EX-10.1 2 wve-ex101_1072.htm EX-10.1 wve-ex101_1072.htm

 

Exhibit 10.1

Execution Copy

 

Collaboration And License Agreement

by and among

Wave Life Sciences USA, Inc.,

Wave Life Sciences UK Limited

and

Takeda Pharmaceutical Company Limited

February 19, 2018

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

TABLE OF CONTENTS

 

 

 

 

Page

 

 

 

 

 

1.

 

DEFINITIONS

 

1

2.

 

COLLABORATION OVERVIEW

 

27

 

 

2.1.

 

Collaboration Overview

 

27

 

 

2.2.

 

[***].

 

27

3.

 

GRANT AND EXERCISE OF OPTIONS

 

28

 

 

3.1.

 

Grant of Options

 

28

 

 

3.2.

 

HTT Target

 

28

 

 

3.3.

 

Information Sharing

 

28

 

 

3.4.

 

Exercise of an Option

 

29

4.

 

SELECTION OF CATEGORY 2 TARGETS

 

33

 

 

4.1.

 

Proposed Category 2 Targets

 

32

 

 

4.2.

 

Dispute Process

 

32

 

 

4.3.

 

Licensed Category 2 Target Replacement

 

33

 

 

4.4.

 

Total Targets

 

33

5.

 

DEVELOPMENT

 

34

 

 

5.1.

 

Development of Category 1 Targets

 

34

 

 

5.2.

 

Research Activities for Licensed Category 2 Targets

 

37

 

 

5.3.

 

Development Activities for Licensed Category 2 Targets

 

40

 

 

5.4.

 

Development Lead Responsibilities

 

42

 

 

5.5.

 

Scientific Records

 

43

 

 

5.6.

 

Third Parties

 

43

 

 

5.7.

 

Technical Failure

 

43

 

 

5.8.

 

[***].

 

44

6.

 

REGULATORY MATTERS

 

44

 

 

6.1.

 

Regulatory Lead Responsibilities

 

44

 

 

6.2.

 

Assignment of Regulatory Materials

 

44

 

 

6.3.

 

Drug Master Files

 

44

 

 

6.4.

 

Communications with Regulatory Authorities

 

45

 

 

6.5.

 

Regulatory Meetings

 

45

 

 

6.6.

 

Submissions

 

45

 

 

6.7.

 

Right of Reference

 

45

 

 

6.8.

 

Pharmacovigilance for Collaboration Targets

 

46

 

 

6.9.

 

Costs of Regulatory Affairs

 

46

7.

 

MANUFACTURING

 

47

 

 

7.1.

 

Manufacturing Lead Responsibilities

 

47

 

 

7.2.

 

Supply to Takeda

 

47

 

 

7.3.

 

Transition to Takeda

 

47

 

 

7.4.

 

Costs and Expenses of Manufacturing

 

47

 

 

7.5.

 

Second Source

 

48

 

 

7.6.

 

Shortages

 

48

 

 

7.7.

 

Manufacturing and Supply Agreements

 

48

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

i


 

 

 

7.8.

 

Supply Failure

 

48

 

 

7.9.

 

Technology Transfer; Transition of Third Party Agreements to Takeda

 

49

8.

 

COMMERCIALIZATION

 

50

 

 

8.1.

 

Commercialization of Licensed Category 1 Products

 

50

 

 

8.2.

 

Commercialization of Licensed Category 2 Products

 

52

 

 

8.3.

 

Commercialization Expenses

 

52

 

 

8.4.

 

Commercialization Diligence Obligations

 

53

 

 

8.5.

 

Advertising and Promotional Materials.

 

53

 

 

8.6.

 

Recalls, Market Withdrawals, or Corrective Actions

 

54

9.

 

GOVERNANCE

 

54

 

 

9.1.

 

Alliance Manager

 

54

 

 

9.2.

 

Joint Steering Committee

 

54

 

 

9.3.

 

Licensed Category 1 Joint Team

 

59

 

 

9.4.

 

Category 2 Research Committee

 

60

 

 

9.5.

 

Subcommittee Meetings

 

61

 

 

9.6.

 

Decision‑Making

 

62

 

 

9.7.

 

Resolution of Committee Disputes

 

62

 

 

9.8.

 

Discontinuation of Participation on the JSC or any Subcommittee

 

64

10.

 

LICENSES

 

64

 

 

10.1.

 

Category 1 Development Program

 

64

 

 

10.2.

 

Licensed Category 1 Targets

 

65

 

 

10.3.

 

Licensed Category 2 Targets

 

66

 

 

10.4.

 

Sublicensing Terms

 

67

 

 

10.5.

 

In‑Licenses

 

68

 

 

10.6.

 

Bankruptcy

 

71

 

 

10.7.

 

No Other Rights

 

71

11.

 

PAYMENTS

 

71

 

 

11.1.

 

Upfront Payment

 

71

 

 

11.2.

 

Equity Investment

 

72

 

 

11.3.

 

Category 1 Targets

 

72

 

 

11.4.

 

Licensed Category 2 Targets

 

75

 

 

11.5.

 

Other Amounts Payable

 

80

 

 

11.6.

 

Payment Terms

 

81

 

 

11.7.

 

Mutual Convenience

 

84

12.

 

CONFIDENTIALITY AND PUBLICATION

 

84

 

 

12.1.

 

Nondisclosure and Non‑Use Obligations

 

84

 

 

12.2.

 

Press Release

 

87

 

 

12.3.

 

Firewall Procedures

 

88

13.

 

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

88

 

 

13.1.

 

Mutual Representations and Warranties as of the Execution Date

 

88

 

 

13.2.

 

Representations and Warranties by Wave

 

89

 

 

13.3.

 

Additional Wave Representations and Warranties as of the Option Notice Date

 

91

 

 

13.4.

 

Warranty Disclaimer

 

94

 

 

13.5.

 

Certain Covenants

 

94

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

ii


 

 

 

13.6.

 

Exclusivity; Competing Programs

 

96

14.

 

INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE

 

98

 

 

14.1.

 

General Indemnification by Takeda

 

98

 

 

14.2.

 

General Indemnification by Wave

 

98

 

 

14.3.

 

Category 1 Third Party Losses

 

99

 

 

14.4.

 

Indemnification Procedure

 

99

 

 

14.5.

 

Limitation of Liability

 

100

 

 

14.6.

 

Insurance

 

100

 

 

14.7.

 

Disclaimer

 

101

15.

 

INTELLECTUAL PROPERTY

 

101

 

 

15.1.

 

Inventorship

 

101

 

 

15.2.

 

Ownership

 

101

 

 

15.3.

 

Disclosure of Inventions

 

102

 

 

15.4.

 

Prosecution and Maintenance of Patents

 

102

 

 

15.5.

 

Third Party Infringement and Defense

 

105

 

 

15.6.

 

Patent Extensions

 

108

 

 

15.7.

 

Patent Listings

 

108

 

 

15.8.

 

Third Party Rights

 

108

 

 

15.9.

 

Common Interest

 

108

16.

 

TERM AND TERMINATION

 

109

 

 

16.1.

 

Term

 

109

 

 

16.2.

 

Termination for Convenience

 

109

 

 

16.3.

 

Termination for Patent Challenge

 

109

 

 

16.4.

 

Termination for Cause.

 

110

 

 

16.5.

 

Termination for Insolvency

 

111

 

 

16.6.

 

Effects of Termination by Wave for Cause or Takeda for Convenience

 

111

 

 

16.7.

 

Effects of Termination by Takeda for Cause

 

114

 

 

16.8.

 

Alternative in Lieu of Termination

 

115

 

 

16.9.

 

Survival

 

115

17.

 

MISCELLANEOUS

 

116

 

 

17.1.

 

Assignment

 

116

 

 

17.2.

 

Governing Law

 

116

 

 

17.3.

 

Dispute Resolution

 

116

 

 

17.4.

 

Entire Agreement; Amendments

 

118

 

 

17.5.

 

Severability

 

118

 

 

17.6.

 

Headings

 

118

 

 

17.7.

 

Waiver of Rule of Construction

 

119

 

 

17.8.

 

Interpretation

 

119

 

 

17.9.

 

No Implied Waivers; Rights Cumulative

 

119

 

 

17.10.

 

Notices

 

119

 

 

17.11.

 

Compliance with Export Regulations

 

120

 

 

17.12.

 

Force Majeure

 

120

 

 

17.13.

 

Independent Parties

 

120

 

 

17.14.

 

Counterparts

 

121

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

iii


 

 

 

17.15.

 

Further Assurances

 

121

 

 

17.16.

 

Performance by Affiliates

 

121

 

 

17.17.

 

Binding Effect; No Third Party Beneficiaries

 

121

 

 

17.18.

 

HSR Act

 

121

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

iv


 

EXHIBITS AND SCHEDULES

SCHEDULE 1.28 – Candidate Category 1 Targets

SCHEDULE 1.80 – Data Package

SCHEDULE 1.95 – Other Eligible Development Expenses

SCHEDULE 1.156 – Lead Initial HTT Compounds

SCHEDULE 1.216– Form of Option Exercise Notice

SCHEDULE 1.242 – POM Criteria

SCHEDULE 1.283 – Takeda Patents

SCHEDULE 4.1 – Form of Proposed Category 2 Target Nomination Notice

SCHEDULE 5.1.2(a) – HTT Candidate Category 1 Development Plan

SCHEDULE 5.1.2(b) – C9orf72 Candidate Category 1 Development Plan

SCHEDULE 5.1.3 – Form of Licensed Category 1 Development Budget

SCHEDULE 7.7(a) – Clinical Supply Term Sheet

SCHEDULE 7.7(b) – Commercial Supply Term Sheet

SCHEDULE 8.1.2– Form of Licensed Category 1 Commercialization Budget

SCHEDULE 10.4.1 – Takeda Sublicensing Rights

SCHEDULE 11.3.4 – Licensed Category 1 Profit & Loss Share

SCHEDULE 12.2.1(a) – Wave Press Release

SCHEDULE 12.2.1(b) – Takeda Press Release

SCHEDULE 13.2.1 – Wave Patents and In‑Licenses

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

v


 

 

COLLABORATION AND LICENSE AGREEMENT

THIS COLLABORATION AND LICENSE AGREEMENT (this “Agreement”), entered into as of February 19, 2018 (the “Execution Date”), is entered into by and among Wave Life Sciences USA, Inc., a corporation organized and existing under the Laws of the State of Delaware (“Wave US”), Wave Life Sciences UK Limited, a private limited company incorporated under the laws of England and Wales (“Wave UK”, and together with Wave US, “Wave”), and Takeda Pharmaceutical Company Limited, a corporation organized and existing under the Laws of the Japan (“Takeda”).  Wave and Takeda are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”

RECITALS:

WHEREAS, Wave is a genetic medicine company focused on advancing Oligonucleotides that precisely target the underlying causes of rare diseases;

WHEREAS, Takeda possesses expertise in developing and commercializing therapeutics;

WHEREAS, Wave intends, through this Agreement, to enter into a collaboration with Takeda in which Takeda will be Wave’s partner in the field of CNS‑related therapeutics, on the terms and conditions set forth herein; and

WHEREAS, Wave and Takeda desire to collaborate to research, develop, and commercialize stereopure Oligonucleotide therapeutics directed toward various CNS indications, and Wave and Takeda would assume further development, manufacturing, and commercialization related to the Collaboration Compounds, the Collaboration Products, and Companion Diagnostics directed to a Collaboration Target, discovered in the collaboration as further described in this Agreement.

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

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

AAA” has the meaning set forth in Section 17.3.8.1 (Expedited Arbitration).

1.2

Accounting Standards” means GAAP, with respect to Wave and IFRS, with respect to Takeda, and GAAP or IFRS, as applicable, with respect to any Related Party, in each case, as generally and consistently applied throughout the Party’s organization.  Each Party will promptly notify the other in the event that it changes the Accounting Standards pursuant to which its records are maintained; provided, however, that each Party may only use internationally recognized accounting principles (e.g., IFRS, GAAP, etc.).

1.3

Acquirer” means, collectively, with respect to the acquisition of a Party by a Third Party, a Third Party referenced in the definition of Change of Control and such Third Party’s Affiliates, other than the applicable Party in the definition of Change of Control and such Party’s Affiliates (determined as of immediately prior to the closing of such Change of Control).

1.4

[***].

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

 

1.5

[***].

1.6

Affiliate” means, with respect to a Person, any other Person that controls, is controlled by, or is under common control with such Person.  For purposes of this Agreement, a Person will be deemed to control another Person if it owns or controls, directly or indirectly, more than fifty percent (50%) 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 the management and policies of such other Person.  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.

1.7

Agreement” has the meaning set forth in the Preamble.

1.8

Alliance Manager” has the meaning set forth in Section 9.1 (Alliance Manager).

1.9

Allowable Overruns” means, (a) on a Licensed Category 1 Target‑by‑Licensed Category 1 Target basis, (i) any amount that is [***]; or (b) on a Licensed Category 2 Target-by-Licensed Category 2 Target basis, (i) any amount that is [***].  

1.10

Analytical Methods” will have the meaning set forth in the applicable Supply Agreement.  

1.11

ANDA” means an Abbreviated New Drug Application and all amendments and supplements thereto filed with the FDA under Section 505(j) of the FD&C Act (21 USC 355(j)), or the equivalent application filed with any equivalent Regulatory Authority outside the U.S. (including any supra‑national agency), including pursuant to Article 10.1 of Directive 2001/83/EC of the European Parliament and Council of 6 November 2001, or any enabling legislation thereof.

1.12

Annual Research Fee” has the meaning set forth in Section 11.4.1.1 (Initial Licensed Category 2 Research Term).

1.13

Antitrust Laws” 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.

1.14

Audited Party” has the meaning set forth in Section 11.6.3 (Records and Audits).

1.15

Auditing Party” has the meaning set forth in Section 11.6.3 (Records and Audits).

1.16

Auditor” has the meaning set forth in Section 11.6.3 (Records and Audits).

1.17

Bankrupt Party” has the meaning set forth in Section 10.6 (Bankruptcy).

1.18

Bankruptcy Code” has the meaning set forth in Section 16.5 (Termination for Insolvency).

1.19

Branding Strategy” has the meaning set forth in Section 8.5.1 (Branding).

1.20

Brief” has the meaning set forth in Section 17.3.8.2 (Expedited Arbitration).

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

2


 

 

1.21

Business Day” means a calendar day other than a Saturday, Sunday, or a bank or other public holiday in Massachusetts or New York in the United States or in Tokyo in Japan.

1.22

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.

1.23

Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.

1.24

Candidate Category 1 Compound” means, for each Candidate Category 1 Target, any Oligonucleotide directed to such Candidate Category 1 Target [***].

1.25

Candidate Category 1 Development Plan” has the meaning set forth in Section 5.1.2 (Candidate Category 1 Development Plan).

1.26

Candidate Category 1 Development Term” means the time period commencing on the Effective Date and ending on the date on which the Candidate Category 1 Development Term has terminated for each Candidate Category 1 Target.  The “Candidate Category 1 Development Term” as it applies to a specific Candidate Category 1 Target [***].

1.27

Candidate Category 1 Products” any pharmaceutical product, including all forms, presentations, strengths, doses and formulations thereof (including any method of delivery), containing or delivering a Candidate Category 1 Compound alone or as a Combination Product.

