Amended and Restated License Agreement By and Between Ionis Pharmaceuticals, Inc. and Otsuka Pharmaceutical Co., Ltd.
CONFIDENTIAL
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Exhibit 10.2
Certain portions of this exhibit, marked by [***], have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Amended and Restated License Agreement
By and Between
Ionis Pharmaceuticals, Inc.
and
Otsuka Pharmaceutical Co., Ltd.
Dated June 18, 2024
TABLE OF CONTENTS
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ARTICLE 1 OVERVIEW
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1
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1.1
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Development and Commercialization
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1 | |
1.2
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Governance
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2
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1.3
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Purpose
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2
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ARTICLE 2 LICENSES
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2
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2.1
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License Grants to Otsuka
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2
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2.2
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License Grant to Ionis
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2
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2.3
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Sublicensing and Subcontracting Terms
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3
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2.4
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Collaboration Technology Enabling License
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3
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2.5
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No Other Rights and Retained Rights; Negative Covenant
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4
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2.6
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Existing Third-Party IP Agreements
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4
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2.7
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New Third-Party IP Agreements
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5
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2.8
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Right of First Negotiation for Follow-On Products
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6
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ARTICLE 3 TECHNOLOGY TRANSFER
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8
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3.1
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Initial Know-How Transfer
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8
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3.2
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Technology Transfer Costs
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8
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ARTICLE 4 DEVELOPMENT
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8 | ||
4.1
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Development Diligence Obligations
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8
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4.2
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Development Plans
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9 | |
4.3
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Otsuka Territory-Specific Development Plans
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10 | |
4.4
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Development Costs
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12 | |
4.5
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Development Reports
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16 | |
4.6
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Development Records; Cooperation
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16 | |
4.7
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Data Transfer
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17 | |
ARTICLE 5 REGULATORY AFFAIRS
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17 | ||
5.1
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Regulatory Responsible Party
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17 | |
5.2
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Europe Regulatory Subcommittee
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17 | |
5.3
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Correspondences with Regulatory Authorities
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18 | |
5.4
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Regulatory Meetings
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18 | |
5.5
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Regulatory Submissions
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18 | |
5.6
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Cooperation
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18 | |
5.7
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Cost of Regulatory Activities
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19 | |
5.8
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No Harmful Actions
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19 |
2
5.9
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Right of Reference
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19 | |
5.10
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Pharmacovigilance; Safety Information
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20 | |
5.11
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Pharmacovigilance Subcommittee
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20 | |
5.12
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Ionis Internal Oligonucleotide Safety Database
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21 | |
5.13
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Recall, Withdrawal, or Field Alerts
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21 | |
ARTICLE 6 COMMERCIALIZATION AND MEDICAL AFFAIRS
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22 | ||
6.1
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Commercialization Responsibilities for Licensed Product
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22 | |
6.2
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Commercialization and Medical Affairs Reporting
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22 | |
6.3
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Pricing
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23 | |
6.4
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Brand Strategy and Operating Plans.
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23 | |
6.5
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Otsuka Commercialization Diligence Obligation
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24 | |
6.6
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Medical Affairs Plans.
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24 | |
6.7
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Standards of Conduct; Compliance
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25 | |
6.8
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Product Materials
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25
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6.9
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Diversion
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26 | |
ARTICLE 7 MANUFACTURING
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26 | ||
7.1
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Responsibility
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26 | |
7.2
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Supply and Quality Agreements; Manufacturing Costs
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27 | |
7.3
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Audits and Inspections
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28 | |
7.4
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Manufacturing Technology Transfer
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29 | |
ARTICLE 8 GOVERNANCE
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29 | ||
8.1
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Executive Committee.
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29 | |
8.2
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Joint Steering Committees
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30 | |
8.3
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Subcommittees
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34 | |
8.4
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Additional Participants
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35
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8.5
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Decision-Making
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35 | |
8.6
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Resolution of Committee Disputes
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36 | |
8.7
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Day-to-Day Responsibilities
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37 | |
8.8
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Alliance Manager
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37 | |
ARTICLE 9 PAYMENTS
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37 | ||
9.1
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Upfront Payment
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37 | |
9.2
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Milestone Payments
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37 | |
9.3
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Royalties
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39 | |
9.4
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Other Amounts Payable
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42 | |
9.5
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Financial Records and Audits
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42 |
3
9.6
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No Refunds
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42 | |
9.7
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Accounting Standards
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42 | |
9.8
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Method of Payment; Exchange Rate
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43 | |
9.9
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Blocked Payments
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43 | |
9.10
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Taxes
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43 | |
9.11
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Late Payments; Disputed Payments
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44 | |
ARTICLE 10 INTELLECTUAL PROPERTY
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44 | ||
10.1
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Inventions
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44 | |
10.2
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Patent Prosecution
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46 | |
10.3
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Enforcement Against Third Party Infringement or Misappropriation
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48 | |
10.4
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Defense of Third-Party Patent Challenges
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49 | |
10.5
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Third Party Infringement Claims
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51 | |
10.6
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Patent Challenges of Third-Party Patent Rights
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51 | |
10.7
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Patent Term Extensions
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52 | |
10.8
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Unified Patent Court;
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52 | |
10.9
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Common Interest
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53 | |
10.10
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Product Trademarks
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53 | |
ARTICLE 11 REPRESENTATIONS, WARRANTIES, AND COVENANTS
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57 | ||
11.1
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Mutual Representations and Warranties
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57 | |
11.2
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Additional Ionis Representations and Warranties
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57 | |
11.3
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Additional Representations and Warranties
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60 | |
11.4
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Additional Covenants
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60 | |
11.5
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Disclaimer
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61 | |
11.6
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Limitation of Liability
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61 | |
ARTICLE 12 CONFIDENTIALITY
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62 | ||
12.1
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Duty of Confidence
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62 | |
12.2
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Confidential Information
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62 |
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12.3
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Exemptions
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63 | |
12.4
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Authorized Disclosures
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63 | |
12.5
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Publications
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65 | |
12.6
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Publicity; Use of Names
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65 | |
12.7
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Acknowledgement
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66 | |
ARTICLE 13 INDEMNIFICATION
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67 | ||
13.1
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Indemnification by Ionis
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67 | |
13.2
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Indemnification by Otsuka
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67 |
4
13.3
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Indemnification Procedure
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67 | |
13.4
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Insurance
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68 | |
ARTICLE 14 TERM AND TERMINATION
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68 | ||
14.1
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Term
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68 | |
14.2
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Termination for Material Breach
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68 | |
14.3
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Termination by Otsuka for Convenience
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69 | |
14.4
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Discontinuation of Development and Commercialization
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69 | |
14.5
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Termination For Patent Challenge
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69 |
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14.6
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Termination for Insolvency
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70 | |
14.7
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Rights in Bankruptcy
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70 | |
14.8
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Full Force and Effect During Notice Period
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70 | |
14.9
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Effects of Termination
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70 | |
14.10
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Survival; Accrued Rights
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75 | |
ARTICLE 15 DISPUTE RESOLUTION; GOVERNING LAW
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76 | ||
15.1
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Executive Officers; Disputes
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76 | |
15.2
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Arbitration
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76 | |
15.3
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Intellectual Property Disputes
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77 | |
15.4
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Equitable Remedies
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77 | |
15.5
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Governing Law; English Language
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77 | |
ARTICLE 16 MISCELLANEOUS
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78 | ||
16.1
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Assignment
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78 | |
16.2
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Entire Agreement; Amendment
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78 |
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16.3
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No Strict Construction; Interpretation
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79 |
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16.4
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Severability
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80 |
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16.5
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Force Majeure
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80 | |
16.6
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Notices
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80 | |
16.7
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Further Assurances
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81 | |
16.8
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Performance by Affiliates
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81 | |
16.9
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Agency
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81 | |
16.10
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Binding Effect; No Third-Party Beneficiaries or Obligors
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82 | |
16.11
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No Waiver
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82 | |
16.12
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Cumulative Remedies
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82 | |
16.13
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Counterparts
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82 |
5
AMENDED AND RESTATED LICENSE AGREEMENT
This Amended and Restated License Agreement (this “Agreement”) is made and entered into as of June 18, 2024 (the “Restatement Date”) between Ionis
Pharmaceuticals, Inc., a Delaware corporation, having its principal place of business at 0000 Xxxxxxx Xxxxx, Xxxxxxxx XX 00000 XXX (“Ionis”), and Otsuka Pharmaceutical Co., Ltd., a company organized and existing under the laws of Japan, having a place of business at 0-0, Xxxxx Xxxxxxx-xxxxx, Xxxxxxx-xx, Xxxxx 000-0000, Xxxxx (“Otsuka”). Xxxxx and Otsuka may be referred to in this Agreement individually as a “Party” and collectively as the “Parties.” Capitalized terms used in this Agreement, whether used in the singular or the plural, have the meaning set forth in Appendix 1 (Definitions). All
attached appendices and schedules are a part of this Agreement.
WHEREAS, Xxxxx possesses certain Patent Rights, Know-How, technology and expertise with respect to research, development, and manufacturing of drugs for the
treatment of HAE, and has regulatory and commercial capabilities in the Ionis Territory;
WHEREAS, Otsuka (itself and through its Affiliates) has expertise in the development and commercialization of biopharmaceutical products and has regulatory,
development, and commercial capabilities in the Otsuka Territory;
WHEREAS, Xxxxx and Otsuka entered into that certain License Agreement, dated as of December 15, 2023 (the “Original Effective Date” and such License Agreement, the “Original Agreement”) for the Development and Commercialization of the Licensed Products in the Europe Territory,
as set forth in, and subject to the terms of, the Original Agreement;
WHEREAS, the Original Agreement will continue to govern the Parties’ rights and obligations during the Original Agreement Term; and
WHEREAS, the Parties desire to amend and restate the Original Agreement from and after the Restatement Date in order to, among other things, expand Otsuka’s
rights to Develop and Commercialize the Licensed Products in the Asia Territory in addition to the Europe Territory, as set forth in, and subject to the terms of, this Agreement.
NOW THEREFORE, the Parties agree as follows:
ARTICLE 1
1.1 |
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1
1.2 |
Governance. The Parties have agreed to form a Europe joint steering committee and an Asia joint steering committee to oversee and coordinate the Development, Manufacturing, and Commercialization
activities with respect to the Licensed Products under this Agreement in the Europe Territory and Asia Territory, respectively, and an executive committee to resolve matters that are subject to approval, but are not unanimously agreed, by
such joint steering committees or other Subcommittees.
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1.3 |
Purpose. The purpose of this Article 1 (Overview) is to provide a high-level overview of the roles, responsibilities, rights, and obligations of each Party under this Agreement, and
therefore, this Article 1 (Overview) is qualified in its entirety by the more detailed provisions of this Agreement set forth below.
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ARTICLE 2
2.1 |
License Grants to Otsuka. Subject to the terms of this Agreement (including Xxxxx’ retained rights set forth in Section 2.5 (No Other Rights and Retained Rights; Negative Covenant)), Ionis
hereby grants to Otsuka:
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2.1.1 |
an exclusive, royalty-bearing license, with the right to grant sublicenses solely in accordance with Section 2.3.1(a) (Rights of Otsuka to Grant Sublicenses), under the Ionis Technology and the Unitary Product Trademarks, in each
case, to (a) Develop the Licensed Products in the Field in the Otsuka Territory in accordance with the Otsuka Territory-Specific Development Plans solely for Commercialization and for the conduct of Medical Affairs for such Licensed
Products in the Field in the Otsuka Territory and (b) Commercialize and conduct Medical Affairs for the Licensed Products in the Field in the Otsuka Territory. For clarity, the license grants under this Section 2.1.1 (License Grants
to Otsuka) do not include the right to Manufacture the Licensed Products.
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2.1.2 |
a non-exclusive, royalty-bearing license, with the right to grant sublicenses solely in accordance with Section 2.3.1(b) (Rights of Otsuka to Grant Sublicenses), under the Ionis Technology and the Unitary Product Trademarks
solely to (a) Package and Label the Licensed Products in the Field in the Territory and (b) Manufacture the Licensed Products in the Field in the Territory from and after the time Otsuka provides a Manufacturing Handover Notice, in each
case ((a) and (b)), solely for Commercialization and for the conduct of Medical Affairs for such Licensed Products in the Field in the Otsuka Territory.
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2.2 |
License Grant to Ionis. Subject to the terms of this Agreement, including Otsuka’s retained rights set forth in Section 2.5 (No Other Rights and Retained Rights; Negative Covenants), Otsuka
hereby grants to Ionis an exclusive, royalty-free, fully-paid, perpetual license, with the right to grant sublicenses through multiple tiers, under the Otsuka Technology solely to (a) Develop the Licensed Products in the Ionis Territory and
the Otsuka Territory; provided that, unless this Agreement has been terminated, any such Development in the Otsuka Territory will be conducted solely in accordance with the Cross-Territory Clinical
Development Plan and the Non-Clinical HAE Development Plans, (b) Manufacture the Licensed Products worldwide in accordance with this Agreement, and (c) Commercialize the Licensed Products in the Ionis Territory in accordance with this
Agreement and, subject to Section 14.9.5 (Sublicenses), worldwide following any termination of this Agreement.
