agreement between BIMA and Amunix for a commercial license to certain XTEN Constructs, which agreement is contemplated in the Amunix Research Agreement to take effect only upon BIMA’s exercise, at its discretion, of the applicable option under the Amunix Research Agreement.

 

1.7                                Amunix Licensed Technology ” has the meaning set forth in each applicable Amunix Agreement.

 

1.8                                Amunix Research Agreement ” means that certain Research Collaboration and Option Agreement dated March 24, 2011 by and between BIMA and Amunix Operating, Inc., as the

 

CONFIDENTIAL TREATMENT REQUESTED

FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE

 

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Execution Version

 

same may be amended from time to time; [**].

 

1.9                                BIMA ” means Biogen Idec MA Inc., a Massachusetts corporation that is, as of the Effective Date, the parent company of Biogen Idec.

 

1.10                         Biogen Idec Background IP ” means Biogen Idec Background Know-How and Biogen Idec Background Patent Rights.

 

1.11        “ Biogen Idec Background Know-How ” means all Information pertaining to Biogen Idec Platform Technology which (a) (i) is Controlled by Biogen Idec as of the Original Execution Date or (ii) first becomes Controlled by Biogen Idec at any time thereafter and is conceived, developed or acquired by Biogen Idec or its Affiliates during the Term outside of the Collaboration, and (b) is useful or necessary for the Development, Post Opt-In Development, Final Development, Manufacture or Commercialization of a Product(s).

 

1.12                         Biogen Idec Background Patent Rights ” means all Patent Rights Controlled by Biogen Idec covering inventions included in Biogen Idec Background Know-How, including the Patent Rights listed on Schedule 1.12 (which also identifies the [**] Patent Rights), as such Schedule may be updated from time to time by the JPT.

 

1.13                         Biogen Idec General Manufacturing Technology ” means any Information or Patent Rights Controlled by Biogen Idec directly related to the process development, analysis or manufacture of proteins other than Fc fusion proteins.

 

1.14                         Biogen Idec Improvement IP ” means Biogen Idec Improvement Know-How and Biogen Idec Improvement Patent Rights.

 

1.15                         Biogen Idec Improvement Know-How ” means any Collaboration Know-How, regardless of which Party conceived, developed or generated the Information, that constitutes an improvement (whether or not patentable) (i) only to any Biogen Idec Platform Technology and Biogen Idec General Manufacturing Technology, or (ii) to [**] portion of an XTEN Construct or otherwise to any Amunix Licensed Technology.

 

CONFIDENTIAL TREATMENT REQUESTED

FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE

 

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Execution Version

 

1.16                         Biogen Idec Improvement Patent Rights ” means all Patent Rights covering inventions included in Biogen Idec Improvement Know-How, including the Patent Rights listed on Schedule 1.16 , as such Schedule may be updated from time to time by the JPT.

 

1.17                         Biogen Idec Indemnified Parties ” means Biogen Idec and its Indemnified Parties.

 

1.18                         Biogen Idec IP ” means Biogen Idec Background IP, Biogen Idec Improvement IP, and Biogen Idec Sole Collaboration IP.  For the avoidance of doubt, for purposes of the license grants set forth herein, Biogen Idec IP does not include any Information or intellectual property rights relating to any product in respect of which Sobi has not exercised its Opt-In Right under Section 4.1(a) or to Biogen Idec General Manufacturing Technology, other than Biogen Idec General Manufacturing Technology that is necessary to enable Sobi to exercise its right to Manufacture Product hereunder.

 

1.19                         Biogen Idec Know-How ” means, collectively, the Biogen Idec Background Know-How, Biogen Idec Improvement Know-How and Biogen Idec Sole Collaboration Know-How.

 

1.20                         Biogen Idec Partner ” means any Sublicensee of Biogen Idec or of any of its Affiliates that (i) with respect to a country, has primary responsibility to the Regulatory Authority in such country for the conduct of a registrational study (i.e., a clinical study needed to support a Regulatory Approval in a country) for the Product, and (ii) is, or is contemplated to be, the MAH for the Product for such country.

 

1.21                         Biogen Idec Patent Rights ” means, collectively, the Biogen Idec Background Patent Rights, Biogen Idec Improvement Patent Rights and Biogen Idec Sole Collaboration Patent Rights.

 

1.22                         Biogen Idec Platform Technology ” means any Information or Patent Rights Controlled by Biogen Idec directly related to the function or structure of neonatal Fc receptor (FcRn), including those pertaining to [**].  For purposes of clarity, Compound Constructs are considered to be Biogen Idec Platform Technology or Biogen Idec Improvement Know-How, as applicable, not Jointly-Owned Know-How.

 

CONFIDENTIAL TREATMENT REQUESTED

FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE

 

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Execution Version

 

1.23                         Biogen Idec Sole Collaboration IP ” means Biogen Idec Sole Collaboration Know-How and Biogen Idec Sole Collaboration Patent Rights.

 

1.24                         Biogen Idec Sole Collaboration Know-How ” means any Collaboration Know-How that is conceived, developed and generated solely by employees, agents or contractors of Biogen Idec or its Affiliates, but excluding in all cases: (x) all Sobi Improvement Know-How, (y) all Biogen Idec Improvement Know-How, and (z) data and other Information  that is, or becomes, Jointly-Owned Know-How pursuant to Sections 4.1(d) or 4.2(c).

 

1.25                         Biogen Idec Sole Collaboration Patent Rights ” means all Patent Rights covering inventions conceived and reduced to practice solely by employees, agents or contractors of Biogen Idec or its Affiliates, which inventions are within the scope of, or made using, Collaboration Know-How, but excluding in all cases, Biogen Idec Improvement Patent Rights and Sobi Improvement Patent Rights.   The Biogen Idec Sole Collaboration Patent Rights include the Patent Rights listed on Schedule 1.25 , as such Schedule may be updated from time to time by the JPT.

 

1.26                         Biogen Idec Territory ” means all countries in the world, excluding the Sobi Territory, and shall comprise the Biogen Idec North America Territory, the Biogen Idec Direct Territory and the Biogen Idec Partner Territory, where the “ Biogen Idec North America Territory ” shall comprise the United States of America, Canada and Mexico, and their territories and possessions (including Guam, Northern Mariana Islands, Puerto Rico, and the United States Virgin Islands), the “ Biogen Idec Direct Territory ” shall comprise all such countries other than the Biogen Idec North America Territory and the Biogen Idec Partner Territory, and “ Biogen Idec Partner Territory ” shall mean all such countries, excluding the Biogen Idec North America Territory, where Biogen Idec engages a Biogen Idec Partner to Commercialize Product, in each case as may be adjusted pursuant to Sections 4.1(e), 4.5 and 14.3(a)(iii) hereof.

 

1.27                         Business Day ” means any day between and including Monday through Friday; provided , that, with respect to any payment to be made or notice to be provided hereunder by a Party, if the date on which such payment or notice is due falls on a national bank holiday in the country in

 

CONFIDENTIAL TREATMENT REQUESTED

FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE

 

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Execution Version

 

which the principal place of business of such Party is located, such payment or notice shall be due on the next day on which banks in such country are open for business.

 

1.28                         [**].

 

1.29                         “[**] Agreement ” means the Amended and Restated License Agreement between [**] and Biogen Idec (as successor in interest to Syntonix) dated [**], as amended by Amendment No. 1 dated as of [**], (and as further amended by the letter agreement between [**] and Biogen Idec (as successor in interest to Syntonix) dated [**] (the “[**] Letter Agreement ”)), as the same may be amended from time to time; provided, that Biogen Idec may not amend the [**] Agreement in any manner that adversely affects Sobi or its rights under this Agreement without Sobi’s prior written consent.

 

1.30                         “[**] Patent Rights ” means the Biogen Idec Patent Rights licensed from [**].

 

1.31                         cGCP ” or “ Good Clinical Practice ” means current Good Clinical Practices as specified in the United States Code of Federal Regulations Parts 50, 54, 56, 312 and 314, at the time of testing, and all FDA and ICH guidelines, including the ICH Consolidated Guidelines on Good Clinical Practices.

 

1.32                         cGLP ” or “ Good Laboratory Practice ” means current Good Laboratory Practices as specified in the United States Code of Federal Regulations at 21 CFR Part 58 at the time of testing and all applicable ICH guidelines.

 

1.33                         cGMP ” or “ Good Manufacturing Practice ” means current Good Manufacturing Practices and standards as provided for (and as amended from time to time) in European Community Directive 91/356/EEC (Principles and Guidelines of Good Manufacturing Practice for Medicinal Products) and in the Current Good Manufacturing Practice Regulations of the United States Code of Federal Regulations Title 21 (21 CFR Parts 210-211) in relation to the production of pharmaceutical intermediates and active pharmaceutical ingredients, as interpreted by ICH Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

 

CONFIDENTIAL TREATMENT REQUESTED

FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE

 

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1.34                         CMO Expenses ” means, with respect to each Product in respect of which Sobi exercises its Opt-In Right, all amounts paid by a Party to the relevant CMO to have Product Manufactured for the conduct of Development and, to the extent applicable, Post Opt-In Development.

 

1.35                         Coagulation Factor-Specific Claims ” means claims within the Biogen Idec Patent Rights or Sobi Patent Rights that are composition of matter, method of use or method of manufacture claims that are specific to one or more Compound Constructs (e.g., that do not pertain to constructs in general, Biogen Idec Platform Technology or Sobi or Biogen Idec General Manufacturing Technology); provided, however , that, (a)  if, pursuant to Section 3.1(c), a Compound Construct is offered to be included in the Collaboration, but the Parties do not agree to include such Compound Construct in the Collaboration within ninety (90) days thereafter, then such claims with respect to such Compound Construct shall not be included in Coagulation Factor-Specific Claims, unless such claims would otherwise be Coagulation Factor-Specific Claims; and (b) if this Agreement is terminated pursuant to Sections 14.2(a) or (b), such claims shall be limited to those specific to the Compound Constructs in the then-current Products.

 

1.36                         Collaboration IP ” means all Collaboration Know-How and Collaboration Patent Rights.

 

1.37                         Collaboration Know-How ” means all Information conceived, developed or generated by employees, agents or contractors of Sobi or Biogen Idec, or their Affiliates, during the course of performing activities under this Agreement.

 

1.38                         Collaboration Patent Rights ” means, collectively, the Biogen Idec Sole Collaboration Patent Rights, the Sobi Sole Collaboration Patent Rights, and the Jointly-Owned Patent Rights.

 

1.39                         Commercialization ” or “ Commercialize ” means, with respect to a Product  and a country, any and all activities directed to marketing, promoting, distributing, importing, offering to sell and/or selling such Product in such country, including market research, medical education programs, product related public relations, planning, detailing, marketing, distribution, creative development of visual sales aids, support of medical meetings, direct mail, e-marketing and e-detailing, media placement and advertising, field marketing events such as peer influence

 

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programs featuring medical thought leaders, educational grants, sales meetings, and pricing and reimbursement strategy and tactics; provided , that Commercialization excludes Development, Post Opt-In Development, Final Development and Manufacture.

 

1.40                         Commercially Reasonable Efforts ” means exerting such effort and employing such resources as would normally be exerted or employed by a global biopharmaceutical company for a product of similar market potential at a similar stage of its product life, taking into account, the phase of development of, and technical risks relating to, the product, the development and proprietary positions of Third Parties, the regulatory structure involved, the likely cost of goods, the competitiveness and size of the relevant marketplace, and the potential profitability of the product, when utilizing sound and reasonable scientific, business and medical practice and judgment in order to develop the product and bring it into commercial use as quickly as is reasonably possible.

 

1.41                         Committee ” means, as the context requires, each of the JSC and, to the extent that Sobi has exercised its Opt-In Right under Section 4.1(a) and is either duly paying, or has paid in full, the Opt-In Consideration, the JMDC and JCC.

 

1.42                         Competitive Product ” means [**].

 

1.43                         Compound Construct ” means [**].  Each of Factor IX:Fc Construct and Factor VIII:Fc Construct is a Compound Construct.

 

1.44                         Confidential Information ” means all Information, whether or not patentable, regarding a Party’s technology, products, business or objectives, which is designated as confidential in writing by the Disclosing Party, whether by letter or by the use of an appropriate stamp or legend, prior to or at the time any such information or material is disclosed to the Receiving Party.  Notwithstanding the foregoing, Information which is orally, electronically or visually disclosed by a Party, or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information of a Party (a) if the Disclosing Party, within thirty (30) days after such disclosure, delivers to the other Party a written document or documents

 

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describing the Information and referencing the place and date of such oral, visual, electronic or written disclosure and the names of the persons to whom such disclosure was made or (b) such Information is of the type that is customarily considered to be confidential by persons engaged in activities that are substantially similar to the activities being engaged in by the Parties pursuant to this Agreement.  Confidential Information of a Party shall include Confidential Information (as defined in the Confidentiality Agreement) disclosed by such Party pursuant to the Confidentiality Agreement.  The Products themselves shall not be considered Confidential Information of either Party.

 

1.45                         Confidentiality Agreement ” means the Confidentiality Agreement between the Parties dated June 1, 2004.

 

1.46                         Continuing HLDP Activities ” means Development activities that were described in the applicable HLDP and that are in process as of the Opt-In or designated in the HLDP as occurring following Opt-In.

 

1.47                         Continuing Party ” means the Non-Withdrawing Party or the Non-Breaching Party, as the case may be.

 

1.48                         Control ” or “ Controlled ” means, with respect to any item of Information or any intellectual property right, the possession (other than pursuant to this Agreement) of the right or ability of a Party or any of its Affiliates to grant to the other Party or a Third Party access to and/or a license under such item or right as provided herein without violating the terms of any agreement or arrangement with any Third Party existing before or after the Original Execution Date.

 

1.49                         Core Countries ” means the countries listed on Schedule 1.49 .  For clarity, the list of Core Countries set forth on Schedule 1.49 may be different for different types of patents, such as composition of matter patents, manufacturing process patents, methods of treatment, etc.

 

1.50                         Cost of Goods Sold ” or “ COGS ” means the fully-burdened aggregate reasonable direct and indirect costs and expenses incurred and recorded in manufacturing a Product consisting

 

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solely of:  (a) direct labor costs (salaries, wages, employee benefits, overtime costs and shift premiums); (b) direct materials (including raw materials and intermediates and packaging) costs; (c) operating costs of facilities and equipment (including start up and cleaning costs of production); (d) quality, release and in-process control costs; (e) charges for reasonable spoilage, scrap, obsolescence, or rework costs; (f) amounts (without markup) that are paid to a Third Party, in connection with the manufacture of such Product or any component thereof; (g) the reasonable allocation of facility overhead, both fixed and variable, to such manufacturing operation (including the allocable costs of administrators and managers overseeing manufacturing and production, materials management, storage and handling, manufacturing and employee training, insurance costs, and the cost of packaging and labeling, if applicable); and (h) tariffs, duties, excises, sales taxes or other taxes imposed and paid (excluding national, state or local taxes based on income), in each case ((a) through (h)), to the extent specifically identifiable to the manufacture of such Product as determined in accordance with the applicable accounting standards.

 

1.51                         CTD ” means the Common Technical Document for the Registration of Pharmaceuticals for Human Use, intended for submission to the FDA or the EMA.

 

1.52                         Develop ” or “ Development ” means, with respect to a Product, any and all activities directed to the discovery, construct development, pre-clinical development, clinical development, and manufacturing process and formulation development; provided , that Development excludes Final Development, Manufacture, Commercialization and Post Opt-In Development.

 

1.53                         Development Expenses ” means, with respect to a Product, all expenses incurred by the Parties with respect to the Development of such Product, measured as follows: [**].

 

1.54                         Disclosing Party ” means the Party that releases, exchanges, or discloses Confidential Information.

 

1.55                         EMA ” means the European Medicines Agency or any successor agency thereto.

 

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1.56                         EMA Centralized Authorization Countries ” means the countries of the European Union (as it may expand or contract from time to time), Iceland, Liechtenstein and Norway, and any other countries that the EMA may acknowledge as included countries for purposes of centralized marketing authorizations at the relevant time.

 

1.57                         Executive Officer ” means (a) with respect to Biogen Idec, the President of Biogen Idec (or a senior executive officer of Biogen Idec designated by Biogen Idec’s President), and (b) with respect to Sobi, the President of Sobi (or a senior executive officer of Sobi designated by Sobi’s President).

 

1.58                         Expected Sobi Development Costs ” means, with respect to a Product, [**]% of the Development Expenses set forth in the budget in the then-current HLDP for such Product.

 

1.59                         Factor VIII:Fc Construct ” means a construct that includes the Fc portion of an immunoglobulin fused to Factor VIII or a derivative of Factor VIII.

 

1.60                         Factor IX:Fc Construct ” means a construct that includes the Fc portion of an immunoglobulin fused to Factor IX or a derivative of Factor IX.

 

1.61                         FDA ” means the U.S. Food and Drug Administration or any successor agency thereto.

 

1.62                         Final Development ” and “ Finalization ” means, with respect to a Product and a country, any and all activities directed to (a) the filing of the relevant Regulatory Filings and the obtaining of Regulatory Approval of such Product in such country or (b) pre-launch market development activities conducted prior to obtaining of Regulatory Approval of such Product, including [**]; provided ,  that Final Development excludes Development, Post Opt-In Development, Manufacture and Commercialization.

 

1.63                         Final Development Expenses ” means, with respect to a Product, all expenses incurred by Biogen Idec with respect to the Final Development of such Product, measured as follows: [**].  “ Sobi Final Development Expenses ” means Final Development Expenses incurred in accordance with the HLDP for mutually agreed Final Development activities solely for the

 

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benefit of the Sobi Territory, including all EMA application fees.

 

1.64                         First Commercial Sale ” means, with respect to a Product and a country, the first sale of such Product in such country by a Party or one of its Affiliates or Sublicensees to a Third Party in accordance with the laws and regulations of such country on arm’s length commercial terms.  Sales for test marketing, clinical trial purposes, Named Patient Supply, compassionate uses or similar use shall not be considered to constitute a First Commercial Sale.

 

1.65                         FTE ” means a full-time equivalent person year consisting of a total of [**] spent on or directly related to the Product.  The Parties may agree to utilize fractions of FTEs, if applicable.

 

1.66                         FTE Rate ” means the rates set forth on Schedule 1.66.

 

1.67                         HLDP ” means the High Level Development Plan applicable to a Product or Products, as further described in Section 3.3(a) and as agreed or amended by the Parties pursuant to Section 3.3(a).

 

1.68                         HLDP Principles ” means the principles for Product Development set out in Section 1 of each HLDP.

 

1.69                         IND ” means an application submitted to a Regulatory Authority to initiate human clinical trials, including (a) an Investigational New Drug application or any successor application or procedure filed with the FDA, (b) except where otherwise specifically provided in this Agreement, any foreign equivalent of the application described in clause (a), and (c) all supplements and amendments that may be filed with respect to the foregoing.

 

1.70                         Indemnified Parties ” means, with respect to a Party, such Party and such Party’s Affiliates and licensors of intellectual property sublicensed under this Agreement, and its and their respective officers, directors, shareholders, successors, assigns, agents, employees and insurers to the extent the same become subject to a claim in such capacity.

 

1.71                         Information ” means any and all technical, scientific and other know-how and

 

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information, inventions, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other intangible materials, including pre-clinical and clinical trial results, manufacturing procedures, test procedures, and purification and isolation techniques (whether or not confidential, proprietary, patented or patentable), and all tangible embodiments of any of the foregoing in written, electronic or any other form or other tangible materials that are used as research or development tools, such as assays and reference substances.  Information shall also include all clinical, technical and other relevant reports, records, data, information and materials relating to the Products and all Regulatory Filings and Regulatory Approvals for the Products.

 

1.72                         Joint Commercialization Plan ” means, with respect to a Product, the comprehensive, rolling multi-year integrated plan (including marketing, medical and market access plans) for Commercializing such Product, which shall include [**].  For clarity, the Joint Commercialization Plan shall include activities that are to be undertaken by the Parties separately for their respective Territories as well as activities that may be undertaken by the Parties jointly for the benefit of both Territories.

 

1.73                         Joint Development Plan ” means, with respect to a Product, a rolling multi-year plan for medical and development activities, including Post Opt-In Development and Final Development,  for a Product to be conducted after Sobi exercises its Opt-In Right for such Product, including [**]. For clarity, the Joint Development Plan shall include activities that are to be undertaken by the Parties separately for their respective Territories as well as activities that may be undertaken by the Parties jointly or for the benefit of both Territories. To the extent costs for any such activities shall be shared by the Parties, the Joint Development Plan shall also contain the budgets and the cost sharing ratios for such costs.

 

1.74                         Jointly-Owned IP ” means the Jointly-Owned Know-How and the Jointly-Owned Patent Rights.

 

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1.75                         Jointly-Owned Know-How ” means all Collaboration Know-How, other than Sobi Improvement Know-How and Biogen Idec Improvement Know-How: (a) that is conceived, developed or generated by (i) one or more employees, agents or contractors of Biogen Idec and/or its Affiliates and (ii) one or more employees, agents or contractors of Sobi and/or its Affiliates; or  (b) that comprises data and other Information that has been generated solely by employees, agents or contractors of one Party or its Affiliates, to the extent that such data and other Information is specified in Sections 4.1(d) or 4.2(c) as constituting  Jointly-Owned Know-How upon the fulfillment of the conditions set forth therein.

 

1.76                         Jointly-Owned Patent Rights ” means all Patent Rights covering inventions that are conceived and reduced to practice by (i) one or more employees, agents or contractors of Biogen Idec and/or its Affiliates and (ii) one or more employees, agents or contractors of Sobi and/or its Affiliates, which inventions are within the scope of, or made using, Collaboration Know-How, but excluding in all cases, Biogen Idec Improvement Patent Rights and Sobi Improvement Patent Rights.  The Jointly-Owned Patent Rights include the Patent Rights listed on Schedule 1.76 , as such Schedule may be updated from time to time by the JPT.

 

1.77                         Lead Product ” means, as applicable, either or both of the Factor VIII:Fc Product (“ Factor VIII:Fc Lead Product ”)  and the Factor IX:Fc Product (“ Factor IX:Fc Lead Product ”) that were the lead compounds in Biogen Idec’s Factor VIII:Fc Product program and Factor IX:Fc Product program, respectively, as of the Effective Date.

 

1.78                         MAH ” means, in connection with a grant of a Regulatory Approval for a Product, the marketing authorization holder.

 

1.79                         MAH Transition Period for EMA ” means, with regard to a specific Product, the period beginning the date upon which Biogen Idec receives a grant of centralized EMA approval for such Product and ending upon the first date that Sobi is registered as the MAH in the European Union for such Product.

 

1.80                         Major Market Country ” means [**].

 

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1.81                         Manufacture ” or “ Manufacturing ” means, with respect to a Product, process scale-up, validation, clinical and commercial manufacturing (including bulk manufacturing, finished pharmaceutical product manufacturing, and label-pack); provided , that Manufacturing excludes Development, Post Opt-In Development, Final Development and Commercialization.

 

1.82                         Manufacturing Expenses ” means:

 

(a)                                   [**];

 

(b)                                   [**];

 

(c)                                    [**].

 

1.83                         Named Patient Supply ” means the sale or other supply of a Product in a given country in the Territory prior to receipt of Regulatory Approval of such Product in such country and in accordance with the applicable laws of that country, directly or through an entity that is qualified to distribute unregistered pharmaceutical products in that country, on a “named-patient” basis to meet the special needs of particular patients under the order of, and at the specific request of, a medical practitioner.

 

1.84                         Net  Partner Revenue ” means [**].

 

1.85                         Net Sales ” means, with respect to a Product in a country during any calendar quarter, the amount invoiced by the Selling Party, its Affiliates, or its permitted Sublicensees (other than Biogen Idec Partners) for such Product ([**]) in such country for such period (including amounts received for Named Patient Supply or compassionate use), less the following deductions (to the extent such amounts are included in the amount invoiced for such Product):

 

(a)                                   trade, quantity, promotional and/or other customary discounts actually allowed and taken directly with respect to such sales;

 

(b)                                   rebates (including price reductions, rebates to social and welfare systems, chargebacks or reserves for chargebacks, managed care, cash rebate incentives, government

 

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mandated rebates and similar types of rebates, for example, Pharmaceutical Price Regulation Scheme, Medicaid);

 

(c)                                    tariffs, duties, excises, sales taxes or other taxes imposed and paid with respect to the production, sale, delivery or use of such Product (excluding national, state or local taxes based on income);

 

(d)                                   the amount of chargebacks, wholesaler and distributor administration fees, and amounts repaid or credited by reason of rejections, wastage, uncollectible amounts, damages or returns of goods, or because of retroactive price adjustments; and

 

(e)                                    charges for freight and insurance directly related to the distribution of Product, to the extent not already deducted or excluded from the gross amount invoiced.

 

Notwithstanding the foregoing, no discount, allowance, rebate, chargeback, or any similar amount, however designated, that is given or associated with the purchase by the Third Party of any product other than the Products, or with the purchase or provision of any service, shall be taken into consideration in calculating any deductions from the invoiced amount.

 

Such amounts shall be determined from the books and records of the Selling Party, its Affiliates or its permitted Sublicensees maintained in accordance with generally accepted accounting principles, consistently applied.

 

In the case of any sale of such Product for consideration other than (or in addition to) cash, such as barter or countertrade, Net Sales shall be calculated on the fair market value of the total consideration received.

 

If such Product is sold to any Third Party together with other products or services ([**]), the price of such Product, solely for purposes of the calculation of Net Sales, shall be deemed to be no less than the price at which such Product would be sold in a similar transaction to a Third Party not also purchasing other products or services.

 

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For avoidance of doubt, in the case of any sale of such Product between or among the Selling Party, its Affiliates, its permitted Sublicensees (other than Biogen Idec Partners) for resale, Net Sales shall be calculated as above only on the value charged or invoiced on the first arm’s length sale thereafter to a Third Party.

 

For the avoidance of doubt, Net Sales excludes any amounts received by Biogen Idec from Biogen Idec Partners.

 

1.86                         Non-Continuing Party ” means the Withdrawing Party or the Breaching Party, as the case may be.

 

1.87                         Non-Owning Party ” means, with respect to the Sobi IP, Biogen Idec, and, with respect to Biogen Idec IP, Sobi.

 

1.88                         North America ” means the United States of America (including its territories and possessions), Canada and Mexico.

 

1.89                         Opt-In ” means, with respect to a given Product, that Sobi has exercised its Opt-In Right for such Product.  For clarity, the phrases “prior to,” ‘upon,” “after” or “following Opt-In” means, respectively, prior to, upon, after or following the date upon which Sobi has exercised the relevant Opt-In Right, and similar phrases shall be construed in the same manner.

 

1.90                         Original Execution Date ” means January 6, 2006, the date the Original Agreement was executed.

 

1.91                         Owning Party ” means, with respect to the Biogen Idec IP, Biogen Idec, and, with respect to Sobi IP, Sobi.

 

1.92                         Patent Right ” means all patents (including all reissues, extensions, substitutions, confirmations, re-registrations, re-examinations, supplementary protection certificates and patents of addition) and patent applications (including all provisional applications, continuations, continuations-in-part and divisionals).

 

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1.93                         Post Opt-In Development ” means all Post-Marketing Commitments, Phase IV studies and other development activities conducted after Sobi’s exercise of its Opt-Right for a Product in respect of such Product other than Continuing HLDP Activities; provided , that Post Opt-In Development excludes Development, Final Development, Commercialization and Manufacture.

 

1.94                         Post Opt-In Development Expenses ” means, with respect to a Product, all expenses incurred by the Parties with respect to the Post Opt-In Development of such Product, measured as follows:  [**].

 

1.95                         Product ” means each product that is developed under the Collaboration, and contains one of the following:  (a) Factor IX:Fc Constructs (a “ Factor IX:Fc Product ”); (b) Factor VIII:Fc Constructs, (a “ Factor VIII:Fc Product ”); or (c) any other Compound Construct.  For clarity, any Compound Construct that is proposed to be a Product pursuant to Sections 3.1(c)(i) or 3.1(c)(ii) but is not elected by Sobi to be treated as a Product under the Collaboration shall be deemed to be a Product for purposes of Section 14.3 and any licenses granted to Biogen Idec hereunder.

 

1.96                         Receiving Party ” means a Party receiving the Disclosing Party’s Confidential Information.

 

1.97                         ReFacto Product ” means the B-domain deleted Factor VIII product manufactured by Sobi for sale by Pfizer Inc. and its Affiliates that is now known as “ReFacto” or “ReFacto AF” and all improvements thereof.

 

1.98                         Regulatory Approval ” means, with respect to a Product and a country, any and all approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations or authorizations of the applicable Regulatory Authority necessary for the use, storage, import, promotion, marketing and sale of such Product in such country, including approval of all relevant Regulatory Filings.

 

1.99                         Regulatory Authority ” means, with respect to a country, any governmental authority (whether federal, state, provincial, municipal or other) regulating the exportation, importation, use, manufacture, distribution, marketing and/or sale of pharmaceuticals, which, in the U.S., shall include the FDA and, in Europe, shall include the EMA.

 

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1.100                  Regulatory Filing ” means, with respect to a Product and a country or region, an application submitted to the relevant Regulatory Authority for marketing approval of such Product, including a biologics licensing application with respect to the United States and a marketing authorization application with respect to the EMA.

 

1.101                  Selling Party ” means (a) with respect to each country in the Biogen Idec Territory, Biogen Idec, and (b) with respect to each country in the Sobi Territory, Sobi.

 

1.102                  Sobi Background IP ” means Sobi Background Know-How and Sobi Background Patent Rights.

 

1.103                  Sobi Background Know-How ” means all Information which (a) (i) is Controlled by Sobi as of the Original Execution Date or (ii) first becomes Controlled by Sobi at any time thereafter and is conceived, developed or acquired by Sobi or its Affiliates during the Term outside of the Collaboration, and (b) is useful or necessary for the Development, Post Opt-In Development, Final Development, Manufacture or Commercialization of a Product(s).  Sobi Background Know-How shall exclude all Information relating to the ReFacto Product, other than Information that otherwise constitutes Sobi Background Know-How and was actually used by Sobi in the Manufacture of Factor IX:Fc Product or was embodied by Sobi in the Factor IX:Fc Product.

 

1.104                  Sobi Background Patent Rights ” means all Patent Rights Controlled by Sobi covering inventions included in Sobi Background Know-How, including the Patent Rights listed on Schedule 1.104 , as such Schedule may be updated from time to time by the JPT.

 

1.105                  Sobi General Manufacturing Technology ” means any Information or Patent Rights Controlled by Sobi directly related to the process development, analysis or manufacture of proteins, other than Fc fusion proteins and any Information or Patent Rights related to manufacture of the ReFacto Product (other than Information or Patent Rights that otherwise constitutes Sobi General Manufacturing Technology and was actually used by Sobi in the Manufacture of Factor IX:Fc Product or was embodied by Sobi in the Factor IX:Fc Product).

 

1.106                  Sobi Improvement IP ” means Sobi Improvement Know-How and Sobi Improvement

 

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Patent Rights.

 

1.107                  Sobi Improvement Know-How ” means all Collaboration Know-How, regardless of which Party conceived, developed or generated the Information, that constitutes an improvement (whether or not patentable) to only any Sobi General Manufacturing Technology.

 

1.108                  Sobi Improvement Patent Rights ” means all Patent Rights covering Sobi Improvement Know-How, including the Patent Rights listed on Schedule 1.108 , as such Schedule may be updated from time to time by the JPT.

 

1.109                  Sobi Indemnified Parties ” means Sobi and its Indemnified Parties.

 

1.110                  Sobi IP ” means Sobi Background IP, Sobi Improvement IP and Sobi Sole Collaboration IP.  For the avoidance of doubt, Sobi Background IP does not include any Information or intellectual property rights relating to the [**].

 

1.111                  Sobi Patent Rights ” means, collectively, the Sobi Background Patent Rights, Sobi Improvement Patent Rights and Sobi Sole Collaboration Patent Rights.

 

1.112                  Sobi Sole Collaboration IP ” means Sobi Sole Collaboration Know-How and Sobi Sole Collaboration Patent Rights.

 

1.113                  Sobi Sole Collaboration Know-How ” means any Collaboration Know-How that is conceived, developed and generated solely by employees, agents or contractors of Sobi or its Affiliates, but excluding in all cases: (x) all Biogen Idec Improvement IP, (y) all Sobi Improvement IP and (z) data and other Information that is, or becomes, Jointly-Owned Know-How pursuant to Sections 4.1(d) or 4.2(c).

 

1.114                  Sobi Sole Collaboration Patent Rights ” means all Patent Rights conceived and reduced to practice solely by employees, agents or contractors of Sobi or its Affiliates, which inventions are within the scope of, or made using, Collaboration Know-How, but excluding in all cases, Sobi Improvement Patent Rights and Biogen Idec Improvement Patent Rights. The Sobi Sole

 

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Collaboration Patent Rights include the Patent Rights listed on Schedule 1.114 , as such Schedule may be updated from time to time by the JPT.

 

1.115                  Sobi Territory ” means each country listed in Schedule 1.115 , as may be adjusted pursuant to Sections 4.1(e), 4.5 and 14.3(a)(iii) hereof, and the territories and possessions of such countries.

 

1.116                  Sole Collaboration IP ” means the Biogen Idec Sole Collaboration IP or the Sobi Sole Collaboration IP, as the context requires.

 

1.117                  Sublicensee ” means a Third Party to which a Party grants rights, or a license or sublicense under any Patent Rights or Know-How that it Controls, to conduct marketing and promotional activities for a Product in a country (and such Third Party conducts (i) significant marketing or promotional activities or (ii) any detailing activities), along with the right to offer for sale and sell such Product in such country.

 

1.118                  Sublicense Income ” means all amounts received by the Continuing Party or its Affiliates with respect to rights granted to Third Parties to Commercialize a relevant Terminated Product, but excluding :

 

(a)                                   [**]

 

(b)                                   [**]

 

(c)                                    [**]

 

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1.119                  Territory ” means, as of the relevant time, the Biogen Idec Territory and the Sobi Territory, as the context may require.

 

1.120                  Third Party ” means any person or entity other than Sobi, Biogen Idec or their respective Affiliates.

 

1.121                  XTEN Construct ” means any fusion protein that contains an unstructured polypeptide licensed to Biogen Idec under any of the Amunix Agreements and either (a) Factor VIII or a derivative of Factor VIII, or (b) Factor IX or a derivative of Factor IX.  XTEN Constructs developed and commercialized by or for Biogen Idec or its Affiliates, or its or their licensees or sublicensees, shall not be deemed to be Competitive Products.  The Parties agree that XTEN Constructs shall be treated as Compound Constructs under this Agreement and shall be subject to all terms and conditions hereof relating to Compound Constructs, except as expressly set forth in this Agreement.

 

1.122                  XTEN Election Consideration ” means, with respect to each XTEN Construct that Sobi elects to treat as a Product pursuant to Section 3.1(c)(ii), [**] plus [**] of the total amount paid by or due from Biogen Idec to Amunix under the Amunix Agreements in connection with such XTEN Construct for the period from the effective date of the Amunix Research Agreement until the date of Sobi’s election with respect to such XTEN Construct, [**].  For avoidance of doubt, such patent prosecution costs shall include the patent prosecution costs attributable to all of the Amunix Licensed Patents (as defined in the Amunix Research Agreement) other than those attributable to the Amunix Pre-Existing Product-Specific Patents and the Collaboration Construct Composition Patents specific to FVII (as defined in the Amunix Research Agreement).

 

1.123                  Other Defined Terms .  Each of the following definitions is set forth in the section of this Agreement indicated below:

 

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Definition:

 

Section:

Additional Cure Period

 

14.2(b)(ii)

Agreement

 

Preamble

Amendments

 

Recital C

Assuming Party

 

4.1(e)

Audited Party

 

8.4

Auditing Party

 

8.4

Batch

 

3.4(b)

Biogen Idec

 

Preamble

Biogen Idec Direct Territory

 

1.26

Biogen Idec North American Territory

 

1.26

Biogen Idec Partner Territory

 

1.26

Breaching Party

 

14.2(b)(i)

2010 Restated Agreement

 

Recital B

Biovitrum

 

Recital A

[**] Letter Agreement

 

1.29

Collaboration

 

Recital A

CRO

 

4.6

CSA

 

3.4(c)

Development Expense Cap

 

3.3(d)

Effective Date

 

Preamble

EMA Filing Date

 

4.1(a)

Escrow Payment

 

4.1(a)

Factor IX:Fc Lead Product

 

1.77

Factor IX:Fc Product

 

1.95

Factor VIII:Fc Lead Product

 

1.77

Factor VIII:Fc Product

 

1.95

First Amendment

 

Recital C

Future Latent Background IP

 

8.1(d)(ii)

 

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Definition:

 

Section:

Futer Latent Background IP Acquisition Date

 

8.1(d)(ii)

Global Safety Database

 

4.6

Initial Cure Period

 

14.2(b)(i)

Invalidity Claim

 

7.4(a)(vii)

JCC

 

2.3(a)

JMDC

 

2.4(a)

JPT

 

7.3(a)

JSC

 

2.2(a)

Kits

 

1.85

Marketing Rights Criteria

 

4.1(e)

Material Operational Change

 

3.3I

Non-Breaching Party

 

14.2(b)(i)

non-publishing Party

 

3.6a

Non-Withdrawing Party

 

14.2(a)

Opt-In Consideration End Date

 

4.1(b)(i)

Opt-In Data Package

 

4.1(a)

Opt-In Period

 

4.1(a)

Opt-In Right

 

4.1(a)

Original Agreement

 

Recital A

Party

 

Preamble

Parties

 

Preamble

Product-Related Infringement

 

7.4(a)(ii)

Product Trademark

 

5.1

Regulatory Filing Acceptance

 

14.3(a)(iii)

Representing Party

 

12.1

Safety Data Exchange Agreement

 

4.6

Safety Event

 

4.6

Second Amendment

 

Recital C

 

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Definition:

 

Section:

Severed Clause

 

16.6

Sobi

 

Preamble

Sobi Development Costs Baseline

 

3.3(d)

SOI

 

Recital D

SOI FIX Assignment and Guaranty

 

Recital E

Syntonix

 

Recital A

Term

 

14.1

Terminated Product

 

14.3(a)

US/EU Post-Approval Commitments

 

4.2(b)

Withdrawing Party

 

14.2(a)

 

2.                                      Management of Collaboration.

 

2.1                                General .  The goal of the Parties is to effectively and efficiently develop and commercialize the Products in a manner to maximize their commercial value. Subject to the terms and conditions of this Agreement and, if applicable, any supply agreement between the Parties, the Parties shall use their Commercially Reasonable Efforts to conduct their Development, Post Opt-In Development, Final Development, Manufacture and Commercialization activities to so maximize such commercial value for both Parties in the Territory.

 

2.2                                Steering Committee .

 

(a)                                   Committee .  The Parties shall establish a Joint Steering Committee (the “ JSC ”), comprised of three (3) representatives of Biogen Idec and three (3) representatives of Sobi, at least one of whom from each Party shall have experience and seniority sufficient to enable him or her to make decisions on behalf of the Party he or she represents.

 

(b)                                   Responsibilities .  The JSC shall be responsible for (i) reviewing and approving any changes to the HLDP Principles and/or Material Operational Changes, (ii) setting up and

 

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supervising the JMDC and JCC and any sub-committees of the JSC, in each case to the extent that Sobi has exercised its Opt-In Right under Section 4.1(a) and is either duly paying, or has paid in full, the Opt-In Consideration, (iii) reviewing, approving and overseeing humanitarian aid programs, and (iv) attempting to resolve disputes between the Parties. Subject to Section 15, the JSC and any Committee, including the JMDC and JCC, or sub-committee established by any Committee shall be the only forum for the discussion and resolution of matters that fall within such Committee’s respective range of responsibilities and, subject to the Parties’ mutual obligation to further the effectiveness of the Collaboration and save as expressly provided in this Agreement, neither Party shall be entitled to oblige the other Party to provide information or discuss Development or Commercialization strategy, tactics or expenditure outside such relevant forum. [**].

 

2.3                                Joint Commercialization Committee .

 

(a)                                   Committee .  To the extent that Sobi has exercised its Opt-In Right under Section 4.1(a), the Parties shall, within 30 days of Sobi’s exercise of its Opt-In Right, establish a Joint Commercialization Committee (the “ JCC ”), comprised of three (3) representatives of Biogen Idec and three (3) representatives of Sobi, at least one of whom from each Party shall have experience and seniority sufficient to enable him or her to make decisions on behalf of the Party he or she represents.  The initial representatives of each Party to the JCC shall be designated within thirty (30) days after the exercise of such Opt-In Right.

 

(b)                                   Responsibilities .  The JCC shall be responsible for:  (i) confirming and, if necessary, preparing updates and revisions to the Joint Commercialization Plan prepared by Biogen Idec prior to Sobi’s exercise of its Opt-In Right (X) promptly following Sobi’s Opt-In (if necessary) and (Y) annually, [**] of each year, thereafter; (ii) monitoring actual Commercialization activities and progress toward milestones for each Product against the relevant approved Joint Commercialization Plan for such Product; (iii) overseeing and evaluating geographic expansion, market access plans and global pricing and reimbursement strategies and tactics; (iv) identifying commercial gaps in the Product profile; (v) overseeing any subcommittee

 

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of the JCC; (vi) reviewing each Party’s core promotional and sales training materials; and (vii) assuming such other responsibilities as are set forth in this Agreement or as designated by the JSC.    For clarity, each Party shall be free, in its absolute discretion, to determine the price, if any, that it charges to Third Parties with respect to the sale of the Product in such Party’s Territory and the JCC shall have no role in setting such prices.  Promptly following the establishment of the JCC for a Product, the Parties shall agree upon a charter to establish further guidelines for the governance and activities of the JCC.

 

2.4                                Joint Medical & Development Committee .

 

(a)                                   Committee .  To the extent that Sobi has exercised its Opt-In Right under Section 4.1(a), the Parties shall, within 30 days of Sobi’s exercise of its Opt-In Right, establish a Joint Medical & Development Committee (the “ JMDC ”), comprised of three (3) representatives of Biogen Idec and three (3) representatives of Sobi, at least one of whom from each Party shall have experience and seniority sufficient to enable him or her to make decisions on behalf of the Party he or she represents.  The initial representatives of each Party to the JMDC shall be designated within thirty (30) days after the exercise of such Opt-In Right.

 

(b)                                   Responsibilities .  With respect to each Product for which Sobi has exercised its Opt-In Right, the JMDC shall be responsible for:  (i) confirming and, if necessary, preparing updates and revisions to the Joint Development Plan prepared by Biogen Idec prior to Sobi’s exercise of its Opt-In Right (X) promptly following Sobi’s Opt-In (if necessary) and (Y) annually, [**] of each year, thereafter; (ii) monitoring activities and progress under the Joint Development Plan; (iii) overseeing the Joint Regulatory Team, Joint Submissions Team, Joint Publications Team, and Joint Clinical Trial Review Committee, and any other subcommittee of the JMDC; (iv) overseeing the maintenance of all Regulatory Approvals, including the performance of US/EU Post-Approval Commitments;  (v) sharing regulatory correspondence and other information and planning for submissions for Regulatory Approvals that are filed after Sobi’s Opt-In; (vi) overseeing further medical and development work for such Product, including Post Opt-In Development; (vii) overseeing Phase IIIb and Phase IV studies, investigator-initiated

 

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studies, post-hoc data analyses, sponsored research arrangements, and other label enhancing activities; (viii) overseeing core data sheets, (ix) overseeing publications; and (x) assuming such other responsibilities as are set forth in this Agreement or as designated by the JSC.  Promptly following the establishment of the JMDC for a Product, the Parties shall agree upon a charter to establish further guidelines for the governance and activities of the JMDC.

 

2.5                                Committee Administration .

 

(a)                                   Subcommittees .  Each of the JSC, JMDC and JCC may, subject to the oversight of such Committee, form subcommittees as it deems appropriate to fulfill its responsibilities.

 

(b)                                   Changes to Representatives .  A Party may change any one or more of its representatives to a Committee at any time upon written notice to the other Party.  The number of representatives appointed by each Party to a Committee may be modified by mutual agreement of the Parties; provided , that at all times the number of representatives from each Party shall be equal.

 

(c)                                    Schedule and Minutes .  The representatives of each Committee will mutually agree on the schedule for meetings, it being understood that the JSC shall, prior to Sobi’s Opt-In with respect to a Product, meet quarterly or more frequently as directed by Biogen Idec and, following such Opt-In, quarterly or more frequently as the JSC itself shall decide.  A representative of the Party hosting a meeting of a Committee shall serve as secretary of that meeting.  The secretary of the meeting shall prepare and distribute to all members of such Committee minutes of the meeting within fifteen (15) days following the meeting to allow adequate review and comment.  Such minutes shall provide a description in reasonable detail of the discussions held at the meeting and a list of any actions, decisions or determinations approved by such Committee.  Minutes of such Committee’s meeting shall be approved or disapproved, and revised as necessary, at the next meeting of such Committee.  The final minutes of any subcommittee shall be provided to its overseeing Committee.  The final minutes of the JMDC and JCC shall be provided to the JSC.

 

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(d)                                   Location and Attendance .  With respect to each Committee, the location of meetings of such Committee shall alternate between Biogen Idec’s principal place of business and Sobi’s principal place of business, or as otherwise agreed by the Parties.  Each Committee may also meet by means of telephone conference call or videoconference, except that at least one (1) meeting per calendar year of each of the JSC, JCC and JMDC will be held in person.  Each Party shall use reasonable efforts to cause its representatives to attend the meetings of each Committee.  If a Party’s representative to a Committee is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative.  In addition, each Party may, at its discretion, invite non-voting employees, and, with the consent of the other Party, consultants or scientific advisors, to attend the meetings of a Committee.

 

(e)                                    Decision Making Process .  Each Party, acting through its representatives to a Committee, shall have one vote on such Committee.  Any decision of a Committee shall require the affirmative vote of both Parties, through their representatives to such Committee; provided , for avoidance of doubt, that this sentence shall not be construed to require affirmative votes of both Parties with respect to patent prosecution matters for which a Party is responsible or controls pursuant to Section 7.3 (Prosecution and Maintenance of Patent Rights). Any dispute shall be resolved in accordance with the provisions of Section 15, except that any dispute under the JMDC or JCC shall first be presented to the JSC.

 

3.                                      Product Selection, Development and Manufacture.

 

3.1                                Selection of Products .

 

(a)                                   The Lead Products shall be the first Products that the Parties plan to Develop, Finalize, Manufacture and Commercialize pursuant to this Agreement.

 

(b)                                   From time to time before the tenth (10 th ) anniversary of the First Commercial Sale of the first Product, either Party may present to the JSC another potential Compound Construct as a potential Product that the Parties may consider Developing, Finalizing, Manufacturing and Commercializing.  With respect to the consideration of any potential Product, each Party shall

 

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present such material information it possesses regarding Development, Final Development, Manufacture and Commercialization opportunities, risks and costs.  Each Party shall consider the information presented to the JSC with respect to each potential Product and, when requested by the other Party, shall determine whether such potential Product will be selected as a Product under this Agreement.  Unless and until such Party selects such potential Product as a Product, it shall not be considered a Product under this Agreement and neither Party shall have any obligation to the other Party with respect to such potential Product under this Agreement, except to the extent provided in Sections 3.1(c) and 3.2 below.

 

(c)                                    Election of Compound Constructs .

 

(i)                                       Compound Constructs other than XTEN Constructs. Subject to the terms of this subsection (c)(i), either Party may freely conduct pre-clinical and non-clinical discovery and research activities on Compound Constructs. Prior to the expiration of the Opt-In Period for a Product and, if Sobi has exercised its Opt-In Right under Section 4.1(a), thereafter, if Biogen Idec elects to transition a novel Compound Construct [**] that is included in such Product into IND enabling toxicology studies, Sobi shall have the option, exercisable within 120 days of Biogen Idec having provided Sobi with information reasonably sufficient to enable Sobi to reach a decision, to elect to treat such novel Compound Construct as a Product under the Collaboration. If Sobi does so elect, it shall pay Biogen Idec [**] and shall thereafter have the Opt-In Right in accordance with Section 4.1(a).  If Sobi does not so elect to treat such Compound Construct as a Product, or if Sobi, having elected to treat such Compound Construct as a Product, does not exercise its Opt-In Rights under Section 4.1(a) in respect of such Product, Biogen Idec shall be free to Develop, Finalize, Manufacture and Commercialize such Product at its own expense and the provisions of Section 14.3(a)(iii) shall apply as if Biogen Idec were the Continuing Party, except that Biogen Idec’s Territory as the Continuing Party shall not be expanded to include all countries of the world. If Sobi does not exercise its Opt-In Right with respect to the Lead Product

 

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containing the same plasma coagulation factor (including any truncated or other modified versions) that is included in such Product (or proposed, but not elected Product) containing such novel Compound Construct, then notwithstanding anything else Biogen Idec shall be free to Develop, Finalize, Manufacture and Commercialize globally such Product (or proposed, but not elected Product) containing such novel Compound Construct, without any royalty obligation to Sobi.

 

(ii)                                    Election of XTEN Constructs .  The following provisions shall apply to XTEN Constructs in lieu of Section 3.1(c)(i) of this Agreement:

 

(A)                                Subject to the terms of this Section 3.1(c)(ii), Biogen Idec may freely conduct pre-clinical and non-clinical discovery and research activities on XTEN Constructs pursuant to the Amunix Agreements.  Prior to the expiration of the Opt-In Period for the correlative Factor IX:Fc Lead Product or Factor VIII:Fc Lead Product and, if Sobi has exercised its Opt-In Right under Section 4.1(a) with respect to the correlative Factor IX:Fc Lead Product or Factor VIII:Fc Lead Product, thereafter, if Biogen Idec exercises its option under the Amunix Research Agreement for a commercial license to an XTEN Construct [**] that is contained in the Factor IX:Fc Lead Product or Factor VIII:Fc Lead Product, as applicable, Sobi shall have the option, exercisable within 120 days of Biogen Idec having notified Sobi of Biogen Idec’s exercise of Biogen Idec’s option under the Amunix Research Agreement and having provided Sobi with relevant pharmacokinetics and bioavailability data from in vitro and in vivo studies conducted by or on behalf of Biogen Idec and all available relevant Collaboration Data (as defined in the Amunix Research Agreement) provided to Biogen Idec from Amunix, to elect to treat such XTEN Construct as a

 

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Product under the Collaboration; provided , for avoidance of doubt, that the foregoing clause shall not be deemed to require Biogen Idec to generate any additional data or information.

 

(B)                                If Sobi does so elect, it shall pay Biogen Idec the XTEN Election Consideration for such Product and shall thereafter have the Opt-In Right in accordance with Section 4.1(a) with respect to such Product.  If Sobi elects to exercise such Opt-In Right, the Opt-In Consideration for such Product shall be equal to [**].

 

(C)                                If Sobi does not so elect to treat such XTEN Construct as a Product, or if Sobi, having elected to treat such XTEN Construct as a Product, does not exercise its Opt-In Rights under Section 4.1(a) in respect of such Product, Biogen Idec shall be free to Develop, Finalize, Manufacture and Commercialize such Product at its own expense and the provisions of Section 14.3(a)(iii) shall apply as if Biogen Idec were the Continuing Party, except that Biogen Idec’s Territory as the Continuing Party shall not be expanded to include all countries of the world. If Sobi does not exercise its Opt-In Right with respect to the correlative Factor IX:Fc Lead Product or Factor VIII:Fc Lead Product, as applicable, [**] that is included in the Product (or proposed, but not elected Product) containing such XTEN Construct, then notwithstanding anything else Biogen Idec shall be free to Develop, Finalize, Manufacture and Commercialize globally such Product (or proposed, but not elected Product) containing such XTEN Construct, without any royalty obligation to Sobi.

 

(d)                                   The Lead Products shall initially be developed for intravenous administration.  [**].

 

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3.2                                Exclusivity .

 

(a)                                   Subject to applicable law, neither Party nor its Affiliates shall directly or indirectly, alone or in collaboration with any Affiliate or Third Party, undertake the following other than in accordance with this Agreement:

 

(i)                                       except as permitted under Section 3.1(c), develop any Product that is being Developed, Finalized or Commercialized by the Parties in the Collaboration, or any Competitive Product of such Product, in each case until the First Commercial Sale of the relevant Product; provided, that the foregoing shall not apply to the development by Sobi and its Affiliates of manufacturing processes for the ReFacto Product, or

 

(ii)                                    except as permitted under Section 3.1(c), Commercialize in the Territory (A) any Product in respect of which Sobi has exercised or not declined to exercise its Opt-In Right under Section 4.1(a), or any Competitive Product of such Product, or (B) any Product that is being Commercialized by the Parties, or any Competitive Product of such Product, in each case during the Term.

 

3.3                                Development Tasks .

 

(a)                                   Following the election of a Compound Construct as a Product under Section 3.1, Biogen Idec shall develop an initial HLDP for the Product to address both the Biogen Idec and Sobi Territories for the Product, which HLDP shall be submitted to the JSC for approval.  Biogen Idec shall Manufacture, Develop and Finally Develop each Product for the United States and EU markets in accordance with the HLDP.

 

(i)                                       As of the Effective Date, the Parties agree on the HLDP contained herein as Schedule 3.3(a)  that addresses both the Biogen Idec and Sobi Territories for the Lead Products.

 

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(ii)                                    Each HLDP shall further define the development principles, operational plans and diligence obligations under which Biogen Idec will carry out Manufacturing, Development and Final Development activities and provide a non-binding budget for each Product.  Each such HLDP shall address and contain HLDP Principles that include, at a minimum, requirements that:

 

(A)                                [**]

 

(B)                                [**]

 

(C)                                [**]

 

(D)                                [**].

 

(iii)                                 [**].  Each updated HLDP shall reference this Agreement but shall not require an amendment to this Agreement.

 

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(b)                                   Biogen Idec shall have responsibility for, and shall be free to make, all operational Manufacturing, Development and Final Development decisions consistent with the principles established by the HLDP.  Biogen Idec shall take Sobi input from JSC meetings into account and shall have final decision-making authority for all Product Development, Manufacturing and Final Development decisions prior to Sobi’s Opt-In for such Product; provided, that Biogen Idec may not take any action that would conflict with the rights granted Sobi hereunder or conflict with the terms of this Agreement. On a periodic basis prior to Opt-In, but not more frequently than quarterly unless otherwise agreed by the JSC, Biogen Idec will update Sobi as to its progress on a Product-by-Product basis and solicit input from Sobi, particularly on matters pertaining to the Sobi Territory. Any input from Sobi on topics discussed in a JSC meeting shall be communicated by Sobi to Biogen Idec during the same JSC meeting unless a later timeframe for providing such input is agreed to and documented in the minutes of that JSC meeting.

 

(c)                                    Material Operational Changes and changes to the HLDP Principles may be made, only by mutual agreement of the Parties, except to the extent that Biogen Idec, in its reasonable discretion, determines that such Material Operational Change is a necessary condition for FDA and/or EMA Regulatory Approval of any Product or has been mandated by the FDA or EMA. “ Material Operational Change ” means [**].

 

(d)                                   Except to the extent resulting from changes to the HLDP approved by each Party or exceptional and unforeseen changes resulting from changes in applicable law relating to the Development activities or requirements of Regulatory Authorities, the Development Expenses for which Sobi shall partially reimburse Biogen Idec following exercise of its Opt-In Right for a

 

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Product, other than an XTEN Product, shall not exceed (i) [**]% of the applicable total Sobi Development Costs Baseline that is allocable to internal costs, and (ii) [**]% of the total applicable Sobi Development Costs Baseline that is allocable to external costs (the “ Development Expense Cap ”).   For clarity, the Opt-In Consideration for any XTEN Product is not subject to any Development Expense Cap. “ Sobi Development Costs Baseline ” means [**].

 

(e)                                    Biogen Idec shall provide Sobi quarterly reports of the Manufacturing, Development and Final Development Expenses incurred by Biogen Idec and of the material results of the Development. Such reports shall contain a level of detail that is consistent with the reports of Development Expenses provided by Biogen Idec immediately prior to the Effective Date with respect to similar phases of Development.

 

(f)                                     The Parties acknowledge that certain activities, as specifically agreed to by the Parties and listed on Schedule 3.3(f)  of the 2010 Restated Agreement, were performed by Sobi and reimbursed to Sobi by Biogen Idec as provided in the 2010 Restated Agreement.  Such Development Expenses reimbursed by Biogen Idec shall not be included in the Development Expenses used to calculate the Opt-In Consideration if Sobi exercises its Opt-In Right.

 

(g)                                    Subject to Sobi’s obligation to pay the Opt-In Consideration for each Product for which it exercises its Opt-In Right, Biogen Idec will fund all Development and Final Development specifically designed for the EU, through Regulatory Approval by the EMA; provided , for clarity, that Biogen Idec shall have no obligation to reimburse Sobi for any Development or Final Development expenses that Sobi incurs, unless specifically agreed by Biogen Idec on a case-by-case basis.

 

(h)                                   The Parties shall prepare, submit and transfer the Regulatory Filings for centralized marketing authorization in the EU as follows:

 

(i)                                       In accordance with the HLDP and in consultation with Sobi via quarterly meetings of the JSC, Biogen Idec will prepare and file the Regulatory Filing for centralized marketing authorization in the EU.  Such Regulatory Filing shall be

 

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based on the packaging design specified by Sobi. Biogen Idec will communicate its planned filing strategy to Sobi via the JSC and will provide the filing documents (except for such portions that the Parties may agree are not then required for the purpose of this review) to Sobi for review prior to filing.  If Sobi exercises its Opt-In Right in accordance with Section 4.1(a), Biogen Idec shall, within thirty (30) days after receiving a written request from Sobi following Biogen Idec’s receipt of the centralized marketing authorization from the EMA and, so long as the EMA does not object, submit an application and other documents required to transfer the centralized marketing authorization to Sobi (including changing the labeling to identify Sobi as the MAH), and use Commercially Reasonable Efforts to complete the transfer as soon as possible.  Concurrent with Sobi’s written request, Sobi shall provide all information and documents that are required to be submitted by a transferee to complete the application for the transfer of the marketing authorization, to the extent that such information is not already in Biogen Idec’s possession.  In the event of any delay on Sobi’s part in providing such documents or information, Biogen Idec shall be entitled to a day-for-day extension of the thirty (30) day period for submitting the application to transfer the centralized marketing application and related documentation.  Sobi acknowledges and agrees that Sobi shall be specified in the centralized marketing application as the party responsible for QP release in the European Union.

 

(ii)                                    If  Biogen Idec has determined that a variation should be submitted for the Product that is the subject of the centralized marketing application, Biogen shall consult with Sobi and, unless such variation is required to be submitted at that time to avoid interruptions of supply in the Biogen Idec Territory or to address safety issues, Biogen Idec shall submit such variation only after the prior written consent of Sobi, which consent shall not be unreasonably withheld. If such a variation has been submitted and not yet approved by the EMA, and the

 

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submission of such variation and the request for MAH transfer cannot be pursued simultaneously for regulatory reasons, or simultaneous submission would impact the timing for either approval of the variation or the MAH transfer, the Parties shall consult each other without undue delay and use good-faith efforts to agree upon an overall submission strategy and appropriate adjustment to the MAH transfer submission deadline.  In the event that failure to submit, or continue to seek approval of, such variation would be reasonably likely to result in an interruption of the supply of the Product in the Biogen Idec Territory, Biogen Idec shall have the right to submit and continue the pursuit of such variation, and to delay the MAH transfer submission pending approval by the EMA of such variation. Such delay of the MAH transfer submission shall not be deemed to be a breach of this Agreement by Biogen Idec.  If a proposed or pending variation is not reasonably likely to result in an interruption of the supply of the Product in the Biogen Idec Territory, and Sobi requires Biogen Idec to submit the application for MAH transfer prior to submission of  such a variation, or requires the retraction of a pending variation submission, Biogen Idec shall not be liable, and Sobi shall be responsible, for any interruption in supply of the Product in the Sobi Territory that arises as a consequence of such decisions on Sobi’s part.

 

(iii)                                 Sobi shall reimburse Biogen Idec for all expenses incurred by Biogen Idec in connection with the transfer of the centralized marketing authorization to Sobi, including internal expenses at the applicable FTE Rate and all amounts paid to Third Parties with respect to the transfer. Following the exercise of its Opt-In Right for a Product, Sobi shall have the sole right to submit all other Regulatory Filings seeking approval to sell such Product in all other jurisdictions in the Sobi Territory.

 

3.4                                Manufacturing .

 

(a)                                   Biogen Idec shall assume all manufacturing responsibilities for all Products

 

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through: (i) finished Product for Development use; (ii) finished pharmaceutical Product for commercial sale in the Biogen Idec Territory; and (iii) bulk drug substance and, if Biogen Idec and Sobi agree that Biogen Idec should also supply fill-finish and/or pack and label activities to Sobi, partially finished pharmaceutical product ready for country-specific labeling and final QP release by Sobi for commercial sale for the Sobi Territory.

 

(b)                                   With respect to supply of the Lead Products for Development, “ Batch ” means the quantity of drug substance produced under cGMP and in accordance with a defined set of release criteria, using with respect to the Factor VIII: Fc Lead Product,  [**].

 

(c)                                    For each Product in respect of which Sobi has exercised its Opt-In Right, Biogen Idec shall supply Product to Sobi pursuant to a commercial supply agreement (each, as it may be amended from time to time, a “ CSA ”) containing commercially reasonable terms to be negotiated by the Parties. [**].  Sobi will pay for Product intended to be used for Commercialization as set forth in the CSA. Subject to the terms of the CSA, Biogen Idec will retain full decision-making on manufacturing operations, [**], but subject to certain parameters agreed between the Parties pursuant to the JSC regarding:

 

(i)                                       forecasting, ordering, scheduling, and delivery consistent with the Joint Commercialization Plan;

 

(ii)                                    processes and procedures for handling and reporting product complaints, other than adverse event reporting;

 

(iii)                                 proposed changes to the Manufacturing process that would require any change to a Regulatory Approval in the Sobi Territory and the strategy for filing any such revised Manufacturing process with the appropriate Regulatory Authorities; and

 

(iv)                                capacity issues, in order to monitor and ensure secure supply.

 

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The CSA shall be concluded on a standard arm’s length basis and will in particular provide Sobi customary protection with regard to:

 

·                   forecasting and ordering

 

·                   specifications and quality

 

·                   defects and returns

 

·                   manufacturing process changes

 

·                   regulatory matters

 

·                   any change requiring a variation of a Regulatory Approval or notice to any Regulatory Authority; and

 

·                   to the extent that Sobi and Biogen Idec agree that Biogen Idec should supply finished or partially finished Product to Sobi, such other matters as are necessary to address any eventual supply of such finished or partially finished Product (rather than bulk drug substance) by Biogen Idec.

 

The Parties acknowledge that a CSA for the Factor VIII:Fc Lead Product was executed on or about May 2, 2013 and a CSA for the Factor IX:Fc Lead Product was executed on or about October 23, 2012.  The Parties further acknowledge that such CSAs do not contemplate the Parties’ respective rights and obligations set forth in Section 4.2(i) hereof relating to Named Patient Supply, and agree to use good-faith efforts to amend such CSAs as necessary to accommodate the objectives of this Agreement relating to Named Patient Supply. The Parties will use Commercially Reasonable Efforts to conclude and execute subsequent CSA for any subsequently developed Products no later than twelve (12) months prior to the estimate receipt of Regulatory Approval from the EMA for each such Product.

 

3.5                                Additional Agreed Activities Designated Before Opt-In . The Parties agree that it may, in some circumstances, be in each Party’s interest to avoid duplication of, and to coordinate,

 

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ongoing medical and development efforts and certain Commercialization activities for the Product that could impact both Parties’ Territories, and to share responsibility for costs of such activities that benefit the Territories of both Parties.  In furtherance of the foregoing, each Party may, prior to Opt-In for a Product, present to the JSC Commercialization and other activities that are not subject to the Parties’ then-existing obligations hereunder concerning Development  or Final Development, but which it believes are likely to be of material benefit to the Product profile in both the Biogen Idec Territory and the Sobi Territory.  To the extent the JSC determines prior to Opt-In that any such activities shall be Additional Agreed Activities, detailed plans to conduct such Additional Agreed Activities shall be set forth in the approved minutes of the JSC, along with budgets and the agreed cost sharing ratio for such activities.    The portion of the Additional Agreed Activities Expenses payable by Sobi that accrues prior to the Opt-In Consideration End Date will be added to the Opt-In Consideration as set forth in Sections 3.1(c)(ii)(B)(v) or 4.1(b)(iii), as applicable.  The portion of the Additional Agreed Activities Expenses payable by Sobi that accrues after the Opt-In Consideration End Date shall be paid as set forth in Section 4.4(b).  [**].

 

3.6                                Scientific Publications .

 

(a)                                   Biogen Idec shall have the right to make disclosures pertaining to the Development of Products in scientific journals or other publications. Following Sobi’s exercise of its Opt-In Right with respect to a Product, each Party shall have the right to make disclosures pertaining to the Development or Post Opt-In Development of such Product in scientific journals or other publications to the extent permitted by the JSC; provided , however, that neither Party may make disclosures in scientific journals or other publications that are based on, or contain, any data or other Information that is solely owned by the other Party, without the prior written consent of the other Party.  If so permitted, the publishing Party shall provide the other Party (the “ non-publishing Party ”) with an advance copy of the proposed publication, and the non-publishing Party shall then have fifteen (15) business days in which to recommend any changes it reasonably believes are necessary to preserve any Patent Rights or Information belonging in whole or in part to the non-publishing Party.  If the non-publishing Party informs the publishing

 

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Party that such publication, in the non-publishing Party’s reasonable judgment, could be expected to have a material adverse effect on any Patent Rights or Information belonging in whole or in part to the non-publishing Party, the publishing Party shall delay or prevent such publication.  In the case of Patent Rights, the delay shall be sufficiently long to permit the timely preparation and filing of a patent application.  In the case of Information, the Information shall be deleted from the publication, except where such Information is required to be published under applicable law.

 

(b)                                   With respect to pre-clinical discovery and research activities on Compound Constructs as permitted in Section 3.1(c), prior to the expiration of the Opt-In Period for the correlative Lead Product, and if Sobi has exercised its Opt-In Right under Section 4.1(a), thereafter, each Party must comply with the guidelines set forth in Section 3.6(a) with respect to disclosures pertaining to the pre-clinical discovery and research of such Compound Constructs in scientific journals or other publications to the extent permitted by the JSC.

 

3.7                                Other Pre-Opt-In Communications by Sobi .  Sobi may not communicate with KOLs, patient advocacy groups, payors, prescribers, nurses, pharmacists and scientific experts about a Product prior to Opt-In for such Product unless expressly permitted under an applicable HLDP and in accordance with any specific requirements set forth in such HLDP, and subject always to Section 9; provided , for avoidance of doubt, that permission to communicate with such groups shall not permit Sobi to discuss the operational aspects of any ongoing or planned Manufacturing, Development or Final Development.  Except to the extent expressly permitted in the HLDP, prior to Opt-In for a Product, Sobi shall not communicate with any Regulatory Authorities concerning such Product without Biogen Idec’s prior written consent, at its sole discretion.

 

4.                                      Sobi Opt-In; Post Opt-In Rights.

 

4.1                                Opt-In .

 

(a)                                   Opt-In Exercise . Following submission of the Regulatory Filing for a Product to

 

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the EMA by Biogen Idec (the “ EMA Filing Date ”) and the submission to Sobi of the Opt-In Data Package for such Product, Sobi shall have the right to take over the further Final Development and Commercialization of the relevant Product in the Sobi Territory (the “ Opt-In Right ”) in accordance with the terms of this Agreement, to be exercised no later than sixty (60) days after the later of the EMA Filing Date and Sobi’s receipt of the Opt-In Data Package. The period of time from the Effective Date until the earlier of the exercise or expiration of an Opt-In Right shall be referred to as an “ Opt-In Period .”  Upon exercise of the Opt-In Right, Sobi shall pay into escrow for the benefit of Biogen Idec the sum of US$10,000,000 (ten million US Dollars) for each Product in respect of which it exercises its Opt-In Right (the “ Escrow Payment ”) and the Parties shall transition Final Development and Commercialization of the relevant Product in the Sobi Territory from Biogen Idec to Sobi. “ Opt-In Data Package ” means a complete copy of the Regulatory Filing submitted to the EMA, statement of the Opt-In Consideration at the EMA Filing Date and supporting information in reasonable detail of all Manufacturing, Development, Final Development and Additional Agreed Activities Expenses included in the calculation of the Opt-In Consideration through the EMA Filing Date. Within thirty (30) days after receipt of an Opt-In Data Package, Sobi may, once only, request such additional information in Biogen Idec’s possession concerning the Development of the applicable Product as may be reasonably required to exercise the Opt-In Right.  Biogen Idec shall, within fifteen (15) days, either (i) confirm that it does not have such information or (ii) provide such information and the applicable Opt-In Right shall be extended, if necessary, so that Sobi has at least thirty (30) days to review such additional information and provided that the total Opt-In Period shall not be extended by more than fifteen (15) days.

 

(b)                                   Opt-In Consideration .  In consideration of Biogen Idec’s at-risk Manufacture, Development and Final Development of each Product in respect of which Sobi has exercised its Opt-In Right, Sobi shall, conditional upon grant of the centralized marketing authorization from the EMA for such Product (excluding pricing and reimbursement approval and any other Regulatory Approval required from any other Regulatory Authority in the Sobi Territory), become liable to pay the sum of:

 

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(i)                                       50% of the sum of all (A) Manufacturing Expenses incurred by Biogen Idec in the production and supply of clinical supplies of such Product, (B) subject to the applicable Development Expense Cap set forth in Section 3.3(d), Development Expenses (excluding the Development Costs reimbursed by Biogen Idec to Sobi pursuant to Section 3.3(f) of the 2010 Restated Agreement) for such Product incurred by Biogen Idec from 1 October 2009 (or, in the case of Products other than the Lead Product, the date of Sobi’s election under Section 3.1(c) to treat the applicable Compound Construct as a Product) through the earlier of (i) the transfer of the centralized marketing authorization to Sobi or (ii) ninety (90) days after receipt of the centralized marketing authorization from the EMA (excluding pricing and reimbursement approval and any other Regulatory Approval required from any other Regulatory Authority in the Sobi Territory) (the “ Opt-In Consideration End Date ”); and (C) Shared Final Development Expenses during such time period;

 

(ii)                                    100% of the Sobi Final Development Expenses incurred by Biogen Idec during such time period;

 

(iii)                                 Sobi’s portion of the Additional Agreed Activities Expenses during such time period; plus

 

(iv)                                Sobi’s share of the costs pursuant to Section 7.3(c)(ii) that have accrued, but are unpaid, as of the date of the applicable Opt-In Consideration End Date.

 

(the total amount described in clauses (i), (ii), (iii) and (iv) are referred to as the “ Opt-In Consideration ”).

 

Notwithstanding the foregoing, the Opt-In Consideration with respect to XTEN Constructs shall be as set forth in Section 3.1(c)(ii)(B).

 

The Escrow Payment, together with all interest thereon, shall be released from escrow and paid to Biogen Idec within three Business Days after the grant of centralized EMA approval

 

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for the relevant Product and shall be credited towards Sobi’s payment of the Opt-In Consideration.  The remainder of the Opt-In Consideration shall be payable in accordance with Section 8.1(b).  Costs incurred by Biogen Idec that apply to more than one Product shall be only reimbursed once by Sobi as part of the Opt-In Consideration.