1.28

Candidate Category 1 Target” means any Target set forth on Schedule 1.28 for which Candidate Category 1 Compounds or Candidate Category 1 Products are being Developed pursuant to an applicable Candidate Category 1 Development Plan.

1.29

Candidate Category 1 Target Development Critical Matters” means the approval of (a) any [***].

1.30

Candidate In‑Licenses” means any agreement entered into [***].

1.31

Candidate Target Know‑How” has the meaning set forth in Section 13.3.2 (Existing Wave In‑License).

1.32

Candidate Target Patents” has the meaning set forth in Section 13.3.1 (Wave Technology).

1.33

Candidate Target Technology” has the meaning set forth in Section 13.3.2 (Existing Wave In‑Licenses).

1.34

Category 1 Compounds” means any Candidate Category 1 Compound or Licensed Category 1 Compound.

1.35

Category 1 Development Milestone Event” has the meaning set forth in Section 11.3.3 (Category 1 Targets Development Milestone Payments).

1.36

Category 1 Development Milestone Payment” has the meaning set forth in Section 11.3.3 (Category 1 Targets Development Milestone Payments).

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

3


 

 

1.37

Category 1 Development Plan” means any Candidate Category 1 Development Plan or Licensed Category 1 Development Plan.

1.38

Category 1 Development Program” has the meaning set forth in Section 5.1.1 (Category 1 Development Overview).

1.39

Category 1 Development Term” means the Candidate Category 1 Development Term and the Licensed Category 1 Development Term.

1.40

Category 1 Development Report” has the meaning set forth in Section 5.1.6 (Category 1 Development Reports).

1.41

Category 1 Products” means any Candidate Category 1 Product or Licensed Category 1 Product.

1.42

Category 1 Targets” means any Candidate Category 1 Target or Licensed Category 1 Target.

1.43

Category 2 Development Milestone Event” has the meaning set forth in Section 11.4.2 (Licensed Category 2 Products Development Milestone Payments).

1.44

Category 2 Development Milestone Payment” has the meaning set forth in Section 11.4.2 (Licensed Category 2 Products Development Milestone Payments).

1.45

Category 2 Research Committee” has the meaning set forth in Section 9.4.1 (Purpose; Formation; Dissolution).

1.46

Category 2 Royalty” has the meaning set forth in Section 11.4.4 (Category 2 Royalties).

1.47

Category 2 Sales Milestone Event” has the meaning set forth in Section 11.4.3 (Licensed Category 2 Targets Category 2 Sales Milestone Payments).

1.48

Category 2 Sales Milestone Payment” has the meaning set forth in Section 11.4.3 (Licensed Category 2 Targets Sales Milestone Payments).

1.49

Category 2 Target Specific Extension” has the meaning set forth in Section 5.2.2 (Licensed Category 2 Research Term).

1.50

cGMP” means current good manufacturing practices as required by the FDA under provisions of 21 C.F.R. Parts 210 and 211 and all applicable FDA rules, regulations, orders and guidances, and the requirements with respect to current good manufacturing practices prescribed by the European Community under provisions of “The Rules Governing Medicinal Products in the European Community, Volume 4, Good Manufacturing Practices, Annex 13, Manufacture of Investigational Medicinal Products, July 2003,” or as otherwise required by applicable Laws.

1.51

Change of Control” means, with respect to a Party, (a) a merger, consolidation, recapitalization, or reorganization 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 at least fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger, consolidation, recapitalization, or reorganization, (b) a transaction or series of

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

4


 

 

related transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of fifty percent (50%) or more 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.  Notwithstanding the foregoing, any transaction or series of transactions effected for the purpose of financing the operations of the applicable Party or changing the form or jurisdiction of organization of such Party (such as an initial public offering or other offering of equity securities to non‑strategic investors or corporate reorganization) will not be deemed a “Change of Control” for purposes of this Agreement.

1.52

Classification Approval Matters” means whether to (a) [***].

1.53

Clinical Study” means a Phase 1 Study, Phase 2 Study, Phase 3 Study, POM Study, Registrational Study, study performed as part of any Post‑Marketing Commitment, or other study (including a non‑interventional study) in humans to obtain information regarding a product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging, or efficacy of such product.

1.54

Clinical Supply Agreement” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements).

1.55

Clinical Supply Term Sheet” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements).

1.56

CMC” means Chemistry and Manufacturing Controls, which includes (a) Manufacturing process development records for a Collaboration Compound, Collaboration Product, or Combination Product directed to any Collaboration Target, (b) all chemistry, Manufacturing, and control procedures necessary for Manufacture of a Collaboration Compound, Collaboration Product, or Combination Product directed to any Collaboration Target, and (c) sourcing and testing of all raw materials and components used in the Manufacture of a Collaboration Compound, Collaboration Product, or Combination Product directed to any Collaboration Target.

1.57

CNS” means central nervous system.

1.58

Collaboration Compound” means any Candidate Category 1 Compound, Licensed Category 1 Compound, or Licensed Category 2 Compound.

1.59

Collaboration In‑License” has the meaning set forth in Section 10.5.4 (Collaboration In‑Licenses).

1.60

Collaboration Product” means any Category 1 Products or Licensed Category 2 Product.

1.61

Collaboration Target” means any Candidate Category 1 Target, Licensed Category 1 Target, or Licensed Category 2 Target.

1.62

Combination Product” means a Licensed Product that is (a) sold in the form of a combination that contains or comprises one or more additional therapeutically active pharmaceutical agents (whether coformulated or copackaged or otherwise sold for a single price) other than a Licensed Compound in the Licensed Product, or (b) sold for a single price together with any (i) delivery device or component therefor, (ii) Companion Diagnostic related to any Licensed Category 2

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

5


 

 

Product, process, service, or therapy, or (iii) product, process, service, or therapy other than the Licensed Product (each, (i) – (iii), an “Other Component”); or (c) defined as a “combination product” by the FDA pursuant to 21 C.F.R. §3.2(e) or its foreign equivalent.  For clarity, a Companion Diagnostic related to a Licensed Category 1 Product will not be an “Other Component” for purposes of this Agreement.

1.63

Commercial Supply Agreement” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements).

1.64

Commercial Supply Term Sheet” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements).

1.65

Commercialization or Commercialize” means any and all activities directed to transporting, storing, marketing, detailing, Promotion, distributing, importing, exporting, using, offering to sell or selling a product, including (a) strategic marketing, sales force detailing, sales force training and allocation, advertising, planning, messaging, branding; (b) all customer support, patient services, case management, Distribution Matters, invoicing and sales activities; (c) design and conduct of Post‑Marketing Commitments or other post‑approval Clinical Studies not required to obtain, support, or maintain Regulatory Approval (other than Pricing Approval) for the applicable product; and (d) activities directed to obtaining Pricing Approvals, negotiating discounts and obtaining product access, as applicable.  For the avoidance of doubt, “Commercialization” includes all Wave Commercialization Activities.

1.66

Commercialization Plans” means, collectively, each Licensed Category 1 Commercialization Plan and Licensed Category 1 Commercialization Budget included therein, and each Licensed Category 2 Commercialization Plan.

1.67

Commercially Reasonable Efforts” means [***].

1.68

Companion Diagnostic” means any product or service that: (a) identifies a person having a disease or condition or a molecular genotype or phenotype that predisposes a person to such disease or condition, in each case, for which a Collaboration Compound or Collaboration Product could be used to treat or prevent such disease or condition; (b) defines the prognosis or monitors the progress of a disease or condition in a person for which a Collaboration Compound or Collaboration Product could be used to treat or prevent such disease or condition; (c) is used to select a therapeutic or prophylactic regimen, wherein at least one (1) potential such therapeutic or prophylactic regimen involves a Collaboration Compound or Collaboration Product, and where the selected regimen is determined to likely be effective or to be safe for a person, based on the use of such product or service; or (d) is used to confirm a biological activity or to optimize dosing or the scheduled administration of a Collaboration Compound or Collaboration Product.

1.69

Competitive Infringement” means, on a Collaboration Product‑by‑Collaboration Product and country‑by‑country basis, where the making, using, selling, offering for sale, importing, or exporting by any Third Party (other than any Sublicensee or authorized purchaser or other transferee of such Collaboration Product), of any pharmaceutical product in a country Covered by a Valid Claim of a Wave Patent or Takeda Patent in such country, including any application, submission, or notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) or a certification that is, or is comparable to, a Paragraph IV Patent Certification by a Third Party filing an ANDA, or other similar patent certification by a Third Party, in each case, that comprises, incorporates, or otherwise competes with any Collaboration Product.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

6


 

 

1.70

Completion of the IND‑Enabling Study(ies)” means the date of receipt of the [***].

1.71

Completion of the POM Study” means, with respect to a Candidate Category 1 Product, the date of  [***] from the applicable POM Study per the applicable protocol for such Candidate Category 1 Product and in a [***].

1.72

Confidential Information” means any and all confidential or proprietary information and data and all other scientific, pre‑clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data that is or has been provided by one Party to the other Party in connection with this Agreement, whether communicated in writing or orally or by any other method.

1.73

Consolidated Report” has the meaning set forth in Paragraph 2.2 of Schedule 11.3.4 (Licensed Category 1 Profit & Loss Share).

1.74

Control” means, with respect to any Materials, Regulatory Materials, or intellectual property rights, including any Patents or Know‑How, the possession (whether by ownership, license, or sublicense, other than by a license, sublicense, or other right granted pursuant to this Agreement (but not assignment)) by a Party of the ability to assign, transfer, or grant to the other Party the licenses, sublicenses, or rights to access and use such Materials, Regulatory Materials, or intellectual property rights as provided for in this Agreement, without violating the terms of any agreement or other arrangement with any Third Party in existence as of the time such Party would be required hereunder to grant such license, sublicense, or rights of access and use.  Notwithstanding anything in this Agreement to the contrary, a Party will be deemed not to Control any Materials, Regulatory Materials, or intellectual property rights that are owned or in‑licensed by an Acquirer, [***].  

1.75

Conversion Notice” has the meaning set forth in Section 3.4.2.1 (Conversion Notice).

1.76

Cover,” “Covering,” or “Covered” means, with respect to a particular subject matter at issue and the relevant Patent, that, but for a license granted to a Person under a claim included in such Patent or ownership of such Patent, the Exploitation by such Person of the subject matter at issue, would infringe such claim or, in the case of a Patent that is a patent application, would infringe a claim in such patent application if it were to issue as a patent.

1.77

Critical Matter” means the (a) [***], (b) determination of any [***], (c) determination of any [***], (d) determination as to whether any [***], (e) determination of whether a [***], (f) determination by [***], (g) any change in scope or other alteration to [***], or (h) changes to the scope of the [***].

1.78

CRO” means a contract research organization.

1.79

Data Lock” means, with respect to a Clinical Study being conducted by or on behalf of a Party, the locking by or on behalf of such Party of the database that contains the data collected from such Clinical Study in a manner consistent with industry standards to enable data analysis and reporting.

1.80

Data Package” means, on a Candidate Category 1 Target‑by‑Candidate Category 1 Target basis, the information set forth on Schedule 1.80 for all Candidate Category 1 Compounds, Candidate Category 1 Products, and Companion Diagnostics directed to such Candidate Category 1 Target, [***].

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

7


 

 

1.81

Develop” and “Development” means any and all activities related to the design, discovery, generation, identification, profiling, characterization, production, process development, testing method development, pre‑clinical development or non‑clinical or pre‑clinical studies, clinical drug development activities conducted before or after obtaining Regulatory Approval 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 or expanding Regulatory Approval (other than Pricing Approval), including all activities related to pharmacokinetic profiling, design and conduct of Clinical Studies (but excluding Post‑Marketing Commitments), research or development of Companion Diagnostics regulatory affairs, statistical analysis, report writing, and regulatory filing creation and submission (including the services of outside advisors and consultants in connection therewith).  

1.82

Development Expenses” means, with respect to a Licensed Category 1 Target, all costs and expenses incurred directly in connection with the performance of any Development activities for Licensed Category 1 Compounds, Licensed Category 1 Products, or Companion Diagnostics directed to such Licensed Category 1 Target, in each case, in accordance with the applicable Licensed Category 1 Development Plans, Licensed Category 1 Development Budgets, or Licensed Category 1 Transition Plans, [***] with respect to Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to such Licensed Category 1 Target, and costs related to preparing and filing for Regulatory Approval or submissions to Regulatory Authorities (including associated filing fees, translation expenses, and legal and other professional services fees), [***].  In addition, Development Expenses will include all Third Party Payments made by a contracting Party under a Collaboration In‑License related to Licensed Category 1 Compounds, Licensed Category 1 Products, or Companion Diagnostics directed to any Licensed Category 1 Target during the Term to the extent not treated as Other Operating Income/Expense.  Development Expenses will be recognized in accordance with applicable Accounting Standards.

1.83

Development Lead” means, [***], (a) Wave for (i) all Category 1 Compounds, Category 1 Products, and Companion Diagnostics directed to each Category 1 Target, and (ii) during the applicable Licensed Category 2 Research Term for a Licensed Category 2 Target, all Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target, and (b) Takeda after the Licensed Category 2 Research Term for all Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to each Licensed Category 2 Target.

1.84

Development Milestone Event” has the meaning set forth in Section 11.4.2 (Licensed Category 2 Products Development Milestone Payments).

1.85

Development Milestone Payment” has the meaning set forth in Section 11.4.2 (Licensed Category 2 Products Development Milestone Payments).

1.86

Development Plans” means collectively all (a) Candidate Category 1 Development Plans, (b) Licensed Category 1 Development Plans, (c) Licensed Category 2 Research Plans, and (d) Licensed Category 2 Development Plans.

1.87

Disclosure Letter” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date).

1.88

Disputes” has the meaning set forth in Section 17.3.1 (Disputes).

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

8


 

 

1.89

Distribution Costs” means the [***].  Distribution expenses should be recognized in accordance with applicable Accounting Standards.  

1.90

Distribution Matters” means all issues and decisions regarding the distribution of a Licensed Product, including decisions as to whether and with which wholesalers and distributors to contract, and the terms of contracts with such wholesalers and distributors.

1.91

DOJ” means the U.S. Department of Justice.

1.92

Dollars” or “$” means the legal tender of the United States of America.

1.93

Effective Date” has the meaning set forth in Section 17.18.4 (Effective Date).

1.94

Eligible Commercialization Expenses” means the [***],

in each case, to the extent such costs are included in the [***].

Eligible Commercialization Expenses specifically exclude (i) the cost of activities that [***], and (ii) any costs or expenses of a Party or its Affiliates to the extent [***].

If any cost or expense is specifically identifiable or reasonably allocable to more than one cost category set forth above in clause (a) through (f), then such cost or expense will only be counted as an Eligible Commercialization Expense with respect to one such category.  [***].

For clarity, Eligible Commercialization Expenses will be recognized in accordance with applicable Accounting Standards.  

1.95

Eligible Development Expenses” means, on a Licensed Category 1 Target‑by‑Licensed Category 1 Target basis, the Development Expenses for such Licensed Category 1 Target [***].  Eligible Development Expenses will also include any [***].  Eligible Development Expenses specifically exclude any costs or expenses of a Party or its Affiliates to the extent [***].  No expense included as an Eligible Development Expense will also be included as an Eligible Commercialization Expense.  