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2
2.3 |
2.3.1 |
(a) |
Subject to the terms of this Agreement, Otsuka will have the right to grant sublicenses of the rights granted under Section 2.1.1 (License Grants to Otsuka) (i) [***], and (ii) [***].
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(b) |
Subject to the terms of this Agreement, Otsuka will have the right to grant sublicenses of the rights granted under Section 2.1.2 (License Grants to Otsuka) (i) [***], and (ii) [***].
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2.3.2 |
Right to Subcontract. Each Party may engage one or more Third Party subcontractors to perform services in furtherance of the performance of its obligations or exercise of its rights under this
Agreement, including any Third Party contract manufacturer, contract research organization, contract sales organization, wholesaler or distributor (including a distributor that is engaged to conduct promotional activities with respect to
the Licensed Products on such Party’s behalf and under such Party’s control) (“Subcontractors”); provided that (a) neither Party will
engage any such Subcontractor that has been Debarred/Excluded; and (b) no engagement of any such Subcontractors will relieve the engaging Party of its obligations under this Agreement or any liability hereunder.
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2.3.3 |
Sublicense and Subcontract Agreements. Each agreement pursuant to which a sublicense is granted to a Sublicensee by Otsuka pursuant to this Section 2.3 (Sublicensing and Subcontracting
Terms), each agreement pursuant to which a sublicense is granted to a Sublicensee by Ionis of the rights granted to it under Section 2.2 (License Grant to Ionis), and each agreement pursuant to which a Party engages any
Subcontractor, in each case after the Restatement Date and during the Term, will (a) be subject and subordinate to this Agreement, (b) be consistent with the terms of this Agreement, (c) include obligations of confidentiality and non-use
applicable to the Confidential Information of the other Party that are at least as stringent as those set forth in Article 12 (Confidentiality), and (d) include terms that are consistent with the intellectual property provisions set
forth in this Agreement. As soon as reasonably practicable after execution of any sublicense agreement with a Sublicensee after the Restatement Date, [***]. In addition, [***].
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2.3.4 |
Responsibility for Sublicensees and Subcontractors. Notwithstanding any sublicense, the sublicensing or subcontracting Party will remain primarily liable to the other Party for the performance of
all of its obligations under, and such Party’s compliance with all provisions of, this Agreement. Each Party agrees that it will be fully responsible and liable for any breach of the terms of this Agreement by any of its Sublicensees or
Subcontractors to the same extent as if such Party itself has committed any such breach.
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2.4 |
Collaboration Technology Enabling License. Subject to the terms and conditions of this Agreement (and without limiting the licenses granted to Otsuka under Section 2.1 (License Grants to
Otsuka)), Otsuka hereby grants Ionis a fully-paid, royalty-free, irrevocable, worldwide, non-exclusive, sublicensable (through multiple tiers) license under any Otsuka Collaboration Know-How and Otsuka Collaboration Patent Rights (excluding
any Product-Specific Patents) to Exploit products that include an oligonucleotide as an active pharmaceutical ingredient (other than a Licensed Product); provided that Ionis may only grant a
sublicense under the rights granted in this Section 2.4 (Collaboration Technology Enabling License) if such sublicense includes the grant of a license under Know-How or Patent Rights Controlled by Ionis or its Affiliates to Exploit
such products that include an oligonucleotide as an active pharmaceutical ingredient (other than a Licensed Product).
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3
2.5 |
2.5.1 |
No Other Rights and Retained Rights. Nothing in this Agreement will be interpreted to grant a Party any rights under any intellectual property rights owned or Controlled by the other Party,
including Ionis Technology or Otsuka Technology, in each case, that are not expressly granted herein, whether by implication, estoppel, or otherwise. Otsuka will not practice the Ionis Technology other than as expressly licensed and
permitted under this Agreement and Ionis will not practice the Otsuka Technology other than as expressly licensed and permitted under this Agreement. Any rights not expressly granted to a Party by the other Party under this Agreement are
hereby retained by such other Party. Without limiting the foregoing, (a) Ionis hereby expressly retains the right to perform (i) Development activities for the Licensed Products worldwide in accordance with the Cross-Territory Clinical
Development Plan and the Non-Clinical HAE Development Plans, (ii) Manufacturing activities worldwide, and (iii) Ionis’ other obligations under this Agreement, and (b) Otsuka hereby expressly retains the right to perform Development
activities for the Licensed Products in the Field in the Otsuka Territory in accordance with the Otsuka Territory-Specific Development Plans solely for Commercialization and for the conduct of Medical Affairs for such Licensed Products in
the Field in the Otsuka Territory and to Manufacture the Licensed Products in the Field in the Territory solely for Commercialization and for the conduct of Medical Affairs for such Licensed Products in the Field in the Otsuka Territory, in
each case, in accordance with this Agreement.
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2.5.2 |
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2.6 |
2.6.1 |
Compliance. Otsuka acknowledges and agrees that (a) the rights and licenses granted to Otsuka under this Agreement are subject to the applicable terms of all Existing Third-Party IP Agreements with
respect to the Ionis Technology that is being sublicensed thereunder to Otsuka, (b) Ionis’ ability to comply with its obligations, and grant rights and licenses to Otsuka, under this Agreement are limited by any and all requirements and
restrictions imposed on Ionis under the Existing Third-Party IP Agreements with respect to the Ionis Technology that is being sublicensed to Otsuka by Ionis under such Existing Third-Party IP Agreements, and (c) Ionis will not be required
to take any action or inaction pursuant to this Agreement that would cause Ionis to be in breach of any Existing Third-Party IP Agreement or to grant any rights to Otsuka hereunder that are in violation of, or inconsistent with, any
Existing Third-Party IP Agreement. Otsuka will abide by the applicable terms of the Existing Third-Party IP Agreements, and, subject to [***], the applicable terms of any amendments, in each case, to the extent such terms are disclosed in
the copies of the Existing Third-Party IP Agreements, and amendments thereto, that are provided or made available to Otsuka.
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4
2.6.2 |
Existing Third-Party IP Amendments. During the Term, Xxxxx will promptly furnish Otsuka with copies of any amendment to any Existing Third-Party IP Agreement to the extent related to any of the
rights sublicensed to Otsuka hereunder, from which copies Ionis may redact confidential or commercially sensitive information or other information that is not relevant to the rights sublicensed to Otsuka pursuant to the applicable Existing
Third-Party IP Agreement. During the Term, Ionis shall: (a) [***]; (b) [***]; (c) [***]; and (d) [***]. Notwithstanding any provision to the contrary in this Agreement, as between the Parties, [***] shall be solely responsible for the
payment of all license fees, royalties, milestone payments, and other payment obligations under all Existing Third-Party IP Agreements.
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2.7 |
2.7.1 |
Identification of New In-License Agreements. If either Party intends to obtain Control of any Patent Rights or Know-How from a Third Party (whether by acquisition or license) that such Party
believes are [***] to Exploit the Licensed Compound or a Licensed Product (other than in connection with a Change of Control of a Party or as a result of the acquisition by a Party of a Third Party by merger, acquisition, or similar
transaction or series of related transactions) (such Patent Rights and Know-How, “Identified Rights”), then such Party will notify the other Party of the Identified Rights.
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2.7.2 |
(a) |
Acquisition of Potential In-Licenses.
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(i) |
[***] that [***] in the Exploitation of a Licensed Product in [***] Territory, whether by license or acquisition, (each agreement to license or acquire such Identified Rights, a “Potential
In-License”) in accordance with this Section 2.7.2 (Potential In-Licenses). If [***] after the Restatement Date, then [***] will [***]. If [***] pursuant to this Section 2.7.2(a) (Acquisition of Potential
In-Licenses), then [***] with respect to [***] to Exploit the Licensed Products. [***] such Potential In-License will [***]. [***]. If the Identified Rights to be licensed or acquired under a Potential In-License would constitute Ionis Core
Technology or Ionis Manufacturing and Analytical Technology if such Identified Rights were Controlled by Ionis (any such Identified Rights, “Core or Manufacturing Identified Rights”)
then, [***], [***] will have the first right to enter into such Potential In-License (a “Core or Manufacturing Potential In-License”) in accordance with Section 2.7.2(c)(i)
([***] Potential In-Licenses).
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(ii) |
If either Party [***] and if the [***], then [***]. At either Party’s request if [***] in accordance with this Section 2.7.2(a)(ii) (Acquisition of Potential In-Licenses), the Parties will [***]. If [***], then the Potential
In-License [***] for all purposes of this Agreement. If [***], then Ionis will [***]. If Ionis [***] pursuant to this Section 2.7.2(a)(ii) (Acquisition of Potential
In-Licenses) and Ionis [***] in accordance with this Section 2.7.2(a)(ii) (Acquisition of Potential In-Licenses), then [***]. If Ionis [***], then Otsuka will [***] in
accordance with the terms of this Section 2.7.2(a)(ii) (Acquisition of Potential In-Licenses) and Otsuka will [***].
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5
(b) |
Collaboration In-Licenses. For any Potential In-License that [***] in accordance with Section 2.7.2(a) (Acquisition of Potential In-Licenses), and for [***], (i) such Potential In-License
will [***], (ii) the Party [***] will [***], to the extent set forth in Section 2.7.2(a)(ii) (Acquisition of Potential In-Licenses), (iii) the Patent Rights or Know-How in-licensed under such [***], and (iv) (A) each Party will
[***], and (B) the Parties will [***]. The Party that [***] will [***] pursuant to this Section 2.7.2(b) (Collaboration In-Licenses), and such other Party will [***].
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(c) |
[***] Potential In-Licenses.
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(i) |
If the [***] a Potential In-License [***], then (A) such Potential In-License [***], (B) subject to Section 2.7.2(c)(ii) ([***] Potential In-Licenses), the Patent Rights and Know-How in-licensed under such Potential In-License
[***], (C) except as set forth in clause (D) of this Section 2.7.2(c)(i) ([***] Potential In-Licenses), Ionis will [***] and, subject to Section 2.7.2(c)(ii) ([***] Potential In-Licenses), will [***]; provided that if such Potential In-License [***], then [***], and Ionis [***] in accordance with Section 2.7.2(c)(ii) ([***] Potential In-Licenses), then Otsuka [***], and (D) if such Potential
In-License (1) was [***] pursuant to Section 2.7.2(a) (Acquisition of Potential In-Licenses), (2) was not [***], and (3) is not [***], then [***] in accordance with this Agreement [***], and the terms of this Section 2.7.2
(Potential In-Licenses) [***]. If Ionis [***] in accordance with Section 2.7.2(a) (Acquisition of Potential In-Licenses), then Otsuka [***]. If Ionis [***], then Otsuka [***] in accordance with this Section 2.7.2(c)(i) ([***] Potential In-Licenses) and Otsuka will [***].
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(ii) |
If Ionis [***], then Ionis [***]. If Ionis [***] in accordance with Section 2.7.2(c)(i) ([***] Potential In-Licenses), then Ionis will [***]. Ionis may
[***]. Within [***], Otsuka will [***]. If Otsuka [***] in accordance with this Section 2.7.2(c)(ii) ([***] Potential In-Licenses), then such [***] and Section 2.7.2(b) (Collaboration In-Licenses) will apply, mutatis mutandis. If Otsuka [***] in accordance with this Section 2.7.2(c)(ii) ([***] Potential In-Licenses), then Otsuka [***].
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2.8 |
2.8.1 |
ROFN Exercise. If (a) during the period from the Original Effective Date until the [***] (such period, the “Europe ROFN Period”), Ionis
intends to grant rights to a Third Party that include the right to Commercialize [***] designed to bind to the RNA encoding PKK for the treatment of HAE (any such compound, a “Follow-On
Product”) in the Europe Territory or (b) during the period from the Restatement Date until the [***] (such period, the “Asia ROFN Period”; provided that [***] Ionis intends to grant rights to a Third Party that include the right to Commercialize a Follow-On Product in the Asia Territory, then, in each case ((a) or (b)) Ionis will provide to Otsuka (i) notice
of whether Ionis intends to grant Commercialization rights to such proposed Follow-On Product in the Europe Territory, Asia Territory or both (such applicable countries within the Europe Territory or the Asia Territory, the “ROFN Territory”; provided that the ROFN Territory will not include any countries within the Europe Territory if the Europe ROFN Period has
expired or any countries within the Asia Territory if the Asia ROFN Period has expired) and the proposed scope of Commercialization rights that Ionis proposes to grant, and (ii) an information package containing, to the extent such
information is in Ionis’ or its Affiliate’s Control: (A) summaries of [***], (B) information about [***], (C) a summary of [***], and (D) [***] related to the Follow-On Product to the extent necessary or reasonably useful for Otsuka to
evaluate whether to obtain rights with respect to Follow-On Product (“ROFN Notice and Package”). Promptly thereafter, Xxxxx will provide a high-level presentation to the JSCs (at a
joint meeting), if during the Europe ROFN Period, or to the Asia JSC, if during the Asia ROFN Period after expiration of the Europe ROFN Period, relating to the Follow-On Product and the rights Ionis proposes to grant. Otsuka will have an
exclusive right, exercisable no later than [***] after receipt of a ROFN Notice and Package from Ionis containing all information set forth in the foregoing clauses ((A) through (D)) to the extent such information is in Ionis’ or its
Affiliate’s Control, to notify Ionis in writing as to whether Otsuka desires to negotiate for such rights to Commercialize such Follow-On Product in the applicable ROFN Territory (a “ROFN
Exercise Notice”). During such [***], Ionis will [***].