 

(c)                                    If Sobi has not exercised the Opt-In Right for any Product within the applicable Opt-In Period, such Opt-In Right shall lapse and, with respect to that Product, Sobi shall be deemed to be the Non-Continuing Party and the provisions of Section 14.3(a)(iii) shall apply.   If the EMA centralized approval for any Product has not been granted within eighteen (18) months of the applicable EMA Filing Date, Sobi shall have the right to require that the Escrow Payment for such Product, together with interest thereon, be released from escrow and to revoke its Opt-In for such Product, in which case Sobi shall be deemed to be the Non-Continuing Party and the provisions of Section 14.3(a)(iii) shall apply.

 

(d)                                   Upon Sobi’s exercise of its Opt-In Right for a Product, all data and other Information generated by either Party in the course of Development or Final Development of such Product prior to Sobi’s Opt-In shall be deemed to be Jointly-Owned Know-How, and Section 7.2(b) shall apply thereto.  Promptly following Sobi’s exercise of its Opt-In Right for a Product, Biogen Idec shall give Sobi a copy of, or other reasonable means of access to, all such data and Information, to the extent not already included in the Opt-In Data Package for such Product, and Sobi shall provide Biogen Idec a copy of, or other reasonable means of access to, all such data and Information, to the extent not already provided to Biogen Idec.

 

(e)                                    Each Party’s right to Commercialize the Product in such Party’s Territory shall be subject to such Party possessing, directly or indirectly through its Affiliates or its or their Sublicensees or distributors, or in the case of Biogen Idec, through a Biogen Idec Partner, the capabilities and resources reasonably required to so Commercialize in such countries, including the capabilities and resources described in Schedule 4.1 hereof, [**] in the relevant country (the “ Marketing Rights Criteria ”).  At the applicable times specified in Schedule

 

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4.1 or, to the extent not specified therein, prior to filing the first Regulatory Filing in the relevant country in the Selling Party’s Territory, the Selling Party shall submit to the JSC (or if the JCC is reconstituted as a result of Sobi exercising its Opt-In Right pursuant to Section 4.1(a), the JCC)  its statement demonstrating compliance with the Marketing Rights Criteria.  The JSC (or the JCC) shall meet within forty-five (45) days after receipt of such statement to review such statement and to provide an opportunity for the other Party to provide input and advice to the Selling Party.  If the JSC (or the JCC) does not affirmatively determine, at the conclusion of this meeting, that the Selling Party has either satisfied the Marketing Rights Criteria or has put agreed upon plans in place to satisfy such criteria, then another meeting of the JSC (or the JCC) shall be scheduled within not less than sixty (60) days nor more than seventy-five (75) days.  The other Party shall, within 10 days after the initial meeting, provide to the Selling Party a written statement of what it regards as the critical and non-critical deficiencies of the plans.  Within forty-five (45) days after the receipt of such statement, the Selling Party shall provide a written response, including a plan to address within ninety (90) days (or such longer period as may be reasonably necessary due to the nature of the proposed remedy (e.g., the hiring of additional personnel)) what were identified by the other Party as critical deficiencies.  The JSC (or the JCC) shall review this plan and respond at the second meeting.  If the JSC does not affirmatively determine, at the conclusion of such meeting, that the Selling Party has either satisfied the Marketing Rights Criteria or has put agreed upon plans in place to satisfy such criteria, the provisions of Section 15 shall apply; provided , for clarity, that if the Parties do not mutually resolve such disagreement under Section 15.2, either Party may submit the matter to arbitration under Section 15.3.  If the Selling Party agrees, or if it is determined, through the dispute resolution procedures of Section 15, that the Selling Party has not satisfied the Marketing Rights Criteria with respect to a country(ies) in the Selling Party’s Territory, [**].

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4.2                                Post Opt-In Activities .

 

(a)                                   Joint Development Plan .

 

(i)                                       Following Sobi’s exercise of its Opt-In Right with respect to that Product, all Development, Post Opt-In Development and Final Development activities (including those designated as Additional Agreed Activities) for a Product, as well as further medical and development activities for such Product, shall be governed by the Joint Development Plan for such Product.  Any Continuing HLDP Activities will be incorporated into the Joint Development Plan.  For clarity, each Joint Development Plan shall specify all of the medical and development activities of each Party, whether to be conducted individually or jointly by the Parties, and shall specify which, if any, of such medical and development activities are Additional Agreed Activities.

 

(ii)                                    Biogen Idec shall prepare the first Joint Development Plan prior to Sobi’s exercise of its Opt-In Right.  Prior to [**] of each year, the JMDC shall update and the JSC shall approve the Joint Development Plan for each Product.  The JMDC may, from time to time, amend or modify the then-current Joint Development Plan.  Each Joint Development Plan shall contain sufficient details for each Party to conduct its typical budgeting activities.   Notwithstanding anything to the contrary in this Agreement, any Joint Development Plan prepared by Biogen Idec prior to Opt-In shall not be binding on Sobi to conduct any activities, or be responsible for any portion of any costs incurred, after the exercise of its Opt-In Right for a Product, except to the extent such Joint Development Plan is confirmed by the JMDC or JSC after Opt-In.

 

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(b)                                   Post-Approval Commitments and other Post Opt-In Development Activities .  Biogen Idec, in consultation with Sobi, will design and conduct all post approval clinical study activities that are required by both the FDA and the EMA as conditions to the Regulatory Approvals granted by such agencies and, if one such Regulatory Approval precedes the other, any activities that are reasonably likely to be conditions to both such Regulatory Approvals (collectively, “ US/EU Post-Approval Commitments ”) in accordance with the applicable Joint Development Plan.  Biogen Idec and Sobi will share [**]. Except as provided in the foregoing sentences and for Additional Agreed Activities, each Selling Party shall conduct, at its expense, all other clinical studies required as conditions to the Regulatory Approvals granted by Regulatory Authorities in its Territory;  provided , that if, at the time of Sobi’s Opt-In for a Product, Biogen Idec is conducting such a clinical study for such Product in the EU, Biogen Idec shall continue to be the sponsor of, and have regulatory responsibility for, such clinical study. The JMDC will consider and make decisions in which a clinical study sponsored in one Party’s Territory would benefit by recruiting patients in the other Party’s Territory.  Subject to proposing to the JSC or JMDC, as the case may be, that a study be an Additional Agreed Activity, each Party may conduct, at its own expense, Phase IV and other additional clinical studies in its Territory to support its post approval commercial efforts; however, the proposing Party shall not conduct clinical studies to which the other Party may reasonably object, following good-faith discussion of such clinical studies.  The clinical studies described on Schedule 3.5 shall be deemed Additional Agreed Activities, which studies shall be set forth in the Joint Development Plan following Opt-In, and the Parties shall share the costs of such studies in accordance with the terms set forth in Section 4.4 and Schedule 3.5 .  The sponsor for each such study shall be as set forth on Schedule 3.5 .   If either Party desires to conduct a clinical study comprising Post Opt-In Development, it shall notify the JMDC and provide the JMDC the protocol, estimated costs and cost sharing ratio and such other information as the JMDC may request so that the other Party may determine whether such study shall be an Additional Agreed Activity and to determine whether it has any reasonable objection to the conduct of such study.  If the other Party agrees to [**] of the costs for such study, it shall be deemed an

 

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Additional Agreed Activity.

 

(c)                                    Post Opt-In Development Data .  Each Party shall use Commercially Reasonable Efforts to maintain records in accordance with its standard procedures of all Post Opt-In Development activities conducted by it hereunder, and of all data and other Information resulting from such activities.  Each Party shall provide the JMDC or JCC, as appropriate, top-line results of all Post Opt-In Development activities promptly after completion of such activities and preparation of such top-line results.  For any Additional Agreed Activity that is [**] by the Parties, including any US/EU Post-Approval Commitments, the Party that is responsible for obtaining data and preparing analyses and reports concerning such data shall, in addition to providing the top-line results, make available to the other Party in a reasonable format the full data and any analyses and additional reports relating thereto.    Any data and other Information arising from an Additional Agreed Activity (whether commenced before or after Opt-In for the relevant Product) that is [**] will trigger access to the full data and analyses and additional reports, then such other agreed ratio) by the Parties or any US/EU Post-Approval Commitments shall be deemed to be Jointly-Owned Know-How, and the provisions of Section 7.2(b) shall apply thereto.  Any data and other Information arising from an Additional Agreed Activity that is [**] by the Parties, or from any Post Opt-In Development that is not an Additional Agreed Activity, shall be solely owned by the Party that generated such data and other Information, and accordingly shall constitute either Sobi Sole Collaboration Know-How or Biogen Idec Sole Collaboration Know-How, as applicable.   Notwithstanding anything herein, all safety data relating to a Product, regardless of how arising, shall be treated in accordance with the applicable Safety Data Exchange Agreement.

 

(d)                                   Joint Commercialization Plan .  Biogen Idec shall prepare the strategic elements of the first Joint Commercialization Plan prior to Sobi’s exercise of the Opt-In Right.  Following Opt-In, the Parties shall use Commercially Reasonable Efforts to develop the operational

 

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elements, and further refine or amend the strategic elements, of the Joint Commercialization Plan, within sixty (60) days of Opt-In.  Prior to [**] of each year, the JCC shall update and the JSC shall approve the Joint Commercialization Plan covering Commercialization activities for each Product.  The JCC may, from time to time, amend or modify the then-current Joint Commercialization Plans.  Each Joint Commercialization Plan shall contain sufficient details for each Party to conduct its typical budgeting activities.  For avoidance of doubt, each Joint Commercialization Plan shall specify all of the Commercialization Activities of each Party, whether to be conducted individually or jointly by the Parties, and shall specify which, if any, of such Commercialization Activities are Additional Agreed Activities. Notwithstanding anything to the contrary in this Agreement, any Joint Commercialization Plan prepared by Biogen Idec prior to Opt-In shall not be binding on Sobi to conduct any activities, or be responsible for any portion of any costs incurred, after the exercise of its Opt-In Right for a Product, except to the extent such Joint Commercialization Plan is confirmed by the JCC or JSC after Opt-In.

 

(e)                                    Commercialization Efforts .  Biogen Idec and Sobi, for each Product in respect of which Sobi has exercised its Opt-In Right, shall use Commercially Reasonable Efforts to (i) Commercialize the Products in their respective Territory in accordance with the then-current Joint Commercialization Plan; and (ii) compile, submit, and prosecute in a timely manner, in accordance with the relevant Joint Commercialization Plan, all necessary data, documents, Regulatory Filings (including labeling) and approvals of pricing and reimbursement in a format acceptable to the applicable Regulatory Authorities and reimbursement authorities in its Territory.

 

(f)                                     Appropriate Resources .  Each Party will maintain sufficient sales representatives and other resources to carry out in a timely manner its Commercialization obligations under this Agreement in such Party’s Territory.  Such sales representative organization will be appropriately dimensioned for the number of hemophilia-treating health care providers in each country in such Party’s Territory and will be appropriately targeted for the predominant prescribers of pharmaceuticals to treat hemophilia.  In performing all such Commercialization activities, each Party shall comply with all applicable laws, regulations and guidelines.

 

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(g)                                    Global Strategies .  To the extent permitted by law, the overall product positioning and marketing messages used by each Party will be consistent with the global strategic marketing plan approved by the JCC, and shall be included within the Joint Commercialization Plan.  Each Party may modify such marketing messages only to the extent required to respond to country-specific needs.  Such global strategic marketing plan will be designed to attempt to maximize the global revenues and profits from the sale of the Product.  The Parties shall jointly create centrally-developed branding elements (e.g., trademark use, trade dress and color schemes) for use with regard to the Products.

 

(h)                                   Core Materials .  Each Party will keep the JCC informed regarding the preparation of its core promotional materials and core materials for training sales representatives with respect to the Products and, to the extent determined by the JCC, will provide the JCC with copies of such materials in advance of distribution.  Each Party will consider in good faith any reasonable suggestions or comments made in a timely manner by the other Party on such materials. Each Selling Party shall have the right, at its own risk, to adapt and use the other Party’s promotional and training materials in the Commercialization of the Products in the Selling Party’s Territory, so long as the Selling Party develops most of the promotional and training materials for use in its Territory and only occasionally adapts the core promotional and training materials prepared by the other Party.  In the event that the Selling Party adapts and uses a substantial portion (as determined by the other Party) of the other Party’s materials, the Selling Party shall share all expenses associated with the development and production of such materials.  Upon the reasonable request of the Selling Party for such adaptation or to the extent that the Parties share the costs for development, the other Party shall provide the Selling Party with such core promotional and training materials in electronic format.

 

(i)                                       Named Patient Supply in the Sobi Territory of US-labeled Product .   Following the Opt-In for a Lead Product and receipt of FDA’s approval of the Regulatory Filing for such Lead Product, if either Party receives a request from a medical practitioner for Named Patient Supply in the Sobi Territory for such Lead Product, such Party shall notify the other Party.  At Sobi’s request prior to the EMA approval of the Regulatory Filing for the applicable Lead

 

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Product, Sobi may, at Sobi’s expense:

 

(i)                                       purchase from Biogen Idec and distribute finished pharmaceutical Lead Product labeled for sale in the United States  to fulfill such requests, and

 

(ii)                                    access and reference the United States Certificate of Pharmaceutical Product (“ CPP ”) and the United States Regulatory Filing approval letter (and related Regulatory Approvals) to the extent necessary to support relevant applications or registrations; provided , that such rights shall only apply to Named Patient Supply programs that begin prior to the EMA approval of the Regulatory Filing for such Lead Product and shall only continue until the date that is two (2)  years after such EMA approval for such Lead Product (unless such period is extended by Biogen Idec in writing, following reasonable discussion with Sobi).  Sobi shall, to the extent legally permitted, be responsible for all interactions and applications with the relevant Regulatory Authorities in connection with such Named Patient Supply.  Sobi shall be responsible for compliance with all applicable laws and regulations in connection with the conduct of such Named Patient Supply, including any applicable laws of the United States and the subject country.  Biogen Idec shall have the right, but not the obligation, to review and approve any filings or correspondence with Regulatory Authorities and to attend any meetings with Regulatory Authorities.  Sobi may not modify, alter or add to the labeling of the Lead Product, without the express written approval of Biogen Idec on a case-by-case basis.  For avoidance of doubt, Biogen Idec shall have no obligation to supply any ancillary items.  Biogen Idec shall supply the Lead Products for such use in accordance with terms of the applicable CSAs.  If Biogen Idec changes the manufacturing process for a Lead Product that is being supplied to Sobi for Named Patient Supply, or if the CPP is otherwise modified, Biogen Idec shall provide written notice to Sobi reasonably in advance, and Sobi shall be responsible for ensuring that any further Named Patient Supply of such Lead Product comply with applicable laws and regulations.  Biogen Idec shall have the

 

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right to terminate each Named Patient Supply program, including the supply therefor, upon written notice to Sobi if Biogen Idec believes, in its reasonable discretion, that such Named Patient Supply program is not compliant with applicable laws or regulations or has, or is likely to have, a material adverse effect on the Commercialization activities for the Lead Product anywhere in the Biogen Idec Territory.  For clarity, following EMA approval of the Regulatory Filing of any Product, Sobi shall be free to make Named Patient Supply in any country in the Sobi Territory of such Product approved by, and bearing an approved label of, any other country in the Sobi Territory.  Biogen Idec shall be free to make Named Patient Supply in any country in the Biogen Idec Territory of any Product approved by, and bearing an approved label of, any other country in the Biogen Idec Territory.

 

(j)                                      Post-Approval, Pre-Transfer Commercialization Activities for Lead Products in Europe .  Biogen Idec and Sobi shall establish a plan for the commercial launch of each Lead Product during the MAH Transition Period for EMA in certain of the EMA Centralized Approval Countries with Biogen Idec as the MAH and Sobi having the exclusive right to sell and distribute such Product in the Sobi Territory pursuant to a distribution agreement to be negotiated in good faith by the Parties and executed no later than six (6) months after the exercise of the Opt-In Right by Sobi.  Such distribution agreement shall contain, among other customary terms for such an interim arrangement, the terms set forth in Schedule 4.2(j).   For the avoidance of doubt, sales of the Lead Products by Sobi under such distribution agreements shall be deemed to be sales by Sobi for purposes of calculating royalties due to Biogen Idec under this Agreement, and Biogen Idec’s sale of Lead Products to Sobi for resale under such distribution agreement shall not be subject to royalties.   For any Products that are developed after the Lead Products, the JSC shall discuss whether a distribution arrangement should be negotiated for the EU depending on the anticipated timing of receipt of the EU centralized  marketing authorization for such Product and the estimated time that MAH transfer is anticipated to require.   Such discussions by the JSC shall begin no later than eighteen (18) months prior to the target date for

 

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the initial submission of an application for the EU centralized marketing authorization. If the JSC determines that a distribution arrangement would expedite timely market entry of such Product in the EU and is desirable to both Parties, the Parties shall negotiate in good faith the terms of a distribution agreement to facilitate such timely market entry following EMA approval.

 

(k)                                   Regulatory Interactions .  Following Sobi’s Opt-In for a Product, the Parties shall share information about material communications with Regulatory Authorities in their respective Territories and reasonably consider the other Party’s comments on such communications.  With respect to the preceding sentence and for purposes of clause (i) below, the “materiality” threshold shall be determined by the Joint Regulatory Team.  Without limiting the foregoing and in accordance with protocols and procedures established by the Joint Regulatory Team, the Parties shall:

 

(i)                                       share all material communications received from, or intended by a Party to be submitted to, a Regulatory Authority (e.g., submissions, contact reports, etc.) in a timely manner;

 

(ii)                                    for planned critical agency interactions (i.e., ones that require collaboration between the Parties rather than administrative interactions), the initiating Party must provide adequate notice to other Party to enable it to:

 

(A)                                participate in formulation of response;

 

(B)                                review written communications prior to submission; and

 

(C)                                to the extent permitted by the applicable Regulatory Authority, send a representative to attend key meetings with Regulatory Authorities (e.g., FDA, EMA).

 

unless the required contact with the Regulatory Authority is urgently required and imminent; and

 

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(iii)                                 for unplanned critical interactions, each Party should notify the other Party as soon as possible; and for clarity, any follow-on activities following such unplanned critical interaction should be handled as planned interactions pursuant to Section 4.2(k)(ii).

 

(l)                                       Rights of Reference .

 

(i)                                       To the extent necessary or useful to exercise Sobi’s rights under the license grants in Section 7.1(a), Biogen Idec hereby grants, and shall ensure that its Affiliates grant, to Sobi and its permitted Sublicensees a “right of reference or use” (as that term is defined in 21 C.F.R. §314.3(b), as amended from time to time), to Biogen Idec’s Regulatory Filings (including CPPs) for the United States, and Biogen Idec shall provide appropriate notification of Sobi’s access and reference rights to the applicable Regulatory Authorities requested by Sobi.

 

(ii)                                    To the extent necessary or useful to exercise Biogen Idec’s rights under the license grants in Section 7.1(b), Sobi hereby grants, and shall ensure that its Affiliates grant, to Biogen Idec and its permitted Sublicensees a “right of reference or use” under Article 10c of Directive 2001/83/EC, as amended, to Sobi’s Regulatory Filings (including CPPs) with respect to the EU, and Sobi shall provide appropriate notification of Biogen Idec’s access and reference rights to the applicable Regulatory Authorities requested by Biogen Idec.

 

(m)                               Regulatory Audits .  If a Regulatory Authority in the Selling Party’s Territory requests Information Controlled by the other Party that was not previously disclosed to such Selling Party or desires to conduct an inspection or audit of any facility in which any Development, Post Opt-In Development or Manufacturing activities were or are being carried out under this Agreement by or on behalf of the other Party or its Sublicensees  or any data (including Collaboration Know-How) generated in the conduct of such activities by or on behalf of the other Party or its Sublicensees, then, in addition to its obligations under Section 4.2(k) above, (a) such other Party shall provide in a timely manner such requested Information, and (b)

 

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such other Party shall cooperate, and cause any Third Party contractor to cooperate, with such Regulatory Authority during such inspection or audit.  Each Party agrees to use Commercially Reasonable Efforts to cause its Sublicensees and Third Party contractors to accept and abide by an audit mechanism substantially similar to the mechanism described in this Section 4.2(m).

 

4.3                                Additional Agreed Activities Designated After Opt-In . The Parties agree that it may, in some circumstances, be in each Party’s interest to avoid duplication of, and to coordinate, ongoing medical and development efforts and certain Commercialization activities for the Product that could impact both Parties’ Territories, and to share responsibility for costs of such activities that benefit the Territories of both Parties.  In furtherance of the foregoing, each Party may, following Opt-In, present to the JCC or JMDC, as appropriate, Commercialization activities or other activities that are not subject to the Parties’ then-existing obligations hereunder concerning Development or Final Development, but which it believes are likely to be of material benefit to the Product profile in both the Biogen Idec Territory and the Sobi Territory.   To the extent the JCC or JMDC, as applicable, determines that any such activities shall be Additional Agreed Activities, detailed plans to conduct such Additional Agreed Activities shall be set forth in the Joint Development Plan or the Joint Commercialization Plan, as applicable, along with budgets and the agreed cost sharing ratio for such activities.    The portion of the Additional Agreed Activities Expenses payable by Sobi that accrues prior to the Opt-In Consideration End Date will be added to the Opt-In Consideration as set forth in Section 4.1(b)(iii) or 3.1(c)(ii)(B)(v).    The portion of the Additional Agreed Activities Expenses payable by Sobi that accrues after the Opt-In Consideration End Date shall be paid as set forth in Section 4.4(b).  For clarity, Additional Agreed Activities conducted after Opt-In may be conducted by or at the direction of either Party as shall be set forth in the Joint Development Plan or Joint Commercialization Plan, as applicable.

 

4.4                                Post Opt-In Expenses .

 

(a)                                   General .  Except as otherwise expressly provided in this Agreement, including this Section 4.4, the election consideration under Sections 3.1(c)(i) and 3.1(c)(ii)(B), the Opt-In

 

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Consideration under Sections 3.1(c)(ii)(B) and 4.1(b), the Additional Agreed Activities under Sections 3.5 and 4.3, and Sections 4.2(b), 4.4, 4.6, 7.3 and 8.1(d), each Party shall bear the costs and expenses incurred by it to Finalize and Commercialize the Products in such Party’s Territory.

 

(b)                                   Additional Agreed Activities Expenses .

 

(i)                                       In respect of each Additional Agreed Activity, each Party shall be responsible for the percentage of Additional Agreed Activities Expenses as set forth in the Schedule 3.5 (with respect to the Lead Products), Joint Commercialization Plan or Joint Development Plan, or for Additional Agreed Activities agreed to by the Parties prior to Sobi’s Opt-In for the relevant Product, in the JSC meeting approved minutes, as applicable.

 

(ii)                                    On a Product-by-Product basis, following the Opt-In Consideration End Date for a Product, the amounts incurred by the Parties for Additional Agreed Activities Expenses relating to such Product shall be calculated and reported in writing in reasonable detail by each Party within 30 days after each quarter, and the net amount owed by one Party to the other Party for such quarter shall be paid within 45 days after issuance of an invoice from the Party to which such net amount is payable after exchange of such reports.

 

(c)                                    Shared Systems and Infrastructure Expenses .  For each Product, the Parties, through the JCC and JMDC, may agree to share responsibility for expenses for certain systems and infrastructure.  The Parties agree that upon Sobi’s Opt-In for a Lead Product, the Parties shall share expenses for the Global Safety Database as set forth in Section 4.6 below and for other systems and infrastructure as set forth in Schedule 4.4(c) ; provided , for clarity, that the Parties may, through the JCC and JMDC and without amending this Agreement, modify, add or remove the sharing of expenses for systems and infrastructure.  The cost sharing arrangement shall be set forth in Schedule 4.4(c), and from time to time may be updated to add or remove systems or infrastructure expenses as determined by the Parties on case-by-case basis based on

 

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good faith determinations of relative benefits and costs of such activities for each Party’s Territory and taking into account the benefits and costs in respect of the use of such systems and infrastructure for other products.   The Parties acknowledge that Schedule 4.4(c)  in the form attached to the Agreement as of the Effective Date contains fee estimates for both Lead Products for the entire calendar year 2014.  The Parties’ respective cost share shall be based on actual expenses applicable to each Lead Product for which Sobi has Opted-In and shall be calculated beginning on the date of Sobi’s Opt-In for such Lead Product in accordance with the allocations, rates and other terms set forth in Schedule 4.4(c) , as it may be amended by the Parties, and, for avoidance of doubt, in accordance with Section 4.6 with respect to the Global Safety Database.  Unless otherwise expressly agreed in writing by the Parties, the amounts incurred by the Parties for such shared systems and infrastructure shall be calculated and reported in reasonable detail in writing by each Party within 30 days after each quarter, and the net amount owed by one Party to the other Party for such quarter shall be paid within 45 days after issuance of an invoice from the Party to which such net amount is payable after exchange of such reports.

 

(d)                                   Other .  Costs required to be shared under Section 4.6, costs in respect of Continuing HLDP Activities, and, to the extent the Parties expressly agree under Section 4.2(b) to share costs incurred in respect of a Product after Sobi’s exercises its Opt-In Right for such Product, such costs under Section 4.2(b) shall, in all such cases, be determined and paid as follows:

 

(i)                                       Unless otherwise expressly provided in this Agreement, the total amount of costs to be shared shall be determined in the same manner that Additional Agreed Activities Expenses are determined;

 

(ii)                                    Unless otherwise agreed by the Parties, Sobi’s share of such amounts shall be: (A) [**]% for costs incurred for US/EU Post-Approval Commitments under Section 4.2(b); (B) [**]% of the Development Expenses, Final Development Expenses and  Manufacturing Expenses incurred by Biogen Idec in the conduct of the Continuing HLDP Activities; provided, that, with respect to Products other

 

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than Products that contain XTEN Constructs, the amount of Development Expenses payable under this clause (B) that are incurred prior to the Opt-In Consideration End Date shall not exceed the amount of the applicable Development Expense Cap set forth in Section 3.3(d) (less the portion of the Opt-In Consideration for such Product paid or payable pursuant to Section 4.1(b)(i)(B)); and (C) Sobi’s portion of costs incurred pursuant to, and determined in accordance with, Section 4.6.

 

(iii)                                 Such amounts shall be calculated and reported in writing in reasonable detail by each Party within 30 days after each quarter, and the net amount owed by one Party to the other Party for such quarter shall be paid within 45 days after issuance of an invoice from the Party to which such net amount is payable after exchange of such reports.

 

4.5                                JCC Oversight .  The JCC shall oversee the Commercialization of the Products in each Territory.  If either Party chooses not to Finalize or Commercialize a Product (either itself or through an Affiliate or Third Party) in a particular country(ies) in such Party’s Territory, such Party shall notify the other Party, through the JCC, in writing and the Parties, through the JCC, shall determine whether to grant to the other Party or a Third Party the right to Finalize and/or Commercialize such Product in such country.  The non-selling Party shall have similar rights if the Selling Party fails to achieve the Marketing Rights Criteria. For clarity, the foregoing is not intended to restrict the Selling Party from appointing Sublicensees as permitted under Section 7.1(d).

 

4.6                                Safety Coordination .  Promptly following Sobi’s exercise of its Opt-In Right for a Product, the Parties shall enter into a safety data exchange agreement with respect to such Product that shall apply to the MAH Transfer Period for EMA (as it may be amended from time to time, the “ Safety Data Exchange Agreement ”).  The Parties shall prepare an amendment to the initial Safety Data Exchange Agreement to be effective upon the completion of the MAH transfer to Sobi to reflect Sobi’s role as the MAH. Promptly after execution of the initial Safety

 

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Data Exchange Agreement, the Parties shall negotiate in good faith such amendment with the intention to execute such amendment no later than six months after the exercise of such Opt-In Right. If there is any conflict between the provisions of a Safety Data Exchange Agreement for a given Product and this Section 4.6, the provisions of such Safety Data Exchange Agreement shall prevail.  The Parties agree to share a single Core Data Sheet.  Biogen Idec shall be responsible, either itself or through a Contract Research Organization (“ CRO ”), for the provision of a centralized pharmacovigilance database for all Products (the “ Global Safety Database ”).  For each Product in respect of which Sobi has exercised its Opt-In Right, Biogen Idec (or its appointed CRO) shall promptly provide to Sobi all information in the Global Safety Database necessary for Sobi to comply with its obligations to report Safety Events (to be defined in the applicable Safety Data Exchange Agreement), including read only electronic access at all times.  Each Party shall, and shall ensure that its Affiliates and Sublicensees shall, promptly provide to such CRO (or if Biogen Idec elects to maintain the Global Safety Database itself, Biogen Idec), for inclusion in the Global Safety Database all Safety Event information with respect to such Product.  Each Selling Party shall comply with all applicable law with respect to the reporting of Safety Events in its Territory where the Product is undergoing Post Opt-In Development or is being Commercialized.  The Party sponsoring any clinical trial with respect to a Product shall be legally responsible for reporting any Safety Events with respect to such Product to the relevant Regulatory Authorities and other government authorities in accordance with regulatory requirements, and the Party Commercializing the Product in a country shall be legally responsible for reporting any Safety Events with respect to such Product to the relevant Regulatory Authorities and other government authorities in such country in accordance with regulatory requirements.  For clarity, the Safety Data Exchange Agreement for such Product shall address the specifics for reporting of Safety Events to relevant Regulatory Authorities and other government authorities.  Notwithstanding anything herein, the procedures set forth in this Section 4.6 shall not be construed as restricting either Party’s ability to take any action that it deems to be appropriate or required of it under applicable law.  Sobi shall reimburse Biogen Idec for the expenses associated with Biogen Idec’s activities to prepare, operate, submit select safety reports, generate aggregate reports from, and manage the Global Safety Database that benefit the

 

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Sobi Territory, and to process safety events, and, until MAH transfer, perform QPPV and pharmacovigilance activities, in the Sobi Territory, to the extent such activities are set forth in the Safety Data Exchange Agreement, as it may be amended. The amount of such reimbursed expenses shall be determined in accordance with the allocations, rates and other terms that are set forth on Schedule 4.4(c) , as it may be amended by the Parties. The Parties may, through the JMDC and without amending this Agreement, modify, add or remove the sharing of such expenses, provided that , in all events, Biogen Idec shall manage the Global Safety Database for the benefit of both Parties (and Sobi shall reimburse Biogen Idec for the costs therefor as otherwise required under this Section 4.6). The amounts incurred by Biogen Idec and subject to such reimbursement shall be calculated and reported in reasonable detail in writing by Biogen Idec within 30 days after the end of each quarter, and such amount for such quarter shall be paid by Sobi within 45 days after invoice from Biogen Idec issued on or after the date of such report.

 

5.                                      Names and Trademarks.

 

5.1                                Selection of Proprietary and Non-Proprietary Names .  Non-proprietary and proprietary/brand naming activities and protections will be pursued by Biogen Idec prior to Sobi’s exercise of its Opt-In Right with the goal of establishing a consistent global brand and generic naming strategy and Sobi will be consulted in this process, via regular updates at JSC meetings.  Biogen Idec will be responsible for global INN designation of all Products.  Unless and until Sobi has elected not to Opt-In to a Product, Biogen Idec will not select a brand for the Sobi Territory without Sobi’s prior written consent.  After Sobi has exercised its Opt-In Right, the Parties will attempt to settle on an acceptable global brand. However, in the event of a disagreement on a global brand, each Party shall have the right to select a brand (“ Product Trademark ”) for its respective Territory, provided that neither Party shall select a Product Trademark for its Territory that the other Party, acting reasonably, objects could adversely affect the Product in its Territory.  Biogen Idec and Sobi agree that the Product Trademark in the Biogen Idec Territory (where allowed by Regulatory Authorities) for the Factor VIII:Fc Lead Product shall be ELOCTATE and the Product Trademark in the Biogen Idec Territory (where allowed by Regulatory Authorities) for the Factor IX:Fc Lead Product shall be ALPROLIX.

 

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5.2                                Product Trademarks .  No Product Trademark shall be the same as or confusingly similar to those trademarks then used by any Party for any of its other products nor contain the words “Sobi”, “Biogen Idec”, “SynFusion” or “Transceptor” and the Parties shall comply with Section 10.3 of the [**] Agreement.  Conditional upon Sobi having exercised its Opt-In Right with respect to each Product, each Party shall own all right, title and interest in and to each Product Trademark, and all goodwill with respect thereto, in each country in such Party’s Territory.  Except as otherwise agreed by the Parties, neither Party shall make any use of any of the Product Trademarks except to identify and promote the relevant Products as contemplated hereunder for Commercialization in such Party’s Territory.

 

5.3                                Protection of Trademarks .  Each Party shall cooperate with the other Party to protect the interest of such other Party in the Product Trademarks in such other Party’s Territory.  Each Party shall promptly inform the other Party of any actual or apparent infringement of such other Party’s interest in the Product Trademarks in such other Party’s Territory which may come to its attention during the Term.

 

6.                                      Additional Obligations.

 

In the performance of the obligations hereunder with respect to the Development, Post Opt-In Development, Final Development, Manufacture and Commercialization of the Products, each Party shall (a) comply, and shall ensure that its Affiliates, Sublicensees or Third Party contractors comply, with cGCP, cGLP and cGMP of the U.S., the European Union and of each country in the applicable Territory, (b) comply with the provisions of Schedule 6 with respect to the export and re-export of Products, and (c) use, and shall ensure that its Affiliates and permitted Sublicensees use, Commercially Reasonable Efforts to carry out its Development, Post Opt-In Development, Final Development, Manufacturing and Commercialization activities in compliance with all applicable laws governing the conduct of such activities, including all applicable export and import control laws.

 

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7.                                      Intellectual Property.

 

7.1                                Licenses .

 

(a)                                   License from Biogen Idec .

 

(i)                                       Subject to the terms and conditions of this Agreement, Biogen Idec hereby grants to Sobi during the Term, (A) the exclusive (except as to Biogen Idec and its Affiliates and permitted sublicensees), royalty-free, worldwide license under the Biogen Idec IP and Biogen Idec’s interest in the Jointly-Owned IP to Develop Products and to engage in Post Opt-In Development with respect to Products for which Sobi has Opted-In; (B) the exclusive (except as to Biogen Idec and its Affiliates and permitted sublicensees), royalty-bearing, worldwide license under the Biogen Idec IP and Biogen Idec’s interest in the Jointly-Owned IP to Manufacture (limited to fill-finish and/or pack and label of commercial Product) the Products; and  (C) the exclusive (except, with respect to Finalization, as to Biogen Idec and its Affiliates prior to Sobi’s exercise of the Opt-In Right for the applicable Product), royalty-bearing license under the Biogen Idec IP and Biogen Idec’s interest in the Jointly-Owned IP to Finalize and, following Opt-In for such Products, to Commercialize the Products in the Sobi Territory.  Sobi may sublicense the rights granted under the Biogen Idec IP and Biogen Idec’s interest in the Jointly-Owned IP, including those that are [**] Patent Rights, to (y) its Affiliates, and (z) a Third Party(ies) to the extent provided in Section 7.1(d).

 

(ii)                                    With respect to the [**] Patent Rights, anything to the contrary herein notwithstanding, the license granted to Sobi shall be (i) limited to the scope of, and by the restrictions imposed on, the license granted to Biogen Idec in the [**] Agreement and (ii) subject to the policies, federal laws and reserved rights set forth in the [**] Agreement.

 

(iii)                                 Upon Sobi’s exercise of its Opt-In Right for a Product containing an XTEN Construct, all Information and Patent Rights that comprise Amunix Licensed Technology or which are otherwise subject to the Amunix License

 

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Agreement(s) shall be deemed to be Biogen Idec IP for purposes of this Agreement.  Notwithstanding Section 3.1(c) or any other provision of this Agreement, Sobi acknowledges that it shall have no rights under the Amunix Licensed Technology prior to Sobi’s exercise of an Opt-In Right for a Product containing an XTEN Construct, at which time, subject to the terms and conditions of this Agreement, Sobi shall be deemed to have a sublicense under the applicable Amunix Licensed Technology pursuant to the license to Sobi of Biogen Idec IP under Section 7.1(a)(i) hereof; provided that such sublicense shall be (i) limited to the scope of, and by the restrictions imposed on, the license granted to Biogen Idec in the applicable Amunix License Agreement and (ii) subject to the policies, federal laws and reserved rights set forth in the applicable Amunix License Agreement.  For clarity, as between Sobi and Biogen Idec, only Biogen Idec shall have the right under the Amunix Licensed Technology to conduct pre-clinical and non-clinical discovery and research activities on XTEN Constructs.

 

(b)                                   License from Sobi .

 

(i)                                       Subject to the terms and conditions of this Agreement, Sobi hereby grants to Biogen Idec during the Term, (A) the exclusive (except as to Sobi and its Affiliates and permitted sublicensees), royalty-free,  worldwide license under the Sobi IP and Sobi’s interest in the Jointly-Owned IP to Develop the Products and to engage in Post Opt-In Development with respect to Products, (B) the exclusive (except as to Sobi’s and its Affiliates’ and permitted sublicensees’ rights to Manufacture packaged and labeled finished drug product from drug substance provided by Biogen Idec), royalty-bearing, worldwide license under the Sobi IP and Sobi’s interest in the Jointly-Owned IP to Manufacture the Products (including, for the avoidance of doubt, any Product in respect of which Sobi does not exercise its Opt-In Right), (C) the exclusive, royalty-bearing license under the Sobi IP and Sobi’s interest in the Jointly-Owned IP to Finalize and Commercialize the Products in the Biogen Idec Territory, and (D) the non-exclusive license under

 

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the Sobi IP and Sobi’s interest in the Jointly-Owned IP to Finalize each Product in the Sobi Territory prior to Sobi’s exercise of its Opt-In Right for such Product and, to the extent set forth in Section 4.2(j), during the MAH Transition Period for EMA, for such Product.  Biogen Idec may sublicense the rights granted hereunder to (x) its Affiliates and (y) a Third Party(ies) to the extent provided in Section 7.1(d).

 

(c)                                    No Implied Rights .  Neither Party makes any grant of intellectual property rights by implication.  All rights or licenses are or shall be granted only as expressly provided in this Agreement.  Without limiting the generality of the foregoing, a license granted under Information Controlled by a Party shall not imply the grant of any license under Patents Rights covering such Information or its practice.

 

(d)                                   Sublicenses . Neither Party may sublicense any of the rights granted under Section 7.1(a) or (b), as the case may be, license any of the Collaboration IP for uses related to a Product, or otherwise appoint Sublicensees without the other Party’s prior written consent, which shall not be unreasonably withheld or delayed, except:

 

(i)                                       Each Party and its Sublicensees may engage contract research organizations or other subcontractors to conduct Development, Post Opt-In Development, Final Development and Additional Agreed Activities so long as such engagements comply with the guidelines established from time to time by the JSC (or, in the case of Additional Agreed Activities, the guidelines established from time to time by the Parties for the applicable Additional Agreed Activities) and such Party remains responsible for all such activities;

 

(ii)                                    Biogen Idec may engage contract manufacturing organizations to provide certain portions of the Manufacturing of the Product(s), to the extent that it determines, in its reasonable discretion, that it would be more cost-effective to do so or that such activities would require unreasonable capital investment. Sobi may engage contract manufacturing organizations to provide fill and finish, pack and

 

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label and certain specialized quality testing services to the extent that it elects to perform these activities;

 

(iii)                                 The Selling Party may, subject to Section 4.1(e), engage contract sales organizations to provide additional sales representatives to supplement the Selling Party’s sales force in the Selling Party’s Territory so long as such Selling Party’s employees continue to perform the marketing and sales management;

 

(iv)                                The Selling Party may, subject to Section 4.1(e),  grant to a Sublicensee any or all of its Development, Final Development, Post Opt-In Development and/or Commercialization rights under Section 7.1(a) or (b), as the case may be, in any country in such Party’s Territory that is not a Major Market Country; provided that if the Selling Party has established a customary business practice in a country, then such grant shall be consistent with the Selling Party’s customary business practices in such country.

 

The Party granting a sublicense or license or otherwise appointing a Sublicensee shall promptly provide written notice to the other Party of any sublicense granted pursuant to this Section 7.1(d).  Upon request, the Selling Party shall provide the other Party copies of any written agreement granting such permitted rights, which written agreements will contain confidentiality, reporting, audit rights and access to records and data, Confidential Information obligations and post-termination obligations comparable to those set forth herein. The Selling Party shall have the right to redact from such copies any confidential information that is not reasonably necessary for the non-Selling Party to confirm compliance with the applicable terms of this Agreement.  The Selling Party shall remain liable for the performance by all sublicensees, licensees and Sublicensees of all obligations of the Selling Party hereunder.  Permitted Sublicensees shall not have the right to grant further sublicenses, except to their Affiliates on terms consistent with the license agreement with the sublicensing or licensing Party.

 

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(e)                                    Amunix Agreements .

 

(i)                                       Sobi acknowledges that Biogen Idec’s decision to exercise its option for a commercial license under the Amunix Research Agreement, or not exercise such option, shall be at Biogen Idec’s sole discretion, and that no rights shall accrue to Sobi with respect to the Amunix Research Agreement, any Amunix License Agreement or any of the Amunix Licensed Technology, except as expressly set forth in this Agreement.

 

(ii)                                    Biogen Idec agrees that, from the period beginning on Sobi’s election under Section 3.1(c)(ii)(A) of this Agreement to treat an XTEN Construct as a Product under the Collaboration until the earlier of (i) Biogen Idec’s granting to Sobi a sublicense under the applicable Amunix License Agreement with respect to such XTEN Construct or (ii) Sobi’s electing not to exercise its Opt-In Right under Section 4.1(a) with respect to such XTEN Construct, Biogen Idec shall comply with the terms and conditions of the Amunix Research Agreement.

 

(iii)                                 Sobi agrees that it shall, with respect to its activities for an XTEN Construct, comply with the terms and conditions of any Amunix License Agreement under which it receives a sublicense, including without limitation, with respect to diligence and confidentiality obligations.

 

7.2                                Ownership .

 

(a)                                   Ownership .  As between the Parties, Sobi shall own all Sobi IP, including all Sobi Sole Collaboration IP, and Biogen Idec shall own all Biogen Idec IP, including all Biogen Idec Sole Collaboration IP.  All Collaboration IP that is Jointly-Owned IP shall be owned jointly by Sobi and Biogen Idec.

 

(b)                                   Assignment .  Each Party hereby assigns to the other Party all of its right, title and interest in and to the Information and all associated intellectual property rights to be solely owned by the other Party in accordance with Section 7.2(a).  The assigning Party shall execute all documents necessary to effectuate this Section 7.2(b).  The assignee Party shall be responsible

 

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for preparing all such assignment documents and for all out-of-pocket costs of the assignor Party required to prepare, authenticate and record such documents, including all such documents required to assign any Jointly-Owned IP as defined in, and that arose under, the 2010 Restated Agreement and which, as of the Effective Date, is a Party’s Sole Collaboration IP.

 

(c)                                    Joint IP .  Subject to the licenses granted hereunder, neither Party shall have an obligation to account to the other, or obtain the consent of the other, with respect to the exploitation (directly or through licensees or other Third Parties) of any Jointly-Owned IP, and each Party hereby waives any right it may have under the laws of any jurisdiction to require such an accounting or consent.  Neither Party will abandon or assign Jointly-Owned IP prior to offering the other Party the right to acquire its interest in such Jointly-Owned IP, except that a Party may assign its interest in Jointly-Owned IP to an Affiliate so long as such assignment is subject to the licenses granted pursuant to this Agreement and is otherwise consistent with this Agreement.  Subject to the foregoing, each Party shall have the right to abandon its interest in the Jointly-Owned IP, or to assign, license or otherwise transfer its interest in the Jointly-Owned IP to any Third Party without the consent of the other Party so long as such sale, license or transfer is subject to the licenses granted pursuant to this Agreement and is otherwise consistent with this Agreement.

 

(d)                                   Restrictions on Sole Collaboration IP .  Neither Party will abandon or assign its Sole Collaboration IP prior to offering the other Party the right to acquire its interest in such Sole Collaboration IP, except that a Party may assign its interest in any of its Sole Collaboration IP to an Affiliate so long as such assignment is subject to the licenses granted pursuant to this Agreement and is otherwise consistent with this Agreement.  If a Party grants a license for any use to a Third Party under any of its Sole Collaboration IP that covers a Product (other than only a Terminated Product for which the other Party is not the Continuing Party), the Party granting the license shall not give the Third Party licensee any prosecution or enforcement rights with respect to the licensed Sole Collaboration IP without the prior written consent of the other Party.  Subject to the foregoing and Section 7.3(d), each Party shall have the right to abandon its interest in its Sole Collaboration IP, or to assign, license or otherwise transfer its interest in its Sole

 

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Collaboration IP to any Third Party without the consent of the other Party so long as such sale, license or transfer is subject to the licenses granted pursuant to this Agreement and is otherwise consistent with this Agreement.

 

(e)                                    Policies .  In order to protect the Parties’ patent rights with respect to Collaboration Know-How, each Party agrees to maintain a policy that requires its employees, contractors and agents to record and maintain all data and information developed in the course of this Agreement in such a manner as to enable the Parties to use such records to establish the earliest date of invention and/or diligence to reduction to practice (e.g., an invention disclosure policy).  Each Party shall require all employees, agents and independent contractors performing activities under or contemplated by this Agreement to enter into written, binding agreements obligating each such employee, agent and independent contractor to assign his, her or its interest in any Information conceived or reduced to practice in the conduct of such activities to the Party for which such employee, agent or independent contractor is providing services; provided, that, in the case of an independent contractor, if obtaining the assignment of such Information to the Party for which such independent contractor is providing services is not practicable, such Party shall use commercially reasonable efforts to have the contractor grant a license to the Party, with right to grant sublicenses to the other Party, with respect to such Information.

 

(f)                                     Status of Amunix .  Biogen Idec and Sobi acknowledge that Amunix is a licensor of BIMA and agree that Amunix shall not be deemed to be a contractor of Biogen Idec for purposes of Section 7.2(e) or any other provision of this Agreement.

 

7.3                                Prosecution and Maintenance of Patent Rights .

 

(a)                                   Joint Patent Team .  The Parties shall establish a Joint Patent Team (the “ JPT ”), comprised of one (1) representative of Biogen Idec and one (1) representative of Sobi,  which representative shall have experience and seniority sufficient to enable him or her to make decisions on behalf of the Party he or she represents.  The initial representatives of each Party to the JPT shall be designated within thirty (30) days after the Effective Date.  The JPT shall meet twice per year (by telephone or video conference) to (i) review and discuss the status of the

 

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Biogen Idec Patent Rights, Sobi Patent Rights and the Jointly-Owned Patent Rights and any invention disclosures received by the JPT members pursuant to Section 7.2(e) since the last JPT meeting; (ii) determine whether patent applications should be filed based on Jointly-Owned Know-How; (iii) determine any amendments to the Core Countries for Jointly-Owned Patent Rights pursuant to Section 7.3(c)(i) and to Core Countries for Biogen Idec Sole Collaboration Patent Rights and Sobi Sole Collaboration Patent Rights pursuant to Section 7.3(d)(i); (iv) review recent filings for the Jointly-Owned Patent Rights and establish budgets for prosecution of the same;  (v) report to the JSC on the matters discussed at such meetings; and (vi) assume such other responsibilities as are set forth in this Agreement. Each Party may invite its outside patent advisors to participate in any such meetings.  The JPT shall update the Schedules for the Biogen Idec Background Patent Rights, Biogen Idec Improvement Patent Rights, Biogen Idec Sole Collaboration Patent Rights, Jointly-Owned Patent Rights, Sobi Background Patent Rights, Sobi Improvement Patent Rights and Sobi Sole Collaboration Patent Rights, from time to time as reasonably necessary or upon request of the JCC.  Each Party will cooperate with the other Party and provide all information and data, and sign any documents, reasonably necessary and requested by the other Party for the purpose of preparing, filing and prosecuting Patent Rights pursuant to this Section 7.3.

 

(b)                                   Sole IP .  Except as provided in subsection (d) in respect of a Party’s Sole Collaboration Patent Rights:

 

(i)                                       Biogen Idec shall be responsible, at its expense, for the preparation, filing, prosecution (including any interferences, oppositions, reissue proceedings and reexaminations) and maintenance of Biogen Idec IP in its sole discretion and shall have no liability to Sobi for any failure to obtain a patent on the Biogen Idec IP or the failure to obtain a patent of commercially useful scope on the Biogen Idec IP.  Sobi shall be responsible, at its expense, for the preparation, filing, prosecution (including any interferences, oppositions, reissue proceedings and reexaminations) and maintenance of Sobi IP in its sole discretion and shall have no liability to Biogen Idec for any failure to obtain a patent on the Sobi IP or the failure to

 

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obtain a patent of commercially useful scope on the Sobi IP.  Notwithstanding the foregoing, the Parties shall consult with each other via the JPT regarding the countries in which patent applications directed to the Biogen Idec IP or Sobi IP, as applicable, should be filed, prosecuted and maintained.  Each Owning Party of such Sole IP shall keep the other Party reasonably informed via the JPT with respect to such activities.

 

(ii)                                    If the Owning Party elects not to pursue the filing, prosecution or maintenance of a Coagulation Factor-Specific Claim in a particular country, then the Owning Party shall so notify the Non-Owning Party promptly in writing and in reasonable time to enable the Non-Owning Party to meet any deadlines by which an action must be taken to establish or preserve any such Coagulation Factor-Specific Claim in such country.  Upon receipt of each such notice from the Owning Party, the Non-Owning Party shall have the right, but not the obligation, to pursue the filing or support the continued prosecution or maintenance of such Coagulation Factor-Specific Claim in such country.  Any such action taken by the Non-Owning Party shall be in the name of the Owning Party and shall be at the Non-Owning Party’s expense.

 

(iii)                                 This Section 7.3(b)(iii) shall apply to XTEN Constructs in lieu of Section 7.3(b)(ii), except as expressly set forth in Section 7.3(b)(iii)(C) below.

 

(A)                                Factor-Specific Amunix Claim ” means a Coagulation Factor-Specific Claim directed to an XTEN Construct in an Amunix Licensed Patent (as defined in the Amunix Research Agreement) for which Biogen Idec is deemed the Owning Party and for which Biogen Idec has the right to prosecute under the applicable Amunix License Agreement.

 

(B)                                Following Sobi’s exercise of its election right for an XTEN Construct under Section 3.1(c)(ii) and for the duration of the Term,

 

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provided that Sobi exercises its Opt-In Right under Section 4.1(a) for such XTEN Construct, with respect to any Factor-Specific Amunix Claim directed to such XTEN Construct, if Biogen Idec elects not to pursue the filing, prosecution or maintenance of such Factor-Specific Amunix Claim in a particular country, then Biogen Idec shall so notify Sobi promptly in writing and within a reasonable period of time prior to any deadlines by which an action must be taken to establish or preserve any such Factor-Specific Amunix Claim in such country.  Within twenty (20) days of such notification, Sobi may elect to have Biogen Idec continue the filing, prosecution and maintenance of such Factor-Specific Amunix Claim at Sobi’s expense (including payments for Biogen Idec’s internal support at Biogen Idec’s then-current time and materials rates). If Sobi elects to have Biogen Idec continue to file, prosecute and maintain these claims, Biogen Idec will continue to control prosecution and will provide Sobi with copies of all proposed substantive communications to, and all substantive communications from, all patent offices regarding such Factor-Specific Amunix Claim, within a reasonable time after the receipt thereof.  Biogen Idec will consider any reasonable comments and instructions from Sobi and will, to the extent allowed under the relevant Amunix Research Agreement or Amunix License Agreement (such determination to be made in Biogen Idec’s discretion), take into account comments and instructions from Sobi, provided that doing so will not conflict with the prosecution strategy of other intellectual property under Biogen Idec’s control.  Sobi shall provide comments and instructions to Biogen Idec on a good faith and timely basis.

 

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(C)                                Notwithstanding the foregoing, Biogen Idec may at any time elect to transition to Sobi the right to pursue the filing or support the continued prosecution or maintenance of such Factor-Specific Amunix Claim that Biogen Idec abandons and Sobi elects to continue in the same manner as provided in Section 7.3(b)(ii).

 

(c)                                    Joint Patent Rights .

 

(i)                                       Biogen Idec shall prepare, file, prosecute (including any interferences, oppositions, reissue proceedings and reexaminations) and maintain, in the Core Countries, jointly in Sobi’s and Biogen Idec’s names, any patent applications necessary to protect the proprietary positions of the Parties in any Jointly-Owned Patent Rights as further set forth in this Section 7.3(c).  Sobi and Biogen Idec shall consult in good faith and mutually agree through the JPT as to any additional countries in which Biogen Idec shall file, prosecute and maintain any such Patent Rights on a case-by-case basis.

 

(ii)                                    The Parties shall share equally (A) all expenses and fees paid by either Party to any patent office for the activities associated with the filing, prosecution, issuance and maintenance of the Jointly-Owned Patent Rights in the Core Countries and any additional countries agreed to by the Parties pursuant to Section 7.3(c)(i), and (B) any other out-of-pocket expenses (including outside counsel fees) incurred by the prosecuting Party for the preparation, filing, prosecution, issuance and maintenance of any such patent application and resulting patent.  Any internal and/or out-of-pocket-expenses (including outside counsel fees) for review costs incurred by the non-prosecuting Party and any internal expenses incurred by the prosecuting Party shall be borne by the Party incurring the expense.  The prosecuting Party shall invoice the non-prosecuting Party for fifty percent (50%) of such costs on a quarterly basis, and payment shall be due within forty-five (45) days after the date of such invoice.  Notwithstanding anything

 

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herein, either Party may decline to pay its share of out-of-pocket expenses and fees for preparing, filing, prosecuting and maintaining any patent application or patent included in any Jointly-Owned Patent Rights in a particular Core Country or additional agreed country, in which case the declining Party shall assign to the other Party all of its right, title and interest in and to any such patent application or patent in the relevant Core Country or additional agreed country and all Patent Rights related thereto shall be considered part of such other Party’s Patent Rights (i.e., Biogen Idec Patent Rights or Sobi Patent Rights, as the case may be).

 

(iii)                                 Each Party shall make available to the other Party, or its authorized attorneys, agents or representatives, such of its employees whom the other Party in its reasonable judgment deems necessary in order to assist it in obtaining patent protection for any inventions included within the Jointly-Owned Patent Rights.  Each Party shall sign or use its best efforts to have signed all legal documents necessary to file and prosecute patent applications or to obtain or maintain patents with respect to Jointly-Owned Patent Rights at no cost to the other Party.

 

(iv)                                Each Party shall provide the other Party with copies of all proposed substantive communications to all patent offices regarding patent applications or patents on any inventions included within the Jointly-Owned Patent Rights in reasonable time before the due date in order to enable the other Party an opportunity to comment on the content thereof, unless the other Party has declined to pay the expenses thereof.  Generally, a reasonable time for review and comment shall be thirty (30) days, unless the time periods set for filing by the relevant patent office is less than two (2) months from the date of receipt of the paper calling for a reply, in which case a shorter reasonable time shall be applicable.  In any such situation where a shorter reasonable time is to be used, the prosecuting Party shall promptly notify the other Party of the shorter period by which it intends to act.  Each Party will provide the other Party with copies of all substantive communications from all patent offices regarding patent applications

 

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or patents on any inventions included within the Jointly-Owned Patent Rights promptly after the receipt thereof, unless the other Party has declined to pay the expenses thereof.

 

(d)                                   Sole Collaboration Patent Rights .

 

(i)                                       Biogen Idec Sole Collaboration Patent Rights . Biogen Idec shall prepare, file, prosecute (including any interferences, oppositions, reissue proceedings and reexaminations) and maintain, at its expense, any patent applications deemed necessary by Biogen Idec, using its reasonable judgment after discussion by the JPT, to protect any Biogen Idec Sole Collaboration Patent Rights, as further set forth in this Section 7.3(d)(i).  Biogen Idec shall so prepare, file, prosecute and maintain any such patent applications and patents in the Core Countries and such additional countries as Biogen Idec desires or Sobi may request.    Biogen Idec’s reasonable out-of-pocket expenses (including all costs of outside counsel) for preparing, filing, prosecuting (including any interferences, oppositions, reissue proceedings and reexaminations) and maintaining such patent applications and patents in such countries (other than the Core Countries) in the Sobi Territory requested by Sobi shall be reimbursed by Sobi.  Biogen Idec shall invoice Sobi for its share of such costs on a quarterly basis, and payment shall be due within forty-five (45) days after the date of such invoice.  Biogen Idec shall  make strategic prosecution and maintenance decisions for the Biogen Idec Sole Collaboration Patent Rights in the Core Countries and additional countries requested by Sobi without regard to whether such country is in a particular Party’s Territory; provided , for clarity, that, in making such decisions about prosecution (including whether to abandon), Biogen Idec shall be free to take into consideration local patent laws, the position of the local patent office in any country in the Sobi Territory that may differ from countries in the Biogen Idec Territory and the impact (other than prosecution costs) that case may reasonably have on Biogen Idec’s prosecution strategy for the patent family to which such Biogen Idec Sole Collaboration Right belongs.

 

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Subject to the foregoing, if Biogen Idec elects, after consulting in good faith with Sobi, not to prepare, file, prosecute or maintain any patent application or patent covering any patentable inventions included in any Biogen Idec Sole Collaboration Patent Rights in a Core Country or additional country requested by Sobi in the Sobi Territory,  Biogen Idec shall promptly notify Sobi and Sobi shall have the right to prepare, file, prosecute and maintain such Patent Rights in such Core Country or additional country in the Sobi Territory, in Biogen Idec’s name, at Sobi’s sole cost.

 

(ii)                                    Sobi Sole Collaboration Patent Rights .   Sobi shall prepare, file, prosecute (including any interferences, oppositions, reissue proceedings and reexaminations) and maintain, at its expense, any patent applications deemed necessary by Sobi, using its reasonable judgment after discussion by the JPT, to protect any Sobi Sole Collaboration Patent Rights, as further set forth in this Section 7.3(d)(ii).  Sobi shall so prepare, file, prosecute and maintain any such patent applications and patents in the Core Countries and such additional countries as Sobi desires or Biogen Idec may request.    Sobi’s reasonable out-of-pocket expenses (including all costs of outside counsel) for preparing, filing, prosecuting (including any interferences, oppositions, reissue proceedings and reexaminations) and maintaining such patent applications and patents in such countries (other than the Core Countries) in the Biogen Idec Territory requested by Biogen Idec shall be reimbursed by Biogen Idec.  Sobi shall invoice Biogen Idec for its share of such costs on a quarterly basis, and payment shall be due within forty-five (45) days after the date of such invoice.  Sobi shall  make strategic prosecution and maintenance decisions for the Sobi Sole Collaboration Patent Rights in the Core Countries and additional countries requested by Biogen Idec without regard to whether such country is in a particular Party’s Territory; provided , for clarity, that, in making such decisions about prosecution (including whether to abandon), Sobi shall be free to take into consideration local patent laws, the position of the local

 

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patent office in any country in the Biogen Idec Territory that may differ from countries in the Sobi Territory and the impact (other than prosecution costs) that case may reasonably have on Sobi’s prosecution strategy for the patent family to which such Sobi Sole Collaboration Right belongs.  Subject to the foregoing, if Sobi elects, after consulting in good faith with Biogen Idec, not to prepare, file, prosecute or maintain any patent application or patent covering any patentable inventions included in any Sobi Idec Sole Collaboration Patent Rights in a Core Country or additional country requested by Biogen Idec in the Biogen Idec Territory,  Sobi shall promptly notify Biogen Idec and Biogen Idec shall have the right to prepare, file, prosecute and maintain such Patent Rights in such Core Country or additional country in the Biogen Idec Territory, in Sobi’s name, at Biogen Idec’s sole cost.

 

(iii)                                 Each Owning Party of Sole Collaboration Patent Rights shall keep the other Party reasonably informed of the preparation, filing, prosecution and maintenance of such Sole Collaboration Patent Rights via the JPT.

 

7.4                                Infringement of Party IP .

 

(a)                                   Sole IP .  The following provisions of this Section 7.4(a) shall apply, subject to Section 7.4(c) (Enforcement of Coagulation Factor-Specific Claims within the Amunix Licensed Patents), to all Biogen Idec IP other than Biogen Idec Sole Collaboration IP and all Sobi IP other than Sobi Sole Collaboration IP, both of which, for clarity, are subject to Section 7.4(d).

 

(i)                                       With respect to any actual or suspected infringement or misappropriation of the Owning Party’s IP applicable to a Product(s), the Owning Party shall have the initial right, but not the obligation, to initiate an appropriate suit against any Third Party who at any time is, or is suspected of, infringing the Owning Party’s Patent Rights anywhere in the world and the Owning Party shall have the sole right, but not the obligation, to initiate an appropriate suit against any Third Party who at any time is, or is suspected of, misappropriating the Owning Party’s Know-How anywhere in the world.

 

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(ii)                                    Subject to any contractual obligations to, or restrictions imposed by, the Owning Party’s Third Party licensors, in the event that the Owning Party does not, within six (6) months of written notice from the Non-Owning Party of a suspected infringement of the Owning Party’s Patent Rights relating to the development, manufacture, use or sale of a Competitive Product (a “ Product-Related Infringement ”), commence and vigorously and continuously pursue thereafter an action to enjoin such infringement, the Non-Owning Party shall be entitled to commence the action in its name or otherwise take appropriate steps to halt such alleged infringement after giving the Owning Party advance notice of its intent to file any such suit and the reasons therefor; provided , however, that the Non-Owning Party shall not take (nor permit any of its licensees or sublicensees to take) any action involving the enforcement of any of the Owning Party’s Patent Rights in any way that would be reasonably likely to directly and adversely affect their scope, validity or enforceability without the prior written consent of the Owning Party, which consent shall not be unreasonably withheld. For clarity, the mere fact that an enforcement action could lead to a counterattack on scope, validity or enforceability by the alleged infringer shall not be grounds for withholding such consent, unless the Owning Party has reasonable grounds for determining that there is a reasonable likelihood of an adverse outcome and communicates the basis for such determination to the Non-Owning Party.

 

(iii)                                 If a Party initiates suit pursuant to paragraphs (i) or (ii) above:

 

(A)                                the enforcing Party shall provide the non-enforcing Party with an opportunity to make suggestions and comments regarding such suit, and shall consider in good faith the suggestions and comments of the non-enforcing Party;

 

(B)                                the enforcing Party shall keep the non-enforcing Party promptly informed and shall from time to time discuss with the non-

 

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enforcing Party the status of any such suit, and shall provide the non-enforcing Party with copies of all material documents filed in, and all material written communications relating to, such suit;

 

(C)                                with respect to any such suit, anything to the contrary notwithstanding, in the event that claims within the [**] Patent Rights are part of the Coagulation Factor-Specific Claims and included in such suit by Sobi, Sobi shall be responsible for complying with the last sentence of Section 7.1 of the [**] Agreement and with Section 7.6 of the [**] Agreement and for holding harmless, indemnifying and paying the costs of Owner (as such term is defined in the [**] Agreement) in accordance with Sections 7.2 and 7.3 of the [**] Agreement; and

 

(D)                                in the case of [**] Patent Rights, Sobi acknowledges the secondary right of [**] (i.e., after the right of Sobi) to pursue actual or suspected infringers as set forth in Section 7.8 of the [**] Agreement.

 

(iv)                                The Parties shall [**] all out-of-pocket expenses of any suit brought by either Party pursuant to this Section 7.4(a), including attorneys’ fees and court costs, with respect to a Product-Related Infringement; provided , however , that the non-enforcing Party may reduce, or decline to pay, its share of such expenses by providing written notice to the other Party.  Any recovery, lump-sum settlement, royalty payment or other consideration received by the Parties as a result of such litigation or settlement of any Product Related Infringement shall be disbursed as follows:

 

(A)                                first, each Party shall be reimbursed pro rata for the out-of-pocket expenses of the suit actually paid by it in connection with the alleged infringement, including attorney’s fees and court costs; and

 

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(B)                                second, the [**].

 

(v)                                   If necessary in order to commence or maintain or to obtain a more effective remedy in any suit referred to in this Section 7.4(a), the other Party shall, at its expense, join as a party to such suit, but shall be under no obligation to participate except to the extent that such participation is required as the result of being a named party to such suit.  Further, such other Party shall, at its expense, offer reasonable assistance to the suing Party in connection therewith.

 

(vi)                                The Non-Owning Party shall not settle any suit involving the Owning Party’s IP which the Non-Owning Party is permitted to bring under this Section 7.4(a) without obtaining the prior written consent of the Owning Party, which consent shall not be unreasonably withheld. The Owning Party shall not settle such claims (including any suit or other proceeding) against such Third Party, including the grant of any rights in respect of the Owning Party’s IP, without the other Party’s written consent if such settlement may adversely affect such other Party’s rights hereunder.

 

(vii)                             In the event that any counterclaims are brought against a Party in any suit commenced by such Party pursuant to this Section 7.4(a), such Party shall have the sole right to defend such counterclaims.  Notwithstanding anything to the contrary herein, in the event of a declaratory judgment action or other claims alleging invalidity or unenforceability of any of the Owning Party’s IP (an “ Invalidity Claim ”), the Non-Owning Party shall have no right to settle such action or other claims by admitting the invalidity or unenforceability of the Owning Party’s IP, without the prior written consent of the Owning Party in its discretion.  Further, notwithstanding the foregoing, in the event of a declaratory judgment action alleging invalidity of any of the [**] Patent Rights, [**] shall have the first right set forth in Section 7.9 of the [**] Agreement.

 

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(b)                                   Joint IP .  In the event that any Jointly-Owned IP is infringed or misappropriated by a Third Party, Sobi and Biogen Idec shall discuss whether, and if so, how, to enforce such Jointly-Owned IP or defend such Jointly-Owned IP (whether in an infringement action, declaratory judgment or otherwise).  If the Parties decide to jointly bring suit to enforce or defend such rights, the Parties shall share equally all out-of-pocket expenses of any such suit, including attorneys’ fees and court costs; provided , however , that either Party may reduce, or decline to pay, its share of such expenses by providing written notice to the other Party.  The recovery allocation provisions of Section 7.4(a)(iv) shall apply with respect to such a suit in the same way as they apply to a Product-Related Infringement.  In the event only one Party wishes to participate in the proceeding or defense, it shall have the right to proceed alone, provided that the proposed action to enforce or defend the Jointly-Owned IP is not reasonably likely to directly and adversely affect its scope, validity or enforceability.  Any such sole proceeding or defense shall be at such Party’s sole expense, and it may retain any recovery.  The other Party agrees, at the initiating Party’s expense, to cooperate and join in any such solely-initiated proceedings in the event that a Third Party successfully asserts that the co-owner of such Jointly-Owned IP is necessary or indispensable to such proceedings.

 

(c)                                    Enforcement of Coagulation Factor-Specific Claims within the Amunix Licensed Patents .  Upon Sobi’s exercise of its Opt-In Right under Section 4.1(a) for an XTEN Construct, Sections 7.4(a)(ii) through (vii) shall apply with respect to any Coagulation Factor-Specific Claim directed to such XTEN Construct in any Amunix Licensed Patents, provided that the time period specified in the first sentence of Section 7.4(a)(ii) shall be [**].  For clarity, any amounts recovered under such enforcement actions shall be allocated as follows: (i) first, to reimburse the Parties for their out-of-pocket expenses in accordance with Section 7.4(a)(iv)(A), [**], (ii) second, any recoveries characterized as lost profits shall be distributed between the Parties in accordance with Section 7.4(a)(iv)(B) [**], and (iii) third, any remaining recoveries shall be distributed between the Parties in accordance with Section 7.4(a)(iv)(B) [**].

 

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(d)                                   Sole Collaboration IP

 

(i)                                       With respect to any actual or suspected infringement or misappropriation of the Owning Party’s Sole Collaboration IP, the Owning Party shall have the initial right, but not the obligation, to initiate an appropriate suit against any Third Party who at any time is, or is suspected of, infringing the Owning Party’s Patent Rights within its Sole Collaboration IP anywhere in the world and the Owning Party shall have the sole right, but not the obligation, to initiate an appropriate suit against any Third Party who at any time is, or is suspected of, misappropriating the Owning Party’s Know-How within the Sole Collaboration IP anywhere in the world.

 

(ii)                                    Subject to any contractual obligations to, or restrictions imposed by, Amunix on Biogen Idec under an Amunix Agreement, if any, in the event that the Owning Party does not, within six (6) months of written notice from the Non-Owning Party of a suspected infringement of the Owning Party’s Sole Collaboration Patent Rights in the Non-Owning Party’s Territory, commence and vigorously and continuously pursue thereafter an action to enjoin such infringement, the Non-Owning Party shall be entitled to commence the action in its name or otherwise take appropriate steps in its Territory to halt such alleged infringement after giving the Owning Party advance notice of its intent to file any such suit and the reasons therefor; provided , however, that the Non-Owning Party shall not take (nor permit any of its licensees or sublicensees to take) any action involving the enforcement of any of the Owning Party’s Patent Rights in any way that would be reasonably likely to directly and adversely affect their scope, validity or enforceability without the prior written consent of the Owning Party, which consent shall not be unreasonably withheld.  For clarity, the mere fact that an enforcement action could lead to a counterattack on scope, validity or enforceability by the alleged infringer shall not be grounds for withholding such consent, unless the Owning Party has reasonable grounds for determining that there is a reasonable likelihood of an adverse outcome and communicates the

 

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basis for such determination to the Non-Owning Party.

 

(iii)                                 If a Party initiates suit pursuant to paragraphs (i) or (ii) above:

 

(A)                                the enforcing Party shall provide the non-enforcing Party with an opportunity to make suggestions and comments regarding such suit, and shall consider in good faith the suggestions and comments of the non-enforcing Party; and

 

(B)                                the enforcing Party shall keep the non-enforcing Party promptly informed and shall from time to time discuss with the non-enforcing Party the status of any such suit, and shall provide the non-enforcing Party with copies of all material documents filed in, and all material written communications relating to, such suit.

 

(iv)                                The Parties shall share equally all out-of-pocket expenses of any suit brought by either Party pursuant to this Section 7.4(d), including attorneys’ fees and court costs, with respect to such infringement; provided , however , that the non-enforcing Party may reduce, or decline to pay, its share of such expenses by providing written notice to the other Party.  Any recovery, lump-sum settlement, royalty payment or other consideration received by the Parties as a result of such litigation or settlement of any such infringement shall be disbursed as follows:

 

(A)                                first, each Party shall be reimbursed pro rata for the out-of-pocket expenses of the suit actually paid by it in connection with the alleged infringement, including attorneys’ fees and court costs; and

 

(B)                                second, the Parties shall share any remaining amount in direct proportion to the share of expenses of such litigation paid by each.

 

(v)                                   If necessary in order to commence or maintain or to obtain a more effective remedy in any suit referred to in this Section 7.4(d), the other Party shall,

 

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at its expense, join as a party to such suit, but shall be under no obligation to participate except to the extent that such participation is required as the result of being a named party to such suit.  Further, such other Party shall, at its expense, offer reasonable assistance to the suing Party in connection therewith.

 

(vi)                                The Non-Owning Party shall not settle any suit involving the Owning Party’s Sole Collaboration IP which the Non-Owning Party is permitted to bring under this Section 7.4(d) without obtaining the prior written consent of the Owning Party, which consent shall not be unreasonably withheld. The Owning Party shall not settle such claims (including any suit or other proceeding) against such Third Party, including the grant of any rights in respect of the Owning Party’s Sole Collaboration IP, without the other Party’s written consent if such settlement may adversely affect such other Party’s rights hereunder.

 

(vii)                             In the event that any counterclaims are brought against a Party in any suit commenced by such Party pursuant to this Section 7.4(d), such Party shall have the sole right to defend such counterclaims.  Notwithstanding anything to the contrary herein, in the event of an Invalidity Claim, the Non-Owning Party shall have no right to settle such action or other claims by admitting the invalidity or unenforceability of the Owning Party’s Sole Collaboration IP, without the prior written consent of the Owning Party in its discretion.

