EX-10 4 sage-ex10_30.htm EX-10.30 EX-10

Execution Version

 

Exhibit 10.30

 

 

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions.

 

 

 

 

 

 

Collaboration and License Agreement

Between

Sage Therapeutics, Inc.,

Biogen MA Inc.

and

Biogen International GmbH

Dated November 27, 2020

 

 

 

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table of contents

 

 

 

 

 

Page

 

 

 

 

 

1.

 

DEFINITIONS

 

1

1.1

 

Definitions

 

1

2.

 

GOVERNANCE

 

30

2.1

 

Alliance Manager

 

30

2.2

 

Joint Steering Committee

 

31

2.3

 

Joint Development Committee

 

34

2.4

 

Joint Commercialization Committee

 

36

2.5

 

Joint Medical Affairs Subcommittee.

 

39

2.6

 

Joint Manufacturing Committee.

 

41

2.7

 

Resolution of Committee Disputes

 

42

2.8

 

General Committee Authority

 

43

3.

 

DEVELOPMENT

 

44

3.1

 

Diligence; Standards of Conduct

 

44

3.2

 

Joint Development Plans

 

44

3.3

 

Operational Responsibilities for Development; Additional Development

 

45

3.4

 

Development Costs

 

46

3.5

 

Development Reports

 

46

3.6

 

Clinical Study Reporting

 

46

3.7

 

Joint Program Activities Records

 

46

3.8

 

Technology and Materials Transfer

 

47

3.9

 

Development Subcontracts

 

47

3.10

 

Licensed [**] Product Development

 

48

4.

 

MEDICAL AFFAIRS ACTIVITIES

 

48

4.1

 

Diligence; Standards of Conduct

 

48

4.2

 

Joint Medical Affairs Plans

 

48

4.3

 

Operational Responsibilities for Medical Affairs Activities

 

49

4.4

 

Medical Affairs Costs

 

50

4.5

 

Medical Affairs Reports

 

50

5.

 

COMMERCIALIZATION

 

50

5.1

 

Diligence; Standards of Conduct

 

50

5.2

 

Joint Commercialization Plans

 

51

 

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5.3

 

Commercialization Principles

 

52

5.4

 

Operational Responsibilities for Commercialization

 

52

5.5

 

Commercialization Costs

 

53

5.6

 

Commercialization Reports

 

53

5.7

 

Pricing Matters; Distribution

 

53

5.8

 

Uniform Training

 

54

5.9

 

Detail Costs; Authority over Sales Forces

 

54

5.10

 

Joint Commercialization Costs Allocation

 

54

5.11

 

Advertising and Promotional Materials in Profit-Share Territory

 

55

5.12

 

Coordination of Operational Activities

 

56

5.13

 

Territorial Restrictions

 

56

5.14

 

Commercialization Subcontracts

 

57

6.

 

REGULATORY

 

58

6.1

 

Regulatory Lead Responsibilities

 

58

6.2

 

Assignment

 

59

6.3

 

Biogen Territory

 

59

6.4

 

Communications with Regulatory Authorities

 

59

6.5

 

Regulatory Meetings

 

59

6.6

 

Submissions

 

60

6.7

 

Costs of Regulatory Affairs

 

60

6.8

 

Right of Reference

 

60

6.9

 

Recalls, Market Withdrawals or Corrective Actions

 

60

6.10

 

Reporting Adverse Events

 

61

6.11

 

Priority Review Voucher

 

61

7.

 

MANUFACTURE

 

61

7.1

 

Manufacturing Responsibilities

 

61

7.2

 

Manufacturing Plans

 

61

7.3

 

Manufacturing Costs

 

62

7.4

 

[**] Manufacturing Assumption Rights

 

62

7.5

 

Supply Agreement

 

62

7.6

 

Second Source and Biogen Manufacturing Sites

 

63

7.7

 

Reporting; Shortages

 

63

7.8

 

Technology Transfer to Biogen

 

63

8.

 

LICENSES

 

64

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8.1

 

License Grants

 

64

8.2

 

Sublicensing

 

65

8.3

 

Third Party In-Licenses Payments

 

67

8.4

 

Combinations

 

68

8.5

 

No Other Rights

 

69

9.

 

PAYMENTS

 

69

9.1

 

Upfront Fee

 

69

9.2

 

Equity Investment

 

69

9.3

 

Licensed Product Reconciliation of Shared Costs; Profit Sharing

 

69

9.4

 

Finance Working Group

 

71

9.5

 

Sage Opt-Out

 

72

9.6

 

Licensed Products Regulatory/Commercial Milestone Payments

 

73

9.7

 

Licensed Products Sales Milestone Payments

 

74

9.8

 

Licensed 217 Product and Licensed 324 Product Royalties

 

77

9.9

 

Royalty Reductions

 

72

9.10

 

Other Amounts Payable

 

79

9.11

 

Payment Terms

 

79

10.

 

CONFIDENTIALITY AND PUBLICATION

 

83

10.1

 

Nondisclosure and Non-Use Obligations

 

83

10.2

 

Publication and Publicity

 

85

10.3

 

Press Release, Public Announcements and Other Public Disclosure

 

86

11.

 

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

87

11.1

 

Mutual Representations and Warranties as of the Execution Date and Effective Date

 

87

11.2

 

Representations and Warranties of Sage as of the Execution Date and Effective Date

 

88

11.3

 

Warranty Disclaimer

 

91

11.4

 

Certain Covenants

 

91

11.5

 

Additional Covenants of the Parties

 

92

11.6

 

[**]

 

92

11.7

 

Exclusivity

 

93

12.

 

INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE

 

93

12.1

 

General Indemnification by Biogen

 

93

12.2

 

General Indemnification by Sage

 

94

12.3

 

Indemnification Procedure

 

94

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12.4

 

Certain Third Party Claims Related to Licensed Products in the Profit-Share Territory

 

94

12.5

 

Limitation of Liability

 

95

12.6

 

Insurance

 

95

13.

 

INTELLECTUAL PROPERTY

 

95

13.1

 

Inventorship

 

95

13.2

 

Ownership

 

96

13.3

 

Disclosure of Inventions

 

96

13.4

 

Prosecution and Maintenance of Patents

 

96

13.5

 

Third Party Infringement, Defense and Post-Grant Proceedings

 

100

13.6

 

Patent Extensions

 

104

13.7

 

Orange Book Listings

 

104

13.8

 

Third Party Rights

 

104

13.9

 

Common Interest

 

104

13.10

 

Trademarks

 

105

14.

 

TERM AND TERMINATION

 

105

14.1

 

Term

 

105

14.2

 

Termination Prior to Effective Date

 

105

14.3

 

Termination by Biogen for Convenience

 

105

14.4

 

Termination for Material Breach

 

105

14.5

 

Termination for Insolvency

 

106

14.6

 

Effect of Termination by Sage for Cause or for Biogen’s Insolvency, or by Biogen for Convenience

 

107

14.7

 

Biogen Right of Termination for Cause or for Sage’s Insolvency

 

111

14.8

 

Effect of Expiration or Termination; Survival

 

111

15.

 

MISCELLANEOUS

 

112

15.1

 

Assignment

 

112

15.2

 

Governing Law

 

113

15.3

 

Dispute Resolution

 

113

15.4

 

Entire Agreement; Amendments

 

115

15.5

 

Severability

 

115

15.6

 

Headings

 

115

15.7

 

Waiver of Rule of Construction

 

115

15.8

 

Interpretation

 

115

15.9

 

No Implied Waivers; Rights Cumulative

 

116

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15.10

 

Notices

 

116

15.11

 

Compliance with Export Regulations

 

117

15.12

 

Force Majeure

 

117

15.13

 

Relationship of the Parties

 

118

15.14

 

Performance by BIMA and BIG

 

118

15.15

 

Coordination between BIMA and BIG

 

119

15.16

 

Expenses

 

119

15.17

 

Counterparts

 

119

15.18

 

Performance by Affiliates

 

119

15.19

 

Binding Effect; No Third Party Beneficiaries

 

119

15.20

 

Further Assurances

 

119

15.22

 

HSR Act

 

120

 

 

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SCHEDULES

 

SCHEDULE 1.1.110

 

Existing Sage Agreements

SCHEDULE 1.1.165

 

Major Development Activities

SCHEDULE 1.1.167

 

Major Medical Affairs Activities

SCHEDULE 1.1.195

 

Ongoing 217 Studies

SCHEDULE 1.1.227

 

Preapproved Subcontractors

SCHEDULE ‎1.1.260

 

SAGE-[**]

SCHEDULE ‎1.1.261

 

SAGE-217

SCHEDULE 1.1.262

 

SAGE-324

SCHEDULE 1.1.268

 

Sage Licensed Patents as of the Execution Date

SCHEDULE 3.2.1

 

Joint Development Plans

SCHEDULE 7.5

 

Supply Agreements Material Terms

SCHEDULE 7.8.2

 

Sage Third Party Manufacturing Agreements

SCHEDULE 9.3.3.2

 

Profit and Loss Statement

SCHEDULE 10.3.1

 

Joint Press Release

SCHEDULE 11.2.17

 

Proceedings

SCHEDULE 13.8

 

Third Party Rights

SCHEDULE 15.21

 

Tax Partnership Agreement Terms

 

 

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COLLABORATION and License AGREEMENT

This COLLABORATION AND LICENSE AGREEMENT (this “Agreement”), dated as of November 27, 2020 (the “Execution Date”), is entered into by and between Sage Therapeutics, Inc., a Delaware corporation having its principal place of business at 215 First Street, Cambridge, Massachusetts 02142, U.S.A., (“Sage”), and Biogen MA Inc., a corporation organized under the laws of the Commonwealth of Massachusetts having an office at 225 Binney Street, Cambridge, MA 02142 (“BIMA”), and Biogen International GmbH, a Gesellschaft mit beschränkter Haftung organized under the laws of Switzerland, whose registered office is at Neuhofstrasse 30, 6340 Baar, Switzerland (“BIG”, together with BIMA, collectively, “Biogen”). Sage and Biogen are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”

RECITALS:

WHEREAS, Sage is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing novel medicines to treat central nervous system (CNS) disorders;

WHEREAS, Biogen is a global pharmaceutical company engaged in the research, development and commercialization of products useful in the treatment and prevention of human diseases and conditions; and

WHEREAS, Sage and Biogen desire to collaborate to Develop, Manufacture, perform Medical Affairs Activities with respect to and Commercialize the Licensed 217 Products and the Licensed 324 Products in the Profit-Share Territory (all as defined below), and Biogen desires to obtain, and Sage desires to grant to Biogen, an exclusive license in the Biogen Territory and a co-exclusive license in the Profit-Share Territory, in each case, to Develop, Manufacture, perform Medical Affairs Activities with respect to and Commercialize the Licensed 217 Products and the Licensed 324 Products, all in accordance with the terms and conditions set forth herein; and

WHEREAS, Biogen desires to have an exclusive option under certain circumstances to be granted an exclusive license in the Biogen Territory and a co-exclusive license in the Profit-Share Territory, in each case, to Develop, Manufacture, perform Medical Affairs Activities with respect to and Commercialize the Licensed [**] Products, all in accordance with the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:

1.
DEFINITIONS
1.1
Definitions.

Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, will have the respective meanings set forth below:

1.1.1
[**] Competing Product” shall have the same definition as the Licensed Product that it replaces as set forth in Section 3.10.2 (Further Development of Licensed [**] Products), if the replacement mechanism of such Section 3.10.2 (Further Development of Licensed [**] Products) is implemented.
1.1.2
[**] Substitution” has the meaning set forth in Section 3.10.2 (Further Development of Licensed [**] Products).