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6
2.8.2 |
Negotiation. If Otsuka provides a ROFN Exercise Notice to Ionis within such [***], then the Parties will negotiate in good faith for [***] from the date of Ionis’ receipt of the ROFN Exercise
Notice, or such longer period as may be agreed upon in writing by the Parties (the “ROFN Negotiation Period”) the terms of a definitive agreement (or amendment to this Agreement)
pursuant to which Ionis would grant to Otsuka the rights to Commercialize (and, as agreed by the Parties, to otherwise Exploit) such Follow-On Product in the applicable ROFN Territory. Neither Party will have any obligation to enter into
any agreement or amendment to this Agreement granting rights to Otsuka to Commercialize or otherwise Exploit such Follow-On Product in the applicable ROFN Territory. If the ROFN Negotiation Period expires before the Parties have entered
into an agreement or amendment to this Agreement with respect to Otsuka’s Commercialization or other Exploitation of such Follow-On Product in the applicable ROFN Territory, and if such ROFN Negotiation Period [***] in such ROFN Territory,
then Ionis will have the right to negotiate and enter into an agreement with any Third Party with respect to a grant of rights to Exploit such Follow-On Product in such ROFN Territory [***]. If Xxxxx does not grant rights to a Third Party
that include the right to Commercialize such Follow-On Product in the applicable ROFN Territory [***], then the terms of this Section 2.8 (Right of First Negotiation for Follow-On Products) will [***]. If the [***] in such ROFN
Territory expires before the Parties have entered into an agreement or amendment to this Agreement with respect to Otsuka’s Commercialization or other Exploitation of such Follow-On Product in such ROFN Territory then Ionis will have no
further obligation to negotiate with Otsuka with respect to any grant of such rights to Otsuka and will be free to negotiate and enter into an agreement with any Third Party with respect to a grant of rights to Exploit such Follow-On
Product in such ROFN Territory.
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2.8.3 |
Follow-On Product Activities. If Xxxxx enters into an agreement with a Third Party granting any rights to Exploit a Follow-On Product, then all Development, Commercialization, and Medical Affairs
activities related to such Follow-On Product (“Follow-On Product Activities”) will be subject to the following: (a)
[***] related to such Follow-On Product; and (b) Ionis and its Affiliates shall conduct the Follow-On Product Activities independently of the activities under this Agreement and [***].
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7
ARTICLE 3
3.1 |
Initial Know-How Transfer. At a time period to be agreed upon by the Parties after the Restatement Date, Ionis will provide and transfer, and in any event will initiate such transfer within [***]
after the Restatement Date, to Otsuka copies of the Ionis Know-How (other than Ionis Manufacturing and Analytical Know-How, the transfer of which will be conducted pursuant to Section 7.4 (Manufacturing Technology Transfer)) that
(a) exists on the Restatement Date, (b) was not previously provided to Otsuka, and (c) is [***] to Develop, Commercialize or conduct Packaging and Labeling or Medical Affairs for a Licensed Product (such transfer, the “Initial Know-How Transfer”). Ionis may make such Ionis Know-How available in such reasonable form as maintained by Xxxxx. In addition to the Initial Know-How Transfer, upon Otsuka’s
reasonable request during the Term, Ionis will provide and transfer to Otsuka copies of or otherwise make available to Otsuka all Ionis Know-How (other than Ionis Manufacturing and Analytical Know-How) not previously provided to Otsuka
hereunder to the extent such Ionis Know-How is [***] to Develop, Commercialize or conduct Packaging and Labeling or Medical Affairs for a Licensed Product, including in accordance with Section 4.7 (Data Transfer), Section 5.6
(Cooperation), Section 6.1.2 (Commercialization in the Otsuka Territory), Section 6.2 (Commercialization and Medical Affairs Reporting), and Section 7.1.1 (Ionis Manufacturing) (the “Continuing Know-How Transfer,” and together with the Initial Know-How Transfer, the “Technology Transfer”).
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3.2 |
Technology Transfer Costs. Ionis will conduct the Technology Transfer, and will provide consultation and assistance with [***] to provide support set forth in Section 7.1.1 (Ionis
Manufacturing) (any such consultation, assistance, or support provided by [***]. Ionis will [***] in connection with the Initial Know-How Transfer, including, for clarity, [***]. In addition, Ionis will [***] in providing Requested
Assistance to Otsuka in connection with such Continuing Know-How Transfer; provided that, with respect to Requested Assistance related to [***] until [***] and, thereafter, [***]. After [***]. At
all times, (a) Otsuka will [***]. Ionis may [***] following [***]. Ionis shall [***]. Notwithstanding the foregoing, [***]. For clarity, the terms of this Section 3.2 (Technology Transfer Costs) shall not apply with respect to [***]
and, for clarity, the terms of this Section 3.2 (Technology Transfer Costs) shall not apply to [***]. Notwithstanding any provision to the contrary, Ionis’ obligations to conduct the Technology Transfer and provide Requested
Assistance will not require Ionis to conduct any additional Clinical Trials or generate any additional data or information that is not expressly contemplated by the Cross-Territory Clinical Development Plan or the Non-Clinical HAE
Development Plans. Notwithstanding any provision to the contrary in this Section 3.2 (Technology Transfer Costs), if Ionis provides to Otsuka any Requested Assistance or Continuing Know-How Transfer, in each case, related to the
Europe Territory, then to the extent such Requested Assistance or Continuing Know-How Transfer is applicable to the Asia Territory and to the extent feasible, Otsuka will seek such support or assistance from Otsuka’s Affiliates rather than
requesting additional Requested Assistance or a Continuing Know-How Transfer from Ionis.
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ARTICLE 4
4.1 |
Development Diligence Obligations. Xxxxx will be responsible for conducting the activities under the Cross-Territory Clinical Development Plan (other than with respect to Clinical Trial sites in
Japan, if applicable) and both of the Non-Clinical HAE Development Plans (other than with respect to any activities allocated to Otsuka under the Non-Clinical Asia HAE Development Plan) and will use Commercially Reasonable Efforts to carry
out such activities. For clarity, Ionis shall not conduct any [***]. Otsuka will be responsible for conducting the activities under the Europe Territory-Specific Development Plan, the Asia Territory-Specific Development Plan, and solely to
the extent any activities are allocated to Otsuka under the Non-Clinical Asia HAE Development Plan, the Non-Clinical Asia HAE Development Plan, [***]. Notwithstanding the foregoing, if, as provided in Section 4.4.1(c)(ii) (Shared
Development Costs), the Parties agree to update the Cross-Territory Clinical Development Plan (including the Shared Development Budget) to include [***], then Otsuka will [***]. Each Party will conduct all Development activities for which
it is responsible under this Agreement in a good scientific manner, in accordance with GLP and GCP, as applicable, and in compliance with Professional Requirements and Applicable Law.
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8
4.2 |
4.2.1 |
Cross-Territory Clinical Development Plan. The current development plan for the clinical Development activities for both the Europe Territory and the Ionis Territory is set forth on Schedule 4.2.1 (such development plan as it may be modified in accordance with the terms and conditions of this Agreement, the “Cross-Territory
Clinical Development Plan”). The current Cross-Territory Clinical Development Plan includes (and any updates to the Cross-Territory Clinical Development Plan will at all times include) all Clinical Trials that are intended to
support obtaining or maintaining Regulatory Approval for any Licensed Product in both the Europe Territory and the Ionis Territory (and Japan, if the Parties agree to include Clinical Trial sites in Japan for any Cross-Territory Clinical
Study as provided in Section 4.4.1(c)(ii) (Shared Development Costs)) (any such Clinical Trials, “Cross-Territory Clinical Studies”), including (a) all Cross-Territory
Clinical Studies that were ongoing as of the Original Effective Date (the “Ongoing Cross-Territory Studies”), (b) all Post-Approval Mandatory Studies that are (i) required to
support maintaining Regulatory Approval for any Licensed Product in both the Europe Territory and the Ionis Territory and (ii) designed to meet the requirements of the EMA for maintaining Regulatory Approval of the Licensed Product in the
Europe Territory (collectively ((i) and (ii)), “Post-Approval Cross-Territory Mandatory Studies”), and (c) all future Cross-Territory Clinical Studies for [***]. From time to time
during the Term, either Party may submit to the Europe JSC any proposed update to the Cross-Territory Clinical Development Plan to include additional Cross-Territory Clinical Studies, including the study designs for such additional
Cross-Territory Clinical Studies. In addition, each Party shall submit to the Europe JSC (or other designated Subcommittee) reasonably in advance proposed updates to the Cross-Territory Clinical Development Plan to take into account changed
circumstances, such as cessation of any Cross-Territory Clinical Study, or the need to amend any Cross-Territory Clinical Study, including amendments in response to Regulatory Authority requirements, for safety reasons or otherwise. The
Europe JSC will review, discuss, and determine whether to approve each update to the Cross-Territory Clinical Development Plan. Once reviewed and approved by the Europe JSC (or the Executive Committee, if the Europe JSC cannot agree), each
update to the Cross-Territory Clinical Development Plan will automatically become effective and supersede the previous Cross-Territory Clinical Development Plan, as of the date of such approval by the Europe JSC (or Executive Committee).
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4.2.2 |
(a) |
Europe Territory. The current development plan for all CMC Development and non-clinical Development, in each case, required to obtain and maintain Regulatory Approval for the Licensed Product for
the treatment of HAE in the Europe Territory is set forth on Schedule 4.2.2 (such development plan, as it may be modified in accordance with the terms and conditions of this
Agreement, the “Non-Clinical Europe HAE Development Plan”). From time to time during the Term, either Party may submit to the Europe JSC any proposed update to the Non-Clinical
Europe HAE Development Plan to include additional CMC Development or non-clinical Development activities required to obtain or maintain Regulatory Approval for the Licensed Product for the treatment of HAE in the Europe Territory. In
addition, each Party shall submit to the Europe JSC reasonably in advance proposed updates to take into account changed circumstances or the need to amend any CMC Development or non-clinical Development activities for the Licensed Product
for the treatment of HAE in the Europe Territory. The Europe JSC will review, discuss, and determine whether to approve each update to the Non-Clinical Europe HAE Development Plan. Once reviewed and approved by the Europe JSC (or the
Executive Committee, if the Europe JSC cannot agree), each update to the Non-Clinical Europe HAE Development Plan will automatically become effective and supersede the previous Non-Clinical Europe HAE Development Plan as of the date of such
approval by the Europe JSC (or Executive Committee).
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9
(b) |
Asia Territory. If any CMC Development or non-clinical Development is required by a Regulatory Authority in the Asia Territory to obtain and maintain Regulatory Approval for the Licensed Product
for the treatment of HAE in the Asia Territory and such Development activities are not set forth in the Non-Clinical Europe HAE Development Plan (such activities, “Asia-Specific
Non-Clinical HAE Development Activities”), then Otsuka may prepare and submit to the Asia JSC a written plan pursuant to which such Asia-Specific Non-Clinical HAE Development Activities will be conducted (such development plan, as
it may be updated in accordance with the terms and conditions of this Agreement, the “Non-Clinical Asia HAE Development Plan”). The Asia JSC will review, discuss, and determine
whether to approve the Non-Clinical Asia HAE Development Plan. From time to time during the Term, either Party may submit to the Asia JSC any proposed update to the Non-Clinical Asia HAE Development Plan to include additional Asia-Specific
Non-Clinical HAE Development Activities and the Asia JSC will review, discuss, and determine whether to approve such update to the Non-Clinical Asia HAE Development Plan. Once reviewed and approved by the Asia JSC (or the Executive
Committee, if the Asia JSC cannot agree), the initial Non-Clinical Asia HAE Development Plan and each update thereto will automatically become effective and supersede the previous Non-Clinical Asia HAE Development Plan as of the date of
such approval by the Asia JSC (or Executive Committee).