1.96

EMA” means the European Medicines Agency and any successor Governmental Authority having substantially the same function.

1.97

Equity Agreements” means that certain (a) Share Purchase Agreement entered into by Takeda and Wave Singapore, on or about the date hereof (the “Share Purchase Agreement”), and (b) Investor Agreement entered into by Takeda and Wave Singapore, on or about the date hereof, in each case, as may be amended or restated from time to time.  

1.98

EU” means the European Union, as its membership may be constituted from time to time, and any successor thereto.

1.99

Execution Date” has the meaning set forth in the preamble.

1.100

Executive Officer” means, for Wave, its Chief Executive Officer, and for Takeda, its Chief Medical and Scientific Officer or another senior executive officer or their respective designee with appropriate responsibilities, seniority, and decision‑making authority; provided that any of

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

9


 

 

the foregoing individuals may designate the Chief Financial Officer as his/her designee for financial related matters.  In the event that the position of any of the Executive Officers identified in this Section 1.100 (Executive Officer) no longer exists due to a Change of Control, corporate reorganization, corporate restructuring, or the like that results in the elimination of the identified position, then the applicable Party will replace the applicable Executive Officer with another executive officer with responsibilities and seniority comparable to the eliminated Executive Officer.

1.101

Existing Takeda In‑License” means any agreements entered into by Takeda or an Affiliate with a Third Party prior to the Effective Date, including any amendments or restatements thereto entered into during the Term in accordance with Section 10.5 (In‑Licenses), pursuant to which Takeda or any of its Affiliates Controls any Takeda Technology, but excluding any Collaboration In‑License to which Takeda or its Affiliates is a party.

1.102

Existing Wave In‑License” means any agreements entered into by Wave or an Affiliate with a Third Party prior to the Effective Date, including any amendments or restatements thereto entered into during the Term in accordance with Section 10.5 (In‑Licenses), pursuant to which Wave or any of its Affiliates Controls any Wave Technology, but excluding any Candidate In‑License and any Collaboration In‑License to which Wave or its Affiliates is a party.

1.103

Expedited Arbitration” has the meaning set forth in Section 17.3.8 (Expedited Arbitration).

1.104

Expedited Dispute” has the meaning set forth in Section 17.3.8 (Expedited Arbitration).

1.105

Expert” means [***].

1.106

Exploit” or “Exploitation” means to make, have made, import, have imported, export, have exported, distribute, have distributed, use, have used, sell, have sold, offer for sale, or have offered for sale, including to research, Develop, Manufacture, Commercialize, register, modify, enhance, improve, or otherwise dispose of.

1.107

Ex‑U.S. Licensed Category 1 Commercialization Budget” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans).

1.108

Ex‑U.S. Licensed Category 1 Commercialization Plan” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans).

1.109

Ex-U.S. Territory Licensed Category 1 Profit & Loss Share” has the meaning set forth in Section 11.3.4 (Licensed Category 1 Profit & Loss Share for Commercialization Activities).

1.110

Ex-U.S. P&L” has the meaning set forth in Schedule 11.3.4 (Licensed Category 1 Profit & Loss Share for Commercialization Activities).

1.111

Ex-U.S. Territory” means the Territory other than the U.S.

1.112

FDA” means the United States Food and Drug Administration or any successor agency thereto.

1.113

FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended.

1.114

Field” means all fields of use.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

10


 

 

1.115

Finance Officers” has the meaning set forth in Section 11.3.2.2 (Eligible Development Expenses Report).

1.116

First Commercial Sale” means, [***].

1.117

FTC” means the U.S. Federal Trade Commission or any successor agency thereto.

1.118

FTE” means a full‑time person, or in the case of less than a full‑time person, a full‑time equivalent [***] of a Party or its Related Parties, based on [***] per year.  Overtime, and work on weekends, holidays, and the like [***].

1.119

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.

1.120

FTE Rate” means [***].  Notwithstanding the foregoing, for any Calendar Year during the Term that is less than a full year, the above referenced rate will be proportionately reduced to reflect such portion of FTEs for such full Calendar Year.

1.121

GAAP” means generally accepted accounting principles as practiced in the United States, as consistently applied.

1.122

GCP” means the ethical, scientific, and quality standards required by FDA for designing, conducting, recording, and reporting trials that involve the participation of human subjects, as set forth in FDA regulations in 21 C.F.R. Parts 11, 50, 54, 56, 312, 314, and 320 and all related FDA rules, regulations, orders, and guidances, and by the International Conference on Harmonization E6:  Good Clinical Practices Consolidated Guideline (the “ICH Guidelines”), or as otherwise required by applicable Laws.

1.123

Generic Product” means, with respect to a particular Licensed Category 2 Product and on a country‑by‑country basis, a generic pharmaceutical product that is marketed for sale by a Third Party (not licensed, supplied or otherwise permitted by a Party or any Related Parties) and that contains the same or substantially the same active ingredient as the Licensed Category 2 Compound in such Licensed Category 2 Product and is approved for use in such country by a Regulatory Authority (a) pursuant to an ANDA; or (b) through a regulatory pathway referencing clinical data submitted by a Party or its Related Parties to obtain Regulatory Approval for such Licensed Category 2 Product.

1.124

Gene Therapy” means a therapy that involves [***].

1.125

GLP” means good laboratory practice as required by the FDA under 21 C.F.R. Part 58 and all applicable FDA rules, regulations, orders, and guidances, and the requirements with respect to good laboratory practices prescribed by the European Community, the OECD (Organization for Economic Cooperation and Development Council) and the ICH Guidelines, or as otherwise required by applicable Laws.

1.126

Governmental Authority” means any applicable government authority, court, council, tribunal, arbitrator, agency, department, bureau, branch, office, 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 supranational body.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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1.127

Granting Party” means the Party that grants any licenses or other rights to the other Party under this Agreement.

1.128

Gross Profit” means, [***].

1.129

H‑W Suit Notice” has the meaning set forth in Section 15.5.2.2 (Hatch‑Waxman).

1.130

HSR Act” means the Hart‑Scott‑Rodino Antitrust Improvements Act of 1976, as amended, and the rules promulgated thereunder.

1.131

HSR Conditions” means the following conditions, collectively: (a) the applicable waiting period under the HSR Act will have expired or earlier been terminated; (b) no injunction (whether temporary, preliminary, or permanent) prohibiting consummation of the transaction contemplated by this Agreement or any material portion hereof will be in effect; and (c) no judicial or administrative proceeding opposing consummation of all or any part of this Agreement will be pending.

1.132

HSR Filing” means filings with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the subject matter of this Agreement, together with all required documentary attachments thereto.

1.133

HTT Compound” means [***].

1.134

HTT Product” means [***].

1.135

HTT Target” means [***].

1.136

ICH Guidelines” has the meaning set forth in Section 1.122 (GCP).

1.137

Improvements” means Wave Improvements and Takeda Improvements.

1.138

IND” means an Investigational New Drug application (as defined in the FD&C Act), clinical trial application or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority anywhere in the world in conformance with the requirement of such Regulatory Authority, and any amendments thereto.

1.139

IND‑Enabling Study” means a toxicology study, in species that satisfies applicable regulatory requirements, using applicable GLP that meets the standard necessary for submission as part of an IND with the applicable Regulatory Authority.

1.140

IND Safety Reporting” has the meaning set forth in Section 1.262 (Safety Concern).

1.141

Indemnified Party” has the meaning set forth in Section 14.4 (Indemnification Procedure).

1.142

Indemnifying Party” has the meaning set forth in Section 14.4 (Indemnification Procedure).

1.143

Indication” means a disease or pathological condition for which clinical results for such disease or condition and a separate NDA application or a supplement (or other addition) to an existing

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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NDA application is required for the purpose of obtaining Regulatory Approval (other than Pricing Approval) in a country; [***].

1.144

Initial Licensed Category 2 Research Term” means the time period commencing on the Effective Date and ending upon the earlier of (a) the fourth (4th) anniversary of the commencement of the Licensed Category 2 Research Term, or (b) the effective date of termination of this Agreement in its entirety or with respect to all Licensed Category 2 Targets.

1.145

Initiation” means, with respect to a Clinical Study of a product, the first dosing of the first human subject pursuant to the applicable protocol for such Clinical Study.

1.146

In‑Licenses” means, collectively, the Existing Wave In‑Licenses, the Existing Takeda In‑Licenses, and the Collaboration In‑Licenses.

1.147

Joint Collaboration IP” means, collectively, (a) any Know-How first developed or conceived jointly by employee(s), agent(s), or consultant(s) acting on behalf of Wave or its Affiliates, on the one hand, and employee(s), agent(s), or consultant(s) acting on behalf of Takeda or its Affiliates, on the other hand, in the performance of any activities under this Agreement, in each case that is not a Wave Improvement or Takeda Improvement as applicable, and (b) any Patents that claim such Know-How.

1.148

Joint Collaboration Patents” has the meaning set forth in 15.4.3.1 (Takeda First Right).

1.149

JRA Exception” has the meaning set forth in Section 15.1.2 (JRA Exception).

1.150

JSC” has the meaning set forth in Section 9.2.1 (Purpose; Formation; Dissolution).

1.151

Know‑How” means all commercial, technical, scientific and other know‑how and information, inventions, discoveries, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, preclinical, clinical, safety, manufacturing and quality control data and know‑how, including regulatory data, study designs and protocols), and Materials, in all cases, whether or not confidential, proprietary, patentable, in written, electronic or any other form now known or hereafter developed, but excluding all Patents.

1.152

Laws” means all applicable laws, statutes, rules, regulations, orders, judgments, injunctions, ordinances, codes, principles of common law, 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).

1.153

Lead Category 1 CP” has the meaning set forth in Section 3.3.1 (Option Notice; Data Package).

1.154

Lead Category 1 LP” means, with respect to each Candidate Category 1 Target for which Takeda exercises an Option in accordance with this Agreement, the Lead Category 1 CP with respect to such Candidate Category 1 Target.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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1.155

Lead Category 2 LP” has the meaning set forth in Section 5.3.2 (Licensed Category 2 Transition Plan).

1.156

Lead Initial HTT Compounds” means those Category 1 Compounds directed to the HTT Target set forth in Schedule 1.156.

1.157

Lead Initial HTT Product” means any pharmaceutical product, including all forms, presentations, strengths, doses and formulations thereof (including any method of delivery), containing or delivering a Lead Initial HTT Compound alone or as a Combination Product.

1.158

Licensed Category 1 Commercialization Budget” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans).

1.159

Licensed Category 1 Commercialization Plans” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans).

1.160

Licensed Category 1 Compounds” means, for each Licensed Category 1 Target, [***].

1.161

Licensed Category 1 Development Budget” has the meaning set forth in Section 5.1.3 (Licensed Category 1 Development Plan).

1.162

Licensed Category 1 Development Plan” has the meaning set forth in Section 5.1.3 (Licensed Category 1 Development Plan).

1.163

Licensed Category 1 Development Term” means, on a Licensed Category 1 Target‑by‑Licensed Category 1 Target basis, the time period commencing on the applicable Licensed Target Date for such Licensed Category 1 Target and ending upon the earlier of (a) the launch of the final Licensed Category 1 Product directed to such Licensed Category 1 Target, or (b) the effective date of termination of this Agreement in its entirety or with respect to such Licensed Category 1 Target.

1.164

Licensed Category 1 Global Commercialization Strategy” has the meaning set forth in Section 8.1.1 (Licensed Category 1 Global Commercialization Strategy).

1.165

Licensed Category 1 Joint Team” has the meaning set forth in Section 9.3.1 (Formation; Composition; Dissolution).

1.166

Licensed Category 1 Products” any pharmaceutical product, including all forms, presentations, strengths, doses and formulations thereof (including any method of delivery), containing or delivering a Licensed Category 1 Compound alone or as a Combination Product.

1.167

Licensed Category 1 Profit & Loss Share” has the meaning set forth in Section 11.3.4 (Licensed Category 1 Profit & Loss Share for Commercialization Activities).

1.168

Licensed Category 1 Program” means, on a Licensed Category 1 Target‑by‑Licensed Category 1 Target basis, the Development and Commercialization in accordance with this Agreement of all Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to a Licensed Category 1 Target during the Licensed Category 1 Development Term.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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1.169

Licensed Category 1 Target” means any Candidate Category 1 Target for which Takeda has exercised an Option in accordance with Section 3.4.4 (Exercise of Options).

1.170

Licensed Category 1 Transition Budget” has the meaning set forth in Section 5.1.7 (Licensed Category 1 Transition Plan).

1.171

Licensed Category 1 Transition Plan” has the meaning set forth in Section 5.1.7 (Licensed Category 1 Transition Plan).

1.172

Licensed Category 2 Commercialization Plan” has the meaning set forth in Section 8.2.1 (Licensed Category 2 Commercialization Plans).

1.173

Licensed Category 2 Compound” means, for each Licensed Category 2 Target, [***].

1.174

Licensed Category 2 Development Plan” has the meaning set forth in Section 5.3.3 (Licensed Category 2 Development Plan).

1.175

Licensed Category 2 Development Program” has the meaning set forth in Section 5.3.1 (Licensed Category 2 Development Overview).

1.176

Licensed Category 2 Development Term” means, on a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, the time period commencing on the [***].  

1.177

Licensed Category 2 Products” means any pharmaceutical product, including all forms, presentations, strengths, doses and formulations thereof (including any method of delivery), containing or delivering a Licensed Category 2 Compound alone or as a Combination Product.

1.178

Licensed Category 2 Program” means, on a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, the Development and Commercialization in accordance with this Agreement of all Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to a Licensed Category 2 Target during the Licensed Category 2 Development Term.

1.179

Licensed Category 2 Research Budget” has the meaning set forth in Section 5.2.3 (Licensed Category 2 Research Plans).

1.180

Licensed Category 2 Research Expenses” means, with respect to a Licensed Category 2 Target, [***] for Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics directed to such Licensed Category 2 Target, in each case, in accordance with the applicable [***].

1.181

Licensed Category 2 Research Plan” has the meaning set forth in Section 5.2.3 (Licensed Category 2 Research Plans).

1.182

Licensed Category 2 Research Program” has the meaning set forth in Section 5.2.1 (Licensed Category 2 Research Overview).

1.183

Licensed Category 2 Research Report” has the meaning set forth in Section 5.2.6 (Licensed Category 2 Research Reports).

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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1.184

Licensed Category 2 Research Term” means, on a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, the time period commencing on the Effective Date and ending upon the earlier of (a) completion of all activities under the Licensed Category 2 Research Plan for such Licensed Category 2 Target, or (b) the effective date of termination of this Agreement in its entirety or with respect to such Licensed Category 2 Target.

1.185

Licensed Category 2 Target” means a Proposed Category 2 Target approved as a Licensed Category 2 Target in accordance with Section 4.1 (Proposed Category 2 Targets).

1.186

Licensed Category 2 Target Cap” has the meaning set forth in Section 4.4 (Total Targets).

1.187

Licensed Category 2 Transition Budget” has the meaning set forth in Section 5.3.2 (Licensed Category 2 Transition Plan).

1.188

Licensed Category 2 Transition Plan” has the meaning set forth in Section 5.3.2 (Licensed Category 2 Transition Plan).