 

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1.1.3
217 Competing Product” means any product (other than a Licensed 217 Product and, in the case of Sage, ZULRESSO® (brexanolone) in PPD), the Principal Mode of Action of which is positive allosteric modulation of the GABAA Receptor intended for the treatment of MDD, PPD, TRD, GAD or BPD. Notwithstanding any provision to the contrary set forth in this Agreement, a 217 Competing Product will include any product (other than a Licensed 217 Product and, in the case of Sage, ZULRESSO® (brexanolone) in PPD) intended for the treatment of MDD, PPD, TRD, GAD or BPD, the Principal Mode of Action of which is positive allosteric modulation of the GABAA Receptor alone or combined with any other therapeutic agent.
1.1.4
217 Regulatory/Commercial Milestone Event” has the meaning set forth in Section 9.6.1 (Licensed 217 Products Regulatory/Commercial Milestones).
1.1.5
217 Regulatory/Commercial Milestone Payment” has the meaning set forth in Section 9.6.1 (Licensed 217 Products Regulatory/Commercial Milestones).
1.1.6
217 Sales Milestone Event” has the meaning set forth in Section 9.7.1.1 (Licensed 217 Products Sales Milestones).
1.1.7
217 Sales Milestone Payment” has the meaning set forth in Section 9.7.1.1 (Licensed 217 Products Sales Milestones).
1.1.8
324 Competing Product” means any product (other than a Licensed 324 Product), the Principal Mode of Action of which is positive allosteric modulation of the GABAA Receptor intended for the treatment of ET, Epilepsy or any symptomatic treatment of Parkinson’s Disease. Notwithstanding any provision to the contrary set forth in this Agreement a 324 Competing Product will include any product (other than a Licensed 324 Product) intended for the treatment of ET, Epilepsy or any symptomatic treatment of Parkinson’s Disease, the Principal Mode of Action of which is positive allosteric modulation of the GABAA Receptor alone or combined with any other therapeutic agent.
1.1.9
324 Regulatory/Commercial Milestone Event” has the meaning set forth in Section 9.6.2 (Licensed 324 Products Regulatory/Commercial Milestones).
1.1.10
324 Regulatory/Commercial Milestone Payment” has the meaning set forth in Section 9.6.2 (Licensed 324 Products Regulatory/Commercial Milestones).
1.1.11
324 Sales Milestone Event” has the meaning set forth in Section 9.7.2.1 (Licensed 324 Products Sales Milestones).
1.1.12
324 Sales Milestone Payment” has the meaning set forth in Section 9.7.2.1 (Licensed 324 Products Sales Milestones).
1.1.13
Abbreviated New Drug Application” or “ANDA” has the meaning set forth in the FD&C Act (21 U.S.C. § 355(b)(2), 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3), as amended.
1.1.14
Acquired Business” has the meaning set forth in Section ‎11.7.2 (Acquired Business Exception).
1.1.15
Acquirer” means, collectively, with respect to a Change of Control of a Party, the Third Party referenced in the definition of Change of Control and such Third Party’s Affiliates, as determined immediately prior to the closing of such Change of Control.

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1.1.16
Additional Development Proposal” has the meaning set forth in Section 3.3.2 (Additional Indications Development).
1.1.17
Additional Indications Development” has the meaning set forth in Section 3.3.2 (Additional Indications Development)
1.1.18
Affiliate” means, with respect to a Person, any other Person that (directly or indirectly) controls, is controlled by, or is under common control with, such Person, whether now or in the future. For purposes of this Agreement, a Person will be deemed to control another Person if it owns or controls, directly or indirectly, fifty percent (50%) or more of the equity securities of such other Person entitled to vote in the election of directors (or, in the case that such other Person is not a corporation, for the election of the corresponding managing authority), or otherwise has the power to direct, or cause the direction of, the management and policies of such other Person, whether through ownership of voting securities, by contract, or otherwise. 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 will be substituted in the preceding sentence; provided that such foreign investor has the power to direct the management and policies of such entity. For clarity, a Person may be or become an Affiliate of another Person and may cease to be an Affiliate of such Person, in each case, during the Term of this Agreement.
1.1.19
Agreement” has the meaning set forth in the preamble.
1.1.20
Alliance Manager” has the meaning set forth in Section 2.1 (Alliance Manager)
1.1.21
Allowable Overruns” means, on a plan-by-plan basis, any amount incurred by a Party in the performance of the activities taken as a whole under a Joint Development Plan, Joint Medical Affairs Plan or Joint Commercialization Plan or with respect to CMC Activities under a Manufacturing Plan, in each case, that is (a) above the applicable amounts budgeted for the performance of such activities taken as a whole under the corresponding Joint Development Budget, Joint Medical Affairs Budget, Joint Commercialization Budget or Manufacturing Budget, as applicable, in each case, by [**] percent ([**]%) or less for such Calendar Year, provided that such amounts were not attributable to a breach of this Agreement by the performing Party; or (b) otherwise approved by the JSC.
1.1.22
Antitrust Law” means any federal, state or foreign law, regulation or decree, including the HSR Act, designed to prohibit, restrict or regulate actions for the purpose or effect of monopolization or restraint of trade.
1.1.23
Audited Party” has the meaning set forth in Section 9.11.3.1 (Record Retention; Audits).
1.1.24
Auditing Party” has the meaning set forth in Section 9.11.3.1 (Record Retention; Audits).
1.1.25
Auditor” has the meaning set forth in Section 9.11.3.1 (Record Retention; Audits).
1.1.26
Bankruptcy Code” has the meaning set forth in Section 14.5.1 (Termination for Insolvency).

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1.1.27
Biogen” has the meaning set forth in the preamble.
1.1.28
Biogen Background Know-How” means any and all Know-How (a) Controlled by Biogen or any of its Affiliates (solely or jointly with any Third Party) as of the Execution Date, or (b) that during the Term arises and is Controlled by Biogen or its Affiliates, or otherwise comes into the Control of, Biogen or its Affiliates, in each case ((a) and (b)), independently from the performance of activities under this Agreement and that is used and incorporated into the Development, Manufacture or Commercialization of any Licensed Product by or on behalf of Biogen or its Affiliates in the performance of activities under any Joint Development Plan, Joint Commercialization Plan, Joint Medical Affairs Plan or Manufacturing Plan.
1.1.29
Biogen Background Patents” means any and all Patents (a) Controlled by Biogen or any of its Affiliates (solely or jointly with any Third Party) as of the Execution Date, or (b) that during the Term arise and are Controlled by Biogen or its Affiliates, or otherwise come into the Control of, Biogen or its Affiliates, in each case ((a) and (b)), independently from the performance of activities under this Agreement and that claim any Biogen Background Know-How.
1.1.30
Biogen Background Technology” means the Biogen Background Know-How and Biogen Background Patents.
1.1.31
Biogen Collaboration Know-How” has the meaning set forth in Section 13.2.1 (Ownership).
1.1.32
Biogen Collaboration Patents” means all Collaboration Patents that claim any Biogen Collaboration Know-How, but expressly excluding all Biogen Background Patents and Biogen’s interest in the Joint Collaboration Patents.
1.1.33
Biogen Collaboration Technology” means the Biogen Collaboration Know-How and the Biogen Collaboration Patents.
1.1.34
Biogen Indemnitees” has the meaning set forth in Section 12.2 (General Indemnification by Sage).
1.1.35
Biogen Licensed Technology” means the Biogen Background Technology and Biogen Collaboration Technology.
1.1.36
Biogen Prosecuted Patents” has the meaning set forth in Section 13.2.1 (General).
1.1.37
Biogen Publications” has the meaning set forth in Section 10.2.1 (Publication).
1.1.38
Biogen Territory” means (a) with respect to all Licensed 217 Products: (i) unless and until Sage exercises an Opt-Out Right in accordance with Section 9.5 (Sage Opt-Out) for such Licensed 217 Products, all countries of the world other than the Profit-Share Territory and the Existing Partner Territory, and (ii) if Sage has exercised an Opt-Out Right in accordance with Section 9.5 (Sage Opt-Out) for such Licensed 217 Products, then from and after the Opt-Out Date, all countries of the world other than the Existing Partner Territory, and (b) with respect to all Licensed 324 Products: (i) unless and until Sage exercises an Opt-Out Right in accordance with Section 9.5 (Sage Opt-Out) for such Licensed 324 Products, all countries of the world other than the Profit-Share Territory, and (ii) if Sage has exercised an

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Opt-Out Right in accordance with Section 9.5 (Sage Opt-Out) for such Licensed 324 Products then from and after the Opt-Out Date, all countries of the world.
1.1.39
Biogen Territory Royalties” has the meaning set forth in Section 9.8.1 (Biogen Territory Royalties).
1.1.40
Blocking New Technology” has the meaning set forth in Section 8.3.2.2 (Inclusion Process).
1.1.41
BPD” means bipolar depression.
1.1.42
Branding Strategy” has the meaning set forth in Section ‎5.11.1 (Branding).
1.1.43
Business Day” means a day other than a Saturday, Sunday or a bank or other public holiday in Massachusetts, United States.
1.1.44
Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31 of each Calendar Year.
1.1.45
Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.1.46
Change of Control” means, with respect to a Party, (a) a merger or consolidation of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s and its controlled Affiliates’ assets in the aggregate. Notwithstanding the foregoing, any transaction or series of transactions effected for the bona fide primary purpose of financing the operations of the applicable Party or changing the form or jurisdiction of organization of such Party will not be deemed a “Change of Control” for purposes of this Agreement.
1.1.47
Clinical Data” means the original source patient data and case report forms (CRFs) collected or generated by, on behalf of, or under the authority of a Party with respect to Clinical Studies conducted for any Licensed Product, together with all analysis, reports and results with respect thereto.
1.1.48
Clinical Study” means, with respect to any product, a Phase 1 Study, Phase 2 Study, Phase 3 Study, Phase 4 Study or other voluntary or required study (including a non-interventional study) in humans to obtain information regarding such product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of such product.
1.1.49
CMC” means, chemistry, manufacturing and controls with respect to a product, which includes (a) manufacturing and process development records for such product and (b) all chemistry, manufacturing and control procedures necessary or reasonably useful for the manufacture of such product.

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1.1.50
CMC Activities” means those formulation development, process development and other CMC-related activities, including sourcing and testing of all raw materials and components used in the manufacture of a product, and activities designed to support preparation of the Chemistry, Manufacturing and Controls sections of any Regulatory Materials or Regulatory Approval.
1.1.51
Collaboration Know-How” has the meaning set forth in Section 13.2.1 (Ownership).
1.1.52
Collaboration Patents” means all Patents with a priority date after the Effective Date that claim any Collaboration Know-How.
1.1.53
Collaboration Technology” means the Collaboration Know-How and Collaboration Patents.
1.1.54
Combination Product” means any Licensed Product containing (a) a Sage Molecule and (b) one or more Other Components sold for a fixed price.
1.1.55
Commercialization or Commercialize” means, with respect to any product, any and all activities directed to marketing, advertising, promoting, distributing, importing, exporting, using, offering to sell, and selling or otherwise commercializing such product, including: pre-launch activities to prepare a market for potential sales, modeling and pharmaco-economic studies, epidemiological studies; government affairs, and public policy activities; patient services, patient advocacy engagement; and activities related to pricing and reimbursement, including seeking and maintaining any required Pricing and Reimbursement Approvals; but excluding, in each case, any activities directed to Manufacturing, Development or Medical Affairs Activities. “Commercialize” and “Commercialized” will be construed accordingly.
1.1.56
Commercialization Lead Party” for a given Commercialization activity has the meaning set forth in Section 5.2.1.1 (General).
1.1.57
Commercialization Wind-Down Period” has the meaning set forth in Section 14.6.5 (Sell-Off and Appointment as Distributor).
1.1.58
Commercially Reasonable Efforts” means with respect to the efforts to be expended by a Party or its Affiliate with respect to any objective related to the Development, Manufacture, performance of Medical Affairs Activities with respect to or Commercialization of a product, [**].
1.1.59
Committee” means the Joint Steering Committee, the Joint Development Committee, the Joint Commercialization Committee or any committees formed by the Joint Steering Committee pursuant to Section 2.2.2.25 (Specific Responsibilities of the JSC) as applicable.
1.1.60
Competing Product” means the 217 Competing Products and the 324 Competing Products, in each case, individually or collectively as the context requires.
1.1.61
Competitive Infringement” means, on a Licensed Product-by-Licensed Product basis, where the making, using, selling, offering for sale, or importing, by any Third Party (other than any Sublicensee or authorized purchaser or other authorized transferee of a Party with respect to such Licensed Product), Acquirer or Acquired Business, in each case, of any pharmaceutical product in the Territory is Covered by any Sage Licensed Patent or any Collaboration Patent, including the filing of an Abbreviated New Drug Application with any applicable Regulatory Authority with respect to a Licensed Product as the reference product by any such Third Party.