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4.3 |
4.3.1 |
Europe Territory-Specific Development Plan. Unless otherwise mutually agreed by the Parties, within [***], then Otsuka will prepare and submit to the Europe JSC a plan setting forth all Development
activities that are intended to support obtaining or maintaining Regulatory Approval for the Licensed Products solely in the Europe Territory other than the activities set forth in the Non-Clinical Europe HAE Development Plan (the “Europe Territory-Specific Development Plan”). If such plan is submitted by Otsuka, then the Europe JSC will review, discuss, and determine whether to approve the Europe
Territory-Specific Development Plan. Notwithstanding the foregoing or anything to the contrary in this Agreement, the Europe Territory-Specific Development Plan (if submitted by Otsuka) will at all times include Development activities that
are (i) necessary to obtain and maintain Regulatory Approval for at least one Licensed Product in [***] consistent with Otsuka’s obligations under Section 4.1 (Development Diligence Obligations) and (ii) not included in the
Cross-Territory Clinical Development Plan or the Non-Clinical Europe HAE Development Plan. For clarity, if no Development activities are necessary to obtain or maintain Regulatory Approval for at least one Licensed Product in [***], other
than the Development activities set forth in the Cross-Territory Clinical Development Plan or the Non-Clinical Europe HAE Development Plan, then Otsuka shall not be obligated to prepare or submit to the Europe JSC a Europe
Territory-Specific Development Plan for the HAE indication.
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10
4.3.2 |
Asia Territory-Specific Development Plan. Within [***] following the Restatement Date, Otsuka will prepare and submit to the Asia JSC a plan setting forth all Development activities that are
intended to support obtaining or maintaining Regulatory Approval for the Licensed Products solely in the Major Asian Countries, other than the activities set forth in the Non-Clinical Europe HAE Development Plan or, if applicable, the
activities set forth in the Non-Clinical Asia HAE Development Plan (the “Asia Territory-Specific Development Plan,” and together with the Europe Territory-Specific Development Plan
(if prepared by Otsuka), the “Otsuka Territory-Specific Development Plans”). The Asia JSC will review, discuss, and determine whether to approve the Asia Territory-Specific
Development Plan. Notwithstanding the foregoing or anything to the contrary in this Agreement, the Asia Territory-Specific Development Plan will at all times include Development activities that are (a) necessary to obtain and maintain
Regulatory Approval [***] consistent with Otsuka’s obligations under Section 4.1 (Development Diligence Obligations) and (b) not included in the Cross-Territory Clinical Development Plan or the Non-Clinical HAE Development Plans.
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4.3.3 |
Consistency with Cross-Territory Clinical Development Plan. The Europe Territory-Specific Development Plan and the Asia Territory-Specific Development Plan will each, at all times during the Term,
be consistent with the then-current Cross-Territory Clinical Development Plan, except to the extent such inconsistency is (a) necessary to conform with any written requirement from any Regulatory Authority or with any Applicable Law
(including compliance requirements) in the Europe Territory or the Asia Territory, as applicable, or (b) approved by the applicable JSC (or the Executive Committee, if the applicable JSC cannot agree) (in each case by unanimous Party Vote).
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4.3.4 |
Updates. At least [***] during the Term (and more frequently as may be necessary), Otsuka will prepare an update to the Asia Territory-Specific Development Plan and, if applicable, the Europe
Territory-Specific Development Plan, to amend or include additional Development activities to be conducted during the [***] Calendar Year that are intended to support obtaining or maintaining Regulatory Approval for the Licensed Products
solely in the Europe Territory or Asia Territory, as applicable, other than the activities set forth in the Non-Clinical HAE Development Plans (or otherwise update the Development activities under the applicable Otsuka Territory-Specific
Development Plan). The applicable JSC will review, discuss, and determine whether to approve each update to the Europe Territory-Specific Development Plan or the Asia Territory-Specific Development Plan. Once approved by the applicable JSC
(or the Executive Committee, if the applicable JSC cannot agree), the Europe Territory-Specific Development Plan and each update thereto or the Asia Territory-Specific Development Plan and each update thereto will automatically become
effective and, in the case of an update, supersede the previous Europe Territory-Specific Development Plan or Asia Territory-Specific Development Plan, as applicable, as of the date of such approval.
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4.4 |
4.4.1 |
(a) |
Ionis Costs. Ionis will be [***] responsible for all costs and expenses incurred in connection with the performance of the [***]. In addition, Ionis will be [***] responsible for all costs and
expenses incurred in connection with the performance of all activities under the [***].
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(b) |
Otsuka Costs. Otsuka will be [***] responsible for all costs and expenses incurred in connection with the performance of all activities under the [***]. In addition, Otsuka will reimburse Ionis for
[***].
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(c) |
(i) |
Subject to Section 4.4.1(c)(ii) (Shared Development Costs), with respect to (A) all Post-Approval Cross-Territory Mandatory Studies for the treatment of HAE that are included in the Cross-Territory Clinical Development Plan as of
the Original Effective Date and (B) any other Post-Approval Cross-Territory Mandatory Studies for the treatment of HAE or any Future Cross-Territory Studies, in each case ((A) and (B)), that are added to the Cross-Territory Clinical
Development Plan in accordance with Section 4.2.1 (Cross-Territory Clinical Development Plan), the Parties will share, [***], in each case, in accordance with the Cross-Territory Clinical Development Plan and Shared Development
Budget (such costs, “Shared Cross-Territory Development Costs”) in accordance with the terms of Section 4.4.3 (Shared Cross-Territory Development Costs).
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(ii) |
If (A) the Parties agree to update the Cross-Territory Clinical Development Plan (including the Shared Development Budget) to include Clinical Trial sites in Japan for any Cross-Territory Clinical Study and (B) the PMDA agrees in advance
that such Cross-Territory Clinical Study (including the Clinical Trial sites in Japan) will be sufficient to obtain Regulatory Approval in Japan for use of the Licensed Product without the need for additional Japan-only Clinical Trials,
then [***]; provided that, if a Cross-Territory Clinical Study has been initiated as of or after the Original Effective Date and is subsequently amended to include Clinical Trial sites in Japan,
then at the time the Parties agree to include Clinical Trial sites in Japan in such Cross-Territory Clinical Study, Ionis will provide to Otsuka a written report of the [***] (the “Ionis
Incurred Development Costs”). Such written report shall include [***]. Ionis will provide an invoice to Otsuka for [***] of the Ionis Incurred Development Costs, and Otsuka will pay such amount [***] after receipt of such invoice
[***]; provided that, if Otsuka disputes any invoiced amount, then Otsuka will pay the undisputed invoiced amount [***] and will pay any disputed amounts [***] following resolution of the dispute
and determination that such amounts are owed; and provided, further that Otsuka shall have the right to [***].
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12
4.4.2 |
(a) |
Shared Development Budget. The current budget for the Shared Cross-Territory Development Costs (such budget as it may be modified in accordance with the terms and conditions of this Agreement, the
“Shared Development Budget”) for the Post-Approval Cross-Territory Mandatory Studies that are included in the Cross-Territory Clinical Development Plan as of the Restatement Date
is set forth in Schedule 4.4.2 (Shared Development Budget). With respect to each other Post-Approval Cross-Territory Mandatory Study for the treatment of HAE and each Future
Cross-Territory Study that is subject to cost sharing by the Parties in accordance with Section 4.4.1(c) (Shared Development Costs), including any Cross-Territory Clinical Study that the Parties agree will include Clinical Trial
sites in Japan, the Europe JSC (or the Executive Committee if the Europe JSC cannot agree) will develop, discuss, and determine whether to approve an update to the Shared Development Budget at the time the Europe JSC (or Executive
Committee) reviews, discusses, and determines whether to approve the update to the Cross-Territory Clinical Development Plan applicable to such additional Cross-Territory Clinical Study. Any update to the Shared Development Budget will at
all times include a detailed written budget for the performance of all Future Cross-Territory Studies and any additional Post-Approval Cross-Territory Mandatory Studies for the treatment of HAE, in each case, that are included in the
Cross-Territory Clinical Development Plan (as updated). From time to time during the Term, either Party may submit to the Europe JSC any proposed update to the Shared Development Budget, including in connection with any update to the
Cross-Territory Clinical Development Plan or to address a potential Cost Overrun. The Europe JSC will review, discuss, and determine whether to approve each update to the Shared Development Budget. Once reviewed and approved by the Europe
JSC (or the Executive Committee if the Europe JSC cannot agree), each update to the Shared Development Budget will automatically become effective and supersede the previous Shared Development Budget, as of the date of such approval by the
Europe JSC (or Executive Committee).
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(b) |
Cost Overruns. Xxxxx (and Otsuka, if the Parties agree to include Clinical Trial sites in Japan in any Cross-Territory Clinical Study as provided in Section 4.4.1(c)(ii) (Shared Development Costs))
[***] for a given Calendar Year [***] for such Calendar Year. Ionis (and Otsuka, if applicable) will notify the Europe JSC (or any other designated Subcommittee) without undue delay if it reasonably anticipates that the Shared
Cross-Territory Development Costs incurred by the applicable Party are reasonably likely to exceed the applicable budgeted amounts under the then-current Shared Development Budget by more than [***] (a “Cost
Overrun”). Ionis (and Otsuka, if applicable) will include [***] and, to the extent reasonably possible, will [***]. Thereafter, the Europe JSC (or other designated Subcommittee) shall promptly hold an ad-hoc meeting to evaluate
whether there are mitigation measures to prevent the Cost Overrun, and if not, the Europe JSC (or other designated Subcommittee) will discuss what steps to take to address such Cost Overrun, including updating the Shared Development Budget
or the Cross-Territory Clinical Development Plan, as applicable. If the Europe JSC (or the Executive Committee if the Europe JSC cannot agree) does not approve an update to the Shared Development Budget to reflect the anticipated Cost
Overrun, then [***] and, to the extent [***]. For clarity, [***].
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13
4.4.3 |
Shared Cross-Territory Development Costs. The Parties will share, at the [***], all Shared Cross-Territory Development Costs incurred by or on behalf of Ionis or its Affiliates and by or on behalf
of Otsuka or its Affiliates (if the Parties agree to include Clinical Trial sites in Japan in any Cross-Territory Clinical Study as provided in Section 4.4.1(c)(ii) (Shared Development Costs)), in accordance with the Cross-Territory
Clinical Development Plan and the amount budgeted therefor in the Shared Development Budget, plus [***] (“Eligible Cross-Territory Development
Costs”). No later than [***] after the end of each Calendar Quarter, Ionis will deliver to Otsuka a written report specifying in reasonable detail the Eligible Cross-Territory Development Costs incurred by or on behalf of Ionis
during such Calendar Quarter, together with reasonable supporting documentation, and if Clinical Trial sites in Japan are included in any Cross-Territory Clinical Study, Otsuka will deliver to Ionis a written report specifying in reasonable
detail the Eligible Cross-Territory Development Costs incurred by or on behalf of Otsuka or its Affiliates during such Calendar Quarter, together with reasonable supporting documentation. Promptly thereafter, Ionis will submit to Otsuka an
invoice (and, if there has been any change to a Payment Form previously submitted, or if a previously submitted Payment Form has expired, an updated Payment Form) for Otsuka’s unpaid share (at the [***]) of such Eligible Cross-Territory
Development Costs (i.e., [***]) or, if applicable, Ionis will submit to Otsuka a statement of Ionis’ unpaid share (at the [***]) of such Eligible Cross-Territory Development Costs. No later than [***] after Otsuka’s receipt of such invoice
(and updated Payment Form, if applicable) for such Calendar Quarter, Otsuka will make a balancing payment to Ionis equal to Otsuka’s unpaid share of the total Eligible Cross-Territory Development Costs to effect the [***] for such Eligible
Cross-Territory Development Costs (or, if applicable, no later than [***] after Ionis’ submission of a statement to Otsuka, Ionis will make a balancing payment to Otsuka equal to Ionis’ unpaid share of the total Eligible Cross-Territory
Development Costs to effect the [***] for such Eligible Cross-Territory Development Costs); provided that, if Otsuka disputes any invoiced amount, then Otsuka will pay the undisputed invoiced amount
within such [***] and will pay any disputed amounts within [***] following resolution of the dispute and determination that such amounts are owed.
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4.4.4 |
(a) |
Shared Costs. At any time during the Term, either Party may propose that the Parties clinically Develop a Licensed Product [***]. Such Party will submit a proposal to the Europe JSC setting forth
the proposed clinical Development activities in the Europe Territory, Japan, or the Ionis Territory for such [***] and a timeline and budget for such activities (a [***]). The Europe JSC (or the Executive Committee if the Europe JSC cannot
agree) will review, discuss, and determine whether to approve such [***], either as proposed or as may be revised by agreement of the Europe JSC (or Executive Committee), within [***] of the submission thereof. If the Europe JSC (or
Executive Committee) approves such [***], as proposed or as revised per the agreement of the Parties, then (i) the Europe JSC (or Executive Committee) will approve an update to the Cross-Territory Clinical Development Plan in accordance
with Section 4.2.1 (Cross-Territory Clinical Development Plan) and to the Shared Development Budget in accordance with Section 4.4.2(a) (Shared Development Budget) to include any Future Cross-Territory Studies in the Europe
Territory, Japan, or the Ionis Territory (as applicable) for such [***] and (ii) the Parties will share the cost of any Eligible Cross-Territory Development Costs incurred in connection with the performance of such Future Cross-Territory
Studies in accordance with Section 4.4.3 (Shared Cross-Territory Development Costs).