1.189

Licensed Compound” means any Licensed Category 1 Compound or Licensed Category 2 Compound.

1.190

Licensed Product” means any Licensed Category 1 Product or Licensed Category 2 Product.

1.191

Licensed Target” means any Licensed Category 1 Target and any Licensed Category 2 Target.

1.192

Licensed Target Date” means, on an Option‑by‑Option basis, the date on which an Option Exercise Notice delivered by Takeda to Wave for such Option in accordance with Section 3.4.1 (Option Exercise Notice) takes effect, including, if applicable, the occurrence of the HSR Conditions with respect to any HSR Filing made in connection therewith; [***], then the “Licensed Target Date” for such Option will be deemed to not have occurred for purposes of this Agreement and the applicable Candidate Category 1 Target for which Takeda exercised such Option will not be a Licensed Category 1 Target and will be a Terminated Target as of the date of expiration of the cure period for such payment.

1.193

Loss of Market Exclusivity” means an event where, with respect to any Licensed Category 2 Product in [***].

1.194

Losses” has the meaning set forth in Section 14.1 (General Indemnification by Takeda).

1.195

Major Market Country(ies)” means [***].  

1.196

Manufacturing” or “Manufacture” means all activities related to the manufacture of compounds or products or any component or ingredient thereof, including manufacturing supplies for Development, or Commercialization, formulation, manufacturing scale‑up, labeling, filling, processing, packaging, in‑process and finished product testing, release of product or any component or ingredient thereof, quality assurance and quality control activities related to manufacturing and release of product, ongoing stability tests, storage, shipment, and regulatory activities related to any of the foregoing.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

16


 

 

1.197

Manufacturing Costs” means, with respect to any Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target, the consolidated fully burdened manufacturing cost in accordance with the applicable Accounting Standards, which will be the sum of:

[***].

1.198

Manufacturing Lead” means, on a Collaboration Target-by-Collaboration Target basis, [***].

1.199

Material Communications” means written, telephonic, or in‑person communications from or with any Regulatory Authority concerning any of the following:  [***].

1.200

Materials” means all tangible compositions of matter, devices, articles of manufacture, assays, biological, chemical, or physical materials, and other similar materials.

1.201

Medical Affairs” means, with respect to a Licensed Product and Companion Diagnostics related to such Licensed Product, the performance of activities by or on behalf of a Party with respect to: continuing medical education therefor; development, publication, and dissemination of publications; exhibiting and presenting at seminars and conventions; conducting health economic studies; conducting health care professional and patient speakers programs; conducting appropriate activities involving opinion leaders; engaging medical science liaisons and conducting medical science liaison activities; conducting advisory board meetings or other consultant programs; and establishing clinical consumer and patient registries.

1.202

Medical Affairs Costs” means the [***].

1.203

Milestone Payments” has the meaning set forth in Section 11.4.3 (Licensed Category 2 Targets Category 2 Sales Milestone Payments).

1.204

Named Candidate Category 1 Compounds” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date).

1.205

Named Candidate Category 1 Products” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date).

1.206

Named Companion Diagnostics” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date).

1.207

NDA” means any (a) New Drug Application pursuant to the FD&C Act submitted to the FDA, or (b) substantially similar application or submission thereto submitted to a Regulatory Authority in a country or group of countries within the Territory to obtain Regulatory Approval (but not Pricing Approval) to Commercialize a Collaboration Product in that country or in that group of countries, including, with respect to the EU, a Marketing Authorization Application submitted to the EMA pursuant to the centralized approval procedure or to the applicable Regulatory Authority of a country in the EU with respect to the mutual recognition or any other national approval.

1.208

Net Sales” means, (a) with respect to a Licensed Category 1 Product or a Companion Diagnostic related to any Licensed Category 1 Product, the gross amounts invoiced or received by or on behalf of a [***] for any Licensed Category 1 Product or Companion Diagnostic related to any

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

17


 

 

Licensed Category 1 Product, in each case, sold to Third Parties, and (b) with respect to a Licensed Category 2 Product, the gross amounts invoiced or received by or on behalf of a [***] for any Licensed Category 2 Product sold to Third Parties [***], in each case ((a) and (b)), in bona fide, arms‑length transactions, as determined in accordance with such Party’s Accounting Standards as consistently applied, less the following deductions, booked on an accrual basis by such (i) [***].

Notwithstanding the foregoing, in no event may the Party calculating Net Sales on gross amounts invoiced or received by or on behalf of such Party or any of its Related Parties for any Licensed Product or Companion Diagnostic related to any Licensed Category 1 Product take a deduction in a manner that is inconsistent with such Party’s Accounting Standard.  

[***].

If a Licensed Product is sold as part of a Combination Product in a country in the Territory, then Net Sales for the Licensed Product included in such Combination Product in such country will be calculated as follows:

If the Licensed Product and the Other Components in such Combination Product are both sold separately in such country, then Net Sales for the Licensed Product will be calculated by [***].

If the Licensed Product is sold separately in such country, but the Other Components contained in the Combination Product are not sold separately in such country, then Net Sales for the Licensed Product will be calculated by [***];

If the Licensed Product is not sold separately in such country, but the Other Components contained in the Combination Product are sold separately in such country, then Net Sales for the Licensed Product will be calculated by multiplying [***]

If neither the Licensed Product nor the Other Components contained in the Combination Product are sold separately in such country, then Net Sales will be calculated by [***].  

1.209

Non‑Bankrupt Party” has the meaning set forth in Section 10.6 (Bankruptcy).

1.210

Non‑Conforming Product” means any Collaboration Product that (a) does not meet the specifications therefor set forth in the applicable Supply Agreement, (b) is adulterated or misbranded, or (c) is otherwise not Manufactured in compliance with applicable Law, including cGMP.

1.211

Non‑Granting Party” means the Party to whom licenses or rights are granted under this Agreement.

1.212

Oligonucleotide” means [***].

1.213

Operating Profits or Losses” means, for all Licensed Category 1 Products and Companion Diagnostics related to any Licensed Category 1 Product, the profits or losses calculated in accordance with Schedule 11.3.4.  

1.214

Option” or “Options” has the meaning set forth in Section 3.1 (Grant of Options).

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

18


 

 

1.215

Option Exercise Fee” has the meaning set forth in Section 11.3.1 (Option Exercise Fee).

1.216

Option Exercise Notice” means the written notice Takeda delivers to Wave to exercise an Option with respect to a Candidate Category 1 Target, substantially in the form set forth on Schedule 1.216, containing the information set forth in such form.

1.217

Option Exercise Period” means, on an Option‑by‑Option basis, the time period commencing upon the Effective Date and ending upon the earliest of (a) the Licensed Target Date for such Option, (b) [***] days after the date of Takeda’s receipt of the Data Package for such Option, as such period may be extended in accordance with Section 3.3.4 (Extension of Option Exercise Period) or as such period may be defined with respect to the HTT Target in accordance with Section 3.2 (HTT Target), (c) the termination of such Option in accordance with Section 3.4.6 (Termination of Option), or (d) the termination of this Agreement in its entirety or with respect to the Candidate Category 1 Target for such Option.

1.218

Option Notice” has the meaning set forth in Section 3.3.1 (Option Notice; Data Package).

1.219

Option Notice Date” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date).

1.220

Other Component” has the meaning set forth in 1.62 (Combination Product).

1.221

Other Operating Income/Expense” means [***].

1.222

Out‑of‑Pocket Costs” means, with respect to certain activities for a Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target, as applicable, hereunder, [***].

1.223

Overhead Costs” means costs incurred by a Party or for its account that are attributable to a Party’s [***].

1.224

Party” or “Parties” has the meaning set forth in the preamble.

1.225

Patent” means all patents and patent applications (including all continuations, continuations‑in‑part, divisionals, and substitutions), or other filings claiming priority thereto or sharing any common priority therewith, as well as any patents issued with respect to any such patent applications, reissues, re‑examinations, renewals, or extensions (including patent term adjustments, patent term extensions, supplemental protection certificates, or the equivalents thereof), registration or confirmation patents, patents resulting from post‑grant proceedings, patents of addition, restorations and extensions thereof, and any inventor’s certificates, and all equivalents and counterparts thereof in any country.  For clarity, a patent filing (a patent or a patent application) is considered to have been made (or to be pending or in force) within a selected time period if the filing itself, or any other filing to which it claims priority or with which it shares any common priority, was made within (or was pending or in force within) the time period.

1.226

Patent Challenge” has the meaning set forth in Section 16.3 (Termination for Patent Challenge).

1.227

Patent(s) Costs” means [***].

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

19


 

 

1.228

Patent Offices” has the meaning set forth in Section 13.2.8 (Validity and Enforceability).

1.229

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.

1.230

Phase 1 Study” means a clinical study of an investigational product in subjects with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. 312.21(a), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States.

1.231

Phase 2 Study” means a clinical study of an investigational product in subjects with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, pharmacokinetics, pharmacodynamics, and dose finding information as described in 21 C.F.R. 312.21(b), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Study (e.g., a phase 1/2 trial).

1.232

Phase 3 Study” means a clinical study of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States.

1.233

Positive Non‑Human Data” has the meaning set forth in Schedule 5.1.2.  

1.234

Post‑Marketing Commitments” means any item, activity, task, a non‑human study, human clinical study, or other commitment with respect to a product initiated after receipt of Regulatory Approval (other than Pricing Approval) for such product in a country or territory, the completion of which is recommended or required by the Regulatory Authority in such country or territory in connection with the initial grant of, or to support or maintain such, Regulatory Approval for such product in such country or territory.

1.235

Potential Candidate Category 1 In‑License” has the meaning set forth in Section 10.5.2(Candidate Category 1 In‑Licenses).

1.236

Potential Candidate Category 1 In‑License Term Sheet” has the meaning set forth in Section 10.5.2 (Candidate Category 1 In‑Licenses).

1.237

Potential In‑License” has the meaning set forth in Section 10.5.3 (Potential In‑Licenses).

1.238

Pricing Approval” means any governmental approval, agreement, determination, or decision establishing the prices for a product that can be charged or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities negotiate, approve, or determine the price or reimbursement of pharmaceutical products.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

20


 

 

1.239

Pricing Matters” means all issues and decisions regarding (a) price, price terms and other contract terms with respect to product sales, including discounts, rebates, other price concessions and service fees to payors and purchasers, and (b) reimbursement programs applicable to a product.  For clarity, “Pricing Matters” includes all financial issues and financial decisions with respect to contracting with managed care entities, hospitals, pharmacies, group purchasing organizations, pharmacy benefit managers, and Governmental Authorities, and specifically includes issues and decisions about the offer of discounts or rebates for formulary placement for products.

1.240

Promotion” means (a) any and all activities directed to the marketing, detailing, promotion of a product after Regulatory Approval has been obtained (including making, having made, using, importing, exporting, selling, and offering for sale such product), and will include post‑launch marketing, promoting, detailing, marketing research, distributing, customer service, administering commercially selling, having sold, or otherwise disposing or offering to dispose of such product, importing, exporting, or transporting such product for commercial sale, and all regulatory compliance with respect to the foregoing, and (b) otherwise marketing, selling, or exploiting commercially a product.

1.241

Promotional Materials” means all marketing training materials, grants, sponsorships, and all written, printed, graphic, 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 Related Parties in connection with any promotion of and education related to a Licensed Product.

1.242

Proof of Mechanism Study” or “POM Study” means, on a Candidate Category 1 Target‑by‑Candidate Category 1 Target basis, the first Clinical Study that is designed to satisfy the POM Criteria set forth on Schedule 1.242 (as may be amended by the JSC in accordance with this Agreement) in patients for a Candidate Category 1 Product directed to a Candidate Category 1 Target.  

1.243

Proposed Category 2 Target” has the meaning set forth in Section 4.1 (Proposed Category 2 Targets).

1.244

Proposed Category 2 Target Nomination Notice” has the meaning set forth in Section 4.1 (Proposed Category 2 Targets).

1.245

Prosecution and Maintenance” or “Prosecute and Maintain” means, with regard to a particular Patent, the preparation, filing, prosecution and maintenance of such Patent, as well as re‑examinations, reissues and the like with respect to that Patent.

1.246

[***].

1.247

Registrational Study” means a Clinical Study (regardless of whether or not called a “Phase 3 Study”) for a product the results of which, together with prior data and information concerning such product, are intended to be sufficient, without any additional Clinical Study, to meet the evidentiary standard for demonstrating the safety and efficacy of such active substance of such product established by a Regulatory Authority in any particular jurisdiction and is sufficient for filing of an NDA for such product in patients having the disease or condition being studied.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

21


 

 

1.248

Regulatory Approval” means, with respect to a country or extra‑national territory, any and all approvals (including approvals of NDAs), licenses, registrations, or authorizations of any Regulatory Authority necessary in order to commercially distribute, sell, or market a pharmaceutical product in such country or some or all of such extra‑national territory, [***].  For the avoidance of doubt, Regulatory Approval received in the US in an expedited manner or in the EU in a conditional manner, in each case, is a Regulatory Approval for purposes of this definition.

1.249

Regulatory Authority” means any Governmental Authority involved in granting Regulatory Approvals of pharmaceutical products, including the FDA, the EMA, the Japanese Ministry of Health, Labour and Welfare, and the Pharmaceuticals and Medical Devices Agency in Japan.

1.250

Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a Licensed Product other than Patents, that limits or prohibits a Person from (a) relying on safety or efficacy data generated by or on behalf of the Parties with respect to such Licensed Product in an application for Regulatory Approval of a Generic Product, or (b) Commercializing a Licensed Product or a Generic Product, including rights conferred in the U.S. under the Hatch‑Waxman Act or the FDA Modernization Act of 1997 (including pediatric exclusivity), orphan drug exclusivity, or rights similar thereto outside the U.S.

1.251

Regulatory Lead” means, [***].

1.252

Regulatory Materials” means any regulatory application, submission, notification, communication, correspondence, registration, Regulatory Approval, or other filing made to, received from or otherwise conducted with a Regulatory Authority related to Developing, Manufacturing, obtaining marketing authorization, marketing, selling or otherwise Commercializing a pharmaceutical product in a particular country or jurisdiction.

1.253

Related Party(ies)” means a Party’s Affiliates and Sublicensees.

1.254

Reversion License” has the meaning set forth in Section 16.6.3 (Reversion License).

1.255

Reversion Product” means all Collaboration Compounds, Collaboration Products, and Companion Diagnostics that are directed to a Terminated Target (which will be all such Collaboration Compounds, Collaboration Products, and Companion Diagnostics in the case of termination of this Agreement in its entirety), in each case, in the form that each such Collaboration Compound, Collaboration Product, and Companion Diagnostic exist as of the date of notice of such termination, and any improvements, modifications or enhancements thereof.

1.256

[***].

1.257

[***].

1.258

[***].  

1.259

Royalty Rates” has the meaning set forth in Section 11.4.4 (Category 2 Royalties).

1.260

Royalty Report” has the meaning set forth in Section 11.6.2 (Reports and Royalty Payments).

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

22


 

 

1.261

Royalty Term” has the meaning set forth in Section 11.4.4.1 (Royalty Term).