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1.1.62
Confidential Information” means (a) the terms of this Agreement and (b) any and all Know-How and other confidential or proprietary information, whether communicated in writing or orally or by any other method, that is or has been provided by or on behalf of one Party or any of its Affiliates to the other Party or any of its Affiliates in connection with the performance of activities under this Agreement, whether prior to, on or after the Execution Date, including information pertaining to the terms of this Agreement.
1.1.63
Control” or “Controlled” means the possession (whether by ownership, license, sublicense or otherwise, other than by a license, sublicense or other right granted pursuant to this Agreement) by a Party or its Affiliates (a) with respect to any Materials or other tangible Know-How, of the legal authority or right to physical possession of such Materials or tangible Know-How, with the right to provide such Materials or tangible Know-How to the other Party on the terms set forth herein, (b) with respect to Patents, Regulatory Approvals, Regulatory Materials, intangible Know-How or other intellectual property or subject matter, of the legal authority or right to grant a license, sublicense, access or right to use or right to reference (as applicable) to the other Party under such Patents, Regulatory Approvals, Regulatory Materials, intangible Know-How or other intellectual property or subject matter on the terms set forth herein, or (c) with respect to a product or component thereof, the legal authority or right to grant a license, sublicense, access or right to use (as applicable) to the other Party under Patents that Cover or Know-How that is incorporated in or embodies, such product or component on the terms set forth herein, in each case ((a), (b) and (c)), (i) without breaching or otherwise violating the terms or conditions of any agreement or other arrangement with any Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant such license, sublicense, rights of access or right of use to or (ii) with respect to Materials, Know-How or Patents developed, acquired or licensed by a Party after the Execution Date, without incurring any additional payment obligations to a Third Party that are not subject to an allocation agreed between the Parties pursuant to this Agreement or otherwise in writing.

Notwithstanding any provision in this Agreement to the contrary, if there is a Change of Control of a Party during the Term, such Party will be deemed not to Control any Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property rights, subject matter or product or component thereof that are owned or in-licensed immediately prior to such Change of Control by such Acquirer of such acquired Party, except if (A) such Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property rights, subject matter or product or component thereof owned or in-licensed by the Acquirer were generated from participation by employees or consultants of such Acquirer in furtherance of Development, Manufacturing, Medical Affairs Activities or Commercialization activities with respect to Licensed Products under this Agreement after such Change of Control, (B) any Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property, subject matter or product or component thereof owned or in-licensed by such Third Party were not used in the performance of Development, Manufacturing, Medical Affairs Activities or Commercialization activities with respect to Licensed Products under this Agreement prior to the consummation of such Change of Control, but after the consummation of such Change of Control, such acquired Party or any of its Affiliates uses any such Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property or proprietary subject matter in the performance of Development, Manufacturing, Medical Affairs Activities or Commercialization activities with respect to Licensed Products under this Agreement, or (C) prior to the consummation of such Change of Control, such acquired Party or any of its Affiliates also Controlled such Patents, Regulatory Approvals, Regulatory Submissions, Know-How or other intellectual property rights, subject matter or product or component thereof owned or in-licensed by such Acquirer, in each of which cases ((A)–(C)), such Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property rights, subject matter or product or component thereof owned or in-licensed by such Acquirer will be deemed Controlled by the acquired Party for purposes of this Agreement.

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1.1.64
Cover,” “Covering” or “Covered” means that, with respect to any Patent and product (including a Licensed Product) in the Territory, but for a license granted to any Person under any claim included in such Patent, the manufacture, use, sale, offer for sale or importation of such product (including a Licensed Product) in the Field in the applicable Territory by such Person would infringe such claim, or in the case of a claim that has not yet issued, would infringe such claim if it were to issue.
1.1.65
Defending Party” has the meaning set forth in Section 13.5.4 (Cooperation Regarding Enforcement, Defense or Post-Grant Proceedings).
1.1.66
Detail” or “Detailing” means, with respect to a Licensed Product in the Profit-Share Territory, the communication by a Sales Representative to a health care provider during a sales call in accordance with the approved Joint Commercialization Plan (a) involving face-to-face contact or contact by means of an e-detail or video, (b) describing in a manner consistent with applicable Law and industry standards and the quality of similar presentations made by a Party’s Sales Representatives for such Party’s other products (if applicable) the FDA-approved indicated uses and other relevant characteristics of such Licensed Product, (c) using the Promotional Materials in an effort to increase the prescribing or hospital ordering preferences of such Licensed Product for its FDA-approved indicated uses and (d) made at such health care provider’s office, in a hospital, at another appropriate alternate care setting, or in any other venue approved by the JCC. A Detail does not include a Sample drop made by a Sales Representative. For the avoidance of doubt, discussions at conventions or other scientific meetings will not constitute “Details” or “Detailing.”
1.1.67
Detail Cost” means with respect to a Detail provided by either Party in the Profit-Share Territory, the cost-per-Detail as set forth in the Joint Commercialization Budget.
1.1.68
Develop” and “Development” means, with respect to any product, any and all activities that relate to obtaining, maintaining or expanding Regulatory Approval of such product, including any and all activities related to the design, research, discovery, generation, identification, profiling, characterization, pre‑clinical development, or Nonclinical Studies of such product, CMC Activities, clinical drug development activities conducted before or after obtaining Regulatory Approval for such product that are reasonably related to or leading to the development, preparation, or submission of data and information to a Regulatory Authority for the purpose of obtaining, supporting, expanding or maintaining Regulatory Approval of such product, together with all activities related to pharmacokinetic profiling, design and conduct of Clinical Studies [**] of such product, pharmacovigilance activities, adverse event reporting, and regulatory affairs, statistical analysis, report writing and the creation and submission of Regulatory Materials related to the foregoing (including the services of outside advisors and consultants in connection therewith); but excluding, in each case, any activities directed to Medical Affairs Activities, Commercialization or Manufacturing.
1.1.69
Development Expense Report” has the meaning set forth in Section 9.3.1 (Joint Development Costs Reconciliation).
1.1.70
Development Lead Party” for a given Development activity has the meaning set forth in Section 3.2.1 (General).
1.1.71
Disclosing Party” has the meaning set forth in Section 10.1.1 (Nondisclosure and Non-Use Obligations).
1.1.72
Disputes” has the meaning set forth in Section 15.3.1 (Disputes).

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1.1.73
Distribution Costs” means the FTE Costs and Out-of-Pocket Costs, incurred by a Party or its Affiliate or for such Party’s or its Affiliate’s account during the Term and pursuant to the Agreement that are directly or reasonably allocable to the distribution of a Licensed Product in the Profit-Share Territory, including: [**].
1.1.74
Distribution Matters” means all issues and decisions regarding the distribution of the Licensed Products in the Profit-Share Territory, including decisions as to whether and with which wholesalers, specialty pharmacies and distributors to contract, and the terms of contracts with such wholesalers and distributors.
1.1.75
Distribution Plan” has the meaning set forth in Section 5.7.3 (Distribution in the Profit-Share Territory).
1.1.76
DOJ” means the U.S. Department of Justice.
1.1.77
Dollars” or “$” means the legal tender of the United States of America.
1.1.78
Effective Date” means the date on which all of the HSR Conditions (as defined in the SPA) have been met, unless either Party terminates this Agreement or the SPA at any time prior to the Closing Date (as defined in the SPA) in accordance with the terms hereof or thereof, in which case the Effective Date will be deemed not to have occurred.
1.1.79
EMA” means the European Medicines Agency.
1.1.80
EP Background Patent” has the meaning set forth in Section 8.3.1.3(a) (Third Party Payments owed to Existing Partner).
1.1.81
EP CMC Patent” has the meaning set forth in Section 8.3.1.3(a) (Third Party Payments owed to Existing Partner).
1.1.82
EP-Enhanced 217 Product” has the meaning set forth in Section 8.3.1.3(a) (Third Party payments owed to Existing Partner).
1.1.83
Execution Date” has the meaning set forth in the preamble.
1.1.84
ET” means the Indication that is Essential Tremor.
1.1.85
Executive Officer” means, for Sage, its Chief Executive Officer or another senior executive designee with decision-making authority, responsibilities and seniority comparable thereto, and for Biogen, its Chief Executive Officer or another senior executive designee with decision-making authority, responsibilities and seniority comparable thereto. In the event that the position of any of the Executive Officers identified in this Section ‎1.1.85 (Executive Officer) no longer exists due to a Change of Control, corporate reorganization, corporate restructuring or the like, then the applicable Executive Officer will be replaced with another executive officer with responsibilities and seniority comparable to the eliminated Executive Officer.
1.1.86
Existing Partner” means Shionogi & Co., Ltd and any successor in interest thereto.

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1.1.87
Existing Partner Agreement” means that certain Collaboration and License Agreement between Sage and the Existing Partner, dated as of June 12, 2018, as may be amended or restated from time to time.
1.1.88
Existing Partner Territory” means Japan, the Republic of Korea (South Korea) and Taiwan.
1.1.89
Existing Sage Agreement” has the meaning set forth in Section 1.1.110 (In-License Agreement).
1.1.90
Exploit” means to make, have made, use, import, export, offer to sell, sell, Develop, Manufacture, perform Medical Affairs Activities, Commercialize or otherwise exploit. “Exploitation” will be construed accordingly.
1.1.91
FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as amended.
1.1.92
FDA” means the United States Food and Drug Administration or any successor agency thereto.
1.1.93
Field” means any and all uses in humans.
1.1.94
Finance Expert” has the meaning set forth in Section 2.7.3.6 (Final Decision-Making Authority).
1.1.95
Finance Officers” has the meaning set forth in Section 9.3.1 (Development Costs Reconciliation).
1.1.96
Finance Working Group” has the meaning set forth in Section 9.4 (Finance Working Group).
1.1.97
First Commercial Sale” means, on a Licensed Product-by-Licensed Product and country-by-country basis, the first commercial sale in such country of such Licensed Product by Biogen or any of its Related Parties to a Third Party for end use consumption in such country following receipt of Regulatory Approval and, if applicable, Pricing and Reimbursement Approval, in each case, for such Licensed Product in such country. First Commercial Sale excludes transfers of a Licensed Product to Third Parties as bona fide Samples, as donations, for Clinical Study purposes or for any expanded access program, compassionate sales or use program (including named patient program or single patient program), indigent program, or for other charitable or promotional purposes or similar limited purposes.
1.1.98
Force Majeure” has the meaning set forth in Section 15.12 (Force Majeure).
1.1.99
FTE” means a full time person, or in the case of less than a full time person, a full time equivalent person year, carried out by an appropriately qualified employee of a Party or its Affiliates, based on [**] person hours per year. Overtime, and work on weekends, holidays, and the like will not be counted with any multiplier (e.g., time and a half or double time) toward the number of hours that are used to calculate the FTE contribution. Each employee utilized by a Party in connection with its performance under this Agreement may be less than or greater than one FTE based on the hours actually worked by such employee and will be treated as an FTE on a pro rata basis based upon the actual number of such hours worked divided by [**].