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14
(b) |
[***] by Xxxxx. If the Europe JSC (or the Executive Committee if the Europe JSC cannot agree) does not approve a [***] for a given [***] or does not approve
an updated Cross-Territory Clinical Development Plan in accordance with Section 4.2.1 (Cross-Territory Clinical Development Plan) or Shared Development Budget in accordance with Section 4.4.2(a) (Shared Development Budget)
to include the Future Cross-Territory Studies for such [***], then (i) Ionis will have the right, but not the obligation, to proceed with the Development of such [***] in the Territory as contemplated by such [***] with such modifications
as Xxxxx xxxxx appropriate [***] (“Ionis [***]”) and such Development will be conducted outside the Cross-Territory
Clinical Development Plan; and (ii) notwithstanding the licenses, rights of reference, and other rights granted to Otsuka under this Agreement, Otsuka will not have any license or rights to use any Ionis [***] (including any right of
reference to use such Ionis [***] contained in the related Regulatory Submissions by Ionis and notwithstanding the inclusion of any such data in the Ionis Technology) in support of any Regulatory Submissions or Regulatory Approval for the
Licensed Product in the Europe Territory or in the Commercialization of such Licensed Product in the Europe Territory, unless and until [***], provided that Otsuka may use safety data in connection
with such Ionis [***] solely to satisfy any safety-related reporting obligations to Regulatory Authorities related to Licensed Products in the Europe Territory without [***]. For clarity, Ionis [***]. For further clarity, the terms of
clause (ii) in this Section 4.4.4(b) ([***] by Ionis) do not apply with respect to [***].
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(c) |
Otsuka Opt-In. If Ionis conducts any Ionis [***] pursuant to Section 4.4.4(b) ([***] by Ionis), then Ionis shall provide Development reports to Otsuka related to such Ionis [***] in
accordance with Section 4.5 (Development Reports), and Otsuka shall have the right, [***] to opt-in with respect to such Ionis [***] in accordance with this Section 4.4.4(c) (Otsuka Opt-In). Upon Otsuka’s written request,
Ionis shall provide to Otsuka a written report of the Internal Costs and External Costs, in each case, incurred directly by or on behalf of Ionis or its Affiliates as of the date of such written request in the performance of such Ionis
[***] (the “Ionis [***] Costs”). Such written report shall include supporting documentation of the External Costs
included within the Ionis [***] Costs. Otsuka shall have the right, exercisable during the [***] period after receipt of such report, to provide notice to Ionis that Otsuka wishes to share the costs of such Ionis [***] (“Opt-In Notice”). Following the receipt of an Opt-In Notice, Ionis shall provide an invoice to Otsuka for [***] of such Ionis [***] (“Opt-In Fee”) as follows: [***]. Otsuka shall pay the Opt-In Fee within [***] after receipt of such invoice and supporting documentation; provided that, if Otsuka disputes any
invoiced amount, then Otsuka will pay the undisputed invoiced amount within such [***] and will pay any disputed amounts within [***] following resolution of the dispute and determination that such amounts are owed. Following Otsuka’s
payment of the Opt-In Fee, (A) the Ionis [***] shall be deemed a Future Cross-Territory Study and will be added to the Cross-Territory Clinical Development Plan, (B) the Parties will share [***] all Internal Costs reasonably incurred and
External Costs incurred, in each case, directly by or on behalf of Ionis or its Affiliates in the performance of the Ionis [***] from the date on which Xxxxx provides a written report of the Ionis [***] Costs, (C) the applicable Ionis [***]
shall be included within Ionis Know-How and subject to the licenses in Section 2.1 (License Grants to Otsuka), and (D) the Ionis [***] included in related Regulatory Submissions will be subject to Otsuka’s right of use and right of
reference provided in Section 5.9 (Right of Reference).
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15
(d) |
Otsuka Use in the Asia Territory. For clarity, if Ionis Develops the Licensed Product in a [***] in accordance with Section 4.4.4(b) ([***] by Ionis), then (i) Otsuka will have the right,
at Otsuka’s [***], to Develop, seek Regulatory Approval for, and otherwise Exploit the Licensed Product in such [***] in the Asia Territory in accordance with this Agreement, (ii) the applicable Ionis [***] shall be included within Ionis
Know-How and subject to the licenses in Section 2.1 (License Grants to Otsuka) solely to the extent such licenses relate to the Asia Territory, and (iii) the Ionis [***] included in related Regulatory Submissions will be subject to
Otsuka’s right of use and right of reference provided in Section 5.9 (Right of Reference) solely in the Asia Territory, in each case, regardless of whether Otsuka has opted in to Ionis [***] in accordance with Section 4.4.4(c)
(Otsuka Opt-In). For further clarity, if the Parties agree (through the Europe JSC or the Executive Committee) on a [***] that includes Clinical Trial sites in Japan, the last sentence of Section 4.4.4(a) (Shared Costs) shall apply
and Otsuka will share the applicable Eligible Cross-Territory Development Costs in accordance with Section 4.4.3 (Shared Cross-Territory Development Costs).
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4.5 |
Development Reports. At each meeting of the Europe JSC or Asia JSC, as applicable, Ionis and Otsuka will each provide (a) the Europe JSC with (i) a written summary of the activities conducted by or
on behalf of such Party under the Cross-Territory Clinical Development Plan, and with respect to Ionis, [***], in each case ((a) and (b)), since the last Europe JSC meeting or Asia JSC meeting, as applicable, including patient enrollment,
the ongoing status, and material results of all Clinical Trials for the Licensed Products conducted by or on behalf of such Party. Each Party will also promptly provide written notice to the other Party and keep the other Party reasonably
informed, (A) through the Europe JSC or Alliance Managers, of (i) any significant Development events under the Cross-Territory Clinical Development Plan, and with respect to Ionis, any additional Development activities conducted by or on
behalf of Ionis or any of its Affiliates for the Licensed Product that are not set forth in the Cross-Territory Clinical Development Plan or the Non-Clinical HAE Development Plans, and (ii) any significant Development events under the
Non-Clinical Europe HAE Development Plan or the Europe Territory-Specific Development Plan and (B) through the Asia JSC or Alliance Managers, of any significant Development events under the Non-Clinical Asia HAE Development Plan and Asia
Territory-Specific Development Plan, in each case ((A) and (B)), that [***] the Development activities of the other Party under this Agreement.
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4.6 |
Development Records; Cooperation. Each Party and its Affiliates will maintain written or electronic records, in sufficient detail, in a good scientific manner, in accordance with Applicable Law
(including GLP, GCP, and GMP, as applicable), and appropriate for regulatory and patent purposes, and that are complete and accurate and reflect all Development work performed and results achieved, in each case, by or on behalf of such
Party and its Affiliates under, as applicable, the Cross-Territory Clinical Development Plan, the Non-Clinical HAE Development Plans, and the Otsuka Territory-Specific Development Plans, and with respect to Ionis, [***]. Each Party shall
retain such records for at least three years after the end of the Term or for such longer period as may be required by Applicable Law. The Parties will cooperate with each other to achieve the Development objectives contemplated herein in a
timely, accurate, and responsive manner. Without limiting the foregoing, [***].
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16
4.7 |
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ARTICLE 5
5.1 |
Regulatory Responsible Party. Ionis will be the Regulatory Responsible Party for the Licensed Products in the Ionis Territory. Otsuka will be the Regulatory Responsible Party for the Licensed
Products in the Otsuka Territory, provided that, Ionis shall have the right to conduct regulatory activities in the Otsuka Territory, including interacting with Regulatory Authorities, solely with
respect to (a) the Development activities for the Licensed Products in the Europe Territory for which Ionis is responsible under the Cross-Territory Clinical Development Plan and the Development activities in the Europe Territory and, if
applicable, the Asia Territory under the Non-Clinical HAE Development Plans and (b) the Manufacturing activities for the Licensed Products for which Ionis is responsible in accordance with Article 7 (Manufacturing), in each case
subject to the remainder of this Article 5 (Regulatory Affairs) (“Ionis Regulatory Activities”). Subject to the
obligations in this Article 5 (Regulatory Affairs), the Regulatory Responsible Party will be responsible for, and [***] all Regulatory Submissions, communications, and other dealings with the Regulatory Authorities relating to the
Licensed Products in the applicable Territory, and for seeking and maintaining all Regulatory Approvals with respect to the Licensed Product in the applicable Territory. The Regulatory Responsible Party will not be required to delay any
submission, correspondence, or communication with any Regulatory Authorities in a manner that affects such Regulatory Responsible Party’s ability to comply with any Regulatory Authority requirement or deadline or Applicable Law in such
jurisdiction. For clarity, Otsuka or its designee shall be the holder of all Regulatory Approvals for the Licensed Product in the Otsuka Territory and will own all Regulatory Submissions in the Otsuka Territory, and Ionis or its designee
shall be the holder of all Regulatory Approvals for the Licensed Product in the Ionis Territory and will own all Regulatory Submissions in the Ionis Territory. Otsuka will only [***] and will not [***].
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5.2 |
Europe Regulatory Subcommittee. The Parties have established a Subcommittee of the Europe JSC to (a) oversee the preparation and submission of any MAA for a Licensed Product in the Europe Territory
and (b) coordinate the regulatory responsibilities between the Parties in the Europe Territory, which allocation will be consistent with this Article 5 (Regulatory Affairs) (such Subcommittee, the “Europe Regulatory Subcommittee”). The Europe Regulatory Subcommittee will review and comment on any proposed MAA application for a Licensed Product in the Europe Territory sufficiently in advance of the filing
or submission thereof by Otsuka, and Otsuka will [***] any comments received from the Europe Regulatory Subcommittee. The Europe Regulatory Subcommittee will meet as often as necessary to carry out the activities described in this Section
5.2 (Europe Regulatory Subcommittee) and the terms of Section 8.3 (Subcommittees) will apply to the Europe Regulatory Subcommittee.
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17
5.3 |
Correspondences with Regulatory Authorities. Otsuka shall be solely responsible for communications with Regulatory Authorities in the Otsuka Territory regarding the Licensed Product and in no event
will [***] regarding the Licensed Product in the Otsuka Territory, except in connection with [***], and subject to the remainder of this Section 5.3 (Correspondences with Regulatory Authorities). Ionis will [***]. In addition, Ionis
will [***]. Furthermore, upon Otsuka’s reasonable request and at [***], Ionis will [***]. The Regulatory Responsible Party will provide the other Party with (a) copies of any material written correspondence submitted to or received from (i)
with respect to Otsuka, the EMA, PMDA, or any other Regulatory Authority in the Europe Territory or [***], and (ii) with respect to Ionis, the FDA or any other Regulatory Authority in the U.S., and (b) summaries of any material oral
communications with such Regulatory Authority in clause (a), in each case ((a) and (b)), relating to Regulatory Submissions in support of Development of the Licensed Products in such jurisdiction or country, reasonably promptly after
receipt or delivery by such Regulatory Responsible Party of such correspondence or communication, as the case may be (but in any event, no later than [***] after receipt or delivery).
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5.4 |
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5.5 |
Regulatory Submissions. Each Party (the “Filing Party”) will provide the other Party with a copy of [***] (including, [***]) that the
Filing Party intends to file with or submit to any Regulatory Authority in support of Development in the Otsuka Territory for the other Party’s review and comment sufficiently in advance of the Filing Party’s filing or submission thereof; provided that, as it relates to the Asia Territory, Otsuka (a) will [***], (b) will [***], and (c) will [***]. The Filing Party will [***] any reasonable comments received from the other Party into such
Regulatory Submissions. In addition and notwithstanding Section 3.2 (Technology Transfer Costs), Ionis will provide to Otsuka, [***].