1.262

Safety Concern” means, with respect to any Collaboration Compound or Collaboration Product, (a) any safety concern required to be reported under 21 C.F.R. § 312.32 (“IND Safety Reporting”) if an IND with respect to such Collaboration Compound or Collaboration Product was open at the time of the observation (or that would be so reportable if an IND was not open at such time), or (b) a toxicity or drug safety issue or a Serious Adverse Event reasonably related to or observed in connection with Development or Commercialization activities with respect to a Collaboration Compound or Collaboration Product.

1.263

Sales and Marketing Costs” means, for a Licensed Category 1 Product or Companion Diagnostic related to any such Licensed Category 1 Product, the [***] by a Party or its Affiliates that are directly attributable to Commercialization activities for such Licensed Category 1 Product or Companion Diagnostic, including [***].

1.264

SDEA” means one or more Safety Data Exchange Agreements entered into by the Parties relating to Collaboration Compounds or Collaboration Products.

1.265

Selling Parties” has the meaning set forth in Section 1.208 (Net Sales).

1.266

Serious Adverse Event” 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) or a congenital anomaly/birth defect, (f) significant intervention required to prevent permanent impairment or damage, or (g) a medical event that may not result in death, be life‑threatening, or require hospitalization but, based on appropriate medical judgment, that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes described in clauses (a) through (f).

1.267

Share Purchase Agreement” has the meaning set forth in Section 1.97 (Equity Agreements).

1.268

Subcommittee” means the Licensed Category 1 Joint Team, the Category 2 Research Committee, and any other subcommittee formed by the JSC in accordance with Section 9.6.2 (Decisions of the JSC).

1.269

Sublicensee” means a Third Party to which a Party or its Affiliate has granted or grants rights to Develop, Manufacture, or Commercialize any Collaboration Compound, Collaboration Product, or Companion Diagnostic, or any further sublicensee of such rights (regardless of the number of tiers, layers or levels of sublicenses of such rights), in each case, in accordance with Section 10.4 (Sublicensing Terms), as applicable.

1.270

Sublicense Revenue” means revenue recognized by [***].

1.271

Supply Agreements” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements).

1.272

[***].

1.273

Supply Price” has the meaning set forth in Section 7.4 (Costs and Expenses of Manufacturing).

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

23


 

 

1.274

Takeda” has the meaning set forth in the preamble.

1.275

Takeda Acquisition” has the meaning set forth in Section 13.6.5 (Takeda Acquisition).

1.276

Takeda Acquisition Program” has the meaning set forth in Section 13.6.5 (Takeda Acquisition).

1.277

Takeda COC Program” has the meaning set forth in Section 13.6.4 (Takeda Change of Control).

1.278

Takeda Collaboration IP” means (a) any Know-How first developed or conceived solely by employees of Takeda or its Affiliates or other persons not employed by Takeda or its Affiliates acting on behalf of Takeda or its Affiliates in the performance of any activities under this Agreement, and (b) any Patents that claim such Know-How. Takeda Collaboration IP excludes Takeda Improvements and Takeda’s interest in Joint Collaboration IP.

1.279

Takeda Improvements” means any [***].  

1.280

Takeda Indemnitees” has the meaning set forth in Section 14.2 (General Indemnification by Wave).

1.281

Takeda In‑Licenses” means any Existing Takeda In‑License or any Collaboration In‑License to which Takeda is a party.

1.282

Takeda Know‑How” means Know‑How Controlled by Takeda or its Affiliates as of the Effective Date or during the Term that is reasonably necessary to Exploit a Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target in the Field in the Territory, but excluding the Takeda Improvements, Takeda’s interest in Joint Collaboration IP, and Takeda Collaboration IP.

1.283

Takeda Patents” means Patents Controlled by Takeda or its Affiliates as of the Effective Date or during the Term that are reasonably necessary to Exploit a Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target in the Field in the Territory, excluding Joint Collaboration Patents, Patents that Cover any of the Takeda Improvements, and any Patents included in the Takeda Collaboration IP.  Schedule 1.283 provides a listing of Patents that are Controlled by Takeda or its Affiliates as of the Effective Date and therefore will be Takeda Patents to the extent that they are reasonably necessary to Exploit a Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target in the Field in the Territory.

1.284

Takeda Prosecuted Patents” has the meaning set forth in Section 15.4.1.1 (General).

1.285

Takeda Technology” means, collectively, (a) the Takeda Patents, (b) Takeda Know‑How, (c) the Takeda Improvements, (d) Takeda Collaboration IP, and (e) Takeda’s interest in the Joint Collaboration IP.

1.286

Target” means any biological target that has or is anticipated to have a [***] to which a pharmaceutical compound binds in order to elicit a therapeutic or other pharmacodynamic response.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

24


 

 

1.287

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.

1.288

Technical Failure” means [***].

1.289

Term” has the meaning set forth in Section 16.1 (Term).

1.290

Term Sheets” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements).

1.291

Terminated Target” means any Collaboration Target for which this Agreement has been terminated by either Party.  All Collaboration Targets will be deemed Terminated Targets to the extent this Agreement is terminated in its entirety.

1.292

Territory” means worldwide.

1.293

Third Party” means any Person other than Takeda, Wave, or their respective Affiliates.

1.294

Third Party Manufacturing Agreements” has the meaning set forth in Section 7.9.2 (Third Party Agreements).

1.295

Third Party Payment” has the meaning set forth in Section 10.5 (In‑Licenses).

1.296

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.

1.297

Transition Plan” means any Licensed Category 1 Transition Plan or Licensed Category 2 Transition Plan.

1.298

[***].    

1.299

[***].

1.300

United States” or “U.S.” means the United States and its territories, possessions and commonwealths.

1.301

US Government” means the federal government of the United States.

1.302

U.S. Licensed Category 1 Commercialization Budgets” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans).

1.303

U.S. Licensed Category 1 Commercialization Plans” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans).

1.304

U.S. Licensed Category 1 Profit & Loss Share” has the meaning set forth in Section 11.3.4 (Licensed Category 1 Profit & Loss Share for Commercialization Activities).

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

25


 

 

1.305

U.S. P&L” has the meaning set forth in Schedule 11.3.4.

1.306

Valid Claim” means a claim of a Patent that (a) has not been rejected, revoked or held to be invalid, unpatentable, or unenforceable by a court or other authority of competent jurisdiction, from which decision no appeal can be further taken, and (b) has not been finally abandoned, disclaimed or admitted to be invalid or unenforceable through reissue, re‑examination, or disclaimer, or otherwise.  In order to be a Valid Claim, any claim being prosecuted in a pending patent application must be prosecuted in good faith and not have been pending for more than [***] from the filing date of the first utility patent application (or equivalent concept in any such country) in the patent application family in the country in question, in which case it will cease to be considered a Valid Claim until the patent issues and recites said claim.

1.307

Validated” means [***].

1.308

VAT” means, within the EU, such Tax as may be charged in accordance with (but subject to derogations from) Directive 2006/112/EC and, outside the EU, 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.

1.309

Wave” has the meaning set forth in the preamble.

1.310

Wave Acquisition” has the meaning set forth in Section 13.6.3 (Wave Acquisition).

1.311

Wave Acquisition Program” has the meaning set forth in Section 13.6.3 (Wave Acquisition).

1.312

Wave COC Program” has the meaning set forth in Section 13.6.2 (Wave Change of Control).

1.313

Wave Collaboration IP” means (a) any Know-How first developed or conceived solely by employees of Wave or its Affiliates or other persons not employed by Wave or its Affiliates, acting on behalf of Wave or its Affiliates in the performance of any activities under this Agreement, and (b) any Patents that claim such Know-How.  Wave Collaboration IP excludes Wave Improvements and Wave’s interest in Joint Collaboration IP.

1.314

Wave Commercialization Activitiesmeans, [***].

1.315

[***].

1.316

Wave Improvements” means any [***].

1.317

Wave Indemnitees” has the meaning set forth in Section 14.1 (General Indemnification by Takeda).

1.318

Wave In‑Licenses” means any Existing Wave In‑License, Candidate In‑Licenses, or any Collaboration In‑License to which Wave is a party.

1.319

Wave Know‑How” means Know‑How Controlled by Wave or its Affiliates as of the Effective Date or during the Term that is reasonably necessary to Exploit a Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target in the Field in the Territory, but excluding the Wave Improvements, Wave’s interest in Joint Collaboration IP, and Wave Collaboration IP.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

26


 

 

1.320

Wave Patents” means those Patents Controlled by Wave or its Affiliates as of the Effective Date or during the Term that (a) Cover the composition of matter of, or the method of making or using, a Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target; or (b) are otherwise reasonably necessary to Exploit a Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target in the Field in the Territory, in each case ((a) and (b)), but excluding any Patents that Cover inventions that (i) arise in the performance of activities under this Agreement and (ii) are Wave Improvements, Joint Collaboration IP, or Wave Collaboration IP.

1.321

Wave Prosecuted Patents” has the meaning set forth in 15.4.2.1 (General).

1.322

Wave Ratio” has the meaning set forth in Section 11.1 (Upfront Payment).

1.323

Wave Singapore” means Wave Life Sciences Ltd.

1.324

Wave Technology” means (a) Wave Know‑How, (b) Wave Patents, (c) Wave Improvements, (d) Wave Collaboration IP, and (e) Wave’s interest in the Joint Collaboration IP.

1.325

Wave UK” has the meaning set forth in the preamble.

1.326

Wave US” has the meaning set forth in the preamble.

2.

COLLABORATION OVERVIEW

2.1.

Collaboration Overview.  Pursuant to this Agreement, Wave and Takeda wish to Develop Collaboration Compounds, Collaboration Products, or Companion Diagnostics directed to Collaboration Targets, with the goal of obtaining Regulatory Approval therefor and thereafter, Commercializing Licensed Compounds, Licensed Products, and Companion Diagnostics directed to any Licensed Target in the Field in the Territory.  For each Candidate Category 1 Target, Wave will lead the Development of Candidate Category 1 Compounds, Candidate Category 1 Products, and Companion Diagnostics directed to such Candidate Category 1 Target through Completion of the POM Study for the first Candidate Category 1 Product directed to such Candidate Category 1 Target, and Takeda will have an Option to participate with Wave in the Development of, and to lead the Commercialization of Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to such Licensed Category 1 Target in the Field in the Territory.  For each Licensed Category 2 Target, Wave will lead the pre‑clinical and non‑clinical Development for Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target through Completion of the IND‑Enabling Studies for the first Major Market Country for the Lead Category 2 LP directed to each Licensed Category 2 Target, and Takeda will thereafter have an exclusive license to Develop and Commercialize Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target in the Field in the Territory.

2.2.

[***].  

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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3.

GRANT AND EXERCISE OF OPTIONS

3.1.

Grant of Options.  On a Candidate Category 1 Target‑by‑Candidate Category 1 Target basis, Wave hereby grants to Takeda an exclusive option to obtain the license set forth in Section 10.2.1 (License Grant to Takeda) and for Takeda to grant to Wave the license set forth in Section 10.2.2 (License Grant to Wave), in each case, with respect to the corresponding Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to the corresponding Licensed Category 1 Target (each, an “Option” and, collectively, the “Options”), which Options may be exercised on a Candidate Category 1 Target‑by‑Candidate Category 1 Target basis at Takeda’s sole discretion during the Option Exercise Period for such Candidate Category 1 Target in accordance with Section 3.4.1 (Option Exercise Notice) and Section 3.4.4 (Exercise of Options).

3.2.

HTT Target.  Notwithstanding anything to the contrary set forth in this Agreement, Takeda may exercise the Option for the HTT Target at any time during the period commencing on the Effective Date and continuing until the latest to occur of the following times:  [***]. If Takeda exercises the Option for the HTT Target at any time in accordance with Section 3.4.1 (Option Exercise Notice) and Section 3.4.4 (Exercise of Options), then (i) Takeda will be deemed to have exercised the HTT Target for all HTT Compounds and HTT Products, (ii) the Licensed Target Date for the Option for the HTT Target will be deemed to have occurred, and (iii) Wave will have no obligation to deliver any subsequent Data Packages for the HTT Target.  

3.3.

Information Sharing.

 

3.3.1.

Option Notice; Data Package.  For each Candidate Category 1 Target, [***], Wave will prepare a complete Data Package for the applicable Candidate Category 1 Target and provide a written notice to Takeda (such notice, an “Option Notice”) that includes:

 

3.3.1.1.

a letter identifying the applicable Candidate Category 1 Target to which the Option applies and the Lead Category 1 CP and other Candidate Category 1 Compounds and Candidate Category 1 Products directed to such Candidate Category 1 Target;

 

3.3.1.2.

the Data Package for such Candidate Category 1 Target, which will be made available to Takeda through an electronic data room;

 

3.3.1.3.

an initial Licensed Category 1 Development Plan for the Lead Category 1 CP directed to such Candidate Category 1 Target;

 

3.3.1.4.

a Disclosure Letter for such Candidate Category 1 Target; and

 

3.3.1.5.

a certification of an officer of Wave as to the accuracy and completeness of the provided information, and a statement that, subject to the disclosures contained in the Disclosure Letter for such Candidate Category 1 Target, the representations and warranties of Wave set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date) are true and correct in all material respects with respect to such Candidate Category 1 Target as of the date of delivery of such Option Notice.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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3.3.2.

Incomplete Data Package.  Following receipt of an Option Notice, Takeda will have [***] Business Days to notify Wave if the Data Package included therein is missing any information required pursuant to the relevant Candidate Category 1 Development Plan or set forth on Schedule 1.80, which notice will describe such missing information.  Wave will provide Takeda with all missing information identified in such notice within [***] after the date of Takeda’s request (if and to the extent that such information is available to Wave).

 

3.3.3.

Due Diligence.  Following the date of delivery of the Option Notice for a Candidate Category 1 Target and during its Option Exercise Period, to assist Takeda in conducting thorough due diligence to decide whether to exercise an Option for such Candidate Category 1 Target Wave will afford to Takeda and its representatives reasonable access during normal business hours to Wave’s personnel, records and data, offices, and laboratories, in each case, that relate to the Development of the applicable Candidate Category 1 Target and Candidate Category 1 Compounds, Candidate Category 1 Products, and Companion Diagnostics directed to such Candidate Category 1 Target.

 

3.3.4.

Extension of Option Exercise Period.  If any information is provided to Takeda following the receipt of an Option Notice for a Candidate Category 1 Target pursuant to (a) Section 3.3.2 (Incomplete Data Package) or (b) Section 3.3.3 (Due Diligence) within [***] Business Days after Takeda’s receipt of the relevant Option Notice, and, in each case ((a)-(b)), such information is, in Takeda’s reasonable discretion, material information not previously provided to Takeda and required to be provided as part of the Data Package for such Candidate Category 1 Target and its Lead Category 1 CP, then Takeda will have the right to elect upon written notice to Wave to extend the applicable Option Exercise Period for such Candidate Category 1 Target such that there are [***] additional days between Takeda’s receipt of such material information and the expiration of such Option Exercise Period.

 

3.3.5.

Effect of Early Option Exercise.  The obligations of this Section 3.3 (Information Sharing) will not apply with respect to any Candidate Category 1 Target for which Takeda has exercised an Option prior to the date of the Completion of the POM Study for the Lead Category 1 CP directed to such Candidate Category 1 Target, except that Wave will deliver to Takeda a Data Package for such Candidate Category 1 Target (to the extent that such information was not previously provided by Wave to Takeda) reasonably promptly after the date on which Takeda exercises such Option and such information becomes available.