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1.1.100
FTE Costs” means, for any period, the FTE Rate multiplied by the number of FTEs in such period. FTEs will be pro-rated on a daily basis if necessary.
1.1.101
FTE Rate” means (a) for scientific, research and development, regulatory or other technical personnel, [**] Dollars ($[**]) per one (1) full scientific, clinical, medical, regulatory or technical FTE per a full Calendar Year, which rate includes all direct and indirect costs of a Party’s FTE, including personnel and travel expenses, and (b) for all distribution, sales and marketing, field-facing medical personnel and medical science liaisons, and other non-scientific, non-clinical, non-research or development, non-regulatory and non-technical personnel, the rates to be determined by the Finance Working Group and approved by the JSC and set forth in the applicable initial Joint Commercialization Plan and Joint Commercialization Budget or the Joint Medical Affairs Plan and Joint Medical Affairs Budget. Starting [**], (i) the foregoing rate in clause (a) will adjust on [**] of each Calendar Year by an amount equal to the change, if any, in the Consumer Price Index for All Urban Consumers (CPI U) for the U.S. City Average, calculated by the Bureau of Labor Statistics during the immediately preceding Calendar Year, and (ii) the rates in clause (b) will be adjusted by [**] of each Calendar Year for the next Calendar Year (concurrently with the JCC’s preparation of annual amendments to each then-current Joint Commercialization Plan and the corresponding Joint Commercialization Budget) based on the reassessments and recommendations of the Finance Working Group and as approved by the JSC. Notwithstanding the foregoing, for any Calendar Year during the Term that is less than a full year, the referenced rate in clause (a) and the rates determined by the Finance Working Group and approved by the JSC under clause (b) will be proportionately reduced to reflect such portion of FTEs for such full Calendar Year.
1.1.102
GAAP” means generally accepted accounting principles as practiced in the United States, as consistently applied.
1.1.103
GABAA Receptor” means the ionotropic receptor for the inhibitory neurotransmitter gamma-aminobutyric acid (GABA).
1.1.104
GAD” means Generalized Anxiety Disorder.
1.1.105
Generic Competition” in a country means (a) a Generic Product with respect to a Licensed Product is being marketed and sold by a Third Party (without a license, authorization or other grant of rights by Biogen or Sage) in such country in the Biogen Territory in a Calendar Quarter and (b) [**].
1.1.106
Generic Product” means (a) (i) a Third Party product containing the same active ingredient as that contained in a Licensed Product (whether approved under an ANDA, or other applicable abbreviated or expedited approval process), and (ii) [**], or (b) [**].
1.1.107
Governmental Authority” means any applicable government authority, court, tribunal, arbitrator, agency, department, legislative body, commission or other instrumentality of (a) any government of any country or territory, (b) any nation, state, province, county, city or other political subdivision thereof or (c) any multinational or supranational body.
1.1.108
Guaranteed Obligations” has the meaning set forth in Section 15.14 (Performance by BIMA and BIG).
1.1.109
HSR Act” means the Hart Scott Rodino Antitrust Improvements Act of 1976, as amended, and the rules promulgated thereunder.

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1.1.110
In-License Agreement” means any agreement between a Party and a Third Party pursuant to which such Party obtains rights to any Third Party intellectual property rights (including Know-How and Patents) or materials that are necessary or reasonably useful for the Development, Manufacture, performance of Medical Affairs with respect to or Commercialization of any Licensed Product pursuant to this Agreement. In-License Agreements existing as of the Execution Date with respect to Sage are those certain agreements between Sage and a Third Party listed on Schedule 1.1.110 (Existing Sage Agreements and Provisions) (each, an “Existing Sage Agreement”).
1.1.111
Incremental Taxes” has the meaning set forth in Section 9.11.5.3 (Tax Actions).
1.1.112
IND” means any Investigational New Drug Application, as defined in 21 C.F.R. § 312, or any corresponding application in any country or jurisdiction other than the United States.
1.1.113
Indemnified Party” has the meaning set forth in Section ‎12.3 (Indemnification Procedure).
1.1.114
Indemnified Persons” means the Sage Indemnitees or the Biogen Indemnitees, as applicable.
1.1.115
Indemnifying Party” has the meaning set forth in Section 12.3‎ (Indemnification Procedure).
1.1.116
Indication” means any separate and distinct human disease, syndrome, disorder, illness or condition intended to be treated by any therapeutic product, excluding different lines of treatment or patient populations (e.g., pediatric) for the same disease, disorder, illness or condition.
1.1.117
Initiation” means, with respect to a Clinical Study of a product, [**] pursuant to the applicable protocol for such Clinical Study.
1.1.118
Inventory Build Costs” means the Manufacturing Costs incurred in connection with the production or acquisition of supplies of a Licensed Product prior to First Commercial Sale of such Licensed Product, to the extent that such costs and expenses are not incurred in connection with the performance of a Clinical Study and would ordinarily be included as a cost of Development under GAAP.
1.1.119
IP Committee” means the intellectual property committee as more fully described in Section 13.4.1 (IP Committee).
1.1.120
IP Counsels” has the meaning set forth in Section 8.3.2.4 (New Technology Disputes).
1.1.121
IP Expert” has the meaning set forth in Section 8.3.2.4 (New Technology Disputes).
1.1.122
IP Head” means (a) with respect to Biogen, the representative designated by Biogen via the IP Committee and (b) with respect to Sage, the representative designated by Sage via the IP Committee, in each case, as confirmed by the Parties to the JSC.
1.1.123
JCC Communication Plan” has the meaning set forth in Section 2.4.3‎ (Meetings).

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1.1.124
JDC Communication Plan” has the meaning set forth in Section 2.3.3 (Meetings).
1.1.125
JMC Communication Plan” has the meaning set forth in Section 2.6.3 (Meetings).
1.1.126
Joint Collaboration Know-How” has the meaning set forth in Section 13.2.1 (Ownership).
1.1.127
Joint Collaboration Patents” means all Collaboration Patents that claim any Joint Collaboration Know-How.
1.1.128
Joint Collaboration Technology” means the Joint Collaboration Know-How and Joint Collaboration Patents.
1.1.129
Joint Commercialization Budget” has the meaning set forth in Section 5.2.1 (General).
1.1.130
Joint Commercialization Committee” or “JCC” has the meaning set forth in Section 2.4.1 (Formation; Composition; Dissolution).
1.1.131
Joint Commercialization Costs” means:
(a)
the FTE Costs and Out-of-Pocket Costs that are directly or reasonably allocable to the performance of Commercialization activities by or on behalf of a Party or any of its Affiliates for the Licensed Products in the Profit-Share Territory in accordance with the applicable Joint Commercialization Plan and the amounts budgeted for the performance of such activities in the applicable Joint Commercialization Budget, whether prior to or after receipt of Regulatory Approvals, including [**], in all cases, plus applicable Allowable Overruns;
(b)
[**];
(c)
[**] to be treated as Joint Commercialization Costs pursuant to Section [**]) and in accordance with the applicable Joint Commercialization Plan and Joint Commercialization Budget [**];
(d)
[**] to be treated as Joint Commercialization Costs pursuant to Section [**];
(e)
[**] to be treated as Joint Commercialization Costs pursuant to Section [**];
(f)
[**] to be treated as Joint Commercialization Costs pursuant to Section [**];
(g)
[**] to be treated as Joint Commercialization Costs pursuant to Section [**]; and
(h)
[**] to be treated as Joint Commercialization Costs pursuant to Section [**].

Joint Commercialization Costs specifically exclude any FTE Costs, Out-of-Pocket Costs and other costs and expenses: [**].

If any cost or expense is directly or reasonably allocable to more than one Commercialization cost category set forth above, then such cost or expense will only be counted

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once (i.e., as a Joint Commercialization Cost with respect to only one such category). No cost or expense included as a Joint Commercialization Cost will (A) also be included as a Joint Development Cost or a Joint Medical Affairs Cost, (B) be (or have been) included in the calculation of Net Sales as a deduction from the total amount billed or invoiced on sales of the applicable Licensed Product in the Profit-Share Territory, or (C) be an amount for which one Party or the other is solely responsible under this Agreement. Joint Commercialization Costs will be recognized and calculated in accordance with GAAP.

1.1.132
Joint Commercialization Plan” has the meaning set forth in Section 5.2.1 (General).
1.1.133
Joint Development Budget” has the meaning set forth in Section 3.2.1 (General).
1.1.134
Joint Development Committee” or “JDC” has the meaning set forth in Section 2.3.1 (Formation; Composition; Dissolution).
1.1.135
Joint Development Costs” means:
(a)
the FTE Costs and Out-of-Pocket Costs that are directly or reasonably allocable to the performance of Development activities by or on behalf of a Party or any of its Affiliates for the Licensed Products for the Profit-Share Territory and incurred by or on behalf of a Party or any of its Affiliates in accordance with the applicable Joint Development Plan and the amounts budgeted for the performance of such activities in the applicable Joint Development Budget plus applicable Allowable Overruns, including: [**];
(b)
[**] to be treated as Joint Development Costs pursuant to Section [**];
(c)
[**] treated as Joint Development Costs pursuant to Section [**] and in accordance with the applicable Joint Development Plan and Joint Development Budget, including [**];
(d)
[**] to be treated as Joint Development Costs pursuant to Section [**];
(e)
[**] to be treated as Joint Development Costs pursuant to Section [**]; and
(f)
[**] to be treated as Joint Development Costs pursuant to Section [**].

Joint Development Costs specifically exclude any FTE Costs, Out-of-Pocket Costs and other costs and expenses [**].

If any cost or expense is directly or reasonably allocable to more than one Joint Development Cost category above, then such cost or expense will only be counted once (i.e., as a Joint Development Cost with respect to only one such category). No cost or expense included as a Joint Development Cost will: (1) also be included as a Joint Commercialization Cost or a Joint Medical Affairs Cost; or (2) be an amount for which one Party or the other is solely responsible under this Agreement. Joint Development Costs will be recognized and calculated in accordance with GAAP.

1.1.136
Joint Development Plan” has the meaning set forth in Section ‎‎‎3.2.1 (General).

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1.1.137
Joint Manufacturing Committee” or “JMC” has the meaning set forth in Section 2.6.1 (Joint Manufacturing Committee; Formation; Composition; Dissolution).
1.1.138
Joint Medical Affairs Budget” has the meaning set forth in Section ‎‎‎4.2 (Joint Medical Affairs Plans).
1.1.139
Joint Medical Affairs Costs” means the FTE Costs and Out-of-Pocket Costs that are directly or reasonably allocable to the performance of Medical Affairs activities by or on behalf of a Party or any of its Affiliates for the Licensed Products in the Profit-Share Territory and incurred by or on behalf of a Party or any of its Affiliates in accordance with the applicable Joint Medical Affairs Plan and the amounts budgeted for the performance of such activities in the applicable Joint Medical Affairs Budget plus applicable Allowable Overruns.

Joint Medical Affairs Costs specifically exclude any FTE Costs, Out-of-Pocket Costs and other costs and expenses [**].

If any cost or expense is directly or reasonably allocable to more than one Joint Medical Affairs Cost category above, then such cost or expense will only be counted once (i.e., as a Joint Medical Affairs Cost with respect to only one such category). No cost or expense included as a Joint Medical Affairs Cost will: (i) also be included as a Joint Development Cost or a Joint Commercialization Cost; or (ii) be an amount for which one Party or the other is solely responsible under this Agreement. Joint Medical Affairs Costs will be recognized and calculated in accordance with GAAP.

1.1.140
Joint Medical Affairs Plan” has the meaning set forth in Section 4.2 (Joint Medical Affairs Plans).
1.1.141
Joint Medical Affairs Subcommittee Communication Plan” has the meaning set forth in Section 2.5.3 (Joint Medical Affairs Subcommittee; Meetings).
1.1.142
Joint Program Activities” means any activities with respect to a Licensed Product conducted by either Party or any of its Affiliates, Sublicensees or Subcontractors during the Term consisting of (a) Development for the purpose of, or in support of, (i) obtaining, maintaining or expanding Regulatory Approval in the Profit-Share Territory of such Licensed Product, or (ii) Commercializing such Licensed Product in the Profit-Share Territory, in each case ((i) and (ii)), in accordance with the corresponding Joint Development Plan for such Licensed Product, (b) Commercialization of such Licensed Product in the Profit-Share Territory in accordance with the corresponding Joint Commercialization Plan for such Licensed Product, (c) Medical Affairs Activities with respect to such Licensed Product in the Profit-Share Territory in accordance with the corresponding Joint Medical Affairs Plan for such Licensed Product or (d) the Manufacture of such Licensed Product for use in any of the activities set forth under clause (a), (b) or (c).
1.1.143
Joint Program Damages” means any Losses incurred in connection with any Third Party Claim, as well as any reasonable attorneys’ fees and costs of litigation incurred by either Party (or any of its Indemnified Persons) from Third Party Claims that arise from or are related to the performance of Joint Program Activities, other than Losses arising out of (a) any breach of, or inaccuracy in, any representation or warranty made by a Party in this Agreement, or any breach or violation of any covenant or agreement of a Party in this Agreement, or (b) the gross negligence, willful misconduct by or of a Party or any of its respective Affiliates or Sublicensees or any of their respective directors, officers, employees or agents in the performance of such Party’s obligations or exercise of its rights under this Agreement.
1.1.144
Joint Publications” has the meaning set forth in Section 10.2.1 (Publication).