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5.6 |
Cooperation. The Parties will cooperate with each other to achieve the regulatory objectives contemplated herein in a timely, accurate, and responsive manner. Without limiting the foregoing or the
terms of Section 5.5 (Regulatory Submissions), at Otsuka’s reasonable request, Ionis will [***] of the Licensed Products in the Otsuka Territory or for obtaining and maintaining Regulatory Approval of the Licensed Products in the
Otsuka Territory. Without limiting the foregoing, if requested by any Regulatory Authority in the Asia Territory or [***] for obtaining Regulatory Approvals in the Asia Territory, Ionis will provide to Otsuka (to the extent not prohibited
by confidentiality obligations to a Third Party) or directly to the applicable Regulatory Authority (to the extent confidentiality obligations to a Third Party prohibit disclosure to Otsuka but permit disclosure to such Regulatory
Authority) reports and other documents related to other antisense oligonucleotide compounds or products (other than the Licensed Products) being developed by Ionis or any of its Affiliates or Third Party licensees. If Otsuka receives any
inquiry from a Regulatory Authority in the Otsuka Territory pertaining to any activities for which Xxxxx is responsible hereunder (including Cross-Territory Clinical Studies, non-clinical or CMC Development or Manufacturing (prior to the
applicable Manufacturing Handover Date)), then notwithstanding Section 3.2 (Technology Transfer Costs), upon Otsuka’s request, Ionis will, [***]. In addition, upon Otsuka’s reasonable request, Ionis shall provide [***] in the Otsuka
Territory (“Regulatory Support”). With respect to the Asia Territory, Regulatory Support includes, and [***] Ionis shall provide, [***]. Ionis will provide all Regulatory Support
[***] (i) with respect to Regulatory Support related to the Europe Territory, until [***] and (ii) with respect to Regulatory Support related to the Asia Territory, until [***]. Thereafter, (A) [***], Ionis will [***], and [***], Ionis will
[***] and (B) [***], Ionis will [***], and [***], Ionis will [***]. At all times, Otsuka will [***]. Ionis may [***] for such (1) [***], and (2) [***] and, in each case ((1) and (2)), [***] (and, with respect to [***]) therefor [***].
[***]. For clarity, if Otsuka requests Regulatory Support in connection with [***], Ionis shall provide such Regulatory Support [***], and Otsuka [***]. Notwithstanding any provision to the contrary, this Section 5.6 (Cooperation)
will not require Ionis to conduct any additional Clinical Trials or generate any additional data or information that is not expressly contemplated by the Cross-Territory Clinical Development Plan or Non-Clinical HAE Development Plans.
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18
5.7 |
Cost of Regulatory Activities. Except to the extent specified otherwise in this Article 5 (Regulatory Affairs), each Party will be responsible for all costs and expenses incurred in
connection with its activities under this Article 5 (Regulatory Affairs), including the preparation or maintenance of Regulatory Submissions and Regulatory Approvals with respect to the Licensed Products for which it is responsible,
including any filing fees and, with respect to Ionis, including all costs and expenses of Ionis Regulatory Activities and all costs and expenses related to the ASMF (if filed) and other regulatory affairs related to Manufacturing of
Licensed Products, which in each case will be borne solely by Ionis.
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5.8 |
No Harmful Actions. If [***], then such first Party will have the right to bring such matter to the attention of the JSCs at a joint meeting (or the applicable JSC if such matter pertains only to
the Europe Territory or the Asia Territory) and the Parties will discuss in good faith to resolve such concern. Without limiting the foregoing and notwithstanding any provision to the contrary in this Agreement, Otsuka will not [***].
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5.9 |
Right of Reference. Subject to the rules of the relevant Regulatory Authority and the terms of this Agreement, including Section 4.4.4(b) ([***] by Xxxxx), each Party hereby grants to the
other Party a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Applicable Law recognized outside of the United States) to, and a right to copy, access, and otherwise use, all
information and data relating to the Licensed Products in any Regulatory Submission or Regulatory Approval Controlled by the grantor Party during the Term (including, with respect to the grant to Otsuka, a right of reference to Ionis’ Drug
Master File and ASMF, if filed), solely for the other Party’s or its Affiliates’ use in the Development or Commercialization of the Licensed Products in the other Party’s Territory in accordance with this Agreement. All such information and
data contained in any such Regulatory Submissions or Regulatory Approvals will be considered Confidential Information of the grantor Party and subject to the terms of Article 12 (Confidentiality). If requested by the grantee Party,
the grantor Party will provide a signed statement to this effect in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor rule or analogous Applicable Law outside of the United States) to give effect to the intent of this Section
5.9 (Right of Reference).
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19
5.10 |
Pharmacovigilance; Safety Information. Each Party will cooperate with the other Party, at no cost to the other Party (notwithstanding Section 3.2 (Technology Transfer Costs)), with regard
to the reporting and handling of safety information involving the Licensed Products in accordance with Applicable Law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. Otsuka will be responsible for all
processing of information related to any adverse events for the Licensed Products in the Otsuka Territory and Ionis will be responsible for all processing of information related to any adverse events for the Licensed Products in the Ionis
Territory, in each case, including any information regarding such adverse events that is received from a Third Party. Each Party will provide to the other Party in a timely manner the relevant safety information it receives (either directly
or indirectly) related to the Licensed Products. At an appropriate time as agreed upon by the Parties following the Restatement Date, but in any event prior to the [***], the Parties will negotiate in good faith and enter into a
Pharmacovigilance Agreement related to the Licensed Products, which will define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the class and
products (e.g., Serious Adverse Events, emerging safety issues) to enable each Party to comply with all of its legal and regulatory obligations related to
such Licensed Product. Prior to the execution of the Pharmacovigilance Agreement, each Party will have the right, upon reasonable notice to the other Party, to [***]. Ionis will own and maintain the global safety database for the Licensed
Products at [***], provided that at Otsuka’s reasonable request, Ionis will run queries of such global safety database and will provide copies of the data contained in such global safety database to
the extent necessary or reasonably useful to the Development and Commercialization of the Licensed Product in the Otsuka Territory. As part of the negotiation of the Pharmacovigilance Agreement, the Parties will [***], taking into account
that Ionis will own and maintain the global safety database, and the Parties’ determination of such matter will be set forth in the Pharmacovigilance Agreement. Subject to compliance with Applicable Law, each Party hereby agrees to comply
with its respective obligations under the Pharmacovigilance Agreement as the Parties may agree to modify it from time to time, and to cause its (sub)licensees to comply with such obligations. If there is a conflict between the terms and
conditions of this Agreement and any terms and conditions of the Pharmacovigilance Agreement, then the terms and conditions of the Pharmacovigilance Agreement will govern with respect to any pharmacovigilance matters and this Agreement will
govern with respect to any other matters.
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5.11 |
Pharmacovigilance Subcommittee. As of the Restatement Date, the Parties have established a joint pharmacovigilance subcommittee (the “PV
Subcommittee”) that will be a Subcommittee of the Executive Committee. In addition to any other matters that the Executive Committee or JSCs may delegate to the PV Subcommittee, the PV Subcommittee shall provide a forum for the
Parties to discuss, share information, and escalate and attempt to resolve safety issues regarding the Licensed Product, and any other pharmacovigilance matters, worldwide. The PV Subcommittee will meet as often as necessary to carry out
such activities, and the terms of Section 8.3 (Subcommittees) will apply to the PV Subcommittee.
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20
5.12 |
5.12.1 |
Ionis maintains an internal database that includes information regarding the tolerability of its drug compounds, individually and as a class, including information discovered during non-clinical and clinical Development (the “Ionis Internal Oligonucleotide Safety Database”). To maximize understanding of the safety profile and pharmacokinetics of Ionis compounds, (a) Ionis will have the right to use any
safety-related information provided by Otsuka pursuant to the Pharmacovigilance Agreement or this Section 5.12 (Ionis Internal Oligonucleotide Safety Database) to maintain the Ionis Internal Oligonucleotide Safety Database and (b)
Otsuka will cooperate, at no cost to Ionis, with Ionis’ reasonable requests in connection with populating the Ionis Internal Oligonucleotide Safety Database, including by providing Ionis with reasonably requested safety-related supporting
data and answering any follow-up questions reasonably requested by Xxxxx or its Affiliates in connection with any information provided under the Pharmacovigilance Agreement, in each case to the extent such data and answers are reasonably
available to Otsuka. In addition, with respect to Clinical Trials of the Licensed Products conducted by or on behalf of Otsuka pursuant to the Otsuka Territory-Specific Development Plans, Otsuka will provide Ionis with copies of annual
safety updates filed with each IND and the safety sections of any final Clinical Trial reports within [***] following the date such information is filed, as applicable. All such information disclosed by Otsuka to Ionis will be Otsuka
Confidential Information; provided, however, that so long as Ionis does not disclose the identity of a Licensed Product or Otsuka’s identity, Ionis may
disclose any such Otsuka Confidential Information to (i) Ionis’ other partners if such information is regarding class generic properties of oligonucleotides, (ii) any Third Party that contributes to the populating of the Ionis Internal
Oligonucleotide Safety Database, or (iii) any Regulatory Authority. Otsuka will also cause its Affiliates and Sublicensees to comply with this Section 5.12 (Ionis Internal Oligonucleotide Safety Database).
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5.12.2 |
From time to time, Xxxxx utilizes the information in the Ionis Internal Oligonucleotide Safety Database to conduct analyses to keep Ionis and its partners informed regarding class generic properties of oligonucleotides, including with
respect to safety. As such, if and when Ionis identifies safety or other related issues that may be relevant to a Licensed Product (including any potential class-related toxicity), Ionis will promptly inform Otsuka of such issues and
provide the data supporting Ionis’ conclusions.
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5.13 |
5.13.1 |
Notification and Determination. Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may
be subject to a recall (whether voluntary or mandated), corrective action, or similar regulatory action by any Governmental Authority or Regulatory Authority (a “Remedial Action”).
The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the applicable Territory, and otherwise reasonably cooperate with
each other with respect to such Remedial Action or potential Remedial Action. Xxxxx will have sole discretion and final decision-making authority with respect to, and control over, any Remedial Action in the Ionis Territory, including any
decision to commence such Remedial Action in the Ionis Territory. Otsuka will have sole discretion and final decision-making authority with respect to, and control over, any Remedial Action in the Otsuka Territory, including any decision to
commence such Remedial Action in the Otsuka Territory; provided that if Ionis notifies Otsuka of [***] that Ionis reasonably believes could give rise to a Remedial Action in the Otsuka Territory
(or applicable Region), then Otsuka will initiate such Remedial Action in accordance with Xxxxx’ request and at [***].
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5.13.2 |
Cost Allocation. Except as otherwise set forth in Section 5.13.1 (Notification and Determination), all costs directly associated with implementing a Remedial Action with respect to a
Licensed Product will be allocated between Ionis and Otsuka as follows:
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(a) |
If, and to the extent, that the Remedial Action arises as a result of [***], then [***] will bear all such costs and expenses; and
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(b) |
in all other cases, Ionis will be responsible for such costs and expenses for such Licensed Product in the Ionis Territory and Otsuka will be responsible for such costs and expenses for such Licensed Product in the Otsuka Territory.
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21
ARTICLE 6
6.1 |
6.1.1 |
Commercialization in the Ionis Territory. Subject to the last sentence of Section 6.4.1 (Global Brand Strategy and American Commercialization Operating Plan) and the last sentence of Section
6.6.1 (Global Medical Affairs Strategy and American Medical Affairs Operating Plan), and without limiting Ionis’ obligations under this Article 6 (Commercialization and Medical Affairs), Ionis and its Affiliates will have
[***] with respect to the Commercialization of the Licensed Products in the Ionis Territory, including, if applicable, [***].
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6.1.2 |
Commercialization in the Otsuka Territory. Subject to the terms and conditions of this Agreement, and without limiting Otsuka’s obligations under this Article 6 (Commercialization and
Medical Affairs), Otsuka and its Affiliates will have [***] with respect to the Commercialization of the Licensed Products in the Otsuka Territory, including [***]. Upon Otsuka’s reasonable request, Ionis shall [***], including [***], and
Ionis will [***].
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6.1.3 |
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6.2 |
Commercialization and Medical Affairs Reporting. At each Europe JSC meeting following the first Regulatory Approval for a Licensed Product in the Europe Territory and at each Asia JSC meeting
following the first Regulatory Approval for a Licensed Product in [***], Otsuka will provide to the applicable JSC a high-level summary (which may be in the form of a slide presentation) of the material Commercialization and Medical Affairs
activities conducted by Otsuka or its Affiliates or Sublicensees for the Licensed Products in the Europe Territory or [***], as applicable, during the period since the last applicable JSC meeting and the material Commercialization and
Medical Affairs activities expected to be conducted by Otsuka or its Affiliates, or Sublicensees in the Europe Territory or [***], as applicable, for the Licensed Products during the period from the date of such update until the next
applicable JSC meeting, and shall answer any reasonable questions asked by Ionis to enable Ionis to assess Otsuka’s compliance with its Commercialization diligence obligations set forth in Section 6.5 (Otsuka Commercialization
Diligence Obligations). In addition, no later than [***], Otsuka will provide to the Europe JSC or the Asia JSC, as applicable, a report of the forecasted Net Sales anticipated to be generated by Otsuka or its Affiliates, licensees, or
Sublicensees in the Europe Territory or [***], as applicable, during the upcoming Calendar Year, which forecast will be broken down on a country-by-country basis. At each Europe JSC meeting following the first Regulatory Approval for a
Licensed Product in the Ionis Territory, Ionis will provide to the Europe JSC a high-level summary (which may be in the form of a slide presentation) of the material Commercialization and Medical Affairs activities conducted by Ionis or its
Affiliates for the Licensed Products in the Ionis Territory during the period since the last Europe JSC meeting and the material Commercialization and Medical Affairs activities expected to be conducted by Ionis or its Affiliates in the
Ionis Territory for the Licensed Products during the period from the date of such update until the next Europe JSC meeting. Without limiting the foregoing, at Otsuka’s reasonable request, Ionis will provide to Otsuka, [***], all information
relating to the [***]. In addition, Otsuka will [***].