 

7.5                                Claimed Infringement .  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, a Party, or any of its Affiliates or sublicensees, claiming infringement of its Patent Rights or unauthorized use or misappropriation of its know-how, based upon an assertion or claim arising out of the Development, Final Development, Manufacture, use, sale or other Commercialization of the Products, such Party shall promptly notify the other Party of the claim or the commencement of such action, suit or proceeding, enclosing a copy of the claim and all papers served.  Subject to the indemnity obligations under Section 10, such Party shall have the sole right to defend such claim, action,

 

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suit or proceeding; provided , however , that, to the extent that any action would involve the enforcement of the other Party’s Patent Rights or the defense of an Invalidity Claim with respect to the other Party’s Patent Rights, the general concepts of Section 7.4 shall apply to the enforcement of such other Party’s Patent Rights or the defense of such Invalidity Claim.

 

7.6                                Mutual Cooperation .  In the event that any Party takes action pursuant to Section 7.4, the other Party shall cooperate with and reasonably assist the Party so acting to the extent reasonably possible, including providing access to relevant witnesses, documents and other records, the joining of suit as required by this Agreement or as otherwise desirable.  If such suit is brought solely by the enforcing Party, the enforcing Party shall pay such other Party’s reasonable out-of-pocket costs incurred in providing such cooperation and assistance.

 

7.7                                Certifications and Notices under Data Exclusivity Legislation .  Each Party shall inform the other of any certification or other notice regarding any Patent Right that such Party receives pursuant to 21 U.S.C. §§ 355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV), or regarding any Patent Right or Third Party application for regulatory approval for a product that cites a Product as a reference product pursuant to Title VII of the United States Patient Protection and Affordable Care Act (also commonly referred to as the Biologics Price Competition and Innovation Act), or any successor provisions to the foregoing, or any similar provisions in a country other than the United States, and shall provide the other Party with a copy of such certification or notice within five (5) days after receipt. The initiation and prosecution of any legal action as a result of such certification or any recovery obtained as a result of such legal action shall be as defined in Section 7.4.

 

7.8                                Patent Term Restoration/Supplemental Protection .  The Parties shall cooperate with each other in obtaining patent term restoration or extensions (including supplemental protection certificates or their equivalents in any country).  If elections with respect to obtaining such patent term restoration or extensions are to be made, the Owning Party shall have the right to make the election after consulting in good faith with the JPT.

 

7.9                                Domain Name Registrations .  Biogen Idec shall have the right to register domain names

 

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incorporating the brand names for any Product in the following top-level domains: .com, .biz, .org and .info.  Each Party shall have the right to register domain names incorporating the brand names for any Product in any country or region-specific top-level domain for a country or region in its Territory.  For purposes of illustration, Biogen Idec would be permitted to register eloctate.com and eloctate.us, and Sobi would be permitted to register eloctate.org.uk and eloctate.eu.  The Party that registers a domain name will take reasonable steps to ensure that renewals for such registrations are docketed and paid in a timely manner to avoid loss of the registration.  A copy of such docket shall be provided to the JPT at least every six (6) months.   If a Party intends not to renew any domain name incorporating the brand name of a Product, it shall so notify the other Party in writing and the other Party shall have the right to require the Party holding the registration to transfer it to such Party free of charge prior to the date the renewal fees are due so that the other Party can renew the registration.

 

8.                                      Payments.

 

8.1                                Royalties .

 

(a)                                   Base Royalty and Net Partner Revenue Share Rates .  Subject to Sobi’s obligation to repay the Opt-In Consideration, the Parties’ respective base royalty and Net Partner Revenue share obligations shall be as follows:

 

(i)                                       For Products Commercialized under the Collaboration:

 

(A)                                Sobi will pay Biogen Idec 12% of Net Sales in the Sobi Territory;

 

(B)                                Biogen Idec will pay Sobi 12% of Net Sales in the Biogen Idec North America Territory;

 

(C)                                Biogen Idec will pay Sobi 17% of Net Sales in the Biogen Idec Direct Territory; and

 

(D)                                In the Biogen Idec Partner Territory, Biogen Idec shall pay to Sobi

 

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fifty percent (50%) of Biogen Idec’s Net Partner Revenue.

 

(ii)                                    Notwithstanding Section 8.1(a)(i), with respect to the two Lead Products only, where only one Lead Product is being Commercialized under the Collaboration and the other Lead Product does not receive Regulatory Approval in either Territory (regardless of any subsequent Products being Commercialized under the Collaboration):

 

(A)                                Sobi will pay Biogen Idec 10% of Net Sales in the Sobi Territory;

 

(B)                                Biogen Idec will pay Sobi 10% of Net Sales in the Biogen Idec North America Territory;

 

(C)                                Biogen Idec will pay Sobi 15% of Net Sales in the Biogen Idec Direct Territory; and

 

(D)                                In the Biogen Idec Partner Territory, Biogen Idec shall pay to Sobi fifty (50%) percent of Biogen Idec’s Net Partner Revenue.

 

(b)                                   Opt-In Consideration Repayment .

 

(i)                                       The Opt-In Consideration exceeding the Escrow Payment for each Product shall be repaid as (1) a supplement to Sobi’s applicable base royalty obligations and (2) a discount on Biogen Idec’s applicable base royalty and Net Partner Revenue share obligations, as follows:

 

(A)                                Sobi’s royalty obligation to Biogen Idec under Section 8.1(a) will be increased by five percentage points from the applicable base rate (for example, from 12% to 17%) in the Sobi Territory;

 

(B)                                Biogen Idec’s royalty obligation to Sobi under Section 8.1(a) will be reduced by five percentage points from the applicable base rate (for example, from 12% to 7% in the Biogen Idec North America

 

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Territory) in the Biogen Idec North America and Direct Territories; and

 

(C)                                the applicable Net Partner Revenue due to Sobi from the Biogen Idec Partner Territory shall be reduced by 15% (e.g. from 50% to 35%),

 

in all cases ((A), (B) and (C)) until the Opt-In Consideration for the applicable Product has been repaid in full. For clarity, the amounts of both such supplemental royalties and such reduction of royalties and Net Partner Revenue shall be deemed repayments of the Opt-In Consideration.

 

Notwithstanding the manner of its repayment, the Parties acknowledge that the Opt-In Consideration is a reimbursement of development expenses and not a milestone or royalty due in consideration for any right or license granted to Sobi hereunder.

 

(ii)                                    If repayment of the Opt-In Consideration for any Product being Commercialized under the Collaboration has not been achieved pursuant to Section 8.1(b)(i) above within 6 years of the First Commercial Sale of such Product, Biogen Idec shall have the right to require Sobi to pay any remaining balance to Biogen Idec within 90 days of the 6 year anniversary date of First Commercial Sale of that Product.

 

(iii)                                 When, as a result of the supplements and/or discounts applied under Section 8.1(b)(i), and subject to any balancing payment due under Section 8.1(b)(ii), Biogen Idec has received the full Opt-In Consideration for a Product, the Parties’ respective royalty and Net Partner Revenue share obligations for such Product will revert to the applicable base levels stated in Section 8.1(a).

 

(iv)                                For the avoidance of doubt, any Opt-In Consideration outstanding upon termination of this Agreement in full or with respect to a particular Product shall

 

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be repaid by supplements and discounts to the amounts otherwise payable after such termination to the extent provided in Section 14.3(a)(iii).

 

(v)                                   Notwithstanding anything to the contrary in Section 8.1(a) or (b), prior to the First Commercial Sale in the Sobi Territory of a Lead Product, Biogen Idec will pay Sobi 2% of Net Sales in the Biogen Idec North America Territory and the Biogen Idec Direct Territory and 10% of Biogen Idec’s Net Partner Revenues in the Biogen Idec Partner Territory in respect of such Lead Product.  Following the First Commercial Sale of such Lead Product in the Sobi Territory, Biogen Idec shall (A) commence paying royalties and a share of Net Partner Revenues as otherwise provided in Section 8.1(a) and (b) (including crediting toward Sobi’s obligation to repay the applicable Opt-In Consideration the amount of any reduction in royalties and Net Partner Revenue otherwise payable by Biogen Idec under Section 8.1(a)), and (B) credit toward Sobi’s obligation to repay the applicable Opt-In Consideration an amount equal to the difference between (1) a calculation of royalties and share of Net Partner Revenues based on the rates set forth in Section 8.1(a) for the Net Sales and Net Partner Revenues that occurred prior to  the First Commercial Sale in the Sobi Territory for such Lead Product (as if such rates were applicable during such time period), less (2) the aggregate royalties and share of Net Partner Revenues actually paid or payable under the first sentence of this Section 8.1(b)(v).  For purposes of illustration only,  assuming the First Commercial Sale of such Lead Product occurs in the Biogen Idec Territory and the base royalty and Net Partner Revenue share rates in Section 8.1(a)(i) apply:

 

1.                                       For the time period between Biogen Idec’s First Commercial Sale of such Lead Product in the Biogen Idec Territory and Sobi’s First Commercial Sale of such Lead Product in the Sobi Territory, Biogen Idec would initially make quarterly cash payments of 2% of Net Sales in the Biogen Idec North America Territory and the Biogen Idec Direct Territory and 10% of Biogen Idec’s Net

 

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Partner Revenues in the Biogen Idec Partner Territory.

 

2.                                       Upon Sobi’s First Commercial Sale in the Sobi Territory, Biogen Idec would credit toward the Opt-In Consideration:

 

(A)                                With respect to the Biogen Idec North America Territory, an amount equal to the difference between 12% and 2% (i.e., 10%) of Biogen Idec’s Net Sales in the Biogen Idec North America Territory for the time period between Biogen Idec’s First Commercial Sale and Sobi’s First Commercial Sale;

 

(B)                                With respect to the Biogen Idec Direct Territory, an amount equal to the difference between 17% and 2% (i.e., 15%) of Biogen Idec’s Net Sales in the Biogen Idec Direct Territory for the time period between Biogen Idec’s First Commercial Sale and Sobi’s First Commercial Sale; and

 

(C)                                With respect to the Biogen Idec Partner Territory, an amount equal to the difference between 50% and 10% (i.e., 40%) of Biogen Idec’s Net Partner Revenue for the time period between Biogen Idec’s First Commercial Sale and Sobi’s First Commercial Sale.

 

(vi)                                Notwithstanding anything to the contrary in Section 8.1(a) or (b), (i) prior to the First Commercial Sale in the Sobi Territory of a Product other than a Lead Product , Biogen Idec will pay Sobi 2% of Net Sales in the Biogen Idec North America Territory and the Biogen Idec Direct Territory and 10% of Biogen Idec’s Net Partner Revenues in the Biogen Idec Partner Territory in respect of such Product.  Following the First Commercial Sale of such Product in the Sobi Territory, Biogen Idec shall (A) commence paying royalties and a share of Net Partner Revenues as otherwise provided in Section 8.1(a) and (b) (including crediting toward Sobi’s obligation to repay the applicable Opt-In Consideration the amount of any reduction in royalties and Net Partner Revenue otherwise

 

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payable by Biogen Idec under Section 8.1(a)), and (B) credit toward Sobi’s obligation to repay the applicable Opt-In Consideration an amount equal to the difference between (1) a calculation of royalties and share of Net Partner Revenues based on the rates set forth in Section 8.1(a) for the Net Sales and Net Partner Revenues that occurred between Opt-In and the First Commercial Sale in the Sobi Territory for such Product (as if such rates were applicable during such time period), less (2) the aggregate royalties and share of Net Partner Revenues actually paid or payable under the first sentence of this Section 8.1(b)(vi) in respect of Net Sales and Net Partner Revenue during such time period after Opt-In.  For purposes of illustration only, assuming the First Commercial Sale of such Product occurs in the Biogen Idec Territory and the base royalty and Net Partner Revenue share rates in Section 8.1(a)(i) apply:

 

1.                                       For the time period between Biogen Idec’s First Commercial Sale of such Product in the Biogen Idec Territory and Sobi’s First Commercial Sale of such Product in the Sobi Territory, Biogen Idec would make quarterly cash payments of 2% of Net Sales in the Biogen Idec North America Territory and the Biogen Idec Direct Territory and 10% of Biogen Idec’s Net Partner Revenues in the Biogen Idec Partner Territory.

 

2.                                       Upon Sobi’s First Commercial Sale in the Sobi Territory, Biogen Idec would credit toward the Opt-In Consideration:

 

(A)                                With respect to the Biogen Idec North America Territory, an amount equal to the difference between 12% and 2% (i.e., 10%) of Biogen Idec’s Net Sales in the Biogen Idec North America Territory for the time period between Opt-In and Sobi’s First Commercial Sale;

 

(B)                                With respect to the Biogen Idec Direct Territory, an amount equal to the difference between 17% and 2% (i.e., 15%) of Biogen Idec’s Net Sales in the Biogen Idec Direct Territory for the time period between Opt-In and Sobi’s First Commercial Sale; and

 

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(C)                                With respect to the Biogen Idec Partner Territory, an amount equal to the difference between 50% and 10% (i.e., 40%) of Biogen Idec’s Net Partner Revenue for the time period between Opt-In and Sobi’s First Commercial Sale.

 

3.                                       [**].

 

(vii)                             The Parties acknowledges that the compensation payable to the other Party under this Agreement is fair and reasonable compensation for the shared costs and risks undertaken and rights granted each other under this Agreement, notwithstanding any expiration of Patent Rights Controlled by such other Party that claim a Product or one Party’s ownership of all Collaboration IP that may be relevant to the applicable Product.

 

(c)                                    Reports and Payments .  The payments owed pursuant to Sections 8.1(a) or (b) shall be paid by the owing Party within forty-five (45) days after the end of each calendar quarter during the Term.  Each such payment shall be accompanied by a written report specifying the calculation of the Net Sales, Net Partner Revenues and the royalty and share of Net Partner Revenue payable thereon.

 

(d)                                   Third Party Fees and Royalties .

 

(i)                                       Except with respect to any payments payable prior to Sobi’s exercise of its Opt-In Right under Section 4.1(a) and any payments to be made to [**] pursuant to Sections 4.1, 4.2, 4.3, 4.4(a)(ii), 4.4(b)(i)(y) and 6.1 of the [**] Agreement, each of which shall be borne solely by Biogen Idec, the Parties shall bear any milestones, royalties and other payments payable to Third Parties in consideration of a license(s) under such Third Party intellectual property rights in respect of the Development, Finalization or Commercialization of the Products, pursuant to (1) the [**] Agreement, (2) any other agreement or understanding entered into with a Third Party licensor if the Parties mutually agree, or if mutually acceptable

 

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independent patent counsel not regularly employed by either Party determines, that such license is reasonably necessary for such Development, Final Development or Commercialization (to the extent determined other than pursuant to a claim subject to indemnification under Section 10) or (3) any other agreement or understanding entered into with a Third Party licensor after the Effective Date with respect to Future Latent Background IP (defined below) as follows:

 

(A)                                [**];

 

(B)                                [**];

 

(C)                                [**];

 

(D)                                [**]

 

(E)                                 [**].

 

(ii)            “ Future Latent Background IP ” means Biogen Idec Background IP or Sobi Background IP acquired from Third Parties after the Effective Date that did not (as of the Future Latent Background IP Acquisition Date) cover a Product in the form it existed (or in the form as planned in written documentation shared between the Parties) at the time the applicable Party first entered into an agreement to acquire rights to such Future Latent Background IP (the “ Future Latent Background IP Acquisition Date ”); provided , however, that such Biogen Idec Background IP or Sobi Background IP shall only qualify as Future Latent Background IP if the Party Controlling the applicable Future Latent Background IP notifies the JSC of its rights to such Future Latent Background IP and the payments and other material terms of the applicable Third Party agreement  (i) promptly after such Party becomes aware of a proposed change that would likely cause such Future Latent Background IP to cover a Product, and (ii) prior to the implementation of the changes to the Product that cause such Future Latent Background IP to cover a Product.

 

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(e)                                    [**].

 

(f)                                     [**].

 

(i)                                       [**].

 

(ii)                                    [**].

 

8.2          Interest .  In addition to any other remedies available to the Party to whom payments are owed pursuant to this Agreement, if the Party owing such payments fails to pay any amounts when due, the Party owing such payments shall pay the Party to whom payments are owed a late payment charge equal to [**] (or the highest rate permitted by law, if lower).

 

8.3                                Records .  Each Party and its Affiliates shall, during the Term and for a period of three (3) years thereafter, maintain complete and accurate books and records of account relating to the sale of the Product in such Party’s Territory, and the calculation of Net Sales, Net Partner Revenues, Manufacturing, Development, Final Development Expenses and Additional Agreed Activities Expenses and the obligations to be shared by the Parties pursuant to Section 8.1, in sufficient detail to permit the accurate calculation of the payments due to the other Party hereunder.

 

8.4                                Audits .  Each Party (the “ Auditing Party ”) shall have the right during the Term and for a period of three (3) years thereafter, to have an independent certified public accountant reasonably acceptable to the other Party (the “ Audited Party ”) examine the relevant books and records of the Audited Party and its Affiliates during normal business hours, not more than once each calendar year, to verify that appropriate accounting and payments have been made under this Agreement.  In the event a determination is made that the Auditing Party has been underpaid or overcharged, the Audited Party shall promptly pay to the Auditing Party the amount by which the Auditing Party was underpaid or overcharged along with interest at a rate of interest provided for in Section 8.2 for the period that such amounts were due.  The fees and expenses of the accountant performing any verification pursuant to this Section 8.4 shall be paid by the Auditing Party; provided , however , that, if a determination is made that the amount paid to the Auditing Party with respect to any calendar year was less than [**] of the amount properly due to the Auditing

 

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Party, the Audited Party shall promptly reimburse the Auditing Party for the costs of such verification.  Any accountant who examines the books and records of the Audited Party pursuant to this Section 8.4 shall sign a confidentiality agreement reasonably satisfactory to the Audited Party.

 

8.5                                Rate of Exchange for Non-U.S.D. Payments .  All payments shall be made in U.S. Dollars.  With respect to any payments that may become payable hereunder based on currencies other than U.S. Dollars, conversion of foreign currency to United States Dollars will be made by applying the monthly average rate of exchange calculated by using the foreign exchange rates published in Bloomberg during the applicable month starting two (2) Business Days before the beginning of such month and ending two (2) Business Days before the end of such month.  If at any time legal restrictions in any country in the Territory prevent the prompt remittance of any payments hereunder, the paying Party shall have the right and option to make such payments by depositing the amount thereof in local currency to the account of the payee Party in a bank or depository in such country designated by the payee Party.

 

8.6                                Taxes .  In the event that laws or regulations require withholding of taxes on behalf of a Party from any payment owed by the other Party hereunder, such taxes will be deducted from such payment by the paying Party and will be remitted by the paying Party on behalf of the paid Party to the appropriate tax authority.  The paying Party will furnish the paid Party with proof of payment of such taxes as soon as practicable after such payment is made.  In the event that documentation is necessary in order for the paid Party to secure an exemption from or a reduction in any withholding of taxes, the paid Party shall provide such documentation in a timely manner to the paying Party.  The Parties will reasonably cooperate in completing and filing documents required under the provisions of any applicable tax laws or under any other applicable law in connection with the making of any required tax payment or withholding payment, or in connection with any claim to a refund of or credit for any such payment.

 

9.                                      Confidentiality.

 

9.1                                Status of Collaboration Know-How .  All solely-owned Collaboration Know-How shall

 

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constitute the Confidential Information of the Party that owns such Information.  The Jointly-Owned Know-How shall constitute the Confidential Information of both Parties.

 

9.2                                Use of Confidential Information .  During the Term and thereafter, each Party shall use the other Party’s Confidential Information solely for the purposes contemplated in this Agreement.

 

9.3                                Disclosure of Confidential Information .

 

(a)                                   During the Term and thereafter, neither Party shall directly or indirectly publish, disseminate or otherwise disclose, deliver or make available to any person outside its organization any of the other Party’s Confidential Information, except as expressly permitted herein.  Each Party shall have the right to provide Confidential Information received from the other Party to its employees, consultants and advisors and permitted Sublicensees, and the employees, consultants and advisors of its Affiliates, who have a need to know the Confidential Information and an obligation to maintain in confidence the Confidential Information of the Disclosing Party.  Either Party shall be entitled to disclose Jointly-Owned Know-How, including data and other Information that become Jointly-Owned Know-How pursuant to Sections 4.1(d) or 4.2(c), to (i) its patent counsel and to patent-granting authorities in, or in connection with, patent applications for purposes of prosecuting its Sole Collaboration Patent Rights, subject to review and discussion by the JPT pursuant to Section 7.3(a); and (ii) other Third Parties for all other purposes which are authorized and contemplated by this Agreement.  For clarity, neither Party shall have the right to disclose the other Party’s Sole Collaboration IP in, or in connection with, any patent applications without the Owning Party’s prior written consent.

 

(b)                                   To the extent that a Party has been granted the right to sublicense under the terms of this Agreement, each Party shall have the right to provide Confidential Information received from the other Party to the employees, consultants and advisors of its sublicensees and potential sublicensees who have a need to know the Confidential Information and an obligation to maintain in confidence the Confidential Information of the disclosing Party.

 

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(c)                                    Biogen Idec may share with [**] the information conveyed to it under Sections 7 and 8 and information about the Development, Post Opt-In Development, Final Development, Manufacture and Commercialization of the Products.  Such disclosure shall be under an obligation to maintain in confidence Sobi’s Confidential Information .

 

(d)                                   The Parties agree that, as between Sobi and Biogen Idec, all Confidential Information provided by Amunix or otherwise arising in connection with any of the Amunix Agreements shall be treated for purposes of this Agreement as Confidential Information of Biogen Idec, subject to any more stringent confidentiality and non-use requirements of the applicable Amunix Agreement to the extent such information is identified as the confidential information of Amunix.

 

9.4                                Release from Restrictions .  Notwithstanding the provisions of Sections 9.2 and 9.3, a Party shall not be prevented from using or disclosing the Confidential Information of the other Party which (a) was known or used by the Receiving Party prior to its date of disclosure to the Receiving Party; (b) either before or after its date of disclosure to the Receiving Party, is lawfully disclosed to the Receiving Party by a Third Party rightfully in possession of the Confidential Information, but only to the extent of the rights obtained from such Third Party; (c) either before or after the date of disclosure to the Receiving Party, becomes published or otherwise publicly known through no fault or omission on the part of the Receiving Party; (d) is independently developed by the Receiving Party without any use of the Confidential Information of the Disclosing Party; or (e) is reasonably necessary to comply with applicable government laws or regulations; provided, that the Receiving Party provides written notice of such disclosure to the Disclosing Party and takes all reasonable actions to avoid and/or minimize the degree of such disclosure.

 

9.5                                Disclosure of Financial and Other Terms.   Except as required by applicable laws, treaties, and regulations (including securities laws), the Parties agree that the terms of this Agreement will be considered Confidential Information of both Parties to which Section 9.3 applies.  Notwithstanding the foregoing, (a) either Party may disclose such terms as are required to be

 

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disclosed in its publicly-filed financial statements or other public statements pursuant to applicable laws, regulations, and stock exchange rules ( e.g. , the U.S. Securities and Exchange Commission, Stockholmbörsen, or any other stock exchange on which securities issued by either Party may be issued) or otherwise disclosed pursuant to applicable law; provided , that (i) the terms of this Agreement shall be redacted to the greatest extent reasonably possible and (ii) to the extent practicable under the circumstances, such Party shall provide the other Party with a copy of the proposed text of such statements or disclosure (including any exhibits containing this Agreement) sufficiently in advance of the scheduled release or publication thereof to afford such other Party a reasonable opportunity to review and comment upon the proposed text (including redacted versions of this Agreement), (b) either Party shall have the further right to disclose the material financial terms of this Agreement under confidentiality undertakings to any actual or potential acquirer, merger partner, or providers of financing (whether in the form of debt, equity or otherwise) and their advisors, (c) either Party shall have the right to disclose information regarding the Development, Post Opt-In Development, Finalization, Manufacturing or Commercialization status of a Product to the extent such disclosure is made under a confidentiality undertaking to actual or prospective investors, or required by applicable laws or stock exchange rules, and (d) either Party shall have the right to disclose the material terms of this Agreement in private meetings with actual or potential providers of financing (whether in the form of debt, equity or otherwise).  Neither Party shall make any other statement to the public regarding the execution and/or any other aspect of the subject matter of this Agreement, except:  (x) where a Party reasonably believes disclosure is required under applicable laws or ethical commercial practice, (y) subject to Section 9.7, for customary discussions with current or prospective investors and analysts, and (z) either Party may use the text of a statement previously approved by the other Party or otherwise publicly disclosed in accordance with this Section 9.5.

 

9.6                                Publicity .  Except for disclosures required by law, regulation or stock exchange requirements, neither Party shall have the right to make any other public announcements with respect to this Agreement without the prior written consent of the other Party, except as provided in Section 9.5.  The Parties agree that any announcement made in respect of this Agreement shall

 

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not contain the other Party’s Confidential Information or, if disclosure of Confidential Information is required by law or regulation, shall make reasonable efforts to minimize such disclosure and obtain confidential treatment for any such information which is disclosed to a government agency, it being understood that the other Party shall have the right, to the extent in accordance with applicable law, to review such Party’s disclosures to government agencies and require redaction of any information the other Party reasonably deems inappropriate for disclosure, including without limitation, key financial terms not previously disclosed as permitted hereunder.  Subject to applicable law and stock exchange requirements, each Party agrees to provide the other Party with a copy of any public announcement as far in advance of its scheduled release as reasonably practicable and such other Party shall have the right to expeditiously review and recommend changes to any announcement regarding this Agreement; provided that such right of review and recommendation shall only apply for the first time that specific information is disclosed and shall not apply to the subsequent disclosure of substantially similar information that has been previously disclosed.

 

9.7                                Investor Communications .   Each Party will use Commercially Reasonable Efforts to keep the other Party informed reasonably in advance of any planned public communications related to a Product or the Collaboration that are likely to impact, or raise questions or concerns, for the other Party’s investors.

 

(a)                                   Each Party agrees to deliver to the other Party the relevant sections of external investor communications, including regulatory filings, annual reports and earnings releases, that cover a Product, potential Product or the Collaboration, and will in good faith consider any changes that are timely recommended by the other Party.  Each disclosing Party will use Commercially Reasonable Efforts to provide the other Party with sufficient time to review such investor-related materials and to notify the other Party of any particularly urgent timeframes.

 

(b)                                   With respect to external earnings calls relevant to a Product, the reporting Party will submit materials (e.g., script, slides, select Q&A) related to such Product to the other Party at least two Business Days in advance of such proposed communication, the other Party will

 

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have the right to review and recommend changes to such materials, and the reporting Party will in good faith consider any changes that are recommended by the other Party within two Business Days of receipt of such materials.

 

(c)                                    The Parties will in good faith cooperate on aligned corporate messaging for the global opportunity for the Products and potential Products.

 

(d)                                   Notwithstanding the foregoing, to the extent information regarding this Agreement, a Product, a potential Product or the Collaboration has already been publicly disclosed in accordance with the procedures above, either Party (or its Affiliates) may subsequently disclose the same information to the public without the consent or review right of the other Party.

 

9.8                                Use of [**] and Other Names .  Notwithstanding anything to the contrary in Sections 9.3 through 9.7, the Parties shall comply with Section 10.3 of the [**] Agreement.

 

10.                               Indemnification.

 

10.1                         Sobi Indemnification .  Sobi shall indemnify, defend and hold harmless the Biogen Idec Indemnified Parties from and against any and all liability, claims, damage, loss, or expense (including reasonable attorneys’ fees) resulting from any Third Party claims made or legal proceedings instituted against any of the Biogen Idec Indemnified Parties that arise out of or result from (a) the Post Opt-In Development, Final Development or Commercialization of a Product by or on behalf of Sobi, its Affiliates, permitted sublicensees and distributors (other than activities conducted on behalf of Sobi by Biogen Idec or its Affiliates) with respect to the Sobi Territory, including any claims of intellectual property infringement, death or bodily injury, or any claims arising from a customer’s use of such Product; (c) the Commercialization of a Product in the Sobi Territory during the MAH Transfer Period for EMA; (d) any Named Patient Supply program in the Sobi Territory; (e) any clinical trial or other Post Opt-In Development of a Product by or on behalf of Sobi (other than a clinical trial conducted on behalf of Sobi by Biogen Idec or its Affiliates), or (f) any actual or alleged breach by Sobi of this Agreement, except, in

 

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each case, to the extent Biogen Idec is obligated to indemnify and hold harmless the Sobi Indemnified Parties therefrom pursuant to Section 10.2 or under any CSA.  Further, with respect to [**], Sobi shall comply with the indemnification obligations set forth in Section 10.2 of the [**] Agreement.  Sobi shall indemnify Biogen Idec for any patent reimbursement expenses, milestone payments, royalties or other amounts payable by Biogen Idec to Amunix to the extent that Sobi has breached its obligations hereunder to pay such amounts to Biogen Idec.  For clarity, the Manufacture of Products for commercial supply shall be subject solely to the applicable indemnification obligations set forth in the applicable CSA.

 

10.2                         Biogen Idec Indemnification .  Biogen Idec shall indemnify, defend and hold harmless the Sobi Indemnified Parties from and against any and all liability, claims, damage, loss, or expense (including reasonable attorneys’ fees) resulting from any Third Party claims made or legal proceedings instituted against any of the Sobi Indemnified Parties that arise out of or result from (a) the Development of a Product by or on behalf of Biogen Idec or Manufacturing of a Product for clinical use by Biogen Idec or its Affiliates or Third Parties to whom Biogen Idec has sublicensed the right to Manufacture such Product, including any claims of intellectual property infringement, death or bodily injury, or any claims arising from a customer’s use of such Product, (b) the Post Opt-In Development, Final Development or Commercialization of a Product by or on behalf of Biogen Idec, its Affiliates, permitted sublicensees and distributors with respect to the Biogen Idec Territory, including any claims of intellectual property infringement, death or bodily injury, or any claims arising from a customer’s use of such Product; (c) any clinical trial of a Product by or on behalf of Biogen Idec (other than a clinical trial conducted on behalf of Biogen Idec by Sobi or its Affiliates), or (d) any actual or alleged breach by Biogen Idec of this Agreement, except, in each case, to the extent Sobi is obligated to indemnify and hold harmless the Biogen Idec Indemnified Parties therefrom pursuant to Section 10.1.  [**].  For clarity, the Manufacture of Products for commercial supply shall be subject solely to the applicable indemnification obligations of the applicable CSA.

 

10.3                         Limitation on Indemnification .  Notwithstanding anything to the contrary set forth elsewhere herein, neither Party shall be obligated to indemnify the other Party or any other Sobi

 

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Indemnified Party or Biogen Idec Indemnified Party for claims or liabilities to the extent arising from such other Party’s, or its Affiliates’, sublicensees’ or assigns’ negligence, intentional misconduct, or breach of its duties, obligations, warranties or representations set forth herein.

 

10.4                         Procedure .  The Party seeking indemnification shall provide the indemnifying Party with written notice of any claim or action within ten (10) days of its receipt thereof, and shall afford the indemnifying Party the right to control the defense and settlement of such claim or action.  The Party seeking indemnification shall provide reasonable assistance to the indemnifying Party in the defense of such claim or action.  If the defendants in any such action include both Parties, and the indemnified Party concludes that there may be legal defenses available to it which are different from, additional to, or inconsistent with, those available to the indemnifying Party, the indemnified Party shall have the right to select separate counsel to participate in the defense of such action on its behalf, and the indemnified Party shall bear the cost and expense of such separate defense, unless and to the extent the Parties otherwise agree or it is determined through arbitration hereunder that such costs and expense are or were required to be indemnified by the indemnifying Party and are or were required to be incurred separately due to such different, additional, or inconsistent defenses.  Should the indemnifying Party determine not to defend such claim or action, the indemnified Party shall have the right to maintain the defense of such claim or action and the indemnifying Party shall provide reasonable assistance to it in the defense of such claim or action and shall bear the reasonable cost and expense of such defense (including reasonable attorneys’ fees).  Neither Party shall settle any such claim or action in a way that prejudices or adversely impacts the other Party without the prior approval of such other Party (which approval shall not be unreasonably withheld).

 

10.5                         Allocation .  In the event a claim is based partially on an indemnified claim described in this Section 10 and partially on a non-indemnified claim, or is based partially on a claim described in Section 10.1 and partially on a claim described in Section 10.2, any payments and reasonable attorney fees incurred in connection with such claims are to be apportioned between the Parties in accordance with the degree of cause attributable to each Party.

 

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11.                               Insurance.

 

11.1                         Without limiting either Party’s undertaking to defend, indemnify, and hold the other Party harmless as set forth in Section 10, each Party shall obtain and maintain, promptly following the development of the CTD, a Commercial General Liability policy including coverage for Commercial General Liability claims and coverage for products liability claims, in an amount and coverage reasonably determined by such Party on a country-by-country basis.  The foregoing coverage shall continue during the Term and, with respect to product liability claims, for a period of five (5) years after the Term.  Notwithstanding the foregoing, either Party  may self-insure to the extent that it self-insures for its other products.

 

12.                               Representations and Warranties.

 

12.1                         Representations .  Each Party (the “ Representing Party ”) represents and warrants to the other Party that, as of the Effective Date:  (a) the Representing Party is a corporation duly organized and in good standing under the laws of the jurisdiction of its incorporation, and it has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement; (b) the Representing Party has the full right, power and authority to enter into this Agreement and to grant the rights and licenses granted by it under this Agreement; (c) there are no existing or, to the Representing Party’s knowledge, threatened actions, suits or claims pending with respect to the subject matter of this Agreement or the Representing Party’s right to enter into and perform its obligations under this Agreement; (d) the Representing Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement; (e) this Agreement has been duly executed and delivered on behalf of the Representing Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof, subject to the general principles of equity and to bankruptcy, insolvency, moratorium and other similar laws affecting the enforcement of creditors’ rights generally; (f) all necessary consents, approvals and authorizations of all regulatory and governmental authorities and other persons required to be

 

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obtained by the Representing Party in connection with the execution and delivery of this Agreement and the performance of its obligations under this Agreement have been obtained; (g) the execution and delivery of this Agreement by the Representing Party and the performance of the Representing Party’s obligations hereunder do not conflict with, or constitute a default under, any of its contractual obligations; and (h) the Representing Party has not been debarred under the Generic Drug Enforcement Act of 1992 (21 U.S.C. §301 et seq.), is not under investigation for debarment action, has not been disqualified as an investigator pursuant to 21 C.F.R. §312.70, does not have a disqualification hearing pending and is not currently employing any person or entity that has been so debarred or disqualified to perform any of the Representing Party’s obligations under this Agreement.

 

12.2                         Debarment Actions .  The Representing Party shall promptly notify the other Party if it is debarred or disqualified as described in Section 12.1(h) and shall terminate any so debarred or disqualified individual’s or entity’s participation in the performance of any of the Representing Party’s obligations under this Agreement promptly upon the Representing Party’s awareness of such debarment or disqualification.

 

12.3                         IP Warranties .  Each Party warrants that as of the Effective Date:  (a) it owns, or is exclusively licensed under, such Party’s Background IP; (b)  no claim has been made against such Party alleging that such Party’s Background Patent Rights are invalid or unenforceable or that the exploitation of such Party’s Background Patent Rights or such Party’s Background Know-How infringes or misappropriates any intellectual property right of any Third Party; (c) it has not granted any Third Party any rights in respect of the Products or that are otherwise inconsistent with the term of this Agreement; (d) except as set forth in Schedules 1.12 or 1.104 , as applicable, it is not aware of any of its existing Background Patent Rights that, in its reasonable judgment, cover the Product (or its method of manufacturing or use) as the Product and such methods exist on the Effective Date and are known to such Party; and (e) all of its Sole Collaboration Patent Rights existing on the Effective Date are listed on Schedules 1.25 or 1.114 .

 

12.4                         Limitation of Warranties .  EXCEPT AS EXPRESSLY SET FORTH IN SECTIONS 12.1

 

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THROUGH 12.3, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND UNDER THIS AGREEMENT (INCLUDING WITH RESPECT TO ANY MATERIALS PROVIDED UNDER THIS AGREEMENT), EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, QUALITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR VALIDITY OF PATENT CLAIMS, WHETHER ISSUED OR PENDING.

 

13.                               Limitation of Liability.

 

13.1                         EXCEPT WITH RESPECT TO A BREACH OF SECTION 9 OR A PARTY’S LIABILITY PURSUANT TO SECTION 10, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY OTHER PERSON FOR INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, PUNITIVE, MULTIPLE OR OTHER INDIRECT DAMAGES, OR FOR LOSS OF PROFITS, LOSS OF DATA OR LOSS OF USE DAMAGES, ARISING OUT OF THIS AGREEMENT, WHETHER BASED UPON WARRANTY, CONTRACT, TORT, STATUTE, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR LOSSES.  The Parties agree that the actual, direct costs incurred by a Party to perform Development, Finalization, Manufacturing or Commercialization obligations hereunder that the other Party was obligated to perform but failed to perform (subject to the right of such other Party to cure such breach and subject to the provisions of Section 15 if the occurrence of such breach is disputed) shall be deemed to be direct damages and not subject to this limitation.

 

14.                               Term and Termination.

 

14.1                         Term .  Unless terminated earlier in accordance with Section 14.2, this Agreement shall remain in force for the period commencing on the Original Execution Date and shall continue, with respect to each Product, for as long as such Product is being sold anywhere in the world (the “ Term ”).

 

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14.2                         Termination .

 

(a)                                   Termination for Convenience .  Either Party (the “ Withdrawing Party ”) may at any time provide to the other Party (the “ Non-Withdrawing Party ”) six (6) months’ written notice of the Withdrawing Party’s intent to terminate this Agreement in its entirety or with respect to a Product, and, upon the expiration of such six (6) month period (or at such earlier time as the Non-Withdrawing Party may designate), this Agreement shall terminate in its entirety or with respect to such Product.  With respect to any Amunix License Agreement pursuant to which a sublicense to Sobi is then in effect hereunder, any termination by Amunix of such Amunix License Agreement for Biogen Idec’s uncured breach thereof shall be deemed to be a termination for convenience by Biogen Idec of this Agreement solely with respect to any Product(s) comprising an XTEN Construct that had been licensed to Biogen Idec under such terminated Amunix License Agreement, and Biogen Idec shall be deemed to be the Withdrawing Party with respect to such Product(s).

 

(b)                                   Breach .

 

(i)                                       Upon any material breach of a material obligation of this Agreement by a Party (the “ Breaching Party ”), the other Party (the “ Non-Breaching Party ”) may, by providing [**] prior written notice to the Breaching Party, terminate this Agreement, which notice shall identify the material breach, the intent to so terminate and the actions or conduct that it considers would be an acceptable cure of such breach.  The Breaching Party shall have a period of [**] after such written notice is provided to cure such breach (the “ Initial Cure Period ”).  If the material breach is not cured within such [**], the Non-Breaching Party may terminate this Agreement upon [**] written notice; provided, that if the Breaching Party disputes such material breach as provided in subsection (ii) below, such termination shall be effective only as provided in such subsection (ii).  Such termination shall apply solely with respect to a Product(s) if such breach related solely to such Product(s) (but not all then-

 

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current Products), and shall otherwise apply to this Agreement in its entirety.

 

(ii)                                    If the Non-Breaching Party gives notice of material breach under this Section 14.2(b) and the Breaching Party disputes whether there is a material breach, then the issue of whether the Non-Breaching Party may properly terminate this Agreement on expiration of such Initial Cure Period shall be resolved in accordance with Section 15, the Parties shall cooperate to allow such determination to be made within [**] after a Party requests such determination (or as promptly thereafter as possible) and this Agreement shall not terminate except as provided in this Section 14.2(b)(ii).  If, as a result of such dispute resolution process, it is determined that the Breaching Party committed a material breach and the Breaching Party does not cure such breach within [**] after the date of the arbitration award (the Additional Cure Period ), then such termination shall be effective upon the expiration of the Additional Cure Period.  If the Parties dispute whether such breach was so cured, either Party alone may request the same arbitration tribunal to determine whether it was so cured and the Parties shall cooperate to allow such determination to be made within thirty (30) days after a Party requests such determination.  Such dispute resolution proceeding does not suspend either Party’s obligations hereunder and each Party shall use reasonable efforts to mitigate all damages.  If, as a result of such dispute resolution proceeding, it is determined that the Breaching Party did not commit a material breach (or that such breach was cured within the permitted time period or, subject to the right to recover damages as provided in Section 15, the Additional Cure Period), then no termination shall be effective and this Agreement shall remain in effect as it was prior to such notice by the Non-Breaching Party.

 

14.3                         Effects of Expiration or Termination .

 

(a)                                   Upon termination of this Agreement in its entirety (in which case all Products are

 

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considered to be terminated), or upon non-election by Sobi pursuant to Sections 3.1(c)(i) or 3.1(c)(ii), or non-exercise by Sobi of its Opt-In Rights under Section 4.1(a), or upon termination with respect to a Product pursuant to Sections 14.2(a) or (b) (each Product that is so terminated or for which Sobi does not exercise its Opt-In Right and any product containing a Compound Construct for which Sobi does not elect its rights under Sections 3.1(c) shall be a “ Terminated Product ”):

 

(i)                                       The licenses granted by the Non-Continuing Party to the Continuing Party with respect to all Terminated  Products shall remain in effect after such termination on a sublicenseable (provided that such sublicensees comply with the relevant provisions of this Agreement) basis and shall be converted to exclusive licenses to (A) Develop, Post Opt-In Develop, Finalize and Commercialize the Terminated Products anywhere in the world, and (B) Manufacture the Terminated Products anywhere in the world (which, if Sobi is the Non-Continuing Party, shall be limited to such rights under the Sobi Sole Collaboration IP and, only to the extent then (x) incorporated into or then being used in the Manufacture of the applicable Terminated Product or (y) planned  (as evidenced by written documentation shared between the Parties prior to the date of termination) on being incorporated into, or being used in the Manufacture of, the applicable Terminated Product, other Sobi IP);

 

(ii)                                    The Non-Continuing Party, with respect to the Terminated Products, (A) shall, at the Non-Continuing Party’s expense, submit letter(s) or application(s) to the relevant Regulatory Authorities and take such other actions to transfer ownership of the Regulatory Filings and Regulatory Approvals in each country in the Territory to the Continuing Party within thirty (30) days after receipt of the required documentation from the Continuing Party for inclusion in such letter(s) or application(s) ( provided , that, if, at the time of termination (or such non-election or non-exercise), any clinical trials are being conducted by the Non-Continuing Party, such transfer may be delayed, in the Continuing Party’s

 

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reasonable discretion, to permit the Non-Continuing Party to complete such clinical trials, and the Non-Continuing Party shall complete such trials at the Continuing Party’s expense); (B) shall, at the Non-Continuing Party’s expense, immediately assign to the Continuing Party, all of its right, title and interest in and to all of its Sole Collaboration IP and other clinical, technical and other relevant reports, records, data and other tangible Information specifically relating to the Terminated Products (provided that the Non-Continuing Party may retain one (1) copy of such Information in its archives solely to verify its compliance with its continuing obligations of confidentiality under this Agreement); (C) shall, at the Non-Continuing Party’s expense, take appropriate steps with the relevant Regulatory Authorities to effect such assignments (to the extent permitted under applicable law); (D) shall, at the Non-Continuing Party’s expense, deliver to the Continuing Party one (1) copy of each physical embodiment of the items in clauses (A) and (B) in a mutually agreeable format promptly but in no event more than thirty (30) days after such termination (or such non-election or non-exercise); (E) hereby grants to the Continuing Party, subject to such termination (or such non-election or non-exercise), a royalty-bearing license, with the right to grant sublicenses, to use the foregoing to Develop, Manufacture, Finalize and Commercialize the Terminated Products anywhere in the world; (F) shall, at the Non-Continuing Party’s expense, (1) assign to the Continuing Party, promptly after such termination (or such non-election or non-exercise), but in any event no later than thirty (30) days after such termination (or such non-election or non-exercise), all of its right, title and interest in and to the Product Trademarks for the Terminated Products and all goodwill therein, and any domain name registrations incorporating the brand names for the Terminated Products; and (2) assist the Continuing Party in taking appropriate steps with the relevant governmental authorities or, with respect to domain name registrations,  domain name registrars, to effect such assignment; (G) the provisions of Sections 7.3, 7.4, 7.6, 7.7,  7.8 and 7.9 shall apply; provided , that the rights granted to a Party in its role as the

 

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Non-Owning Party thereunder shall apply only if the Non-Owning Party is the Continuing Party;

 

(iii)                                 The Non-Continuing Party shall assign to the Continuing Party any then-current Commercialization agreements with Third Parties (except as otherwise requested by the Continuing Party), the Continuing Party’s Territory shall be expanded to include all countries of the world, and the Continuing Party shall pay to the Non-Continuing Party, based on the date of which the Agreement is so terminated (or the date of such non-election or non-exercise), (A) the percentage (listed in the following table) of Net Sales by the Continuing Party or its Affiliates of each Terminated Product in each calendar quarter ( provided , that, for purposes of this Section 14.3(a)(iii), sales made by Sublicensees of the Continuing Party shall not be considered in calculating Net Sales), and (B) the percentage (listed in the following table) of Sublicense Income or Net Partner Revenue received by the Continuing Party or its Affiliates with respect to rights granted to Third Parties to Commercialize each Terminated Product in any calendar quarter:

 

 

 

Date of Termination
(or non-election or non-exercise)

 

Percentage of Net
Sales payable by the
Continuing Party

 

Percentage of
Sublicense
Income/Net Partner
Revenue payable by
the Continuing
Party

Row A

 

[**]

 

[**]

 

[**]

Row B

 

[**]

 

[**]

 

[**]

Row C

 

[**]

 

[**]

 

[**]

 

[**].

 

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Such payments shall be paid within forty (45) days after the end of each calendar quarter, and Sections 8.2 through 8.6 shall apply mutatis mutandis to such payments and for as long as each Terminated Product is being Developed, Manufactured, Finalized or Commercialized;

 

(iv)                                The Parties shall in good faith draft and execute an agreement reflecting the terms of this Section 14.3(a) and, to the extent applicable, Section 14.3(b); and

 

(v)                                   Except as set forth in Section 10.2, the Continuing Party shall be solely responsible for any milestones, royalties and other payments payable to Third Parties following termination in consideration of a license(s) under such Third Party intellectual property rights in respect of the Development, Post Opt-In Development, Finalization or Commercialization of the Terminated Products, regardless of whether such payments are to be made with respect to intellectual property rights licensed (i) to the Continuing Party, other than as described in the following clauses (ii) and (iii); (ii) to the Non-Continuing Party and sublicensed to the Continuing Party hereunder (including pursuant to the [**] Agreement), provided that the Non-Continuing Party has provided a copy of the relevant Third Party license agreement to the Continuing Party; or (iii) to both Parties.  If the Continuing Party wishes to discontinue making such payments pursuant to clauses (ii) or (iii), the Continuing Party shall provide written notice thereof to the Non-Continuing Party and the Continuing Party shall thereafter not be required to make such payments nor shall the Continuing Party be licensed under the relevant Third Party intellectual property rights.

 

(vi)                                [**].

 

(b)                                   Upon termination or expiration of this Agreement in its entirety for any reason, in addition to the provisions of Section 14.3(a):

 

(i)                                       each Receiving Party shall (A) promptly return to the Disclosing Party all

 

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materials and records in its possession or control containing Confidential Information of the Disclosing Party or, at the election of the Receiving Party, destroy such Confidential Information of the Disclosing Party, and (B) destroy:  (1) any notes, reports or other documents prepared by the Receiving Party which contain Confidential Information of the Disclosing Party; and (2) any Confidential Information of the Disclosing Party (and all copies and reproductions thereof) which is in electronic form or cannot otherwise be returned to the Disclosing Party; provided , however , that (3) each Party may retain the Confidential Information of the other Party to the extent necessary to exercise its rights which survive termination or expiration, and (4) the Receiving Party may retain one (1) copy of the Disclosing Party’s Confidential Information in its archives solely to verify its compliance with its continuing obligations of confidentiality under this Agreement;

 

(ii)                                    the provisions of Sections 4.2(l)(to the extent the licenses granted under Section 7.1 continue in accordance with this Section 14.3), 4.2(m), 7.1(b)(last unenumerated paragraph only and to the extent the Continuing Party appoints Sublicensees),  7.2(a), 7.2(c), 8.1(c), 8.2-8.6, 9, 10, 11, 12.4, 13, 14.3, 14.4, 14.5, 15 and 16 shall survive in accordance with their terms and, to the extent required to give effect to such sections, the provisions of Section 1 and other Sections referred to in any of the foregoing shall survive.

 

14.4                         Non-Exclusive Remedy .  Termination of this Agreement in whole or in part shall be in addition to, and shall not prejudice, the Parties’ remedies at law or in equity, including, without limitation, the Parties’ ability to seek legal damages and/or equitable relief with respect to any breach of this Agreement, regardless of whether or not such breach was the reason for the termination.  Upon termination or expiration of this Agreement in whole or in part for any reason, in addition to the provisions of Section 14.3, neither Party will be released from any obligations that accrued prior to the effective date of expiration or termination.

 

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14.5                         Rights from [**] .  Anything to the contrary notwithstanding, in the case of the [**] Patent Rights, upon any termination of the [**] Agreement [**] shall honor Sobi’s sublicense to the [**] Patent Rights as provided in the [**] Letter Agreement, unless [**] is at that time the Non-Continuing Party.

 

15.                               Dispute Resolution.

 

15.1                         JSC Resolution Procedure .  The JSC shall attempt in good faith to resolve any dispute (a) between the Parties arising out of or relating to the execution, interpretation and performance of this Agreement (including the validity, scope and enforceability of this provision) or (b) within any other Committee arising out of or relating to any matter within the scope of responsibilities of such Committee.  The JSC shall meet within fourteen (14) days after delivery of the notice of dispute from a Committee or any Party and shall attempt in good faith to resolve the dispute.  If the dispute has not been so resolved, either Party may present a notice of dispute to the Executive Officers of the Parties.

 

15.2                         Negotiation Between Officers .  Within fifteen (15) days after delivery of the notice of dispute pursuant to Section 15.1, the Executive Officers of the Parties shall meet or converse by telephone at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, to attempt to resolve the dispute.  All reasonable requests for information made by one Party to the other will be honored.  All negotiations pursuant to this clause are confidential and shall be treated as compromise and settlement negotiations for purposes of applicable rules of evidence.  If the Executive Officers do not resolve the dispute within thirty (30) days after the initial delivery of the notice pursuant to Section 15.1 (or such lesser or longer period as they may agree is a useful period for their discussions), then:

 

(a)                                   to the extent such dispute relates to (i) research activities (including in vitro and in vivo testing) or Development prior to Opt-In, (ii) Manufacturing (other than alleged breach of a CSA, which shall be resolved as set forth therein), (iii) Post Opt-In Development, Final Development or Commercialization in the Biogen Idec Territory or (iv) until Sobi has exercised its Opt-In Right for the relevant Product, Final Development for the Sobi Territory, then Biogen

 

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Idec shall have the final authority to resolve such dispute in its reasonable discretion; provided, that Biogen Idec shall not have such final authority in respect to the approval of any amendments to the HLDP Principles or Material Operational Changes and further provided, that Biogen Idec may not take any action that would conflict with the rights granted Sobi hereunder or conflict with the terms of this Agreement, the CSAs or the Safety Data Exchange Agreement;

 

(b)                                   to the extent [**];

 

(c)                                    in its exercise of its decision rights hereunder, neither Party shall knowingly act in a way that will adversely affect the Commercialization of a Product in the other Party’s Territory; and

 

(d)                                   with respect to any other dispute, either Party may institute a formal arbitration of such matter pursuant to Section 15.3.

 

15.3                         Arbitration .

 

(a)                                   Any dispute, controversy or claim arising out of or relating to this Agreement, or the breach, termination or invalidity thereof, which has not been resolved pursuant to Sections 15.1 or 15.2 shall be finally settled by binding arbitration conducted in the English language in London, England under the commercial arbitration rules of the London Court of International Arbitration.  Each Party shall appoint an arbitrator and the two (2) arbitrators so appointed shall jointly appoint a third arbitrator; provided , however , that if they cannot agree (or if one Party refuses to appoint an arbitrator) within thirty (30) days after the initiation of the arbitration, then such unappointed arbitrator(s) shall be appointed by the President of the London Court of International Arbitration.  Disputes about arbitration procedure shall be resolved by the

 

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arbitrators or failing agreement, by the London Court of International Arbitration in London, England.  The arbitrators may proceed to an award notwithstanding the failure of the other Party to participate in the proceedings.  Discovery shall be limited to mutual exchange of documents relevant to the dispute, controversy or claim; depositions shall not be permitted unless agreed to by both Parties.

 

(b)                                   The arbitrators shall be authorized to grant interim relief, including to prevent the destruction of goods or documents involved in the dispute, protect trade secrets and provide for security for a prospective monetary award.  The limitations on liability set out in Section 13 shall apply to an award of the arbitrators.  Specifically, but without limitation, under no circumstances shall the arbitrators be authorized to award punitive or multiple damages.  Any purported award of punitive or multiple damages or of other damages not permitted under Section 13 shall be beyond the arbitrators’ authority, void, and unenforceable.

 

(c)                                    If the dispute subject to such arbitration proceeding arises under Section 14.2(b)(ii), the arbitral tribunal shall be directed to first determine whether the applicable Party is entitled to terminate under Section 14.2(b).  The arbitral tribunal’s decision on such issue shall be the arbitration award referred to in Section 14.2(b)(ii) for the purpose of commencing the Breaching Party’s final right to cure during the Additional Cure Period.  The same tribunal shall then continue such proceeding for the purpose of determining all damages and other remedies, including a monetary amount to compensate the Non-Breaching Party for all damages and other losses incurred or suffered as a result of a material breach and any failure to cure such breach while dispute resolution proceeding is pending and the Additional Cure Period (subject to the limitations of Section 13).

 

(d)                                   [**].  The award of the arbitrators shall be the sole and exclusive remedy of the Parties and shall be enforceable in any court of competent jurisdiction, subject only to revocation on grounds of fraud or clear bias on the part of the arbitrators.  Notwithstanding anything contained in this Section 15 to the contrary, each Party shall have the right to institute judicial proceedings against the other Party or anyone acting by, through or under such other Party, in

 

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order to enforce the instituting Party’s rights hereunder through reformation of contract, specific performance, injunction or similar equitable relief.

 

16.                               Miscellaneous.

 

16.1                         Notice .

 

(a)                                   All notices, requests, consents and other communications required or permitted under this Agreement shall be in writing and shall be sent by e-mail, hand delivered by messenger or courier service, or mailed by registered or certified mail (postage prepaid), return receipt requested, or delivered by reputable international air courier delivery service, addressed to:

 

If to Sobi:

Swedish Orphan Biovitrum AB (publ.)

 

Tomtebodavägen 23A, Solna

 

SE-112 76 Stockholm

 

Sweden

 

Attn: General Counsel

 

E-mail: legal@sobi.com

 

 

with a copy to:

Wiggin and Dana LLP

 

281 Tresser Blvd.

 

Stamford, CT 06901

 

USA

 

Attn: James F. Farrington, Jr.

 

E-mail: jfarrington@wiggin.com

 

 

If to Biogen Idec:

Biogen Idec Hemophilia Inc.

 

14 Cambridge Center

 

Cambridge, Massachusetts 02142

 

USA

 

Attention: President

 

E-mail: legaldepartment@biogenidec.com

 

 

with a copy to:

General Counsel

 

Biogen Idec Inc.

 

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225 Binney Street

Cambridge, MA 02142

USA

E-mail: legaldepartment@biogenidec.com

 

(b)                                   Each such notice shall be deemed delivered (i) on the date delivered if by personal delivery, (ii) on the date of transmission if by e-mail (so long as the receiving party acknowledges receipt thereof by email within two business days thereafter), (iii) on the date upon which the return receipt is signed or delivery is refused or the notice is designated by the postal authorities as not deliverable, as the case may be, if mailed, or (iv) four (4) calendar days after delivery to the applicable air courier.

 

(c)                                    Either Party may from time to time to change its address upon written notice to the other Party in accordance with this Section 16.1.

 

16.2                         Force Majeure .  No failure or omission by a Party in the performance of any obligation of this Agreement shall be deemed a breach of this Agreement or create any liability if the same shall arise from any cause or causes beyond the reasonable control of such Party, which may include, but are not limited to, the following:  acts of God; acts or omissions of any government; any rules, regulations or orders issued by any governmental authority or by any officer, department, agency or instrumentality thereof; fire; flood; storm; earthquake; accident; war; rebellion; insurrection; riot; and invasion; and provided that such failure or omission resulting from one of the foregoing causes is cured as soon as is practicable after its occurrence.

 

16.3                         Assignment; Binding Effect; Performance of Obligations .

 

(a)                                   Neither this Agreement nor any of the rights or obligations hereunder may be assigned by either Party without the prior written consent of the other Party, except to a single Third Party that acquires, by merger, sale of assets or otherwise, all or substantially all of the business of the assigning Party to which the subject matter of this Agreement relates.  Notwithstanding the foregoing, each Party shall have the right to assign this Agreement, in whole or in part, to an Affiliate of such Party, or to procure the performance by an Affiliate of some or

 

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all of such Party’s obligations hereunder, without the prior written consent of the other Party, provided that such Party guarantees the performance of such Affiliate of its obligations hereunder.  Any assignment not in accordance with the foregoing shall be void.  The Parties acknowledge that (i) with regard to the performance of obligations owed to Amunix by Biogen Idec as referenced in this Agreement, performance by BIMA will be deemed to satisfy performance obligations of Biogen Idec and (ii) references in this Agreement to amounts paid or due from Biogen Idec to Amunix shall be deemed to be amounts paid or due from BIMA and/or Biogen Idec, as the case may be, to Amunix.

 

(b)                                   Each Party agrees that, notwithstanding any provisions of this Agreement to the contrary, in the event that this Agreement is assigned by either Party in connection with the sale or transfer of all or substantially all of the business and assets of such Party to which the subject matter of this Agreement pertains, such assignment shall not provide the non-assigning Party with rights or access to intellectual property or technology of the acquirer of such Party.

 

16.4                         Modifications; Waivers .  No change, modification, extension, termination or waiver of any obligation, term or provision contained herein shall be valid or enforceable unless same is reduced to writing and signed by a duly authorized representative of each of the Parties to be bound thereby.  No waiver of any right in any one instance shall constitute a waiver of that right or of any other right in other instances under this Agreement.

 

16.5                         Entire Agreement .  This Agreement, the SOI FIX Assignment and Guaranty, the Equity Agreements, and the Schedules attached hereto, the Factor VIII and Factor IX CSAs between the Parties dated respectively on or about May 2, 2012 and October 23, 2012, any additional supply agreement between the Parties (if and when executed), the Safety Data Exchange Agreement, any quality agreement between the Parties (when executed) and the distribution agreement between the Parties for the MAH Transition Period (when executed pursuant to Section 4.2(j)) contain every obligation and understanding between the Parties relating to the subject matter hereof and supersedes all prior discussions, negotiations and agreements, if any, between them relating to the subject matter hereof (including the Confidentiality Agreement), and neither of the

 

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Parties shall be bound by any conditions, definitions, understandings, warranties or representations other than as expressly provided or referred to herein.

 

16.6                         Severability .  If, under applicable law or regulation, any provision of this Agreement is invalid or unenforceable, or otherwise directly or indirectly affects the validity of any other material provision(s) of this Agreement (“ Severed Clause ”), it is mutually agreed that this Agreement shall endure except for the Severed Clause.  The Parties shall consult and use their best efforts to agree upon a valid and enforceable provision which shall be a reasonable substitute for such Severed Clause in light of the intent of this Agreement.

 

16.7                         Section Headings .  The section headings in this Agreement are for convenience of reference only and shall not be deemed to affect the interpretation of any provision of this Agreement.

 

16.8                         Relationship of Parties .  This Agreement shall not constitute or be construed as creating a partnership, employer-employee or joint venture relationship between the Parties, and neither Party shall be liable for any debts or obligations of the other Party.  Neither Party shall have any power to enter into any contracts or commitments in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever.

 

16.9                         Construction .  Each Party acknowledges that it has been advised by counsel during the course of negotiation of this Agreement and, therefore, that this Agreement shall be interpreted without regard to any presumption or rule requiring construction against the Party causing this Agreement to be drafted. Except where the context otherwise requires, wherever used, the use of any gender will be applicable to all genders and the word “or” is used in the inclusive sense (and/or).  The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement.  The term “including” as used herein means including, without limiting the generality of any description preceding such term.  Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document refer to such agreement, instrument or other document as from time to time amended,

 

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supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any laws refer to such laws as from time to time enacted, repealed or amended, (c) the words “herein”, “hereof” and “hereunder”, and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof, and (d) all references herein to Sections and Schedules, unless otherwise specifically provided, refer to the Sections of and Schedules to this Agreement.

 

16.10                  Governing Law .  This Agreement has been entered into and shall be construed and enforced in accordance with the laws of the State of New York, without reference to the choice of law principles thereof.

 

16.11                  Counterparts .  This Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

 

[Remainder of Page Intentionally Left Blank]

 

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IN WITNESS WHEREOF, this Agreement has been executed by the Parties as of the Effective Date.

 

 

BIOGEN IDEC HEMOPHILIA INC.

 

 

 

By:

/s/ Glenn Pierce

 

 

 

 

Name:

Glenn Pierce

 

 

 

 

Title:

President, Biogen Idec Hemophilia

 

 

 

SWEDISH ORPHAN BIOVITRUM AB

 

 

 

By:

/s/ Geoffrey McDonough

 

 

 

 

Name:

Geoffrey McDonough

 

 

 

 

Title:

CEO

 

 

 

 

 

 

 

By:

/s/ Fredrik Berg

 

 

 

 

Name:

Fredrik Berg

 

 

 

 

Title:

General Counsel

 

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SCHEDULE 1.12

 

BIOGEN IDEC BACKGROUND PATENT RIGHTS

 

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SCHEDULE 1.16

 

BIOGEN IDEC IMPROVEMENT PATENT RIGHTS

 

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SCHEDULE 1.25

 

BIOGEN IDEC SOLE COLLABORATION PATENT RIGHTS

 

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SCHEDULE 1.49

 

CORE COUNTRIES

 

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SCHEDULE 1.66

 

FTE RATES

 

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SCHEDULE 1.76

 

JOINTLY–OWNED PATENT RIGHTS

 

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SCHEDULE 1.104

 

SOBI BACKGROUND PATENT RIGHTS

 

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SCHEDULE 1.108

 

SOBI IMPROVEMENT PATENT RIGHTS

 

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SCHEDULE 1.114

 

SOBI SOLE COLLABORATION PATENT RIGHTS

 

 

 

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SCHEDULE 1.115

 

SOBI TERRITORY

 

Albania, Algeria, Andorra, Armenia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Bulgaria, Corsica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Egypt, Estonia, Falkland Islands, Finland, Former Yugoslav Republic of Macedonia, France, Georgia, Germany, Gibraltar, Greece, Guadaloupe, Guyane, Hungary, Iceland, Iran, Iraq, Ireland, Italy, Jordan, Kuwait,  Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malta, Martinique, Mauritania, Mayotte, Moldova, Monaco, Morocco, New Caledonia, Norway, Oman, Poland, Polynesia, Portugal, Qatar, Réunion, Romania, Russia, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Somalia, Spain, Sudan, Sweden, Switzerland, Syria, The Netherlands, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Vatican City, Yemen.

 

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SCHEDULE 3.3(A)

 

HIGH LEVEL DEVELOPMENT PLAN FOR THE LEAD PRODUCTS

 

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APPENDIX A

 

TIMELINE OF PROPOSED LEAD PRODUCT DEVELOPMENT ACTIVITIES

 

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APPENDIX B

 

OUTLINE BUDGETS FOR LEAD PRODUCTS

 

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SCHEDULE 3.5

 

CERTAIN ADDITIONAL AGREED ACTIVITIES FOR THE LEAD PRODUCTS

 

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SCHEDULE 4.1

 

REQUIREMENTS TO MAINTAIN SALES TERRITORY

 

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SCHEDULE 4.2(J)

 

DISTRIBUTION TERMS

 

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SCHEDULE 4.4(C)

 

SHARED SYSTEMS AND INFRASTRUCTURE EXPENSES

 

[Three (3) pages omitted.]

 

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SCHEDULE 6

 

CERTAIN EXPORT PROVISIONS

 

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SCHEDULE 8.1(F)(II)

 

ALLOCATION OF ROYALTIES TO AMUNIX

 

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Exhibit 21.1

 

Subsidiaries of Bioverativ Inc.

 

The following entities are expected to be subsidiaries of Bioverativ Inc. upon completion of the distribution described in the information statement.

 

Name

 

Country or State in which a
Subsidiary was Organized

Bioverativ Therapeutics Inc.

 

Delaware

Bioverativ U.S. LLC

 

Delaware

Bioverativ Pacific LLC

 

Delaware

Bioverativ Canada Inc.

 

Canada

Bioverativ Japan

 

Japan

 




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INDEX TO FINANCIAL STATEMENTS


Exhibit 99.1

LOGO

[      ·     ] , [     ·     ]

Dear Biogen Stockholder:

        In May 2016, we announced plans to spin-off our hemophilia business into an independent, publicly traded company. The strategic goal of this separation is to establish two focused companies dedicated to driving current and long-term value creation. We believe the best way to realize our full potential is to allow each company to operate independently with a management team dedicated to our respective and distinct disease areas. Following the spin-off, we believe each company will be well-positioned with the resources, talent, and foundation to be a leader in its respective fields.

        Biogen Inc. (Biogen) will continue to focus principally on therapies for patients with neurological and neurodegenerative diseases for which there are few or no effective treatment options. We plan to continue our efforts to develop novel, transformative therapies for patients with multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, neuropathic pain, and other neurological and neurodegenerative diseases.

        The new company, which has been named Bioverativ Inc. (Bioverativ), will focus on the discovery, research, development, and commercialization of therapies for the treatment of hemophilia and other blood disorders. Its existing marketed products will include ELOCTATE and ALPROLIX, indicated for the treatment of hemophilia A and B, respectively. In addition, Bioverativ will continue to engage in the research and development of pipeline candidates intended to provide additional meaningful advances in the treatment of people living with hemophilia and other blood disorders.

        We believe the spin-off of our hemophilia business will benefit both companies in that each will be positioned to:

        As a result of the distribution, each Biogen stockholder will receive one share of Bioverativ common stock for every two shares of Biogen common stock held of record on January 17, 2017, the record date for the distribution. You do not need to take any action to receive the common stock of Bioverativ to which you are entitled as a Biogen stockholder.

        Please read the attached information statement, which is being made available to all Biogen stockholders who hold our common stock on the record date for the distribution. It describes the separation in detail and contains important information about Biogen and Bioverativ.

        We are extremely proud of the talented and dedicated hemophilia team which, with the launch of ELOCTATE and ALPROLIX, brought the first major treatment advances in nearly 20 years for people living with hemophilia. With a dedicated, focused management team, we believe Bioverativ has the potential to become a leading company in the treatment of hemophilia and other blood disorders and will be well-positioned to compete effectively for years to come.

        We thank you for your continued support of Biogen.

Sincerely,

George A. Scangos, Ph.D.
Chief Executive Officer
Biogen Inc.


LOGO

[     ·     ], [     ·     ]

Dear Future Bioverativ Inc. Stockholder:

        It's an honor to welcome you as a future stockholder of our new company, Bioverativ Inc. (Bioverativ).

        I am extremely excited about the opportunity to lead Bioverativ. A number of years ago, I became intimately involved with the hemophilia business by leading manufacturing, technical development and product supply for Biogen Inc.'s launches of ELOCTATE and ALPROLIX for the treatment of hemophilia A and hemophilia B, respectively. Today, our team stands ready to dedicate ourselves full-time to helping people living with hemophilia.

        In 2014, ELOCTATE and ALPROLIX were the first extended half-life clotting factor technologies to receive regulatory approval, and represented the first major advancements in the treatment of hemophilia in nearly two decades. Our team is committed to supporting ELOCTATE and ALPROLIX through our commercialization efforts, as well as through additional research and development activities. These activities include ongoing and future post-marketing studies to explore the potential of Fc fusion technology on long-term joint health, immunogenicity and immune tolerance induction in hemophilia patients who develop inhibitors.

        Beyond ELOCTATE and ALPROLIX, we are working and intend to further advance research and development for promising new technologies. Our pipeline includes the development of extended half-life therapies using XTEN technology, the development of non-factor bi-specific antibody technology for the treatment of hemophilia and hemophilia-related gene therapy programs. In addition, we intend to leverage our expertise and early research work to pursue adjacent disease areas, including other blood disorders, such as sickle cell disease and beta-thalassemia.

        We have applied for listing of Bioverativ common stock on the Nasdaq Global Select Market under the symbol "BIVV".

        We encourage you to learn more about us by reviewing the information statement being made available to you.

        With our technology, our current commercial products, and the commitment, expertise and passion of the Bioverativ employees, we are eager to continue to improve the quality of life for people living with hemophilia and other blood disorders, now and into the future. We look forward to our future as an independent, publicly traded company and to your support as a stockholder of Bioverativ.

Sincerely,

John G. Cox
Chief Executive Officer
Bioverativ Inc.


Information contained herein is subject to completion or amendment. A Registration Statement on Form 10 relating to these securities has been filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended.

PRELIMINARY AND SUBJECT TO COMPLETION, DATED DECEMBER 20, 2016

INFORMATION STATEMENT

Bioverativ Inc.



        This information statement is being furnished to you as a holder of common stock of Biogen Inc. (Biogen) in connection with the distribution of shares of common stock of Bioverativ Inc. (Bioverativ). Bioverativ is a wholly owned subsidiary of Biogen that will hold, directly or indirectly, assets and liabilities related to Biogen's hemophilia business. To implement the distribution, Biogen will distribute all of the outstanding shares of Bioverativ common stock on a pro rata basis to holders of Biogen common stock in a manner that is intended to be tax-free for U.S. federal income tax purposes.

        You will receive one share of Bioverativ common stock for every two shares of Biogen common stock held of record by you as of the close of business on January 17, 2017, the record date for the distribution. Holders of Biogen common stock will receive cash in lieu of any fractional shares of Bioverativ common stock that those holders would have received after application of the above ratio. As discussed under "The Separation and Distribution—Trading Between the Record Date and Distribution Date," if you sell your shares of Biogen common stock in the "regular way" market after the record date and before the distribution, you also will be selling your right to receive shares of Bioverativ common stock in connection with the distribution. Bioverativ expects the shares of Bioverativ common stock to be distributed by Biogen to you on February 1, 2017. The date of distribution of Bioverativ common stock is referred to in this information statement as the "distribution date."

        No vote of Biogen stockholders is required for the distribution. Therefore, you are not being asked for a proxy, and you are requested not to send Biogen a proxy, in connection with the distribution. You do not need to pay any consideration, exchange or surrender your existing shares of Biogen common stock or take any other action to receive your shares of Bioverativ common stock.

        There is no current trading market for Bioverativ common stock. Bioverativ expects that a limited market, commonly known as a "when issued" trading market, will develop on or shortly before the record date for the distribution, and that "regular way" trading of Bioverativ common stock will begin on the first trading day following the completion of the distribution. Bioverativ has applied for listing of its common stock on the Nasdaq Global Select Market under the symbol "BIVV".

        We are an "emerging growth company" as that term is used in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). As an emerging growth company, we will be subject to reduced public company reporting requirements.



In reviewing this information statement, you should carefully consider the matters described under the caption " Risk Factors " beginning on page 18.

Neither the U.S. Securities and Exchange Commission nor any state securities commission has approved or disapproved these securities or determined if this information statement is truthful or complete. Any representation to the contrary is a criminal offense.