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1.1.145
Joint Publications Working Group” has the meaning set forth in Section 10.2.1 (Publication).
1.1.146
Joint Steering Committee” or “JSC” has the meaning set forth in Section 2.2.1 (Formation; Composition; Dissolution).
1.1.147
JRA Exception” has the meaning set forth in Section ‎13.1.2 (JRA Exception).
1.1.148
KINETIC Study” means the double-blind, placebo-controlled Phase 2 Study to evaluate the safety and efficacy of the Licensed 324 Product compared to placebo on upper limb tremor reduction in individuals with Essential Tremor (ET) entitled “A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor” and identified as NCT04305275 and SAGE324-ETD-201, ongoing as of the Execution Date.
1.1.149
Know-How” means any proprietary data, results and information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, knowledge, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, instructions, skills, materials or compositions of matter of any type or kind (patentable or otherwise), experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, software, algorithms, specifications, marketing reports, study designs, protocols, Materials, clinical and non-clinical study reports, clinical and non-clinical information or data, regulatory submission documents and summaries, expertise, stability, technology, test data including pharmacological, biological, chemical, biochemical, toxicological, and clinical test data, analytical and quality control data, stability data and other data, studies and procedures.
1.1.150
Launch Window” means, for a Licensed Product in the Profit-Share Territory, the time period beginning [**] before the anticipated date of the First Commercial Sale for such Licensed Product in the Profit-Share Territory (as determined by the JCC and for which Sage has received written notice) and ending on [**].
1.1.151
Laws” means all applicable laws, statutes, rules, regulations, orders, judgments, injunctions, ordinances or other pronouncements having the binding effect of law of any Governmental Authority, including if either Party is or becomes subject to a legal obligation to a Regulatory Authority or other Governmental Authority (such as a corporate integrity agreement or settlement agreement with a Governmental Authority).
1.1.152
Lead Publishing Party” for a given publication has the meaning set forth in Section ‎10.2.1 (Publication).
1.1.153
Licensed [**] Product Substitution Date” has the meaning set forth in Section 3.10.3 (Effects of [**] Substitution).
1.1.154
Licensed [**] Products” means (a) the product containing SAGE-[**], for which data from Nonclinical Studies exists as of the Execution Date, in any dosage strength, and (b) any and all other products containing SAGE-[**], in any dosage strength, formulation or method of delivery, whether as the sole active ingredient or in combination with one or more Other Components.
1.1.155
Licensed 217 Products” means (a) the product containing SAGE-217 or “zuranolone” (as its International Nonproprietary Name (INN) and United States Adopted Name (USAN)), which is the subject of Clinical Studies as of the Execution Date, in any dosage strength, and (b) any and

16

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all other products containing SAGE-217, in any dosage strength, formulation or method of delivery, whether as the sole active ingredient or in combination with one or more Other Components.
1.1.156
Licensed 324 Products” means (a) the product containing SAGE-324, which is the subject of Clinical Studies as of the Execution Date, in any dosage strength, and (b) any and all other products containing SAGE-324, in any dosage strength, formulation or method of delivery, whether as the sole active ingredient or in combination with one or more Other Components.
1.1.157
Licensed Products” means the Licensed 217 Products and the Licensed 324 Products, in each case, individually or collectively as the context requires.
1.1.158
Long Term Joint Commercialization Budget” has the meaning set forth in Section 5.2.1.1 (General).
1.1.159
Long Term Joint Development Budget” has the meaning set forth in Section 3.2.1 (General).
1.1.160
Long Term Joint Medical Affairs Budget” has the meaning set forth in Section 4.2.1 (General).
1.1.161
Losses” has the meaning set forth in Section 12.1 (General Indemnification by Biogen).
1.1.162
LP U.S. TM Strategy” has the meaning set forth in Section 5.11.4.1 (Profit-Share Territory).
1.1.163
LP U.S. Trademark” means those Trademarks to be used in connection with the Commercialization of each Licensed Product in the Profit-Share Territory, as selected jointly by the Parties through the JCC pursuant to Section 5.11.4.1 (Profit-Share Territory).
1.1.164
Major Commercialization Activity” means any of the following matters with respect to a Licensed Product in the Profit-Share Territory: [**].
1.1.165
Major Development Activity” means the Development activities set forth on Schedule 1.1.165 (Major Development Activities).
1.1.166
Major European Countries” means [**].
1.1.167
Major Medical Affairs Activity” means the Medical Affairs activities set forth on Schedule 1.1.167 (Major Medical Affairs Activities).
1.1.168
Manufacturing” or “Manufacture” means, with respect to any product (including active pharmaceutical ingredient and other material contained therein), any and all activities related to the manufacture of such product, including qualification, validation and scale-up, pre-clinical, clinical and commercial manufacture, packaging, labeling, filling, finishing, assembly, processing, in-process and finished product testing, release of such product or any component or ingredient thereof, quality assurance, quality control and audit activities related to manufacturing, testing and release of such product, ongoing stability tests, storage, shipping, supply or storage of such product (or any components or process steps involving such product or any companion diagnostic), placebo or comparator agent, as the case may be, product characterization, technical support activities, and regulatory activities related to any of the

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foregoing, but excluding any activities directed to Development, Medical Affairs Activities or Commercialization of such product.
1.1.169
Manufacturing Budget” has the meaning set forth in Section 7.2 (Manufacturing Plans).
1.1.170
Manufacturing Costs” means the consolidated fully burdened manufacturing cost incurred by a Party or its Affiliate for a Sage Molecule or Licensed Product and in accordance with GAAP (consistently applied by such Party and its Affiliates with respect to all small molecule compounds and products), which will be the sum of:

for Manufacturing activities with respect to a Sage Molecule or Licensed Product performed by or on behalf of a Party or its Affiliates, [**]%) of the actual costs of materials consumed or incorporated into, and direct labor and other actual costs incurred in the performance of such Manufacturing activities specifically related or reasonably allocable to the relevant Sage Molecule or Licensed Product, as applicable, including: ordinary course quality assurance costs, stability testing cost, characterization testing, quality control, release testing of drug substance and drug product, reasonably allocable equipment maintenance costs, customs and duty and charges levied by governmental authorities, labelling and packaging, failed lot charges, excess and obsolete inventory write-off, and manufacturing scrap incurred in the ordinary course of production (and not attributable to the gross negligence of such Party or its Affiliates), reasonably allocable cost of freight into or between Manufacturing sites, technology transfer costs related to new processes or facilities, any actual amounts paid by a Party or its Affiliate to a contract manufacturing organization Subcontractor that are solely and specifically related to the Manufacture of such Licensed Product (or Sage Molecules included therein or any components of the foregoing), including capacity reservation or cancellation fees paid to a Third Party, and costs to manage arrangements with contract manufacturing organizations that are specifically related or reasonably allocable the Manufacture of a Sage Molecule or Licensed Product (including to qualify or audit Manufacturing sites of such contract manufacturing organizations utilized in the Manufacture of a Sage Molecule or Licensed Product), plus a reasonable allocation of the Manufacturing site’s fixed and direct overhead consistent with the applicable Party’s costing methodology, including leasing costs and depreciation for capital expenditures for equipment (but not other capital expenses) and facilities costs, in each case, to the extent specifically related or reasonably allocable to the relevant Sage Molecule or Licensed Product (or components of the foregoing), which will be calculated in accordance with GAAP; provided that any such allocation of overhead will be made on the basis of normal capacity operation of the relevant facility and in any event will exclude (a) except as otherwise set forth in this definition, any costs and charges related to excess, idle or unused manufacturing capacity and (b) allocation of general corporate overhead; provided, further that such allocation of overhead may take into account idle capacity at a Party or its Affiliate’s own Manufacturing sites that was originally reserved under the Manufacturing Plan in good faith and not more than [**] in advance for Manufacture of the relevant Sage Molecule or Licensed Product and such idle capacity if not otherwise able to be filled by such Party or its applicable Affiliates despite reasonable efforts to do so.

1.1.171
Manufacturing Lead Party” for a given Manufacturing activity means the Party with day-to-day operational responsibility with respect to the Manufacture of the applicable Licensed Products as set forth under the applicable Manufacturing Plan.
1.1.172
Manufacturing Plan” has the meaning set forth in Section 7.2 (Manufacturing Plans).
1.1.173
Manufacturing Technology Transfer” has the meaning set forth in Section 7.8.1 (Manufacturing Technology Transfer).

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1.1.174
Material Adverse Product Effect” means (a) [**], or (b) [**].
1.1.175
Material Communications” means written, telephonic or in person communications from or with any Regulatory Authority concerning any of the following: product quality attributes (e.g., purity, toxicity, drug/drug interactions); significant or new safety findings (e.g., Serious Adverse Events, emerging safety signals); clinical or non-clinical findings affecting patient safety; lack of efficacy; potential pathways to Regulatory Approval; receipt or denial of Regulatory Approval; the design of Clinical Studies, or the need for additional Clinical Studies or Nonclinical Studies (e.g., additional toxicology or carcinogenicity studies).
1.1.176
Material Commercialization Subcontractor” has the meaning set forth in Section 5.14 (Commercialization Subcontract).
1.1.177
Material Development Subcontractor” has the meaning set forth in Section 3.9 (Development Subcontract).
1.1.178
Materials” means all tangible compositions of matter, devices, articles of manufacture, assays, biological, chemical or physical materials and other similar materials.
1.1.179
MDD” means the Indication that is Major Depressive Disorder.
1.1.180
Medical Affairs Activities” means, with respect to a Licensed Product, any and all activities performed by or on behalf of a Party’s or its Affiliates’ medical affairs departments interacting with physicians or other healthcare professionals who may utilize or conduct research related to a drug or biological product, including: supporting continuing medical education and other medical programs and communications; development, publication, and dissemination of publications; development and fulfillment of medical information responses; development and execution of disease awareness education including symposia and digital education initiatives; sponsorship and booth exhibition at key congresses; conducting health economic, burden of illness/disease, natural history and real world evidence studies;; supporting educational fellowships and research grants, supporting external research efforts such as scientific research agreements and investigator initiated trials (following Regulatory Approval); medical resourcing, training and allocation; medical and scientific platform and content development; conducting appropriate activities involving opinion leaders, including communications and engagement; conducting medical science liaison activities; advisory boards or other consulting programs (to the extent related to medical affairs or clinical guidance) ; establishing patient registries and expanded access programs; post-approval investigator initiated trials or scientific research agreements; life cycle management activities and clinical research (including Phase 4 Optional Studies and investigator initiated research (IIR)).
1.1.181
Medical Affairs Lead Party” for a given Medical Affairs Activity has the meaning set forth in Section 4.2 (Joint Medical Affairs Plans).
1.1.182
NDA” means any New Drug Application as described in 21 C.F.R. § 314, or any corresponding application for Regulatory Approval in any country or jurisdiction other than the United States.
1.1.183
Net Revenues” means, to the extent allocable to a Licensed Product in the Profit-Share Territory, and, if applicable, for one or more such Licensed Products: (a) the total Net Sales of all such Licensed Products in the Profit-Share Territory; plus (b) Other Income received in connection with such Licensed Products in the Profit-Share Territory. Net Revenues will be accounted for in accordance with GAAP, as consistently applied by such Party in the Profit-Share Territory.

19

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1.1.184
Net Sales” means with respect to a Licensed Product, the gross amount invoiced in a country by or on behalf of [**], (each of the foregoing Persons, a “Selling Party”) for the sale or other disposition of such Licensed Product in such country to Third Parties [**] in bona fide arms’ length transactions in the Territory, less the following deductions:

[**].

Such amounts will be determined consistent with a Selling Party’s customary practices and in accordance with GAAP. It is understood that any accruals for individual items reflected in Net Sales are periodically (at least [**]) trued up and adjusted by each Selling Party consistent with its customary practices and in accordance with GAAP.

 

Notwithstanding anything to the contrary set forth in this Agreement, [**].