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22
6.3 |
Pricing. All decisions for the Licensed Products related to list price, targeted net pricing, sales-weighted average discounts and rebates, pricing strategy (including the approach to pricing with
different types of accounts and plans, including types of discounts and rebates), and modifications to any of the foregoing, will be made by (a) Ionis in the Ionis Territory and (b) Otsuka in the Otsuka Territory; provided that, [***].
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6.4 |
6.4.1 |
Global Brand Strategy and American Commercialization Operating Plan. Prior to the Restatement Date, Ionis developed and [***], a global brand strategy for the Commercialization of the Licensed
Products throughout the Territory (the “Global Brand Strategy”) and an operating plan with respect to Commercialization activities in the U.S. (the “American Commercialization Operating Plan”). The Global Brand Strategy and the American Commercialization Operating Plan shall at all times conform to applicable Professional Requirements and Applicable Law
(including compliance requirements). Ionis, through the Europe JSC, will update the Global Brand Strategy and the American Commercialization Operating Plan [***]. In addition, [***], either Party may propose material updates or
modifications to the Global Brand Strategy and Ionis may propose material updates to the American Commercialization Operating Plan to [***]. No update or modification to the Global Brand Strategy or to the American Commercialization
Operating Plan will be effective unless and until [***]. Once [***], such updated version of the Global Brand Strategy or the American Commercialization Operating Plan will automatically become effective and replace the then-prior version
of the Global Brand Strategy or the American Commercialization Operating Plan, as applicable. The Global Brand Strategy will include, in reasonable detail, the Trademarks to be used by the Parties or its Affiliates or its or their
Sublicensees for the Commercialization of Licensed Product, trade dress, positioning, market access strategy, and marketing strategic imperatives, objectives and messaging with respect to the Licensed Products. At Otsuka’s reasonable request, Ionis will provide to Otsuka, [***]. Ionis will, [***], lead and conduct all Commercialization activities for the Licensed Products in the Ionis Territory [***].
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23
6.4.2 |
Otsuka Territory Brand Strategy and Commercialization Operating Plans. Within [***] after the date [***] approves the initial Global Brand Strategy and the initial American Commercialization
Operating Plan, Otsuka will prepare and submit to [***] a brand strategy for the Commercialization of the Licensed Products in the Europe Territory (the “Europe Territory Brand Strategy”)
and an operating plan with respect to the Commercialization of the Licensed Products in the Europe Territory (the “Europe Territory Commercialization Operating Plan”). If Otsuka’s
brand strategy for the Commercialization of the Licensed Products in any country in the Asia Territory will be materially inconsistent with the Global Brand Strategy, then, [***], Otsuka will prepare and submit to [***] a brand strategy for
the Commercialization of the Licensed Products in such country in the Asia Territory (the “Asia Territory Brand Strategy,” and together with the Europe Territory Brand Strategy,
the “Otsuka Territory Brand Strategy”). For clarity, Otsuka shall not be required to prepare or submit to [***] any brand strategy with respect to the Commercialization of the
Licensed Products in any country in the Asia Territory unless such strategy for such country is materially inconsistent with the Global Brand Strategy. [***], Otsuka will prepare and submit to [***] an operating plan with respect to the
Commercialization of the Licensed Products in [***] (each such plan for [***], the “Asia Territory Commercialization Operating Plan,” and together with the Europe Territory
Commercialization Operating Plan, the “Otsuka Territory Commercialization Operating Plans”). [***] will review, discuss, and determine whether to approve the initial Europe
Territory Brand Strategy and the initial Europe Territory Commercialization Operating Plan and [***] will review, discuss, and determine whether to approve each initial Asia Territory Brand Strategy (if any) and each initial Asia Territory
Commercialization Operating Plan. Each Otsuka Territory Brand Strategy will, at all times during the Term, be consistent with the then-current Global Brand Strategy, except to the extent such inconsistency is (i) necessary to (A) conform
with any written requirement from any Regulatory Authority or with any Applicable Law or Professional Requirements in the Europe Territory or the Asia Territory, as applicable, or (B) avoid infringement of a Third Party Trademark in the
Europe Territory or Asia Territory, as applicable, or (ii) approved by the applicable JSC or Executive Committee (by unanimous Party Vote). On [***] during the Term (and more frequently as may be necessary), Otsuka will prepare an update to
each Otsuka Territory Brand Strategy and each Otsuka Territory Commercialization Operating Plan. [***] will review, discuss, and determine whether to approve each update to the Europe Territory Brand Strategy and each update to the Europe
Territory Commercialization Operating Plan and [***] will review, discuss, and determine whether to approve each update to each Asia Territory Brand Strategy and each update to each Asia Territory Commercialization Operating Plan. Once
approved by [***], the applicable Otsuka Territory Brand Strategy and the applicable Otsuka Territory Commercialization Operating Plan will automatically become effective and, in the case of an update, will supersede the applicable previous
Otsuka Territory Brand Strategy and the applicable previous Otsuka Territory Commercialization Operating Plan as of the date of such approval by [***]. Otsuka will, at its cost and expense, lead and conduct all Commercialization activities
in the Otsuka Territory [***].
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6.5 |
Otsuka Commercialization Diligence Obligations. On a country-by-country basis in the Otsuka Territory, following [***], Otsuka will use Commercially Reasonable Efforts to obtain Reimbursement
Approval for and otherwise Commercialize such Licensed Product in such country.
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6.6 |
6.6.1 |
Global Medical Affairs Strategy and American Medical Affairs Operating Plan. Prior to the
Restatement Date, Ionis developed and [***], a plan for the global Medical Affairs activities for the Licensed Products throughout the Territory (the “Global Medical Affairs Strategy”) and an operating plan with respect to Medical Affairs activities in the U.S. (the “American Medical Affairs Operating Plan”). The Global Medical Affairs Strategy and the American Medical Affairs Operating Plan shall at all times conform to applicable Professional
Requirements and Applicable Law (including compliance requirements) with adjustments with respect to the Global Medical Affairs Strategy as necessary to comply with local Applicable Law and Professional Requirements in the Otsuka Territory.
Ionis, through the Europe JSC, will update the Global Medical Affairs Strategy and the American Commercialization Operating Plan on [***] basis. In addition, between [***] updates, either Party may propose material updates or modifications
to the Global Medical Affairs Strategy and Ionis may propose material updates or modifications to the American Medical Affairs Operating Plan [***]. No update or modification to the Global Medical Affairs Strategy or the American Medical
Affairs Operating Plan will be effective unless and until approved by [***]. Once approved by [***], such updated version of the Global Medical Affairs Strategy or the American Medical Affairs Operating Plan will become effective and
replace the then-prior version of the Global Medical Affairs Strategy or American Medical Affairs Operating Plan. Ionis will, at its cost and expense, lead and conduct all Medical Affairs activities for the Licensed Products in the Ionis
Territory [***].
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24
6.6.2 |
Otsuka Territory Medical Affairs Plans. Within [***] after
the date [***] approves the initial Global Medical Affairs Strategy and the initial American Medical Affairs Operating Plan, Otsuka will prepare and submit to [***] a plan for the Medical
Affairs activities for the Licensed Products in the Europe Territory (such plan, the “Europe Territory Medical Affairs Plan”). [***], Otsuka will prepare and submit to [***] a plan
for the Medical Affairs activities for the Licensed Products in [***] (each such plan for [***], the “Asia Territory Medical Affairs Plan,” and together with the Europe Territory
Medical Affairs Plan, the “Otsuka Territory Medical Affairs Plans”). [***] will review, discuss, and determine whether to approve the initial Europe Territory Medical Affairs Plan
and [***] will review, discuss, and determine whether to approve the initial Asia Territory Medical Affairs Plan. Each Otsuka Territory Medical Affairs Plan will, at all times during the Term, be consistent with the then-current Global
Medical Affairs Strategy, except to the extent such inconsistency is (i) necessary to conform with any written requirement from any Regulatory Authority or with any Applicable Law or Professional Requirements in the Europe Territory or the
Asia Territory, as applicable, or (ii) approved by the applicable JSC or Executive Committee (by unanimous Party Vote). On [***] during the Term (and more frequently as may be necessary), Otsuka will prepare an update to each Otsuka
Territory Medical Affairs Plan. [***] will review, discuss, and determine whether to approve each update to the Europe Territory Medical Affairs Plan and [***] will review, discuss, and determine whether to approve each update to the Asia
Territory Medical Affairs Plan. Once approved by [***], the applicable Otsuka Territory Medical Affairs Plan will automatically become effective and, in the case of an update, supersede the previous Otsuka Territory Medical Affairs Plan as
of the date of such approval by [***]. Otsuka will, at its cost and expense, lead and conduct all Medical Affairs activities in the Otsuka Territory [***].
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6.7 |
Standards of Conduct; Compliance. Each Party will perform, or will ensure that each of its Affiliates, Sublicensees, and Subcontractors perform, all Commercialization and Medical Affairs activities
in a professional and ethical business manner and in compliance with Applicable Law and applicable Professional Requirements.
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6.8 |
Product Materials. Each Party will, at its cost and expense, be responsible for preparing, developing, producing, or otherwise obtaining, and utilizing promotional materials, training materials,
medical education materials, Packaging and Labeling, and all other literature or other information related to the Licensed Products (“Product
Materials”) to support its Commercialization and Medical Affairs activities in such Party’s Territory, which Product Materials will at all times [***]. From time to time, and in any event upon Otsuka’s request, Ionis will share with Otsuka samples of Product Materials Controlled by Ionis and which are used by Ionis, its Affiliates, or licensees in connection
with the Commercialization of or conduct of Medical Affairs activities for the Licensed Products. From time to time, and in any event upon Xxxxx’ request, Otsuka will share with Ionis samples of
Product Materials Controlled by Otsuka and which are used by Otsuka, its Affiliates or sublicensees in connection with the Commercialization of or conduct of Medical Affairs activities the Licensed
Products in the Otsuka Territory.
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25
6.9 |
|
6.9.1 |
such Party and its Affiliates will not engage, nor permit its Sublicensees, licensees, and Subcontractors to engage, in any advertising or promotional activities relating to any Licensed Product for use directed primarily to customers or
other buyers or users of the Licensed Products located in any such country or jurisdiction;
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6.9.2 |
such Party and its Affiliates will not solicit orders of the Licensed Products from any prospective purchaser located in any such country or jurisdiction;
|
6.9.3 |
such Party and its Affiliates will not, and will take reasonable measures to cause its Sublicensees, licensees and Subcontractors to not, deliver or tender (or cause to be delivered or
tendered) any Licensed Product to Third Parties for use in such country or jurisdiction; and
|
6.9.4 |
if either Party or its Affiliates, Sublicensees, or licensees receive any order for any Licensed Product from a prospective purchaser located in any such country or jurisdiction, then such Party will immediately refer that order to the
other Party or its designee and will not accept any such orders.
|
ARTICLE 7
7.1 |
7.1.1 |
(a) |
Ionis Territory. Xxxxx will have sole control over and decision-making authority with respect to, at its cost and expense, the Manufacture of (i) all supplies of the Licensed Products required for
Ionis’ activities under the Cross-Territory Clinical Development Plan and the Non-Clinical HAE Development Plans, and for all Development activities in the Ionis Territory and (ii) all supplies of the Licensed Products for Commercialization
purposes in the Ionis Territory.
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(b) |
Europe Territory. Subject to the remainder of this Section 7.1.1(b) (Europe Territory) and Section 7.1.2 (Otsuka Manufacturing), in accordance with the Supply Agreements and Quality
Agreements, Ionis will Manufacture and supply Otsuka with all Licensed Product that is necessary for Otsuka to (i) [***] and (ii) [***].
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(c) |
Asia Territory. Subject to the remainder of this Section 7.1.1(c) (Asia Territory) and Section 7.1.2 (Otsuka Manufacturing), in accordance with the Supply Agreements and Quality
Agreements, Ionis will Manufacture and supply Otsuka with all Licensed Product that is necessary for Otsuka to (i) [***] and (ii) [***]. Notwithstanding the foregoing, on a country-by-country basis in the Asia Territory, (A) if required by
Applicable Law, any Regulatory Authority or the conditions and requirements of Regulatory Approvals in such country in the Asia Territory, Ionis will [***], or (B) if mutually agreed by the Parties (such agreement not to be unreasonably
withheld, conditioned or delayed), Ionis will [***], provided that, in each case ((A) and (B)), [***]. Notwithstanding any provision to the contrary in this Agreement, Ionis will [***].