This information statement does not constitute an offer to sell or the solicitation of an offer to buy any securities.

The date of this information statement is                        , 2016.

A Notice of Internet Availability of Information Statement Materials containing instructions for how to access this information statement is first being mailed to Biogen stockholders on or about January 17, 2017.

This information statement will be mailed to Biogen stockholders who previously elected to receive a paper copy of Biogen's materials.



TABLE OF CONTENTS

Questions and Answers about the Separation and Distribution

   
1
 

Information Statement Summary

   
9
 

Summary Historical and Unaudited Pro Forma Combined Financial Information

   
16
 

Risk Factors

   
18
 

Cautionary Statement Concerning Forward-Looking Statements

   
39
 

Dividend Policy

   
40
 

Capitalization

   
41
 

Unaudited Pro Forma Combined Financial Statements

   
42
 

Selected Historical Combined Financial Data

   
46
 

Management's Discussion and Analysis of Financial Condition and Results of Operations

   
47
 

Business

   
64
 

Management

   
84
 

Executive Compensation

   
91
 

Certain Relationships and Related Person Transactions

   
98
 

Security Ownership by Certain Beneficial Owners and Management

   
103
 

The Separation and Distribution

   
105
 

U.S. Federal Income Tax Consequences

   
113
 

Description of Bioverativ's Capital Stock

   
117
 

Where You Can Find More Information

   
122
 

Glossary of Scientific Terms

   
123
 

Index to Financial Statements

   
F-1
 

i



Presentation of Information

        Except as otherwise indicated or unless the context otherwise requires, the information included in this information statement about Bioverativ assumes the completion of all of the transactions referred to in this information statement in connection with the separation and distribution.

        Unless the context otherwise requires, references in this information statement to the following terms shall have the following respective meanings:

        See "Glossary of Scientific Terms" for definitions of certain additional terms as they are used in this information statement.

        This information statement describes the businesses to be transferred to Bioverativ by Biogen in the separation as if the transferred businesses were Bioverativ's businesses for all historical periods described. References in this information statement to Bioverativ's historical assets, liabilities, products, businesses or activities of Bioverativ's business are generally intended to refer to the historical assets, liabilities, products, businesses or activities of the transferred businesses as the businesses were conducted as part of Biogen prior to the separation.

        You should not assume that the information contained in this information statement is accurate as of any date other than the date set forth on the cover. Changes to the information contained in this information statement may occur after that date, and we undertake no obligation to update the information, except in the normal course of our public disclosure obligations or as required by applicable law.

        Websites described in this information statement and the content therein or connected thereto shall not be deemed incorporated into this information statement.


Trademarks, Trade Names and Service Marks

        Bioverativ owns or has rights to use the trademarks, service marks and trade names that it uses in conjunction with the operation of its business. Some of the trademarks that Bioverativ owns or has rights to use that appear in this information statement include: ALPROLIX® and ELOCTATE®, which may be registered or trademarked in the United States and other jurisdictions. Bioverativ's rights to some of these trademarks may be limited to select markets. Each trademark, trade name or service mark of any other company appearing in this information statement is, to Bioverativ's knowledge, owned by such other company. References to ELOCTATE in this information statement shall also refer

ii


to ELOCTA, the approved trade name for ELOCTATE in the European Union, as the context may require.


Industry and Other Data

        We obtained the industry and market data in this information statement from our own internal estimates and, where noted in this information statement, from industry and general publications and research, surveys, studies and trials conducted by third parties. While we believe that this third party data is generally reliable, we have not independently verified industry and market data from third party sources. In addition, while we believe our estimates are reliable, they have not been verified by any independent source.

        Estimates in this information statement of the patient populations for the diseases that we are targeting are based on published estimates of the rates of incidence of the diseases from scientific and general publications and research, surveys and studies conducted by third parties that we consider to be reliable, although such publications do not guarantee the accuracy or completeness of this information.

iii



QUESTIONS AND ANSWERS ABOUT THE SEPARATION AND DISTRIBUTION

What is Bioverativ and why is Biogen separating Bioverativ's business and distributing Bioverativ's common stock?   Bioverativ, which is currently a wholly owned subsidiary of Biogen, was formed to hold Biogen's hemophilia business. The separation of Bioverativ from Biogen and the distribution of Bioverativ common stock are intended to provide you with equity investments in two separate, independent public companies, each of which is able to focus on its respective business strategies. Biogen and Bioverativ believe the separation will enable each business to pursue focused growth and investment strategies in its respective therapeutic areas of expertise resulting in the enhanced long-term performance of each business, as discussed in "The Separation and Distribution—Overview" and "The Separation and Distribution—Reasons for the Separation."

Why am I receiving this document?

 

Biogen is delivering this information statement to you because you are a holder of record of shares of Biogen common stock. If you remain a holder of shares of Biogen common stock as of the close of business on January 17, 2017, you will be entitled to receive one share of Bioverativ common stock for every two shares of Biogen common stock that you held of record at the close of business on such date. This information statement will help you understand how the separation will affect your investment in Biogen and your investment in Bioverativ after the distribution.

How will the separation of Bioverativ from Biogen work?

 

To accomplish the separation, Biogen will distribute all of the outstanding shares of Bioverativ common stock to Biogen stockholders on a pro rata basis.

Why is the separation of Bioverativ structured as a distribution?

 

Biogen believes that a tax-free distribution for U.S. federal income tax purposes of shares of Bioverativ common stock to the Biogen stockholders is an efficient way to separate its hemophilia business in a manner that will create long-term value for Biogen, Bioverativ and their respective stockholders. Biogen's obligation to complete the separation is conditioned on the receipt by Biogen of an opinion from tax counsel or other third party advisor to Biogen that the distribution of Bioverativ common stock to Biogen stockholders is a tax-free distribution for U.S. federal income tax purposes. This condition is waivable by Biogen in its sole discretion. For more information, see "The Separation and Distribution—Conditions to the Distribution."

What is the record date for the distribution?

 

The record date for the distribution will be January 17, 2017.

When will the distribution occur?

 

It is expected that all of the shares of Bioverativ common stock will be distributed by Biogen on February 1, 2017, to holders of record of Biogen common stock at the close of business on January 17, 2017. We refer to the date on which shares of Bioverativ common stock are distributed as the "distribution date."

1


What do stockholders need to do to participate in the distribution?   Nothing. Stockholders of Biogen as of the record date will not be required to take any action to receive Bioverativ common stock, but are urged to read this entire information statement carefully. No stockholder approval of the distribution is required or sought. Therefore, you are not being asked for a proxy to vote on the separation, and you are requested not to send us a proxy. You will neither be required to pay anything for the shares of Bioverativ common stock nor be required to surrender any shares of Biogen common stock to participate in the distribution. Please do not send in your Biogen stock certificates.

 

 

The distribution will not affect the number of outstanding shares of Biogen common stock or any rights of Biogen stockholders, although it will affect the market value of each outstanding share of Biogen common stock. See "Questions and Answers about the Separation and Distribution—Will the distribution affect the market price of my Biogen common stock?" for more information.

How will Biogen distribute shares of Bioverativ common stock?

 

Registered stockholders : If you are a registered stockholder (meaning you hold physical Biogen stock certificates or you own your shares of Biogen common stock directly through an account with Biogen's transfer agent, Computershare Trust Company, N.A. (Computershare)), the distribution agent will credit the number of whole shares of Bioverativ common stock you receive in the distribution to your book-entry account on or shortly after the distribution date, and the distribution agent will mail you a check for any cash in lieu of fractional shares you are entitled to receive.

 

 

"Street name" or beneficial stockholders : If you own your shares of Biogen common stock beneficially through a bank, broker or other nominee, your bank, broker or other nominee will credit your account with the number of whole shares of Bioverativ common stock you receive in the distribution on or shortly after the distribution date. Please contact your bank, broker or other nominee for further information about your account.

 

 

We will not issue any physical stock certificates to any stockholders receiving shares in the distribution, even if requested. See "The Separation and Distribution—When and How You Will Receive the Distribution" for more information.

How many shares of Bioverativ common stock will I receive in the distribution?

 

Biogen will distribute to you one share of Bioverativ common stock for every two shares of Biogen common stock you hold of record as of the close of business on January 17, 2017, the record date. Based on approximately 215,904,010 shares of Biogen common stock outstanding as of December 1, 2016 a total of approximately 107,952,005 shares of Bioverativ common stock will be distributed. For more information, see "The Separation and Distribution—The Number of Shares of Bioverativ Common Stock You Will Receive."

2


Will Bioverativ issue fractional shares in the distribution?   Bioverativ will not distribute fractional shares of its common stock in the distribution. Instead, all fractional shares that Biogen registered stockholders would otherwise have been entitled to receive will be aggregated into whole shares and sold in the open market by the distribution agent. We expect the distribution agent, acting on behalf of Biogen, to take about two weeks after the distribution date to fully distribute the aggregate net cash proceeds of these sales on a pro rata basis (based on the fractional share such holder would otherwise be entitled to receive) to those stockholders who would otherwise have been entitled to receive fractional shares. Recipients of cash in lieu of fractional shares will not be entitled to any interest on the amounts of payment made in lieu of fractional shares. For more information, see "The Separation and Distribution—The Number of Shares of Bioverativ Common Stock You Will Receive."

What are the conditions to the distribution?

 

The distribution is subject to the satisfaction (or waiver by Biogen in its sole discretion) of a number of conditions, including, among others:

 

the internal reorganization to separate the Biogen and Bioverativ businesses having been effectuated, except for such steps (if any) as Biogen in its sole discretion has determined need not be completed or may be completed after the effective time of the distribution;

 

the receipt and continuing validity of an opinion from tax counsel or other third party advisor to Biogen that is in substance and form satisfactory to Biogen, substantially to the effect that, among other things, the distribution of shares of Bioverativ common stock, together with certain related transactions, will qualify under Sections 355 and 368(a) of the Internal Revenue Code of 1986, as amended (the Code), with the result that Biogen and Biogen's stockholders will not recognize any taxable income, gain or loss for U.S. federal income tax purposes as a result of the distribution, except to the extent of cash received in lieu of fractional shares;

 

the receipt and continuing validity of an opinion from an independent appraisal firm to the Biogen board of directors confirming the solvency and financial viability of Bioverativ after the distribution and, as to compliance by Biogen in declaring to pay the distribution, with surplus requirements under Delaware corporate law, that is in form and substance acceptable to Biogen in its sole discretion;

3


 

the U.S. Securities and Exchange Commission (SEC) declaring effective Bioverativ's registration statement on Form 10 of which this information statement forms a part, no stop order relating to the registration statement being in effect and no proceedings for such purpose pending before or threatened by the SEC and the distribution of this information statement (or the Notice of Internet Availability of the Information Statement) to all holders of record of shares of Biogen common stock as of the close of business on the record date;

 

Bioverativ having executed and delivered the transaction agreements relating to the separation;

 

no order, injunction or decree issued by any court of competent jurisdiction or other legal restraint or prohibition preventing the consummation of the distribution or any of the related transactions being pending, threatened, issued or in effect;

 

the board of directors of Biogen having declared the distribution and having approved all related transactions (and such declaration and approval not having been withdrawn);

 

the shares of Bioverativ common stock to be distributed having been accepted for listing on the Nasdaq Global Select Market, subject to official notice of distribution; and

 

no other event or development existing or having occurred that, in the judgment of Biogen's board of directors, in its sole and absolute judgement, makes it inadvisable to effect the distribution and other related transactions.


 

 

Biogen and Bioverativ cannot assure you that any or all of these conditions will be met, and Biogen may waive any of these conditions to the distribution. In addition, Biogen can determine, at any time, not to proceed with the distribution. For more information, see "The Separation and Distribution—Conditions to the Distribution."

What is the expected date of completion of the distribution?

 

The completion and timing of the distribution are dependent upon a number of conditions. It is expected that the shares of Bioverativ common stock will be distributed by Biogen on February 1, 2017 to the holders of record of shares of Biogen common stock at the close of business on the record date. However, no assurance can be provided as to the timing of the distribution or that all conditions to the distribution will be met.

Can Biogen decide to cancel the distribution of Bioverativ common stock even if all the conditions have been met?

 

Yes, until the distribution has occurred, Biogen has the right to terminate the distribution, even if all of the conditions are satisfied. See "The Separation and Distribution—Conditions to the Distribution" for more information.

What if I want to sell my Biogen common stock or my Bioverativ common stock?

 

You should consult with your advisors, such as your broker, bank or tax advisor.

4


What is "regular way" and "ex- distribution" trading of Biogen stock?   Beginning on or shortly before the record date and continuing up to and including the distribution date, it is expected that there will be two markets in shares of Biogen common stock: a "regular way" market and an "ex-distribution" market. Shares of Biogen common stock that trade in the "regular way" market will trade with an entitlement to shares of Bioverativ common stock distributed pursuant to the distribution. Shares that trade in the "ex-distribution" market will trade without an entitlement to shares of Bioverativ common stock distributed pursuant to the distribution.

 

 

If you hold shares of Biogen common stock on the record date and you decide to sell any shares of Biogen common stock before the distribution date, you should make sure your broker, bank or other nominee understands whether you want to sell your shares of Biogen common stock with or without your entitlement to receive Bioverativ common stock pursuant to the distribution. See "The Separation and Distribution—Trading Between the Record Date and Distribution Date" for more information.

Where will I be able to trade shares of Bioverativ common stock?

 

Currently, there is no public market for Bioverativ common stock. Bioverativ has applied to have its common stock authorized for listing on the Nasdaq Global Select Market under the symbol "BIVV".

 

 

Bioverativ anticipates that trading in shares of its common stock will begin on a "when issued" basis on or shortly before the record date for the distribution and will continue up to and including the distribution date. "When issued" trading in the context of a separation refers to a sale or purchase made conditionally on or before the distribution date because the securities of the separated entity have not yet been distributed. "When issued" trades generally settle within two weeks after the distribution date. On the first trading day following the distribution date, any "when issued" trading of our common stock will end and "regular way" trading will begin. "Regular way" trading refers to trading after the security has been distributed and typically involves a trade that settles on the third full trading day following the date of the trade. See "The Separation and Distribution—Trading Between the Record Date and Distribution Date" for more information. We cannot predict the trading prices for our common stock before, on or after the distribution date.

What will happen to the listing of shares of Biogen common stock?

 

Shares of Biogen common stock will continue to trade on the Nasdaq Global Select Market after the distribution.

Will the number of shares of Biogen common stock that I own change as a result of the distribution?

 

No. The number of shares of Biogen common stock that you own will not change as a result of the distribution.

5


Will the distribution affect the market price of my Biogen common stock?   Yes. As a result of the distribution, Biogen expects the trading price of shares of Biogen common stock immediately following the distribution to be lower than the "regular way" trading price of such shares immediately prior to the distribution because the trading price will no longer reflect the value of the hemophilia business. Furthermore, as the market assesses Biogen following the separation, the trading price of shares of Biogen common stock may fluctuate. There can be no assurance that, following the distribution, the combined trading prices of Biogen common stock and Bioverativ common stock will equal or exceed what the trading price of Biogen common stock would have been in the absence of the separation, and it is possible the post-distribution combined equity value of Biogen and Bioverativ will be less than Biogen's equity value prior to the distribution.

What are the U.S. federal income tax consequences of the distribution?

 

It is a condition to the distribution that Biogen receive an opinion of tax counsel or other third party advisor, satisfactory to Biogen's board of directors, to the effect that the distribution, together with certain related transactions, will qualify under Sections 355 and 368(a)(1)(D) of the Code; this condition is waivable by Biogen in its sole discretion. Except as otherwise noted, it is expected that the distribution will qualify as a transaction that is tax-free for U.S. federal income tax purposes to Biogen and the holders of Biogen common stock. Assuming that the distribution, together with certain related transactions, so qualifies, for U.S. federal income tax purposes, no gain or loss will be recognized by you and no amount will be included in your income upon receipt of shares of Bioverativ common stock pursuant to the distribution. You will, however, recognize gain or loss for U.S. federal income tax purposes with respect to cash received in lieu of a fractional share of Bioverativ common stock.

 

 

You should consult your own tax advisor as to the particular consequences of the distribution to you, including the applicability and effect of any U.S. federal, state and local tax laws, as well as non-U.S. tax laws. For more information regarding the U.S. federal income tax consequences of the distribution, see "U.S. Federal Income Tax Consequences."

How will I determine my tax basis in the shares of Bioverativ common stock I receive in the distribution?

 

For U.S. federal income tax purposes, your aggregate basis in the common stock that you hold in Biogen and the new Bioverativ common stock received in the distribution (including any fractional share interest in Bioverativ common stock for which cash is received) will equal the aggregate basis in the shares of Biogen common stock held by you immediately before the distribution, allocated between your shares of Biogen common stock and Bioverativ common stock (including any fractional share interest in Bioverativ common stock for which cash is received) you receive in the distribution in proportion to the relative fair market value of each on the distribution date, for which the relative closing prices on the Nasdaq Stock Market will be used.

6


    You should consult your own tax advisor as to the particular consequences of the distribution to you, including the application of the tax basis allocation rules and the application of state, local and non-U.S. tax laws.

What will Bioverativ's relationship be with Biogen following the distribution?

 

To effect the separation and provide a framework for Bioverativ's relationship with Biogen after the distribution, Bioverativ intends to enter into a separation agreement and certain other agreements with Biogen, including a tax matters agreement, an employee matters agreement, an intellectual property license agreement, a manufacturing and supply agreement and a transition services agreement. These agreements will provide for the separation between Biogen and Bioverativ of the assets, employees, liabilities and obligations (including investments, property and employee benefits and tax-related assets and liabilities) of Biogen attributable to periods prior to, at and after the distribution and will govern the relationship between Biogen and Bioverativ subsequent to the completion of the distribution. For additional information regarding the separation agreement and other transaction agreements, see "Risk Factors—Risks Related to the Separation" and "Certain Relationships and Related Person Transactions—Agreements with Biogen."

Are there risks associated with owning Bioverativ common stock?

 

Yes. Ownership of Bioverativ common stock is subject to both general and specific risks related to Bioverativ's business, the industry in which it operates, its ongoing relationships with Biogen and its status as a separate, publicly traded company. Ownership of Bioverativ common stock is also subject to risks related to the separation. These risks are described in the "Risk Factors" section of this information statement beginning on page 18. You are encouraged to read that section carefully.

Does Bioverativ plan to pay dividends?

 

Bioverativ does not expect to pay a regular cash dividend following the distribution. The payment of any dividends in the future, and the timing and amount thereof, is within the discretion of Bioverativ's board of directors. See "Dividend Policy."

Who will be the distribution agent, transfer agent and registrar for the Bioverativ common stock?

 

The distribution agent, transfer agent and registrar for Bioverativ common stock will be Computershare. For registered holders with questions relating to the transfer or mechanics of the stock distribution, you should contact:


 


 


Computershare Investor Services
    211 Quality Circle, Suite 210
    College Station, TX 77845
    Tel: (877) 282-1168

7


How can I contact Biogen or Bioverativ with any questions?   Before the distribution, if you have any questions relating to Biogen or Bioverativ's business performance, you should contact:

 

 

Biogen Inc.
    Investor Relations Department
    225 Binney Street
    Cambridge, MA 02142
    Tel: (781) 464-2442
    Email: ir@biogen.com

 

 

After the distribution, Bioverativ stockholders who have any questions relating to Bioverativ's business performance should contact Bioverativ at:

 

 

Bioverativ Inc.
    Investor Relations
    225 Second Avenue
    Waltham, MA 02451
    Email: ir@bioverativ.com

8


 


INFORMATION STATEMENT SUMMARY

         The following is a summary of material information discussed in this information statement. This summary may not contain all the details concerning the separation or other information that may be important to you. To better understand the separation and Bioverativ's business and financial position, you should carefully review this entire information statement, including the risks discussed under "Risk Factors."

         Except as otherwise indicated or unless the context otherwise requires, the information included in this information statement assumes the completion of all of the transactions referred to in this information statement in connection with the separation. Some of the statements in this summary constitute forward-looking statements. See "Cautionary Statement Concerning Forward-Looking Statements."

Bioverativ

        Bioverativ is a global biotechnology company focused on the discovery, research, development and commercialization of innovative therapies for the treatment of hemophilia and other blood disorders.

        We market two products, ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] and ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], extended half-life clotting-factor therapies for the treatment of hemophilia A and hemophilia B, respectively. ELOCTATE and ALPROLIX use a process known as Fc fusion to link recombinant factor VIII and factor IX, respectively, to a protein fragment in the body known as Fc. The fusion of the factor with the Fc protein fragment uses a naturally occurring pathway and is designed to extend the half-life of the factor, thereby making the product last longer in a person's blood than traditional factor therapies.

        We collaborate with Swedish Orphan Biovitrum AB (publ) (Sobi) to develop and commercialize ELOCTATE and ALPROLIX globally. We have rights to commercialize ELOCTATE and ALPROLIX in the United States, Japan, Canada, Australia and all other markets excluding Sobi's commercialization territory. Sobi's commercialization territory includes Europe, Russia and certain countries in Northern Africa and the Middle East. See "Business—Our Development and Commercialization Arrangements with Sobi." ELOCTATE and ALPROLIX were approved in the United States and Japan in 2014, and in the European Union in 2015 and 2016, respectively.

        We have multiple programs intended to further support our marketed products and an innovative product pipeline devoted to the creation and delivery of new therapies:

        We generate revenue through sales of our products, royalties earned on sales of ELOCTATE and ALPROLIX by Sobi in its commercialization territory and the supply of ELOCTATE and ALPROLIX to Sobi. For the nine month period ended September 30, 2016, we generated revenue of approximately $631.2 million primarily from our sales of ELOCTATE and ALPROLIX in the United States, Japan and Canada, and for the year ended December 31, 2015, we generated revenue of approximately $560.3 million primarily from our sales of ELOCTATE and ALPROLIX in the United States and Japan.

9


 

Strengths

        We believe we possess a number of competitive advantages that distinguish us from our competitors, including:

10


 

Strategies

        Our objective is to develop therapies to improve the lives of patients living with hemophilia and other blood disorders. The key elements of our strategy include:

11


 

Summary of Risk Factors

        An investment in Bioverativ common stock is subject to a number of risks, including risks related to our business, risks related to the separation and risks related to our common stock. The following list of risk factors is not exhaustive. Please read the information in the section captioned "Risk Factors" for a more thorough description of these and other risks.

Risks Related to Our Business

12


 

Risks Related to the Separation

13


 

Risks Related to Our Common Stock

The Separation and Distribution

        On May 3, 2016, Biogen announced its plans to separate its hemophilia business from its neurological and neurodegeneration businesses. The distribution is intended to be tax-free for U.S. federal income tax purposes, except as otherwise noted.

        In furtherance of this plan, on December 20, 2016, Biogen's board of directors approved the distribution of all of the issued and outstanding shares of Bioverativ common stock on the basis of one share of Bioverativ common stock for every two shares of Biogen common stock issued and outstanding on January 17, 2017, the record date for the distribution. As a result of the distribution, Bioverativ will become an independent, publicly traded company.

14


 

Bioverativ's Post-Distribution Relationship with Biogen

        Bioverativ intends to enter into a separation agreement with Biogen, which is referred to in this information statement as the "separation agreement," and various other agreements with Biogen, including a tax matters agreement, an employee matters agreement, an intellectual property license agreement, a manufacturing and supply agreement and a transition services agreement. These agreements will effectuate the separation and provide a framework for Bioverativ's relationship with Biogen after the distribution. These agreements will provide for the allocation between Biogen and Bioverativ of Biogen's assets, employees, liabilities and obligations (including investments, property and employee benefits and tax-related assets and liabilities) attributable to periods prior to, at and after Bioverativ's separation from Biogen. These agreements will also govern certain relationships between Biogen and Bioverativ after the separation. For additional information regarding the separation agreement and the other related agreements, see "Risk Factors—Risks Related to the Separation" and "Certain Relationships and Related Person Transactions—Agreements with Biogen."

Reasons for the Separation

        The Biogen board of directors believes that separating the hemophilia business from the remainder of Biogen is in the best interests of Biogen and its stockholders for a number of reasons, including that:

        The Biogen board of directors considered a number of potentially negative factors in evaluating the separation, including risks relating to the creation of a standalone company and possible increased overall costs as well as one-time separation costs, but concluded that the potential benefits of the separation outweighed these factors. For more information, see "The Separation and Distribution—Reasons for the Separation" and "Risk Factors" included elsewhere in this information statement.

Corporate Information

        Bioverativ Inc. was incorporated in the State of Delaware on August 4, 2016 for the purpose of holding Biogen's hemophilia business in connection with the separation described in this information statement. The contribution of this business to Bioverativ is occurring over a period of time prior to the distribution, and Bioverativ will have no operations prior to such contribution. At the time of the distribution, the address of Bioverativ's principal executive offices will be 225 Second Avenue, Waltham, MA 02451. Bioverativ's telephone number is (888) 862-0575. Bioverativ will also maintain an Internet site at www.bioverativ.com.

15


 

Reason for Furnishing this Information Statement

        This information statement is being furnished solely to provide information to stockholders of Biogen who will receive shares of Bioverativ common stock in the distribution. It is not, and is not to be construed as, an inducement or encouragement to buy or sell any of Bioverativ's securities.

Implications of Being an Emerging Growth Company

        We qualify as an "emerging growth company" as defined in the JOBS Act. As an emerging growth company we may take advantage of specified reduced disclosure and other obligations that are otherwise applicable generally to public companies. These may include the following:

        We may take advantage of these provisions for up to five years or such earlier time that we are no longer an emerging growth company. We will cease to be an emerging growth company on the date that is the earliest of (i) the last day of the fiscal year in which we have total gross annual revenues of $1 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the distribution; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

        We have irrevocably elected not to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act, and, therefore, we will be subject to the same new or revised accounting standards as other public companies that do not qualify as emerging growth companies.

Summary Historical and Unaudited Pro Forma Combined Financial Information

        The following table sets forth summary historical financial information for the periods indicated below. The summary balance sheet data as of December 31, 2015 and 2014 and the summary statement of income (loss) data for the years ended December 31, 2015, 2014 and 2013 have been derived from the audited combined financial statements for the hemophilia business of Biogen which are included elsewhere in this information statement. The summary balance sheet data as of September 30, 2016 and the summary statement of income data for the nine months ended September 30, 2016 and 2015 are derived from the unaudited condensed combined interim financial statements for the hemophilia business of Biogen which are included elsewhere in this information statement. The unaudited condensed combined interim financial data have been prepared on a basis consistent with the basis on which the audited combined financial statements have been prepared. In the opinion of Bioverativ's management, the unaudited condensed combined interim financial data includes all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of such data. These interim results are not necessarily indicative of results to be expected for the full year.

        The combined financial statements were prepared on a "carve-out" basis for purposes of presenting what Bioverativ's financial position, results of operations and cash flows would have been for the periods presented had Bioverativ operated the business as a standalone entity. Bioverativ did not

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operate as a standalone entity in the past and, accordingly, the summary financial data presented herein is not necessarily indicative of Bioverativ's future performance and does not reflect what Bioverativ's financial performance would have been had the company operated as an independent, publicly traded company during the periods presented, and should not be relied upon as an indicator of our future results.

        The unaudited pro forma combined statement of income data for the year ended December 31, 2015 and for the nine months ended September 30, 2016 assumes that the separation occurred as of January 1, 2015. The unaudited pro forma combined balance sheet assumes that the separation occurred as of September 30, 2016. The pro forma adjustments are based upon available information and assumptions that Bioverativ believes are factually supportable. The summary unaudited pro forma condensed financial information is for illustrative and informational purposes only and does not purport to represent what the financial position or results of operations would have been if Bioverativ had operated as an independent company during the periods presented or if the transactions described therein had actually occurred as of the date indicated, nor does it project the financial position at any future date or the results of operations for any future period, and should not be relied upon as an indicator of our future results. Please see the notes to the unaudited pro forma combined financial statements included elsewhere in this information statement for a discussion of adjustments reflected in the unaudited pro forma combined financial statements.

        The summary financial information should be read in conjunction with the discussion in "Capitalization," "Management's Discussion and Analysis of Financial Condition and Results of Operations," the unaudited pro forma combined financial statements and corresponding notes, the audited combined financial statements and corresponding notes and the unaudited condensed combined interim financial statements and corresponding notes included elsewhere in this information statement.

 
  For the Nine Months Ended
September 30,
  For the Years Ended
December 31,
 
(In millions)
  Pro forma
2016
  2016   2015   Pro forma
2015
  2015   2014   2013  

Combined Statement of Income (Loss) Data

                                           

Total revenues

  $ 631.2   $ 631.2   $ 386.1   $ 560.3   $ 560.3   $ 134.4   $  

Net income (loss)

  $ 148.1   $ 210.7   $ 36.1   $ 61.6   $ 108.6   $ (360.3 ) $ (344.6 )

 

 
  As of September 30,   As of December 31,  
(In millions)
  Pro forma
2016
  2016   2015   2015   2014  

Combined Balance Sheet Data

                               

Total assets

  $ 669.1   $ 540.9   $ 433.9   $ 475.6   $ 376.4  

Total long term liabilities

  $ 53.8   $ 53.8   $ 18.9   $ 30.7   $ 17.1  

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RISK FACTORS

         You should carefully consider the following risks and other information in this information statement in evaluating Bioverativ and Bioverativ's common stock. Any of the following risks could materially and adversely affect our results of operations or financial condition and could adversely impact, or result in volatility to, our stock price following the distribution. The risk factors generally have been separated into three groups: risks related to our business, risks related to the separation and risks related to our common stock.

Risks Related to Our Business

We are dependent on revenues from our products, ELOCTATE and ALPROLIX. If we or Sobi are unable to successfully commercialize ELOCTATE or ALPROLIX, our results of operations would be materially harmed.

        Net sales of ELOCTATE and ALPROLIX represent substantially all of our revenues, and this concentration makes us dependent on these two products. Further, we currently have limited resources for commercializing ELOCTATE and ALPROLIX outside of the United States, Japan and Canada, and are dependent on the efforts of Sobi in its commercialization territory. If we were to experience difficulty with the commercialization of ELOCTATE or ALPROLIX, or if Sobi were to experience difficulty with the commercialization of ELOCTATE or ALPROLIX in its commercialization territory, we could experience a significant reduction in revenue and may not be profitable.

        We expect that continued commercialization of ELOCTATE and ALPROLIX will depend on many factors, including the following:

        Many of these factors are beyond our control, and success in any one of these factors will not guarantee success in any of the others. Accordingly, we cannot assure you that we will be able to continue to generate revenue through the sale of ELOCTATE or ALPROLIX.

If our hemophilia products fail to compete effectively, our business and market position would suffer.

        Due to our dependence on sales of our hemophilia products, our business may be harmed if our products are unable to successfully compete in the hemophilia treatment market. The hemophilia treatment market is highly competitive. We compete in the marketing and sale of our products, and in the development of, and acquisition of rights to, new products and technologies.

        We compete with biotechnology and biopharmaceutical companies that have greater financial, technological and other resources. One or more of our competitors may benefit from significantly greater sales and marketing capabilities, may develop products that are accepted more widely than ours or may receive patent protection that dominates, blocks or adversely affects our product development or business.

        Our ability to successfully compete with other hemophilia treatments may be adversely affected if our therapies are not regarded by patients, healthcare providers or payors as offering significant benefits and value as compared to other current treatments. We are aware of a number of companies,

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including large biopharmaceutical companies, such as Bayer AG, Pfizer Inc., CSL Ltd., Roche Holding AG and Shire Plc. that currently market or are pursuing the development of products for the treatment of hemophilia. We are also aware of other extended half-life factor products as well as other new technologies, such as gene therapies and bi-specific antibodies, that are in development and, if successfully developed and approved, would compete with ELOCTATE or ALPROLIX. New therapies and technologies have the potential to transform the standard of care for hemophilia patients, and our products may be unable to compete successfully with such new therapies and technologies that may be developed and marketed by other companies.

        In addition, our relatively recent entrance into the hemophilia treatment market relative to certain of our competitors may impact our ability to develop relationships with the associated medical and scientific community that are necessary to properly inform these communities regarding the relative benefits that our products offer.

Issues with product quality or safety, including the perception of such issues, could negatively affect our business, subject us to regulatory or other actions and cause a loss of confidence in us or our products.

        Our success depends upon the quality and safety of our products. Even after a product is approved for marketing, new safety data may emerge from adverse event reports or post-marketing studies. Previously unknown risks and adverse effects of our products may also be discovered in connection with unapproved or off-label uses of our products. A quality or safety issue, including the perception of such issues, may result in investigations by regulatory authorities, product liability, adverse inspection reports, warning letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, requirements for additional labeling or safety monitoring, refusal of a government to grant approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses. An inability to address any of these issues in an effective and timely manner may cause negative publicity, loss of physician and patient confidence in the company or its current or future products and may negatively impact physicians' decisions to prescribe our products. These issues could also result in liabilities, loss of revenue, material write-offs of inventory, withdrawal or voluntary recall of our products from the marketplace, delays or limitations in regulatory approvals, material impairments of intangible assets, goodwill and fixed assets, material restructuring charges, difficulty in successfully launching new products and other adverse impacts on our results of operations.

Our reliance on third parties for our manufacturing and distribution processes increases the risk that we will not have available sufficient quantities of ELOCTATE and ALPROLIX, or that such quantities may not be available at an acceptable cost, which could delay, prevent or impair our commercialization efforts and materially harm our business, results of operations and financial condition.

        We rely, and expect to continue to rely, on third parties for the commercial manufacture and distribution of ELOCTATE and ALPROLIX. For example, in connection with the separation and the distribution, we intend to enter into a manufacturing and supply agreement with Biogen as our sole supplier of ELOCTATE and ALPROLIX for a specified period of time. Biogen is currently the sole manufacturer of ELOCTATE and ALPROLIX. Biogen also relies on third parties with respect to certain aspects of its manufacturing process, including certain sole sources of raw materials. We also rely, and expect to continue to rely, on third parties to distribute our products, including global, regional, and specialty distribution and logistics providers and, for a transition period, Biogen.

        Biogen and other third party providers are independent entities subject to their own unique operational and financial risks that are outside of our control. Any of these third parties may not perform their obligations in a timely and cost-effective manner or in compliance with applicable regulations. Biogen, for instance, may be unable or unwilling to increase production capacity

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commensurate with demand for our products. Finding alternative providers could take a significant amount of time and involve significant expense due to the specialized nature of these services.

        In the event we change manufacturing partners or the third parties providing packaging, labeling and/or storage of our products, we may need to obtain approval from applicable regulatory authorities. Manufacturers are generally required to maintain compliance with current Good Manufacturing Practices (cGMPs) and other stringent requirements and are subject to inspections by the FDA and comparable agencies in other jurisdictions to confirm such compliance. These cGMP requirements and regulations are not prescriptive instructions on how to manufacture products, but rather a series of principles that must be observed during manufacturing; as a result, their implementation may not be clearly delineated and may present a challenging task as these regulatory requirements are complex, time-consuming and expensive. Moreover, as our products are biologics, they require processing steps that are more difficult than those required for most chemical pharmaceuticals. Any delay, interruption or other issues that arise in the manufacture, fill-finish, packaging or storage of our products as a result of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency inspection could result in administrative sanctions by the FDA or other U.S. or non-U.S. regulatory agencies. Significant noncompliance could also result in the imposition of monetary penalties or other civil or criminal sanctions.

        We cannot be certain that we could reach agreement with alternative providers or that the FDA or other regulatory authorities would approve our use of alternative manufacturers or providers on a timely basis. Any adverse developments affecting our supply chain may result in development delays, shipment delays, inventory shortages, lot failures, product withdrawals or recalls or other interruptions in the commercial supply of our products. In addition, loss or damage to a manufacturing facility or storage site due to a natural disaster or otherwise could adversely affect our ability to manufacture sufficient quantities of our products or to deliver products to meet customer demand or contractual requirements, any of which may result in a loss of revenue and other adverse business consequences. We may also have to take inventory write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. Such developments could increase our manufacturing or development costs, cause us to lose revenue or market share as patients and physicians turn to competing therapeutics, diminish our profitability or damage our reputation. Moreover, any failure of Biogen to supply ELOCTATE and ALPROLIX could cause us to breach our supply agreements to Sobi for these products, which may subject us to liability under those agreements and impair our relationship with Sobi.

Our inability to maintain adequate coverage, pricing or reimbursement for our products, could have an adverse effect on our business and results of operations.

        Sales of ELOCTATE and ALPROLIX are dependent, in large part, on the availability and extent of coverage, pricing and reimbursement from government health administration authorities, private health insurers and other organizations. When a new biopharmaceutical product is approved, the availability of government and private insurance coverage for that product may be uncertain, as is the pricing of the product and extent to which the product will be reimbursed. Failure to maintain adequate coverage, pricing or reimbursement for our products could have an adverse effect on our business and results of operations.

        Pricing and reimbursement for our products may be adversely affected by a number of factors, including:

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        Our ability to set the price for our products can vary significantly from country to country and, as a result, so can the price of our products. Pricing and acceptance of ELOCTATE and ALPROLIX in certain countries are also subject to risks due to the tendering process required in those countries, as well as the comparison of dose pricing of our products against conventional treatments. If we are unable to demonstrate to healthcare providers and payors the value of prophylaxis treatment and reduced consumption of our products compared to conventional treatments, our products may not be accepted or we may not secure adequate prices in a particular country. Our inability to secure adequate prices in a particular country may limit the marketing of our products within that country, and may also adversely affect our ability to obtain acceptable prices in other markets. This may create the opportunity for third party cross-border trade or influence our decision to sell or not to sell a product in a particular country, thus adversely affecting our geographic expansion plans and revenues.

        Pricing for therapies and other health care costs are under significant scrutiny in the markets in which our products are prescribed and continue to be subject to intense political and societal pressures which we anticipate will continue and escalate. As a result, our business and reputation may be harmed.

If we are unable to obtain and maintain adequate protection for our intellectual property and other proprietary rights, or if we are unable to avoid violation of the intellectual property or proprietary rights of others, we may be subject to liability, the operation of our business may be interrupted or our business or prospects may be otherwise harmed.

        Our commercial success depends in part on our ability to obtain and defend patent and other intellectual property rights that are important to the development, manufacture and commercialization of our products and product candidates. The degree of patent protection that will be afforded to our products and processes in the United States and in other important non-U.S. markets remains uncertain and is dependent upon the scope of protection decided upon by the patent offices, courts and lawmakers in those countries. We can provide no assurance that we will successfully obtain or preserve patent protection for the technologies incorporated into our products and processes, or that the scope of patent protection obtained will be sufficient to protect our commercial interests in all countries where we conduct business. If we cannot prevent others from exploiting our inventions, we will not derive the benefit from them that we currently expect.

        We exclusively license, under an agreement with Amunix Operating Inc. (Amunix), the XTEN technology that is used in connection with certain of our pipeline product candidates. If that agreement were to be terminated or if we otherwise lost our rights to such technology, our ability to develop, manufacture and commercialize such product candidates could be adversely affected, and could materially harm our business prospects.

        We also rely on regulatory exclusivity for protection of our products. Implementation and enforcement of regulatory exclusivity varies widely from country to country. Failure to qualify for regulatory exclusivity, or failure to obtain or maintain the extent or duration of such protections that we expect for our products in each of these markets due to challenges, changes of interpretations in the law or otherwise, could affect the revenue for our products, our decision on whether to market our

21


products in a particular country or countries or could otherwise have an adverse impact on our results of operations.

        Additionally, we rely in part on confidentiality and non-use agreements with our employees, consultants, collaborators and other business partners to protect our proprietary technology and processes. If any of these individuals or entities breaches their confidentiality, non-use or similar agreements with us, we may not have adequate remedies for that breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors and even patented by them. If that happens, the potential competitive advantages provided by our intellectual property may be adversely affected. We may then need to license such competing technologies, and we may not be able to obtain licenses on reasonable terms, if at all, which could cause material harm to our business. Moreover, to the extent that our employees, consultants, parties to collaboration agreements and other business partners use intellectual property owned by others in their work for the company, disputes may arise as to the rights in related or resulting know-how and inventions.

        Our success also depends in part on our, and on the people with whom we collaborate and do business, not infringing patents and proprietary rights of others, and not breaching any licenses or other agreements that we or they have entered into with regard to our technologies, products and business. We cannot be certain that patents have not or will not be issued to others that would block our ability to obtain patents or to operate our business as we would like or at all. There may be patents in some countries that, if valid and if we are unsuccessful in circumventing or acquiring rights to them, could block our ability to commercialize products in those countries. There also may be claims in patent applications filed in some countries that, if granted and valid, and if we are unable to circumvent or license them, could also block our ability to commercialize products or processes in those countries.

        Litigation, interferences, oppositions, inter partes reviews or other proceedings are, and may in the future be, necessary in some instances to determine the validity and scope of certain of our proprietary rights, and in other instances to determine the validity, scope or non-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products. Patent-related claims could include challenges to the scope and validity of our patents on products or processes as well as allegations that our products infringe patents held by competitors or others. We may also face challenges to regulatory or patent protections covering our products by manufacturers of biosimilars that may choose to launch or attempt to launch their products before the expiration of our regulatory or patent exclusivity.

        Biogen has received communications from a third party, Pfizer, regarding a proposal that Biogen take a license to Pfizer's U.S. Patent No. 8,603,777 (Expression of Factor VII and IX Activities in Mammalian Cells) and pay royalties on past and future sales of ALPROLIX. There is no pending litigation with Pfizer and an estimate of a possible loss or range of loss cannot be made at this time. We do not believe this patent would adversely affect our ability to sell ALPROLIX; however, we cannot assure you that we would ultimately prevail if this or any other intellectual property infringement claim is asserted against us, and we may receive in the future other communications from third parties claiming infringement of third party intellectual property rights.

        The disposition of claims or proceedings is unpredictable and, regardless of the merits or the outcome, may be protracted, expensive and distracting to management. Moreover, the disposition and outcome of any such claims or proceedings could adversely affect the validity and scope of our patent or other proprietary rights; hinder our ability to manufacture, market and sell our products; lead to attempts on the part of other parties to pursue similar claims; force us to redesign those products or processes that use any allegedly infringing or misappropriated technology, which may result in significant cost or delay to us, or which the redesign of could be technically infeasible; require us to seek a license for the impacted product or technology and pay royalties; or result in the assessment of significant monetary damages against us that may exceed amounts, if any, accrued in our financial

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statements, including the possibility of treble damages in a patent case if a court finds us to have willfully infringed certain intellectual property rights. In addition, payments under any licenses that we are able to obtain would reduce our profits derived from the covered products and services. Furthermore, many of our collaboration agreements, including with Sobi, require us to indemnify the collaboration parties for third party intellectual property infringement claims, which would increase the cost to us of any such claim. Any of these adverse effects may be material and, consequently, may adversely impact our cash flow, financial position and results of operations.

Our sales and operations are subject to the risks of doing business in Japan and other international markets, which could adversely impact our business, results of operations and financial condition.

        We are increasing our presence in Japan, Canada and other non-U.S. markets, which subjects us to many risks that could adversely affect our business and revenues, such as:

        We cannot guarantee that our efforts to initiate or expand sales in these markets will succeed. Some non-U.S. markets may be especially vulnerable to periods of financial instability or may have very limited resources to spend on health care. To successfully implement our strategy in non-U.S. markets, we must attract and retain qualified personnel or may be required to increase our reliance on third party distributors within those markets. In addition, many of the countries in emerging markets have currencies that fluctuate substantially. If such currencies devalue and we cannot offset the devaluations, our financial performance within those countries could be adversely affected. In addition, price and currency exchange controls, limitations on participation in local enterprises, expropriation,

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nationalization and other governmental actions could affect our business and results of operations in these markets.

        In addition, our non-U.S. operations are subject to regulation under U.S. law. For example, the U.S. Foreign Corrupt Practices Act (the FCPA) prohibits U.S. companies and their representatives from offering, promising, authorizing or making payments to foreign officials for the purpose of obtaining or retaining business abroad. In many countries, the health care professionals we regularly interact with may meet the definition of a foreign government official for purposes of the FCPA. Failure to comply with U.S. or non-U.S. laws could result in various adverse consequences, including: possible delay in approval or refusal to approve a product; recalls, seizures or withdrawal of an approved product from the market; disruption in the supply or availability of our products or suspension of export or import privileges; the imposition of civil or criminal sanctions; the prosecution of executives overseeing our international operations; and damage to our reputation. Any significant impairment of our ability to sell products outside of the U.S. could adversely impact our business and financial results.

Development of our product candidates is expensive and uncertain. If we are unable to successfully develop and test our product candidates, our business, financial condition, results of operations and prospects will be harmed.

        A part of our long-term strategy is the continued development of marketed products and our product pipeline programs. The research and development of biological products is subject to numerous risks and uncertainties and requires significant capital expenditures and management resources. Only a small percentage of product candidates that enter the development process ever receive regulatory approval. The process of conducting the preclinical and clinical testing required to establish safety and efficacy and obtain regulatory approval is expensive and uncertain and takes many years. The FDA and non-U.S. regulatory agencies generally require pre-clinical (animal) testing as well as multiple stages of clinical (human) testing before a product gains regulatory approval, and failure may occur at any stage of testing. Positive results in a trial may not be replicated in subsequent or confirmatory trials, and success in preclinical work or early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful or that regulatory approval will be obtained. Furthermore, our ability to commence and complete clinical trials may be delayed, and our existing trials may be stopped, due to various factors, including: variability in the number and types of patients available for each study; difficulty in maintaining contact with patients after treatment, resulting in incomplete data, unforeseen safety issues or side effects; varying interpretations of clinical trial data; poor or unanticipated effectiveness of candidates during clinical trials; and government or regulatory delays.

        These risks are enhanced by our reliance on third parties for aspects of the research and development process. We rely, and expect to continue to rely, on third parties to store and distribute drug supplies for our clinical trials as well as contract research organizations (CROs), clinical data management organizations, medical institutions and clinical investigators to conduct and manage our preclinical and clinical trials and to accurately report their results. Reduced control over these activities may impact our ability to control the timing, conduct, expense, reliability and quality of our clinical trials, but does not relieve us of our regulatory responsibility for trials that we sponsor. For example, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial as well as regulatory standards such as current Good Clinical Practices (cGCPs). Failure to fully comply with the study protocol or applicable regulations or regulatory standards could result in the clinical data generated in those studies being deemed unreliable. This failure may also result in the rejection of our product candidates by the FDA or a non-U.S. regulatory agency, or may result in our having to conduct additional audits or require additional clinical studies, which would delay our development programs, require us to incur additional costs and could substantially harm our business and financial condition. If the third parties we rely on for research and development activities do not successfully carry out their contractual duties, do not

24


meet expected deadlines, experience work stoppages, terminate their agreements with us, need to be replaced or do not conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we may need to enter into new arrangements with alternative third parties, which could be difficult, costly or impossible. As a result, our clinical trials may be extended, delayed, terminated or may need to be repeated.

        Even if we are able to successfully develop new products or indications, sales of new products or products with additional indications may not meet expectations. Our products may not achieve an adequate level of acceptance in the medical community until longer-term clinical data or other factors demonstrate their safety and efficacy as compared to other alternative treatments. We may also make a strategic decision to discontinue development of a product or indication if, for example, we believe commercialization will be difficult relative to the standard of care or other opportunities in our pipeline.

        The occurrence of any of these events could result in significant costs and expenses and lost market opportunities.

If our business development activities are unsuccessful, our business could suffer and our financial performance could be adversely affected.

        We intend to engage in business development activities, including evaluating potential acquisitions, strategic alliances, collaborations, technology licensing arrangements and other opportunities. These activities may require a substantial investment of our resources. Our success developing products or expanding our product portfolio from such business development activities will depend on a number of factors, including:

        If we are unsuccessful in our business development activities, we may be unable to grow or meet our financial targets and our business and financial performance could be adversely affected.

We depend on relationships with collaborators and other third parties for revenue, and for the development, regulatory approval, commercialization and marketing of certain products, which are outside our full control. If our collaborative efforts are unsuccessful, our commercialization strategies or product development may be delayed, which could have an adverse impact on our business, prospects and results of operations.

        We rely, and expect to continue to rely, on a number of significant collaborative and other third party relationships for revenue, and for the development, regulatory approval, commercialization and marketing of our products and product candidates. These third parties may include other biotechnology and biopharmaceutical companies, academic and research institutions, governments and government agencies and other public and private research organizations. For example, in addition to our

25


collaboration with Sobi, we are pursuing programs with other third parties in hemophilia A and hemophilia B using XTEN technology, gene therapy and non-factor bi-specific antibodies.

        Reliance on collaborative and other third party relationships subjects us to a number of risks, including:

        Given these risks, there is considerable uncertainty regarding the success of our current and future collaborative efforts. If these efforts fail, our product development or commercialization of new products could be delayed or revenues from products could decline.

If we or third parties with whom we do business fail to comply with the extensive legal and regulatory requirements affecting the health care industry, we could face increased costs, penalties and harm to our business.

        Our activities, and the activities of our collaborators, distributors and other third party providers, are subject to extensive government regulation and oversight both in the U.S. and in non-U.S. jurisdictions.

        To be approved for marketing, a potential product must undergo lengthy and rigorous testing and other extensive, costly and time-consuming procedures mandated by the FDA and non-U.S. regulatory authorities. Satisfaction of these regulatory requirements typically takes many years. Moreover, regulatory oversight continues to apply after product marketing approval and covers, among other things, testing, manufacturing, distribution, quality control, labeling, advertising, promotion, risk mitigation and adverse event reporting requirements. Our facilities, or those of third parties on which we rely, must be licensed prior to production and remain subject to inspection from time to time thereafter. Separately, if previously unknown problems occur with regards to our marketed products, any of our products may have to be withdrawn from the market or subject to restrictions. Regulatory agencies may also require additional clinical trials or testing for our products, and our products may be recalled or may be subject to reformulation, changes in labeling, warnings to the public and negative publicity. We will rely on Biogen for a period following the effective time of the distribution to supply and distribute our products to customers while we obtain appropriate regulatory authorizations in the United States and Canada. In the United States, we are in the process of securing a Department of Health and Human Services United States License Number, certain state authorizations and other

26


regulatory and government authorizations. In Canada, we are in the process of applying for additional licenses, including a Drug Establishment License from Health Canada. We cannot guarantee that we will be able to obtain or maintain regulatory approval to market or engage in distribution or other activities regarding our products.

        Further, even if we are successful in gaining regulatory approval of any of our product candidates, the extent to which we are able to commercialize the product may be less than we anticipate. Regulatory authorities may grant marketing approval that is more restricted than anticipated. These restrictions may include limiting indications to narrow patient populations and imposing safety monitoring, educational requirements and risk evaluation and mitigation strategies (REMS). In addition, if we seek to expand or change the use of any of our marketed products, those changes may be subject to vigorous review and include multiple regulatory submissions, and approvals are not certain.

        In addition to FDA and related regulatory requirements, we are subject to health care "fraud and abuse" laws governing our interactions in the U.S. and non-U.S. jurisdictions with physicians or other health care providers that prescribe or purchase our products. In the United States, these laws include the federal False Claims Act, the anti-kickback provisions of the federal Social Security Act, the Physician Payment Sunshine provisions, and other state and federal laws and regulations. In both the United States and other jurisdictions, health care companies such as ours are facing heightened scrutiny of their relationships with health care providers from anti-corruption enforcement officials and private individuals. Many biotechnology and biopharmaceutical companies have been the target of lawsuits and investigations alleging violations of government regulation, including claims asserting submission of incorrect pricing information, impermissible off-label promotion of biotechnology and biopharmaceutical products, payments intended to influence the referral of health care business, submission of false claims for government reimbursement, antitrust violations or violations related to environmental matters. There also recently has been enhanced scrutiny of company-sponsored patient assistance programs, including insurance premium and co-pay assistance programs and donations to third party charities that provide such assistance. If we, or our vendors or donation recipients, fail to comply with relevant laws, regulations or government guidance in the operation of these programs, we could be subject to significant fines or penalties. Our risks under health care fraud and abuse laws may be heightened as we continue to expand our global operations and if we enter new therapeutic areas with different patient populations, which may have product distribution methods distinct from those we currently utilize.

        Violations of governmental regulation, such as a failed inspection or a failure in our adverse event reporting system, or any health care fraud and abuse law may be punishable by criminal, civil and administrative sanctions against us as well as against executives overseeing our business. These may include adverse inspection reports; refusal to grant approvals or licenses; warning letters; fines and civil monetary penalties; withdrawal of regulatory approval or licenses; interruption of production; operating restrictions; product recall or seizure; injunctions; criminal prosecution and exclusion from participation in government programs, including Medicare and Medicaid, as well as against executives overseeing our business. In addition to penalties for violation of laws and regulations, we could be required to repay amounts we received from government payors, or pay additional rebates and interest if we are found to have miscalculated the pricing information we have submitted to the government. We cannot ensure that our compliance controls, policies, and procedures will, in every instance, protect us from acts committed by our employees, collaborators, partners or third party providers that would violate the laws or regulations of the jurisdictions in which we operate. Whether or not we have complied with the law, an investigation into alleged unlawful conduct could increase our expenses, damage our reputation, divert management time and attention and adversely affect our business. Any of these actions could cause a loss of confidence in us and our products, which could adversely affect our sales. Even if it is later determined that we are not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our position and have to divert significant management resources from other matters.

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Our business and results of operations may be adversely affected by current and potential future health care reforms.

        In the United States, federal and state legislatures, health agencies and third party payors continue to focus on containing the cost of health care. Legislative and regulatory proposals and enactments to reform health care insurance programs could significantly influence the manner in which our products are prescribed and purchased. For example, provisions of the Patient Protection and Affordable Care Act (the PPACA) have resulted in changes in the way health care is paid for by both governmental and private insurers in the United States, including increased rebates owed by manufacturers under the Medicaid Drug Rebate Program, annual fees and taxes on manufacturers of certain branded prescription drugs, the requirement that manufacturers participate in a discount program for certain outpatient drugs under Medicare Part D and the expansion of the number of hospitals eligible for discounts under Section 340B of the Public Health Service Act. Many of the PPACA requirements are new and uncertain, and the penalties for failing to comply with these requirements are unclear. All of these changes have had and are expected to continue to have a significant impact on our business.

        There is also significant economic pressure on U.S. state budgets that may result in states increasingly seeking to achieve budget savings through mechanisms that limit coverage or payment for our drugs. In recent years, some states have considered legislation and ballot initiatives that would control the prices of drugs, including laws to allow importation of biotechnology and biopharmaceutical products from lower cost jurisdictions outside the U.S. and laws intended to impose price controls on state drug purchases. State Medicaid programs are increasingly requesting manufacturers pay supplemental rebates and requiring prior authorization by the state program for use of any drug for which supplemental rebates are not paid. Government efforts to reduce Medicaid expenses may lead to increased use of managed care organizations by Medicaid programs. This may result in managed care organizations influencing prescription decisions for a larger segment of the population and a corresponding constraint on prices and reimbursement for our products. In addition, under the PPACA, as states implement their health care marketplaces or operate under the federal exchange, the impact on drug manufacturers, including us, will depend in part on the formulary and benefit design decisions made by insurance sponsors or plans participating in these programs. It is possible that we may need to provide discounts or rebates to such plans in order to maintain favorable formulary access to our products for this patient population, which could have an adverse impact on our sales and results of operations.

        In the European Union and some other non-U.S. markets, the government provides health care at low cost to consumers and regulates biotechnology and biopharmaceutical prices, patient eligibility or reimbursement levels to control costs for the government-sponsored health care system. Many countries have announced or implemented measures to reduce health care costs to constrain their overall level of government expenditures. These measures vary by country and may include, among other things, patient access restrictions, suspensions on price increases, prospective and possibly retroactive price reductions and other recoupments and increased mandatory discounts or rebates, recoveries of past price increases and greater importation of drugs from lower-cost countries. These measures have negatively impacted our revenues and may continue to adversely affect our revenues and results of operations in the future.

A breakdown or breach of our technology systems could subject us to liability or interrupt the operation of our business.

        We will be increasingly dependent upon technology systems and data, many of which are new or unfamiliar systems following our spin-off from Biogen. Our intellectual property, computer systems, other proprietary technology and other sensitive company data is potentially vulnerable to loss, damage or misappropriation from system malfunction, computer viruses, unauthorized access to data or misappropriation or misuse thereof by those with permitted access and other events. Likewise, data

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privacy or security breaches by individuals authorized to access our technology systems or others may pose a risk that sensitive data, including intellectual property, trade secrets or personal information belonging to us, our patients, customers or other business partners, may be exposed to unauthorized persons or to the public. The increasing use and evolution of technology, including cloud-based computing, creates additional opportunities for the unintentional dissemination of information and the intentional destruction of confidential information stored in the company's systems or in non-encrypted portable media or storage devices. Cyber attacks are increasing in their frequency, sophistication and intensity. While we continue to build and improve our systems and infrastructure and take appropriate security measures to reduce these risks to our intellectual property, data and information technology systems, there can be no assurance that our efforts will prevent breakdowns, breaches, cyber incidents or other events. Such events could have a negative effect on our reputation, business, financial condition or results of operations. Further, the misappropriation or other loss of our intellectual property from any of the foregoing could have an adverse effect on our competitive position and may cause us to incur substantial litigation costs.

Our business involves environmental risks, which include the cost of compliance and the risk of contamination or injury, which could harm our business.

        Our business and the business of several of our third party contractors involve the controlled use of hazardous materials, chemicals, biologics and radioactive compounds. Although we believe that our and their safety procedures for the handling and disposing of such materials comply with state, federal and non-U.S. laws and standards, there will always be the risk of accidental contamination or injury. If we were to become liable for an accident, or if a facility in which our products or product candidates were manufactured suffered an extended shutdown, we could incur significant costs, damages or penalties that could harm our business. Manufacturing, distribution and disposal of our products and product candidates also requires compliance with environmental laws and may require permits from government agencies, including governmental authorizations or permits for water supply, wastewater discharge and waste disposal. If we or our contract parties do not obtain or comply with appropriate permits and other requirements of environmental laws, we or they could incur significant penalties and other costs and limits on manufacturing volumes that could harm our business.

Significant legal proceedings may adversely affect our results of operations or financial condition.

        We are subject to the risk of litigation, derivative claims, securities class actions, regulatory and governmental investigations and other proceedings, including proceedings arising from investor dissatisfaction with us or our performance. If any claims were brought against us and resulted in a finding of substantial legal liability, the finding could materially adversely affect our business, financial condition or results of operations or cause significant reputational harm to us, which could seriously adversely impact our business. Allegations of improper conduct by private litigants or regulators, regardless of veracity, may harm our reputation and adversely impact our ability to grow our business.

Risks Related to the Separation

We may not achieve some or all of the expected benefits of the separation, and the separation could harm our business, results of operations and financial condition.

        We may not be able to achieve some or all of the anticipated strategic, financial, operational, marketing or other benefits expected to result from the separation, or such benefits may be delayed or not occur at all. For example, in order to position ourselves for the separation, we are undertaking strategic, structural and process realignment actions within our operations. These actions may not provide the benefits we currently expect, and could lead to disruption of our operations, loss of, or inability to recruit, key personnel needed to operate and grow our businesses following the separation, weakening of our internal standards, controls or procedures and impairment of our key customer and

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supplier relationships. In addition, completion of the separation will require significant amounts of management's time and effort, which may divert management's attention from operating and growing our businesses.

        By separating from Biogen, we may become more susceptible to market fluctuations and other adverse events than we would have been if we were still a part of the current Biogen organizational structure. As part of Biogen, we have been able to enjoy certain benefits from Biogen's operating diversity, purchasing power and opportunities to pursue integrated strategies with Biogen's other businesses. As an independent, publicly traded company, we will not have similar diversity or integration opportunities and may not have similar purchasing power or access to capital markets. Additionally, as part of Biogen, we have been able to leverage Biogen's historical market reputation, performance and brand identity to recruit and retain key personnel to run our business. As an independent, publicly traded company, we will not have the same historical market reputation and performance or brand identity as Biogen. If we fail to achieve some or all of the benefits that we expect to achieve as an independent company, or do not achieve them in the time we expect, our business, operating results, financial condition or prospects may suffer.

We may be unable to make, on a timely or cost-effective basis, the changes necessary to operate as an independent company, and we will be reliant on Biogen for the provision of certain services for a period of time.

        We have historically operated as part of Biogen's corporate organization, and Biogen has assisted us by providing various corporate and other business functions. Following the separation, Biogen will have no obligation to provide us with assistance other than providing certain services pursuant to agreements described under "Certain Relationships and Related Person Transactions—Agreements with Biogen." If Biogen is unable or unwilling to satisfy its obligations under these agreements, we could incur operational difficulties or losses that could have a material and adverse effect on our business, operating results and financial condition.

        The services to be provided by Biogen do not include every service or all of the information and technology systems that we have received from Biogen in the past, and Biogen is only obligated to provide these services for limited periods of time from the distribution date. Accordingly, following the separation, we will need to provide internally or obtain from unaffiliated third parties the systems and services we currently receive from Biogen.

        If we do not have in place our own systems and services, including technology systems and services, or if we do not have agreements with other providers of these services in a timely manner or on terms and conditions as favorable as those we receive from Biogen, we may not be able to operate our business effectively and our profitability may decline. Furthermore, if we fail to obtain the quality of services necessary to operate effectively or incur greater costs in obtaining these services, our profitability, operating results and financial condition may be materially and adversely affected.

We have no history of operating as an independent company and we expect to incur increased administrative and other costs following the separation by virtue of our status as an independent public company. Our historical and pro forma financial information is not necessarily representative of the results that we would have achieved as a separate, publicly traded company and should not be relied upon as an indicator of our future results.

        Our historical information provided in this information statement refers to our business as operated by and integrated with Biogen. Our historical and pro forma financial information included in this information statement is derived from the consolidated financial statements and accounting records of Biogen. Accordingly, the historical and pro forma financial information included in this information statement may not reflect the operating results, financial condition or cash flows that we would have

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achieved as a separate, publicly traded company during the periods presented or what we will achieve in the future primarily as a result of the following factors, among others:

        Other significant changes may occur in our cost structure, management, financing and business operations as a result of operating as a company separate from Biogen. For additional information about the past financial performance of our business and the basis of preparation of the historical combined financial statements and the unaudited pro forma condensed combined financial statements of our business, see "Unaudited Pro Forma Combined Financial Statements," "Selected Historical Combined Financial Data," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our financial statements and accompanying notes included elsewhere in this information statement.

The separation may adversely impact our ability to attract and retain key personnel, which could materially harm our business.

        Our success depends in large part upon the leadership and performance of our management team and other key employees. Operating as an independent company will demand a significant amount of time and effort from our management and other employees and may give rise to increased employee turnover. If we lose the services of members of our management team or other key employees, we may not be able to successfully manage our business or achieve our business objectives.

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        Following the separation, we will need to continue to attract and retain qualified key personnel in a highly competitive environment. Our ability to attract, recruit and retain such talent will depend on a number of factors, including the hiring practices of our competitors, the performance of our late stage programs, our compensation and benefits, work location and work environment and economic conditions affecting our industry generally. If we cannot effectively hire and retain qualified employees, our business, results of operations and prospects could suffer.

The separation may result in disruptions to, and negatively impact our relationships with, our customers and other business partners.

        Uncertainty related to the separation may lead customers and other parties with which we currently do business or may do business in the future to terminate or attempt to negotiate changes in our existing business relationships, or cause them to delay entering into business relationships with us or consider entering into business relationships with parties other than us. These disruptions could have a material and adverse effect on our business, operating results, financial condition and prospects. The effect of such disruptions could be exacerbated by any delays in the completion of the separation.

Our accounting and other management systems and resources may not be adequately prepared to meet the financial reporting and other requirements to which we will be subject following the distribution.

        Our financial results historically were included within the consolidated results of Biogen, and until the distribution occurs, we have not been and will not be directly subject to reporting and other requirements of the Securities and Exchange Act of 1934 (Exchange Act) and Section 404 of the Sarbanes-Oxley Act of 2002. After the distribution, we will qualify as an "emerging growth company" and for so long as we remain so qualified we will be exempt from Section 404(b) of the Sarbanes-Oxley Act of 2002, which requires auditor attestation to the effectiveness of internal control over financial reporting. We will, however, be immediately subject to Section 404(a) of the Sarbanes-Oxley Act of 2002 and, as of the expiration of our emerging growth company status, we will be broadly subject to reporting and other requirements under the Exchange Act and Sarbanes-Oxley Act of 2002, which will require, among other things, annual management assessments of the effectiveness of our internal control over financial reporting and a report by our independent registered public accounting firm addressing these assessments. These and other obligations will place significant demands on our management, administrative and operational resources, including accounting and information technology resources. To comply with these requirements, we anticipate that we will need to further upgrade our systems, including duplicating computer hardware infrastructure, implement additional financial and management controls, reporting systems and procedures and hire additional accounting, finance and information technology staff. If we are unable to do this in a timely and effective fashion, our ability to comply with our financial reporting requirements and other rules that apply to reporting companies could be impaired and our business could be harmed.

If the distribution, together with certain related transactions, does not qualify as a transaction that is tax-free for U.S. federal income tax purposes, Biogen and its stockholders could be subject to significant tax liabilities, and we could be required to indemnify Biogen for material taxes pursuant to indemnification obligations under the tax matters agreement.

        A condition to the distribution is the receipt by Biogen of an opinion from Biogen's tax counsel or other third party advisor regarding the qualification of the distribution, together with certain related transactions, as a transaction that will qualify under Sections 368(a)(1)(D) and 355 of the Code; this condition is waivable by Biogen in its sole discretion. Except as otherwise noted, it is expected that the distribution will qualify as a transaction that is tax-free for U.S. federal income tax purposes to Biogen and the holders of Biogen common stock. The opinion will be based on and rely on, among other things, certain facts and assumptions, as well as certain representations, statements and undertakings of

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us and Biogen, including those relating to the past and future conduct of us and Biogen. If any of these facts, assumptions, representations, statements or undertakings are, or become, inaccurate or incomplete, or if we or Biogen breach any of our respective covenants in the separation documents, the opinion of counsel may be invalid and the conclusions reached therein could be jeopardized.

        Notwithstanding the opinion of counsel, the Internal Revenue Service (the IRS) could determine on audit that the distribution, together with certain related transactions, is taxable for U.S. federal income tax purposes if it determines that any of these facts, assumptions, representations, statements or undertakings are incorrect or have been violated or if it disagrees with the conclusions in the opinion of counsel. An opinion of counsel is not binding on the IRS or any court and there can be no assurance that the IRS will not challenge the conclusions reached in the opinion. The IRS will not provide a ruling in advance of the separation that our proposed transaction will be tax-free.

        If the distribution, together with certain related transactions, is ultimately determined to be taxable, Biogen and its stockholders that are subject to U.S. federal income tax could incur significant tax liabilities. For example, if the distribution fails to qualify for tax-free treatment, Biogen would, for U.S. federal income tax purposes, be treated as if it had sold our common stock in a taxable sale for its fair market value, and those Biogen stockholders who are subject to U.S. federal income tax would be treated as receiving a taxable distribution in an amount equal to the fair market value of our common stock received in the distribution.

        Under the tax matters agreement to be entered into between us and Biogen, we would potentially be required to indemnify Biogen against taxes incurred by Biogen that arise as a result of our taking or failing to take, as the case may be, certain actions that result in the distribution failing to meet the requirements of a tax-free distribution under Section 355 of the Code. If we are required to indemnify Biogen under the circumstances set forth in the tax matters agreement, we may be subject to substantial liabilities, which could materially adversely affect our financial condition.

        For more information, please refer to "Certain Relationships and Related Person Transactions—Agreements with Biogen— Tax Matters Agreement ."

We will be subject to numerous restrictions to preserve the tax-free treatment of the transactions in the United States, which may reduce our strategic and operating flexibility.

        Our ability to engage in significant equity transactions could be limited or restricted after the distribution in order to preserve, for U.S. federal income tax purposes, the tax-free nature of the distribution by Biogen. Even if the distribution otherwise qualifies for tax-free treatment, the distribution may result in corporate-level taxable gain to Biogen under Section 355(e) of the Code if 50% or more, by vote or value, of shares of our stock or Biogen's stock are acquired or issued as part of a plan or series of related transactions that includes the distribution. The process for determining whether an acquisition or issuance triggering these provisions has occurred is complex, inherently factual and subject to interpretation of the facts and circumstances of a particular case. Any acquisitions or issuances of our stock or Biogen's stock within a two-year period after the distribution generally are presumed to be part of such a plan, although we or Biogen, as applicable, may be able to rebut that presumption. Accordingly, under the tax matters agreement that we intend to enter into with Biogen, for the two-year period following the distribution, we will be prohibited, except in certain circumstances, from:

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        These restrictions may limit our ability to pursue certain strategic transactions or other transactions that we may believe to otherwise be in the best interests of our stockholders or that might increase the value of our business. In addition, under the tax matters agreement, we will be required to indemnify Biogen against any such tax liabilities as a result of the acquisition of our stock or assets, even if we do not participate in or otherwise facilitate the acquisition. For a more detailed description, see "Certain Relationships and Related Person Transactions—Agreements with Biogen— Tax Matters Agreement ."

Our agreements with Biogen may not reflect terms that would have resulted from negotiations with unaffiliated third parties .

        The agreements related to the separation, including, among others, the separation agreement, the tax matters agreement and the transition services agreement, will have been entered into in the context of the separation while we are still controlled by Biogen. Until the distribution occurs, Biogen will effectively have the sole and absolute discretion to determine and change the terms of the separation, including the terms of any agreements between Biogen and us and the establishment of the record date and distribution date. As a result, any changes could be unfavorable to us and may not reflect terms that would have resulted from negotiations between unaffiliated third parties. In addition, Biogen may decide at any time not to proceed with all or any part of the separation. For a more detailed description, see "Certain Relationships and Related Person Transactions—Agreements with Biogen."

We will be subject to continuing contingent tax related liabilities of Biogen following the distribution.

        After the distribution, there will be several significant areas where the liabilities of Biogen may become our obligations. For example, under the Code and the related rules and regulations, each corporation that was a member of Biogen's consolidated tax reporting group during any taxable period or portion of any taxable period is jointly and severally liable for the U.S. federal income tax liability of the entire consolidated tax reporting group for such taxable period. We intend to enter into a tax matters agreement with Biogen that will allocate the responsibility for prior period taxes of Biogen's consolidated tax reporting group between us and Biogen. If Biogen were unable to pay any prior period taxes for which it is responsible, however, under applicable law we could be required to pay the entire amount of such taxes, and such amounts could be significant. Other provisions of federal, state, local or foreign law may establish similar liability for other matters, including laws governing tax-qualified pension plans, as well as other contingent liabilities. For a more detailed description, see "Certain Relationships and Related Person Transactions—Agreements with Biogen— Tax Matters Agreement ."

In connection with the separation, we will assume and agree to indemnify Biogen for certain liabilities. If we are required to make payments pursuant to these indemnities to Biogen, we may need to divert cash to meet those obligations and our financial results could be negatively impacted.

        Pursuant to the separation agreement and certain other agreements we intend to enter into with Biogen, we will assume and agree to indemnify Biogen for certain liabilities for uncapped amounts, which may include, among other items, associated defense costs, settlement amounts and judgments, as discussed further in "Certain Relationships and Related Person Transactions—Agreements with Biogen" and "Index to Financial Statements—Audited Combined Financial Statements—Notes to Combined Financial Statements." Payments pursuant to these indemnities may be significant and could negatively impact our business, particularly indemnities relating to our actions that could impact the tax-free nature of the distribution and certain related transactions. Third parties could also seek to hold us responsible for any of the liabilities of the Biogen business. Biogen will agree to indemnify us for liabilities of the Biogen business, but such indemnity from Biogen may not be sufficient to protect us

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against the full amount of such liabilities, and Biogen may not fully satisfy its indemnification obligations. Moreover, even if we ultimately succeed in recovering from Biogen any amounts for which we are held liable, we may be temporarily required to bear these losses ourselves. Each of these risks could negatively affect our business, operating results, financial condition and cash flows.