3.4.

Exercise of an Option.

 

3.4.1.

Option Exercise Notice.  Takeda will exercise an Option, if at all, by delivering a completed Option Exercise Notice in respect of such Option to Wave at any time during the applicable Option Exercise Period for such Option.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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3.4.2.

Conversion.

 

3.4.2.1.

Conversion Notice.  On a Licensed Category 1 Target‑by‑Licensed Category 1 Target basis, within [***] Business Days after Takeda’s delivery to Wave of an Option Exercise Notice for a Candidate Category 1 Target, upon written notice to Takeda (each, a “Conversion Notice”), Wave may elect, at its sole discretion, to convert the Candidate Category 1 Target that is the subject of such Option Exercise Notice into a Licensed Category 2 Target and to convert all Candidate Category 1 Compounds, Candidate Category 1 Products, and Companion Diagnostics directed to such Candidate Category 1 Target into Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target (as applicable).  In the event that Wave delivers a Conversion Notice with respect to a Licensed Category 1 Target, then (without any further action by the Parties) upon the date of Wave’s delivery of such Conversion Notice with respect to such Candidate Category 1 Target:  (a) the Candidate Category 1 Target will convert to a Licensed Category 2 Target, (b) all Candidate Category 1 Compounds, Candidate Category 1 Products, and Companion Diagnostics directed to such Candidate Category 1 Target will convert into Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target, respectively, (c) the licenses set forth in Section 10.1 (Category 1 Development Program) and 10.2 (Licensed Category 1 Targets) will terminate with respect to such Candidate Category 1 Target and the corresponding Licensed Category 1 Target, (d) the licenses set forth in Section 10.3 (Licensed Category 2 Targets) will apply to such new Licensed Category 2 Target and to such new Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such new Licensed Category 2 Target, and (e) the further Development and Commercialization of Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target will thereafter be governed by Sections 5.3 (Development Activities for Licensed Category 2 Targets) and Section 8 (Commercialization), respectively. [***].

 

3.4.2.2.

Conversion for Failure to Pay.  In addition, on a Licensed Category 1 Target‑by‑Licensed Category 1 Target basis, if Wave fails to fund its fifty percent (50%) share of applicable Eligible Development Expenses for any Licensed Category 1 Target in accordance with this Agreement and fails to cure such failure after written notice thereof from Takeda in accordance with Section 16.4.1.2 (Termination by Takeda), then, Takeda may, in its sole discretion, elect to deem such failure to pay as the delivery to Takeda of a Conversion Notice with respect to such Licensed Category 1 Target pursuant to this Section 3.4.2 (Conversion Notice) and thereafter (a) the Licensed Category 1 Target will convert to a Licensed Category 2 Target, (b) all Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to such Licensed Category 1 Target will convert into Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target, respectively, (c) the licenses set forth in Section 10.2 (Licensed

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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Category 1 Targets) will terminate with respect to such Licensed Category 1 Target, (d) the licenses set forth in Section 10.3 (Licensed Category 2 Targets) will apply to such new Licensed Category 2 Target and to such new Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such new Licensed Category 2 Target, and (e) the further Development and Commercialization of Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target will thereafter be governed by Section 5.3 (Development Activities for Licensed Category 2 Targets) and Section 8 (Commercialization), respectively.  Notwithstanding anything in this Agreement to the contrary, if Takeda elects to convert a Licensed Category 1 Target to a Licensed Category 2 Target in accordance with the previous sentence, then such conversion will be Takeda’s sole and exclusive remedy with respect to the applicable funding failure that gave rise to Takeda having the right to make such election.

 

3.4.3.

Option Exercise Fee.  If Takeda delivers an Option Exercise Notice with respect to a Candidate Category 1 Target in accordance with this Agreement, then Takeda will pay the Option Exercise Fee with respect to such Option to Wave in accordance with Section 11.3.1 (Option Exercise Fee).

 

3.4.4.

Exercise of Options.  On the Licensed Target Date for the applicable Option, (a) the applicable Candidate Category 1 Target for which such Option was exercised will automatically become a “Licensed Category 1 Target” for all purposes under this Agreement, (b) the Lead Category 1 CP and all other Candidate Category 1 Compounds and Candidate Category 1 Products, in each case, that are directed to such Candidate Category 1 Target will automatically be “Licensed Category 1 Compounds” and “Licensed Category 1 Products,” respectively, for all purposes under this Agreement, (c) Wave will automatically grant to Takeda the license set forth in Section 10.2.1 (License Grant to Takeda) and Takeda will automatically grant to Wave the license set forth in Section 10.2.2 (License Grant to Wave), and (d) all of the obligations of Wave and Takeda with respect to such Licensed Category 1 Target, including the payment obligations relating thereto, will become the binding obligations of the applicable Party in respect of such Licensed Category 1 Target and the Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed thereto.  

 

3.4.5.

Development and Commercialization Following Option Exercise.  Following the Licensed Target Date for an Option with respect to a Candidate Category 1 Target, the Development and Commercialization of all Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to the applicable Candidate Category 1 Target will thereafter be governed by Section 5 (Development) and Section 8 (Commercialization), respectively.  For the avoidance of doubt, in no event will Wave have any responsibility to continue to perform any activities under a Candidate Category 1 Development Plan for a Candidate Category 1 Target following the conversion of such Candidate Category 1 Target to a Licensed Category 2 Target.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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3.4.6.

Termination of Option.  On an Option‑by‑Option basis and Candidate Category 1 Target‑by‑Candidate Category 1 Target basis, if (a) Takeda does not deliver to Wave an Option Exercise Notice for such Candidate Category 1 Target during the applicable Option Exercise Period for such Option (which, for the HTT Target will be as described in Section 3.2 (HTT Target)), or (b) Takeda elects, in its sole discretion, to deliver written notice to Wave to terminate an Option with respect to such Candidate Category 1 Target prior to the expiration of the applicable Option Exercise Period, then, in either case ((a) or (b)), (i) Takeda’s Option with respect to such Candidate Category 1 Target will expire, (ii) the Option Exercise Period with respect to such Candidate Category 1 Target will terminate effective as of the date of such written notice, (iii) each Party’s rights and obligations under this Agreement (including the exclusivity set forth in Section 13.6.1 (Exclusivity)) with respect to such Candidate Category 1 Target and any Candidate Category 1 Compounds, Candidate Category 1 Products, and Companion Diagnostics directed to such Candidate Category 1 Target, in each case, will terminate effective as of the date of such written notice and such Candidate Category 1 Target will become a “Terminated Target” and the Category 1 Compounds, Candidate Category 1 Products, or Companion Diagnostics directed to such Candidate Category 1 Target will become “Reversion Products” for all Candidate Category 1 Targets excluding the HTT Target, for which each Party’s rights and obligations (including such exclusivity) will only terminate if Takeda terminates the Option for the HTT Target in its entirety or upon the expiration of the Option Exercise Period for the HTT Target as described in Section 3.2 (HTT Target), (iv) the effects of termination set forth in Section 16.6 (Effects of Termination by Wave for Cause or Takeda for Convenience), as applicable, will apply to such Terminated Target and Reversion Products, and (v) Wave will thereafter be free to Exploit, alone or with one or more Third Parties, any compounds, products, or companion diagnostics directed to such Candidate Category 1 Target without any further obligation to Takeda.

 

3.4.7.

Delay for HSR Filing.  Notwithstanding Takeda’s right to exercise an Option with respect to a particular Candidate Category 1 Target, in the event that, in Takeda’s reasonable opinion, Takeda would be required to file any HSR Filing as a result of Takeda’s exercise of an Option with respect to such Candidate Category 1 Target upon the date on which an Option Exercise Notice was delivered by Takeda to Wave for such Option in accordance with Section 3.4.1 (Option Exercise Notice), the effectiveness of such Option will be delayed beyond the date on which an Option Exercise Notice was delivered by Takeda to Wave for such Option in accordance with Section 3.4.1 (Option Exercise Notice) to the extent necessary to avoid a violation of the HSR Act until Takeda will have made such HSR Filing and to cause the occurrence of the HSR Conditions.  Wave will provide Takeda with any information (including financial information) reasonably requested by Takeda for purposes of determining whether an HSR Filing is necessary or advisable.  If Takeda determines that an HSR Filing is necessary or advisable, then each of Takeda and Wave will make or cause to be made such notifications and filings as promptly as practicable (but in any event within [***] Business Days of such determination).  The Parties will reasonably cooperate with one another to the extent necessary in the preparation of any such HSR Filing.  Each Party will be responsible for its own costs and expenses associated with such HSR Filing, and Takeda will be responsible for all premerger filing fees associated with any such HSR Filing.  Each of Wave and Takeda hereby covenants and agrees to use reasonable efforts to secure, and not to take any action that will have the effect of delaying, impairing, or impeding, the occurrence of the HSR Conditions with

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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respect to the exercise of the Option.  Notwithstanding the foregoing, nothing in this Section 3.4.7 (Delay for HSR Filing) will require either Party or such Party’s Affiliates to (a) disclose to the other Party any information that is subject to obligations of confidentiality or non‑use owed to Third Parties (nor will either Party be required to conduct joint meetings with any Governmental Authority in which such information might be shared with the other Party), or (b) to consent to the divestiture or other disposition of any of its or its Affiliates’ assets or to consent to any other structural or conduct remedy.

4.

SELECTION OF CATEGORY 2 TARGETS

4.1.

Proposed Category 2 Targets.  Subject to the limit set forth in Section 4.4 (Total Targets), during the Initial Licensed Category 2 Research Term, each Party may nominate one or more Targets for consideration as possible Licensed Category 2 Targets (each, a “Proposed Category 2 Target”) by providing writing notice to the JSC, which notice will be substantially in the form attached as Schedule 4.1 (the “Proposed Category 2 Target Nomination Notice”).  Subject to the dispute process set forth in Section 4.2 (Dispute Process), within [***] days after the date on which the JSC receives a Proposed Category 2 Target Nomination Notice, the JSC will review the Proposed Category 2 Target Nomination Notice and determine whether to approve such Proposed Category 2 Target as a Licensed Category 2 Target and following such approval by the JSC such Proposed Category 2 Target will be a “Licensed Category 2 Target” for purposes of this Agreement.

4.2.

Dispute Process.  If a Party believes that a Proposed Category 2 Target identified in a Proposed Category 2 Target Nomination Notice is [***].

4.3.

Licensed Category 2 Target Replacement.  At any time during the Initial Licensed Category 2 Research Term, either Party may propose to the JSC, subject to the dispute process set forth in Section 4.2 (Dispute Process), to replace a relevant, previously‑selected Licensed Category 2 Target with a new Proposed Category 2 Target.  If the JSC approves the replacement of such previously‑selected Licensed Category 2 Target with a new Proposed Category 2 Target in accordance with this Section 4.3 (Licensed Category 2 Target Replacement) [***], then (a) such new Proposed Category 2 Target will be a Licensed Category 2 Target for purposes of this Agreement, (b) each Party’s rights and obligations under this Agreement with respect to such replaced Licensed Category 2 Target and any Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such replaced Licensed Category 2 Target (including the exclusivity set forth under Section 13.6.1 (Exclusivity)), in each case, will terminate, (c) such replaced Licensed Category 2 Target will be a “Terminated Target” and the applicable Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such replaced Licensed Category 2 Target will be “Reversion Products,” in each case, for purposes of this Agreement, (d) the effects of termination set forth in Section 16.6 (Effects of Termination by Wave for Cause or Takeda for Convenience), as applicable, will apply to such Terminated Target and Reversion Products, and (e) Wave will thereafter be free, alone or with one or more Third Parties, to Exploit any compounds, products, or companion diagnostics directed to such replaced Licensed Category 2 Target.

4.4.

Total Targets.  During the Initial Licensed Category 2 Research Term, the then current Licensed Category 2 Research Plans may not provide for the concurrent Development of Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics directed to more than six (6) Licensed Category 2 Targets (the “Licensed Category 2 Target Cap”).  A

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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Licensed Category 2 Target will cease to be under a current Licensed Category 2 Research Plan if (a) such Licensed Category 2 Target is replaced in accordance with Section 4.3 (Licensed Category 2 Target Replacement), (b) the JSC determines that a Technical Failure has occurred with respect to such Licensed Category 2 Target, (c) Takeda files an IND with respect to any Licensed Category 2 Product directed to such Licensed Category 2 Target; provided, however, that if Takeda requests that Wave perform additional Development activities for any Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics directed to such Licensed Category 2 Target during the Initial Licensed Category 2 Research Term, then such Licensed Category 2 Target will continue to be counted towards the Licensed Category 2 Target Cap until the completion of such additional Development activities, or (d) such Licensed Category 2 Target becomes a Terminated Target for any other reason.

5.

DEVELOPMENT

5.1.

Development of Category 1 Targets.

 

5.1.1.

Category 1 Development Overview.  On a Category 1 Target‑by‑ Category 1 Target basis, Wave will use Commercially Reasonable Efforts to Develop all Category 1 Compounds, Category 1 Products, and Companion Diagnostics directed to the applicable Category 1 Target in accordance with this Agreement, including the applicable Candidate Category 1 Development Plan or Licensed Category 1 Development Plan (each a “Category 1 Development Program”).  Notwithstanding the foregoing, the Parties may agree upon certain activities that Takeda will conduct under a Category 1 Development Plan for a Category 1 Development Program.  Each Category 1 Development Program will include the [***].  Each Party will conduct all Development of Category 1 Compounds, Category 1 Products, and Companion Diagnostics directed to the applicable Category 1 Target as part of the applicable Category 1 Development Program and in accordance with the applicable Category 1 Development Plan [***].  

 

5.1.2.

Candidate Category 1 Development Plan.  An initial development plan for all activities to be conducted by the Parties with respect to Candidate Category 1 Compounds, Candidate Category 1 Products, and Companion Diagnostics directed to (a) the HTT Target is attached hereto as Schedule 5.1.2(a), [***], (b) C9orf72 is attached hereto as Schedule 5.1.2(b), and (c) ATXN3 will be prepared and agreed by the Parties following the Effective Date (each, a “Candidate Category 1 Development Plan”). Notwithstanding anything to the contrary set forth in this Agreement, the Candidate Category 1 Development Plan [***].  Each Candidate Category 1 Development Plan includes and each update thereto will include: (a) all Development, Manufacturing, and regulatory activities to be conducted by the Parties for Candidate Category 1 Compounds, Candidate Category 1 Products, and Companion Diagnostics directed to the applicable Candidate Category 1 Target through Completion of the POM Study for at least one (1) Candidate Category 1 Product directed to the applicable Candidate Category 1 Target; and (b) the allocation of responsibilities between Parties of the activities under such Candidate Category 1 Development Plan, together with a detailed budget for any activities allocated to Takeda that takes into account the expected costs of such activities, including a Calendar Quarter forecast and a long‑range forecast.  On at least an annual basis, the Development Lead will update each Candidate Category 1 Development Plan based on the currently available information and data and the JSC will review, discuss, and determine whether to approve any such update that is material.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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5.1.3.