 

In the case of any Combination Product sold in a given country and reporting period, Net Sales for the purpose of determining royalties and Sales Milestone Events of the Combination Product in such country will be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B), where A is the invoice price of the applicable Sage Molecule if sold separately in the same indication in such country, and B is the total invoice price of the Other Components in the Combination Product, if sold separately in the same indication in such country.

 

If, on a country-by-country basis in a particular reporting period, the Licensed Product is sold separately in the same indication in a country, but the Other Components in the Combination Product are not sold separately in the same indication in such country, then Net Sales for the purpose of determining royalties and Sales Milestone Events of the Combination Product for such country will be calculated by multiplying actual Net Sales of the Combination Product by the fraction A/C, where A is the invoice price of the Sage Molecule if sold separately in the same indication in such country, and C is the invoice price of the Combination Product in such country.

 

If, on a country-by-country basis in a particular reporting period, the Licensed Product in the Combination Product is not sold separately in the same indication in such country, but the Other Components included in the Licensed Product are sold separately in the same indication in such country, then Net Sales for the purpose of determining royalties and Sales Milestone Events of the Combination Product for such country will be calculated by multiplying actual Net Sales of the Combination Product by the fraction (C-B)/C, where B is the invoice price of the Other Components included in such Combination Product if sold separately in the same indication in such country, and C is the invoice price of the Combination Product in such country.

 

If neither the Licensed Product nor the Other Components are sold separately in the same indication in a given country during a particular reporting period, then Net Sales will be calculated based on [**].

 

Any disputes between the Parties relating to the calculation of Net Sales under this Section 1.1.184 (Net Sales) based on non-cash consideration or allocation of Net Sales for a Combination Product will be resolved pursuant to the dispute resolution procedures in Section 15.3.5 (Expert Arbitration).

 

1.1.185
New License Agreement” has the meaning set forth in Section 14.6.8 (Sublicense Survival).

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1.1.186
New Technology” has the meaning set forth in Section 8.3.2.1 (New Technology).
1.1.187
New Technology Terms” has the meaning set forth in Section 8.3.2.2 (Inclusion Process).
1.1.188
Non-Defending Party” has the meaning set forth in Section ‎13.5.4 (Cooperation Regarding Enforcement, Defense or Post-Grant Proceedings).
1.1.189
Non-Major Commercialization Activities” means the day-to-day, operational Commercialization activities performed for a Licensed Product in the Profit-Share Territory under a Joint Commercialization Plan, including any Commercialization matter within a Joint Commercialization Plan that is not a Major Commercialization Activity.
1.1.190
Non-Major Development Activities” means the day-to-day, operational Development activities performed for a Licensed Product in the Profit-Share Territory under a Joint Development Plan.
1.1.191
Non-Major Medical Affairs Activities” means the day-to-day, operational Medical Affairs Activities performed for a Licensed Product in the Profit-Share Territory under a Joint Medical Affairs Plan.
1.1.192
Non-Major Regulatory Activities” means the day-to-day, operational regulatory matters within the scope of a Party’s responsibility under Section 6.1 (Regulatory Lead Responsibilities).
1.1.193
Non-Proposing Party” has the meaning set forth in Section 3.3.2 (Additional Indications Development).
1.1.194
Nonclinical Studies” means all non-human animal studies for any Licensed Product, including preclinical studies, non-clinical and toxicology studies.
1.1.195
Ongoing 217 Studies” means the Clinical Studies and Nonclinical Studies for the Licensed 217 Product ongoing, paused or planned as of the Execution Date, as identified on Schedule 1.1.195 (Ongoing 217 Studies).
1.1.196
OP&L Share” means the Parties’ equal sharing of the Operating Profits or the Operating Losses for the Licensed Products pursuant to Section ‎9.3.3 (Profit Sharing Following First Commercial Sale).
1.1.197
Operating Profit (or Loss)” means, for a given period of time, Net Revenue of a Licensed Product for the Profit-Share Territory during such period, less the sum of: (a) Joint Development Costs for such Licensed Product plus (b) Joint Medical Affairs Costs for such Licensed Product plus (c) Joint Commercialization Costs for such Licensed Product, in each case ((a), (b) and (c)) incurred during such time period. For clarity, Operating Profit (or Loss) will be determined prior to application of any income taxes, and if such terms are used individually, “Operating Profit” will mean a positive Operating Profit (or Loss), and “Operating Loss” will mean a negative Operating Profit (or Loss). Operating Profit (or Loss) will be recognized and calculated in accordance with GAAP.
1.1.198
Opt-Out Date” has the meaning set forth in Section 9.5.1 (Exercise of Opt-Out).

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1.1.199
Opt-Out Products” has the meaning set forth in Section 9.5.1 (Exercise of Opt-Out).
1.1.200
Opt-Out Right” has the meaning set forth in Section 9.5.1 (Exercise of Opt-Out).
1.1.201
Opt-Out Wind-Down Activities” has the meaning set forth in Section 9.5.2 (Effect of Opt-Out).
1.1.202
Opt-Out Wind-Down Costs” has the meaning set forth in Section 9.5.2 (Effect of Opt-Out).
1.1.203
Opt-Out Wind-Down Period” has the meaning set forth in Section 9.5.2 (Effect of Opt-Out).
1.1.204
Other Component” means one or more additional therapeutic agents (other than any Sage Molecule) [**].
1.1.205
Other Income” means with respect to a Product Class (a) any payment received by a Party or its Affiliate from a Sublicensee prior to Sage’s exercise of its Opt-Out Right with respect to the Product Class of such Licensed Product in consideration for the grant of rights (including an option to obtain rights) to Develop, Manufacture, perform Medical Affairs Activities for or Commercialize a Licensed Product in the Profit-Share Territory, and (b) to the extent not already described in clause (a), other payments when recognized as income or an offset to an expense in accordance with GAAP by a Party or its Affiliate that is attributable to such Licensed Product described in the foregoing clause (a) in the Profit-Share Territory; provided, however, that Other Income will not include any such payments received by such Party or its Affiliate from a Sublicensee [**].
1.1.206
Out-of-Pocket Costs” means, with respect to certain activities for a Licensed Product hereunder, specifically identifiable expenses paid or payable by either Party or its Affiliates to Third Parties in consideration for the conduct of such activities, including payments to contract personnel (including contractors, consultants and Subcontractors).
1.1.207
Panel” has the meaning set forth in Section 15.3.5.1 (Expert Arbitration).
1.1.208
Parties” has the meaning set forth in the preamble.
1.1.209
Party” has the meaning set forth in the preamble.
1.1.210
Patents” means all (a) patents, (b) patent applications, including all provisional and non-provisional applications, patent cooperation treaty (PCT) applications, substitutions, divisions and renewals, continuations, continuations-in-part, any patent issued with respect to any such patent applications, (c) all patents-of-addition, reissues, reexaminations, renewals, extensions or restorations by existing or future extension or restoration mechanisms (including any supplementary protection certificate or equivalents thereof), (d) inventor’s certificates or letters patent, and (e) and all other counterparts and substantially equivalent form of government issued right substantially similar to any of the foregoing described in clauses (a) through (d) above, in any country or jurisdiction.
1.1.211
Patent Costs” means the Out-of-Pocket Costs paid to outside legal counsel or other Third Parties, and filing and maintenance expenses, incurred in Prosecuting and Maintaining Patents

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and enforcing and defending them, but excluding any Third Party Payments described in Section 8.3 (Third Party In-Licenses Payments).
1.1.212
Paying Party” has the meaning set forth in Section ‎9.11.1 (Manner of Payment).
1.1.213
Payments” has the meaning set forth in Section 9.11.5.1 (General).
1.1.214
Person” means any natural person, corporation, unincorporated organization, partnership, association, sole proprietorship, joint stock company, joint venture, limited liability company, trust or government, or Governmental Authority, or any other similar entity.
1.1.215
Pharmacovigilance Agreement” has the meaning set forth in Section 6.10 (Reporting Adverse Events).
1.1.216
Phase 1 Study” means a clinical study of an investigational product in human subjects with the primary objective of characterizing its safety, metabolism, tolerability, pharmacokinetics and clinical pharmacology and identifying a recommended dose and regimen for future studies and that satisfies the requirements of 21 C.F.R. § 312.21(a), as amended (or its successor regulation), or, with respect to any other country or region, the equivalent of such a clinical trial in such other country or region.
1.1.217
Phase 2 Study” means a clinical study of an investigational product in human subjects with the objective of exploring the feasibility, safety, dose ranging, or efficacy of a pharmaceutical or biologic product that satisfies the requirements of 21 C.F.R. § 312.21(b), as amended (or its successor regulation), or, with respect to any other country or region, the equivalent of such a clinical trial in such other country or region. Notwithstanding the foregoing, solely for purposes of Section ‎9.6.1 (Licensed 217 Products Regulatory/Commercial Milestones) and Section 9.6.2 (Licensed 324 Products Regulatory/Commercial Milestones), the Phase 2 Study must be prospectively designed to generate sufficient data (if successful) to commence a Phase 3 Study for such product.
1.1.218
Phase 3 Study” means a clinical study of an investigational product in human subjects that the FDA permits to be conducted under an open IND and that is performed to gain evidence with statistical significance of the efficacy of such product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA by a Regulatory Authority and to provide an adequate basis for physician labeling, in a manner that meets the requirements of 21 C.F.R. § 312.21(c), as amended (or its successor regulation), or, with respect to any other country, the equivalent of such a clinical study in such other country. Notwithstanding any provision to the contrary set forth in this Agreement, treatment of patients as part of an expanded access program, compassionate sales or use program (including named patient program or single patient program), or an indigent program, in each case, will not be included in determining whether or not a clinical trial is a Phase 3 Study or whether a patient has been dosed thereunder.
1.1.219
Phase 4 Optional Study” any post-approval clinical study for a product in a country with respect to any Indication for which Regulatory Approval has been received in a particular country, including investigator-initiated clinical studies initiated after Regulatory Approval of a product or post-marketing surveillance studies of a product, in each case, that is not a Phase 4 Required Study.
1.1.220
Phase 4 Required Study” means any post-approval clinical study initiated following receipt of Regulatory Approval for a product in a country in an Indication or to be conducted after receipt of Regulatory Approval of a product in an Indication, in each case, that was required by the applicable Regulatory Authority in any country in the Territory as a condition of receiving or maintaining

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a Regulatory Approval for such product with respect to such Indication in such country (such as post-marketing approval studies and observational studies, if required by any Regulatory Authority in any country in the Territory to support or maintain Regulatory Approval for such product in such Indication in such country) or that is required for a label extension for a product in such country.
1.1.221
Phase 4 Study” means any Phase 4 Required Study or any Phase 4 Optional Study.
1.1.222
PhRMA Code” means the Code of the Pharmaceutical Research and Manufacturers of America.
1.1.223
PM Strategy” has the meaning set forth in Section 13.4.1.3(a) (IP Committee Responsibilities).
1.1.224
Post-Grant Proceedings” means, with respect to a particular Patent, [**] and other similar proceedings by or against a Third Party with respect to such Patent.
1.1.225
PPD” means the Indication that is Postpartum Depression.
1.1.226
Pre-Commercialization Expense Report” has the meaning set forth in Section 9.3.2 (Reconciliation/Reimbursement Prior to First Commercial Sale).
1.1.227
Preapproved Subcontractor” means any of the Subcontractors set forth on Schedule 1.1.227 (Preapproved Subcontractors) as such list may be updated from time-to-time as set forth in Section 3.9 (Development Subcontracts) or Section 5.14 (Commercialization Subcontracts), as applicable.
1.1.228
Pricing and Reimbursement Approval” means an approval, agreement, determination or other decision by the applicable Governmental Authority of a country or jurisdiction that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by the Regulatory Authority or other applicable Governmental Authority in such country or jurisdiction.
1.1.229
Pricing Matters” means, with respect to a Licensed Product in the Profit-Share Territory, [**].
1.1.230
Principal Mode of Action” means, for an individual molecule, [**].
1.1.231
Prior Confidentiality Agreement” has the meaning set forth in Section 15.4 (Entire Agreement; Amendments).
1.1.232
Proceeding” means any action, suit, claim, investigation or other proceeding.
1.1.233
Product Class” means collectively, either (a) all Licensed 217 Products, or (b) all Licensed 324 Products.
1.1.234
Profit-Share Regulatory Strategy” has the meaning set forth in Section 6.1 (Regulatory Lead Responsibilities).
1.1.235
Profit-Share Territory” means the United States.