The combined post-separation value of Biogen and our common stock may not equal or exceed the pre-separation value of Biogen common stock.

        As a result of the distribution, Biogen expects the trading price of Biogen common stock immediately following the distribution to be lower than the "regular way" trading price of such common stock immediately prior to the distribution because the trading price will no longer reflect the value of the our business held by Biogen. The aggregate market value of Biogen common stock and our common stock following the separation may be higher or lower than the market value of Biogen common stock immediately prior to the separation.

No vote of Biogen stockholders is required in connection with this distribution. As a result, if the distribution occurs and you do not want to receive our common stock in the distribution, your sole recourse will be to divest yourself of your Biogen common stock prior to the record date.

        No vote of the Biogen stockholders is required in connection with the distribution. Accordingly, if the distribution occurs and you do not want to receive Bioverativ common stock in the distribution, your only recourse will be to divest yourself of your Biogen common stock prior to the record date for the distribution.

Risks Related to Our Common Stock

There is no existing market for our shares of common stock and an active trading market may not develop for our shares. In addition, once our shares of common stock begin trading, the market price of these shares may fluctuate widely.

        There is currently no public market for our shares of common stock. It is anticipated that on or prior to the record date for the distribution, trading of our shares of common stock will begin on a "when issued" basis and will continue up to and including through the distribution date. However, there can be no assurance that an active trading market for our shares of common stock will develop as a result of the distribution or be sustained in the future.

        We cannot predict the prices at which our shares of common stock may trade after the distribution. The market price of our shares of common stock may fluctuate widely, depending upon many factors, some of which are beyond our control, including the following:

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        Stock markets in general often experience volatility that is unrelated to the operating performance of a particular company. These broad market fluctuations may adversely affect the trading price of our shares of common stock. You may not be able to resell your shares of common stock following periods of volatility because of the market's adverse reaction to volatility.

Substantial sales of shares of our common stock may occur immediately following the distribution which could cause the market price of shares of our common stock to decline.

        It is possible that many of Biogen's stockholders will sell the shares of our common stock that they receive in the distribution immediately in the public market because our business profile or market capitalization does not fit their investment objectives, because the shares are not included in certain indices or for other reasons. The sale of significant amounts of our shares or the perception in the market that this will occur may result in the lowering of the market price of our shares. We can offer no assurance that Biogen's stockholders will continue to hold the shares they receive in the distribution.

If securities or industry analysts fail to initiate or maintain coverage of our stock, publish a negative report or change their recommendations regarding our stock adversely, our stock price and trading volume could decline.

        The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us, our business, our market or our competitors. If securities or industry analysts fail to initiate coverage of our stock, the lack of exposure to the market could cause our stock price or trading volume to decline. If any of the analysts who cover us or may cover us in the future publish a negative report or change their recommendation regarding our stock adversely, or provide more favorable relative recommendations about our competitors, our stock price would likely decline. If any analyst who covers us or may cover us in the future were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

The reduced disclosure requirements applicable to us as an "emerging growth company" may make our shares of common stock less attractive to investors.

        We are an "emerging growth company" as defined in the JOBS Act, and we may avail ourselves of certain exemptions from various reporting requirements of public companies that are not "emerging growth companies," including without limitation, an exemption from complying with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirement of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We may remain an emerging growth company for up to five full fiscal years following the distribution date. If some investors find our shares of common stock less attractive as a result of the exemptions available to us as an emerging growth company, there may be a less active trading market for our shares of common stock (assuming a market develops) and the trading price of shares of our common stock may be more volatile than that of an otherwise comparable company that does not avail itself of the same or similar exemptions. We cannot predict if investors will find our shares of common stock less attractive because we rely on some or all of the JOBS Act exemptions.

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Your percentage ownership in the company may be diluted in the future.

        In the future, your percentage ownership in the company may be diluted because of equity issuances for acquisitions, capital market transactions or otherwise, including equity awards that we plan to grant to our directors, officers and employees. Such awards will have a dilutive effect on our earnings per share, which could adversely affect the market price of our common stock. From time to time, we expect to issue stock options or other share-based awards to employees under our employee benefits plans.

        In addition, our amended and restated certificate of incorporation will authorize us to issue, without the approval of stockholders, one or more classes or series of preferred stock having such designation, powers, preferences and relative, participating, optional and other special rights, including preferences over the company's common stock respecting dividends and distributions, as the board of directors generally may determine. The terms of one or more classes or series of preferred stock could dilute the voting power or reduce the value of our common stock. For example, we could grant the holders of preferred stock the right to elect some number of directors in all events or on the happening of specified events or the right to veto specified transactions. Similarly, the repurchase or redemption rights or liquidation preferences we could assign to holders of preferred stock could affect the residual value of the common stock. See "Description of Bioverativ's Capital Stock."

The public announcement of data from clinical studies or news of any developments related to our or our competitors' products or pipeline may cause significant volatility in our stock price.

        As we evolve into a standalone company, we will be focusing efforts and resources on further commercializing our existing products, as well as building a diversified pipeline of products into areas of unmet medical need. We expect that investors may place heightened scrutiny on some of our products in development when making investment decisions in the company compared to how such product developments relating to our business were previously viewed by investors when such programs part of the larger Biogen. The announcement of data from clinical studies by us or our collaborators or news of any developments related to our or our competitors' products or pipeline may cause significant volatility in our stock price. Furthermore, the announcement of any negative or unexpected data or the discontinuation of development of any of our key pipeline product candidates, or any delay in anticipated timelines for filing for regulatory approval, could cause our stock price to decline significantly.

We do not expect to declare any dividends in the foreseeable future.

        We do not anticipate declaring any cash dividends to holders of our common stock in the foreseeable future. Consequently, stockholders must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize any future gains on the value of their shares of our common stock.

Provisions to be contained in our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions of Delaware law, could impair a takeover attempt.

        Our amended and restated certificate of incorporation and amended and restated bylaws will contain certain provisions that could have the effect of rendering more difficult or discouraging an acquisition deemed undesirable by our board of directors. For example, our corporate governance documents will include provisions:

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These provisions, alone or together, could delay hostile takeovers and changes in control of our company or changes in our management.

        As a Delaware corporation, we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation Law (DGCL), which prevents some stockholders holding more than 15% of our outstanding common stock from engaging in certain business combinations without approval of the holders of substantially all of our outstanding common stock. Any provision of our certificate of incorporation or bylaws or Delaware law that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock, and could also affect the price that some investors are willing to pay for our common stock.

        In addition, an acquisition or further issuance of our stock could trigger the application of Section 355(e) of the Code. For a discussion of Section 355(e), see "U.S. Federal Income Tax Consequences." Under the tax matters agreement, we would be required to indemnify Biogen for any resulting taxes, and this indemnity obligation might discourage, delay or prevent a change of control that our stockholders may consider favorable.

        Please refer to "Certain Relationships and Related Person Transactions—Agreements with Biogen— Tax Matters Agreement " and "Description of Bioverativ's Capital Stock" for a more detailed description of these agreements and provisions.

Our amended and restated certificate of incorporation will designate the state courts of the State of Delaware, or, if no state court located in the State of Delaware has jurisdiction, the federal court for the District of Delaware, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against us and our directors and officers.

        Our amended and restated certificate of incorporation will provide that unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware, to the fullest extent permitted by law, will be the sole and exclusive forum for:

This exclusive forum provision may limit the ability of our stockholders to bring a claim in a judicial forum that such stockholders find favorable for disputes with us or our directors or officers, which may discourage such lawsuits against the company and our directors and officers. Alternatively, if a court outside of Delaware were to find this exclusive forum provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings described above, we may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business, operating results or financial condition.

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CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

        This information statement and other materials Bioverativ has filed or will file with the SEC include, or will include, forward-looking statements. Use by Bioverativ of the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "seeks," "intends," "evaluates," "pursues," "anticipates," "continues," "designs," "impacts," "affects," "forecasts," "target," "outlook," "initiative," "objective," "designed," "priorities," "goal" or the negative of those words or other similar expressions is intended to identify forward-looking statements that represent Bioverativ's current judgment about possible future events. All statements in this information statement, in other materials Bioverativ has filed or will file with the SEC and in related comments by management, other than statements of historical facts, including statements about future events or financial performance, are forward-looking statements that involve certain risks and uncertainties.

        These forward-looking statements may include statements with respect to: accounting estimates, assumptions and policies; estimates of liabilities; contingent payments including milestone and royalty payment obligations; financial flexibility; our exposure to market volatility and foreign currency and interest rate risks; costs, discounts or rebates in connection with our products; revenues; expected capitalization; future cash flows; future transactions in our securities and debt issuances; dividends; litigation related matters including outcomes; the impact of healthcare reform; business development activities; business and strategic objectives; our manufacturing, supply and distribution arrangements; our research and development activities and priorities; expected clinical trials; geographic expansion; our growth, including patient share growth; the sufficiency of our facilities; our relationship with our employees; our operation as a standalone company; the timing and expected impact of the separation; receipt of necessary regulatory authorization and approvals; agreements to be entered into in connection with the separation; and all other statements that do not relate to historical facts.

        These forward-looking statements are based on certain assumptions and analyses made in light of experience and perception of historical trends, current conditions and expected future developments as well as other factors that Bioverativ believes are appropriate in the circumstances. While these statements represent Bioverativ's current judgment on what the future may hold, and Bioverativ believes these judgments are reasonable, whether actual future results and developments will conform to expectations and predictions is subject to a number of risks and uncertainties. Consequently, all of the forward-looking statements made in this information statement are qualified by these cautionary statements, and there can be no assurance that the actual results or developments anticipated will be realized or, even if realized, that they will have the expected consequences or effects on Bioverativ or its subsidiaries, business or operations. Bioverativ does not undertake any obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events or other such factors that affect the subject of these statements, except where we are expressly required to do so by law. Factors that could cause actual results or events to differ materially from those anticipated include the matters described under the sections entitled "Information Statement Summary," "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Business" and "The Separation and Distribution," all of which contain forward-looking statements.

39



DIVIDEND POLICY

        We do not expect to pay a regular cash dividend following the distribution. The payment of any dividends in the future, and the timing and amount thereof, is within the discretion of our board of directors. Our board of directors' decisions regarding the payment of dividends will depend on many factors, such as our financial condition, earnings, capital requirements, industry practice, legal requirements, regulatory constraints and other factors that our board of directors deems relevant. Our ability to pay dividends will depend on our ongoing ability to generate cash from operations and on our access to the capital markets. We cannot guarantee that we will pay a dividend in the future or continue to pay any dividends if and when we commence paying dividends.

40



CAPITALIZATION

        The following table sets forth Bioverativ's capitalization as of September 30, 2016 on a historical basis and on a pro forma basis to give effect to the pro forma adjustments included in Bioverativ's unaudited pro forma financial information. The information below is not necessarily indicative of what Bioverativ's capitalization would have been had the separation, distribution and related financing transactions been completed as of September 30, 2016. In addition, it is not indicative of Bioverativ's future capitalization. This table should be read in conjunction with "Unaudited Pro Forma Combined Financial Statements," "Selected Historical Combined Financial Data," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and Bioverativ's combined financial statements and notes included elsewhere in this information statement.

 
  As of September 30,
2016
(unaudited)
 
(In millions)
  Actual   Pro Forma  

Cash and cash equivalents

  $   $ 325.0  

Debt:

             

Long-term debt

  $   $  

Total debt

  $   $  

Equity:

   
 
   
 
 

Common stock, par value $0.001 per share

  $   $ 0.1  

Additional paid-in capital

        531.3  

Net parent company investment

    401.6      

Accumulated other comprehensive loss

    4.3     4.3  

Total Capitalization

  $ 405.9   $ 535.7  

        Although Bioverativ has not yet finalized its post-distribution capitalization, we expect to be capitalized by Biogen prior to the distribution with $325.0 million in cash and do not expect to have any indebtedness for borrowed money as of the distribution date.

41



UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS

        The following unaudited pro forma combined financial statements consist of unaudited pro forma combined statements of income (loss) for the nine months ended September 30, 2016 and for the year ended December 31, 2015 and an unaudited pro forma condensed combined balance sheet as of September 30, 2016.

        The unaudited pro forma financial statements illustrate the financial impacts of the separation and the related transactions described below. The unaudited pro forma balance sheet gives effect to the separation and related transactions described below as if they had occurred as of September 30, 2016. The unaudited pro forma combined statements of income (loss) for the nine months ended September 30, 2016 and for the year ended December 31, 2015 assume that the separation and related transactions described below had occurred as of January 1, 2015.

        The unaudited pro forma combined balance sheet and statements of income (loss) have been derived from the historical audited combined annual and unaudited condensed combined interim financial statements included elsewhere in this information statement, and have been adjusted to give effect to the following items related to the separation and the associated transactions:

        The unaudited pro forma combined financial statements are for informational purposes only and do not purport to represent what Bioverativ's financial position and results of operations actually would have been had the separation and related transactions occurred on the dates indicated, or to project Bioverativ's financial performance for any future period. The unaudited pro forma combined financial statements are based on information and assumptions, which are described in the accompanying notes.

        The historical financial information of the hemophilia business of Biogen, which was the basis for the unaudited pro forma combined financial statements, was prepared on a carve-out basis as Bioverativ was not operated as a separate, independent company for the periods presented. Accordingly, such financial information reflects an allocation of certain research and development and selling, general and administrative costs not directly attributable to the hemophilia business of Biogen. The research and development costs include depreciation and other facility-based expenses, regulatory affairs function, pharmacovigilance, other infrastructure and management costs supporting multiple projects. The selling, general and administrative costs include certain services provided by Biogen, which include executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology, investor relations, shared services, insurance, employee benefits and incentives and share-based compensation. These historical allocations may not be indicative of Bioverativ's future cost structure; however, the pro forma results have not been adjusted to reflect any potential changes associated with Bioverativ being an independent public company since amounts are not factually supportable.

        The unaudited pro forma combined financial statements reported below should be read in conjunction with the section herein entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations," as well as the historical audited combined annual and unaudited condensed combined interim financial statements and the corresponding notes included elsewhere in this information statement.

42



UNAUDITED PRO FORMA COMBINED STATEMENT OF INCOME
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2016

(In millions, except share and per share data)
  Historical   Pro Forma
Adjustments
  Pro Forma  

Total revenues

  $ 631.2   $ —    $ 631.2  

Costs and expenses

   
 
   
 
   
 
 

Cost of sales

    162.2     (30.0) (A)     132.2  

Research and development

    122.6     —      122.6  

Selling, general and administrative

    138.4     —      138.4  

Total costs and expenses

    423.2     (30.0)      393.2  

Income from operations

    208.0     30.0      238.0  

Other income (expense)

    (1.0 )   —      (1.0 )

Income before tax

    207.0     30.0      237.0  

Income tax (benefit) expense

    (3.7 )   3.7 (B)        

          88.9 (C)     88.9  

Net income

  $ 210.7   $ (62.6)    $ 148.1  

Earnings per share

                   

Basic

    N/A   $ 1.36 (D)   $ 1.36  

Diluted

    N/A   $ 1.35 (D)   $ 1.35  

Common shares outstanding

   
 
   
 
   
 
 

Basic

    N/A     108.8      108.8  

Diluted

    N/A     110.0      110.0  

(A)
Reflects elimination of accelerated depreciation associated with a Biogen manufacturing facility that will not transfer to Bioverativ.

(B)
Reflects elimination of historical Bioverativ tax benefit.

(C)
Reflects expected tax expense using an effective income tax rate of 37.5%.

(D)
The number of Bioverativ shares used to compute basic earnings per share for the nine months ended September 30, 2016 is based on the number of shares of Biogen common stock outstanding on September 30, 2016 assuming the anticipated distribution ratio of one share of Bioverativ common stock for every two shares of Biogen common stock outstanding. The number of Biogen shares used to determine the assumed distribution reflects the Biogen shares outstanding as of the balance sheet date, which is the most current information as of the date of those financial statements. Pro forma diluted shares outstanding includes an adjustment for potential dilution from shares equity awards granted to Bioverativ employees under Biogen's share plans as of the balance sheet date.

43



UNAUDITED PRO FORMA COMBINED STATEMENT OF INCOME
FOR THE YEAR ENDED DECEMBER 31, 2015

(In millions, except share and per share data)
  Historical   Pro Forma
Adjustments
  Pro Forma  

Total revenues

  $ 560.3   $ —    $ 560.3  

Costs and expenses

   
 
   
 
   
 
 

Cost of sales

    52.9     —      52.9  

Research and development

    186.1     —      186.1  

Selling, general and administrative

    223.3     —      223.3  

Total costs and expenses

    462.3     —      462.3  

Income from operations

    98.0     —      98.0  

Other income and expense

    0.6     —      0.6  

Income before tax

    98.6     —      98.6  

Income tax expense

    (10.0 )   10.0 (A)      

          37.0 (B)     37.0  

Net income

  $ 108.6   $ (47.0)    $ 61.6  

Earnings per share

                   

Basic

    N/A   $ 0.56 (C)   $ 0.56  

Diluted

    N/A   $ 0.56 (C)   $ 0.56  

Common shares outstanding

   
 
   
 
   
 
 

Basic

    N/A     109.1      109.1  

Diluted

    N/A     109.9      109.9  

(A)
Reflects elimination of historical Bioverativ tax benefit.

(B)
Reflects expected tax expense using an effective income tax rate of 37.5%.

(C)
The number of Bioverativ shares used to compute basic earnings per share for the year ended December 31, 2015 is based on the number of shares of Biogen common stock outstanding on December 31, 2015 assuming the anticipated distribution ratio of one share of Bioverativ common stock for every two shares of Biogen common stock outstanding. The number of Biogen shares used to determine the assumed distribution reflects the Biogen shares outstanding as of the balance sheet date, which is the most current information as of the date of those financial statements. Pro forma diluted shares outstanding includes an adjustment for potential dilution from equity awards granted to Bioverativ employees under Biogen's share plans as of the balance sheet date.

44



UNAUDITED PRO FORMA COMBINED BALANCE SHEET
AS OF SEPTEMBER 30, 2016

(In millions)
  Historical   Pro Forma
Adjustments
  Pro Forma  

ASSETS

                   

Current Assets

                   

Cash and cash equivalents

  $   $ 325.0 (B)     $ 325.0  

Accounts receivable, net

    126.8     —      126.8  

Inventory

    283.3     (169.7) (C)       113.6  

Other current assets

    10.3     (0.2) (A)       10.1  

Total current assets

    420.4     155.1      575.5  

Property, Plant and Equipment, Net

    45.0     (26.9) (A)       18.1  

Intangibles, net

    53.1     —      53.1  

Other long-term assets

    22.4     —      22.4  

Total assets

  $ 540.9   $ 128.2    $ 669.1  

LIABILITIES AND EQUITY

                   

Current Liabilities

                   

Accounts payable

  $ 12.3   $ —    $ 12.3  

Accrued expense and other current liabilities

    68.9     (1.6) (A)       67.3  

Total current liabilities

    81.2     (1.6)      79.6  

Long-term liabilities

    53.8           53.8  

Total liabilities

    135.0     (1.6)      133.4  

Equity

                   

Common stock

          0.1 (D)       0.1  

Additional paid-in capital

          531.3 (A)(B)(C)(D)     531.3  

Net parent company investment

    401.6     (401.6) (E)        

Accumulated other comprehensive loss

    4.3     —      4.3  

Total equity

    405.9     129.8      535.7  

Total liabilities and equity

  $ 540.9   $ 128.2    $ 669.1  

(A)
Reflects the net book value of a Biogen manufacturing facility and related assets and liabilities that was reflected in the historical combined financial statements but will not transfer to Bioverativ.

(B)
Reflects the initial cash contribution from Biogen to Bioverativ.

(C)
Reflects certain raw material and work-in process inventory retained by Biogen.

(D)
Reflects the 1:2 distribution of Bioverativ stock to Biogen shareholders using Biogen shares outstanding as of December 1, 2016 of 215.9 million.

(E)
Reflects the elimination of Biogen's parent company investment in Bioverativ.

45



SELECTED HISTORICAL COMBINED FINANCIAL DATA

        The selected combined income (loss) statement data for the years ended December 31, 2015, 2014 and 2013 and the selected combined balance sheet data as of December 31, 2015 and 2014 have been derived from the audited combined financial statements for the hemophilia business of Biogen, which are included elsewhere in this information statement.

        The combined income (loss) statement data for the nine months ended September 30, 2016 and 2015 and the combined balance sheet data as of September 30, 2016 have been derived from the unaudited condensed combined interim financial statements for the hemophilia business of Biogen, which are included elsewhere in this information statement.

        The unaudited combined financial statement data has been prepared on a basis consistent with which the audited combined financial statements have been prepared, and in the opinion of management, includes all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of such data. These interim results are not necessarily indicative of results to be expected for the full year.

        The historical combined financial statements have been prepared on a carve-out basis for the purpose of presenting what the company's historical financial position, results of operations and cash flows would have been for the periods presented had Bioverativ operated the hemophilia business as a standalone entity. Bioverativ did not operate as a standalone entity in the past and accordingly the selected financial data presented herein is not necessarily indicative of the company's future performance and does not reflect what the company's performance would have been had Bioverativ operated as an independent, publicly traded company during the periods presented, and accordingly should not be relied upon as an indicator of our future results.

        The selected financial information should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations," the audited combined financial statements and the corresponding notes, the unaudited condensed combined interim financial statements and the corresponding notes, and the unaudited pro forma combined financial statements and the corresponding notes included elsewhere in this information statement.

 
  For the
Nine Months Ended
September 30,
  For the
Years Ended
December 31,
 
(In millions)
  2016   2015   2015   2014   2013  

Combined Statement of Income (Loss) Data

                               

Total revenues

  $ 631.2   $ 386.1   $ 560.3   $ 134.4   $  

Net income (loss)

  $ 210.7   $ 36.1   $ 108.6   $ (360.3 ) $ (344.6 )

 

 
  As of September 30,   As of December 31,  
(In millions)
  2016   2015   2015   2014  

Combined Balance Sheet Data

                         

Total assets

  $ 540.9   $ 433.9   $ 475.6   $ 376.4  

Total long term liabilities

  $ 53.8   $ 18.9   $ 30.7   $ 17.1  

46



MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

         The following discussion should be read in conjunction with the audited combined financial statements and the corresponding notes, the unaudited condensed combined interim financial statements and the corresponding notes, and the unaudited pro forma combined financial statements and the corresponding notes included elsewhere in this information statement. This Management's Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements. The matters discussed in these forward-looking statements are subject to risk, uncertainties and other factors that could cause actual results to differ materially from those made, projected or implied in the forward-looking statements. Please see "Risk Factors" and "Cautionary Statement Concerning Forward-Looking Statements" for a discussion of the uncertainties, risks and assumptions associated with these statements.

         On May 3, 2016, Biogen announced its plans to separate into two independent, publicly traded companies. For purposes of the following discussion, Bioverativ refers to the hemophilia business of Biogen prior to the separation. To accomplish this separation, Biogen created a new company, Bioverativ Inc., to be the parent company for the hemophilia business. Bioverativ Inc. was incorporated in the State of Delaware on August 4, 2016 and is currently a wholly owned subsidiary of Biogen. To effect the separation, Biogen will make a pro rata distribution of Bioverativ Inc.'s common stock to Biogen's stockholders. The distribution is subject to a number of conditions, including the receipt of an opinion from tax counsel or a third party advisor that is in substance and form satisfactory to Biogen. See "The Separation and Distribution" section of this information statement for additional details on these conditions. After the distribution, Bioverativ Inc. will operate as an independent, publicly traded company.

Overview

        We are a global biotechnology company focused on the discovery, research, development and commercialization of innovative therapies for the treatment of hemophilia and other blood disorders. We have two marketed products, ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] and ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], and an innovative product pipeline.

        Our business strategy is aimed at improving treatment and standards of care for hemophilia and other blood disorder patients by further increasing sales and market share of our marketed products, advancing treatment attributes for our marketed products, leveraging our internal expertise to develop new products that meaningfully advance treatment and opportunistically pursuing strategic alliances and tactical acquisitions.

        The audited combined financial statements and unaudited condensed combined interim financial statements have been prepared on a carve-out basis for the purpose of presenting our historical financial position, results of operations and cash flows. We did not operate on a standalone basis during the periods presented.

        Our revenues are primarily derived from sales of ELOCTATE and ALPROLIX in the United States, Japan and Canada. We also earn revenue from the supply of ELOCTATE and ALPROLIX to Sobi and royalties on sales of ELOCTATE and ALPROLIX by Sobi in its commercialization territory, which is Europe, Russia and certain countries in Northern Africa and the Middle East. See "Business—Our Development and Commercialization Arrangements with Sobi."

47


Financial Results Overview—Nine Months Ended September 30, 2016 and 2015

 
  Nine Months Ended
September 30,
   
 
 
  Percent change  
(In millions, except percentages)
  2016   2015  

Total revenues

  $ 631.2   $ 386.1     63.5 %

Net income (loss)

  $ 210.7   $ 36.1     483.7 %

        Refer to the "Results of Operations—Nine Months Ended September 30, 2016 and 2015" section below for further discussion of our results.

Financial Results Overview—Full-Year 2015, 2014 and 2013

 
  Years ended December 31,   Percent change  
(In millions, except percentages)
  2015   2014   2013   2015   2014  

Total revenues

  $ 560.3   $ 134.4   $     316.9 %   **  

Net income (loss)

  $ 108.6   $ (360.3 ) $ (344.6 )   130.1 %   4.6 %

**
Percentage not meaningful.

        Refer to the "Management's Discussion and Analysis and Results of Operations—Years Ended December 31, 2015, 2014 and 2013" section below for further discussion of our results.

Key Commercial Highlights

        The United States, Japan and Canada are currently the principal markets outside of Sobi's commercialization territory for our marketed products. We began selling ELOCTATE in the United States, Japan and Canada in the third quarter of 2014, the first quarter of 2015 and the first quarter of 2016, respectively. We began selling ALPROLIX in the United States, Japan and Canada in the second quarter of 2014, the fourth quarter of 2014 and the first quarter of 2016, respectively. We expect to continue to drive revenue growth and increased patient share of ELOCTATE and ALPROLIX by expanding into new geographies and continuing to penetrate our existing geographies. In addition, in 2016 we began earning royalties from Sobi on sales of ELOCTA and ALPROLIX following Sobi's commercial launch of ELOCTA and ALPROLIX in the European Union.

Research and Development

        We continue to make substantial investments in research and development in support of our ongoing proprietary research programs and through collaborations with third parties for the development of new products and therapies. Research and development expenses were $186.1 million, or approximately 33% of total revenue, during 2015, and $122.6 million, or approximately 19% of total revenue during the first nine months of 2016. We believe our product pipeline has the potential to provide a catalyst for future growth. See "Business—Pipeline and Research and Development Activities."

        Our overall research and development strategy includes the continued pursuit of collaborations and strategic relationships with third parties that are developing new products and therapies. These collaborations and relationships generally involve the granting or obtaining development and commercialization rights to or from third parties in exchange for an upfront payment upon execution of the agreement and potential future payments related to the achievement of development, regulatory approval or commercial milestones, as well as royalties. Our most significant collaboration is our relationship with Sobi for the development and commercialization of ELOCTATE and ALPROLIX. Please refer to Note 3, Collaborations , to the audited combined financial statements included elsewhere in this information statement for additional details on our collaboration with Sobi.

48


Key Factors Affecting Results of Operations

Separation from Biogen

        We have not previously operated as an independent, standalone company, but rather as a part of Biogen. There are limitations inherent in the preparation of all carve-out financial statements due to the fact that the business was previously part of a larger organization. The basis of preparation included in the combined financial statements provides a detailed description of the treatment of historical transactions. Our net income has been most notably impacted by the following consequences of carve-out accounting and the planned separation:

    Biogen utilizes a centralized treasury management system and cash or debt was not allocated to Bioverativ in the carve-out financial statements. In connection with the separation, the capital structures of both companies will be re-aligned on or before the distribution date, resulting in Bioverativ having adequate cash to fund its operations.

    The combined statements of income include an allocation from Biogen to us for certain research and development and selling, general and administrative costs not directly attributable to the hemophilia business of Biogen. The research and development costs include depreciation and other facility-based expenses, regulatory affairs function, pharmacovigilance, other infrastructure and management costs supporting multiple projects. The selling, general and administrative costs include certain services provided by Biogen, which include executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology, investor relations, shared services, insurance, employee benefits and incentives and share-based compensation. The amounts of these allocations may not necessarily be indicative of the similar costs we will incur as an independent, standalone company. The total amount allocated to us from Biogen was $106.9 million and $109.6 million during the nine months ended September 30, 2016 and 2015, respectively, and $148.6 million, $155.2 million and $110.1 million, in 2015, 2014 and 2013, respectively.

    We may incur certain one-time separation costs, which are primarily associated with the design and establishment of us as a standalone public company.

    Income tax expense is computed on a separate company basis, as if operated as a standalone entity or a separate entity or a separate consolidated group in each material jurisdiction in which we operate. As a result of potential changes to our business model, income tax expense included in the combined financial statements may not be indicative of our future expected effective income tax rate.

    Concurrent with the separation, we will enter into a manufacturing and supply agreement with Biogen whereby Biogen will continue to produce ELOCTATE and ALPROLIX for us on terms to be agreed upon. The manufacturing and supply obligations will generally be performed on a cost-plus basis under this agreement. As products were historically transferred at cost between Biogen and Bioverativ, these manufacturing and supply arrangements will likely result in changes to cost of goods sold in future periods.

49


Results of Operations—Nine Months Ended September 30, 2016 and 2015

Revenues

Total Revenues

 
  For the
Nine Months Ended
  Percent change  
 
  2016 compared to 2015  
(In millions, except percentages)
  2016   2015  

Product Revenues:

                   

United States

  $ 513.4   $ 361.3     42.1 %

All Other Markets

    91.4     20.4     348.0 %

Total product revenues

    604.8     381.7     58.4 %

Revenue from collaborative partners

    26.4     4.4     500.0 %

Total revenues

  $ 631.2   $ 386.1     63.5 %

Product Revenues

 
  For the
Nine Months Ended
  Percent change  
 
  2016 compared to 2015  
(In millions, except percentages)
  2016   2015  

ELOCTATE

  $ 364.3   $ 218.5     66.7 %

ALPROLIX

    240.5     163.2     47.4 %

Total product revenues

  $ 604.8   $ 381.7     58.4 %

50


ELOCTATE   ALPROLIX

GRAPHIC

 

GRAPHIC

For the nine months ended September 30, 2016, compared to the same period in 2015, the increase in U.S. ELOCTATE revenues was primarily due to an increase in unit sales volume of 52%. The increase in all other markets' ELOCTATE revenues was due to an increase in unit sales volume in Japan compared to the same period in 2015, due to its launch in the second quarter of 2015, as well as ELOCTATE's launch in Canada in the first quarter of 2016.

 

For the nine months ended September 30, 2016, compared to the same period in 2015, the increase in U.S. ALPROLIX revenues was primarily due to an increase in unit sales volume of approximately 31%. The increase in all other markets' ALPROLIX revenues was due to an approximately 97% unit sales volume increase in Japan compared to the same period in 2015, as well as ALPROLIX's launch in Canada in the first quarter of 2016.

Discounts and allowances

        Discounts and allowances for the nine months ended September 30, 2016 and 2015 were both 27% of gross sales.

Revenue from collaborative partners

        For the nine months ended September 30, 2016, compared to the same period in 2015, the increase in revenue from collaborative partners is attributable to a $19.5 million increase in contract manufacturing revenue and $2.5 million of royalty revenue from Sobi. See Note 3, Collaborations , to the audited combined financial statements included elsewhere in this information statement for additional information on our collaboration with Sobi.

51


Costs and Expenses

 
  For the
Nine Months Ended
September 30,
   
 
 
  Percent
change
 
(In millions, except percentages)
  2016   2015  

Costs and expenses:

                   

Cost of sales

  $ 162.2   $ 50.8     219.3 %

Research and development

    122.6     135.4     (9.5 )%

Selling, general and administrative

    138.4     167.7     (17.5 )%

Total costs and expenses

  $ 423.2   $ 353.9     19.6 %

Cost of Sales

 
  For the
Nine Months Ended
September 30,
   
 
 
  Percent
change
 
(In millions, except percentages)
  2016   2015  

Product

  $ 99.4   $ 38.0     161.6 %

Royalty

    59.4     10.6     460.4 %

Amortization of acquired intangible assets

    3.4     2.2     54.5 %

Total cost of sales

  $ 162.2   $ 50.8     219.3 %

        For the nine months ended September 30, 2016 compared to the same period in 2015, the increase in cost of sales was driven by increased volume of both ELOCTATE and ALPROLIX and an increase in royalty rate as a result of Sobi's first commercial sales of ELOCTATE and ALPROLIX. Also included in product cost of sales in the nine months ended September 30, 2016 is approximately $25.8 million of accelerated depreciation associated with Biogen's Cambridge, Massachusetts manufacturing facility, which is primarily dedicated to hemophilia manufacturing. In June 2016, Biogen announced its intent to cease manufacturing at this facility by the end of 2016. In November 2016, Biogen agreed to sublease the facility to a third party. See Note 11, Subsequent Events , of the condensed combined financial statements.

        Inventory amounts written down as a result of excess, obsolescence, unmarketability or other reasons totaled $8.2 million and $1.5 million, for the nine months ended September 30, 2016 and 2015, respectively.

Research and Development Expenses

 
  For the
Nine Months Ended
September 30,
 
(In millions)
  2016   2015  

Upfront and milestone payments

  $   $  

Research and discovery

    31.3     21.0  

Early stage programs

         

Late stage programs

         

Marketed programs

    38.0     61.6  

Other research and development expenses

    53.3     52.8  

Total research and development

  $ 122.6   $ 135.4  

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        Research and discovery includes costs incurred to support our discovery research and translational science efforts up to the initiation of Phase 1 development. Early stage programs are programs in Phase 1 or Phase 2 development activities. Late stage programs are programs in Phase 3 development or in registration stage. Marketed programs are programs in support of our marketed products, including costs associated with product lifecycle management activities and, if applicable, costs associated with the development of new indications for existing products. Other research and development expenses consist mainly of allocations from Biogen and include costs not directly attributable to individual projects and include depreciation and other facility-based expenses, regulatory affairs function, pharmacovigilance and other infrastructure and management costs supporting multiple projects. Costs are reflected in the development stage based upon the program status when incurred. Therefore, the same program could be reflected in different development stages in the same year.

        For the nine months ended September 30, 2016 compared to the same period in 2015, the decrease in research and development is primarily due to a decrease in clinical trial costs, pre-commercial production and collaboration costs partially offset by an increase in workforce costs.

Selling, General and Administrative Expenses

 
  For the
Nine Months Ended
September 30,
   
 
 
  Percent
change
 
(In millions, except percentages)
  2016   2015  

Selling, general and administrative

  $ 138.4   $ 167.7     (17.5 )%

        For the nine months ended September 30, 2016 compared to the same period in 2015, the decrease in selling, general and administrative was mainly due to a decrease in workforce costs and fees paid to third party service providers.

Income Taxes

        We recorded income tax benefit of $3.7 million and $3.3 million for the nine months ended September 30, 2016 and 2015, respectively. Our effective income tax rate was (1.8)% and (10.1)% of income before income tax expense (benefit) for the nine months ended September 30, 2016 and 2015, respectively.

Results of Operations—Years Ended December 31, 2015, 2014 and 2013

Revenue

Total Revenue

 
  For the Years Ended
December 31,
  Percent change  
 
  2015 compared to 2014   2014 compared to 2013  
(In millions, except percentages)
  2015   2014   2013  

Product revenues

                               

United States

  $ 517.1   $ 130.5   $     296.2 %   **  

All Other Markets

    37.0     3.9         848.7 %   **  

Total product revenues

    554.1     134.4         312.3 %   **  

Revenue from collaborative partners

    6.2             **     **  

Total revenues

  $ 560.3   $ 134.4   $     316.9 %   **  

**
Percentage not meaningful.

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Product Revenues

 
  For the Years Ended
December 31,
  Percent change  
 
  2015 compared
to 2014
  2014 compared
to 2013
 
(In millions, except percentages)
  2015   2014   2013  

ELOCTATE

  $ 319.7   $ 58.4   $     447.4 %   **  

ALPROLIX

    234.4     76.0         208.4 %   **  

Total product revenues

  $ 554.1   $ 134.4   $     312.3 %   **  

**
Percentage not meaningful.

        Revenues totaled $560.3 million in 2015, an increase of 316.9% over 2014. In 2015, product sales in the United States totaled $517.1 million, an increase of 296.2% over 2014 and sales outside the United States totaled $37.0 million, an increase of 848.7% over 2014. Net sales growth was attributable to a full year of sales of ELOCTATE and ALPROLIX in 2015. We had no sales in 2013 as our products launched in 2014.

        In the first and second quarters of 2016, Sobi had its first commercial sales of ELOCTATE and ALPROLIX, respectively. As a result, we expect to continue to receive both contract manufacturing revenue and royalty revenue, which will be a component of revenue from collaborative partners.

ELOCTATE   ALPROLIX

GRAPHIC

 

GRAPHIC

Sales of ELOCTATE for the year ended December 31, 2015 increased $261.3 million or 447.4%. The increase in ELOCTATE revenues was due to increases in unit sales volume since the product launch in 2014. Sales of ELOCTATE in the United States and Japan began in the third quarter of 2014 and in the first quarter of 2015, respectively.

 

Sales of ALPROLIX for the year ended December 31, 2015 increased $158.4 million or 208.4%. The increase in ALPROLIX revenues was primarily due to increases in unit sales volume since the product launch in 2014. Sales of ALPROLIX in the United States and Japan began in the second and fourth quarters of 2014, respectively.

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Discounts and allowances

        Discounts and allowances for the years ended December 31, 2015 and 2014 were 28% and 27% of gross sales, respectively.

Costs and Expenses

 
  For the Years Ended
December 31,
  Percent change  
(In millions, except percentages)
  2015   2014   2013   2015 compared
to 2014
  2014 compared
to 2013
 

Costs and expenses:

                               

Cost of sales

  $ 52.9   $ 34.7   $ 0.4     52.4 %   **  

Research and development

    186.1     239.8     191.8     (22.4 )%   25.0 %

Selling, general and administrative

    223.3     220.0     149.8     1.5 %   46.9 %

Total costs and expenses

  $ 462.3   $ 494.5   $ 342.0     (6.5 )%   44.6 %

**
Percentage not meaningful.

Cost of Sales

 
  For the Years Ended
December 31,
  Percent change
(In millions, except percentages)
  2015   2014   2013   2015 compared
to 2014
  2014 compared
to 2013

Product

  $ 34.7   $ 28.8   $ 0.4     20.5 % **

Royalty

    15.2     3.7         310.8 % **

Amortization of acquired intangibles

    3.0     2.2         36.4 % **

Total cost of sales

  $ 52.9   $ 34.7   $ 0.4     52.4 % **

**
Percentage not meaningful.

        For 2015 compared to 2014, the increase in cost of sales was driven by a full year of sales for both ELOCTATE and ALPROLIX partially offset by higher inventory write downs in 2014 compared to 2015 due mainly to process rejects associated with ALPROLIX and excess and obsolete inventory associated with ELOCTATE.

        For 2014 compared to 2013, the increase in cost of sales was due to the launch of ALPROLIX and ELOCTATE in 2014 as well as the inventory write down noted above.

        Royalty cost of sales consists mainly of our royalty to Sobi. As a result of Sobi's first commercial sales of ELOCTATE and ALPROLIX in 2016, our royalty rate to Sobi for our sales of ELOCTATE and ALPROLIX will increase from 2% to a full year effective rate of approximately 11%. Please refer to Note 3, Collaborations , to the audited combined financial statements included elsewhere in this information statement for further information regarding our royalty structure with Sobi.

        Inventory amounts written down as a result of excess, obsolescence, unmarketability or other reasons totaled $1.3 million and $14.3 million for 2015 and 2014, respectively. Inventory written down in 2014 was related to excess and obsolete inventory associated with ELOCTATE and process rejects associated with ALPROLIX. There were no significant write-offs during the year ended December 31, 2013.

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Research and Development Expenses

 
  For the Years Ended
December 31,
 
(In millions)
  2015   2014   2013  

Upfront and milestone payments

  $   $ 20.0   $  

Research and discovery

    30.8     23.9     9.9  

Early stage programs

             

Late stage programs

        34.7     111.6  

Marketed programs

    81.9     67.5      

Other research and development expenses

    73.4     93.7     70.3  

Total research and development

  $ 186.1   $ 239.8   $ 191.8  

        Research and discovery includes costs incurred to support our discovery research and translational science efforts up to the initiation of Phase 1 development. Early stage programs are programs in Phase 1 or Phase 2 development activities. Late stage programs are programs in Phase 3 development or in registration stage. Marketed programs are programs in support of our marketed products, including costs associated with product lifecycle management activities and, if applicable, costs associated with the development of new indications for existing products. Other research and development expenses consist mainly of allocations from Biogen and include costs not directly attributable to individual projects and include depreciation and other facility-based expenses, regulatory affairs function, pharmacovigilance, other infrastructure and management costs supporting multiple projects. Costs are reflected in the development stage based upon the program status when incurred. Therefore, the same program could be reflected in different development stages in the same year.

        For 2015 compared to 2014, the decrease in research and development is primarily due to the approval of ELOCTATE and ALPROLIX in 2014 resulting in a decrease in costs associated with regulatory approvals, as well as a decrease in workforce expenses and allocations from Biogen due to lower Bioverativ allocation rates and lower overall allocation amounts. Also included in 2014 is a $20.0 million upfront fee paid to a third party collaborator.

        For 2014 compared to 2013, the increase in research and development is primarily due to higher allocations from Biogen due to higher overall allocation amounts partially offset by lower Bioverativ allocation rates and a $20.0 million upfront payment to a third party collaborator.

Selling, General and Administrative Expenses

 
  For the Years Ended
December 31,
  Percent change  
 
  2015 compared
to 2014
  2014 compared
to 2013
 
(In millions, except percentages)
  2015   2014   2013  

Selling, general and administrative

  $ 223.3   $ 220.0   $ 149.8     1.5 %   46.9 %

        For 2015 compared to 2014, the increase in selling, general and administrative expenses was mainly due to an increase in the allocations from Biogen partially offset by decreases in costs associated with third party service providers and corporate giving. The increase in allocations from Biogen is due to higher Bioverativ allocation rates.

        For 2014 compared to 2013, the increase in selling, general and administrative expenses was due to increased selling and marketing activities supporting the launches of ELOCTATE and ALPROLIX as well as an increase in the allocations from Biogen. The increase in allocations from Biogen is due to higher overall allocation amounts and higher Bioverativ allocation rates.

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Income Taxes

        We recorded income tax (benefit) expense of $(10.0) million, $1.3 million and $0.6 million for 2015, 2014 and 2013, respectively. Our effective income tax rate was (10.2)%, (0.4)% and (0.2)% of income (loss) before income taxes for 2015, 2014 and 2013, respectively. See Note 8, Income Taxes , in our audited combined financial statements included elsewhere in this information statement for further information regarding our income taxes.

        We have deferred tax assets of $255.7 million and $298.0 million as of December 31, 2015 and 2014, respectively, comprised primarily of net operating losses and general business credit carryforwards for federal and state income tax purposes. We have incurred cumulative operating losses to date and, as such, we have established a valuation allowance of $247.3 million and $288.7 million as of December 31, 2015 and 2014, respectively. Management continues to monitor the positive and negative evidence supporting the realization of the deferred tax assets. Given our cumulative losses as of September 30, 2016, we continue to believe a full valuation allowance is appropriate. Factors that affect our judgment around the realizability of our deferred tax assets include our ongoing profitability, establishment of our cost structure as a standalone company and the determination of the terms of transition services agreements with Biogen. The valuation allowance could be released in 2016 or 2017 once it is determined it is more likely than not that the deferred tax assets will be realizable. Following the release of the valuation allowance, which will create substantial tax benefit in the period it is released, our tax rate will increase substantially to be more in line with the statutory rates of the jurisdictions where the income is earned.

        The net operating losses and general business credit carryforwards represent tax attributes that the business would have generated on a standalone basis had the company filed separate returns. While the income statement effect is reflected in our standalone financial statements, the deferred tax assets resulting from our net losses and business credit carryforwards generally will not be available to reduce our tax liabilities in the future since those attributes have already been utilized in the tax returns of Biogen, thereby increasing our future taxes payable.

Liquidity and Capital Resources

        We have historically participated in Biogen's centralized treasury management, including centralized cash pooling and overall financing arrangements. Since the third quarter of 2015, we have generated and expect to continue to generate positive cash flow from operations on an annual basis. Net cash provided from (used for) financing activities in the historical periods primarily reflects changes in Biogen's investment in us. We have not reported cash or cash equivalents on our balance sheet for the periods presented due to our participation in Biogen's centralized treasury management.

        Subsequent to the separation, we will no longer participate in cash management and funding arrangements with Biogen. Our ability to fund our operations and capital needs will depend on our ongoing ability to generate cash from operations and access to capital markets, as further described under the "Debt and Capital" caption directly below. We anticipate that our principal uses of cash in the future will be primarily to fund our operations, working capital needs, capital expenditures and strategic investments.

Debt and Capital

        We expect to be capitalized by Biogen prior to the distribution with $325.0 million in cash and we do not expect to have any indebtedness for borrowed money as of the distribution date. We expect that our initial cash capitalization, future cash from operations and access to capital markets will provide adequate resources to fund our ongoing cash flow obligations.

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Historical Cash Flow Trends

 
  For the Nine
Months Ended
September 30,
  For the Years Ended
December 31,
 
(In millions)
  2016   2015   2015   2014   2013  

Net cash (used for) provided from operations

  $ 233.3   $ (5.7 ) $ 41.4   $ (456.3 ) $ (418.9 )

Net cash used for investing activities

  $ (30.3 ) $ (6.3 ) $ (10.6 ) $ (56.3 ) $ (19.2 )

Net cash provided from (used for) financing activities

  $ (203.0 ) $ 12.0   $ (30.8 ) $ 512.6   $ 438.1  

        Net cash provided by operations increased $239.0 million during the first nine months of 2016 as compared to the prior period driven primarily by increases in total revenues of $245.1 million, a decrease in operating expenses of $42.1 million and increases in accounts payable, accrued expenses, other current liabilities and other liabilities of $44.4 million partially offset by an $111.4 million increase in cost of sales due to volume increases of ELOCTATE and ALPROLIX.

        Net cash provided by operations increased by $497.7 million in 2015 compared to 2014 driven primarily by an increase in ELOCTATE and ALPROLIX sales of $425.9 million and a $32.2 million decrease in operating expenses.

        Net cash used for operations increased in 2014 compared to 2013. The growth in net cash used for operations was driven primarily by an increase in operating expenses associated with launching ELOCTATE and ALPROLIX in the United States.

Contractual Obligations

        The following table summarizes our contractual obligations as of December 31, 2015, excluding funding commitments and contingent regulatory milestone payments, as described below.

 
  Payments due by period  
(In millions)
  Total   Less than
1 year
  1 to 3 years   3 to 5 years   After 5 years  

Non-cancellable operating leases (1)

  $ 37.4   $ 4.2   $ 8.4   $ 8.3   $ 16.5  

Purchase and other obligations (2)

    37.5     15.4     18.6     3.5      

Net minimum payments

  $ 74.9   $ 19.6   $ 27.0   $ 11.8   $ 16.5  

(1)
We lease property and equipment for use in our operations. We also lease cars for use by our sales force. Amounts reflected in the table above detail future minimum rental commitments under non-cancelable operating leases as of December 31, 2015 for each period presented. In addition to the minimum rental commitments, these leases may require us to pay additional amounts for taxes, insurance, maintenance and other operating expenses.

(2)
Purchase and other obligations primarily include our obligations to purchase materials or services.

        In the third quarter of 2016, we entered into a 10 year lease for our corporate headquarters in Waltham, Massachusetts. Future minimum lease payments as of September 30, 2016 associated with this lease are $51.6 million and are described below.

 
  Payments due by period  
 
  Total   Less than
1 year
  1 to 3 years   3 to 5 years   After 5 years  
    $ 51.6   $ 3.0   $ 9.3   $ 9.9   $ 29.4  

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Funding Commitments

        As of December 31, 2015, we have several ongoing clinical studies in various stages. Our most significant clinical trial expenditures are to CROs. The contracts with CROs are generally cancellable, with notice, at our option.

Former Syntonix Shareholders

        In connection with the acquisition of Syntonix in 2007, we agreed to pay an additional $80.0 million if certain milestone events associated with the development of ALPROLIX were achieved. The first $40.0 million milestone payment was achieved in 2010 and was recorded as research and development expense. The final milestone payments of $20.0 million each were paid in the second quarter of 2014 and the third quarter of 2016 in connection with the approval of ALPROLIX in the United States and European Union, respectively. Both milestones were capitalized as intangible assets in the second quarters of 2014 and 2016, respectively.

Other Contingent Development, Regulatory and Commercial Milestone Payments

        Based on our development plans primarily in gene therapy for hemophilia and other blood disorders as of September 30, 2016, we could make potential future milestone payments to third party collaborators of up to approximately $440.0 million. The milestones are comprised of the following:

(In millions)
   
 

Development

  $ 110.0  

Regulatory

    70.0  

Commercial

    260.0  

Total

  $ 440.0  

        A further description of our collaboration and potential milestone payments we may make to Sangamo BioSciences, Inc. (Sangamo) is described below.

        Payments to our collaborators generally become due and payable upon achievement of certain development, regulatory or commercial milestones. Because the achievement of these milestones had not occurred as of September 30, 2016, such contingencies have not been recorded in our financial statements. We do not expect to make any significant milestone payments in the next twelve months. Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory approval and commercial milestones. Many of our programs are in preclinical and early stage development and the outcomes of these activities are uncertain. The amount we pay to third parties upon the achievement of future milestones is based on current assumptions and estimates, which are subject to change as programs progress.

Sangamo BioSciences, Inc.

        On January 8, 2014, Biogen MA Inc., a subsidiary of Biogen, entered into an exclusive worldwide research, development and commercialization collaboration and license agreement with Sangamo under which both companies agreed to develop and commercialize product candidates for the treatment of two inherited blood disorders, sickle cell disease and beta-thalassemia. In connection with the separation, we will succeed to Biogen's rights and obligations under this agreement. Accordingly, the historical results of this collaboration are included in our financial statements in this information statement.

        Under the collaboration, Sangamo is responsible for identifying a product candidate for the treatment of beta-thalassemia and advancing that candidate through a completed Phase 1 human

59


clinical trial, at which point we would assume responsibility for development. The collaboration contemplates our joint development of a sickle cell disease candidate through the potential filing of an investigational new drug application (IND), after which we would assume clinical responsibilities. We have the right to lead the global development and commercialization efforts and Sangamo has the option to assume co-promotion responsibilities in the United States. The collaboration is currently in the pre-clinical stage of development.

        Under the terms of the agreement, in January 2014, we paid Sangamo an upfront payment of $20 million in cash, with additional contingent payments of up to approximately $300 million based on the achievement of certain development, regulatory and commercial milestones, plus royalties based on sales. We recorded the $20 million upfront payment as a research and development expense.

Off-Balance Sheet Arrangements

        We do not have any relationships with entities often referred to as structured finance or special purpose entities that were established for the purpose of facilitating off-balance sheet arrangements. As such, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships.

Quantitative and Qualitative Disclosures About Market Risk

Market Risk

        We are subject to certain risks which may affect our results of operations, cash flows and fair values of assets and liabilities, including volatility in foreign currency exchange rates, interest rate movements, pricing pressures worldwide and weak economic conditions in the foreign markets in which we operate.

Foreign Currency Exchange Risk

        Our results of operations are subject to foreign currency exchange rate fluctuations due to the global nature of our operations. We currently have operations in the United States, Japan and Canada. As a result, our financial position, results of operations and cash flows can be affected by market fluctuations in foreign exchange rates, primarily with respect to the Japanese yen and the Canadian dollar.

        While the financial results of our global activities are reported in U.S. dollars, the functional currency for our foreign subsidiaries is their respective local currency. Fluctuations in the foreign currency exchange rates of the countries in which we do business will affect our operating results, often in ways that are difficult to predict. In particular, as the U.S. dollar strengthens versus other currencies, the value of the non-U.S. revenue will decline when reported in U.S. dollars. The impact to net income as a result of a strengthening U.S. dollar will be partially mitigated by the value of non-U.S. expense which will also decline when reported in U.S. dollars. As the U.S. dollar weakens versus other currencies, the value of the non-U.S. revenue and expenses will increase when reported in U.S. dollars.

Pricing Pressure

        In the United States, federal and state legislatures, health agencies and third party payors continue to focus on containing the cost of health care. Legislative and regulatory proposals, enactments to reform health care insurance programs and increasing pressure from social sources could significantly influence the manner in which our products are prescribed and purchased. It is possible that additional federal health care reform measures will be adopted in the future, which could result in increased pricing pressure and reduced reimbursement for our products and otherwise have an adverse impact on our financial position or results of operations.

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        There is also significant economic pressure on state budgets that may result in states increasingly seeking to achieve budget savings through mechanisms that limit coverage or payment for our drugs.

        Governments in some international markets in which we operate have also implemented measures aimed at reducing healthcare costs to constrain the overall level of government expenditures. These implemented measures vary by country and include, among other things, mandatory rebates and discounts, prospective and possible retroactive price reductions and suspensions on price increases of pharmaceuticals.

Interest Rate Risk

        While we do not expect to have any indebtedness for borrowed money as of the distribution date, to the extent we later incur such indebtedness we will be exposed to interest rate fluctuation and risk. We may or may not attempt to mitigate this risk by entering into hedging arrangements that effectively convert floating interest rate payments into fixed rate obligations, or vice-versa, as applicable.

Critical Accounting Policies and Estimates

        The preparation of financial statements in accordance with U.S. generally accepted accounting principles (GAAP) requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. A summary of our significant accounting policies is included in Note 2, Summary of Significant Accounting Policies , to the audited combined financial statements included elsewhere in this information statement. Certain of our accounting policies are considered critical because these policies are the most important to the depiction of our financial statements and require significant, difficult or complex judgments by us, often requiring the use of estimates about the effects of matters that are inherently uncertain. Actual results that differ from our estimates could have an unfavorable effect on our results of operations and financial position. We apply estimation methodologies consistently from year to year. The following is a summary of accounting policies that we consider critical to the combined financial statements.

Revenue Recognition

        We recognize revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the price to the customer is fixed or determinable; and collectability is reasonably assured.

Product Revenues

        We sell mainly to specialty distributors, specialty pharmacies, public hospitals and other government entities with whom we have contracted directly. Any discounts offered to these customers are reflected as on-invoice discounts. We also sell to specialty distributors who receive both on-invoice discounts as well as chargebacks for sales to various U.S. government agencies such as the U.S. Public Health Service (PHS). Provisions for rebates, chargebacks to distributors, and discounts are provided for at the time the related sales are recorded, and are reflected as a reduction of sales. Reserves established for these discounts and allowances are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). Our estimates take into consideration our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Actual amounts may ultimately differ from our estimates. If actual results vary, we adjust these estimates, which could have an effect on earnings in the period of adjustment.

        Product revenue reserves are categorized as discounts and contractual adjustments. Discounts include trade term discounts and volume discounts. Trade term discounts relate to estimated obligations for credits to be granted to customers for remitting payment on their purchases within established

61


incentive periods. Volume discounts are earned as customers reach certain tier levels based upon their purchases. Contractual adjustments primarily relate to Medicaid and PHS discounts. Historically, adjustments have not been significant.

Accounts Receivable

        The majority of accounts receivable arise from product sales and primarily represent amounts due from specialty distributors, specialty pharmacies, public hospitals and other government entities. We monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile. We provide reserves against trade receivables for estimated losses that may result from a customer's inability to pay. Amounts determined to be uncollectible are charged or written-off against the reserve. To date, we have not had any write-offs.

Concentration of Credit Risk

        Sales to two specialty pharmacies individually represent 19% and 15%, respectively, of total revenues for the nine months ended September 30, 2016; 21% and 16%, respectively, of total revenues for the year ended December 31, 2015; and 20% for each of total revenues for the year ended December 31, 2014. Concentration of credit risk with respect to receivables, which are typically unsecured, is largely mitigated due to the wide variety of customers. The majority of accounts receivable currently arise from product sales in the United States, Japan and Canada and have standard payment terms which generally require payment within 30 to 90 days. We monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile. We continue to monitor these conditions and assess their possible impact on our business.

Inventory

        Inventories are stated at the lower of cost or market with cost based on the first-in, first-out method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when selected for use in a clinical manufacturing campaign.

Capitalization of Inventory Costs

        We capitalize inventory costs associated with our products prior to regulatory approval, when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. In determining whether or not to capitalize such inventories, we evaluate, among other factors, information regarding the drug candidate's safety and efficacy, the status of regulatory submissions and communications with regulatory authorities and the outlook for commercial sales, including the existence of current or anticipated competitive drugs and the availability of reimbursement. In addition, we evaluate risks associated with manufacturing the drug candidate and the remaining shelf-life of the inventories.

Obsolescence and Unmarketable Inventory

        We periodically review our inventories for excess or obsolescence and write-down obsolete or otherwise unmarketable inventory to our estimated net realizable value.

Impairment of Long-Lived Assets

        Long-lived assets to be held and used, including property, plant and equipment and definite-lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable.

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        Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their fair values. Long-lived assets to be disposed of are carried at fair value less costs to sell.

Income Taxes

        In our combined financial statements, income tax expense and deferred tax balances have been calculated on a separate return basis although our operations have historically been included in the tax returns filed by the respective Biogen entities of which our business is a part. In the future, as a standalone entity, we will file tax returns on our own behalf and our deferred taxes and effective income tax rate may differ from those in historical periods.

        Deferred taxes are recognized for the future tax effects of temporary differences between financial and income tax reporting based on enacted tax laws and rates. We maintain valuation allowances unless it is more likely than not that the deferred tax asset will be realized. With respect to uncertain tax positions, we determine whether the position is more likely than not to be sustained upon examination, based on the technical merits of the position. Any tax position that meets the more-likely-than-not recognition threshold is measured and recognized in the combined financial statements at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. The liability relating to uncertain tax positions is classified as current in the combined balance sheets to the extent we anticipate making a payment within one year. Interest and penalties associated with income taxes are classified in the income tax expense line in the combined statements of income.

        We maintain an income taxes payable to/from account with Biogen. We are deemed to settle current tax balances with the Biogen tax paying entities in the respective jurisdictions. Our current income tax balances are reflected as income taxes payable and settlements, which are deemed to occur in the year following incurrence, are reflected as changes in net parent company investment in the combined balance sheets. As a standalone entity, we will no longer maintain an income tax payable to/from account with Biogen and we will file tax returns on our own behalf. Our deferred taxes and effective income tax rate may differ from those in historical periods.

New Accounting Standards

        We have irrevocably elected not to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act, and, therefore, we will be subject to the same new or revised accounting standards as other public companies that do not qualify as emerging growth companies.

        For a discussion of new accounting standards please read Note 2, Summary of Significant Accounting Policies , to the audited combined financial statements included elsewhere in this information statement.

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BUSINESS

Summary

        Bioverativ is a global biotechnology company focused on the discovery, research, development and commercialization of innovative therapies for the treatment of hemophilia and other blood disorders.

        We market two products, ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] and ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], extended half-life clotting-factor therapies for the treatment of hemophilia A and hemophilia B, respectively. ELOCTATE and ALPROLIX use a process known as Fc fusion to link recombinant factor VIII and factor IX, respectively, to a protein fragment in the body known as Fc. The fusion of the factor with the Fc protein fragment uses a naturally occurring pathway and is designed to extend the half-life of the factor thereby making the product last longer in a person's blood than traditional factor therapies.

        We collaborate with Sobi to develop and commercialize ELOCTATE and ALPROLIX globally. We have rights to commercialize ELOCTATE and ALPROLIX in the United States, Japan, Canada, Australia and all other markets excluding Sobi's commercialization territory. Sobi's commercialization territory includes Europe, Russia and certain countries in Northern Africa and the Middle East. See "—Our Development and Commercialization Arrangements with Sobi" below. ELOCTATE and ALPROLIX were approved in the United States and Japan in 2014, and in the European Union in 2015 and 2016, respectively.

        We have multiple programs intended to further support our marketed products and an innovative product pipeline devoted to the creation and delivery of new therapies:

    Research activities relating to our marketed products include ongoing and planned post-marketing studies exploring the potential of Fc fusion technology on long-term joint health, immunogenicity and immune tolerance induction in hemophilia patients who develop inhibitors.

    Research activities relating to new products include discovery and preclinical programs studying longer-acting extended half-life hemophilia product candidates, non-factor products to treat hemophilia (such as bi-specific antibody technology) and gene therapies for both hemophilia A and B. We also have ongoing research programs relating to sickle cell disease and beta-thalassemia. See "—Pipeline and Research and Development Activities" below.

        We generate revenue through sales of our products, royalties earned on sales of ELOCTATE and ALPROLIX by Sobi in its commercialization territory and the supply of ELOCTATE and ALPROLIX to Sobi. For the nine month period ended September 30, 2016, we generated revenue of approximately $631.2 million primarily from our sales of ELOCTATE and ALPROLIX in the United States, Japan and Canada, and for the year ended December 31, 2015, we generated revenue of approximately $560.3 million primarily from our sales of ELOCTATE and ALPROLIX in the United States and Japan.

        Bioverativ Inc. was incorporated in the State of Delaware on August 4, 2016 in connection with the separation of Biogen's hemophilia business from Biogen. At the time of the distribution, the address of Bioverativ's principal executive offices will be 225 Second Avenue, Waltham, MA 02451.

Strengths

        We believe we possess a number of competitive advantages that distinguish us from our competitors, including:

    Portfolio of marketed hemophilia products.   In 2014, the FDA approved ELOCTATE and ALPROLIX as the first extended half-life clotting-factor therapies for hemophilia A and B, respectively. The extended half-life supported by Fc fusion effectively offers one less infusion per

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      week for hemophilia patients on average relative to typical dosing regimens for conventional short-acting therapies.

    Scientific team with significant expertise in the development of hemophilia and other blood disorders.   Our scientific team is highly experienced and includes scientists formerly of Syntonix (now known as Bioverativ Therapeutics Inc.), a company acquired by Biogen in 2007, who are principally responsible for the discovery and application of the Fc monomer technology used in ELOCTATE and ALPROLIX. We believe our experience in developing this technology, combined with our expertise in developing hemophilia treatments, positions us well to advance next generation technologies in our product pipeline. We also believe that this scientific expertise is applicable to other blood disorders, such as sickle cell disease and beta-thalassemia. Our scientific team includes Dr. Robert Peters, a leading hematology medical and research expert who will join us from Biogen, and is expected to include the addition of a head of research and development.

    Strong relationships with the hemophilia community.   Our team has developed strong ties with the hemophilia community, earning the trust and confidence of patients and health care providers through our commitment to transforming the standard of care in hemophilia. Our commitment is demonstrated by the introduction of ELOCTATE and ALPROLIX, the first major advances in hemophilia treatment in nearly two decades, ongoing community outreach and global humanitarian aid efforts.

    Exclusive relationship with Biogen to supply high-quality, complex hemophilia products.   Our exclusive manufacturing and supply arrangement with Biogen for hemophilia products, together with manufacturing expertise of our personnel, positions us to offer patients and providers with a consistent supply of complex products for the treatment of hemophilia that meet strict standards of quality at all stages of the manufacturing process and throughout our supply chain. See "Certain Relationships and Related Person Transactions—Agreements with Biogen— Manufacturing and Supply Agreement ."

    Financial flexibility to drive future growth.   Since the third quarter of 2015, Bioverativ has generated and expects to continue to generate positive cash flows from operations, which we anticipate will allow us to further invest in our marketed products and pipeline, and to pursue strategic opportunities to enhance growth. In addition, we expect to be capitalized by Biogen prior to the distribution with $325.0 million in cash and do not expect to have any indebtedness for borrowed money as of the distribution date.

    Innovative pipeline with multiple approaches to targeting hemophilia and other blood disorders.   A key element of our growth strategy is advancing our current products and building and advancing our pipeline. We have multiple research initiatives and programs focused on addressing areas of unmet need in hemophilia and other blood disorders, including (i) research on the use of ELOCTATE to induce immune tolerance induction in hemophilia A patients who develop inhibitors, (ii) BIVV 001, a next generation recombinant factor protein using XTEN technology, which has the potential to achieve once weekly or less frequent dosing in hemophilia A, (iii) a non-factor bi-specific antibody program to treat patients with hemophilia A and patients with inhibitors, (iv) two gene therapy programs for hemophilia A and B and (v) early-stage programs in sickle cell disease and beta-thalassemia.

    Experienced management team with track record of successful performance.   Our management team has a strong track record of leadership, performance and execution in the biopharmaceutical industry. John Cox, appointed as our Chief Executive Officer in July 2016, joined Biogen in 2003, and served as Biogen's Executive Vice President, Pharmaceutical Operations and Technology from 2010 through June 2016. During his tenure at Biogen, Mr. Cox was part of its executive leadership team, where he was responsible for many critical areas of Biogen's business,

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      including leading its complex manufacturing operations, growing its biosimilars business and, most recently, serving as head of its global therapeutic operations. John Greene, appointed as our Executive Vice President, Chief Financial Officer and Treasurer, has over 20 years of experience in various finance roles and as chief financial officer at several companies. Rogério Vivaldi, appointed as our Executive Vice President, Chief Global Therapeutic Operations Officer, has over 20 years of extensive experience leading biopharmaceutical business units, mainly in rare diseases. In addition, other experienced leaders joining us from Biogen include Richard Brudnick, Executive Vice President of Business Development, Lucia Celona, Executive Vice President and Chief Human Resources and Corporate Communications Officer, and Andrea DiFabio, Executive Vice President and Chief Legal Officer.

Strategies

        Our objective is to develop therapies to improve the lives of patients living with hemophilia and other blood disorders. The key elements of our strategy include:

    Increase sales and market share of ELOCTATE and ALPROLIX.   We aim to grow sales of ELOCTATE and ALPROLIX through continued differentiation of our long-acting technology platform, increased patient access and expansion of our geographic footprint. We believe we have opportunities to grow sales of these products in existing markets, such as the United States, Japan and Canada, by continuing to increase awareness of the clinical value of ELOCTATE and ALPROLIX through long-term study data and the real world experience of the hemophilia community. In addition, we intend to extend our geographic presence into additional countries and regions.

    Advance treatment attributes for marketed products.   We are dedicated to improving the lives of hemophilia patients and the options available to patients and healthcare providers through continued innovation and advancement of our marketed products. While our marketed products provide a more convenient dosing regimen than conventional therapies, there are still serious unmet medical needs for persons living with hemophilia. Our research activities relating to ELOCTATE and ALPROLIX include studies of Fc fusion and its potential to reduce immunogenicity, improve long-term joint health and shorten the time to immune tolerance for patients who develop inhibitors.

    Develop new products providing meaningful advances in treatment.   We intend to leverage our internal expertise and continue our efforts to actively develop novel therapies for hemophilia A and B and other blood disorders through our research and development platform. In particular, we believe that the development of a longer-acting hemophilia A product, enabling once weekly dosing, could have a meaningful treatment impact. Preclinical work on our novel BIVV 001 molecule suggests that our scientists have overcome some of the half-life limitations associated with Factor VIII binding to von Willebrand Factor, and may have the ability to achieve once weekly or less frequent dosing in humans. We intend to move this product candidate to human clinical trials in 2017.

    Pursue strategic opportunities to enhance our pipeline and product portfolio.   We plan to expand our product portfolio through collaborations, licensing opportunities, strategic alliances and tactical acquisitions that meet our strategic business objectives. We also intend to focus on strategic opportunities that enhance our existing research and development platform, product pipeline and commercial effectiveness. One area of particular strategic interest is sickle cell disease, a genetically defined blood disorder affecting an underserved patient population that the Centers for Disease Control and Prevention reported in February 2016 affected an estimated 100,000 individuals in the United States alone.

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        We can provide no assurance that we will be able to implement our business strategies or achieve our desired growth. Our business is subject to a number of risks and uncertainties. See "Risk Factors" beginning on page 18.

Hemophilia A and B

        Hemophilia A and hemophilia B are rare, x-linked genetic disorders that impair the ability of a person's blood to clot due to reduced levels of a protein known as factor VIII or factor IX, respectively. This impairment can lead to recurrent and extended bleeding episodes that may cause pain, irreversible joint damage and life-threatening hemorrhages. In 2014, the World Federation of Hemophilia (WFH) estimated that over 143,000 people worldwide were identified as living with hemophilia A and nearly 29,000 people were diagnosed with hemophilia B.

        Hemophilia is usually diagnosed at birth or at a very young age, and predominantly affects males. An individual's hemophilia is classified as mild, moderate or severe and is based on the level of factor activity in the blood. Although hemophilia care varies widely across the globe, in the United States a majority of patients receive care from specialized hemophilia treatment centers.

        Hemophilia is treated by injecting the missing clotting factor directly into the patient's bloodstream. Therapies can be administered either on a schedule to help prevent or reduce bleeding episodes (prophylaxis) or to control bleeding when it occurs (on-demand). Over time, regimens have shifted from on-demand treatment to routine prophylaxis due to observed improvements in long-term clinical outcomes, such as joint damage. In the United States, the February 2016 guidelines of the Medical and Scientific Advisory Council of the National Hemophilia Foundation recommend routine prophylaxis as optimal for the treatment of people with severe hemophilia.

        Historically, hemophilia treatments were derived from factors taken from human blood plasma. In the early 1990's, recombinant factor products, developed in a lab through the use of DNA technology, became available. In 2014, use of recombinant factor product accounted for over 70% of sales globally. In 2014, ELOCTATE and ALPROLIX became the first available extended half-life recombinant factor therapies in the United States with the benefit of less frequent, more convenient dosing requirements.

        Patients may experience complications with factor therapies. In some cases, patients may develop inhibitors that recognize the infused factor as a foreign body. Inhibitors occur when a person with hemophilia has an immune response to treatment with clotting factor concentrates. According to the WFH, an inhibitor usually occurs within the first 75 exposures to factor concentrates and thus is most often seen in children with severe hemophilia. In 2014, the WFH estimated that approximately 25% to 30% of children with severe hemophilia A and approximately 1% to 6% of individuals with hemophilia B will develop inhibitors. A common treatment to rid the body of the inhibitor is immune tolerance induction. Immune tolerance induction involves exposure to frequent doses of factor until the body can tolerate the factor. While this treatment can be effective, the treatment burden is high as it can take weeks or even years for the inhibitor to resolve.

Our Marketed Products

        Our marketed products, ELOCTATE and ALPROLIX, leverage expertise in Fc fusion technology that was originally acquired by Biogen from Syntonix in 2007. Fc fusion is a proprietary technology used to link recombinant factor VIII and factor IX in the case of ELOCTATE and ALPROLIX, respectively, to a protein fragment in the body known as Fc. The fusion with Fc uses a naturally occurring pathway and is designed to extend the half-life of the factor, thereby making the product last longer in a patient's blood than traditional factor therapies. ELOCTATE consists of the Coagulation

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Factor VIII molecule (historically known as Antihemophilic Factor) linked to Fc and ALPROLIX consists of the Coagulation Factor IX molecule linked to Fc.