Licensed Category 1 Development Plan.  Upon the commencement of the Licensed Category 1 Development Term, on a Licensed Category 1 Target‑by‑Licensed Category 1 Target basis, the Licensed Category 1 Joint Team will prepare and the JSC will determine whether to approve, an individualized development plan for the further Development of the Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to such Licensed Category 1 Target (each a “Licensed Category 1 Development Plan”).  Each Licensed Category 1 Development Plan and each update thereto will include (a) all Development, regulatory, and Manufacturing activities to be performed in furtherance of seeking Regulatory Approval of Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to such Licensed Category 1 Target in the Territory (which may include Development in China); (b) the allocation of responsibilities between the Parties of the activities set forth under such Licensed Category 1 Development Plan; (c) include a detailed budget for such activities in accordance with the format set forth on Schedule 5.1.3, that takes into account the expected costs of such activities; and (d) a [***] year forecast (such [***] year forecast to include a quarterly budget for the first year and an annual forecast for the remaining [***] years) (collectively, for each Licensed Category 1 Target, the “Licensed Category 1 Development Budget”).  The Development Lead will prepare an initial draft of each Licensed Category 1 Development Plan, which draft will be included in the Data Package for the corresponding Candidate Category 1 Target provided by Wave to Takeda under Section 3.3.1 (Option Notice; Data Package).  Within [***] days after the Licensed Target Date for such Licensed Category 1 Target, or as soon as reasonably practicable thereafter, the Licensed Category 1 Joint Team will review and update the Licensed Category 1 Development Plan for the Lead Category 1 LP and the JSC will determine whether to approve such updated Licensed Category 1 Development Plan.  Thereafter, on an annual basis, the Licensed Category 1 Joint Team will review and update each Licensed Category 1 Development Plan (including the Licensed Category 1 Development Budget set forth therein) based on the currently available information and data and the JSC will review, discuss, and determine whether to approve any such update that is material.

 

5.1.4.

Development Diligence Obligations.

 

5.1.4.1.

Candidate Category 1 Development Diligence.  On a Candidate Category 1 Target‑by‑Candidate Category 1 Target basis, during the Candidate Category 1 Development Term for a Candidate Category 1 Target, (a) Wave (itself or through its Affiliates or by permitted subcontracting in accordance with Section 5.6 (Third Parties)) will use [***], and (b) each Party (itself or through its Affiliates or by permitted subcontracting in accordance with Section 5.6 (Third Parties)) will use [***].  

 

5.1.4.2.

Licensed Category 1 Development Diligence.  On a Licensed Category 1 Target‑by‑Licensed Category 1 Target basis, during the Licensed Category 1 Development Term for a Licensed Category 1 Target, (a) the Development Lead for such Category 1 Target (itself or through its Affiliates or by permitted subcontracting in accordance with Section 5.6 (Third Parties)) will use [***]; and (b) each Party (itself or through its Affiliates or by permitted subcontracting in accordance with Section 5.6 (Third Parties)) will use [***].

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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5.1.4.3.

Breach of Licensed Category 1 Development Diligence Obligations.  [***].  

 

5.1.5.

Category 1 Development Expenses.  Wave will be responsible for [***] of all costs and expenses incurred by or on behalf of Wave in furtherance of the activities for which Wave is responsible under each Candidate Category 1 Development Plan.  Takeda will be responsible for all FTE Costs incurred by or on behalf of Takeda in furtherance of those activities for which Takeda is responsible under each Candidate Category 1 Development Plan.  Wave will reimburse Takeda in accordance with Section 11.5 (Other Amounts Payable) for any reasonable Out‑of‑Pocket Costs incurred by Takeda in furtherance of those activities for which Takeda is responsible under each Candidate Category 1 Development Plan in accordance with the budget set forth therein.  The Parties will share the Eligible Development Expenses incurred in connection with the performance of Development activities for each Licensed Category 1 Compound, Licensed Category 1 Product, and Companion Diagnostic directed to each Licensed Category 1 Target as set forth in Section 11.3.2 (Eligible Development Expenses for Licensed Category 1 Targets).

 

5.1.6.

Category 1 Development Reports.  On a Category 1 Target‑by‑Category 1 Target basis, each Party will keep the JSC (and the Licensed Category 1 Joint Team, with respect to Licensed Category 1 Targets) informed regarding the progress of Development activities for the corresponding Category 1 Development Program during the Category 1 Development Term.  In addition, the Development Lead will provide to the JSC and the Licensed Category 1 Joint Team (if applicable) reasonably in advance of each meeting of the JSC during the Category 1 Development Term a written report, in a format agreed upon by the JSC, reviewing results, progress against timelines in the applicable Category 1 Development Plan, and Development activities planned to be undertaken for all Category 1 Compounds, Category 1 Products, and Companion Diagnostics directed to the applicable Category 1 Target, including, for each Category 1 Development Program, a reasonable summary of results, information, and data generated from Clinical Studies for all such Category 1 Compounds, Category 1 Products, and Companion Diagnostics directed to the applicable Category 1 Target, any activities planned with respect to Development going forward under such Category 1 Development Program (including, for example, updates regarding regulatory matters and Development activities for the next Calendar Quarter), challenges anticipated, and updates regarding intellectual property issues (such report, a “Category 1 Development Report”).  During the Category 1 Development Term, each Party will promptly share with the other Party all other material developments and information that it comes to possess relating to the Development of any Category 1 Compounds, Category 1 Products, or Companion Diagnostics directed to such Category 1 Target, including Safety Concerns for Category 1 Compounds or Category 1 Products, or Companion Diagnostics directed to such Category 1 Target and any additional information regarding such Development activities with respect to Category 1 Compounds, Category 1 Products, or Companion Diagnostics directed to such Category 1 Target as reasonably requested by the other Party through the JSC and the Licensed Category 1 Joint Team (if applicable) from time to time to the extent and in the form readily available to such Party and transferable to the other Party.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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5.1.7.

Licensed Category 1 Transition Plan.  In the event that the JSC determines that the Development Lead for any Licensed Category 1 Target will transition from one Party to the other Party, then no later than [***] days following the date of the JSC’s decision, the Licensed Category 1 Joint Team will prepare a plan for the transition from such Party to the other Party of all further Development and regulatory activities for Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to the applicable Licensed Category 1 Target, including any required technology transfer (for each Licensed Category 1 Target, a “Licensed Category 1 Transition Plan”).  Each Licensed Category 1 Transition Plan will include (a) the assignment from the applicable Party to the other Party of all INDs, Regulatory Approvals, Regulatory Materials, and other regulatory documentation related to Licensed Category 1 Compounds, Licensed Category 1 Products, and Companion Diagnostics directed to the applicable Licensed Category 1 Target, and (b) a detailed budget for such activities, that takes into account the expected costs of such activities, together with a forecast for each Calendar Quarter and a long range forecast (for each Licensed Category 1 Target, the “Licensed Category 1 Transition Budget”). The JSC will review, discuss, and determine whether to approve each such Licensed Category 1 Transition Plan.  Each Party will use Commercially Reasonable Efforts to complete the activities for which it is responsible under each Licensed Category 1 Transition Plan.

5.2.

Research Activities for Licensed Category 2 Targets.

 

5.2.1.

Licensed Category 2 Research Overview.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, during the Licensed Category 2 Research Term for each Licensed Category 2 Target, unless otherwise agreed by the JSC, Wave will lead the pre‑clinical and non‑clinical Development for all Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to the applicable Licensed Category 2 Target in accordance with this Agreement, including the applicable Licensed Category 2 Research Plan (each, a “Licensed Category 2 Research Program”).  Notwithstanding the foregoing, the Parties may agree upon certain activities that Takeda will conduct under a Licensed Category 2 Research Plan for a Licensed Category 2 Program.  Each Licensed Category 2 Research Program will include the performance of all activities reasonably necessary to Develop at [***] directed to the corresponding Licensed Category 2 Target through [***].  Each Party will conduct all Development of Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to the applicable Licensed Category 2 Target as part of the applicable Licensed Category 2 Research Program and in accordance with the applicable Licensed Category 2 Research Plan and will not conduct any Development activities for such Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics outside of the applicable Licensed Category 2 Research Program or other than as set forth under such Licensed Category 2 Research Plan.

 

5.2.2.

Licensed Category 2 Research Term.  The Parties will perform Development activities under the Licensed Category 2 Research Plans only during the Initial Licensed Category 2 Research Term, unless during the [***] day period prior to the expiration of the Initial Licensed Category 2 Research Term Takeda requests in writing an extension of such initial term for any then-ongoing Licensed Category 2 Research Program for which one or both Parties is pursuing activities under the applicable

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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Licensed Category 2 Research Plan, which written request will specify the Licensed Category 2 Research Plan under which Takeda wishes to extend activities and the time period for which Takeda wishes to extend the performance of such activities (the “Category 2 Target Specific Extension”), provided that such time period may not exceed a period of two (2) additional years following the Initial Licensed Category 2 Research Term.  If Takeda so requests during such sixty (60) day period, then Wave will and Takeda may (to the extent allocated to Takeda in any applicable Licensed Category 2 Research Plan) continue to perform Development activities for such specified Licensed Category 2 Research Programs under the applicable Licensed Category 2 Research Plans during the Category 2 Target Specific Extension.

 

5.2.3.

Licensed Category 2 Research Plans.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, no later than thirty (30) days after the JSC’s approval of a Proposed Category 2 Target as a Licensed Category 2 Target in accordance with Section 4.1 (Proposed Category 2 Targets), the applicable Development Lead will prepare, and the JSC will determine whether to approve, an individualized research plan for all Development activities to be conducted by the Parties for Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to each Licensed Category 2 Target during the Licensed Category 2 Research Term (each a “Licensed Category 2 Research Plan”).  Each Licensed Category 2 Research Plan and each update thereto will include: (a) all Development, Manufacturing, and regulatory activities (if any) to be performed by the Parties through the Completion of the IND‑Enabling Studies for the first Major Market Country for Licensed Category 2 Compound and Licensed Category 2 Products directed to such Licensed Category 2 Target; (b) the allocation of responsibilities between Parties of the activities set forth under such Licensed Category 2 Research Plan; (c) a detailed budget for such activities that takes into account the expected costs of such activities; (d) a three (3) year forecast (such three (3) year forecast to include a quarterly budget for the first year and an annual forecast for the remaining two (2) years) (collectively, for each Licensed Category 2 Target, the “Licensed Category 2 Research Budget”); and (e) identified criteria for the advancement of Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to each Licensed Category 2 Target into the next phase of Development, including the criteria for the commencement of any Clinical Study of any Licensed Category 2 Product.  On an annual basis, the Category 2 Research Committee will review and update each Licensed Category 2 Research Plan (including the Licensed Category 2 Research Budget) based on the currently available information and data and the JSC will review, discuss, and determine whether to approve any such update that is material.  The Licensed Category 2 Research Budget will be prepared by [***].  The Parties agree that, notwithstanding anything in this Agreement to the contrary, [***].  In addition, Wave will not be required to perform any work that is not contemplated by a Licensed Category 2 Research Plan or that would impose any additional financial or other resource obligations beyond the scope of those required to perform the then-current Licensed Category 2 Research Plan, unless such additional scientific work is reflected in an amendment to the Licensed Category 2 Research Plan (including an updated Licensed Category 2 Research Budget) agreed by each Party and Wave’s FTE Costs and Out-of-Pocket Costs therefor are funded by Takeda.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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5.2.4.

Research Diligence Obligations.

 

5.2.4.1.

Licensed Category 2 Research Diligence.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, during the Licensed Category 2 Research Term, each Party (itself or through its Affiliates or by permitted subcontracting in accordance with Section 5.6 (Third Parties)) will use [***].  Without limiting the generality of the foregoing, during the Licensed Category 2 Research Term, the applicable Development Lead will use [***].

 

5.2.4.2.

Breach of Licensed Category 2 Research Diligence Obligations.  [***].  

 

5.2.5.

Licensed Category 2 Research Expenses.  During each twelve (12) month period of the Licensed Category 2 Research Term, Wave will carry forward any unspent amounts paid by Takeda for activities under the Licensed Category 2 Research Plans during such twelve (12) month period and apply such amounts against Licensed Category 2 Research Expenses incurred in the next twelve (12) month period before Takeda is obligated to reimburse Wave for excess expenditures in such twelve (12) month period.  Wave will not be obligated to reimburse Takeda for any unspent amounts remaining at the end of the Licensed Category 2 Research Term that have been paid by Takeda for activities under the Licensed Category 2 Research Plans for Licensed Category 2 Targets.

 

5.2.6.

Licensed Category 2 Research Reports.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, each Party will keep the JSC (and the Category 2 Research Committee during the Licensed Category 2 Research Term) informed regarding the progress of Development activities for the corresponding Licensed Category 2 Research Program during the Licensed Category 2 Research Term.  In addition, the Development Lead will provide to the JSC and the Category 2 Research Committee (if applicable) reasonably in advance of each meeting of the JSC during the Licensed Category 2 Research Term a written report reviewing results, progress against timelines in the applicable Licensed Category 2 Research Plan, and Development activities planned to be undertaken for all Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to the applicable Licensed Category 2 Target, a reasonable summary of results, information, and data generated from non‑clinical studies for all such Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to the applicable Category 1 Target, any activities planned with respect to Development going forward under such Licensed Category 2 Research Program (including, for example, updates regarding Development activities for the next Calendar Quarter), challenges anticipated, and updates regarding intellectual property issues (such report, a “Licensed Category 2 Research Report”).  During the Licensed Category 2 Research Term, each Party will promptly share with the other Party all other material developments and information that it comes to possess relating to the Development of any Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics directed to such Licensed Category 2 Target, including Safety Concerns for Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics directed to such Licensed Category 2 Target and any additional information regarding such Development activities with respect to Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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directed to such Licensed Category 2 Target as reasonably requested by the other Party through the JSC and the Category 2 Research Committee (if applicable) from time to time to the extent and in the form readily available to such Party and transferable to the other Party.

5.3.

Development Activities for Licensed Category 2 Targets.

 

5.3.1.

Licensed Category 2 Development Overview.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, during the Licensed Category 2 Development Term, Takeda will Develop the Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target in the Field in the Territory in accordance with this Agreement, including the applicable Licensed Category 2 Development Plan (the “Licensed Category 2 Development Program”).

 

5.3.2.

Licensed Category 2 Transition Plan.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, no later than sixty (60) days prior to the anticipated completion of activities under each Licensed Category 2 Research Plan for a Licensed Category 2 Target, Wave will prepare a draft plan for the transition from Wave to Takeda of all further Development and regulatory activities for Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to the applicable Licensed Category 2 Target, including a draft IND for the first Licensed Category 2 Product directed to such Licensed Category 2 Target for the first Major Market Country (a “Lead Category 2 LP”) and any required technology transfer (for each such Licensed Category 2 Target, such plan and IND, collectively, a “Licensed Category 2 Transition Plan”).  Each Licensed Category 2 Transition Plan will include (a) the plan and timeline for the assignment from Wave to Takeda of all Regulatory Materials and other regulatory documentation (if any) related to Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to the applicable Licensed Category 2 Target, and (b) a detailed budget for such activities, that takes into account the expected costs of such activities, including a forecast for each Calendar Quarter and a long range forecast (for each Licensed Category 2 Target, the “Licensed Category 2 Transition Budget”).  The JSC will review, discuss, and determine whether to approve, each such Licensed Category 2 Transition Plan.  The Parties understand that a Licensed Category 2 Transition Plan, along with the Parties’ obligations thereunder, will commence after the Completion of the IND‑Enabling Studies for the Licensed Category 2 Compounds and Licensed Category 2 Products directed to such Licensed Category 2 Target for the first Major Market Country, and such obligations will continue beyond the transfer to Takeda of Regulatory Lead with respect thereto.  The Parties agree that, notwithstanding anything in this Agreement to the contrary, Wave will not be required to perform activities under a Licensed Category 2 Transition Plan unless Takeda fully funds Wave’s activities in accordance with and to the extent set forth in Section 5.3.5 (Licensed Category 2 Development Expenses) other than any costs or expenses of Wave or its Affiliates to the extent caused by Wave’s breach of this Agreement.    