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1.1.236
Promotional Materials” means (a) all written, printed, graphic, digital, electronic, audio or video matter, including journal advertisements, sales visual aids, leave-behind items, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements intended for use or used by or on behalf of either Party or their respective Affiliates in connection with any promotion of a Licensed Product, or in connection with market access, pricing, contracting or patient support activities related to a Licensed Product, and (b) all field and patient support training materials.
1.1.237
Promotional Materials Rules” has the meaning set forth in Section 2.2.2.13 (Specific Responsibilities of the JSC).
1.1.238
Proposing Party” has the meaning set forth in Section 3.3.2 (Additional Indications Development).
1.1.239
Prosecution and Maintenance” means, with respect to a particular Patent, the preparation, filing, prosecution and maintenance of such Patent (and the foreign equivalents of any of the foregoing), [**]. “Prosecute and Maintain” and “Prosecuting and Maintaining” have corresponding meanings.
1.1.240
Post-Commercialization Expense Report” has the meaning set forth in Section 9.3.3.2 (Calculation and Payment).
1.1.241
Publications” means any and all publications, abstracts, posters and other presentations in scientific or medical journals or forums of data and results generated from activities in furtherance of this Agreement.
1.1.242
Publications Plan” has the meaning set forth in Section 10.2.1 (Publication).
1.1.243
Receiving Party” has the meaning set forth in Section ‎10.1.1 (Nondisclosure and Non-Use Obligations).
1.1.244
Region” means any of [**].
1.1.245
Regulatory Approval” means, with respect to a particular country or other regulatory jurisdiction, any approvals, licenses, registrations, or authorizations of any Regulatory Authority necessary for the Manufacture, Development, marketing, importation or sale of a product for one or more indications in such country or regulatory jurisdiction, excluding, if applicable, Pricing and Reimbursement Approvals in such country or regulatory jurisdiction.
1.1.246
Regulatory Authority” means any Governmental Authority involved in granting approvals for the Development, Manufacturing or Commercialization of pharmaceutical products, including the FDA, the EMA, the European Commission, the Japanese Ministry of Health, Labour and Welfare, Japan’s Pharmaceuticals and Medical Devices Agency and the People’s Republic of China’s National Medical Products Administration.
1.1.247
Regulatory Exclusivity” means any exclusive marketing rights or data protection or other exclusivity rights (other than Patents) conferred by any Regulatory Authority with respect to a product in a country or jurisdiction in the Territory that prohibits the Commercialization of a Generic Product, including orphan drug exclusivity or pediatric exclusivity.

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1.1.248
Regulatory Lead Party” for a given activity has the meaning set forth in Section ‎6.1 (Regulatory Lead Responsibilities).
1.1.249
Regulatory Materials” means (a) any submission to a Regulatory Authority, including all INDs, NDAs and other applications, registrations, licenses, authorizations and approvals (including Regulatory Approvals, Pricing and Reimbursement Approvals and product labeling) and designations (including designations of a product as an “orphan” drug or its equivalent outside of the United States), (b) correspondence, communication, materials, reports and documentation submitted to or received from Regulatory Authorities (including meeting requests, pre-meeting submissions, minutes and official contact reports relating to any communications with any Regulatory Authority) related to Developing, Manufacturing, obtaining marketing authorization, marketing, selling or otherwise Commercializing a pharmaceutical product in a particular country or jurisdiction, and all supporting documents with respect thereto, including all investigator brochures, regulatory drug lists, drug safety and signaling update reports, adverse event files and complaint files (including product technical complaints communications and handling) and other material regulatory submissions and (c) Clinical Data contained in any of the foregoing, and any supplement or amendment to any of the foregoing.
1.1.250
Related Party(ies)” means, (a) with respect to Biogen, Biogen’s Affiliates and Sublicensees, and (b) with respect to Sage, Sage’s Affiliates and Sublicensees.
1.1.251
Returned Country” has the meaning set forth in Section 11.1.6 ([**]).
1.1.252
Reversion License” has the meaning set forth in Section ‎14.6.2 (Reversion License).
1.1.253
Reversion Technology” means, with respect to a Terminated Product in the Terminated Territory, [**].
1.1.254
Reversion Trademarks” has the meaning set forth in Section 14.6.9 (Biogen Trademarks).
1.1.255
[**]” has the meaning set forth in Section ‎11.6 ([**]).
1.1.256
Royalty Bearing Patents” means, with respect to a Licensed Product, the Sage Licensed Patents, Biogen Collaboration Patents and Joint Collaboration Patents, in each case, that [**] of such Licensed Product.
1.1.257
Royalty Term” means, with respect to a Licensed Product and a country, the period commencing upon the First Commercial Sale of such Licensed Product in such country and continuing until the later of: (a) expiration of the last Valid Claim of the last to expire of the Royalty-Bearing Patents that would be infringed (absent a license granted hereunder) by the sale of such Licensed Product in such country, (b) expiration of the Regulatory Exclusivity for such Licensed Product in such country, and (c) 12 years after the First Commercial Sale of such Licensed Product in such country.
1.1.258
[**]” has the meaning set forth in Section 3.10.1 (Licensed [**] Product Development).
1.1.259
Sage” has the meaning set forth in the preamble.
1.1.260
SAGE-[**]” means (a) the molecule described on Schedule 1.1.260 (SAGE-[**]) or (b) any metabolite, salt, ester, hydrate, solvate, crystalline form, co-crystalline form, amorphous

26

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form, pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, tautomer, stereoisomer, enantiomer, conjugate, complex, free acid, free base or optically active form thereof.
1.1.261
SAGE-217” means (a) the molecule described on Schedule 1.1.261 (SAGE-217) or (b) any metabolite, salt, ester, hydrate, solvate, crystalline form, co-crystalline form, amorphous form, pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, tautomer, stereoisomer, enantiomer, conjugate, complex, free acid, free base or optically active form thereof.
1.1.262
SAGE-324” means (a) the molecule described on Schedule 1.1.262 (SAGE-324) or (b) any metabolite, salt, ester, hydrate, solvate, crystalline form, co-crystalline form, amorphous form, pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, tautomer, stereoisomer, enantiomer, conjugate, complex, free acid, free base or optically active form thereof.
1.1.263
Sage Collaboration Patents” means all Collaboration Patents that claim any Sage Collaboration Know-How, but expressly excluding Sage’s interest in any Joint Collaboration Patents.
1.1.264
Sage Collaboration Know-How” has the meaning set forth in Section 13.2.1 (Ownership).
1.1.265
Sage Collaboration Technology” means the Sage Collaboration Know-How and Sage Collaboration Patents.
1.1.266
Sage Indemnitees” has the meaning set forth in Section ‎12.1 (General Indemnification by Biogen).
1.1.267
Sage Licensed Know-How” means any and all Know-How, other than Joint Collaboration Know-How, Controlled by Sage or any of its Affiliates (solely or jointly with any Third Party) as of the Execution Date or during the Term, that (a) is necessary for the Development, Manufacture, performance of Medical Affairs Activities with respect to or Commercialization of a Licensed Product in the Field in the Territory, or (b) is reasonably useful for the Development, Manufacture, performance of Medical Affairs with respect to or Commercialization of a Licensed Product in the Field in the Territory; [**]. The Sage Licensed Know-How includes all Sage Collaboration Know-How.
1.1.268
Sage Licensed Patents” means any and all Patents, other than Joint Collaboration Patents, Controlled by Sage or any of its Affiliates (solely or jointly with any Third Party) as of the Execution Date or during the Term that (a) are necessary for or Cover the Development, Manufacture, performance of Medical Affairs with respect to or Commercialization of a Licensed Product in the Field in the Territory, or (b) are reasonably useful for the Development, Manufacture, performance of Medical Affairs Activities with respect to or Commercialization of a Licensed Product in the Field in the Territory [**]. The Sage Licensed Patents include all Sage Collaboration Patents. The Sage Licensed Patents existing as of the Execution Date are set forth on Schedule ‎1.1.268 (Sage Licensed Patents as of the Effective Date). Sage Licensed Patents exclude Sage’s interest in the Joint Collaboration Patents.
1.1.269
Sage Licensed Technology” means, collectively, the Sage Licensed Know-How, the Sage Licensed Patents and Sage’s interest in the Joint Collaboration Technology and Joint Collaboration Technology.
1.1.270
Sage Molecule” means SAGE-217 or SAGE-324.
1.1.271
Sage Prosecuted Patents” has the meaning set forth in Section 13.4.3.1 (General).

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1.1.272
Sales & Marketing Costs” means the FTE Costs and Out-of-Pocket Costs incurred in the performance of the following sales and marketing activities for a Licensed Product in the Profit-Share Territory to the extent in accordance with applicable Law and applicable industry codes, including the PhRMA Code: (a) activities directed to the advertising and marketing of a Licensed Product in the Profit-Share Territory; (b) public relations with respect to a Licensed Product in the Profit-Share Territory; (c) peer-to-peer activities with respect to a Licensed Product in the Profit-Share Territory, such as ‘lunch and learns’; (d) promotional speaker programs with respect to a Licensed Product in the Profit-Share Territory, including the training of such speakers; (e) developing, obtaining and providing training with respect field-based personnel and patient support with respect to a Licensed Product in the Profit-Share Territory, as well as training packages; (f) generating Promotional Materials; (g) developing and performing market research with respect to a Licensed Product in the Profit-Share Territory and developing branding and communications plans; (h) conducting promotional symposia with respect to a Licensed Product in the Profit-Share Territory; (i) developing and implementing reimbursement programs with respect to a Licensed Product in the Profit-Share Territory; (j) patient support costs; and (k) developing information and materials specifically intended for national accounts, managed care organizations and group purchasing organizations with respect to a Licensed Product in the Profit-Share Territory and related interactions; but, in each case ((a)-(k)), excluding the costs and expenses of any activity the costs and expenses of which are already included in the any Detail Costs.
1.1.273
Sales Representative” means a pharmaceutical sales representative engaged or employed by either Party to conduct Detailing and other promotional efforts with respect to the Licensed Products in the Profit-Share Territory in accordance with the terms of this Agreement.
1.1.274
Samples” means a Licensed Product that is not intended to be sold and that is instead intended to promote the sale of such Licensed Product in the Profit-Share Territory in accordance with applicable Law.
1.1.275
Second Source” has the meaning set forth in Section 7.6 (Second Source and Biogen Manufacturing Sites).
1.1.276
Securitization Transaction” has the meaning set forth in Section ‎15.1.2 (Securitization).
1.1.277
Selling Party” has the meaning set forth in Section 1.1.184 (Net Sales).
1.1.278
Serious Adverse Event” has the meaning set forth in 21 C.F.R. § 312.32 and generally means an adverse drug experience or circumstance that results in any of the following outcomes (a) death, (b) life threatening condition, (c) inpatient hospitalization or a prolongation of existing hospitalization, (d) persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, (e) a congenital anomaly/birth defect or (f) based upon appropriate medical judgment is considered an important medical event that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
1.1.279
Shared Resource” has the meaning set forth in Section 5.10 (Joint Commercialization Costs Allocation).
1.1.280
SPA” has the meaning set forth in Section ‎9.2 (Equity Investment).
1.1.281
Strategic Enforcement or Defense Reasons” has the meaning set forth in Section 13.5.2.1 (Rights to Enforce; In the Territory).