Product
  General Description
LOGO   ELOCTATE is approved in the United States, Japan, Canada, Australia, Brazil, the European Union and certain other countries for the treatment of adults and children with hemophilia A to control and prevent bleeding episodes. In the United States, it is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding and routine prophylaxis to reduce the frequency of bleeding episodes. ELOCTATE has received orphan designation in the United States.

 

 

Bioverativ's principal markets for ELOCTATE currently include the United States, Japan and Canada. Sobi began commercializing ELOCTA (the approved tradename for ELOCTATE in the European Union) in some European countries in 2016.

LOGO

 

ALPROLIX is approved in the United States, Japan, Canada, Australia, Brazil, the European Union and certain other countries for the treatment of adults and children with hemophilia B to control and prevent bleeding episodes. In the United States, it is indicated for use in adults and children with hemophilia B for control and prevention of bleeding episodes, perioperative management and routine prophylaxis to reduce the frequency of bleeding episodes. ALPROLIX has received orphan designation in the United States and the European Union.

 

 

Bioverativ's principal markets for ALPROLIX currently include the United States, Japan and Canada. Sobi began commercializing ALPROLIX in some European countries in 2016 following its approval by the European Medicines Agency (EMA) in May 2016.

        Through a development and commercialization agreement with Sobi, Bioverativ has rights to commercialize ELOCTATE and ALPROLIX in the United States, Japan, Canada, Australia and all other markets excluding Sobi's commercialization territory. Sobi's commercialization territory for these therapies is Europe, Russia and certain countries in Northern Africa and the Middle East. For a further description of our development and collaboration agreement with Sobi, see "—Our Development and Commercialization Arrangements with Sobi" below.

Pipeline and Research and Development Activities

        Our research activities relating to ELOCTATE and ALPROLIX include ongoing and planned post-marketing studies exploring the potential impact of the Fc fusion technology on long-term joint health, immunogenicity and immune tolerance induction in hemophilia patients who develop inhibitors.

        In addition to work relating to our current marketed products, we are also engaged in discovery and preclinical programs focused on advancing new technologies for the treatment of hemophilia and other blood disorders, such as sickle cell disease and beta-thalassemia. Our scientific and medical

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leaders, many of whom were part of Biogen's research and development organization, plan to renew focus on advancing discovery work with small molecules and cell and gene therapy in the hopes of developing treatments for this disease. We anticipate that Biogen will continue to provide us with technical services related to our pipeline and research and development activities. A brief description of our most advanced programs, together with certain related business relationships and collaborations, is described below.

        BIVV 001(rFVIIIFc-VWF-XTEN).     A preclinical program of the combination of our proprietary recombinant factor VIII-VWF fusion protein with proprietary XTEN technology licensed from Amunix. The product candidate is being developed with the objective of achieving once weekly or less frequent dosing by intravenous administration in patients with hemophilia A.

        BIVV 002 (rFIXFc-XTEN).     A preclinical program for a next generation recombinant factor IX replacement product using XTEN technology exploring the use of subcutaneous dosing for patients with hemophilia B with the objective of achieving once weekly or less frequent dosing, which we believe would simplify the administration process for patients with hemophilia B.

        Gene Therapy Programs.     We are collaborating with Fondazione Telethon and Ospedale San Raffaele S.r.l. to develop gene therapies for hemophilia A and B. This collaboration centers on advanced lentiviral gene transfer technology of the San Raffaele Telethon Institute for Gene Therapy.

        Bi-Specific Antibody Program.     A preclinical program to develop a non-factor bi-specific antibody for the treatment of patients with hemophilia A with inhibitors and the general hemophilia A population.

        Other Blood Disorders.     We are currently pursuing opportunities in sickle cell disease, including carrying out small molecule screens against targets that we believe have potential to intervene in sickle cell disease as well as performing clinical research in an effort to develop better measures of efficacy. In addition, in connection with the separation we will succeed to Biogen's rights and obligations under an exclusive, worldwide research, development and commercialization collaboration and license agreement with Sangamo under which the companies will develop and commercialize product candidates using genome editing technologies for the treatment of two inherited blood disorders, sickle cell disease and beta-thalassemia. For more information on Bioverativ's collaboration with Sangamo, refer to "Management's Discussion and Analysis and Results of Operations—Years Ended December 31, 2015, 2014 and 2013—Contractual Obligations— Funding Commitments Sangamo BioSciences, Inc ."

        Our expenses for research and development activities were $186.1 million in 2015, $239.8 million in 2014 and $191.8 million in 2013. These expenses include costs associated with research and development activities performed while part of Biogen, collaboration payments and expenses primarily to Sobi, salaries and related expenses for personnel, license fees, consulting payments, contract research, clinical trial costs, manufacturing and the costs of laboratory equipment and facilities. In addition these expenses include allocations from Biogen to us for depreciation and other facility-based expenses, regulatory affairs function, pharmacovigilance, other infrastructure and management costs supporting multiple projects. As a result, these expenses are not necessarily indicative of Bioverativ's expenses for research and development activities as a standalone company.

        Investment in research and development is critical to our future growth and our ability to remain competitive in the markets in which we participate. We intend to continue to make significant investment in research and development programs in addition to seeking to enhance future growth through internal efforts, acquisitions and collaborations with third parties.

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Our Development and Commercialization Arrangements with Sobi

        Bioverativ Therapeutics Inc. (formerly Biogen Idec Hemophilia Inc.), which will be our wholly owned subsidiary as of the distribution, is a party to a development and commercialization agreement with Sobi, under which it has agreed to develop and commercialize in defined territories ELOCTATE, ALPROLIX and certain compound constructs that Sobi elects to designate as subject to the parties' collaboration. Generally, these compound constructs include fusion proteins containing both a recombinant factor and the Fc portion of an immunoglobulin, including certain constructs that may be developed using technology we license from Amunix.

        The development and commercialization agreement generally defines Bioverativ's commercialization territory as the United States, Japan, Canada, Australia, Brazil and all other markets excluding Sobi's commercialization territory, and Sobi's commercialization territory as Europe, Russia and certain countries in Northern Africa and the Middle East.

        Under the development and commercialization agreement, prior to May 5, 2024, either Bioverativ or Sobi may present a compound construct as a potential product candidate that the parties may consider developing and commercializing under the collaboration. Upon Sobi's election to treat a compound construct as a product, and in the case of a novel compound construct Sobi's payment of an upfront fee to us, Sobi is granted the right to opt-in to such compound construct and become responsible for final development and commercialization of that compound construct in Sobi's commercialization territory. Generally, upon opt-in, Sobi becomes obligated to make an advance payment and reimburse Bioverativ for certain development expenses incurred with respect to the compound construct. Until Sobi's portion of the development expenses are fully paid, Sobi's royalty rate payable to Bioverativ is increased, and the royalty payment payable by Bioverativ to Sobi for the sale of products in Bioverativ's territory is decreased.

        The development and commercialization agreement provides for royalty payments between the parties for sales of collaboration products, including ELOCTATE and ALPROLIX, that vary based upon, among other things, the territory in which the sale was made and how the product is commercialized.

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        The following is a summary of the royalty rates between the parties:

 
   
   
  Rates post Sobi Opt-In (3)
Royalty and Net Revenue Share Rates (1)
  Method   Rate prior to
1st commercial
sale in the
Sobi Territory
  Base Rate
following
1st commercial
sale in the
Sobi Territory
  Rate
during the
Reimbursement
Period

Sobi rate to Bioverativ on net sales in the Sobi Territory

  Royalty     N/A   10 or 12%   Base Rate plus 5%

Bioverativ rate to Sobi on net sales in the Bioverativ North America Territory

  Royalty     2 % 10 or 12%   Base Rate less 5%

Bioverativ rate to Sobi on net sales in the Bioverativ Direct Territory

  Royalty     2 % 15 or 17%   Base Rate less 5%

Bioverativ rate to Sobi on net revenue (2) from the Bioverativ Distributor Territory

  Net Revenue Share     10 % 50%   Base Rate less 15%

(1)
For purposes of this table, the "Sobi Territory" means territories in which Sobi has commercial rights, meaning Europe, Russia and certain countries in Northern Africa and the Middle East; the "Bioverativ North America Territory" means territories in North America in which Bioverativ has commercial rights; the "Bioverativ Direct Territory" means territories in which Bioverativ has commercial rights other than the Sobi Territory and the Bioverativ North America Territory; and the Bioverativ Distributor Territory means Bioverativ territories where sales are derived by Bioverativ utilizing a third party distributor.

(2)
Net revenue represents Bioverativ's pre-tax receipts from third party distributors, less expenses incurred by Bioverativ in the conduct of commercialization activities supporting the distributor activities.

(3)
A credit will be issued to Sobi against its reimbursement of the Opt-in Consideration in an amount equal to the difference in the rate paid by Bioverativ to Sobi on sales in the Bioverativ territories for certain periods prior to the first commercial sale in the Sobi Territory versus the rate that otherwise would have been payable on such sales. The first commercial sale of ELOCTA and ALPROLIX in the Sobi Territory occurred in January 2016 and June 2016, respectively.

        The development and commercialization agreement is terminable in its entirety or with respect to a product developed under the collaboration by either party upon six months' written notice. The agreement is also terminable in its entirety under certain conditions and subject to certain dispute resolution procedures following a party's uncured material breach of a material obligation of the agreement. Unless earlier terminated, the duration of the agreement continues with respect to each product, for so long as such product is being sold anywhere in the world.

        In September 2014, Sobi elected to treat BIVV 001 ( rFVIIIFc-VWF-XTEN) , a preclinical compound construct developed using the XTEN technology licensed by Bioverativ from Amunix, as subject to the collaboration.

        In November 2014, Sobi exercised its option to assume final development and commercialization activities in Sobi's commercialization territory for ELOCTA, the approved trade name for ELOCTATE in the European Union. ELOCTA was approved by the European Commission (EC) in November 2015, and Sobi had its first commercial sales in January 2016. In March 2016, the EC approved the transfer of the marketing authorization for ELOCTA to Sobi, making Sobi the marketing authorization holder of ELOCTA in the European Union. As the marketing authorization holder, Sobi has legal responsibility for ELOCTA, from a regulatory perspective, during its entire life cycle in the European Union. The opt-in consideration and aggregate amount reimbursable by Sobi to us for ELOCTA was

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$211.0 million. As of September 30, 2016, approximately $143.9 million remained reimbursable to us by Sobi.

        In July 2015, Sobi exercised its option to assume final development and commercialization activities in the Sobi territory for ALPROLIX. ALPROLIX was approved by the EC in May 2016. In October 2016, the EC approved the transfer of the marketing authorization for ALPROLIX to Sobi, making Sobi the marketing authorization holder of ALPROLIX in the European Union. As the marketing authorization holder, Sobi has legal responsibility for ALPROLIX, from a regulatory perspective, during its entire life cycle in the European Union. The opt-in consideration and aggregate amount reimbursable by Sobi to us for ALPROLIX was $187.0 million. As of September 30, 2016, approximately $124.5 million remained reimbursable to us by Sobi.

        Pursuant to the development and commercialization agreement, Bioverativ and Sobi are also parties to ancillary agreements, including manufacturing and supply agreements for ELOCTATE and ALPROLIX pursuant to which Sobi forecasts, orders and purchases drug substance and drug product that is supplied to Sobi by Bioverativ. Bioverativ expects to satisfy its supply obligations to Sobi by obtaining ELOCTATE and ALPROLIX drug substance and drug product through Bioverativ's manufacturing and supply arrangements with Biogen as well as other third party contract manufacturing organizations. See "—Manufacturing and Facilities" below.

        The foregoing summary of the development and commercialization agreement with Sobi does not purport to be complete and is subject to, and qualified in its entirety by, reference to the actual agreement, a copy of which, together with its amendments, is filed as an exhibit to the registration statement of which this information statement is a part.

        For more information on Bioverativ's collaboration with Sobi, see Note 3, Collaborations, to the audited combined financial statements included elsewhere in this information statement.

Our International Operations

        We anticipate that, in addition to the United States and Canada, Japan will remain a significant focus for growing patient share of ELOCTATE and ALPROLIX in the near term. We have conducted research and development activities for hemophilia treatments in Japan since 2010. Through our dedicated Japanese sales force and marketing team, we have sold ELOCTATE and ALPROLIX in Japan since receipt of marketing approval in December 2014 and June 2014, respectively. For the year ended December 31, 2015, we generated revenue of approximately $37.0 million outside the United States, primarily from our sales of ELOCTATE and ALPROLIX in Japan, and for the nine month period ended September 30, 2016, we generated revenue of approximately $91.4 million outside the United States, primarily from our sales of ELOCTATE and ALPROLIX in Japan and Canada.

Intellectual Property

        We rely on patents and other proprietary rights to develop, maintain and strengthen our competitive position. We own a number of patents and trademarks throughout the world and have entered into license arrangements relating to various third party patents and technologies.

Patents

        Patents are important to obtaining and protecting exclusivity in our products and product candidates. We regularly seek patent protection in the U.S. and in selected countries outside the U.S. for inventions originating from our research and development efforts. In addition, we license rights from others to various patents and patent applications.

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        U.S. patents, as well as most non-U.S. patents, are generally effective for 20 years from the date the earliest application was filed; however, U.S. patents that issue on applications filed before June 8, 1995 may be effective until 17 years from the issue date, if that is later than the 20 year date. In some cases, the patent term may be extended to recapture a portion of the term lost during regulatory review of the claimed therapeutic, and in the case of the United States, also because of U.S. Patent and Trademark Office (USPTO) delays in prosecuting the application. Specifically, in the U.S., under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, a patent that covers an FDA approved drug may be eligible for patent term extension (for up to five years, but not beyond a total of 14 years from the date of product approval) as compensation for patent term lost during the FDA regulatory review process, but only one patent per approved drug product may be so extended. The duration and extension of the term of foreign patents varies, in accordance with local law.

        Our patent portfolio includes issued patents and pending applications relating to our marketed products and our product pipeline. We hold patents for ELOCTATE and ALPROLIX that cover the composition of matter and methods of treatment of those therapies. Patents of primary importance to ELOCTATE and ALPROLIX have issued in the United States and Europe and, based on the applicable patent statutes and in the ordinary course, generally expire between 2024 and 2031. We also continue to pursue additional patents and patent term extensions in the United States and other territories covering various aspects of our products that may, if issued, extend exclusivity beyond the expiration of these patents.

        The existence of patents does not guarantee our right to practice the patented technology or commercialize the patented product. Patents relating to biopharmaceutical and biotechnology products, compounds and processes, such as those that cover our existing compounds, products and processes and those that we will likely file in the future, do not always provide complete or adequate protection. Our patents may be invalidated earlier based on a competitor's challenge in an applicable patent office or court proceeding.

Regulatory Exclusivity

        In addition to patent protection, certain of our products are entitled to regulatory exclusivity which may consist of regulatory data protection and market protection. The expected expiration of this regulatory exclusivity in the United States and the European Union is set forth below:

Product
  Territory   Expected Expiration  

ELOCTATE

  United States     2026  

ELOCTA (1)

  European Union     2025  

ALPROLIX

  United States     2026  

ALPROLIX (1)

  European Union     2026 (2)

(1)
Sobi has assumed responsibility for commercializing ELOCTA and ALPROLIX in Sobi's commercialization territory pursuant to our development and commercialization agreement with Sobi.

(2)
This date has the potential to be extended by two years subject to EMA review and certification of activities conducted under our pediatric investigational plan.

        Regulatory data protection provides to the holder of a drug or biologic marketing authorization, for a set period of time, the exclusive use of the proprietary preclinical and clinical data that it created at significant cost and submitted to the applicable regulatory authority to obtain approval of its product. After the applicable set period of time, third parties are then permitted to rely upon our data to file for approval of their abbreviated applications for, and to market (subject to any applicable market protection), their generic drugs and biosimilars referencing our data. Market protection provides to the holder of a drug or biologic marketing authorization the exclusive right to

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commercialize its product for a set period of time, thereby preventing the commercialization of another product containing the same active ingredient(s) during that period. Although the World Trade Organization's agreement on trade-related aspects of intellectual property rights requires signatory countries to provide regulatory exclusivity to innovative pharmaceutical products, implementation and enforcement varies widely from country to country. In the United States, biologics, such as ELOCTATE and ALPROLIX, are entitled to exclusivity under the Biologics Price Competition and Innovation Act, which was passed on March 23, 2010 as Title VII to the PPACA. The PPACA provides a pathway for approval of biosimilars following the expiration of 12 years of exclusivity for the innovator biologic and a potential additional 180 day-extension term for conducting pediatric studies. Under this framework, FDA cannot make a product approval effective for any biosimilar application until at least 12 years after the reference product's date of first licensure. The PPACA also includes an extensive process for the innovator biologic and biosimilar manufacturer to litigate patent infringement, validity, and enforceability prior to the approval of the biosimilar. The PPACA does not, however, change the duration of patents granted on biologic products.

        Japan also provides for market exclusivity through a re-examination system, which prevents the entry of generics and biosimilars until the end of the re-examination period (REP), which can be up to eight years from marketing approval. ELOCTATE and ALPROLIX are expected to have REPs ending in 2022.

Other Proprietary Rights

        We also rely upon other forms of unpatented confidential information to remain competitive. We protect such information principally through confidentiality and non-use agreements with our employees, consultants, outside scientific collaborators and scientists whose research we sponsor and other advisers. In the case of our employees, these agreements also provide, in compliance with relevant law, that inventions and other intellectual property conceived by such employees during their employment shall be our exclusive property.

        Our trademarks are important to us and are generally covered by trademark applications or registrations in the USPTO and the patent or trademark offices of other countries. Trademark protection varies in accordance with local law, and continues in some countries as long as the trademark is used and in other countries as long as the trademark is registered. Trademark registrations generally are for fixed but renewable terms.

        Litigation, interferences, oppositions, inter partes reviews or other proceedings are, have been and may in the future be necessary in some instances to determine the validity and scope of certain of our patents, regulatory exclusivities or other proprietary rights, and in other instances to determine the validity, scope or non-infringement of certain patent rights claimed by others to be pertinent to the manufacture, use or sale of our products. We may also face challenges to our patents, regulatory exclusivities and other proprietary rights covering our products by manufacturers of generic drugs and biosimilars. A discussion of certain risks and uncertainties that may affect our patent position, regulatory exclusivities and other proprietary rights is set forth in "Risk Factors" and for information on our litigation and other claims against us, see "Business—Legal Proceedings."

Manufacturing and Facilities

        ELOCTATE and ALPROLIX are currently manufactured at Biogen-owned facilities located in North Carolina and Massachusetts. The manufacturing process for bulk drug substance includes protein production, purification and viral clearance. Manufacture and supply of drug product, which includes fill finish, labelling and packaging, are provided primarily through third party contract manufacturing organizations.

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        In connection with our separation from Biogen, we intend to enter into a manufacturing and supply agreement with Biogen for hemophilia products, pursuant to which Biogen will manufacture and supply, exclusively for us, drug substance, drug product and finished goods with respect to ELOCTATE and ALPROLIX, as well as for certain of our pipeline product candidates. Fill finish, label and packaging, distribution and logistics services for ELOCTATE and ALPROLIX drug product will initially continue to be provided by Biogen directly or through third party contract manufacturing organizations. We anticipate increasing our level of direct contractual responsibility with third party contract manufacturing organizations, logistics providers and distributors as we scale up our internal supply management capabilities. For additional information regarding manufacturing services following the separation, see the discussion of the manufacturing and supply and transition services arrangements to be entered into between Biogen and Bioverativ under "Certain Relationships and Related Person Transactions—Agreements with Biogen."

        Following the separation, our corporate offices will be located at 225 Second Avenue, Waltham, MA 02451. Our properties include facilities which, in our opinion, are suitable and adequate for development and distribution of our products.

Raw Materials

        We expect to rely on Biogen for all supplies and raw materials used in the production of ELOCTATE and ALPROLIX drug substance for a limited time period.

Sales, Marketing and Distribution

        We have our own direct sales force. Our products are distributed to and through specialty pharmacies, hemophilia treatment centers, public and private hospitals and independent distributors. In the United States, our two largest customers are CVS Health Corporation and Accredo Health Incorporated. No individual customer accounted for greater than 20% of our total revenues for the nine months ended September 30, 2016. Our sales, particularly to specialty pharmacies and hemophilia treatment centers, are subject to discounted pricing. See "—Regulatory Matters— Pricing and Reimbursement " below. We review our sales channels from time to time, and will make changes in our sales and distribution model as we believe necessary to best implement our business plan and strategies.

        We will rely on Biogen for a period following the effective time of the distribution to supply and distribute our products to customers while we obtain appropriate regulatory authorizations in the United States and Canada. In the United States, we are in the process of securing a Department of Health and Human Services United States License Number, certain state authorizations and other regulatory and government authorizations. In Canada, we are in the process of applying for additional licenses, including a Drug Establishment License from Health Canada. We anticipate these interim arrangements to remain in place no later than the fourth quarter of 2017.

        In the United States, a third party warehouses and ships a significant portion of our products through its distribution centers. These centers are generally stocked with adequate inventories to facilitate prompt customer service. Sales and distribution methods include frequent contact by sales and customer service representatives, automated communications via various electronic purchasing systems, circulation of catalogs and merchandising bulletins, direct-mail campaigns, trade publication presence and advertising.

        Our non-U.S. sales and product distributions, which currently occur only in Japan and Canada, are made on a direct basis. We use and expect to continue to use a variety of collaboration, distribution and other marketing arrangements with one or more third parties to commercialize our products outside the United States. Under our development and commercialization arrangement with Sobi, for example, Sobi has assumed responsibility for commercializing ELOCTATE and ALPROLIX in its territory. See "—Our Development and Commercialization Arrangements with Sobi" above.

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Competition

        Bioverativ faces substantial competition from biotechnology, biopharmaceutical and other companies of all sizes, in the United States and other countries, as such competitors continue to expand their manufacturing capacity and sales and marketing channels. Many of our competitors are working to develop products similar to those we are developing or those that we already market. Competition is primarily focused on cost-effectiveness, price, service, product effectiveness and quality, patient convenience and technological innovation, such as longer-acting, extended half-life therapies for hemophilia. The introduction of new products by competitors and changes in medical practices and procedures can impact our products.

        The principal sources of competition for Bioverativ's products globally are as follows:

    ELOCTATE: ELOCTATE competes with recombinant Factor VIII products including:

    ADVATE® (Antihemophilic Factor (Recombinant))—Shire

    ADYNOVATE (Antihemophilic Factor (Recombinant), PEGylated)—Shire

    KOVALTRY® Antihemophilic Factor (Recombinant)—Bayer KOGENATE® FS (Antihemophilic Factor (Recombinant))—Bayer

    HELIXATE® FS (Antihemophilic Factor (Recombinant))—CSL Behring

    NovoEight® (Antihemophilic Factor (Recombinant))—Novo Nordisk

    Nuwiq® Recombinant Factor VIII—Octapharma.

    RECOMBINATE (Antihemophilic Factor (Recombinant))—Shire

    XYNTHA®/ReFacto AF® (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free)—Pfizer and Sobi

    ALPROLIX: competes with recombinant Factor IX products including:

    BENEFIX® (Coagulation Factor IX (Recombinant))—Pfizer

    IDELVION® (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)—CSL Behring

    IXINITY® (Coagulation Factor IX (Recombinant))—Aptevo (a spin-off from Emergent Biosolutions completed in August 2016)

    RIXUBIS® (Coagulation Factor IX (Recombinant))—Shire

        Our products also compete with a number of plasma derived Factor VIII and IX products. We are also aware of other longer-acting products and new technologies, such as gene therapies and bi-specific antibodies, that are in development and, if successfully developed and approved, would compete with our hemophilia products. New therapies and technologies have the potential to transform the standard of care for hemophilia patients, and our products may be unable to compete successfully with such new therapies and technologies that may be developed and marketed by other companies.

        There are additional competitive products or alternative therapy regimens available on a more limited geographic basis throughout the world.

        For additional information regarding competition, see the discussion of such matters in the "Risk Factors" section of this information statement, including the following: "Risk Factors—Risks Related to Our Business— If our hemophilia products fail to compete effectively, our business and market position would suffer ."

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Regulatory Matters

        The operations of Bioverativ and many of the products it manufactures or sells are subject to extensive regulation by numerous government agencies, both within and outside the United States. The FDA, the EMA, the Ministry of Health, Labour and Welfare in Japan (the MHLW) and other government agencies both inside and outside of the United States, regulate the testing, safety, effectiveness, manufacturing, labeling, promotion and advertising, distribution and post-market surveillance of Bioverativ's products. Bioverativ must obtain specific approval from FDA and non-U.S. regulatory authorities before it can market and sell most of its products in a particular country. The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country.

Clinical Trial and Approval Process

        The FDA, the EMA and other regulatory agencies promulgate regulations and standards for designing, conducting, monitoring, auditing and reporting the results of clinical trials to ensure that the data and results are accurate and that the rights and welfare of trial participants are adequately protected (commonly referred to as current cGCPs). Regulatory agencies enforce cGCPs through periodic inspections of trial sponsors, principal investigators and trial sites, CROs, and institutional review boards. If studies fail to comply with applicable cGCPs, the clinical data generated may be deemed unreliable and relevant regulatory agencies may conduct additional audits or require additional clinical trials before approving a marketing application. Noncompliance can also result in civil or criminal sanctions. We rely on third parties, including CROs, to carry out many of our clinical trial-related activities. Failure of such third parties to comply with cGCPs can likewise result in rejection of our clinical trial data or other sanctions.

        Before new biologic products may be sold in the United States, preclinical studies and clinical trials of the products must be conducted and the results submitted to the FDA for approval. With limited exceptions, the FDA requires companies to register both pre-approval and post-approval clinical trials and disclose clinical trial results in public databases. Failure to register a trial or disclose study results within the required time periods could result in penalties, including civil monetary penalties. To support marketing approval, clinical trial programs must establish a candidate product's efficacy, determine an appropriate dose and dosing regimen and define the conditions for safe use. This is a high-risk process that requires stepwise clinical studies, usually conducted in three phases, in which the candidate product must successfully meet predetermined endpoints. The results of the preclinical and clinical testing of a product are then submitted to the FDA in the form of a Biologics License Application (BLA). In response to a BLA, the FDA may grant marketing approval, request additional information or deny the application if it determines the application does not provide an adequate basis for approval.

        Product development and receipt of regulatory approval takes a number of years, involves the expenditure of substantial resources and depends on a number of factors, including the severity of the disease in question, the availability of alternative treatments, potential safety signals observed in preclinical or clinical tests and the risks and benefits of the product as demonstrated in clinical trials. Many research and development programs do not result in the commercialization of a product. The FDA has substantial discretion in the product approval process, and it is impossible to predict with any certainty whether and when the FDA will grant marketing approval, or whether an approval, if granted, will be subject to limitations based on the FDA's interpretation of the relevant pre-clinical or clinical data. The agency also may require the sponsor of a BLA to conduct additional clinical studies or to provide other scientific or technical information about the product, and these additional requirements may lead to unanticipated delay or expense.

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        Most non-U.S. jurisdictions have product approval and post-approval regulatory processes that are similar in principle to those in the United States. In Europe, for example, there are several tracks for marketing approval, depending on the type of product for which approval is sought. Under the centralized procedure in Europe, a company submits a single application to the EMA that is similar to the BLA in the United States. A marketing application approved by the EC is valid in all member states. In addition to the centralized procedure, Europe also has various other methods for submitting applications and receiving approvals. Regardless of the approval process employed, various parties share responsibilities for the monitoring, detection and evaluation of adverse events post-approval, including national authorities, the EMA, the EC and the marketing authorization holder. In some regions, it is possible to receive an "accelerated" review whereby the national regulatory authority will commit to truncated review timelines for products that meet specific medical needs.

        Under the U.S. Orphan Drug Act, the FDA may grant orphan drug designation to biologics intended to treat a "rare disease or condition," which generally is a disease or condition that affects fewer than 200,000 individuals in the United States. If a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity. This means that the FDA may not approve any other applications to market the same drug for the same indication for a period of seven years following marketing approval, except in certain very limited circumstances, such as if the later product is shown to be clinically superior to the orphan product. Legislation similar to the U.S. Orphan Drug Act has been enacted in other countries to encourage the research, development and marketing of medicines to treat, prevent or diagnose rare diseases. In the European Union, medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases affecting less than five in 10,000 people receive 10-year market exclusivity, protocol assistance, and access to the centralized procedure for marketing authorization. ELOCTATE and ALPROLIX have each received an orphan drug designation in the United States and have received orphan exclusivity through June and March 2021, respectively. ALPROLIX has received an orphan drug designation in the European Union.

        Biologic products may be subject to increased competition from biosimilar formulations of reference biologic products in the future. The complex nature of biologic products has warranted the creation of biosimilar regulatory approval pathways with strict, science-based approval standards that take into account patient safety considerations. These biosimilar approval pathways are considered to be more abbreviated than for new biologics, although they are significantly different from the abbreviated approval pathways available for "generic drugs" (small-molecule drugs that are the same as, and bioequivalent to, an already-approved small molecule drug). The European Union has created a pathway for the approval of biosimilars, and has published guidance for approval of certain biosimilar products. More recently, in 2010, the PPACA authorized the FDA to approve biosimilars, but only a small number of biosimilars have been approved by the FDA to date and the U.S. approval pathway for biosimilars remains subject to ongoing guidance from the FDA. While mature pathways for regulatory approval of generic drugs and healthcare systems exist around the globe that support and promote the substitutability of generic drugs, the approval pathways for biosimilar products remain in various stages of development, as do private and public initiatives or actions supporting the substitutability of biosimilar products. Thus, the extent to which biosimilars will be viewed as readily substitutable, and in practice readily substituted, for the reference biologic product is largely yet to be determined.

Post-Approval Requirements

        The FDA may require a sponsor to conduct additional post-marketing studies as a condition of approval to provide data on safety and effectiveness. If a sponsor fails to conduct the required studies, the agency may withdraw its approval. In addition, if the FDA concludes that a product that has been shown to be effective can be safely used only if distribution or use is restricted, it can mandate

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post-marketing restrictions as necessary to assure safe use. These may include requiring the sponsor to establish rigorous systems, such as REMS, to assure use of the product under safe conditions. The FDA can impose financial penalties for failing to comply with certain post-marketing commitments, including REMS. In addition, any changes to approved REMS must be reviewed and approved by the FDA prior to implementation.

        Changes to approved products, such as adding an indication, making certain manufacturing changes, or changing manufacturers or suppliers of certain ingredients or components, may be subject to vigorous review, including multiple regulatory submissions, and approvals are not certain. For example, to obtain a new indication, a company must demonstrate with additional clinical data that the product is safe and effective for the new use. FDA regulatory review may result in denial or modification of the planned changes, or requirements to conduct additional tests or evaluations that can substantially delay or increase the cost of the planned changes.

        Even after a company obtains regulatory approval to market a product, the product and the company's manufacturing processes and quality systems are subject to continued review by the FDA and other regulatory authorities globally. We and our contract manufacturers also must adhere to cGMPs and product-specific regulations enforced by regulatory agencies both before and after product approval. Regulatory agencies regulate and inspect equipment, facilities and processes used in the manufacturing and testing of biologic products prior to approving a product, as well as periodically following the initial approval of a product. If, as a result of these inspections, it is determined that our equipment, facilities or processes or that of our manufacturers do not comply with applicable regulations and conditions of product approval, we may face civil, criminal or administrative sanctions or remedies, including significant financial penalties and the suspension of our manufacturing operations.

        Manufacturers are also required to monitor information on side effects and adverse events reported during clinical studies and after marketing approval and report such information and events to regulatory agencies. Non-compliance with the FDA's safety reporting requirements may result in civil or criminal penalties. Side effects or adverse events that are reported during clinical trials can delay, impede or prevent marketing approval. Based on new safety information that emerges after approval, the FDA can mandate product labeling changes, impose a new REMS or the addition of elements to an existing REMS, require new post-marketing studies (including additional clinical trials) or suspend or withdraw approval of the product. These requirements may affect a company's ability to maintain marketing approval of its products or require a company to make significant expenditures to obtain or maintain such approvals.

Pricing and Reimbursement

        In both U.S. and non-U.S. markets, sales of our products depend, in part, on the availability and amount of reimbursement by third party payors, including governments, private health plans and other organizations. Substantial uncertainty exists regarding the coverage, pricing and reimbursement of our products. Governments may regulate coverage, reimbursement and pricing of our products to control healthcare cost or affect utilization of the products. The U.S. and non-U.S. governments have enacted and regularly consider additional reform measures that affect health care and drug coverage and costs. Private health plans may also seek to manage cost and utilization by implementing coverage and reimbursement limitations. Other payors, including managed care organizations, health insurers, pharmacy benefit managers, government health administration authorities and private health insurers, seek price discounts or rebates in connection with the placement of our products on their formularies and, in some cases, the imposition of restrictions on access or coverage of particular drugs or pricing determined based on perceived value.

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Within the United States

    Medicaid:   Medicaid is a joint federal and state program that is administered by the states for low-income and disabled beneficiaries. Under the Medicaid Drug Rebate Program, we are required to pay a rebate for each unit of product reimbursed by the state Medicaid programs. For most brand name drugs, the amount of the basic rebate for each product is set by law as 17.1% for clotting factors and certain other products of the average manufacturer price (AMP) or the difference between AMP and the best price available from us to any customer (with limited exceptions). The rebate amount must be adjusted upward if AMP increases more than inflation (measured by the Consumer Price Index—Urban). This adjustment can cause the total rebate amount to exceed the minimum 17.1% basic rebate amount. The rebate amount is calculated each quarter based on our report of current AMP and best price for each of our products to the Centers for Medicare & Medicaid Services (CMS). The requirements for calculating AMP and best price are complex. We are required to report any revisions to AMP or best price previously reported within a certain period, which revisions could affect our rebate liability for prior quarters. In addition, if we fail to provide information timely or are found to have knowingly submitted false information to the government, the statute governing the Medicaid Drug Rebate Program provides for civil monetary penalties.

    Medicare:   Medicare is a federal program that is administered by the federal government and covers individuals age 65 and over, as well as those with certain disabilities. Medicare Part B generally covers drugs that must be administered by physicians or other health care practitioners; are provided in connection with certain durable medical equipment; or certain oral anti-cancer drugs and certain oral immunosuppressive drugs. Clotting factors for hemophilia are typically paid under Medicare Part B. Medicare Part B pays for such drugs under a payment methodology based on the average sales price (ASP) of the drugs. Manufacturers, including us, are required to provide ASP information to the CMS on a quarterly basis. The manufacturer-submitted information is used to calculate Medicare payment rates. For drugs administered outside the hospital outpatient setting, the current payment rate for Medicare Part B drugs is ASP plus six percent, but CMS has proposed a model that would test whether changing the add-on payment to 2.5% plus a flat fee payment of $16.80 per drug per day changes prescribing incentives and leads to improved quality and value, and that would incorporate certain "value-based pricing" tools. The payment rates for drugs in the hospital outpatient setting are subject to periodic adjustment. If a manufacturer is found to have made a misrepresentation in the reporting of ASP, the governing statute provides for civil monetary penalties.

      Medicare Part D provides coverage to enrolled Medicare patients for self-administered drugs (i.e., drugs that are not administered by a physician). Medicare Part D is administered by private prescription drug plans approved by the U.S. government and each drug plan establishes its own Medicare Part D formulary for prescription drug coverage and pricing, which the drug plan may modify from time-to-time. The prescription drug plans negotiate pricing with manufacturers and may condition formulary placement on the availability of manufacturer discounts. In addition, manufacturers, including us, are required to provide to CMS a 50% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries reach the coverage gap in their drug benefits.

    Federal Agency Discounted Pricing:   Our products are subject to discounted pricing when purchased by federal agencies via the Federal Supply Schedule (FSS). FSS participation is required for our products to be covered and reimbursed by the Veterans Administration (VA), Department of Defense, Coast Guard and PHS. Coverage under Medicaid, Medicare and the PHS pharmaceutical pricing program is also conditioned upon FSS participation. FSS pricing is intended not to exceed the price that we charge our most-favored non-federal customer for a product. In addition, prices for drugs purchased by the VA, Department of Defense (including

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      drugs purchased by military personnel and dependents through the TriCare retail pharmacy program), Coast Guard, and PHS are subject to a cap on pricing equal to 76% of the non-federal average manufacturer price (non-FAMP). An additional discount applies if non-FAMP increases more than inflation (measured by the Consumer Price Index—Urban). In addition, if we fail to provide information timely or are found to have knowingly submitted false information to the government, the governing statute provides for civil monetary penalties.

    340B Discounted Pricing:   To maintain coverage of our products under the Medicaid Drug Rebate Program and Medicare Part B, we are required to extend significant discounts to certain covered entities that purchase products under Section 340B of the PHS pharmaceutical pricing program. Purchasers eligible for discounts include hospitals that serve a disproportionate share of financially needy patients, community health clinics, hemophilia treatment centers and other entities that receive certain types of grants under the Public Health Service Act. For all of our products, we must agree to charge a price that will not exceed the amount determined under statute (the "ceiling price") when we sell outpatient drugs to these covered entities. In addition, we may, but are not required to, offer these covered entities a price lower than the 340B ceiling price. The 340B discount formula is based on AMP and is generally similar to the level of rebates calculated under the Medicaid Drug Rebate Program.

Outside the United States

        Within the European Union, products sold by Sobi are paid for by a variety of payors, with governments being the primary source of payment. Governments may determine or influence reimbursement of products. Governments may also set prices or otherwise regulate pricing. Negotiating prices with governmental authorities can delay commercialization of our products. Governments may use a variety of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, "value-based pricing" and reference pricing (i.e., referencing prices in other countries and using those reference prices to set a price). Budgetary pressures in many countries in the European Union are continuing to cause governments to consider or implement various cost-containment measures, such as price freezes, increased price cuts and rebates and expanded generic substitution and patient cost-sharing.

Japanese Regulatory Matters

        In Japan, the MHLW is responsible for regulating biological and pharmaceutical products under the Pharmaceuticals and Medical Devices Law, which provides a regulatory framework similar to that of the United States. Specifically, with regard to the clinical trial and approval process, before a new biological product may be sold in Japan, clinical trials must be conducted for the product of which the MHLW/ the Pharmaceuticals and Medical Devices Agency (PMDA), a governmental organization authorized by the MHLW, must be notified. For the product to be approved, the results of such clinical trials must then be submitted to the PMDA. Approved products are subject to regulatory requirements similar to those of the United States, including (i) the possibility of the MHLW requiring post-marketing studies to gather data on a product's safety and efficacy as a condition for approval, (ii) re-examination of the approved product within a specific time period following approval (e.g., 8 years for a new product) to verify its safety and efficacy and (iii) the reporting of any adverse event to the PMDA. With regard to pricing and reimbursement, Japan has a single health insurance system (National Health Insurance), under which drugs are provided to patients at a price designated by the MHLW in its discretion after negotiations between the applicable biopharmaceutical company and the MHLW under the National Health Insurance Act.

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Other Laws

        We and our products are also subject to various other regulatory regimes both inside and outside the United States. Various laws, regulations and recommendations relating to data privacy and protection, safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement, import, export and use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research work are or may be applicable to our activities. In the United States alone, we are subject to the oversight of FDA, the Office of the Inspector General within the Department of Health and Human Services, the CMS, the Department of Justice, the Environmental Protection Agency, the Department of Defense and Customs and Border Protection, in addition to others. In jurisdictions outside the United States, our activities are subject to regulation by government agencies including the EMA in Europe, and other agencies in other jurisdictions. Many of the agencies enforcing these laws have increased their enforcement activities with respect to healthcare companies in recent years. These actions appear to be part of a general trend toward increased enforcement activity globally. In addition, certain agreements entered into by us involving exclusive license rights may be subject to national or international antitrust regulatory control, the effect of which cannot be predicted. The extent of government regulation, which might result from future legislation or administrative action, cannot accurately be predicted.

Patient Engagement and Access

        We interact with patients, advocacy organizations and healthcare societies in order to gain insights into unmet needs in the hemophilia treatment community. The insights gained from these engagements help develop services, programs and applications that are designed to help patients lead better lives.

        We are dedicated to helping patients obtain access to our therapies. For example, we provide charitable contributions that may assist eligible patients to receive our products. We expect to continue Biogen's commitment, together with Sobi, to donate up to one billion international units (IUs) of clotting factor therapy for humanitarian use, of which up to 500 million IUs will be donated to the WFH over a period of five years. We will be responsible for half of the committed donation. In 2015, the first shipments of hemophilia therapy were made to the WFH.

Employees

        We expect to employ approximately 400 persons as of the distribution date. We believe that we have good relations with our employees.

Environmental Matters

        Our environmental policies require compliance with all applicable environmental regulations and contemplate, among other things, appropriate capital expenditures for environmental protection.

Legal Proceedings

        We are involved in various claims and legal proceedings, including the matters described below.

Patent Matter

        Biogen has received communications from a third party, Pfizer, regarding a proposal that Biogen take a license to Pfizer's U.S. Patent No. 8,603,777 (Expression of Factor VII and IX Activities in Mammalian Cells) and pay royalties on past and future sales of ALPROLIX. There is no pending litigation with Pfizer and an estimate of a possible loss or range of loss cannot be made at this time.

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Government Matters

        On March 4, 2016, Biogen received a subpoena from the federal government for documents relating to our relationship with non-profit organizations that provide assistance to patients taking drugs sold by Biogen. Biogen is cooperating with the government.

        On July 1, 2016, Biogen received civil investigative demands from the federal government for documents and information relating to our treatment of certain service agreements with wholesalers when calculating and reporting AMPs in connection with the Medicaid Drug Rebate Program. Biogen is cooperating with the government.

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MANAGEMENT

Executive Officers Following the Distribution

        The following sets forth information regarding individuals who are expected to serve as our executive officers following completion of the distribution, including their positions and age as of the date of this information statement. Biographical information for Mr. Cox is contained below in the section entitled "Management—Board of Directors Following the Distribution." While some of these individuals currently serve as officers and employees of Biogen, after the distribution, none of our executive officers will be officers or employees of Biogen.

Name
  Age   Title

John G. Cox

    54   Chief Executive Officer

John Greene

    51   Executive Vice President, Chief Financial Officer and Treasurer

Rogério Vivaldi, M.D. 

    53   Executive Vice President and Chief Global Therapeutic Operations Officer

Richard Brudnick

    60   Executive Vice President of Business Development

Lucia Celona

    50   Executive Vice President, Chief Human Resources and Corporate Communications Officer

Andrea DiFabio

    48   Executive Vice President and Chief Legal Officer

         John Greene became Executive Vice President, Chief Financial Officer and Treasurer of Bioverativ in November 2016. Prior to joining Bioverativ, Mr. Greene served as the Chief Financial Officer of Willis Group Holdings (Willis), a multinational risk advisory, insurance and reinsurance brokerage firm, from June 2014 until January 2016. Following Willis's merger with Towers Watson in January 2016, Mr. Greene served as a transition advisor to the new management team until May 2016. Before joining Willis, he served for over eight years in senior executive roles at HSBC, a global financial services company, including as Chief Financial Officer of HSBC Retail Bank and Wealth Management from May 2011 to May 2014, Chief Financial Officer of HSBC Insurance from August 2009 until May 2011 and Chief Financial Officer of HSBC's Consumer and Mortgage Lending business prior to August 2009. Before joining HSBC, Mr. Greene served for 12 years in various roles at General Electric Company, including as Chief Financial Officer for GE Global Business Finance.

         Rogério Vivaldi, M.D. became Executive Vice President, Chief Global Therapeutic Operations Officer of Bioverativ in October 2016. Prior to joining Bioverativ, Dr. Vivaldi served as Chief Commercial Officer of Spark Therapeutics, Inc. (Spark) from December 2014 to October 2016. Prior to joining Spark, Dr. Vivaldi was Chief Executive Officer and President of Minerva Neurosciences, Inc. from November 2013 to December 2014. Prior to joining Minerva, Dr. Vivaldi served as Senior Vice President—Head of the Rare Diseases business unit at Genzyme Corporation, from October 2011 to October 2013. From July 2010 to September 2011, he was the Senior Vice President—Head of the Renal and Endocrinology business unit at Genzyme and from January 2004 to June 2010 he was the Senior Vice President—Head of Genzyme Latin America. Previously, Dr. Vivaldi founded Genzyme Brazil in 1997. Dr. Vivaldi served on Spark's board of directors from April 2014 to December 2014 and served on the board of directors of Minerva Neurosciences from November 2013 to December 2014. Dr. Vivaldi holds a medical degree from the University of Rio de Janeiro and his M.B.A. from Federal University of Rio de Janeiro. Dr. Vivaldi completed his residency in metabolism and endocrinology at Rio de Janeiro State University and his fellowship at Mount Sinai Hospital Center in New York, department of genetics, with an emphasis on Gaucher's disease.

         Richard Brudnick has been named to serve as the Executive Vice President of Business Development of Bioverativ. Mr. Brudnick has served as Biogen's Senior Vice President of Corporate Development since 2014. Mr. Brudnick joined Biogen in 2001 and has held senior positions in the areas of Portfolio Strategy & Business Development and Corporate Development. Before joining Biogen, Mr. Brudnick was the Chief Executive Officer of a regional pharmaceutical distribution business, a co-founder of two companies and a strategy consultant at Bain & Company.

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         Lucia Celona has been named to serve as the Executive Vice President, Chief Human Resources and Corporate Communications Officer of Bioverativ. Ms. Celona served as the Vice President of Human Resources for the Pharmaceutical Operations and Technology function of Biogen from 2013 through June 2016. Ms. Celona joined Biogen in 2006 and has held senior level positions including Vice President, Talent Acquisition & Global Mobility, interim Vice President of Compensation & Benefits, Chief of Staff to the Executive Vice Presidents of Human Resources and Executive Vice President of Global Therapeutic Operations. Before joining Biogen, Ms. Celona was head of human resources for Sentillion Inc., a privately held company that focused on single-sign on solutions for healthcare providers, and the human resources director for two manufacturing sites at Philips Medical Systems in Andover, Massachusetts.

         Andrea DiFabio has been named to serve as the Executive Vice President and Chief Legal Officer of Bioverativ. Ms. DiFabio has served as Biogen's Senior Vice President, Chief Research and Business Development Counsel since 2015. Ms. DiFabio joined Biogen in 2006 and has held various positions including serving as Chief US Counsel, Interim Chief Compliance Officer and Chief Research and Development Counsel. Prior to Biogen, she was Corporate Vice President and Deputy General Counsel at Parexel International, a global contract research organization. Prior to her work at Parexel International, Ms. DiFabio was a trial lawyer for two Boston law firms, Brown Rudnick Freed & Gesmer and Robins, Kaplan Miller & Ceresi.

Board of Directors Following the Distribution

        The following table sets forth information with respect to those persons who are expected to serve on our board of directors immediately following the completion of the distribution. The nominees will be presented to Bioverativ's sole shareholder, Biogen, for election prior to the distribution.

Name
  Age   Title

John G. Cox

    54   Director and Chief Executive Officer

Alexander J. Denner, Ph.D. 

    47   Director

Louis J. Paglia

    59   Director

Brian S. Posner

    55   Director

         John G. Cox became Chief Executive Officer of Bioverativ in July 2016. Previously, from June 2010 through June 2016, Mr. Cox served on Biogen's executive committee as Executive Vice President, Pharmaceutical Operations & Technology, where he oversaw Biogen's global manufacturing facilities, supply chain operations, technical development, quality and engineering. Mr. Cox also had responsibility for the development and commercialization of Biogen's biosimilar business. From October 2015 to May 2016, Mr. Cox also served as interim Executive Vice President, Global Therapeutic Operations, responsible for Biogen's therapeutic groups of Specialty Medicines and Rare Diseases, which included responsibility for the global commercial performance of Biogen's marketed products. Mr. Cox joined Biogen in 2003, holding several senior executive positions including Senior Vice President of Technical Operations, Senior Vice President of Global Manufacturing and Vice President of Manufacturing and General Manager of Biogen's operations in Research Triangle Park, North Carolina. He reported to Biogen's Chief Executive Officer as a member of Biogen's executive committee, since 2010. Mr. Cox serves on the board of directors of Repligen Corporation, a life sciences company. He also served on the board of Biogen's biosimilars joint venture, Samsung Bioepis, until July 2016. Mr. Cox received his B.S. in biology from Arizona State University, M.B.A. from the University of Michigan, and M.S. in cell biology from California State University.

         Alexander J. Denner, Ph.D. is a founding partner and Chief Investment Officer of Sarissa Capital Management LP (Sarissa Capital). Sarissa Capital focuses on improving the strategies of companies to better provide stockholder value. From 2006 to 2011, Dr. Denner served as a Senior Managing Director at Icahn Capital. Prior to that, he served as a portfolio manager at Viking Global Investors and

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Morgan Stanley Investment Management. He is currently chairman of the board of ARIAD Pharmaceuticals, and a member of the boards of directors of Biogen and The Medicines Company. During the past five years, Dr. Denner previously served on the boards of directors of Amylin Pharmaceuticals Inc., Vivus, Inc. and Enzon Pharmaceuticals. Dr. Denner's qualifications for service on our board of directors include his significant experience overseeing the operations and research and development of healthcare companies and evaluating corporate governance matters. He also has extensive experience as an investor, particularly with respect to healthcare companies, and possesses broad healthcare industry knowledge.

         Louis J. Paglia is the founding member of Oakstone Capital LLC, a private investment firm. He previously founded Customer Choice LLC in April 2010, a data analytics company serving the electric utility industry. He previously served as Executive Vice President of UIL Holdings Corporation (UIL), an electric utility, contracting and energy infrastructure company. Mr. Paglia also served as UIL's Chief Financial Officer and as President of its investment subsidiaries. Prior to joining UIL, Mr. Paglia was Executive Vice President and Chief Financial Officer of eCredit.com, a credit evaluation software company. Prior to that, Mr. Paglia served as the Chief Financial Officer both for TIG Holdings Inc., a property and casualty insurance and reinsurance holding company, and for Emisphere Technologies, Inc., a specialty pharmaceutical company. He is currently a member of the boards of directors of Arch Capital Group Ltd., NorthStar Realty Finance Corp. and NorthStar Asset Management Group Inc. Mr. Paglia's qualifications for service on our board of directors include his strong financial background, experience in investment banking and extensive executive management and operating experience in publicly-held companies.

         Brian S. Posner is the President of Point Rider Group LLC, a consulting and advisory services firm within the financial services industry, and has served as private investor since 2008. From 2005 to March 2008, Mr. Posner served as the President, Chief Executive Officer and Co-Chief Investment Officer of ClearBridge Advisors, LLC, an asset management company and a wholly owned subsidiary of Legg Mason. Prior to that, Mr. Posner co-founded Hygrove Partners LLC, a private investment fund, in 2000 and served as its Managing Member for five years. He served as a portfolio manager and an analyst at Fidelity Investments, a financial services company, from 1987 to 1996 and, from 1997 to 1999, at Warburg Pincus Asset Management/Credit Suisse Asset Management where he also served as co-Chief Investment Officer and Director of Research. Mr. Posner currently serves on the boards of directors of Biogen and Arch Capital Group Ltd. and he is a trustee of the AQR Funds. During the past five years, Mr. Posner previously served on the boards of directors of BG Medicine, Inc. and Riverpark Funds Trust. Mr. Posner's qualifications for service on our board of directors include his substantial experience as a leading institutional investment manager and advisor and significant management and financial expertise.

Director Independence

        It is anticipated that at least a majority of our board of directors will satisfy the independence standard established by the listing standards of Nasdaq Global Select Market.

Committees of the Board of Directors

        Effective upon the completion of the distribution, our board of directors will have the following standing committees: an Audit Committee, a Compensation Committee and a Corporate Governance Committee. Our board of directors will adopt a written charter for each of these committees, which will be posted on our website, www.bioverativ.com.

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Audit Committee

        The responsibilities of the Audit Committee will be more fully described in our Audit Committee Charter and are expected to include, among other duties:

    overseeing the independence, qualifications and performance of our independent registered public accounting firm and ensuring receipt of their annual independence statement;

    appointing and approving the compensation of our independent registered public accounting firm;

    pre-approving, with sole authority and direct responsibility, all audit, audit-related and permitted non-audit services to be provided to us by the independent registered public accounting firm;

    reviewing annual audited and quarterly financial statements, as well as disclosures required to be reviewed under applicable legal, regulatory or stock exchange requirements;

    obtaining and reviewing periodic reports, at least annually, from management assessing the effectiveness of our internal control over financial reporting;

    reviewing our accounting, financial reporting and other processes to assure compliance with all applicable laws, regulations and corporate policy;

    reviewing our tax strategy and internal audit and corporate compliance functions;

    establishing procedures for confidential and anonymous submission and treatment of complaints regarding our accounting, internal controls, disclosure or other financial or auditing matters;

    preparing audit committee reports required by applicable SEC rules; and

    overseeing management's exercise of its responsibility to assess and manage risks associated with the company's financial, accounting and disclosure matters.

        The Audit Committee will consist entirely of independent directors, and we intend that each will meet the independence requirements set forth in the listing standards of the Nasdaq Global Select Market and Rule 10A under the Exchange Act. Each member of the Audit Committee will be financially literate and have accounting or related financial management expertise, as such terms are interpreted by our board of directors in its business judgment. Additionally, at least one member of the Audit Committee will be an "audit committee financial expert" under SEC rules and the Nasdaq Global Select Market listing standards applicable to audit committees. The initial members of the Audit Committee will be determined prior to the completion of the distribution.

Compensation Committee

        The responsibilities of the Compensation Committee will be more fully described in our Compensation Committee Charter and are expected to include, among other duties:

    reviewing our strategy, policies and practices in the areas of compensation, benefits, management and leadership development, diversity and equal employment opportunity and human resource planning;

    assisting our board of directors in succession plans for executives and other senior management;

    overseeing the performance evaluation of the Chief Executive Officer;

    recommending, for approval by the independent directors, the Chief Executive Officer's compensation;

    approving the compensation of our other executive officers;

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    approving the grant of awards under our equity and other management incentive plans;

    preparing the compensation committee report required by applicable SEC rules; and

    reviewing with management our assessment of significant risks with respect to the workforce and compensation and benefits programs, and steps taken by management to monitor or mitigate those risks.

        The Compensation Committee will consist entirely of independent directors, and we intend that each will meet the independence requirements set forth in the listing standards of the Nasdaq Global Select Market. We also intend the members of the Compensation Committee will qualify as "non-employee directors" (within the meaning of Rule 16b-3 of the Exchange Act) and "outside directors" (within the meaning of Section 162(m) of the Code). The initial members of the Compensation Committee will be determined prior to the completion of the distribution.

Corporate Governance Committee

        The responsibilities of the Corporate Governance Committee will be more fully described in our Corporate Governance Committee Charter and are expected to include, among other duties:

    developing and recommending a set of corporate governance principles, making recommendations for changes as needed from time to time and monitoring compliance with the principles;

    identifying individuals qualified to become directors, including reviewing director candidates recommended by stockholders, and recommending candidates for all directorships;

    reviewing the committee structure of the board of directors and recommending directors to serve as chair and as members of each committee;

    considering questions of independence and possible conflicts of interest and related party transactions involving directors and executive officers; and

    taking an oversight role in shaping our policies and procedures and considering risk exposures relating to corporate governance and board succession.

        The Corporate Governance Committee will consist entirely of independent directors, and we intend that each will meet the independence requirements set forth in the listing standards of the Nasdaq Global Select Market. The initial members of the Corporate Governance Committee will be determined prior to the completion of the distribution.

Compensation Committee Interlocks and Insider Participation

        During the 2015 fiscal year, Bioverativ did not exist and did not have a compensation committee or any other committee serving a similar function. Decisions as to the compensation of those who are expected to serve as our executive officers were made by Biogen's Compensation and Management Development Committee.

Corporate Governance

Corporate Governance Principles and Codes

        In connection with the separation and the distribution, our board of directors is expected to adopt corporate governance principles that set forth the responsibilities of the board of directors and the qualifications and independence of its members and the members of its standing committees. In addition, in connection with the separation and distribution, our board of directors is expected to adopt, among other codes and policies, a code of conduct setting forth standards applicable to all of

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our companies and our directors, officers and employees. The corporate governance principles and code of conduct will be available on Bioverativ's website at www.bioverativ.com. We expect that any amendment to the code, or any waivers of its requirements, will be disclosed on our website as required.

Communications with the Board of Directors and Procedures for Treatment of Complaints Regarding Accounting, Internal Accounting Controls and Auditing Matters

        Upon the distribution, Bioverativ expects that the Audit Committee will establish procedures for (i) the receipt, retention and treatment of complaints regarding accounting, internal accounting controls or auditing matters (accounting matters) and (ii) the confidential, anonymous submission by employees of concerns regarding questionable accounting matters. Such complaints or concerns are expected to be able to be submitted to Bioverativ, care of its Secretary or through another method as published on Bioverativ's website. Stockholders who wish to communicate directly with our board of directors, or any individual director, should direct questions in writing to the Secretary, Bioverativ, 225 Second Avenue, Waltham, MA 02451. Communications addressed in this manner will be forwarded directly to our board of directors or named individual director(s).

Board Leadership Structure

        Our governing documents allow the roles of chairman and chief executive officer to be filled by the same or different individuals. This approach allows our board of director's flexibility to determine whether the two roles should be separated or combined based upon our needs and our board of director's assessment of our leadership from time to time. It is expected that our board of directors will regularly consider the advantages of having an independent chairman and a combined chairman and chief executive officer and is open to different structures as circumstances may warrant.

        At this time, our board of directors believes that separating the roles of chairman and chief executive officer serves the best interests of Bioverativ and its stockholders. We believe that having an independent chairman promotes a greater role for the independent directors in the oversight of our company, including oversight of material risks facing the company, encourages active participation by the independent directors in the work of our board of directors, enhances our board of directors' role of representing stockholders' interests and improves our board of directors' ability to supervise and evaluate our chief executive officer and other executive officers.

Qualification and Nomination of Directors

        The Corporate Governance Committee charter that is expected to be adopted in connection with the separation and the distribution will provide that the Corporate Governance Committee considers and recommends to our board of directors nominees for election to, or for filling any vacancy on, Bioverativ's board of directors in accordance with its bylaws, its corporate governance principles and the committee's charter. The committee is expected to periodically review the requisite skills and characteristics of board members as well as the size, composition, functioning and needs of Bioverativ's board of directors as a whole. To be considered for board membership, a nominee for director must be an individual who has the highest personal and professional ethics and integrity, understands and is aligned with our core values and is committed to representing the long-term interests of our stockholders. Our directors must also be inquisitive and objective and have practical wisdom and mature judgment. In accordance with our corporate governance principles, we will endeavor to have a board of directors that collectively represents diverse experience at strategic and policy making levels in business, government, education, healthcare, science and technology and the international arena, and collectively has knowledge and expertise in the functional areas of accounting and finance, risk management and compliance, strategic and business planning, corporate governance, human resources, marketing and commercial and research and development. We expect that in selecting nominees to our

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board of directors, the Corporate Governance Committee will consider the diversity of skills and experience that a potential nominee possesses and the extent to which such diversity would enhance the perspective, background, knowledge and experience of our board of directors as a whole. We expect that the board of directors will consider personal diversity, including gender, ethnic and racial diversity, as an additional benefit to the board of directors as a whole.

        Whenever the Corporate Governance Committee concludes, based on the reviews or considerations described above or due to a vacancy, that a new nominee to Bioverativ's board of directors is required or advisable, it will consider recommendations from directors, management, stockholders and, if it deems appropriate, consultants retained for that purpose. In such circumstances, it will evaluate individuals recommended by stockholders in the same manner as nominees recommended from other sources. Stockholders who wish to recommend an individual for nomination should send that person's name and supporting information to the committee, care of the Secretary, Bioverativ, 225 Second Avenue, Waltham, MA 02451. Stockholders who wish to directly nominate an individual for election as a director, without going through the Corporate Governance Committee must comply with the procedures in Bioverativ's amended and restated bylaws.

Director Compensation

        Director compensation will be determined by our board of directors. At present, it is anticipated that each non-employee director of Bioverativ will receive:

    An annual cash retainer of $60,000.

    An initial election stock option grant with a grant date value of $450,000. The initial election grant will generally vest ratably on each of the first three anniversaries of the date of grant (subject to continued service) and will be granted pursuant to a non-employee director equity plan to be adopted in connection with the distribution.

    For each term of service after the initial term, an annual equity retainer with a grant date value of $300,000, divided equally between stock options and full value awards such as restricted stock or restricted stock units (RSUs). The annual equity retainer will generally vest on the first anniversary of the date of grant (subject to continued service) and will be granted pursuant to a non-employee director equity plan to be adopted in connection with the distribution.

        In addition to the foregoing remuneration, it is anticipated that (i) our non-executive chair of the board of directors will receive an additional $100,000 annual retainer, of which $50,000 will be paid in cash and the remaining $50,000 will be divided equally between stock options and full value awards such as restricted stock or RSUs generally vesting on the first anniversary of the date of grant (subject to continued service); (ii) the chair of each of the Audit Committee, Compensation Committee and the Corporate Governance Committee will receive an additional annual cash retainer of $25,000, $20,000 and $15,000, respectively; and (iii) directors serving on each of the Audit Committee, Compensation Committee and the Corporate Governance Committee, other than the chairs of such committees, will receive an additional annual cash retainer of $10,000, $8,000 and $6,000, respectively.

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EXECUTIVE COMPENSATION

        The disclosure set forth below describes the compensation paid to or earned by the Chief Executive Officer of Bioverativ from Biogen for the 2015 fiscal year. Prior to the distribution, Bioverativ will continue to be part of Biogen and, therefore, compensation of executives of Bioverativ will be determined by Biogen's Compensation and Management Development Committee. In connection with the distribution, Bioverativ's board of directors will form the Compensation Committee. Following the distribution, Bioverativ's Compensation Committee will determine the executive compensation policies of Bioverativ following the distribution. The "Named Executive Officers" for purposes of the disclosure set forth below are John G. Cox, the Chief Executive Officer of Bioverativ, and Mr. John Greene and Dr. Rogério Vivaldi, the two other executive officers who are expected to be the most highly compensated executive officers of Bioverativ. Because neither Mr. Greene nor Dr. Vivaldi were employed by Biogen during the 2015 fiscal year, the compensation tables set forth below do not include information with respect to their historic compensation.


SUMMARY COMPENSATION TABLE

        The Summary Compensation Table shows the compensation paid to or earned by the Bioverativ Named Executive Officer listed below for 2015 under Biogen's compensation programs and plans. Following the separation, Named Executive Officers will receive compensation and benefits under our compensation programs and plans.

Name and Principal Position
  Year   Salary
($)
  Stock Awards
($) (1)
  Non-Equity
Incentive
Plan
Compensation
($) (2)
  Change In Pension
Value and
Nonqualified
Deferred
Compensation
Earnings
($) (3)
  All Other
Compensation
($) (4)
  Total
($)
 

John G. Cox

    2015     674,753     3,559,612     258,348     144,138     340,997     4,977,848  

Chief Executive Officer

                                           

(1)
The amount reflects the grant date fair value computed in accordance with FASB ASC Topic 718 for market stock units (MSUs) and cash-settled performance units (CSPUs) granted by Biogen during 2015, excluding the effect of estimated forfeitures. The fair value of the MSU grant is estimated as of the date of grant using a lattice model with a Monte Carlo simulation. Assumptions used in this calculation are included in Note 9, Share-Based Compensation , to the audited combined financial statements elsewhere in this information statement. The MSU and CSPU grants are estimated based on target performance. The table below shows the target and maximum payouts possible for the 2015 MSU and CSPU awards based on the value at the date of grant and the payout ranges.
Named Executive Officer
  Target Payout
($)
  Maximum Payout
($)
 

Mr. Cox

    3,559,612     7,119,225  
(2)
The amount in the column titled "Non-Equity Incentive Plan Compensation" reflects the actual bonus paid under Biogen's 2008 Performance-Based Management Incentive Plan.

(3)
The amount in the column titled "Change in Pension Value and Nonqualified Deferred Compensation Earnings" reflects earnings in Biogen's Supplemental Savings Plan that are in excess of 120% of the applicable federal long-term rate. The federal long-term rate applied in this calculation is 3.16% for 2015.

(4)
The amount in the column titled "All Other Compensation" is reflected in the following table:
Executive Officer
  Biogen Matching
Contribution
to 401(k)
Plan Account
($)
  Biogen
Contribution
to SSP Account
($)
  Personal
Financial and
Tax Planning
Reimbursement
($) (A)
  Value of
Biogen-Paid
Life
Insurance
Premiums
($)
 

Mr. Cox

    15,900     308,927     15,000     1,170  

(A)
The amount for Mr. Cox includes the 2015 benefit of $7,500 and reimbursement during 2015 of the 2014 benefit of $7,500, each provided under Biogen's personal financial and tax planning reimbursement program.

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OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END TABLE

        The Outstanding Equity Awards At Fiscal Year-End Table summarizes the number of securities underlying equity awards outstanding under Biogen's equity plans for the Bioverativ Named Executive Officer listed below as of December 31, 2015.

Option Awards (1)   Stock Awards  
Name
  Grant
Date
  Number of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
  Number of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
  Option
Exercise
Price
($)
  Option
Expiration
Date
  Number of
Shares
or Units
of Stock
That Have
Not Vested
(#) (2)
  Market Value
of Shares or
Units of
Stock That
Have Not
Vested
($) (3)
  Equity
Incentive Plan
Awards:
Number of
Unearned
Shares, Units
or Other
Rights That
Have Not
Vested
(#) (4)
  Equity
Incentive Plan
Awards:
Market or
Payout Value of
Unearned
Shares, Units
or Other
Rights That
Have Not Vested
($) (4)
 

John G. Cox

  2/12/2008     2,892         60.56     2/11/2018                  

  2/24/2009     7,588         49.65     2/23/2019                  

  2/8/2012                             4,026     1,233,365  

  2/12/2013                     3,459     1,059,518          

  2/12/2013                             4,494     1,376,737  

  2/12/2014                     4,965     1,520,951          

  2/12/2014                             2,447     749,638  

  2/23/2015                     3,428     1,050,168          

  2/23/2015                             3,630     1,112,051  

(1)
All stock options were granted with a ten-year term. Stock options vest 25% on each of the first four anniversaries of the grant date.

(2)
CSPUs were granted in 2015, 2014 and 2013. Numbers reflect the number of CSPUs earned and eligible to vest based on Biogen's financial performance for each of 2015, 2014 and 2013, but that have not satisfied the service-based vesting requirement as of December 31, 2015. CSPUs that have been earned upon satisfaction of the performance conditions vest ratably over three years from the grant date. The cash payout for these awards will be based on Biogen's 60-day average stock price at vesting for awards granted prior to 2014 and Biogen's 30-day average stock price at vesting for awards granted in 2014 and 2015.

(3)
The market value of awards is based on the closing price of Biogen's stock on December 31, 2015 ($306.35), as reported by the Nasdaq Global Select Market.

(4)
MSUs were granted in 2015, 2014, 2013 and 2012. These are performance-based RSUs tied to the growth in Biogen's stock price between the dates of grant and vesting. MSUs are eligible to vest ratably over four years for grants made prior to 2014, and three years for grants made in 2014 and 2015. The numbers and values shown reflect maximum performance results for MSUs granted in 2012 and 2013 and target performance results for MSUs granted in 2014 and 2015 based on Biogen's prior year's performance in each case.

Bioverativ Employment Arrangements

John G. Cox Letter Agreement

        In connection with the planned separation of Biogen and Bioverativ, Biogen entered into an offer letter agreement with our Chief Executive Officer, John G. Cox, on May 19, 2016. Pursuant to the terms of the offer letter agreement, Mr. Cox's employment with Bioverativ will be on an at-will basis and he will be entitled to a post-distribution starting annual base salary of $800,000 and an annual cash target bonus of 100% of his annual base salary. Following the distribution, Mr. Cox will receive a one-time Founder's Grant of Bioverativ stock options with an approximate grant date expected value of $6,500,000, with a per share exercise price equal to the fair market value of Bioverativ's common stock on the date of grant. The initial grant of stock options will vest on the third anniversary of the date of grant and will be subject to the Bioverativ omnibus incentive plan (the Omnibus Plan) (described below). Subject to the annual determination of Bioverativ's board of directors and Compensation Committee, the offer letter agreement also provides that Mr. Cox will be eligible for a post-distribution

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annual long-term incentive award with a current planning reference value of $6,500,000, which award is expected to be divided equally between RSUs and stock options.

        In the event that, within one year following the distribution, Mr. Cox is involuntarily terminated other than for cause or resigns his employment following adverse changes to his terms and conditions of employment under certain circumstances (and subject to his execution of a release of claims), Mr. Cox will be entitled to receive (i) a lump sum severance payment equal to 24 months of base salary and target bonus, (ii) up to 12 months of outplacement services and (iii) continued subsidized health benefits for up to 21 months. It is expected that a termination of employment following the first anniversary of the distribution will be governed by a Bioverativ executive severance plan. The offer letter agreement further provides that no gross-up payment would be made in the event that a severance payment or benefit due to Mr. Cox is subject to a "golden parachute" excise tax, and specifies that if the amounts payable to Mr. Cox otherwise would be subject to such an excise tax, the payment amount will be reduced to the maximum amount that will not trigger the excise tax.

John Greene Letter Agreement

        In connection with the planned separation of Biogen and Bioverativ, Biogen entered into an offer letter agreement with John Greene, our Executive Vice President and Chief Financial Officer. Pursuant to the terms of the offer letter agreement, Mr. Greene's employment with Bioverativ will be on an at will basis and he will be entitled to a post distribution starting annual base salary of $625,000 and an annual cash target bonus of 50% of his annual base salary. Following the distribution, Mr. Greene will receive a one-time Founder's Grant of Bioverativ stock options with an approximate grant date expected value of $1,900,000, with a per share exercise price equal to the fair market value of Bioverativ's common stock on the date of grant. The initial grant of stock options will vest on the third anniversary of the date of grant and will be subject to the Omnibus Plan. Subject to the annual determination of Bioverativ's board of directors and Compensation Committee, the offer letter agreement also provides that Mr. Greene will be eligible for a post-distribution annual long term incentive award with a current planning reference value of $1,900,000, which award is expected to be divided equally between RSUs and stock options.

        In the event that, within one year following the distribution, Mr. Greene is involuntarily terminated other than for cause or resigns his employment following adverse changes to his terms and conditions of employment under certain circumstances (and subject to his execution of a release of claims), Mr. Greene will be entitled to receive (i) a lump sum severance payment equal to 18 months of base salary and target bonus, (ii) up to 9 months of outplacement services and (iii) continued subsidized health benefits for up to 18 months. It is expected that a termination of employment following the first anniversary of the distribution will be governed by a Bioverativ executive severance plan.

Rogério Vivaldi Letter Agreement

        In connection with the planned separation of Biogen and Bioverativ, Biogen entered into an offer letter agreement with Rogério Vivaldi, our Executive Vice President and Chief Global Therapeutic Operations Officer. Pursuant to the terms of the offer letter agreement, Dr. Vivaldi's employment with Bioverativ will be on an at will basis and he will be entitled to a post-distribution starting annual base salary of $500,000 and an annual cash target bonus of 50% of his annual base salary. Following the distribution, Dr. Vivaldi will receive a one-time Founder's Grant of Bioverativ stock options with an approximate grant date expected value of $1,900,000, with a per share exercise price equal to the fair market value of Bioverativ's common stock on the date of grant. The initial grant of stock options will vest on the third anniversary of the date of grant and will be subject to the Omnibus Plan. Subject to the annual determination of Bioverativ's board of directors and Compensation Committee, the offer letter agreement also provides that Dr. Vivaldi will be eligible for a post-distribution annual long term

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incentive award with a current planning reference value of $1,900,000, which award is expected to be divided equally between RSUs and stock options.