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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5.3.3.

Licensed Category 2 Development Plan.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, promptly following commencement of the Licensed Category 2 Development Term for such Licensed Category 2 Target, Takeda will prepare and the JSC will review and discuss an individualized development plan for the Development of Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target (each a “Licensed Category 2 Development Plan”).  Each Licensed Category 2 Development Plan and each update thereto will include (a) all Development, regulatory, and Manufacturing activities to be performed in furtherance of seeking Regulatory Approval of Licensed Category 2 Compounds, Licensed Category 2 Products and Companion Diagnostics directed to such Licensed Category 2 Target in the Territory (which may include Development in China), (b) the allocation of responsibilities between the Parties of the activities set forth under such Licensed Category 2 Development Plan, including any preclinical or nonclinical studies to be performed by Wave during the Licensed Category 2 Development Term, and (c) a detailed budget for such activities to be performed by Wave.  The Parties agree that, notwithstanding anything in this Agreement to the contrary, Wave will not be required to perform activities under a Licensed Category 2 Development Plan unless Takeda fully funds Wave’s activities in accordance with and to the extent set forth in Section 5.3.5 (Licensed Category 2 Development Expenses) other than any costs or expenses of Wave or its Affiliates to the extent caused by Wave’s breach of this Agreement.  On at least an annual basis or more frequently as necessary, Takeda will update each Licensed Category 2 Development Plan based on the currently available information and data and provide a copy to the JSC for informational purposes only.

 

5.3.4.

Licensed Category 2 Development Diligence.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, Takeda (itself or through its Affiliates or Sublicensees) will use [***].  In addition, each Party (itself or through its Affiliates or by permitted subcontracting in accordance with Section 5.6 (Third Parties)) will use [***].

 

5.3.5.

Licensed Category 2 Development Expenses.  Takeda will be solely responsible for any documented FTE Costs and Out‑of‑Pocket Costs either Party incurs in furtherance of a Transition Plan for a Licensed Category 2 Target and will reimburse Wave for any such costs in accordance with Section 11.5 (Other Amounts Payable).  In addition, during the Licensed Category 2 Development Term, (a) Takeda will be responsible for [***] it incurs in the performance of Development activities related to Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to any Licensed Category 2 Target, and (b) Takeda will be solely responsible for any documented FTE Costs and Out‑of‑Pocket Costs that Wave incurs in furtherance of a Licensed Category 2 Development Plan for a Licensed Category 2 Target within the applicable budget plus Applicable Overruns (other than as a result of Wave’s breach of this Agreement) and will reimburse Wave for any such costs in accordance with Section 11.5 (Other Amounts Payable) to the extent such costs and overruns exceed Takeda’s obligations under Section 11.4.1.1 (Initial Licensed Category 2 Research Term).

 

5.3.6.

Licensed Category 2 Development Reports.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, Takeda will keep the JSC informed regarding the progress of Development activities for the corresponding Licensed

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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Category 2 Development Program during the Licensed Category 2 Development Term.  In addition, Takeda will provide to the JSC reasonably in advance of each meeting of the JSC during the Licensed Category 2 Development Term a written report reviewing results, progress against timelines in the applicable Licensed Category 2 Development Plan, and Development activities planned to be undertaken for all Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to the applicable Licensed Category 2 Target, including, for each Licensed Category 2 Development Program, a reasonable summary of results, information, and data generated from Clinical Studies for all such Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to the applicable Licensed Category 2 Target, any activities planned with respect to Development going forward under such Licensed Category 2 Development Program (including, for example, updates regarding regulatory matters and Development activities for the next Calendar Quarter) and challenges anticipated (such report, a “Licensed Category 2 Development Report”).  During the Licensed Category 2 Development Term, each Party will promptly share with the other Party all other material developments and information that it comes to possess relating to the Development of any Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics directed to such Licensed Category 2 Target, including Safety Concerns for Licensed Category 2 Compounds or Licensed Category 2 Products, or Companion Diagnostics directed to such Licensed Category 2 Target and any additional information regarding such Development activities with respect to Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics directed to such Licensed Category 2 Target as reasonably requested by the other Party through the JSC from time to time to the extent and in the form readily available to such Party and transferable to the other Party.  The Parties will share any Safety Concerns with respect to such Licensed Category 2 Compounds and Licensed Category 2 Products in accordance with the SDEA.  

 

5.3.7.

Wave Personnel.  On a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, during the period commencing after the completion of the activities under the Licensed Category 2 Transition Plan for a Licensed Category 2 Target and ending upon Regulatory Approval in each Major Market Country of the Lead Category 2 LP directed to such Licensed Category 2 Target, Takeda may request that Wave reasonably make available certain of its employees for consultation regarding the Development of or regulatory activities relating to Licensed Category 2 Compounds, Licensed Category 2 Products, or Companion Diagnostics directed to such Licensed Category 2 Target.  [***].

5.4.

Development Lead Responsibilities.  For each Collaboration Compound, Collaboration Product, and Companion Diagnostic for which such Party is the Development Lead, such Development Lead will be principally responsible for overseeing the execution of the applicable Development Plan, including researching and developing related Companion Diagnostics, preparing Clinical Study designs and protocols, sponsoring Clinical Studies, engaging CROs, and being primarily responsible for managing activities at Clinical Study sites.  Notwithstanding the foregoing, the non‑Development Lead with respect to a Collaboration Target may conduct Development activities for Collaboration Compounds, Collaboration Products, and Companion Diagnostics directed to such Collaboration Target to the extent set forth in, and in accordance with, the applicable Development Plan for such Collaboration Target.

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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5.5.

Scientific Records.  Each Party will maintain scientific records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with GLP, cGMP, and GCP with respect to activities intended to be submitted in regulatory filings (including INDs), all of which records will fully and accurately reflect all work done and results achieved in the performance of the Development activities and Clinical Studies by or on behalf of such Party with respect to Collaboration Compounds, Collaboration Products, and Companion Diagnostics directed to each Collaboration Target.

5.6.

Third Parties.  Each Party may utilize the services of Third Parties to perform its Development activities under this Section 5 (Development); provided that (a) such Party will require that each such Third Party operates in a manner consistent with the terms of this Agreement, and (b) such Party will remain at all times fully liable for its respective responsibilities under this Agreement and for the acts and omissions of such Third Parties under this Agreement.  Each Party will require that any Third Party agreement utilized to perform any Development activities under this Section 5.6 (Third Parties) is engaged by such Party pursuant to an agreement that (i) includes confidentiality and non‑use provisions that are no less stringent than those set forth in Section 12.1 (Nondisclosure and Non‑Use Obligations) (but of duration customary in confidentiality agreements entered into for a similar purpose); and (ii) assigns to such Party ownership of, or grants to such Party an irrevocable, perpetual, fully‑paid, worldwide, fully sublicensable license (through multiple tiers) under and to, any Know‑How or Patents that are developed by such Third Party in the performance of its obligations under such agreement and are reasonably necessary or reasonably useful to Exploit Collaboration Compounds, Collaboration Products, or Companion Diagnostics directed to the applicable Collaboration Target in the Field in the Territory (which license must be exclusive with respect to any Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target, but may be non-exclusive with respect to such Third Party’s background technology and improvements thereof to the extent incorporated in any Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Collaboration Target).  Each Party will be solely responsible for direction of and communications with each such Third Party, but such Party will provide the other Party through the JSC a reasonably detailed updates regarding any such activities from time to time.

5.7.

Technical Failure.

 

5.7.1.

Effects of Technical Failure.  On a Collaboration Target‑by‑Collaboration Target basis, if the JSC determines that a Technical Failure has occurred with respect to such Collaboration Target during the Candidate Category 1 Development Term (with respect to Candidate Category 1 Targets) or during the Licensed Category 2 Research Term (with respect to Licensed Category 2 Targets), [***] (a) Takeda’s Option with respect to such Candidate Category 1 Target will expire, (b) the Option Exercise Period with respect to such Candidate Category 1 Target will terminate effective as of the date of such written notice, (c) each Party’s rights and obligations under this Agreement with respect to such Collaboration Target and any Collaboration Compounds, Collaboration Products, or Companion Diagnostics directed to such Collaboration Target, in each case, will terminate effective as of the date the JSC determines that a Technical Failure has occurred with respect to such Collaboration Target and thereafter such Collaboration Target will become a “Terminated Target” and the Collaboration Compounds, Collaboration Products, or Companion Diagnostics directed to such Collaboration Target will become “Reversion Products”  (including the exclusivity provisions set forth in Section 13.6.1 (Exclusivity)), (d) the effects of

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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termination set forth in Section 16.6 (Effects of Termination by Wave for Cause or Takeda for Convenience), as applicable, will apply to such Terminated Target and Reversion Products, and (e) Wave will thereafter be free to directly, or indirectly through one or more Third Parties, Exploit any compounds, products, or companion diagnostics directed to such Collaboration Target without any further obligation to Takeda.

 

5.7.2.

[***].

 

5.7.3.

[***].

5.8.

[***].

6.

REGULATORY MATTERS

6.1.

Regulatory Lead Responsibilities.  Subject to Section 8.6 (Recalls, Market Withdrawals, or Corrective Actions), the Regulatory Lead will be solely responsible for all regulatory matters in the Territory relating to the Collaboration Compounds, Collaboration Products, and Companion Diagnostics for which such Party is the Regulatory Lead.  The Regulatory Lead will own all INDs, NDA, Regulatory Approvals, Regulatory Materials, and related regulatory documents in the Territory with respect to such Collaboration Compounds, Collaboration Products, and Companion Diagnostics (in each case, as applicable), including any drug master files maintained by such Regulatory Lead solely with respect thereto in the Territory.  Upon approval of the JSC, the role of Regulatory Lead may transition from one Party to the other Party.

6.2.

Assignment of Regulatory Materials.  On a Licensed Target‑by‑Licensed Target basis, promptly following transition to Takeda of Regulatory Lead with respect to a Licensed Target and all Licensed Compounds, Licensed Products, and Companion Diagnostics directed to such Licensed Target (for clarity, including any HTT Compounds, HTT Products, and any Companion Diagnostics related thereto):  (a) within sixty (60) days following the such transition to Takeda of Regulatory Lead Wave will send a letter to the each Regulatory Authority in the Territory to transfer and assign to Takeda Wave’s entire right, title, and interest in and to all Regulatory Approvals with respect to all such Licensed Compounds, Licensed Products, and Companion Diagnostics directed to such Licensed Target, and (b) within thirty (30) days following such transition to Takeda, (i) Wave will transfer and assign to Takeda Wave’s entire right, title, and interest in and to all INDs, NDAs, other Regulatory Materials, and other regulatory documentation in the Territory with respect to such all Licensed Compounds, Licensed Products, and Companion Diagnostics directed to such Licensed Target that is in the possession and control of Wave, excluding any drug master files maintained by Wave or a Third Party solely with respect thereto, and (ii) the Parties will complete all other transition activities within thirty (30) days of such transition to Takeda of Regulatory Lead.

6.3.

Drug Master Files.  If Takeda does not have access to or rights to cross‑reference any drug master files maintained by any Third Party (including any contract manufacturer) pursuant to Section 6.7 (Right of Reference) reasonably sufficient to permit Takeda to exercise its rights and comply with its regulatory obligations, in each case, in connection with the Development, Manufacture, and Commercialization of Collaboration Compounds, Collaboration Products, and Companion Diagnostics directed to any Collaboration Target under this Agreement, then, (a) with respect to any agreement between Wave and any such Third Party that exists as of the Effective Date, Wave will use Commercially Reasonable Efforts to secure for Takeda such reasonably

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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sufficient access to or rights to cross‑reference any such drug master files maintained by such Third Party, and (b) with respect to any agreement between Wave and any such Third Party that is entered into on or after the Effective Date, Wave will secure for Takeda such reasonably sufficient access to or rights to cross‑reference any such drug master files maintained by such Third Party.

6.4.

Communications with Regulatory Authorities.  Each Regulatory Lead will provide the JSC for its review and discussion with a brief description in English of the principal issues raised in each Material Communication with Regulatory Authorities with respect to any Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to a Collaboration Target for which such Party is the Regulatory Lead.  The Regulatory Lead will provide such descriptions of such Material Communications to the JSC within fifteen (15) Business Days after receipt thereof, if related to any Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to a Category 1 Target, and as part of the quarterly updates regarding Development activities described in Section 5.2.6 (Licensed Category 2 Research Reports) or Section 5.3.6 ( Licensed Category 2 Development Reports), as applicable, if related to any Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to any Licensed Category 2 Target.  [***].

6.5.

Regulatory Meetings.  Each Regulatory Lead will provide the other Party with reasonable advance notice of all meetings with the Governmental Authorities in the Territory pertaining to each Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to each Collaboration Target for which such Party is the Regulatory Lead, or with as much advance notice as practicable under the circumstances.  [***].  

6.6.

Submissions.  Each Regulatory Lead will provide the other Party, through the JSC, with written notice of each of the following events with regard to each Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to each Collaboration Target for which such Party is the Regulatory Lead (a) within a reasonable period of time following the occurrence thereof (but in any event no later than thirty (30) days thereafter), to the extent notice was not previously provided:  (i) the submission of any filings or applications for Regulatory Approval (other than INDs) of such Collaboration Compounds, Collaboration Products, or Companion Diagnostics in the Territory to any Regulatory Authority; and (ii) receipt or denial of Regulatory Approval for any such filings or applications for Collaboration Products or Companion Diagnostics in the Territory; and (b) on a quarterly basis, (i) all IND materials (as well as orphan drug applications and designations) that were filed for such Collaboration Compounds, Collaboration Products, or Companion Diagnostics during such preceding Calendar Quarter and (ii) a summary of all INDs anticipated to be filed within the upcoming Calendar Quarter, in each case ((i) and (ii)), will be provided electronically; provided, however, that each Party will inform the other Party of such event under (a) or (b) prior to public disclosure of such event by such Party.  [***].

6.7.

Right of Reference. Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected, or otherwise generated in the conduct of any Clinical Studies, or early access/named patient programs for the Collaboration Compounds, Collaboration Products, or Companion Diagnostics directed to a Collaboration Target included in or used in support of any regulatory filing, Regulatory Approval, drug master

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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file or other regulatory documentation (including orphan drug applications and designations) Controlled by such Party or its Related Parties that relates to any Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to a Collaboration Target solely for the purpose or obtaining or maintaining any Regulatory Approval of a Collaboration Product or Companion Diagnostic directed to a Collaboration Target.  In addition, upon the reasonable request of the other Party (on behalf of itself or a Sublicensee), each Party will provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States) that the other Party may rely on, and the Regulatory A