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1.1.282
Strategic Prosecution Reasons” has the meaning set forth in Section 13.4.2.2 (Sage Step-In).
1.1.283
Subcontractor” means a Third Party contractor (including contract research organizations, contract manufacturing organizations or Third Party distributors) engaged by a Party or its Affiliates on a fee-for-service basis to perform certain services or activities on behalf of and for the benefit of such Party or its Affiliates or exercise certain rights on behalf of such Party or its Affiliates, in each case, under this Agreement.
1.1.284
Sublicensee” means a Third Party to which a Party or its Affiliate has granted or grants rights under the rights granted to such Party pursuant to this Agreement to Develop, perform Medical Affairs Activities for or Commercialize a Licensed Product, or any further sublicensee of such rights (regardless of the number of tiers, layers or levels of sublicenses of such rights), other than any Subcontractor that is granted any such sublicense or other rights solely for the purpose of performing specific limited services or activities solely on behalf of and for the benefit of a Party or its Affiliate.
1.1.285
Supply Agreement” has the meaning set forth in Section ‎7.5 (Supply Agreement).
1.1.286
Supply Price” has the meaning set forth in Section 7.3 (Manufacturing Costs).
1.1.287
Substitution Termination Date” means, unless otherwise agreed by the Parties, the date on which [**].
1.1.288
Tax” and “Taxation” means any U.S. and non-U.S. federal, state, local, regional, municipal, or other tax or taxation, levy, duty, charge, withholding or other assessment of any kind (including any related fine, penalty, addition to tax, surcharge, or interest) imposed by, or payable to, a Governmental Authority, including sales, use, excise, stamp, transfer, property, value added, goods and services, withholding, and franchise taxes (whether imposed directly or through withholding, and whether or not disputed).
1.1.289
Tax Partnership” has the meaning set forth in Section 15.21.1.1 (Tax Matters).
1.1.290
Term” has the meaning set forth in Section ‎14.1 (Term).
1.1.291
Terminated Products” means all Licensed Products within a Product Class with respect to which this Agreement has been terminated pursuant to Article 14 (Term and Termination). All Licensed 217 Products will be deemed Terminated Products if this Agreement is terminated with respect to the Product Class of Licensed 217 Products and all Licensed 324 Products will be deemed Terminated Products if this Agreement is terminated with respect to the Product Class of Licensed 324 Products. All Licensed Products will be deemed Terminated Products if this Agreement is terminated in its entirety.
1.1.292
Terminated Territory” means, on a Product Class-by-Product Class basis, those countries with respect to which this Agreement has been terminated for such Product Class in accordance with Article 14 (Term and Termination). The Terminated Territory will be worldwide if this Agreement is terminated in its entirety with respect to a Product Class.
1.1.293
Territory” means, collectively, the Profit-Share Territory and the Biogen Territory.

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1.1.294
Third Party” means any Person other than Biogen, Sage or their respective Affiliates.
1.1.295
Third Party Action” has the meaning set forth in Section 13.5.3 (Defense and Post-Grant Proceedings).
1.1.296
Third Party Claims” has the meaning set forth in Section 12.1 (General Indemnification by Biogen).
1.1.297
Third Party Manufacturing Agreements” has the meaning set forth in Section 7.8.2 (Third Party Agreements).
1.1.298
Third Party Payments” has the meaning set forth in Section 8.3.2 (After Effective Date Executed In-License Agreements).
1.1.299
Trademark” means any trademark, trade name, service mark, service name, brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership, including the goodwill and activities associated with each of the foregoing.
1.1.300
Trademark Costs” means the fees and expenses paid to outside counsel and other Third Parties, in each case, in connection with the establishment and maintenance of rights for Trademarks, including costs of filing, registration, maintenance and renewal fees, actions to enforce or defend a Trademark and other Trademark proceedings, but expressly excluding all Sales and Marketing Costs.
1.1.301
TRD” means the Indication that is Treatment-Resistant Depression.
1.1.302
United States” means the United States and its territories, possessions and commonwealths.
1.1.303
United States Royalties” has the meaning set forth in Section ‎9.8.2 (United States Royalties).
1.1.304
Valid Claim” means (a) a claim of an issued, unexpired patent that has not been rejected, revoked or held to be invalid, unenforceable or unpatentable by a court or other authority of competent jurisdiction, from which decision no appeal can be further taken, and which claim has not been finally abandoned, disclaimed or admitted to be invalid, unenforceable or unpatentable, including through reissue or disclaimer or (b) a pending claim of an unissued, pending patent application that has been prosecuted in good faith and has not been pending for more than [**] and which claim has not been revoked, cancelled, withdrawn, held invalid or abandoned in the country of question, in which case it will cease to be considered a Valid Claim, unless the patent application issues and recites said claim and otherwise satisfies clause (a) of this definition.
1.1.305
VAT” means, within the European Union, such Tax as may be charged in accordance with (but subject to derogations from) Directive 2006/112/EC and, outside the European Union, value added Tax or any form of consumption Tax, as well as all other forms of Taxes charged on the supply of a good or a service, including but not limited to sales Tax and goods and services Tax.
1.1.306
VAT Restructuring” has the meaning set forth in Section 9.11.5.2 (VAT).

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1.1.307
WATERFALL Study” means a placebo-controlled Phase 3 Study evaluating a two-week course of zuranolone 50 mg in patients with MDD, with additional short-term follow-up.
1.1.308
Withholding Taxes” has the meaning set forth in Section 9.11.5.1 (General).
2.
GOVERNANCE
2.1
Alliance Manager. Promptly following the Effective Date, each Party will designate an individual to facilitate communication and coordination of the Parties’ activities under this Agreement relating to the Licensed Products (each, an “Alliance Manager”). For clarity, an Alliance Manager will not be a representative of its respective Party on any Committee, and will have no voting right on any Committee, unless otherwise agreed in writing by the Parties.
2.2
Joint Steering Committee.
2.2.1
Formation; Composition; Dissolution. Within [**] after the Effective Date, the Parties will establish a committee (the “Joint Steering Committee” or “JSC”) to provide strategic oversight of the Parties’ activities under this Agreement. Each Party will initially appoint [**] representatives to the JSC, with each representative having knowledge and expertise in the Development, Manufacture, performance of Medical Affairs with respect to and Commercialization of molecules and products similar to the Licensed Products, and having sufficient decision-making authority and seniority within the applicable Party to provide meaningful input and make decisions arising within the scope of the JSC’s responsibility. The JSC may change its size from time to time by agreement of the Parties, provided that the JSC will consist at all times of an equal number of representatives of each of Sage and Biogen. Each Party may replace its JSC representatives at any time upon written notice to the other Party. The JSC will be chaired by co-chairpersons designated by Sage and Biogen, respectively. The JSC co-chairpersons may invite non-members to participate in the discussions and meetings of the JSC, if necessary, provided that such participants have no voting authority at the meetings of the JSC and are bound under enforceable obligations of confidentiality and non-use no less protective of the Parties’ Confidential Information than those set forth in this Agreement. The JSC co-chairpersons’ responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achieved. The JSC will exist for so long as the JDC or JCC exists or there is at least one Licensed Product being Commercialized under this Agreement.
2.2.2
Specific Responsibilities of the JSC. The JSC will have the following responsibilities:
2.2.2.1
reviewing, discussing and determining whether to approve all annual and interim amendments to each Joint Development Plan and each corresponding Joint Development Budget for the Licensed 217 Products and the Licensed 324 Products (including the designation of Development Lead Party between the Parties for each of the activities thereunder, changes to the Major Development Activities, and the proposed allocation of responsibility between the Parties for each of the activities thereunder), as proposed by the JDC, including, in each case, to add to the applicable Joint Development Plan any Clinical Study or Indication, as described in Section 3.2 (Joint Development Plans) and Section 3.3 (Operational Responsibilities for Development; Additional Development);
2.2.2.2
determining whether any proposed Additional Indication Development would result in a Material Adverse Product Effect, as described in Section 3.3.2 (Additional Indications Development);

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2.2.2.3
reviewing, discussing and determining whether to approve each Joint Medical Affairs Plan and corresponding Joint Medical Affairs Budget for the Licensed 217 Products and the Licensed 324 Products and all annual and interim amendments thereto (including the designation of Medical Affairs Lead Party between the Parties for each of the activities thereunder, changes to the Major Medical Affairs Activities and the proposed allocation of responsibility between the Parties for each of the activities thereunder), as recommended by the Joint Medical Affairs Subcommittee, as described in Section 4.2 (Joint Medical Affairs Plan), as described in Section 4.2.2 (Amendments to Joint Medical Affairs Plans);
2.2.2.4
reviewing, discussing and determining whether to approve each Joint Commercialization Plan and the corresponding Joint Commercialization Budget for the Licensed 217 Products and the Licensed 324 Products and all annual and interim amendments thereto (including the designation of Commercialization Lead Party between the Parties for each of the activities thereunder, changes to the Major Commercialization Activities, and the proposed allocation of responsibility between the Parties for each of the activities thereunder), as recommended by the JCC, each as described in Section 5.2 (Joint Commercialization Plans), as such plans and amendments may be submitted to the JSC by the JCC, as described in Section 5.2.2 (Amendments to Joint Commercialization Plans);
2.2.2.5
reviewing, discussing and determining whether to approve each Distribution Plan for the Licensed 217 Products and the Licensed 324 Products, as such plans and amendments may be submitted to the JSC by the JCC, as described in Section 5.7.3 (Distribution in the Profit-Share Territory);
2.2.2.6
approving FTE rates included in clause (b) of Section 1.1.101 (FTE Rate) and approving [**];
2.2.2.7
reviewing, discussing and determining whether to approve the Pricing Matters for Licensed Products for the Profit-Share Territory submitted to the JSC by the JCC; [**];
2.2.2.8
reviewing, discussing and determining whether to approve the rate to be applied to determine Detail Costs that are included in the Joint Commercialization Costs for Licensed Products in the Profit-Share Territory, as described in Section 5.9 (Detail Costs; Authority over Sales Forces);
2.2.2.9
reviewing and discussing [**];
2.2.2.10
reviewing, discussing and determining whether to approve the Branding Strategy recommended by the JCC for each Licensed Product in the Profit-Share Territory, including the selection and use of all LP U.S. Trademarks, as described in Section 5.11.1 (Branding);
2.2.2.11
reviewing, discussing and determining whether to approve the packaging and labeling recommended by the applicable Regulatory Lead Party for each Licensed Product in the Profit-Share Territory, as described in Section 5.11.3 (Licensed Product Packaging);
2.2.2.12
reviewing, discussing and determining whether to approve the LP U.S. TM Strategy recommended by the JCC, as described in Section 5.11.4.1 (Profit-Share Territory);
2.2.2.13
developing the process by which the Parties will approve the Promotional Materials relating to each Licensed Product to be used in the Profit-Share Territory such that, unless

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the Parties otherwise agree, appropriate representatives of each Party will approve such Promotional Materials, and reviewing, discussing and determining whether to approve the key messaging to be included in such Promotional Materials (the “Promotional Materials Rules”), as described in Section 5.11.2 (Promotional Materials);
2.2.2.14
in addition to those responsibilities set forth in Section 2.2.2.6 (with respect to changes to Pricing Matters) and Section 2.2.2.10 (with respect to changes to Branding Strategy), reviewing, discussing and determining whether to approve decisions for and any changes to the Major Commercialization Activities;
2.2.2.15
discussing and determining whether to approve the Regulatory Strategy for the Licensed Products in the Profit-Share Territory, as described in Section 6.1 (Regulatory Lead Responsibilities);
2.2.2.16
serving as a forum for the Parties to exchange information relating to NDAs for the Licensed Products in the Territory, as described in Section 6.6 (Submissions);
2.2.2.17
discussing and determining whether to conduct a recall of a Licensed Product in the Profit-Share Territory, as described in Section 6.9 (Recalls, Market Withdrawals or Corrective Actions);
2.2.2.18
determining whether [**];
2.2.2.19
reviewing, discussing and determining whether to approve [**];
2.2.2.20
reviewing, discussing and determining whether to approve the engagement of a Second Source by Sage during the period for which Sage is the Manufacturing Lead Party and reviewing and discussing the engagement of a Second Source by Biogen, in each case, as described in Section 7.6 (Second Source and Biogen Manufacturing Sites);
2.2.2.21
reviewing, discussing and determining whether to approve the execution by either Party of any agreement for New Technology for the Profit-Share Territory (including the terms thereof), as described in Section 8.3.2 Licensed Product (After Effective Date Executed In-License Agreements);
2.2.2.22
reviewing, discussing and determining whether to approve a Publications Plan for each Product Class, and any additions or other amendments to an existing Publications Plan, as described in