        In the event that, within one year following the distribution, Dr. Vivaldi is involuntarily terminated other than for cause or resigns his employment following adverse changes to his terms and conditions of employment under certain circumstances (and subject to his execution of a release of claims), Dr. Vivaldi will be entitled to receive (i) a lump sum severance payment equal to 18 months of base salary and target bonus, (ii) up to 9 months of outplacement services and (iii) continued subsidized health benefits for up to 18 months. It is expected that a termination of employment following the first anniversary of the distribution will be governed by a Bioverativ executive severance plan.

        Copies of the Cox, Greene and Vivaldi letter agreements are filed as exhibits to the registration statement of which this information statement is a part.

Anticipated Bioverativ Compensation Plans

        It is expected that, prior to the completion of the distribution, Bioverativ will adopt an equity compensation plan and a cash incentive compensation plan with terms substantially as set forth below.

Bioverativ Omnibus Incentive Plan

        In connection with the distribution, we expect to adopt the Omnibus Plan. The Omnibus Plan will become effective as of the distribution date, subject to the occurrence of the distribution. The following is a summary of the expected material terms of the Omnibus Plan; it is anticipated that Bioverativ will have approximately 400 employees immediately following the distribution.

        General.     The Compensation Committee will administer the Omnibus Plan. Awards under the Omnibus Plan may include stock options, stock appreciation rights (SARs), restricted stock, RSUs, performance shares, other stock or cash-based awards, CSPUs, converted Biogen awards (Conversion Awards) and dividend equivalents (each individually, an Award, and collectively, the Awards). The Compensation Committee will have discretionary authority to determine the size of an Award, whether it will be tied to meeting performance criteria and whether it will be settled in the form of stock and/or cash. Bioverativ expects that all employees of Bioverativ will be eligible to participate in the Omnibus Plan.

        Shares Available; Award Limits.     A total of 8,000,000 million shares of Bioverativ common stock will be reserved for issuance under the Omnibus Plan, inclusive of Conversion Awards. Shares subject to options or SARs will count against the shares authorized as one (1) share. Shares subject to restricted stock or other full-value Awards will count as 1.5 shares. In any calendar year, no participant may receive Awards covering more than 2,250,000 shares in the aggregate, and for performance-vested Awards that are settled in cash, no more than $15,000,000 may be paid to our Chief Executive Officer and no more than $6,000,000 may be paid to any other participant in any given calendar year.

        Performance Goals.     Awards under the Omnibus Plan that are intended to qualify as performance-based compensation under Section 162 (m), will be based on objectively determinable measures of performance relating to any of or to any combination of the following (measured either absolutely or by reference to an index or indices and determined either on a consolidated basis or, as the context permits, on a divisional, functional, subsidiary, line of business, project or geographical basis or in combinations thereof): sales; revenues; assets; expenses; earnings before or after deduction for all or any portion of interest, taxes, depreciation, or amortization or other items, whether or not on a continuing operations or an aggregate or per share basis; return on equity, investment, capital or assets; one or more operating ratios; borrowing levels, leverage ratios or credit rating; market share; capital expenditures; cash flow; stock price; stockholder return; sales of particular products or services; customer acquisition, expansion or retention; acquisitions and divestitures (in whole or in part); joint

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ventures and strategic alliances; spin-offs, split-ups and the like; reorganizations; recapitalizations, restructurings, financings (issuance of debt or equity) or refinancings; or achievement of clinical trial or measurable research objectives. To the extent consistent with the requirements for satisfying the performance-based compensation exception under Section 162(m), the Compensation Committee may provide that one or more of the performance goals applicable to an Award will be adjusted in an objectively determinable manner to reflect events (such as acquisitions or dispositions) occurring during the performance period that affect the applicable performance criteria. Before the grant, exercisability, vesting, payment or full enjoyment of any Award that is designed to be performance-based compensation under Section 162(m), the Compensation Committee must determine that the applicable performance goals have been attained and such determination will be conclusive. If the performance criteria are not attained, payment will not be made with respect to the Award and no other Award will be provided in substitution of the performance Award with respect to which such performance criteria have not been met.

        Adjustments.     The Compensation Committee may make appropriate adjustments in outstanding Awards and the number of shares available for issuance under the Omnibus Plan, including the individual limitations on Awards, to reflect changes to our stock, such as stock dividends, stock splits, reverse stock splits, recapitalizations, distributions to stockholders other than stock or normal cash dividends, material changes in accounting practices, or any other event, if it determines that adjustments are appropriate to avoid distortion in the operation of the Omnibus Plan and to preserve the value of Awards made under the Omnibus Plan.

        Stock Options and SARs.     The exercise price of stock options and base value of SARs granted under the Omnibus Plan generally may not be less than the fair market value of our common stock on the date of grant, and the term may not be longer than 10 years. The Compensation Committee will determine at the time of grant when each Award becomes exercisable, but the minimum vesting period for time-based Awards will be equal increments over three years. Payment of the exercise price of a stock option may be in cash, common stock owned by the participant or such other consideration, including a cashless exercise, or by a combination of these payment methods. We may require that the participant remit an amount in cash or common stock sufficient to satisfy tax withholding requirements. Similar provisions govern awards of SARs, which entitle the holder upon exercise to receive common stock or cash equal to the excess of the fair market value of the underlying shares on the date of exercise over the base value of the SAR.

        Restricted Stock and RSUs.     Awards of restricted stock and RSUs will vest, and the related restrictions will lapse, based on either the conclusion of a specified period of continuous employment or upon the satisfaction of pre-established performance conditions approved by the Compensation Committee. For time-based Awards, the minimum ordinary course vesting period will be in equal increments over three years.

        Effect of a Corporate Change in Control or Corporate Transaction.     In the event of a specified corporate transaction or a change in control, as described below, the Omnibus Plan will provide for the ability to make various adjustments to outstanding awards depending upon the circumstances. These adjustments may include assumption and substitution of our awards by the acquirers, or cash payment of the value of the Awards.

        If the transaction is a corporate transaction or a corporate change in control, certain participants designated by the Compensation Committee who terminate employment for certain reasons within two years following the corporate transaction will be eligible to receive accelerated vesting of their Awards, and Awards requiring exercise will generally remain exercisable for one year. In order to be eligible, the designated participants must have terminated employment as a result of an involuntary employment action within two years following the corporate transaction. A "corporate transaction" includes a consolidation, merger or similar transaction, a sale of substantially all of our assets or a liquidation or

95


dissolution. A "corporate change in control" will generally mean a sale of more than 50% of the voting power of our stock (other than in a merger) or a change in membership of a majority of our board of directors without the approval of the incumbent board. In general, an involuntary employment action will mean that we have terminated the participant's employment without cause or the participant has resigned because of a material reduction in authority, duties and responsibilities; a reduction in base pay or target bonus opportunity; or a relocation of the participant's principal office by more than 100 miles round-trip.

        Termination, Death and Retirement.     Generally, the unvested Awards held prior to termination by reason of death or disability will vest upon death or disability, and awards requiring exercise generally will remain exercisable for one year. If a participant retires (defined as termination after age 55 with at least 10 years of service), a portion of the unvested Awards will become vested, and Awards requiring exercise generally will remain exercisable for three years. If a participant terminates for cause, all Awards, whether vested or unvested, terminate immediately. If a participant terminates for reasons other than death, disability, retirement or for cause, then upon termination the unvested Awards will terminate automatically and vested awards requiring exercise generally will remain exercisable for six months.

        Amendment and Termination.     Our board of directors will be able to amend, alter or discontinue the Omnibus Plan at any time, subject to any requirement under applicable law to obtain stockholder approval of the amendment, and provided that our board may not amend the Omnibus Plan to permit the repricing of stock options or SARs without first obtaining stockholder approval. No amendment to the Omnibus Plan will amend or impair any rights or obligations under any Award theretofore granted under the Omnibus Plan without the written consent of the holder of the affected award. Unless earlier terminated by our board of directors, the Omnibus Plan will terminate on the tenth anniversary of the date the Omnibus Plan is approved.

Bioverativ Performance-Based Management Incentive Plan

        In connection with the distribution, Bioverativ expects to adopt a performance-based management incentive plan (the Incentive Plan). The Incentive Plan will become effective as of the distribution date, subject to the occurrence of the distribution. Under the Incentive Plan, the Compensation Committee may grant performance awards to participants, the payment of which is determined by the achievement of one or more performance goals over a performance period. Participation in the Incentive Plan is limited to our executive officers and certain other key employees who are nominated by our Chief Executive Officer and approved by the Compensation Committee. Payments made to a participant in any calendar year may not exceed (i) $6,000,000 for our Chief Executive Officer, (ii) $3,000,000 for any other participant and (iii) 225% of a participant's target incentive award. Each performance period may be a minimum of six (6) and a maximum of sixty (60) consecutive months in length, as determined by the Compensation Committee.

        Awards under the Incentive Plan may qualify as performance-based compensation under Section 162(m), and performance goals must be based on one or more objectively determinable measures of performance relating to any one or to any combination of the following (measured either absolutely or by reference to an index or indices and determined either on a consolidated basis or, as the context permits, on a divisional, functional, subsidiary, line of business, project or geographical basis or in combinations thereof): sales; revenues; assets; expenses; earnings before or after deduction for all or any portion of interest, taxes, depreciation, or amortization or other items, whether or not on a continuing operations or an aggregate or per share basis; return on equity, investment, capital or assets; one or more operating ratios; borrowing levels, leverage ratios or credit rating; market share; capital expenditures; cash flow; stock price; stockholder return; sales of particular products or services; customer acquisition, expansion or retention; acquisitions and divestitures (in whole or in part); joint ventures and strategic alliances; spin-offs, split-ups and the like; reorganizations; recapitalizations,

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restructurings, financings (issuance of debt or equity) or refinancings; or achievement of clinical trial or measurable research objectives. To the extent consistent with the requirements for satisfying the performance-based compensation exception under Section 162(m), the Compensation Committee may provide that one or more of the performance goals applicable to an award will be adjusted in an objectively determinable manner to reflect events (such as acquisitions or dispositions) occurring during the performance period that affect the applicable performance criteria. Before the vesting or payment of any award that is designed to be performance-based compensation under Section 162(m), the Compensation Committee must determine that the applicable performance goals have been attained.

        No incentive awards are paid unless the Compensation Committee certifies in writing that the applicable performance criteria have been attained, and such determination will be final and conclusive. The Compensation Committee has no discretion to increase the amount of a participant's incentive award as determined under the applicable formula, but it may in its sole discretion reduce an incentive award otherwise payable to a participant, on the basis of Bioverativ and/or specific individual goals, which may be based on objective or non-objective factors related to Bioverativ's and/or the participant's performance.

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CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS

Agreements with Biogen

        Following the distribution, Bioverativ and Biogen will operate separately, each as an independent public company. Prior to the distribution, Bioverativ and Biogen intend to enter into a separation agreement and several other agreements to effect the separation and provide a framework for Bioverativ's relationship with Biogen after the distribution. These agreements will govern the relationships between Biogen and Bioverativ subsequent to the completion of the distribution and provide for the separation between Biogen and Bioverativ of the assets, employees, liabilities and obligations (including investments, property and employee benefits and tax-related assets and liabilities) attributable to periods prior to, at and after the distribution. In addition to the separation agreement (which contains many of the key provisions related to Bioverativ's separation from Biogen, including the distribution of Bioverativ's shares of common stock to Biogen stockholders), these agreements include:

    the tax matters agreement;

    the employee matters agreement;

    the intellectual property license agreement;

    the manufacturing and supply agreement; and

    the transition services agreement.

        The forms of material agreements described below are or will be filed as exhibits to the registration statement on Form 10 of which this information statement is a part, and the summaries below set forth the terms of the agreements that Bioverativ believes are material. These summaries are qualified in their entireties by reference to the full text of the applicable agreements, which are incorporated by reference into this information statement.

        The terms of the agreements described below that will be in effect following the distribution have not yet been finalized. Changes to these agreements, some of which may be material, may be made prior to the distribution.

The Separation Agreement

        We intend to enter into a separation agreement with Biogen prior to the distribution of our common stock to Biogen stockholders. The separation agreement will set forth our agreements with Biogen regarding the principal actions to be taken in connection with the separation, including the distribution. The separation agreement will identify assets to be transferred, liabilities to be assumed and contracts to be assigned to each of Bioverativ and Biogen as part of the separation, and it will provide for when and how these transfers, assumptions and assignments will occur.

        Transfer of Assets and Assumption of Liabilities.     The separation agreement will identify assets to be transferred, liabilities to be assumed and contracts to be assigned to each of Biogen and us as part of an internal reorganization, and will describe when and how these transfers, assumptions and assignments will occur, though many of the transfers, assumptions and assignments will have already occurred prior to the parties' entering into the separation agreement. The separation agreement will provide for those transfers of assets and assumptions of liabilities that are necessary in connection with the separation so that we and Biogen retain the assets necessary to operate our respective businesses and retain or assume the liabilities allocated in accordance with the separation. The separation agreement will also provide for the settlement or extinguishment of certain liabilities and other obligations between us and Biogen.

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        Except as otherwise set forth in the separation agreement or any ancillary agreement, each party to the separation agreement will assume the liability for, and control of, all pending, threatened and future legal matters related to its own business or its assumed or retained liabilities.

        The allocation of liabilities with respect to taxes, except for payroll taxes and reporting and other tax matters expressly covered by the employee matters agreement, are solely covered by the tax matters agreement.

        Further Assurances.     Each party will agree to use commercially reasonable efforts to take or to cause to be taken all actions, and to do, or to cause to be done, all things reasonably necessary under applicable law or contractual obligations to consummate and make effective the transactions contemplated by the separation agreement and other transaction agreements.

        Employee Non-Solicit.     Biogen and Bioverativ will be subject to mutual nine month employee non-solicitation and non-hire obligations, subject to customary exceptions.

        Certain Restrictions.     For two years after the distribution date, Biogen and Bioverativ will be subject to non-compete obligations, subject to customary carve-outs for performance under ancillary agreements and acquisitions of entities engaged in a restricted business. Generally, Biogen will not engage in the field of hemoglobinopathies, and Bioverativ will not engage in the field of multiple sclerosis or the business of discovering, researching, developing, importing, exporting, manufacturing, marketing, distributing, promoting or selling any pharmaceutical product that contains dimethyl fumerate. The non-compete restrictions will fall-away upon a change of control (as defined in the agreement) of either Biogen or Bioverativ.

        The Distribution.     The separation agreement will govern the rights and obligations of the parties with respect to the distribution and certain actions that must occur prior to the distribution. Biogen will cause its agent to distribute to holders of shares of Biogen's common stock as of the record date for the distribution all of the issued and outstanding shares of our common stock. Biogen will have the sole and absolute discretion to determine (and change) the terms of, and whether to proceed with, the distribution and, to the extent it determines to so proceed, to determine the date of the distribution.

        Conditions.     The separation agreement will provide that the distribution is subject to several conditions that must be satisfied (or waived by Biogen, in its sole discretion). For further information regarding these conditions, see "The Separation and Distribution—Conditions to the Distribution." Biogen may, in its sole discretion, determine the record date, the distribution date and the terms of the distribution and may at any time prior to the completion of the distribution decide to abandon or modify the distribution.

        Indemnification.     The separation agreement will provide for cross-indemnities that, except as otherwise provided in the separation agreement, are principally designed to place financial responsibility for the obligations and liabilities allocated to us under the separation agreement with us and financial responsibility for the obligations and liabilities allocated to Biogen under the separation agreement with Biogen.

        The separation agreement will also specify procedures with respect to claims subject to indemnification and related matters. Indemnification with respect to taxes will be governed by the tax matters agreement.

        Term/Termination.     Prior to the distribution, Biogen will have the unilateral right to terminate or modify the terms of the separation agreement. After the effective time of the distribution, the term of the separation agreement is indefinite and it may only be terminated with the prior written consent of both Biogen and us.

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        Other Matters Governed by the Separation Agreement.     Other matters governed by the separation agreement include, without limitation, access to financial and other information, insurance, confidentiality and access to and provision of records.

Tax Matters Agreement

        We intend to enter into a tax matters agreement with Biogen prior to the distribution which will generally govern Biogen's and Bioverativ's respective rights, responsibilities and obligations after the distribution with respect to taxes for any tax period ending on or before the distribution date, as well as tax periods beginning before and ending after the distribution date. In addition, the tax matters agreement will address the allocation of liability for taxes that are incurred as a result of restructuring activities undertaken to effectuate the distribution. The tax matters agreement will also provide that Bioverativ is liable for taxes incurred by Biogen that may arise if Bioverativ takes, or fails to take, as the case may be, certain actions that may result in the distribution failing to meet the requirements of a tax-free distribution under Section 355 of the Code.

Employee Matters Agreement

        We intend to enter into an employee matters agreement with Biogen prior to the distribution. The employee matters agreement will allocate assets, liabilities and responsibilities relating to employee compensation and benefit plans and programs and other related matters in connection with the separation, including the treatment of outstanding incentive awards and certain retirement and welfare benefit obligations, both in and outside of the United States. The employee matters agreement will generally provide that, unless otherwise specified, Bioverativ will be responsible for liabilities associated with employees who transfer to Bioverativ, whether incurred prior to or after the distribution, and Biogen will be responsible for liabilities associated with other employees, including employees retained by Biogen.

        Participation in Bioverativ Benefit Plans.     The employee matters agreement will provide that Bioverativ employees will be eligible to participate in Bioverativ's benefit plans as of the distribution date. In general, Bioverativ benefit plans will contain terms substantially similar to those of the corresponding Biogen benefit plans, and Bioverativ will credit each Bioverativ employee with his or her service with Biogen prior to the distribution for all purposes under the Bioverativ benefit plans, so long as such crediting does not result in a duplication of benefits.

        Bioverativ Omnibus Plan; Bioverativ Employee Stock Purchase Plan.     The employee matters agreement will provide that, prior to the distribution, Biogen will cause Bioverativ to adopt the Omnibus Plan and an employee stock purchase plan intended to meet the requirements of Section 423 of the Code and the regulations promulgated thereunder and take all actions that may be necessary to approve such plans in order to satisfy the requirements of the Code and the regulations of the Nasdaq Global Select Market.

        Bioverativ 401(k) Plan; Supplemental Savings Plan.     The employee matters agreement will provide that, prior to the distribution, Biogen and Bioverativ will adopt, or cause to be adopted, a defined contribution pension plan and a supplemental savings plan. The assets and liabilities under the Biogen defined contribution plan and accounts under the supplemental savings plan with respect to Bioverativ employees will be transferred to the corresponding Bioverativ plans.

        Welfare Plans.     The employee matters agreement will provide that Bioverativ will establish health and welfare plans that correspond to the Biogen health and welfare plans in which Bioverativ employees participate prior to the distribution. Bioverativ will generally assume liability for claims incurred under the Biogen health and welfare plans for Bioverativ employees. Following the distribution, Bioverativ employees will generally participate in Bioverativ's health and welfare plans.

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Bioverativ will cause such plans to waive any preexisting condition limitations and will honor any deductible, co-payment and out-of-pocket maximums incurred by the Bioverativ employees under Biogen plans during the portion of the calendar year elapsed prior to the distribution for the purpose of satisfying any deductibles, co-payments or out-of-pocket maximums under the Bioverativ plans in which they are eligible to participate after the distribution in the same year in which such deductibles, co-payments or out-of-pocket maximums were incurred.

        Equity Compensation.     The employee matters agreement will provide that the outstanding Biogen equity awards held by Biogen and Bioverativ employees will be treated as described in the section entitled "The Separation and Distribution—Treatment of Equity-Based Compensation."

Intellectual Property License Agreement

        We intend to enter into an intellectual property license agreement with Biogen prior to the distribution pursuant to which each party will grant a license under certain intellectual property and technology. Biogen will grant Bioverativ a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license to certain intellectual property to allow Bioverativ to use such intellectual property in connection with therapies for the treatment of hemophilia and other blood disorders. Biogen will also grant Bioverativ a perpetual, non-exclusive, worldwide license to certain intellectual property and technology in connection with the manufacturing of products for the treatment of hemophilia and other blood disorders.

        Bioverativ will grant Biogen a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license to certain intellectual property for use outside of therapies for the treatment of hemophilia and other blood disorders. Bioverativ will grant Biogen a non-exclusive, worldwide license to certain technology for the term of the manufacturing and supply agreement to allow Biogen to fulfill its obligations under the manufacturing and supply agreement. Such licenses between the parties generally will allow current or future uses of the intellectual property in connection with each party's respective fields.

Manufacturing and Supply Agreement

        We intend to enter into a manufacturing and supply agreement with Biogen prior to the distribution pursuant to which Biogen will manufacture, label and package products for Bioverativ, including drug substance, drug product and finished goods with respect to ELOCTATE and ALPROLIX, as well as certain clinical products. Pursuant to the agreement, Biogen will agree not to manufacture or supply the drug substance, drug product or finished goods contemplated by the agreement, or any biosimilar of any such products, to any person other than Bioverativ until the date that is one year after the expiration or termination of the agreement.

        The manufacturing and supply agreement will have an initial term of five years, with a five year extension in Bioverativ's sole discretion and a further five year extension with the consent of the parties. The supply of certain products will depend on the regulatory approvals and licenses obtained by Bioverativ on a jurisdiction-by-jurisdiction basis in accordance with the phases of production and supply provided for in the agreement. The manufacturing and supply obligations will generally be performed under the agreement on a cost-plus basis. The agreement will contain customary provisions for the transfer of manufacturing technology and processes to other manufacturers for the benefit of Bioverativ.

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Transition Services Agreement

        We intend to enter into a transition services agreement with Biogen prior to the distribution pursuant to which Biogen will provide functional and supply-chain related and other services to Bioverativ, on an interim, transitional basis, following the distribution. The services are expected to include, among other things, distribution services in the United States for ELOCTATE and ALPROLIX to Bioverativ's customers until Bioverativ obtains all of the required regulatory authorizations. The agreement will provide for Biogen to provide such services for a limited time, generally for a period of eighteen months following the date of the distribution, for specified fees. Bioverativ will have the right to terminate any or all services upon 45 days' notice or such longer period as may be required to effect termination.

Review and Approval of Transactions with Related Persons

        We expect that our board of directors will adopt a written policy for the review of related party transactions. It is expected that this policy will provide that when any related person has a direct or indirect material interest in a transaction that involves Bioverativ and involves or is expected to involve payments of $120,000 or more in the aggregate per fiscal year, our Corporate Governance Committee will review and approve all such proposed transactions or courses of dealing. In determining whether to approve or ratify a transaction with a related person, among the factors the Corporate Governance Committee may consider (as applicable) are:

    the business reasons for entering into the transaction;

    the size of the transaction and the nature of the related person's interest in the transaction;

    whether the transaction terms are as favorable to us as they would be to an unaffiliated third party;

    whether the transaction terms are more favorable to the related person than they would be to an unaffiliated third party;

    the availability of alternative sources for comparable products, services or other benefits;

    whether the transaction would impair the independence or judgment of the related person in the performance of his or her duties to us;

    for non-employee directors, whether the transaction would be consistent with NASDAQ's requirements for independent directors;

    whether the transaction is consistent with our conflict of interest policy which prohibits related persons and others from having a financial interest in any competitor, customer, vendor or supplier of ours;

    the related person's role in arranging the transaction;

    the potential for the transaction to be viewed as representing or leading to an actual or apparent conflict of interest; and

    any other factors that the Corporate Governance Committee deems appropriate.

        There are no relationships or transactions with related persons that are required to be disclosed in this information statement under SEC rules.

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SECURITY OWNERSHIP BY CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

        Prior to the distribution, all of the outstanding shares of our common stock will be owned beneficially and of record by Biogen. The following table sets forth information with respect to the expected beneficial ownership of our common stock by: (1) each person who we believe will be a beneficial owner of more than five percent of our common stock, (2) each expected director, director nominee and named executive officer of us and (3) all of our expected directors, director nominees and executive officers as a group. Except as noted below, we based the share amounts on each person's beneficial ownership of Biogen common stock as of December 1, 2016, giving effect to a distribution ratio of one share of our common stock for every two shares of Biogen common stock. Immediately following the distribution, we estimate that 107,952,005 of our shares of common stock will be issued and outstanding based on the number of shares of Biogen common stock expected to be outstanding as of the record date. The actual number of our outstanding shares of our common stock following the distribution will be determined on January 17, 2017, the record date.

Security Ownership of Certain Beneficial Owners

        Based solely on the information available as of December 1, 2016, reporting beneficial ownership of Biogen common stock, we anticipate the following stockholders will beneficially own more than five percent of our common stock following the distribution.

Name and Address of Beneficial Owner
  Number of Owned Shares of
Biogen Common Stock (1)
  Number of Owned Shares
of Our Common Stock
  Percent of
Shares
Outstanding
 

BlackRock, Inc. (2)
55 East 52 nd  Street
New York, NY 10022

    16,712,457     8,356,228     7.74 %

PRIMECAP Management Company (3)
225 South Lake Avenue
Suite 400
Pasadena, CA 91101

   
15,810,625
   
7,905,312
   
7.3

%

The Vanguard Group (4)
100 Vanguard Boulevard
Malvern, PA 19355

   
13,228,502
   
6,614,251
   
6.13

%

FMR LLC (5)
245 Summer Street
Boston, MA 02110

   
12,925,994
   
6,462,997
   
6.0

%

(1)
The shares described as "owned" are shares of Biogen common stock directly or indirectly owned by each listed person.

(2)
Based solely on information as of December 31, 2015 contained in a Schedule 13G/A filed with the SEC by BlackRock, Inc. on February 10, 2016, which also indicates that it has sole voting power with respect to 14,501,480 Biogen shares and sole dispositive power with respect to 16,712,457 Biogen shares.

(3)
Based solely on information as of December 31, 2015 contained in a Schedule 13G/A filed with the SEC by PRIMECAP Management Company on February 12, 2016, which also indicates that it has sole voting power over 1,707,399 Biogen shares and sole dispositive power over 15,810,625 Biogen shares.

(4)
Based solely on information as of December 31, 2015 contained in a Schedule 13G/A filed with the SEC by The Vanguard Group on February 10, 2016, which also indicates that it has sole voting power with respect to 419,533 Biogen shares, sole dispositive power with respect to 12,783,069 Biogen shares, shared voting power with respect to 23,400 Biogen shares and shared dispositive power with respect to 445,433 Biogen shares.

(5)
Based solely on information as of December 31, 2015 contained in a Schedule 13G/A filed with the SEC by FMR LLC and Abigail P. Johnson on February 12, 2016, which also indicates that FMR LLC, and Abigail P. Johnson each have sole dispositive power over 12,925,994 Biogen shares and FMR LLC has sole voting power over 846,221 Biogen shares.

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Security Ownership of Directors and Executive Officers

        The following table provides information regarding beneficial ownership of our named executive officers, our expected directors, director nominees and all of our expected directors, director nominees and executive officers as a group. At the time of the distribution, the address of each director and executive officer shown in the table below will be 225 Second Avenue, Waltham, MA 02451.

 
  Amount and Nature of Beneficial
Ownership (Number of Bioverativ Shares)
 
Name
  Direct   Indirect   Right to
Acquire (1)
  Total   Percent of
Class (2)
 

John G. Cox

    15,300               15,300     *  

Alexander J. Denner, Ph.D. (3)

    3,945     155,000           158,945     *  

John Greene

                      *  

Louis J. Paglia

                      *  

Brian S. Posner

    2,637               2,637     *  

Rogério Vivaldi, M.D.

                      *  

Directors and Officers as a Group (9)

    23,106     155,000           178,106     *  

*
Less than one percent

(1)
Does not include shares of Bioverativ stock that may be issued upon exercise or settlement of Bioverativ equity awards that will be converted from Biogen equity awards and cash settled performance awards in the distribution, as the conversion ratio is not currently calculable.

(2)
The calculation of percentages is based upon our expectation that, immediately following the distribution, approximately 107,952,005 shares of our common stock will be issued and outstanding based upon approximately 215,904,010 shares of Biogen common stock outstanding as of December 1, 2016.

(3)
Includes (i) 95,071 shares of common stock directly beneficially owned by Sarissa Capital Domestic Fund LP, a Delaware limited partnership (Sarissa Domestic); and (ii) 59,929 shares of common stock directly beneficially owned by Sarissa Capital Offshore Master Fund LP, a Cayman Islands limited partnership (Sarissa Offshore and, together with Sarissa Domestic, the Sarissa Funds). Sarissa Capital Management GP LLC, a Delaware limited liability company (Sarissa Capital GP), is the general partner of Sarissa Capital, the investment advisor to the Sarissa Funds. Alexander Denner is the Chief Investment Officer of Sarissa Capital and the managing member of Sarissa Capital GP. By virtue of the foregoing, Dr. Denner may be deemed to indirectly beneficially own the shares that the Sarissa Funds directly beneficially own. Dr. Denner disclaims beneficial ownership of such shares of common stock owned by the Sarissa Funds.

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THE SEPARATION AND DISTRIBUTION

Overview

        On May 3, 2016, Biogen announced its plans to separate its hemophilia business from its neurological and neurodegeneration businesses through a pro rata distribution of Bioverativ common stock to stockholders of Biogen. The distribution is intended to be generally tax-free for U.S. federal income tax purposes.

        In furtherance of this plan, on December 20, 2016, Biogen's board of directors approved the distribution of all of the issued and outstanding shares of Bioverativ common stock on the basis of one share of Bioverativ common stock for every two shares of Biogen common stock issued and outstanding as of the close of business on January 17, 2017, the record date for the distribution. As a result of the distribution, Bioverativ and Biogen will become two independent, publicly traded companies.

        On February 1, 2017, the distribution date, each Biogen stockholder will receive one shares of Bioverativ common stock for every two shares of Biogen common stock held of record at the close of business on the record date, as described below. Registered stockholders will receive cash in lieu of any fractional shares of Bioverativ common stock that they would have received as a result of the application of the distribution ratio. Stockholders will not be required to make any payment, surrender or exchange their Biogen common stock or take any other action to receive shares of Bioverativ common stock in the distribution.

        The distribution of Bioverativ common stock as described in this information statement is subject to the satisfaction or waiver of certain conditions. For a more detailed description of these conditions, see this section under "—Conditions to the Distribution."

Reasons for the Separation

        Biogen's board of directors determined that separating the hemophilia business from Biogen would be in the best interests of Biogen and its stockholders and approved the plan of separation. A wide variety of factors were considered by Biogen's board of directors in evaluating the separation. Among other things, Biogen's board of directors considered the following potential benefits of the separation:

    Enhanced business and strategic focus —The separation will allow each business to pursue focused operational, commercial and strategic priorities that address the distinct patient, physician and stakeholder dynamics of each business;

    More efficient allocation of resources —The separation will offer each business the ability to achieve operating efficiencies through the allocation of resources to areas presenting high growth potential for its respective business;

    Increased opportunity and flexibility —The separation will give each business the opportunity and flexibility to pursue its own investment, capital allocation and growth strategies consistent with its long-term objectives and with a goal of enhancing value for patients, healthcare providers and other key stakeholders;

    More rapid response to markets —The separation will allow each business to more quickly respond to trends, developments and opportunities in its respective markets; and

    Separate investment identity —The separation will allow investors to separately value each business based on its unique investment identity, including the merits, performance and future prospects of each company's respective business, providing investors with two distinct and targeted investment opportunities.

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        Biogen's board of directors also considered a number of potentially negative factors in evaluating the separation, including the following factors impacting Bioverativ:

    Loss of synergies and joint purchasing power and increased costs —As a current part of Biogen, Bioverativ takes advantage of Biogen's size and purchasing power in procuring certain goods and services. After the distribution, as a separate, independent entity, Bioverativ may be unable to obtain these goods, services, and technologies at prices or on terms as favorable as those Biogen obtained prior to the distribution. Bioverativ will also incur costs for certain functions previously performed by Biogen, including executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology, investor relations, shared services, insurance, employee benefits and incentives and share-based compensation, that may be higher than the amounts reflected in Bioverativ's historical financial statements, which could cause Bioverativ's profitability to decrease.

    Disruptions to the business as a result of the separation —The actions required to separate Biogen's and Bioverativ's respective businesses could disrupt Bioverativ's operations.

    Increased significance of certain costs and liabilities —Certain costs and liabilities that were otherwise less significant to Biogen as a whole will be more significant for Bioverativ as a standalone company.

    One-time costs of the separation —Bioverativ will incur costs in connection with the transition to being a standalone public company that will include establishment of accounting, tax, auditing, legal and other professional services costs, recruiting and relocation costs associated with hiring key senior management personnel new to Bioverativ and costs to separate information systems.

    Inability to realize anticipated benefits of the separation —Bioverativ may not achieve the anticipated benefits of the separation for a variety of reasons, including: (i) the separation will require significant amounts of management's time and effort, which may divert management's attention from operating and growing the Bioverativ business and (ii) following the separation, the Bioverativ business will be less diversified than Biogen's business prior to the separation.

    Limitations on Strategic Transactions —Under the terms of the tax matters agreement that Bioverativ intends to enter into with Biogen, for a period of two years following the distribution, Bioverativ will be restricted from taking certain actions that could cause the distribution, together with certain related transactions, to fail to qualify as a tax-free transaction for U.S. federal income tax purposes. During this period, these restrictions may limit Bioverativ's ability to pursue certain strategic transactions and equity issuances or engage in other transactions that might increase the value of its business.

    Uncertainty Regarding Stock Prices —We cannot predict the effect of the separation on the trading prices of Bioverativ or Biogen common stock or whether the combined market value of one share of Bioverativ common stock and two shares of Biogen common stock will be less than, equal to, or greater than the market value of two shares of Biogen common stock prior to the distribution.

        Biogen's board of directors concluded that the potential benefits of the separation outweighed these factors. However, neither Biogen nor Bioverativ can assure you that, following the separation, any of the benefits described above or otherwise will be realized to the extent anticipated or at all. For more information on the risks involved in the separation process, see "Risk Factors—Risks Related to the Separation."

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Formation of a Holding Company Prior to the Distribution

        In connection with and prior to the distribution, Bioverativ Inc. was incorporated by Biogen in the State of Delaware on August 4, 2016, for the purpose of holding Biogen's hemophilia business in connection with the separation described herein. As part of the plan to create two independent public companies, Biogen plans to transfer the assets and liabilities of the hemophilia business to Bioverativ and its subsidiaries prior to the distribution through an internal reorganization.

When and How You Will Receive the Distribution

        With the assistance of the distribution agent, Biogen expects to distribute Bioverativ common stock on February 1, 2017, the distribution date, to all holders of outstanding Biogen common stock as of the close of business on January 17, 2017, the record date. Computershare will serve as the distribution agent in connection with the distribution, and will also serve as the transfer agent and registrar for Bioverativ common stock.

        If you own Biogen common stock as of the close of business on the record date, Bioverativ common stock that you are entitled to receive in the distribution will be issued electronically, as of the distribution date, to you in direct registration form or to your bank or brokerage firm on your behalf. If you are a registered holder, the distribution agent or the transfer agent will then mail you a direct registration account statement that reflects your shares of Bioverativ common stock. "Direct registration form" refers to a method of recording share ownership when no physical share certificates are issued to stockholders, as is the case in this distribution.

        Commencing on or shortly after the distribution date, if you hold physical share certificates that represent your Biogen common stock and you are the registered holder of the shares represented by those certificates, the distribution agent will mail to you an account statement that indicates the number of shares of Bioverativ common stock that have been registered in book-entry form in your name, and the distribution agent will mail you a check for any cash in lieu of fractional shares you are entitled to receive. If you sell Biogen common stock in the "regular way" market up to and including the distribution date, you will be selling your right to receive shares of Bioverativ common stock in the distribution.

        Most Biogen stockholders hold their common stock through a bank or brokerage firm. In such cases, the bank or brokerage firm would be said to hold the shares in "street name" and ownership would be recorded on the bank or brokerage firm's books. If you hold your Biogen common stock through a bank or brokerage firm, your bank or brokerage firm will credit your account for the Bioverativ common stock that you are entitled to receive in the distribution. If you have any questions concerning the mechanics of having shares held in "street name," please contact your bank or brokerage firm.

Results of the Distribution

        After its separation from Biogen, Bioverativ will be an independent, publicly traded company. The actual number of shares to be distributed will be determined on January 17, 2017, the record date for the distribution, and will reflect any exercise of Biogen options between the date the Biogen board of directors declares the distribution and the record date for the distribution. The distribution will not affect the number of outstanding shares of Biogen common stock or any rights of Biogen's stockholders. Biogen will not distribute any fractional shares of Bioverativ common stock.

        Prior to the distribution, Bioverativ intends to enter into a separation agreement and other agreements with Biogen to effect the separation and provide a framework for Bioverativ's relationship with Biogen after the separation. These agreements will provide for the allocation between Biogen and Bioverativ of Biogen's assets, liabilities and obligations (including employee benefits, intellectual

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property, and tax-related assets and liabilities) attributable to periods prior to, at and after Bioverativ's separation from Biogen and will govern certain relationships between Biogen and Bioverativ after the separation. For a more detailed description of these agreements, see "Certain Relationships and Related Person Transactions—Agreements with Biogen."

The Number of Shares of Bioverativ Common Stock You Will Receive

        For every two shares of Biogen common stock that you own at the close of business on January 17, 2017, the record date, you will receive one share of Bioverativ common stock on the distribution date. Biogen will not distribute any fractional shares of Bioverativ common stock to its stockholders. Instead, the distribution agent will aggregate fractional shares into whole shares, sell the whole shares in the open market at prevailing market prices and distribute the aggregate cash proceeds (net of discounts and commissions) of the sales pro rata (based on the fractional share such holder would otherwise have been entitled to receive) to each holder who otherwise would have been entitled to receive a fractional share in the distribution. The distribution agent, in its sole discretion, without any influence by Biogen or Bioverativ, will determine when, how, through which broker-dealer and at what price to sell the whole shares. Computershare is not an affiliate of either Biogen or Bioverativ. Any broker-dealer used by the transfer agent will not be an affiliate of either Biogen or Bioverativ. Neither Bioverativ nor Biogen will be able to guarantee any minimum sale price in connection with the sale of these shares. Recipients of cash in lieu of fractional shares will not be entitled to any interest on the amounts of payment made in lieu of fractional shares.

        The aggregate net cash proceeds of these sales will be taxable for U.S. federal income tax purposes. See "U.S. Federal Income Tax Consequences" for an explanation of the U.S. federal income tax consequences of the distribution. If you hold physical certificates for Biogen common stock and are the record holder, you will receive a check from the distribution agent in an amount equal to your pro rata share of the aggregate net cash proceeds of the sales. Bioverativ estimates that it will take approximately two weeks from the distribution date for the distribution agent to complete the distributions of the aggregate net cash proceeds. If you hold your Biogen common stock through a bank or brokerage firm, your bank or brokerage firm will receive, on your behalf, your pro rata share of the aggregate net cash proceeds of the sales and will distribute to your account your share of such proceeds.

Transferability of Shares You Receive

        Shares of Bioverativ common stock distributed to holders through the distribution will be transferable without registration under the U.S. Securities Act of 1933, as amended (Securities Act), except for shares received by persons who may be deemed to be Bioverativ affiliates. Persons who may be deemed to be Bioverativ's affiliates after the distribution generally include individuals or entities that control, are controlled by or are under common control with Bioverativ, which may include certain of Bioverativ executive officers, directors or principal stockholders. Securities held by Bioverativ affiliates will be subject to resale restrictions under the Securities Act. Bioverativ affiliates will be permitted to sell shares of Bioverativ common stock only pursuant to an effective registration statement or an exemption from the registration requirements of the Securities Act, such as the exemption afforded by Rule 144 promulgated under the Securities Act.

Market for Bioverativ Common Stock

        There is currently no public trading market for Bioverativ common stock. Bioverativ has applied to have its common stock authorized for listing on the Nasdaq Global Market Select under the symbol "BIVV". Bioverativ has not and will not set the initial price of its common stock. The initial price will be established by the public markets.

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        Bioverativ cannot predict the price at which its common stock will trade after the distribution. In fact, the combined trading prices, after the distribution, of the shares of Bioverativ common stock that each Biogen stockholder will receive in the distribution and Biogen common stock held at the record date may not equal the "regular way" trading price of a share of Biogen common stock immediately prior to the distribution. The price at which Bioverativ common stock trades may fluctuate significantly, particularly until an orderly public market develops. Trading prices for Bioverativ common stock will be determined in the public markets and may be influenced by many factors. See "Risk Factors—Risks Related to Our Common Stock."

Trading Between the Record Date and Distribution Date

        Beginning on or shortly before the record date and continuing up to and including through the distribution date, we expect that there will be two markets in Biogen common stock: a "regular way" market and an "ex-distribution" market. Shares of Biogen common stock that trade on the "regular way" market will trade with an entitlement to Bioverativ common stock distributed pursuant to the separation. Shares of Biogen common stock that trade on the "ex-distribution" market will trade without an entitlement to Bioverativ common stock distributed pursuant to the distribution. Therefore, if you sell Biogen common stock in the "regular way" market up to and including through the distribution date, you will be selling your right to receive Bioverativ common stock in the distribution. If you own Biogen common stock at the close of business on the record date and sell those shares on the "ex-distribution" market up to and including through the distribution date, you will receive the shares of Bioverativ common stock that you are entitled to receive pursuant to your ownership as of the record date of Biogen common stock.

        Furthermore, we anticipate that trading in our common stock will begin on a "when issued" basis on or shortly before the record date for the distribution and will continue up to and including the distribution date. "When issued" trading in the context of a separation refers to a sale or purchase made conditionally on or before the distribution date because the securities of the separated entity have not yet been distributed. The "when issued" trading market will be a market for Bioverativ common stock that will be distributed to holders of Biogen common stock on the distribution date. If you owned Biogen common stock at the close of business on the record date, you would be entitled to Bioverativ common stock distributed pursuant to the distribution. You may trade this entitlement to shares of Bioverativ common stock, without Biogen common stock you own, on the "when issued" market. On the first trading day following the distribution date, "when issued" trading with respect to Bioverativ common stock will end, and "regular way" trading will begin.

Treatment of Equity Based Compensation

        Prior to the distribution, Bioverativ and Biogen are expected to enter into an employee matters agreement, as generally discussed in the section entitled "Certain Relationships and Related Person Transactions—Agreements with Biogen." Pursuant to the terms of the employee matters agreement, it is expected that Biogen equity incentive awards outstanding as of the distribution date will be adjusted in accordance with the following principles:

    For each award, the intent is to maintain, immediately following the distribution date, the economic value of the award immediately before the distribution date.

    For Bioverativ employees at the time of distribution, Biogen equity awards will be converted into Bioverativ equity awards and denominated in shares of Bioverativ common stock.

    For Biogen employees, the awards will remain Biogen equity awards.

        The following table contains a summary of the expected treatment of each type of Biogen equity award. As a result of the adjustments to such awards in connection with the distribution, the precise

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number of Bioverativ awards resulting from the conversion of Biogen awards will not be known until following the distribution date.

Type of Biogen Award
  Bioverativ Employees   Biogen Employees

Stock Options

  Biogen stock options will be converted into Bioverativ stock options of comparable value to purchase Bioverativ common stock   Continue to hold Biogen stock options, as equitably adjusted to reflect the distribution

Time-Vesting Restricted Stock Units (RSUs)

 

Biogen RSUs will be replaced with Bioverativ RSUs of comparable value

 

Continue to hold Biogen RSUs, as equitably adjusted to reflect the distribution

Cash-Settled Performance Units (CSPUs)

 

Biogen CSPUs will be converted into time-based Bioverativ RSUs of comparable value and, to the extent the distribution occurs prior to the conclusion of the applicable performance period, with performance measured as of the date of the distribution

 

Continue to hold Biogen CSPUs, as equitably adjusted to reflect the distribution

Market Stock Units (MSUs)

 

Biogen MSUs will be converted into time-based Bioverativ RSUs of comparable value and, to the extent the distribution occurs prior to the conclusion of the applicable performance period, with performance measured as of the date of the distribution

 

Continue to hold Biogen MSUs, as equitably adjusted to reflect the distribution

        It is expected that Biogen RSUs held by current non-employee directors of Biogen who will continue to serve in such capacity with Biogen and who also serve as Bioverativ's non-employee directors upon the distribution (if any) will continue to vest based on continued service with Biogen. Biogen RSUs held by current or former non-employee directors of Biogen who cease serving in such capacity with Biogen and who become Bioverativ's non-employee directors upon the distribution (if any) will be replaced with Bioverativ RSU awards of comparable value.

        Options.     Each Biogen stock option held by a Bioverativ employee was fully vested under the terms of the applicable award agreement prior to the distribution date. At the time of the distribution, it is expected that such Biogen stock options will be converted into a vested Bioverativ stock option on substantially the same terms as were applicable to each such Biogen stock option prior to the time of the distribution. The number of shares of Bioverativ common stock subject to each Bioverativ stock option will be equal to the product (rounded down to the nearest whole share) of (i) the number of shares of Biogen common stock subject to such stock options multiplied by (ii) a fraction, the numerator of which will be the volume weighted average trading price over 10 trading days of a share of Biogen common stock prior to the distribution and the denominator of which will be the volume weighted average trading price over 10 trading days of a share of Bioverativ common stock following the distribution (such fraction, the "conversion fraction"). The per share exercise price of the

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Bioverativ stock options will be equal to the per share exercise price of the original Biogen option divided by the Conversion Fraction, with the result being rounded up to the nearest whole cent.

        RSUs.     At the time of the distribution, it is expected that each Biogen RSU held by a Bioverativ employee will be converted into a Bioverativ RSU on substantially the same terms and vesting conditions as were applicable to each such Biogen RSU prior to the time of the distribution. The number of shares of Bioverativ common stock subject to each Bioverativ RSU will be equal to the product (rounded down to the nearest whole share) of (i) the number of shares of Biogen common stock subject to such RSU multiplied by (ii) the conversion fraction. Following the distribution, each such Bioverativ RSU will continue to vest based on the Bioverativ employee's continued service with Bioverativ.

        CSPUs.     At the time of the distribution, it is expected that each Biogen CSPU held by a Bioverativ employee will be converted into a Bioverativ RSU, and to the extent the distribution occurs prior to the conclusion of the applicable performance period, with the attainment of the applicable performance goals, to be measured at the actual level of performance at the time of the distribution. The number of shares of Bioverativ common stock subject to each Bioverativ RSU will be equal to the product (rounded down to the nearest whole share) of (i) the number of shares of Biogen common stock subject to such Biogen CSPU multiplied by (ii) the conversion fraction, with outstanding performance-based vesting requirements measured at the actual level of performance at the time of distribution. Following the distribution, each such Bioverativ RSU will continue to vest based on continued service with Bioverativ and, other than with respect to performance-based vesting conditions, on the same terms and conditions as were applicable to such Biogen CSPU immediately prior to the distribution.

        MSUs.     At the time of the distribution, it is expected that each Biogen MSU held by a Bioverativ employee will be converted into a Bioverativ RSU, and to the extent the distribution occurs prior to the conclusion of the applicable performance period, with performance-based vesting requirements measured at the actual level of performance at the time of the distribution. The number of shares of Bioverativ common stock subject to each Bioverativ RSU will be equal to the product (rounded down to the nearest whole share) of (i) the number of shares of Biogen common stock subject to such MSU, with outstanding performance-based vesting requirements measured at the actual level of performance at the time of distribution multiplied by (ii) the conversion fraction. Following the distribution, each such Bioverativ RSU will continue to vest based on continued service with Bioverativ and, other than with respect to performance-based vesting conditions, on substantially the same terms and conditions as were applicable to such Biogen MSU immediately prior to the distribution.

Conditions to the Distribution

        Bioverativ expects that the distribution will be effective at 12:01 a.m., Eastern Time, on February 1, 2017, the distribution date, provided that, among other conditions described in this information statement, the following conditions shall have been satisfied or waived by Biogen in its sole discretion:

    the internal reorganization to separate the Biogen and Bioverativ businesses having been effectuated, except for such steps (if any) as Biogen in its sole discretion has determined need not be completed (or may be completed after the effective time of the distribution);

    the receipt and continuing validity of an opinion from tax counsel or other third party advisor to Biogen that is in substance and form satisfactory to Biogen, substantially to the effect that, among other things, the distribution of our ordinary shares, together with certain related transactions, will qualify under Sections 355 and 368(a) of the Code, with the result that Biogen and Biogen's stockholders will not recognize any taxable income, gain or loss for U.S. federal

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      income tax purposes as a result of the distribution, except to the extent of cash received in lieu of fractional shares;

    the receipt and continuing validity of an opinion from an independent appraisal firm to the Biogen board of directors confirming the solvency and financial viability of Bioverativ after the distribution and, as to compliance by Biogen in declaring to pay the distribution, with surplus requirements under Delaware corporate law, that is in form and substance acceptable to Biogen in its sole discretion;

    the SEC declaring effective Bioverativ's registration statement on Form 10 of which this information statement forms a part, and no stop order relating to the registration statement shall be in effect and no proceedings for such purpose shall be pending before or threatened by the SEC, and the distribution of the information statement (or the Notice of Internet Availability of the Information Statement) to all holders of record of shares of Biogen common stock as of the close of business on the record date;

    Bioverativ shall have executed and delivered the transaction agreements relating to the separation;

    no order, injunction, or decree issued by any court of competent jurisdiction or other legal restraint or prohibition preventing the consummation of the distribution or any of the related transactions shall be pending, threatened, issued or in effect;

    the board of directors of Biogen shall have declared the distribution and approved all related transactions (and such declaration and approval not having been withdrawn);

    the shares of Bioverativ common stock to be distributed shall have been accepted for listing on the Nasdaq Global Select Market, subject to official notice of distribution; and

    no other event or development existing or having occurred that, in the sole and absolute judgment of Biogen's board of directors, makes it inadvisable to effect the distribution and other related transactions.

        Biogen and Bioverativ cannot assure you that any or all of these conditions will be met and, to the extent permissible under applicable law, Biogen in its sole discretion may waive any of the conditions to the distribution. In addition, Biogen will have the sole and absolute discretion to determine (and change) the terms of, and whether to proceed with, the distribution and, to the extent it determines to so proceed, to determine the record date for the distribution and the distribution date and the distribution ratio. Biogen does not intend to notify its stockholders of any modifications to the terms of the separation that, in the judgment of its board of directors, are not material. For example, the Biogen board of directors might consider material such matters as significant changes to the distribution ratio, the assets to be contributed or the liabilities to be assumed in the separation. To the extent that the Biogen board of directors determines that any modifications by Biogen materially change the material terms of the distribution or to abandon the distribution, Biogen will notify Biogen stockholders in a manner reasonably calculated to inform them about the modification as may be required by law, by, for example, publishing a press release, filing a Current Report on Form 8-K, or circulating a supplement to this information statement.

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U.S. FEDERAL INCOME TAX CONSEQUENCES

        The following is a discussion of the U.S. federal income tax consequences of the distribution of Bioverativ common stock to "U.S. holders" (as defined below) of Biogen common stock. This summary is based on the Code, U.S. Treasury Regulations promulgated thereunder, rulings and other administrative pronouncements issued by the IRS, and judicial decisions, all as in effect as of the date of this information statement, and all of which are subject to differing interpretation and change at any time, possibly with retroactive effect. This discussion applies only to "U.S. holders" of Biogen common stock who hold such shares of Biogen common stock as capital assets within the meaning of the Code (generally, property held for investment). This summary does not discuss all aspects of U.S. federal income taxation that may be relevant to particular holders of Biogen common stock in light of their particular circumstances, nor does it address the consequences to holders of Biogen common stock subject to special treatment under the Code (including, but not limited to, insurance companies, tax-exempt organizations, financial institutions, broker-dealers, partners in partnerships (or entities or arrangements treated as partnerships for U.S. federal income tax purposes) that hold Biogen common stock, pass-through entities (or investors therein), traders in securities who elect to apply a mark-to-market method of accounting, stockholders who hold Biogen common stock as part of a "hedge," "straddle," "conversion," "synthetic security," "integrated investment" or "constructive sale transaction," individuals who receive Biogen or Bioverativ common stock upon the exercise of employee stock options or otherwise as compensation, holders who are liable for the alternative minimum tax or any holders who actually or constructively own five percent or more of Biogen common stock). This discussion also does not address any U.S. federal estate, gift or other non-income tax consequences or any state, local or non-U.S. tax consequences or the consequences of the Medicare tax on net investment income. The distribution may be taxable under such other tax laws and all holders should consult their own tax advisors with respect to the applicability and effect of any such tax laws.

        For purposes of this section, a "U.S. holder" is a beneficial owner of Biogen common stock that is, for U.S. federal income tax purposes:

    an individual who is a citizen or resident of the United States;

    a corporation, or other entity taxable as a corporation for U.S. federal income tax purposes, created or organized under the laws of the United States or any state or political subdivision thereof;

    an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or

    a trust, if (i) a court within the United States is able to exercise primary jurisdiction over its administration and one or more U.S. persons have the authority to control all of its substantial decisions, or (ii) that has a valid election in place under the applicable Treasury Regulations to be treated as a U.S. person.

        If a partnership (including any entity or arrangement taxable as a partnership for U.S. federal income tax purposes) holds shares of Biogen common stock, the tax treatment of a partner in such partnership generally will depend upon the status of the partner and the activities of the partner and the partnership. Holders of Biogen common stock that are partnerships (or other entities or arrangements taxable as partnerships for U.S. federal income tax purposes) and partners in such partnerships should consult their own tax advisors regarding the U.S. federal income tax consequences of the distribution .

         The following discussion is a summary of the U.S. federal income tax consequences of the distribution under current law and is for general information only. All holders should consult their

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own tax advisors as to the particular tax consequences of the distribution to them, including the application and effect of U.S. federal, state, local and non-U.S. tax laws.

General

        It is a condition to the distribution that Biogen receive an opinion from Biogen's tax counsel or other third party advisor, satisfactory to Biogen's board of directors, to the effect that the distribution, together with certain related transactions, will qualify under Sections 355 and 368(a)(1)(D) of the Code; this condition is waivable by Biogen in its sole discretion. Except as otherwise noted, it is expected that the distribution will qualify as a transaction that is tax-free for U.S. federal income tax purposes to Biogen and the holders of Biogen common stock. The tax opinion is generally expected to conclude that, for United States federal income tax purposes:

    no gain or loss will be recognized by, and no amount will be includible in the income of, Biogen as a result of the distribution, other than gain or income arising in connection with certain internal restructurings undertaken in connection with the distribution and with respect to any "excess loss account" or "intercompany transaction" required to be taken into account by Biogen under U.S. Treasury Regulations relating to consolidated federal income tax returns;

    no gain or loss will be recognized by, and no amount will be included in the income of, U.S. holders of Biogen common stock upon the receipt of Bioverativ common stock in the distribution, except with respect to any cash received in lieu of fractional shares of Bioverativ common stock (as described below) for U.S. federal income tax purposes;

    the aggregate tax basis of Biogen common stock and Bioverativ common stock received in the distribution (including any fractional share interest in Bioverativ common stock for which cash is received) in the hands of each U.S. holder of Biogen common stock immediately after the distribution will equal the aggregate basis of Biogen common stock held by the U.S. holder immediately before the distribution, allocated between Biogen common stock and Bioverativ common stock (including any fractional share interest in Bioverativ common stock for which cash is received) in proportion to the relative fair market value of each on the date of the distribution;

    each U.S. holder's holding period in Bioverativ common stock received in the distribution (including any fractional share interest in Bioverativ common stock for which cash is received) will generally include the holding period at the time of the distribution for Biogen common stock with respect to which the distribution is made; and

    a U.S. holder of Biogen common stock who receives cash in lieu of a fractional share of Bioverativ common stock in the distribution will be treated as having sold such fractional share for cash, and will recognize capital gain or loss measured by the difference between the U.S. holder's tax basis of the fractional share deemed to be received, as determined above, and the amount of cash received.

        The tax opinion will be based upon various factual representations and assumptions, as well as certain undertakings made by Biogen and Bioverativ. If any of those factual representations or assumptions are untrue or incomplete in any material respect, any undertaking is not complied with, or the facts upon which the opinion will be based are materially different from the facts at the time of the distribution, the distribution may not qualify for tax-free treatment. Opinions of counsel are not binding on the IRS or the courts. As a result, the conclusions expressed in an opinion of counsel could be challenged by the IRS, and if the IRS prevails in such a challenge, the tax consequences described above would not apply and Biogen and the holders of Biogen common stock could be subject to significant U.S. federal income tax liability.

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        If the distribution were determined not to qualify as a tax-free transaction under Sections 355 and 368(a)(1)(D) of the Code, each U.S. holder generally would be treated as receiving a taxable distribution in an amount equal to the fair market value of the shares of Bioverativ common stock received by the holder, including any fractional shares deemed received. Any such taxable distributions would be treated as dividends to the extent of Biogen's current and accumulated earnings and profits, as determined under U.S. federal income tax principles. To the extent such taxable distributions exceeded Biogen's current and accumulated earnings and profits, each U.S. holder generally would be treated as receiving a tax-free return of capital to the extent of the U.S. holder's adjusted basis in its Biogen common stock, with any amount exceeding that U.S. holder's adjusted basis treated as capital gain. It is expected that Biogen would have current and accumulated earnings and profits at the time of the distribution equal to or in excess of the fair market value of the Bioverativ shares distributed in the distribution, and thus U.S. holders of Biogen common stock should assume that if the distribution were determined not to qualify as a tax-free transaction under Section 355 and 368(a)(1)(D) of the Code, the distribution would be treated as a dividend in full. In addition, Biogen generally would recognize gain with respect to the distribution of Bioverativ common stock and certain related transactions.

        Even if the distribution otherwise qualifies as a tax-free transaction under Sections 355 and 368(a)(1)(D) of the Code, the distribution and certain related transactions could be taxable to Biogen and could result in a significant U.S. federal income tax liability to Biogen under Section 355(e) of the Code if one or more persons acquire a 50% or greater interest (measured by vote or value) in the stock of Biogen or in the stock of Bioverativ as part of a plan or series or related transactions that includes the distribution. The process for determining whether an acquisition is part of a plan or series of related transactions under these rules is complex, inherently factual and subject to interpretation of the facts and circumstances of a particular case. If the distribution is determined to be taxable to Biogen, Biogen would generally recognize gain with respect to the distribution of Bioverativ common stock and certain related transactions.

        In connection with the distribution, Biogen and Bioverativ will enter into a tax matters agreement pursuant to which Bioverativ will be responsible for certain liabilities and obligations following the distribution. In general under the terms of the tax matters agreement, for the two-year period following the distribution, we will be prohibited, except in certain circumstances, from:

    entering into any transactions resulting in the acquisition of 40% or more of our stock or substantially all of our assets, whether by merger or otherwise;

    merging, consolidating or liquidating;

    issuing equity securities beyond certain thresholds;

    repurchasing our capital stock; or

    ceasing to actively conduct our business.

        For a discussion of the tax matters agreement, see "Certain Relationships and Related Person Transactions—Agreements with Biogen— Tax Matters Agreement ." The indemnification obligations of Bioverativ to Biogen under the tax matters agreement are not expected to be limited in amount or subject to any cap. If Bioverativ is required to pay any taxes or indemnify Biogen and its subsidiaries and their respective officers and directors under the circumstances set forth in the tax matters agreement, Bioverativ may be subject to substantial liabilities.

Cash in Lieu of Fractional Shares

        No fractional shares of Bioverativ common stock will be distributed to Bioverativ stockholders. All such fractional shares resulting from the distribution will be aggregated and sold, and the proceeds, less any brokerage commissions or other fees, will be distributed to registered Biogen stockholders in

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accordance with their fractional market interest in the aggregate number of shares sold. A U.S. holder that receives cash in lieu of fractional shares of Bioverativ common stock as a result of the distribution generally will recognize capital gain or loss measured by the difference between the cash received for such fractional shares and the holder's tax basis in the fractional shares determined as described under "—General" above. Any such capital gain or loss will be long-term capital gain or loss if the U.S. holder is treated as having held its Biogen common stock for more than one year. Long-term capital gains generally are subject to preferential rates of U.S. federal income tax for certain non-corporate U.S. holders (including individuals). The deductibility of capital losses is subject to significant limitations.

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DESCRIPTION OF BIOVERATIV'S CAPITAL STOCK

        Our certificate of incorporation and bylaws will be amended and restated prior to the distribution. The following is a summary of the material terms of our capital stock that will be contained in the amended and restated certificate of incorporation and amended and restated bylaws, and is qualified in its entirety by reference to these documents. You should refer to our amended and restated certificate of incorporation and amended and restated bylaws, forms of which are included as exhibits to the registration statement of which this information statement is a part, along with the applicable provisions of Delaware law. Prior to the distribution date, Biogen, as our sole stockholder, will approve and adopt our amended and restated certificate of incorporation, and our board of directors will approve and adopt our amended and restated bylaws. For more information on how you can obtain our amended and restated certificate of incorporation and our amended and restated bylaws, see "Where You Can Find More Information" on page 122 of this information statement. We urge you to read our amended and restated certificate of incorporation and our amended and restated bylaws in their entirety.

Authorized Capital Stock

        Our authorized capital stock will consist of eight hundred million (800,000,000) shares of common stock, par value $0.001 per share, and fifty million (50,000,000) shares of preferred stock, par value $0.001 per share.

Common Stock

        Immediately following the distribution, we expect that approximately 107,952,005 shares of our common stock will be issued and outstanding based upon approximately 215,904,010 shares of Biogen common stock outstanding as of December 1, 2016.

        Voting Rights.     The holders of our common stock will be entitled to one vote in person or by proxy for each share on all matters on which such stockholders are entitled to vote except as specifically stated in our amended and restated certificate of incorporation. Our amended and restated certificate of incorporation will not authorize cumulative voting for holders of shares of our common stock.

        Quorum.     The holders of a majority of the shares of our capital stock issued and outstanding and entitled to vote, present in person or represented in proxy, will constitute a quorum at all meetings of the stockholders.

        Annual Election of Directors.     Commencing with the first annual meeting of stockholders following the distribution, directors will be elected at the annual meeting of stockholders. Thereafter, each director elected will hold office until the next annual meeting of stockholders and until his or her successor is duly elected and qualified or until his or her earlier resignation, removal from office, death or incapacity. Except in a contested election, the vote required for the election of a director by the stockholders will be a majority of the votes cast in favor of the nominee. In a contested election, a director shall be elected by a plurality of the votes so cast in favor of the nominee. Unless otherwise provided in the certificate of incorporation, each stockholder represented at a meeting of the stockholders shall be entitled to cast one vote for each share of capital stock of the corporation entitled to vote thereat held by such stockholder. "Votes cast" do not include abstentions or shares as to which a stockholder gives no authority or discretion, including "broker non-votes." A majority of the votes cast means that the number of votes cast "for" a director's election exceeds the number of votes cast "against" that director's election.

        Meetings of Stockholders.     At the time of the distribution, our amended and restated bylaws will provide that special meetings of the stockholders may be called by our corporate secretary at the request of our chairman, chief executive officer or by a resolution duly adopted by the affirmative vote of a majority of our board of directors and may be called by our corporate secretary at the request in

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writing of a stockholder or group of stockholders that have, among other things, at least 25% or more of the outstanding stock entitled to vote as of the date of the request.

        Dividends and Liquidation Rights.     The holders of shares of common stock will be entitled to receive ratably the dividends and other distributions in cash, stock or property of our company when, as and if declared thereon by the board of directors in its sole discretion from time to time out of our assets or funds legally available, subject to any preferential rights of any then outstanding preferred stock and any other provisions of the certificate of incorporation. Upon liquidation, dissolution or winding-up of our company, whether voluntary or involuntary, after payment or provision for payment of our debts and other liabilities, holders of our common stock would be entitled to receive all remaining assets of our company available for distribution to the stockholders, ratably in proportion to the number of shares of common stock held by the stockholders and subject to any preferential rights of any then outstanding preferred stock.

        Miscellaneous.     After the distribution, all outstanding shares of our common stock will be fully paid and non-assessable. Holders of common stock will not be entitled to preemptive or subscription rights. There are no redemption or sinking fund provisions applicable to our common stock.

Preferred Stock

        Our amended and restated certificate of incorporation will authorize the Bioverativ board of directors, without further action by our stockholders, to issue shares of preferred stock and to fix by resolution the designations, preferences and relative, participating, optional or other special rights, and such qualifications, limitations or restrictions thereof, including, without limitation, redemption rights, dividend rights, liquidation preferences and conversion or exchange rights of any class or series of preferred stock, and to fix the number of classes or series of preferred stock, the number of shares constituting any such class or series and the voting powers for each class or series.

Anti-Takeover Considerations

        The provisions of the DGCL, our amended and restated certificate of incorporation and our amended and restated bylaws contain provisions that could serve to discourage or to make more difficult a change in control of us without the support of our board of directors or without meeting various other conditions. These provisions, summarized below, are expected to discourage certain types of coercive takeover practices and takeover bids that our board of directors may consider inadequate and to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the advantages of increased protection resulting from the greater likelihood of negotiation with the proponent of an unfriendly or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouraging takeover or acquisition proposals because, among other things, negotiation of these proposals could result in an improvement of their terms.

State Takeover Legislation

        Upon the distribution, we will be subject to Section 203 of the DGCL, an anti-takeover statute. In general, Section 203 of the DGCL, subject to certain exceptions set forth therein, prohibits a business combination between a corporation and an interested stockholder within three years of the time such stockholder became an interested stockholder, unless (a) prior to such time, the board of directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder, (b) upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, exclusive of shares owned by directors who are also officers and by certain employee stock plans, or (c) at or subsequent to such time, the business combination is approved by the board of directors and

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authorized by the affirmative vote at a stockholders' meeting of at least 66 2 / 3 % of the outstanding voting stock which is not owned by the interested stockholder.

        Except as otherwise set forth in Section 203, an interested stockholder is defined to include (i) any person that is the owner of 15% or more of the outstanding voting stock of the corporation, or is an affiliate or associate of the corporation and was the owner of 15% or more of the outstanding voting stock of the corporation at any time within three years immediately prior to the date of determination; and (ii) the affiliates and associates of any such person.

        The provisions of Section 203 may encourage persons interested in acquiring us to negotiate in advance with our board of directors, because the stockholder approval requirement would be avoided if a majority of the directors then in office approve either the business combination or the transaction which results in any such person becoming an interested stockholder. These provisions also may have the effect of preventing changes in our management. It is possible that these provisions could make it more difficult to accomplish transactions which our stockholders may otherwise deem to be in their best interests.

No Cumulative Voting

        Delaware law permits stockholders to cumulate their votes and either cast them for one candidate or distribute them among two or more candidates in the election of directors only if expressly authorized in a corporation's certificate of incorporation. Our amended and restated certificate of incorporation will not authorize cumulative voting for holders of shares of our common stock.

Requirements for Advance Notification of Stockholder Nominations and Proposals

        Our amended and restated bylaws will establish advance notice procedures with respect to stockholder proposals and nomination of candidates for election as directors other than nominations made by or at the direction of its board of directors or a committee of its board of directors. Generally, such proposal shall be made not later than the close of business on the 90 th  day, nor earlier than the close of business on the 120 th  day in advance of the first anniversary of the date of the previous year's annual meeting of stockholders. For purposes of the first annual meeting of stockholders after the company's shares of common stock are first publicly traded, proposals and nominations must be received from stockholders not later than the close of business on the 30 th  day following the day on which notice of the date of the first public annual meeting was mailed or public announcement of the date of the first public annual meeting was first made, whichever occurs first.

        Our amended and restated bylaws will establish proxy access notice procedures with respect to stockholder nominations of candidates for election as directors whereby whenever the board of directors solicits proxies with respect to the election of directors at an annual meeting of stockholders, the company shall include in its proxy statement for such annual meeting, the name, together with certain required information of any eligible stockholder nominee for election to the board of directors for any eligible stockholder or stockholders that provide a timely notice of proxy access nomination and expressly elect to have their nominee included in the company's proxy materials.

        These advance notice provisions may have the effect of precluding a contest for the election of our directors or the consideration of stockholder proposals if the proper procedures are not followed, and of discouraging or deterring a third party from conducting a solicitation of proxies to elect its own slate of directors or to approve its own proposal, without regard to whether consideration of those nominees or proposals might be harmful or beneficial to us and our stockholders.

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Stockholder Action by Written Consent

        Our amended and restated certificate of incorporation will expressly eliminate the right of our stockholders to act by written consent. Stockholder action must take place at the annual or a special meeting of our stockholders.

Size of Our Board of Directors and Vacancies

        Our amended and restated bylaws will provide that the number of directors on our board of directors will be fixed from time to time by resolution adopted by a majority of the entire board of directors. Under our amended and restated bylaws, sole power to fill vacancies and newly created directorships resulting from any increase in the authorized number of directors will be vested in the board of directors, except that either the board of directors or stockholders may fill vacancies resulting from stockholder removal of a director. If there are no directors in office, then an election of directors may be held in the manner provided by statute. In the event of one or more vacancies in the board of directors, the remaining directors, except as otherwise provided by law or the amended and restated bylaws, may exercise the powers of the full board of directors until the vacancies are filled.

Undesignated Preferred Stock

        The authority that our board of directors will possess to issue preferred stock could potentially be used to discourage attempts by third parties to obtain control of Bioverativ through a merger, tender offer, proxy contest or otherwise by making such attempts more difficult or more costly. Our board of directors may be able to issue preferred stock with voting rights or conversion rights that, if exercised, could adversely affect the voting power of the holders of common stock.

Limitations on Liability and Indemnification of Officers and Directors

        The DGCL authorizes corporations to limit or eliminate the personal liability of directors to corporations and their stockholders for monetary damages for breaches of directors' fiduciary duties as directors, and our amended and restated certificate of incorporation will include such an exculpation provision. Under the provisions of our amended and restated certificate of incorporation and amended and restated bylaws, each person who is or was one of our directors or officers or is or was serving at the request of us (or any predecessor) as an employee, fiduciary, representative, partner or agent of another corporation or of a partnership, joint venture, trust, employee benefit plan sponsored or maintained by us, or another enterprise (or any predecessor of any of such entities), shall be indemnified by us as of right to the fullest extent authorized by the DGCL against all expense, liability and loss (including attorneys' fees) reasonably incurred or suffered by such person in connection with the proceeding.

        Under the DGCL, to the extent that a person is successful on the merits in defense of a suit or proceeding brought against him because he is or was one of our directors or officers, he or she shall be indemnified against expenses (including attorneys' fees) actually and reasonably incurred in connection with such action.

        Under our amended and restated bylaws, the right to indemnification includes the right to be paid by us the expenses incurred in defending any action, suit or proceeding in advance of its final disposition, subject to the receipt by us of a statement or statements from the claimant requesting and reasonably evidencing such advance or advances from time to time. In any action by an indemnitee to enforce a right to indemnification or by us to recover advances made, the burden of proving that the indemnitee is not entitled to be indemnified is placed on us.

        The limitation of liability and indemnification provisions in our amended and restated certificate of incorporation and amended and restated bylaws may discourage stockholders from bringing a lawsuit

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against directors for breach of their fiduciary duty. These provisions may also have the effect of reducing the likelihood of derivative litigation against our directors and officers, even though such an action, if successful, might otherwise benefit Bioverativ and our stockholders. However, these provisions do not limit or eliminate our rights, or those of any stockholder, to seek non-monetary relief such as injunction or rescission in the event of a breach of a director's duty of care. The provisions do not alter the liability of directors under the federal securities laws. In addition, your investment may be adversely affected to the extent that, in a class action or direct suit, we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions. There is currently no pending material litigation or proceeding against any of our directors, officers or employees for which indemnification is sought.

        Prior to the distribution, we also plan to enter into separate agreements with our directors and executive officers providing for indemnification and advancement of expenses in addition to any rights such person may have under our governing documents.

Exclusive Forum

        Our amended and restated certificate of incorporation will provide that unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware, to the fullest extent permitted by law, will be the sole and exclusive forum for:

    any derivative action or proceeding brought on behalf of us;

    any action asserting a claim for breach of a fiduciary duty owed by any of our directors, officers or other employees of the company to us or our stockholders;

    any action asserting a claim arising pursuant to any provision of the DGCL; or

    any action asserting a claim governed by the internal affairs doctrine under Delaware state corporate law.

        However, the Court of Chancery shall not be the exclusive forum in any of the foregoing actions or proceedings in which the Court of Chancery of the State of Delaware concludes that it lacks subject matter jurisdiction over any such actions or proceedings. In such case, the sole and exclusive forum for such action or proceeding will be another state or federal court located within the State of Delaware, and unless the Court of Chancery (or such other state or federal court located within the State of Delaware, as applicable) has dismissed a prior action by the same plaintiff asserting the same claims because such court lacked personal jurisdiction over an indispensable party named as a defendant therein.

Sale of Unregistered Securities

        On August 4, 2016, in connection with the formation of Bioverativ Inc., we issued 1,000 shares of common stock, par value $0.001 per share, to Biogen pursuant to Section 4(a)(2) of the Securities Act. We did not register the issuance of the issued shares under the Securities Act because such issuance did not constitute a public offering.

Transfer Agent and Registrar

        After the distribution, the transfer agent and registrar for our common stock will be Computershare.

Listing

        We have applied to have our common stock authorized for listing on the Nasdaq Global Market Select under the symbol "BIVV".

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WHERE YOU CAN FIND MORE INFORMATION

        We have filed a registration statement on Form 10 with the SEC with respect to the shares of our common stock being distributed as contemplated by this information statement. This information statement is a part of, and does not contain all of the information set forth in, the registration statement and the exhibits and schedules to the registration statement. For further information with respect to us and our common stock, please refer to the registration statement, including its exhibits and schedules. Statements made in this information statement relating to any contract or other document are not necessarily complete, and you should refer to the exhibits attached to the registration statement for copies of the actual contract or document. You may review a copy of the registration statement, including its exhibits and schedules, at the SEC's public reference room, located at 100 F Street, N.E., Washington, D.C. 20549, by calling the SEC at 1-800-SEC-0330 as well as on the Internet website maintained by the SEC at www.sec.gov.

        As a result of the distribution, we will become subject to the information and reporting requirements of the Exchange Act and, in accordance with the Exchange Act, we will file periodic reports, proxy statements and other information with the SEC, which will be available at www.sec.gov.

        We intend to furnish holders of our common stock with annual reports containing consolidated financial statements prepared in accordance with GAAP and audited and reported on, with an opinion expressed, by an independent registered public accounting firm.

        You should rely only on the information contained in this information statement or to which we have referred you. We have not authorized any person to provide you with different information or to make any representation not contained in this information statement.

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GLOSSARY OF SCIENTIFIC TERMS

        Below is a list of additional scientific terms and their respective meanings which are used throughout this information statement.

ALPROLIX:     [Coagulation Factor IX (Recombinant), Fc Fusion Protein], our recombinant factor IX therapy for the treatment of hemophilia B.

Beta-Thalassemia:     An inherited blood disorder caused by mutations in the gene for beta-globin, a sub-unit of the oxygen-carrying protein of red blood cells, that results in excessive destruction of red blood cells and their precursors that could lead to life-threatening anemia, enlarged spleen, liver and heart, and bone abnormalities.

Biologics:     Medical products made from a variety of natural sources (human, animal or microorganism) intended to treat diseases and medical conditions or used to prevent or diagnose diseases; products include vaccines, blood and blood products, allergenic extracts, human cells and tissues, gene therapies and cellular therapies.

Biosimilars:     A biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product.

Bi-specific antibodies:     A class of antibodies that combine two antigen-recognizing elements into a single construct to bind two targets at the same time.

ELOCTATE:     [Antihemophilic Factor (Recombinant), Fc Fusion Protein], our recombinant factor VIII therapy for the treatment of hemophilia A. ELOCTA is the approved trade name for ELOCTATE in the European Union.

Extended Half-Life:     Prolonged circulation of the replacement clotting factor therapy in the body.

Generic Drug:     A small-molecule drug that is the same as, and bioequivalent to, an already-approved small molecule drug.

Hemophilia A:     A medical condition that occurs when clotting factor VIII, a naturally occurring protein in blood that controls bleeding, is not present in sufficient amounts or is absent.

Hemophilia B:     A medical condition that occurs when clotting factor IX, a naturally occurring protein in blood that controls bleeding, is not present in sufficient amounts or is absent.

Sickle Cell Disease:     A group of genetic disorders that occurs due to inheritance of mutations in hemoglobin, the oxygen carrying molecule inside red blood cells, resulting in chronic anemia and vascular obstructive complications.

von Willebrand Factor:     A naturally occurring protein in blood and the lining of blood vessels involved in bleeding and clotting that also binds to and stabilizes clotting factor VIII.

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INDEX TO FINANCIAL STATEMENTS

F-1



Report of Independent Registered Public Accounting Firm

To the Board of Directors and Shareholders of Biogen Inc.

        In our opinion, the accompanying combined balance sheets and the related combined statements of income (loss) and comprehensive income (loss), changes in equity and cash flows present fairly, in all material respects, the financial position of the Hemophilia Business of Biogen Inc. at December 31, 2015 and 2014, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2015 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with the standards of the Public Company Accounting Oversight Board (United States) and in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

/s/ PricewaterhouseCoopers LLP

Boston, Massachusetts
August 11, 2016

F-2



HEMOPHILIA BUSINESS OF BIOGEN INC.

Combined Statements of Income (Loss) and Comprehensive Income (Loss)

(In millions)

 
  For the Years Ended
December 31,
 
 
  2015   2014   2013  

Revenues:

                   

Product, net

  $ 554.1   $ 134.4   $  

Collaboration revenue

    6.2          

Total revenues

    560.3     134.4      

Cost and expenses:

                   

Cost of sales

    52.9     34.7     0.4  

Research and development

    186.1     239.8     191.8  

Selling, general and administrative

    223.3     220.0     149.8  

Total cost and expenses

    462.3     494.5     342.0  

Income (loss) from operations

    98.0     (360.1 )   (342.0 )

Other income (expense), net

    0.6     1.1     (2.0 )

Income (loss) before income tax expense (benefit)

    98.6     (359.0 )   (344.0 )

Income tax expense (benefit)

    (10.0 )   1.3     0.6  

Net income (loss)

  $ 108.6   $ (360.3 ) $ (344.6 )

Other comprehensive income (loss):

                   

Currency translation adjustment

    (0.2 )   0.4     0.1  

Total other comprehensive income (loss)

    (0.2 )   0.4     0.1  

Comprehensive income (loss)

  $ 108.4   $ (359.9 ) $ (344.5 )

   

The accompanying notes are an integral part of these Combined Financial Statements.

F-3



HEMOPHILIA BUSINESS OF BIOGEN INC.

Combined Balance Sheets

(In millions)

 
  As of December 31,  
 
  2015   2014  

ASSETS

             

Current assets:

             

Accounts receivable, net

  $ 94.4   $ 67.4  

Inventory

    252.1     179.3  

Other current assets

    4.0     2.2  

Total current assets

    350.5     248.9  

Property, plant and equipment, net

    75.5     78.5  

Intangible assets, net

    30.0     33.0  

Other long-term assets

    19.6     16.0  

Total assets

  $ 475.6   $ 376.4  

LIABILITIES AND EQUITY

             

Current liabilities:

             

Accounts payable

  $ 10.8   $ 13.6  

Accrued expenses and other current liabilities

    49.4     51.9  

Total current liabilities

    60.2     65.5  

Long-term liabilities

    30.7     17.1  

Total liabilities

  $ 90.9   $ 82.6  

Commitments and contingencies

             

Equity:

             

Net parent company investment

    384.4     293.3  

Accumulated other comprehensive loss

    0.3     0.5  

Total equity

    384.7     293.8  

Total liabilities and equity

  $ 475.6   $ 376.4  

   

The accompanying notes are an integral part of these Combined Financial Statements.

F-4



HEMOPHILIA BUSINESS OF BIOGEN INC.

Combined Statements of Cash Flows

(In millions)

 
  For the Years Ended December 31,  
 
  2015   2014   2013  

Cash flows from operating activities:

                   

Net income (loss)

  $ 108.6   $ (360.3 ) $ (344.6 )

Adjustments to reconcile net income (loss) to net cash flows from operating activities:

                   

Depreciation and amortization

    15.6     12.3     10.6  

Stock-based compensation

    13.2     13.9     12.1  

Changes in operating assets and liabilities, net:

                   

Accounts receivable

    (27.0 )   (67.4 )    

Inventory

    (72.9 )   (72.7 )   (106.5 )

Other assets

    (5.4 )   (12.2 )   (3.5 )

Accounts payable, accrued expenses and other current liabilities          

    (4.3 )   22.2     7.5  

Other liabilities

    13.6     7.9     5.5  

Net cash flows provided by (used in) operating activities

    41.4     (456.3 )   (418.9 )

Cash flows from investing activities:

                   

Purchases of property, plant and equipment

    (10.6 )   (21.2 )   (19.2 )

Acquisition of intangible assets

        (35.1 )    

Net cash flows used in investing activities

    (10.6 )   (56.3 )   (19.2 )

Cash flows from financing activities:

                   

Transfers from (to) Biogen

    (30.8 )   512.6     438.1  

Net cash flows used in (provided by) financing activities

    (30.8 )   512.6     438.1  

Net (decrease) increase in cash and cash equivalents

             

Cash and cash equivalents, beginning of the year

  $   $   $  

Cash and cash equivalents, end of the year

  $   $   $  

   

The accompanying notes are an integral part of these Combined Financial Statements.

F-5



HEMOPHILIA BUSINESS OF BIOGEN INC.

Combined Statements of Equity

(In millions)

 
  Net Parent
Company
Investment
  Accumulated
Other
Comprehensive
Income
  Total equity  

Balance, December 31, 2012 (unaudited)

  $ 20.2   $   $ 20.2  

Net loss

    (344.6 )         (344.6 )

Transfers from Biogen

    451.9           451.9  

Foreign currency translation adjustments

          0.1     0.1  

Balance, December 31, 2013 (unaudited)

    127.5     0.1     127.6  

Net loss

    (360.3 )         (360.3 )

Transfers from Biogen

    526.1           526.1  

Foreign currency translation adjustments

          0.4     0.4  

Balance, December 31, 2014

    293.3     0.5     293.8  

Net income

    108.6         108.6  

Transfers to Biogen

    (17.5 )         (17.5 )

Foreign currency translation adjustments

          (0.2 )   (0.2 )

Balance, December 31, 2015

  $ 384.4   $ 0.3   $ 384.7  

   

The accompanying notes are an integral part of these Combined Financial Statements

F-6



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements

1. Nature of Business and Basis of Preparation

Nature of Business

        On May 3, 2016, Biogen Inc. (Biogen) announced its plan to separate its hemophilia business, including certain additional assets and liabilities associated with Biogen's pipeline programs related to hemophilia and other blood disorders (the hemophilia business), into an independent, publicly traded company named Bioverativ Inc. (Bioverativ). Following the separation, Bioverativ intends to focus on the discovery, research, development and commercialization of innovative therapies for the treatment of hemophilia and other blood disorders. Unless the context otherwise requires, the combined hemophilia business of Biogen is referred to throughout these Notes as "Bioverativ", "we", "us", "our" or the "company."

        To accomplish the separation, Biogen intends to make a pro rata distribution of 100% of Bioverativ's common stock to Biogen's stockholders. At the time of the distribution, Bioverativ will hold the assets and liabilities of Biogen's hemophilia business. The distribution is subject to a number of conditions, including the receipt of a favorable opinion from tax counsel or other third party advisor with respect to the tax-free nature of the distribution, approval by the Biogen board of directors and the U.S. Securities and Exchange Commission declaring the effectiveness of a Registration Statement on Form 10. In addition, Biogen can decline at any time to go forward with the distribution.

        Bioverativ's marketed products include ELOCTATE and ALPROLIX, extended half-life factors for the treatment of hemophilia A and hemophilia B, respectively. Pursuant to a development and commercialization agreement, Bioverativ collaborates with Swedish Orphan Biovitrum AB (publ) (Sobi) to jointly develop and commercialize ELOCTATE and ALPROLIX globally. Sobi has assumed responsibility for commercialization of ELOCTATE and ALPROLIX in Europe, Russia and certain countries in Northern Africa and the Middle East, while Bioverativ retains rights to commercialize those therapies in the United States, Japan, Canada, Australia and all other markets excluding Sobi's commercialization territory. See Note 3, Collaborations , for further information on Bioverativ's collaboration with Sobi.

Basis of Preparation

        The accompanying combined financial statements have been prepared on a standalone basis and are derived from Biogen's consolidated financial statements and accounting records. The combined financial statements reflect the company's historical financial position, results of operations and cash flows as the business was operated as part of Biogen prior to the distribution, in conformity with U.S. generally accepted accounting principles (GAAP).

        These combined financial statements include allocations from Biogen to us for certain research and development and selling, general and administrative costs not directly attributable to the hemophilia business. The research and development costs include depreciation and other facility-based expenses, regulatory affairs function, pharmacovigilance, other infrastructure and management costs supporting multiple projects. The selling, general and administrative costs include certain services provided by Biogen, which include, but are not limited to, executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology, investor relations, shared services, insurance, employee benefits and incentives and share-based compensation. These expenses have been allocated to the company based on direct usage or benefit where specifically identifiable, with the remainder allocated primarily based on hours or direct costs. The company considers the expense methodology and results to be reasonable for all periods presented. However, the

F-7



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

1. Nature of Business and Basis of Preparation (Continued)

allocations may not be indicative of the actual expense that would have been incurred had the company operated as an independent, publicly traded company for the years presented.

        The income tax amounts in these combined financial statements have been calculated based on a separate return methodology and presented as if the company's operations were separate taxpayers in the respective jurisdictions.

        Biogen maintains various benefit and share-based compensation plans at a corporate level and other benefit plans at a country level. The company's employees participate in such programs and a portion of the cost of those plans is included in the company's financial statements. However, the combined balance sheets do not include any equity related to share-based compensation plans.

        The company's equity balance in these combined financial statements represents the excess of total assets over total liabilities, including the due to/from balances between the company and Biogen (net parent company investment) and accumulated other comprehensive income. Net parent company investment is primarily impacted by contributions from Biogen which are the result of treasury activities and net funding provided by or distributed to Biogen.

2. Summary of Significant Accounting Policies

Use of Estimates

        The preparation of the combined financial statements requires the company to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosures of contingent assets and liabilities. On an ongoing basis the company evaluates the estimates, judgments and methodologies. The company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. Actual results may differ from these estimates under different assumptions or conditions.

Revenue Recognition

        The company recognizes revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the price to the customer is fixed or determinable; and collectability is reasonably assured.

Product Revenues

        We sell mainly to specialty pharmacies, hemophilia treatment centers, public and private hospitals and independent distributors. Any discounts offered to these customers are reflected as on-invoice discounts. We also sell to specialty distributors who receive both on-invoice discounts as well as chargebacks for sales to various U.S. government agencies such as U.S. Public Health Service (PHS). Provisions for rebates, chargebacks to distributors, and discounts are provided for at the time the related sales are recorded, and are reflected as a reduction of sales. Reserves established for these discounts and allowances are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). Our estimates take into consideration our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying

F-8



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

and payment patterns. Actual amounts may ultimately differ from our estimates. If actual results vary, we adjust these estimates, which could have an effect on earnings in the period of adjustment.

        Product revenue reserves are categorized as follows: discounts and contractual adjustments. Discounts include trade term discounts and volume discounts. Trade term discounts relate to estimated obligations for credits to be granted to customers for remitting payment on their purchases within established incentive periods. Volume discounts are earned as customers reach certain tier levels based upon their purchases. Contractual adjustments primarily relate to Medicaid and PHS discounts. Product returns are insignificant and are limited to product damaged in transit or incorrectly shipped.

Collaborations

        Our development and commercialization arrangement with Sobi represents a collaborative arrangement because both Sobi and us are active participants and exposed to significant risks and rewards of the arrangement. Where we are the principal on sales transactions with third parties, we recognize revenue, cost of sales, including royalty cost of sales, and operating expenses on a gross basis in our income statement. We recognize payments between Sobi and us based upon their nature. These payments consist of royalty cost of sales, royalty revenue and contract manufacturing revenue. Royalty revenue and contract manufacturing revenue represent collaboration revenue in our income statement. See Note 3, Collaborations .

Accounts Receivable

        The majority of accounts receivable arise from product sales and primarily represent amounts due from specialty pharmacies, hemophilia treatment centers, public and private hospitals and independent distributors. The company monitors the financial performance and creditworthiness of its customers so that the company can properly assess and respond to changes in their credit profile. The company provides reserves against trade receivables for estimated losses that may result from a customer's inability to pay. Amounts determined to be uncollectible are charged or written-off against the reserve. To date, the company has not had any write-offs.

Concentration of Credit Risk

        Sales to two specialty pharmacies individually represent 19% and 15%, respectively, of total revenues for the nine months ended September 30, 2016 (unaudited); 21% and 16%, respectively, of total revenues for the year ended December 31, 2015; and 20% for each of total revenues for the year ended December 31, 2014. Concentration of credit risk with respect to receivables, which are typically unsecured, are largely mitigated due to the wide variety of customers. The majority of accounts receivable arise from product sales in the United States and Japan and have standard payment terms which generally require payment within 30 to 90 days. The company monitors the financial performance and creditworthiness of its customers so that the company can properly assess and respond to changes in their credit profile. The company continues to monitor these conditions and assess their possible impact on its business.

Inventory

        Inventories are stated at the lower of cost or market with cost based on the first-in, first-out (FIFO) method. Inventory that can be used in either the production of clinical or commercial products

F-9



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

is expensed as research and development costs when selected for use in a clinical manufacturing campaign.

Contingencies

        We are currently involved in various claims and legal proceedings. Loss contingency provisions are recorded if the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated or a range of loss can be determined. These accruals represent management's best estimate of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible that the amount of a loss will exceed the recorded provision. On a quarterly basis, we review the status of each significant matter and assess its potential financial exposure. Significant judgment is required in both the determination of probability and the determination as to whether an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information available at the time. As additional information becomes available, we reassess the potential liability related to pending claims and litigation and may change our estimates. These changes in the estimates of the potential liabilities could have a material impact on our consolidated results of operations and financial position.

Capitalization of Inventory Costs

        The company capitalizes inventory costs associated with its products prior to regulatory approval, when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. In determining whether or not to capitalize such inventories, the company evaluates, among other factors, information regarding the drug candidate's safety and efficacy, the status of regulatory submissions and communications with regulatory authorities and the outlook for commercial sales, including the existence of current or anticipated competitive drugs and the availability of reimbursement. In addition, the company evaluates risks associated with manufacturing the drug candidate and the remaining shelf-life of the inventories.

Obsolescence and Unmarketable Inventory

        The company periodically reviews its inventories for excess or obsolescence and write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value.

Property, Plant and Equipment

        Property, plant and equipment is comprised of assets whereby a majority of its use was dedicated to the hemophilia business. Amounts are carried at cost. The cost of normal, recurring or periodic repairs and maintenance activities related to property, plant and equipment are expensed as incurred. The cost for planned major maintenance activities, including the related acquisition or construction of assets, is capitalized if the repair will result in future economic benefits.

F-10



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

        The company generally depreciates or amortizes the cost of its property, plant and equipment using the straight-line method over the estimated useful lives of the respective assets, which are summarized as follows:

Asset Category
  Useful Lives

Land

  Not depreciated

Buildings

  15 to 40 years

Leasehold Improvements

  Lesser of the useful life or the term of the respective lease

Furniture and Fixtures

  5 to 7 years

Machinery and Equipment

  5 to 20 years

Computer Software and Hardware

  3 to 5 years

Acquired Intangibles

        Acquired intangibles include product rights and patents, which are recorded at fair value, assigned an estimated useful life, and are amortized over their estimated useful lives of approximately twelve years. See Note 6, Acquired Intangible Assets . Amortization is included in cost of sales in the combined statements of income.

Impairment of Long-Lived Assets

        Long-lived assets to be held and used, including property, plant and equipment and definite-lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable.

        Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their fair values. Long-lived assets to be disposed of are carried at fair value less costs to sell.

Translation of Foreign Currencies

        The functional currency for the company's non-U.S. subsidiaries is their local currency. For non-U.S. subsidiaries that transact in a functional currency other than the U.S. dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign exchange rates for the period. Adjustments resulting from the translation of the financial statements of non-U.S. operations into U.S. dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of equity.

Research and Development Expenses

        Research and development costs are expensed as incurred. Milestone payments prior to regulatory approval are expensed when the milestone is achieved. Payments made to counterparties on or after regulatory approval are capitalized and amortized over the remaining useful life of the related product. Amounts capitalized for such payments are included in acquired intangible assets, net of accumulated

F-11



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

amortization. Also included in research and development expenses are allocations from Biogen. See Note 10, Related Parties.

Selling, General and Administrative Expenses

        Selling, general and administrative expenses are comprised of compensation and benefits associated with direct sales personnel, outside marketing, advertising and legal expenses directly attributable to the company as well as allocations from Biogen. See Note 10, Related Parties .

Income Taxes

        In the company's combined financial statements, income tax expense and deferred tax balances have been calculated on a separate return basis although the company's operations have historically been included in the tax returns filed by the respective Biogen entities of which the company's business is a part. In the future, as a standalone entity, the company will file tax returns on its own behalf and its deferred taxes and effective income tax rate may differ from those in historical periods.

        Deferred taxes are recognized for the future tax effects of temporary differences between financial and income tax reporting based on enacted tax laws and rates. The company maintains valuation allowances unless it is more likely than not that the deferred tax asset will be realized. With respect to uncertain tax positions, the company determines whether the position is more likely than not to be sustained upon examination, based on the technical merits of the position. Any tax position that meets the more-likely-than-not recognition threshold is measured and recognized in the combined financial statements at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. The liability relating to uncertain tax positions is classified as current in the combined balance sheets to the extent the company anticipates making a payment within one year. Interest and penalties associated with income taxes are classified in the income tax expense line in the combined statements of income.

        The company maintains an income taxes payable to/from account with Biogen. The company is deemed to settle current tax balances with the Biogen tax paying entities in the respective jurisdictions. The company's current income tax balances are reflected as income taxes payable and settlements, which are deemed to occur in the year following incurrence, are reflected as changes in net parent company investment in the combined balance sheets.

Accounting for Share-Based Compensation

        Share-based compensation programs are based upon Biogen share-based compensation plans. The Biogen plans grant awards that include stock options, restricted stock units which vest based on stock performance known as market stock units (MSUs), performance-vested restricted stock units which settle in cash (CSPUs), time-vested restricted stock units (RSUs), performance-vested restricted stock units which can be settled in cash or shares of our common stock (PUs) at the sole discretion of Biogen's Compensation and Management Development Committee of the Board of Directors. We charge the estimated fair value of awards against income over the requisite service period, which is generally the vesting period. Where awards are made with non-substantive vesting periods (for instance, where a portion of the award vests upon retirement eligibility), we estimate and recognize expense based on the period from the grant date to the date on which the employee is retirement eligible.

F-12



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

        The fair values of our stock option grants are estimated as of the date of grant using a Black-Scholes option valuation model. The estimated fair values of the stock options are then expensed over the options' vesting periods. The fair values of our MSUs are estimated using a lattice model with a Monte Carlo simulation. We apply an accelerated attribution method to recognize share-based compensation expense over the applicable service period, net of estimated forfeitures, when accounting for our MSUs. The probability of actual shares expected to be earned is considered in the grant date valuation, therefore the expense is not adjusted to reflect the actual units earned. The fair values of our RSUs are based on the market value of our stock on the date of grant. Compensation expense for RSUs is recognized on a straight-line basis over the applicable service period. We apply an accelerated attribution method to recognize share-based compensation expense when accounting for our CSPUs and PUs and the fair value of the liability is re-measured at the end of each reporting period through expected settlement. Compensation expense associated with CSPUs and PUs are based upon Biogen's common stock price and the number of units expected to be earned after assessing the probability that certain performance criteria will be met and the associated targeted payout level that is forecasted will be achieved, net of estimated forfeitures. Cumulative adjustments are recorded each quarter to reflect changes in the Biogen common stock price and estimated outcome of the performance-related conditions until the date results are determined and settled.

New Accounting Pronouncements

        From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies that the company adopts as of the specified effective date. Unless otherwise discussed, the company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on the company's financial position or results of operations upon adoption.

        In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which delayed the effective date of the new standard from January 1, 2017 to January 1, 2018. The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations, which clarifies the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies certain aspects of identifying performance obligations and licensing implementation guidance. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients related to disclosures of remaining performance obligations, as well as other amendments to guidance on collectability, non-cash consideration and the presentation of sales and other similar taxes collected from customers. These standards have the same effective date and transition date of January 1, 2018. We are currently evaluating the method of adoption and the potential impact that these standards may have on our financial position and results of operations.

F-13



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

        In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. The new standard applies only to inventory for which cost is determined by methods other than last-in, first-out and the retail inventory method, which includes inventory that is measured using FIFO or average cost. Inventory within the scope of this standard is required to be measured at the lower of cost and net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The new standard will be effective for the company on January 1, 2017. The adoption of this standard is not expected to have an impact on the company's financial position or results of operations.

        In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The new standard requires that all lessees recognize the assets and liabilities that arise from leases on the balance sheet and disclose qualitative and quantitative information about its leasing arrangements. The new standard will be effective for us on January 1, 2019. The adoption of this standard is not expected to have a material impact on our net financial position, but will impact our assets and liabilities. We are currently evaluating the potential impact that this standard may have on our results of operations.

        In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. The new standard requires recognition of the income tax effects of vested or settled awards in the income statement and involves several other aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The new standard will be effective for us on January 1, 2017. We are currently evaluating the potential impact that this standard may have on our financial position and results of operations.

3. Collaborations

        In connection with the company's business strategy, the company has entered into various collaboration agreements which provide the company with rights to develop, produce and market products using certain know-how, technology and patent rights maintained by the company's collaborative partners. Terms of the various collaboration agreements may require the company to make milestone payments upon the achievement of certain product research and development objectives and pay royalties on future sales, if any, of commercial products resulting from the collaboration.

Swedish Orphan Biovitrum AB (publ)

        In January 2007, Biogen acquired 100% of the stock of Syntonix Pharmaceuticals (Syntonix). Syntonix, now known as Biogen Hemophilia Inc. (BIH), had previously entered into a development and commercialization agreement with Sobi to jointly develop and commercialize Factor VIII and Factor IX hemophilia products, including ELOCTATE and ALPROLIX. Under the development and commercialization agreement, as has been amended and restated, BIH has commercial rights for North America (the Biogen North America Territory) and for all other markets outside of the Sobi territory (the Biogen Direct Territory), which consists of Europe, Russia and certain countries in Northern Africa and the Middle East (the Sobi Territory).

        In November 2014, Sobi exercised its option under the agreement to assume final development and commercialization activities in the Sobi Territory for ELOCTA (the trade name for ELOCTATE in

F-14



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

3. Collaborations (Continued)

the European Union). In July 2015, Sobi exercised its option under the agreement to assume final development and commercialization of ALPROLIX within the Sobi Territory. Upon each exercise of opt-in right under the terms of the development and commercialization agreement, Sobi made a $10.0 million payment in escrow.

        Upon European Medicines Agency (EMA) regulatory approval of each such product, Sobi is obligated to reimburse BIH 50% of all shared manufacturing and development expenses incurred by BIH from October 1, 2009 through the earlier of the date on which Sobi is registered as the marketing authorization holder for the applicable product or 90 days post-regulatory approval, as well as 100% of certain development expenses incurred exclusively for the benefit of the Sobi Territory (the Opt-In Consideration).

        ELOCTA was approved by the European Commission (EC) in November 2015. Through June 30, 2016, approximately $157.0 million in expenditures for ELOCTA, net of the $10.0 million escrow payment discussed above, represents the Opt-In Consideration and is reimbursable by Sobi under the development and commercialization agreement.

        ALPROLIX was approved by the EC in February 2016. Through June 30, 2016, approximately $130.0 million in expenditures for ALPROLIX, net of the $10.0 million escrow payment, represents the Opt-In Consideration and is reimbursable by Sobi under the development and commercialization agreement.

        The Opt-In Consideration will be paid by Sobi using a cross-royalty cash payment structure for sales in each company's respective territories. If the reimbursement of the Opt-in Consideration for a product has not been achieved within six years of the first commercial sales of such product (the Reimbursement period), the company maintains the right to require Sobi to pay any remaining balances due to us within 90 days of the six year anniversary date of the first commercial sales. After Sobi's Opt-In Consideration has been repaid, the royalty paid and received by the company resets to the contractual royalty rate of 12%.

        For the years ended December 31, 2015, 2014 and 2013, the royalty payable to Sobi based upon sales in the company's territory was 2%. Upon Sobi's first commercial sale in 2016, and during the Reimbursement period, the royalty rate the company will pay Sobi on sales of ELOCTATE and ALPROLIX in our territory is 7%. After the Reimbursement period concludes, the royalty rate we pay to Sobi increases to 12%. We are recording cost of sales at the effective royalty rate expected over the term of the agreement of approximately 11%.

        The company is accounting for the development and commercialization agreement under a right to use model and is recognizing revenue over the term of the commercialization period.

        The royalty rate received by the company, during the Reimbursement period on sales of ELOCTATE and ALPROLIX in Sobi's territory is 17%. After the Reimbursement period concludes, the royalty we receive decreases to 12%. We are recording revenue at the effective royalty rate expected over the term of the agreement of approximately 14%.

4. Reserves for Discounts and Allowances

        Following the company's product launches, the company began recognizing reserves for discounts and allowances related to these products' revenue.

F-15



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

4. Reserves for Discounts and Allowances (Continued)

        An analysis of the change in reserves is summarized as follows:

(In millions)
  Discounts   Contractual
Adjustments
  Total  

Balance at December 31, 2013

  $   $   $  

Provision related to current period sales

    23.9     25.9     49.8  

Credits/payments made

    (22.0 )   (16.1 )   (38.1 )

Balance at December 31, 2014

  $ 1.9   $ 9.8   $ 11.7  

Provision related to current period sales

    109.9     105.8     215.7  

Adjustment related to prior period sales

        (1.3 )   (1.3 )

Credits/payments made

    (106.0 )   (98.3 )   (204.3 )

Balance at December 31, 2015

  $ 5.8   $ 16.0   $ 21.8  

 

 
  As of
December 31,
 
(In millions)
  2015   2014  

Reduction of accounts receivable

  $ 8.1   $ 4.8  

Current liability

    13.7     6.9  

Total reserves

  $ 21.8   $ 11.7  

5. Inventory

        The components of inventory are summarized as follows:

 
  As of
December 31,
 
(In millions)
  2015   2014  

Raw materials

  $ 41.7   $ 19.9  

Work in process

    177.3     129.2  

Finished goods

    33.1     30.2  

Total inventory

  $ 252.1   $ 179.3  

        Inventory amounts written down as a result of excess, obsolescence, unmarketability or other reasons are charged to cost of sales, and totaled $1.3 million and $14.3 million in the years ended December 31, 2015 and 2014, respectively.

6. Acquired Intangible Assets

        Acquired intangibles primarily relate to approval milestones for ALPROLIX paid to the former Syntonix shareholders. In 2014, upon the U.S. Food and Drug Administration's approval of ALPROLIX for the treatment of hemophilia B, a $20.0 million milestone was paid. The $20.0 million milestone and the corresponding deferred tax liability of $7.3 million were capitalized as an acquired intangible asset. In May 2016, upon EMA approval of ALPROLIX in the European Union, an additional $20.0 million milestone was owed to the former Syntonix shareholders. The $20.0 million

F-16



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

6. Acquired Intangible Assets (Continued)

milestone and the corresponding deferred tax liability of $6.5 million were capitalized as an acquired intangible asset.

        Acquired intangible assets, net of accumulated amortization for 2015 and 2014 are $30.0 million and $33.0 million, respectively. During the years ending December 31, 2015 and 2014, amortization expense associated with acquired intangible assets was $3.0 million and $2.2 million, respectively.

7. Property, Plant and Equipment

        Property, plant and equipment are recorded at historical cost, net of accumulated depreciation. Components of property, plant and equipment, net are summarized as follows:

 
  As of
December 31,
 
(In millions)
  2015   2014  

Land

  $   $  

Buildings

    8.0     8.0  

Leasehold improvements

    38.5     36.8  

Machinery and equipment

    102.7     95.0  

Computer software and hardware

    19.2     15.7  

Furniture and fixtures

    1.5     1.4  

Construction in progress

    2.9     12.3  

Total cost

    172.8     169.2  

Less: accumulated depreciation

    97.3     90.7  

Total property, plant and equipment, net

  $ 75.5   $ 78.5  

8. Income Taxes

        In the company's combined financial statements, income tax expense and deferred tax balances have been calculated on a separate tax return basis although the company's operations have historically been included in the tax returns filed by the respective Biogen entities of which the company's business is a part. In the future, as a standalone entity, the company will file tax returns on its own behalf and its deferred taxes and effective income tax rate may differ from those in the historical periods.

        The company maintains an income taxes payable to/from account with Biogen. The company is deemed to settle current tax balances with the Biogen tax paying entities in the respective jurisdictions. The company's current income tax balances are reflected as income taxes payable and settlements, which are deemed to occur in the year following incurrence, are reflected as changes in net parent company investment in the combined balance sheets.

F-17



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

8. Income Taxes (Continued)

Income before income tax provision and income tax expense

 
  For the Year Ended
December 31,
 
(In millions)
  2015   2014   2013  

Income (loss) before income taxes expense (benefit):

                   

Domestic

  $ 94.2   $ (363.5 ) $ (345.1 )

Foreign

    4.4     4.5     1.1  

Total

  $ 98.6   $ (359.0 ) $ (344.0 )

Income tax expense (benefit):

                   

Current

                   

Foreign

    1.4     1.2     0.5  

Deferred

                   

Domestic

    (11.4 )   0.1     0.1  

Total income tax expense

  $ (10.0 ) $ 1.3   $ 0.6  

Deferred Tax Assets and Liabilities

 
  As of December 31,  
(In millions)
  2015   2014  

Deferred tax assets

             

Net operating loss

  $ 186.7   $ 234.7  

Tax credits

    46.8     43.6  

Inventory, other reserves, and accruals

    9.5     6.5  

Share-based compensation

    3.1     3.9  

Intangibles, net

    9.6     9.3  

Valuation allowance

    (247.3 )   (288.7 )

Total deferred tax assets

  $ 8.4   $ 9.3  

Deferred tax liabilities

             

Purchased intangible assets

  $ (8.4 ) $ (9.3 )

Total deferred tax liabilities

  $ (8.4 ) $ (9.3 )

        We have deferred tax assets of $255.7 million and $298.0 million as of December 31, 2015 and 2014, respectively comprised primarily of net operating losses and general business credit carryforwards for federal and state income tax purposes. We have incurred cumulative operating losses to date and, as such, we have established a valuation allowance of $247.3 million and $288.7 million as of December 31, 2015 and 2014, respectively. Management continues to monitor the positive and negative evidence supporting the realization of the deferred tax assets. Given our cumulative losses as of June 30, 2016, we continue to believe a full valuation allowance is appropriate. Factors that affect our judgment around the realizability of our deferred tax assets include our ongoing profitability, establishment of our cost structure as a standalone company and the determination of the terms of transition services agreements with Biogen. The valuation allowance could be released in 2016 or 2017

F-18



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

8. Income Taxes (Continued)

once it is determined it is more likely than not that the deferred tax assets will be realizable. Following the release of the valuation allowance, which will create substantial tax benefit in the period it is released, our tax rate will increase substantially to be more in line with the statutory rates of the jurisdictions where the income is earned.

        The net operating losses and general business credit carryforwards represent tax attributes that the business would have generated on a standalone basis had the company filed separate returns. While the income statement effect is reflected in our standalone financial statements, the deferred tax assets resulting from our net losses and business credit carryforwards will not be available to reduce our tax liabilities in the future since those attributes have already been utilized in the tax returns of Biogen, thereby increasing our future taxes payable.

Income Tax Expense Reconciliation

 
  For the Year Ended
December 31,
 
 
  2015   2014   2013  

Statutory rate

    35.0 %   35.0 %   35.0 %

State taxes

    1.0     1.1     1.1  

Taxes on foreign earnings

    (0.3 )   0.1     (0.1 )

Credits and NOLs

    (3.0 )   2.7     8.8  

Changes in valuation allowance

    (42.7 )   (38.3 )   (41.9 )

Other permanent items

    (0.2 )   (1.0 )   (3.1 )

Effective income tax rate

    (10.2 )%   (0.4 )%   (0.2 )%

9. Share-Based Compensation

        Biogen maintains an incentive stock plan for the benefit of its officers, directors, and employees, including company employees. As the company receives employee services in consideration for the participation of the company's employees in these plans, a share-based payment expense for the awards granted to the company's employees has been reflected in the combined statements of income. The company's employees participate in (i) the Biogen Inc. 2008 Amended and Restated Omnibus Equity Plan (2008 Omnibus Plan) and (ii) the Biogen Inc. 2015 Employee Stock Purchase Plan (ESPP).

        The company's share-based compensation has been derived from the equity awards granted by Biogen to the company's employees. As the share-based compensation plans are Biogen's plans, the amounts have been recognized through net parent company investment on the combined balance sheets.

        All shares described herein represent shares of Biogen.

Share-Based Compensation Expense

        Share-based compensation expense relating to the company's employees was $13.2 million, $13.9 million and $12.1 million in 2015, 2014 and 2013, respectively.

F-19



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

9. Share-Based Compensation (Continued)

        Approximately 16% and 10% of share-based compensation expense was classified in cost of sales expenses in 2015 and 2014, respectively. Approximately 36%, 43% and 53% of share-based compensation expense was classified in research and development expenses in 2015, 2014 and 2013, respectively. Approximately 48%, 47% and 47% of share-based compensation expense was classified in selling, general and administrative expenses in 2015, 2014 and 2013, respectively.

Market Stock Units

        MSUs awarded by Biogen to Bioverativ employees prior to 2014 vested in four equal annual increments beginning on the first anniversary of the grant date. Participants may ultimately earn between 0% and 150% of the target number of units granted based on actual stock performance. MSUs awarded by Biogen to Bioverativ employees in 2014 and 2015 vest in three equal annual increments beginning on the first anniversary of the grant date, and participants may ultimately earn between 0% and 200% of the target number of units granted based on actual stock performance.

        The vesting of these awards is subject to the respective employee's continued employment. The number of MSUs granted represents the target number of units that are eligible to be earned based on the attainment of certain market-based criteria involving our stock price. The number of MSUs earned is calculated at each annual anniversary from the date of grant over the respective vesting periods, resulting in multiple performance periods. Accordingly, additional MSUs may be issued or currently outstanding MSUs may be cancelled upon final determination of the number of awards earned. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period.

        The following table summarizes our MSU activity:

(In thousands)
  Shares   Weighted
Average
Per Share
Grant
Date Fair Value
 

Unvested at December 31, 2014

    25,000   $ 206.44  

Granted (a)

    12,000   $ 499.25  

Vested

    (18,000 ) $ 162.15  

Unvested at December 31, 2015

    19,000   $ 328.55  

(a)
MSUs granted in 2015 include approximately 6,000 MSUs issued in 2015 based upon the attainment of performance criteria set forth in those years

        MSUs are valued using a lattice model with a Monte Carlo simulation. This valuation methodology utilizes several key assumptions, including the 60 calendar day average closing stock price on grant date for MSUs awarded prior to 2014, the 30 calendar day average closing stock price on the date of grant

F-20



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

9. Share-Based Compensation (Continued)

for MSUs awarded in 2014 and 2015, expected volatility of our stock price, risk-free rates of return and expected dividend yield. The assumptions used in our valuation are summarized as follows:

 
  For the Years Ended December 31,
 
  2015   2014   2013

Expected dividend yield

  —%   —%   —%

Range of expected stock price volatility

  31.0% - 33.2%   31.7% - 35.1%   21.7% - 25.7%

Range of risk-free interest rates

  0.2% - 1.0%   0.1% - 0.7%   0.1% - 0.7%

30 calendar day average stock price on grant date

  $277.35 - $426.27   $280.88 - $335.65   N/A

60 calendar day average stock price on grant date

  N/A   N/A   $150.33 - $240.14

Weighted-average per share grant date fair value

  $499.25   $393.97   $169.15

        The total fair values of MSUs vested in 2015, 2014 and 2013 totaled $7.1 million, $6.0 million, and $2.3 million, respectively.

Cash-Settled Performance Units

        CSPUs awarded to employees vest in three equal annual increments beginning on the first anniversary of the grant date. The vesting of these awards is subject to the respective employee's continued employment with such awards settled in cash. The number of CSPUs granted represents the target number of units that are eligible to be earned based on the attainment of certain performance measures established at the beginning of the performance period, which ends on December 31 of each year. Participants may ultimately earn between 0% and 200% of the target number of units granted based on the degree of actual performance metric achievement. Accordingly, additional CSPUs may be issued or currently outstanding CSPUs may be cancelled upon final determination of the number of units earned. CSPUs awarded prior to 2014 are settled in cash based on the 60 calendar day average closing stock price through each vesting date once the actual vested and earned number of units is known. CSPUs awarded in 2014 and 2015 will be settled in cash based on the 30 calendar day average closing stock price through each vesting date, once the actual vested and earned number of units is known. Since no shares are issued, these awards do not dilute equity. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period.

        The following table summarizes our CSPU activity:

(In thousands)
  Shares  

Unvested at December 31, 2014

    22,000  

Granted (a)

    6,000  

Vested

    (15,000 )

Unvested at December 31, 2015

    13,000  

(a)
CSPUs granted in 2015 include approximately 2,000 CSPUs issued in 2015 based upon the attainment of performance criteria set forth in that year.

F-21



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

9. Share-Based Compensation (Continued)

        The total cash paid in settlement of CSPUs vested in 2015, 2014 and 2013 totaled $5.3 million, $5.9 million and $2.8 million, respectively.

Performance-Vested Restricted Stock Units

        Beginning in the first quarter of 2014, Biogen revised its long term incentive program to include a new type of award granted to certain employees in the form of restricted stock units that may be settled in cash or shares of Biogen common stock at the sole discretion of the Compensation and Management Development Committee of Biogen's board of directors. These awards are structured and accounted for the same way as the cash settled performance units, and vest in three equal annual increments beginning on the first anniversary of the grant date. The number of PUs granted represents the target number of units that are eligible to be earned based on the attainment of certain performance measures established at the beginning of the performance period, which ends on December 31 of each year. Participants may ultimately earn between 0% and 200% of the target number of units granted based on the degree of actual performance metric achievement. Accordingly, additional PUs may be issued or currently outstanding PUs may be cancelled upon final determination of the number of units earned. PUs settling in cash are based on the 30 calendar day average closing stock price through each vesting date once the actual vested and earned number of units is known. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period.

        The following table summarizes our PU activity:

(In thousands)
  Shares  

Unvested at December 31, 2014

    4,000  

Granted (a)

    7,000  

Vested

    (2,000 )

Unvested at December 31, 2015

    9,000  

(a)
PUs granted in 2015 include approximately 3,000 PUs issued in 2015 based upon the attainment of performance criteria set forth in that year.

        During 2015, PUs that vested in 2015 were settled in cash totaling $0.9 million.

Time-Vested Restricted Stock Units

        RSUs awarded to employees generally vest no sooner than one-third per year over three years on the anniversary of the date of grant, or upon the third anniversary of the date of the grant, provided the employee remains continuously employed with us, except as otherwise provided in the plan. Shares of Biogen common stock will be delivered to the employee upon vesting, subject to payment of applicable withholding taxes. The fair value of all RSUs is based on the market value of our stock on the date of grant. Compensation expense, including the effect of forfeitures, is recognized over the applicable service period.

F-22



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

9. Share-Based Compensation (Continued)

        The following table summarizes our RSU activity:

(In thousands)
  Shares   Weighted Average
Per Share Grant
Date Fair Value
 

Unvested at December 31, 2014

    50,000   $ 219.45  

Granted

    20,000   $ 392.20  

Vested

    (28,000 ) $ 187.47  

Unvested at December 31, 2015

    42,000   $ 325.14  

        RSUs granted in 2014 and 2013 had weighted average per share grant date fair values of $320.72 and $186.17, respectively.

        The total fair values of RSUs vested in 2015, 2014 and 2013 totaled $10.6 million, $10.9 million and $7.1 million, respectively.

Employee Stock Purchase Plan

        The company recognized share-based compensation expense associated with the Biogen ESPP plans of $0.6 million, $0.5 million and $0.4 million in 2015, 2014 and 2013, respectively.

10. Related Parties

        The company has not historically operated as a standalone business and has various relationships with Biogen whereby Biogen provides services to the company.

Corporate Overhead and Other Allocations from Biogen

        These combined financial statements include an allocation from Biogen to us for certain research and development and selling, general and administrative costs not directly attributable to the hemophilia business of Biogen. The research and development costs include depreciation and other facility-based expenses, regulatory affairs function, pharmacovigilance, other infrastructure and management costs supporting multiple projects. The selling, general and administrative costs include certain services provided by Biogen, which include, but are not limited to, executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology, investor relations, shared services, insurance, employee benefits and incentives and share-based compensation. Also included in the allocations from Biogen are costs associated with its corporate restructuring announced in October 2015. The restructuring included an 11% reduction in Biogen's workforce. Allocated amounts have been included in research and development, selling, general and administrative and other income and expense. These expenses have been allocated to the company based on direct usage or benefit where specifically identifiable, with the remainder allocated primarily based on hours or direct costs. The company considers the expense methodology and results to be reasonable for all periods presented. However, the allocations may not be indicative of the actual expense that would have been incurred had the company operated as an independent, publicly traded

F-23



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

10. Related Parties (Continued)

company for the periods presented. These allocations were reflected as follows in the combined financial statements:

 
  For the Years Ended
December 31,
 
(In millions)
  2015   2014   2013  

Research and development allocations

  $ 73.4   $ 93.7   $ 70.3  

Selling, general and administrative allocations

    75.1     60.1     41.7  

Other (income) expense, net allocations

    0.1     1.4     (1.9 )

Total corporate overhead and other allocations from Biogen

  $ 148.6   $ 155.2   $ 110.1  

11. Other Consolidated Financial Statement Detail

Other Income (Expense), Net

        Components of other income (expense), net, are summarized as follows:

 
  For the Years Ended
December 31,
 
(In millions)
  2015   2014   2013  

Foreign exchange gains (losses), net

  $ 0.6   $ 1.7   $ (0.5 )

Other, net

        (0.6 )   (1.5 )

Total other income (expense), net

  $ 0.6   $ 1.1   $ (2.0 )

Accrued Expenses and Other

        Accrued expenses and other consists of the following:

 
  As of
December 31,
 
(In millions)
  2015   2014  

Revenue-related rebates

  $ 13.7   $ 6.9  

Employee compensation and benefits

    12.9     17.1  

Clinical development expenses

    11.9     15.9  

Royalty and collaboration expenses

    6.3     6.1  

Other

    4.6     5.9  

Total accrued expenses and other

  $ 49.4   $ 51.9  

F-24



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

11. Other Consolidated Financial Statement Detail (Continued)

Long-Term Liabilities

        Long-term liabilities consist of the following:

(In millions)
  2015   2014  

Employee compensation and benefits

  $ 16.5   $ 12.0  

Sobi payments

    10.0      

Other

    4.2     5.1  

Total long term liabilities

  $ 30.7   $ 17.1  

12. Litigation

        We are involved in various claims and legal proceedings, including the matters described below. For information as to our accounting policies relating to claims and legal proceedings, including use of estimates, and contingencies, see Note 2, Summary of Significant Accounting Policies , to these combined financial statements.

        With respect to some loss contingencies, an estimate of the possible loss or range of loss cannot be made until management has further information, including, for example, (i) which claims, if any, will survive dispositive motion practice; (ii) information to be obtained through discovery; (iii) information as to the parties' damages claims and supporting evidence; (iv) the parties' legal theories; and (v) the parties' settlement positions.

Patent Matter

        Biogen has received communications from a third party, Pfizer, regarding a proposal that Biogen take a license to Pfizer's U.S. Patent No. 8,603,777 (Expression of Factor VII and IX Activities in Mammalian Cells) and pay royalties on past and future sales of ALPROLIX. There is no pending litigation with Pfizer and an estimate of a possible loss or range of loss cannot be made at this time.

Government Matters

        On March 4, 2016, Biogen received a subpoena from the federal government for documents relating to our relationship with non-profit organizations that provide assistance to patients taking drugs sold by Biogen. Biogen is cooperating with the government.

        On July 1, 2016, Biogen received civil investigative demands from the federal government for documents and information relating to our treatment of certain service agreements with wholesalers when calculating and reporting Average Manufacturer Prices in connection with the Medicaid Drug Rebate Program. Biogen is cooperating with the government.

13. Commitments and Contingencies

Former Syntonix Shareholders

        In connection with the acquisition of Syntonix Pharmaceuticals in 2007, we agreed to pay an additional $80.0 million if certain milestone events associated with the development of ALPROLIX were achieved. The first $40.0 million milestone payment was achieved in 2010 and was recorded as

F-25



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

13. Commitments and Contingencies (Continued)

research and development expense. The final milestone payments of $20.0 million each were paid in the second quarter of 2014 and the third quarter of 2016 in connection with the approval of ALPROLIX in the United States and European Union, respectively. Both milestones were capitalized as intangible assets in the second quarters of 2014 and 2016, respectively.

Other Contingent Development, Regulatory and Commercial Milestone Payments

        Based on our development plans primarily in gene therapy for hemophilia and other blood disorders as of June 30, 2016, we could make potential future milestone payments to third party collaborators of up to approximately $440.0 million most of which are development milestones. Payments under these agreements generally become due and payable upon achievement of certain development, regulatory or commercial milestones. Because the achievement of these milestones had not occurred as of June 30, 2016, such contingencies have not been recorded in our financial statements. Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory approval and commercial milestones.

14. Guarantees

        As of December 31, 2015 and 2014, the company did not have significant liabilities recorded for guarantees.

        The company enters into indemnification provisions under agreements with other companies in the ordinary course of business, typically with business partners, contractors, clinical sites and customers. Under these provisions, the company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of our activities. These indemnification provisions generally survive termination of the underlying agreement. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited. However, to date the company has not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of these agreements is minimal. Accordingly, the company has no liabilities recorded for these agreements as of December 31, 2015 and 2014.

15. Employee Benefit Plans

401(k) Savings Plan

        Biogen maintains a 401(k) Savings Plan which is available to substantially all regular employees in the U.S. over the age of 21. Participants may make voluntary contributions. Biogen makes matching contributions according to the 401(k) Savings Plan's matching formula. All matching contributions and participant contributions vest immediately. The 401(k) Savings Plan also holds certain transition contributions on behalf of participants who previously participated in the Biogen Inc. Retirement Plan. The expense related to Biogen's 401(k) Savings Plan primarily consists of matching contributions.

        Expense related to the company's share of Biogen's 401(k) Savings Plan was approximately $2.9 million, $2.2 million and $1.5 million for 2015, 2014 and 2013, respectively.

F-26



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Combined Financial Statements (Continued)

16. Segment Information

        We operate as one operating segment, which is discovering, researching, developing and commercializing innovative therapies for the treatment of hemophilia and other blood disorders, and, therefore, our chief operating decision-maker manages the operations of our company as a single operating segment. Enterprise-wide disclosures about product revenues, other revenues and long-lived assets by geographic area and information relating to major customers are presented below. Revenues are primarily attributed to individual countries based on location of the customer or licensee.

        Revenue by product is summarized as follows:

 
  For the Years Ended
December 31,
 
(In millions)
  2015   2014   2013  

United States

                   

ELOCTATE

  $ 308.3   $ 58.4   $  

ALPROLIX

    208.8     72.1      

Total product revenues

  $ 517.1   $ 130.5   $  

All Other Markets

                   

ELOCTATE

  $ 11.4   $   $  

ALPROLIX

    25.6     3.9      

Total product revenues

  $ 37.0   $ 3.9   $  

Total

                   

ELOCTATE

  $ 319.7   $ 58.4   $  

ALPROLIX

    234.4     76.0      

Total product revenues

  $ 554.1   $ 134.4   $  

Geographic Information

 
  For the Years Ended
December 31,
 
(In millions)
  2015   2014   2013  

U.S.

                   

Product revenues from external customers

  $ 517.1   $ 130.5   $  

Revenue from collaborative partners

  $ 6.2   $   $  

Long-lived assets

  $ 75.0   $ 78.4   $  

Japan

                   

Product revenues from external customers

  $ 37.0   $ 3.9   $  

Long-lived assets

  $ 0.5   $ 0.1   $  

Total

                   

Product revenues from external customers

  $ 554.1   $ 134.4   $  

Revenue from collaborative partners

  $ 6.2   $   $  

Long-lived assets

  $ 75.5   $ 78.5   $  

17. Subsequent Events

        The company has evaluated subsequent events from the balance sheet through August 10, 2016, the date at which these combined financial statements were available to be issued, and determined that there were no other material items to disclose.

F-27



HEMOPHILIA BUSINESS OF BIOGEN INC.

Condensed Combined Statements of Income (Loss) and Comprehensive Income (Loss)

(Unaudited) (In millions)

 
  For the
Nine Months
Ended
September 30,
 
 
  2016   2015  

Revenues:

             

Product, net

  $ 604.8   $ 381.7  

Collaboration revenue

    26.4     4.4  

Total revenues

  $ 631.2   $ 386.1  

Cost and expenses:

             

Cost of sales

    162.2     50.8  

Research and development

    122.6     135.4  

Selling, general and administrative

    138.4     167.7  

Total cost and expenses

    423.2     353.9  

Income (loss) from operations

    208.0     32.2  

Other income (expense), net

    (1.0 )   0.6  

Income (loss) before income tax expense (benefit)

    207.0     32.8  

Income tax expense (benefit)

    (3.7 )   (3.3 )

Net income (loss)

  $ 210.7   $ 36.1  

Other comprehensive income (loss):

             

Currency translation adjustment

    4.0     (0.3 )

Total other comprehensive income (loss)

    4.0     (0.3 )

Comprehensive income (loss)

  $ 214.7   $ 35.8  

   

The accompanying notes are an integral part of these unaudited Condensed Combined Financial Statements.

F-28



HEMOPHILIA BUSINESS OF BIOGEN INC.

Condensed Combined Balance Sheets

(Unaudited) (In millions)

 
  As of
September 30,
2016
  As of
December 31,
2015
 

ASSETS

             

Current assets:

             

Accounts receivable, net

  $ 126.8   $ 94.4  

Inventory

    283.3     252.1  

Other current assets

    10.3     4.0  

Total current assets

    420.4     350.5  

Property, plant and equipment, net

    45.0     75.5  

Intangible assets, net

    53.1     30.0  

Other long-term assets

    22.4     19.6  

Total assets

  $ 540.9   $ 475.6  

LIABILITIES AND EQUITY

             

Current liabilities:

             

Accounts payable

  $ 12.3   $ 10.8  

Accrued expenses and other current liabilities

    68.9     49.4  

Total current liabilities

    81.2     60.2  

Long-term liabilities

    53.8     30.7  

Total liabilities

    135.0     90.9  

Commitments and contingencies

             

Equity:

             

Net parent company investment

    401.6     384.4  

Accumulated other comprehensive loss

    4.3     0.3  

Total equity

    405.9     384.7  

Total liabilities and equity

  $ 540.9   $ 475.6  

   

The accompanying notes are an integral part of these unaudited Condensed Combined Financial Statements.

F-29



HEMOPHILIA BUSINESS OF BIOGEN INC.

Condensed Combined Statements of Cash Flows

(Unaudited) (In millions)

 
  For the
Nine Months
Ended
September 30,
 
 
  2016   2015  

Cash flows from operating activities:

             

Net income (loss)

  $ 210.7   $ 36.1  

Adjustments to reconcile net income (loss) to net cash flows from operating activities:          

             

Depreciation and amortization

    39.5     11.7  

Share-based compensation

    11.3     9.5  

Changes in operating assets and liabilities, net:

             

Accounts receivable

    (32.3 )   (18.6 )

Inventory

    (31.1 )   (38.7 )

Other assets

    (9.0 )   (5.5 )

Accounts payable, accrued expenses and other current liabilities

    21.1     (2.0 )

Other liabilities

    23.1     1.8  

Net cash flows provided by (used in) operating activities

    233.3     (5.7 )

Cash flows from investing activities:

             

Purchases of property, plant and equipment

    (3.8 )   (6.3 )

Acquisition of intangible assets

    (26.5 )    

Net cash flows used in investing activities

    (30.3 )   (6.3 )

Cash flows from financing activities:

             

Transfers from (to) Biogen

    (203.0 )   12.0  

Net cash flows used in (provided by) financing activities

    (203.0 )   12.0  

Net (decrease) increase in cash and cash equivalents

         

Cash and cash equivalents, beginning of the year

  $   $  

Cash and cash equivalents, end of the year

  $   $  

   

The accompanying notes are an integral part of these unaudited Condensed Combined Financial Statements.

F-30



HEMOPHILIA BUSINESS OF BIOGEN INC.

Condensed Combined Statements of Equity

(Unaudited) (In millions)

 
  Net Parent
Company
Investment
  Accumulated
Other
Comprehensive
Income
  Total equity  

Balance, December 31, 2014

  $ 293.3   $ 0.5   $ 293.8  

Net income

    36.1           36.1  

Transfers from Biogen

    22.9           22.9  

Foreign currency translation adjustments

          (0.3 )   (0.3 )

Balance, September 30, 2015

  $ 352.3     0.2   $ 352.5  

Balance, December 31, 2015

  $ 384.4     0.3   $ 384.7  

Net income

    210.7           210.7  

Transfers from Biogen

    (193.5 )         (193.5 )

Foreign currency translation adjustments

          4.0     4.0  

Balance, September 30, 2016

  $ 401.6   $ 4.3   $ 405.9  

   

The accompanying notes are an integral part of these unaudited Condensed Combined
Financial Statements.

F-31



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Condensed Combined Financial Statements (Unaudited)

1. Nature of Business and Basis of Preparation

Nature of Business

        On May 3, 2016, Biogen Inc. (Biogen) announced its plan to separate its hemophilia business, including certain additional assets and liabilities associated with Biogen's pipeline programs related to hemophilia and other blood disorders (the hemophilia business), into an independent, publicly traded company named Bioverativ Inc. (Bioverativ). Following the separation, Bioverativ intends to focus on the discovery, research, development and commercialization of innovative therapies for the treatment of hemophilia and other blood disorders. Unless the context otherwise requires, the combined hemophilia business of Biogen is referred to throughout these Notes as "Bioverativ", "we", "us", "our" or the "company."

        To accomplish the separation, Biogen intends to make a pro rata distribution of 100% of Bioverativ's common stock to Biogen's stockholders. At the time of the distribution, Bioverativ will hold the assets and liabilities of Biogen's hemophilia business. The distribution is subject to a number of conditions, including the receipt of a favorable opinion from tax counsel or other third party advisor with respect to the tax-free nature of the distribution, approval by the Biogen board of directors and the U.S. Securities and Exchange Commission (SEC) declaring the effectiveness of a Registration Statement on Form 10. In addition, Biogen can decline at any time to go forward with the distribution.

        Bioverativ's marketed products include ELOCTATE and ALPROLIX, extended half-life factors for the treatment of hemophilia A and hemophilia B, respectively. Pursuant to a development and commercialization agreement, Bioverativ collaborates with Swedish Orphan Biovitrum AB (publ) (Sobi) to jointly develop and commercialize ELOCTATE and ALPROLIX globally. Sobi has assumed responsibility for commercialization of ELOCTATE and ALPROLIX in Europe, Russia and certain countries in Northern Africa and the Middle East, while Bioverativ retains rights to commercialize those therapies in the United States, Japan, Canada, Australia and all other markets excluding Sobi's commercialization territory. See Note 3, Collaborations , for further information on Bioverativ's collaboration with Sobi.

Basis of Preparation

        The accompanying unaudited condensed combined financial statements have been prepared on a standalone basis and are derived from Biogen's condensed consolidated financial statements and accounting records. The condensed combined financial statements reflect the company's historical financial position, results of operations and cash flows as the business was operated as part of Biogen prior to the distribution, in conformity with U.S. generally accepted accounting principles (GAAP).

        These condensed combined financial statements include the attribution of certain assets and liabilities that have historically been held at the Biogen corporate level but which are specifically identifiable or attributable to the company. All intercompany transactions and accounts within the company have been eliminated. All transactions between the company and Biogen are considered to be effectively settled in the combined financial statements at the time the transaction is recorded. The total net effect of the settlement of these intercompany transactions is reflected in the condensed combined statements of cash flows as a financing activity and in the combined balance sheets as net parent company investment.

        These condensed combined financial statements include allocations from Biogen to us for certain research and development and selling, general and administrative costs not directly attributable to the

F-32



HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Condensed Combined Financial Statements (Unaudited) (Continued)

1. Nature of Business and Basis of Preparation (Continued)

hemophilia business of Biogen. The research and development costs include depreciation and other facility-based expenses, regulatory affairs function, pharmacovigilance, other infrastructure and management costs supporting multiple projects. The selling, general and administrative costs include certain services provided by Biogen, which include, but are not limited to, executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology, investor relations, shared services, insurance, employee benefits and incentives and share-based compensation. These expenses have been allocated to the company based on direct usage or benefit where specifically identifiable, with the remainder allocated primarily based on hours or direct costs. The company considers the expense methodology and results to be reasonable for all periods presented. However, the allocations may not be indicative of the actual expense that would have been incurred had the company operated as an independent, publicly traded company for the periods presented.

        Biogen maintains various benefit and share-based compensation plans at a corporate level and other benefit plans at a country level. The company's employees participate in such programs and a portion of the cost of those plans is included in the company's financial statements. However, the condensed combined balance sheets do not include any equity related to share-based compensation plans.

        The company's equity balance in these condensed combined financial statements represents the excess of total assets over total liabilities, including the due to/from balances between the company and Biogen (net parent company investment) and accumulated other comprehensive income. Net parent company investment is primarily impacted by contributions from Biogen which are the result of treasury activities and net funding provided by or distributed to Biogen.

        These condensed combined financial statements of the company have been prepared pursuant to the rules and regulations of the SEC. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. The condensed combined balance sheet as of December 31, 2015 has been derived from the audited combined balance sheet as of December 31, 2015. These condensed combined financial statements should be read in conjunction with the combined financial statements and notes for the three years ended December 31, 2015, included elsewhere in this Information Statement.

        In the opinion of management, these condensed combined financial statements reflect all adjustments necessary for a fair statement of the interim periods. All such adjustments, unless otherwise noted herein, are of a normal, recurring nature. The results of operations for the interim period are not necessarily indicative of the results of operations to be expected for the full year.

2. Summary of Significant Accounting Policies

        For additional information related to Significant Accounting Policies and New Accounting Pronouncements, see Note 2, Summary of Significant Accounting Policies , in our combined financial statements included in elsewhere in this information statement.

        During 2015, the Financial Accounting Standards Board issued an Accounting Standards Update No. 2015-11, Inventory (Topic 33): Simplifying the Measurement of Inventory which was adopted effective January 1, 2016 and did not have a material impact on our results of operations or statement of position.

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Notes to Condensed Combined Financial Statements (Unaudited) (Continued)

3. Reserves for Discounts and Allowances

        Following the company's recent product launches, the company began recognizing reserves for discounts and allowances related to these products' revenue.

        An analysis of the change in reserves is summarized as follows:

(In millions)
  Discounts   Contractual
Adjustments
  Returns   Total  

Balance as of December 31, 2015

  $ 5.8   $ 16.0   $   $ 21.8  

Provision related to current period sales

    115.0     113.7     0.9     229.6  

Adjustment related to prior period sales

    (2.0 )   (0.5 )       (2.5 )

Credits/payments made

    (113.7 )   (108.3 )   (0.9 )   (222.9 )

Balance as of September 30, 2016

  $ 5.1   $ 20.9   $   $ 26.0  

 

(In millions)
  As of
September 30, 2016
  As of
December 31, 2015
 

Reduction of accounts receivable

  $ 6.9   $ 8.1  

Current liability

    19.1     13.7  

Total reserves

  $ 26.0   $ 21.8  

        In the third quarter of 2016, the company received a return associated with launch product in Canada that had been sold with less than one year of dating. Future returns are expected to be insignificant.

4. Inventory

        The components of inventory are summarized as follows:

(In millions)
  As of
September 30, 2016
  As of
December 31, 2015
 

Raw materials

  $ 49.9   $ 41.7  

Work in process

    199.1     177.3  

Finished goods

    34.3     33.1  

Total inventory

  $ 283.3   $ 252.1  

        Inventory amounts written down as a result of excess, obsolescence, unmarketability or other reasons are charged to cost of sales, and totaled $8.2 million and $1.5 million in the nine months ended September 30, 2016 and 2015, respectively.

5. Acquired Intangible Assets

        Acquired intangibles primarily relate to approval milestones for ALPROLIX paid to the former Syntonix Pharmaceuticals (Syntonix) shareholders. In 2014, upon the U.S. Food and Drug Administration's approval of ALPROLIX for the treatment of hemophilia B, a $20.0 million milestone was paid. The $20.0 million milestone and the corresponding deferred tax liability of $7.3 million were capitalized as an acquired intangible asset. In May 2016, upon the European Medicines Agency approval of ALPROLIX in the European Union, the final $20.0 million milestone was owed to the

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HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Condensed Combined Financial Statements (Unaudited) (Continued)

5. Acquired Intangible Assets (Continued)

former Syntonix shareholders. The $20.0 million milestone and the corresponding deferred tax liability of $6.3 million were capitalized as an acquired intangible asset.

        For the periods ending September 30, 2016 and 2015, amortization expense associated with acquired intangible assets was $3.4 million and $2.2 million, respectively.

6. Income Taxes

Effective Income Tax Rate

        The company's effective income tax rate was (1.8)% and (10.1)% in the nine months ended September 30, 2016 and 2015, respectively. The company's effective income tax rate differs from the U.S. federal statutory rate each year due to mainly to the company's valuation allowance. In addition, the effective income tax rate can be impacted each period by discrete factors and events.

7. Share-Based Compensation

        Share-based compensation expense relating to the company's employees was $11.3 million and $9.5 million for the nine months ended September 30, 2016 and 2015, respectively.

        Approximately 51% and 20% of share-based compensation expense was classified in cost of sales expenses in the nine months ended September 30, 2016 and 2015, respectively. Approximately 22% and 34% of share-based compensation expense was classified in research and development expenses in the nine months ended September 30, 2016 and 2015, respectively. Approximately 27% and 46% of share-based compensation expense was classified in selling, general and administrative expenses in the nine months ended September 30, 2016 and 2015, respectively.

        All shares described herein represent shares of Biogen.

Grants Under Share-based Compensation Plans

        The following table summarizes our equity grants to employees, officers and directors under Biogen's stock plans:

 
  For the Nine
Months Ended
September 30,
 
(In thousands)
  2016   2015  

Market stock units

    10,000     7,000  

Time-vested restricted stock units

    42,000     18,000  

Cash-settled performance units

    5,000     3,000  

Performance units

    7,000     4,000  

8. Related Parties

Corporate Overhead and Other Allocations from Biogen

        Included in research and development allocations are costs not directly attributable to individual projects. These costs include depreciation and other facility-based expenses, regulatory affairs function, pharmacovigilance, other infrastructure and management costs supporting multiple projects. Included in

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HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Condensed Combined Financial Statements (Unaudited) (Continued)

8. Related Parties (Continued)

selling, general and administrative allocations are certain services provided by Biogen, which include executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology, investor relations, shared services, insurance, employee benefits and incentives and share-based compensation.

 
  For the Nine
Months Ended
September 30,
 
(In millions)
  2016   2015  

Research and development allocations

  $ 53.3   $ 52.8  

Selling, general and administrative allocations

    52.4     57.4  

Other (income) expense, net allocations

    1.2     (0.6 )

Total corporate overhead and other allocations from Biogen

  $ 106.9   $ 109.6  

        The financial information herein may not necessarily reflect the condensed combined financial position, results of operations and cash flows of the company in the future or what they would have been had the company been a separate, standalone entity during the periods presented. Management believes that the methods used to allocate expenses to the company are reasonable.

9. Other Consolidated Financial Statement Detail

Other Income (Expense), Net

        Components of other income (expense), net, are summarized as follows:

 
  For the Nine
Months Ended
September 30,
 
(In millions)
  2016   2015  

Foreign exchange gains (losses), net

  $ (0.5 ) $ 0.5  

Other, net

    (0.5 )   0.1  

Total other income (expense), net

  $ (1.0 ) $ 0.6  

Accrued Expenses and Other

        Accrued expenses and other consists of the following:

(In millions)
  As of
September 30, 2016
  As of
December 31, 2015
 

Revenue-related rebates

  $ 19.1   $ 13.7  

Employee compensation and benefits

    13.1     12.9  

Clinical development expenses

    5.8     11.9  

Royalty and collaboration expenses

    20.3     6.3  

Other

    10.6     4.6  

Total accrued expenses and other

  $ 68.9   $ 49.4  

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HEMOPHILIA BUSINESS OF BIOGEN INC.

Notes to Condensed Combined Financial Statements (Unaudited) (Continued)

9. Other Consolidated Financial Statement Detail (Continued)

        Long-term liabilities consist of the following:

(In millions)
  As of
September 30, 2016
  As of
December 31, 2015
 

Employee compensation and benefits

  $ 17.1   $ 16.5  

Sobi payments

    36.7     10.0  

Other

        4.2  

Total long term liabilities

  $ 53.8   $ 30.7  

10. Litigation

        We are involved in various claims and legal proceedings, including the matters described below. For information as to our accounting policies relating to claims and legal proceedings, including use of estimates, and contingencies, see Note 2, Summary of Significant Accounting Policies , to our audited combined financial statements included elsewhere in this information statement.

        With respect to some loss contingencies, an estimate of the possible loss or range of loss cannot be made until management has further information, including, for example, (i) which claims, if any, will survive dispositive motion practice; (ii) information to be obtained through discovery; (iii) information as to the parties' damages claims and supporting evidence; (iv) the parties' legal theories; and (v) the parties' settlement positions.

Patent Matter

        Biogen has received communications from a third party, Pfizer, regarding a proposal that Biogen take a license to Pfizer's U.S. Patent No. 8,603,777 (Expression of Factor VII and IX Activities in Mammalian Cells) and pay royalties on past and future sales of ALPROLIX. There is no pending litigation with Pfizer and an estimate of a possible loss or range of loss cannot be made at this time.

Government Matters

        On March 4, 2016, Biogen received a subpoena from the federal government for documents relating to our relationship with non-profit organizations that provide assistance to patients taking drugs sold by Biogen. Biogen is cooperating with the government.

        On July 1, 2016, Biogen received civil investigative demands from the federal government for documents and information relating to our treatment of certain service agreements with wholesalers when calculating and reporting Average Manufacturer Prices in connection with the Medicaid Drug Rebate Program. Biogen is cooperating with the government.

11. Subsequent Events

        On November 10, 2016, Biogen entered into an agreement with Brammer Bio MA, LLC (Brammer) for the Biogen manufacturing facility in Cambridge, MA. Upon closing of the transaction, which is expected to be December 31, 2016, Brammer will sublease the manufacturing facility and purchase certain manufacturing equipment, leasehold improvements and other assets at the facility in exchange for shares of Brammer common LLC interests.

        Certain Biogen employees not offered employment with Brammer will be separated from Biogen. The expected cost of these separations will be approximately $7.7 million which will be recorded in the fourth quarter of 2016.

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