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26
(d) |
Support. Upon Otsuka’s reasonable request prior to the applicable Manufacturing Handover Date, Ionis will provide (or will use commercially reasonable efforts to cause its CMOs to provide) to
Otsuka (i) [***], (ii) [***], and (iii) [***], in each case ((i) – (iii)), to the extent [***]. Ionis will provide all such Requested Assistance to Otsuka in accordance with the terms of Section 3.2 (Technology Transfer Costs) and
will provide such data and information to Otsuka [***]. For clarity, and notwithstanding anything to the contrary herein, Ionis will provide to the Qualified Person for the Licensed Products in the Europe Territory, [***], Manufacturing
audit or inspection reports as required under EU GMP, Annex 16, section 2.2 for the purposes of batch certification in the Europe Territory.
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7.1.2 |
Otsuka Manufacturing. [***], Otsuka will have the right to assume responsibility for Manufacturing (a) all supplies of the Licensed Products required for Otsuka’s activities under the Otsuka
Territory-Specific Development Plans in [***] the Otsuka Territory and (b) all supplies of the Licensed Products for Commercialization purposes in [***] the Otsuka Territory, in each case, upon written notice to Ionis at any time after the
earliest of (i) [***], (ii) [***], and (iii) [***] (such notice [***], the “Manufacturing Handover Notice” [***]). If Otsuka provides Ionis with a Manufacturing Handover Notice
[***], then Ionis’ obligations to Manufacture and supply Otsuka in accordance with Section 7.1.1 (Ionis Manufacturing) will terminate [***], following the completion of all activities under the Manufacturing Technology Transfer
Agreement in accordance with Section 7.4 (Manufacturing Technology Transfer) [***], and the initiation of actual Manufacturing of the Licensed Products to be sold by or on behalf of Otsuka [***] at Otsuka’s or its designee’s
manufacturing facility (such date [***], the “Manufacturing Handover Date” [***]).
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7.2 |
7.2.1 |
Clinical Supply Agreement. Unless otherwise agreed by the Parties, within a timeframe following the Restatement Date to be agreed by the Parties, the
Parties will negotiate in good faith and enter into a supply agreement on reasonable and customary terms for the supply of Licensed Products by Ionis to Otsuka for clinical use (the “Clinical
Supply Agreement”), which agreement (together with the related Quality Agreement) will govern the terms and conditions of the Manufacture and supply of the Licensed Products for Development purposes in the Otsuka Territory. Otsuka
will pay a supply price to Ionis under the Clinical Supply Agreement equal to [***].
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27
7.2.2 |
Commercial Supply Agreement. Within a timeframe following the Restatement Date to be agreed by the Parties, the Parties will negotiate in good faith and enter into a commercial supply agreement on
reasonable and customary terms for the commercial-grade supply of Licensed Products by Ionis to Otsuka (the “Commercial Supply Agreement” and together with the Clinical Supply
Agreement, the “Supply Agreements”), which agreement (together with the related Quality Agreement) will govern the terms and conditions of the Manufacture and supply of the
Licensed Products for Commercialization purposes in the Otsuka Territory. Otsuka will pay a supply price to Ionis under the Commercial Supply Agreement equal to [***]. The Commercial Supply Agreement shall allow Otsuka to order, and Ionis
to supply, a portion of a batch as the minimum order quantity, as further detailed in such Commercial Supply Agreement; provided that [***].
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7.2.3 |
Quality Agreements. The Parties will negotiate in good faith and enter into one or more quality technical agreements pertaining to clinical and commercial supply of Licensed Products to Otsuka
(each, a “Quality Agreement”) containing reasonable and customary terms and conditions regarding quality assurance, quality control, compliance with GMP, GDP and GCP (as
applicable), specifications, change control procedures, and provisions relating to audits and inspections. If Otsuka is required by Regulatory Authority or Applicable Law in any country in the Asia Territory to enter into a Quality
Agreement directly with a CMO that Manufactures Licensed Product (including drug substance (API) and bright stock or finished Licensed Product) for Commercialization in such country, then the Parties will [***]. If there are terms or
conditions that are required to be in a quality agreement by Applicable Law or a Regulatory Authority in the Asia Territory but that are inconsistent with an existing quality agreement between Ionis and its CMO, Ionis will [***].
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7.2.4 |
Manufacturing Cost Increases. If the Manufacturing Costs, whether for clinical or commercial supplies of Licensed Product, are reasonably anticipated to increase, on a per unit basis, such that the
[***], then Ionis will provide prompt written notice to Otsuka of such increase. If such increase is anticipated to result in [***], on a per unit basis, then [***]. If such increase is anticipated to result in [***] on a per unit basis,
then [***].
|
7.2.5 |
Capital Expenditures. Ionis [***]. In addition, if any CMO requests or requires [***], then Ionis will notify Otsuka and the Parties will [***].
|
7.2.6 |
[***]. If the reasonable allocation of [***], then [***].
|
7.3 |
7.3.1 |
By Otsuka. Prior to execution of the first Quality Agreement, Otsuka shall be entitled to conduct [***]. In addition, if Ionis elects to inspect or audit any facilities of its CMOs with respect to
the Manufacture of Licensed Products for the Otsuka Territory, Ionis shall notify Otsuka of such inspection or audit and, [***]. In addition, to the extent permitted under Ionis’ agreement with the applicable CMO and subject to any
conditions set forth in such agreement with respect to any inspection or audit (e.g., an obligation to enter into a confidentiality agreement with the applicable CMO), Ionis shall [***]. If Otsuka
identifies the need to perform a “for cause” audit of such facilities to address quality or compliance issues related to any Licensed Product Manufactured for the Otsuka Territory (including to address any notice from a Governmental
Authority in the Otsuka Territory of noncompliance with Applicable Laws), as well as in connection with the preparation of Regulatory Submissions for the Otsuka Territory and in response to Regulatory Authority requirements in the Otsuka
Territory, then Otsuka shall notify Ionis and if Xxxxx agrees with Otsuka’s determination that a “for cause” audit is needed, Ionis will schedule and conduct such audit and Otsuka will [***], in each case, to the extent permitted pursuant
to the applicable agreement with the applicable CMO.
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28
7.3.2 |
By Governmental Authority. If any Governmental Authority carries out or gives notice of its intention to carry out any inspection or audit of any of Ionis’ CMOs in relation to Manufacture of
Licensed Products for the Otsuka Territory and Ionis is aware of such upcoming inspection or audit, then Ionis shall promptly notify Otsuka thereof and Ionis shall, to the extent permitted by its agreement with the applicable CMO and the
applicable Governmental Authority, [***]. Following receipt by Ionis of the inspection results or audit observations of the Governmental Authority from such inspection or audit (a redacted copy of which Ionis will promptly provide to Otsuka
to the extent it relates to Licensed Products Manufactured for the Otsuka Territory), Ionis will (a) prepare any appropriate responses and (b) provide a copy of such responses to Otsuka [***] in advance of the date such responses are due,
to the extent such responses pertain to the Manufacture of Licensed Products for the Otsuka Territory, and Ionis shall [***], in each case ((a) and (b)), to the extent permitted under Ionis’ agreement with such CMOs and subject to any
conditions set forth in the applicable agreement with such CMOs with respect to any inspection or audit (e.g., an obligation to enter into a confidentiality agreement with the applicable CMO).
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7.3.3 |
|
7.4 |
Manufacturing Technology Transfer. At Otsuka’s request any time after Otsuka provides a Manufacturing Handover Notice [***], Ionis will make available to Otsuka all Ionis Manufacturing and
Analytical Know-How and materials (the “Manufacturing Technology Transfer”) for [***]. Otsuka will (a) use Ionis Manufacturing and Analytical Know-How and materials provided by
Ionis in connection with the Manufacturing Technology Transfer only in the fulfillment of obligations or exercise of rights under this Agreement, and (b) not transfer such Ionis Manufacturing and Analytical Know-How or materials or deliver
the same to any Third Party, without Xxxxx’ prior written consent. For purposes of a Manufacturing Technology Transfer, the Parties together with Xxxxx’ CMO (subject to the next sentence) will enter into a manufacturing technology transfer
agreement, which will also provide for reasonable technical assistance and support by Ionis and Xxxxx’ CMOs as reasonably requested by Otsuka to enable Otsuka or its Affiliates, or if agreed by Ionis, a Third Party manufacturer (other than
Ionis’ CMOs), to Manufacture the Licensed Products (a, “Manufacturing Technology Transfer Agreement”). Ionis will use reasonable efforts to [***]. If Xxxxx agrees to transfer Ionis
Manufacturing and Analytical Know-How to a Third Party manufacturer other than Ionis’ CMOs, such transfer shall be carried out pursuant to a direct license between Ionis and such Third Party manufacturer. If Otsuka [***]. Otsuka will [***].
Accordingly, Ionis may [***]. Otsuka will [***].
|
ARTICLE 8
8.1 |
8.1.1 |
Formation and Purpose of the Executive Committee. Promptly, but not more than [***] after the Restatement Date, Ionis and Otsuka will establish an executive
committee (“Executive Committee”), which will have the responsibilities set forth in this Section 8.1 (Executive Committee). The Executive Committee will dissolve upon the expiration of the Term.
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29
8.1.2 |
Membership. The Executive Committee will be composed of an equal number of representatives from each Party who have the appropriate and direct knowledge and expertise and requisite decision-making
authority; provided that at least one representative from each Party will be an Executive Officer of such Party. Any such representative
who serves on the Executive Committee may also serve on one or more other committees under this Agreement. Each Party may replace any of
its representatives on the Executive Committee and appoint a person to fill the vacancy arising from each such replacement. A Party that replaces a representative will notify the other Party at least [***] prior to the next
scheduled meeting of the Executive Committee. Xxxxx will designate one of its Executive Committee members as one of the co-chairpersons of the Executive Committee and Otsuka will designate one of its members as the other co-chairperson of
the Executive Committee (each, an “Executive Committee Co-Chairperson”). The Executive Committee Co-Chairpersons or their designees, in collaboration with the Alliance Managers,
will be responsible for calling meetings, preparing and circulating an agenda and related information in advance of each meeting, and preparing and issuing minutes of each meeting within [***] thereafter. Such minutes will not be finalized
until the Executive Committee Co-Chairpersons or their designees have had [***] to review and confirm the accuracy of such minutes.
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8.1.3 |
Meetings. The Executive Committee will hold meetings [***]. The Executive Committee may meet in person or by means of teleconference, Internet conference, video conference, or other similar
communication method. Each Party will be responsible for all of its own costs and expenses of participating in any JSC meeting.
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8.1.4 |
Meeting Agendas. Unless agreed otherwise by the Parties, the Parties will jointly prepare the agenda for each Executive Committee meeting, facilitated by the Alliance Managers working closely with
the Executive Committee Co-Chairpersons and, as appropriate, other Executive Committee members and Subcommittee Co-Chairpersons, at least [***] in advance of each meeting of the Executive Committee, and each Party will provide the other
Party with all relevant materials to be presented at each Executive Committee meeting at least [***] in advance of each meeting of the Executive Committee; provided that under exigent circumstances
requiring Executive Committee input, the agenda may be prepared or presentation materials may be provided within a shorter period of time in advance of a meeting, with the approval of the Executive Committee Co-Chairpersons. Either Party
may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to the later addition or modification of agenda items or the absence of a specific agenda for such Executive Committee meeting.
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8.1.5 |
Specific Responsibilities of the Executive Committee. The responsibilities of the Executive Committee will be to:
|
(a) |
establish and delegate specifically defined duties to any Subcommittees, as described in Section 8.3.1 (Formation; Authority);
|
(b) |
attempt to resolve any disputes or disagreements arising from matters within the jurisdiction of the Europe JSC, the Asia JSC, the PV Subcommittee or any other Subcommittee established by the Executive Committee; and
|
(c) |
perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.
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8.2 |
8.2.1 |
Formation and Purposes of the Joint Steering Committees. As of the Restatement Date, the Parties have established a Joint Steering Committee for the Europe Territory, which will have the
responsibilities set forth in this Section 8.2 (Joint Steering Committees) (“Europe JSC”). Promptly, but not more than [***] after the Restatement Date, Ionis and Otsuka
will establish a Joint Steering Committee for the Asia Territory, which will have the responsibilities set forth in this Section 8.2 (Joint Steering Committees) (the “Asia JSC,”
and together with the Europe JSC, the “JSCs”).
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30
8.2.2 |
|
8.2.3 |
Specific Responsibilities of the Europe JSC. The Europe JSC will have the following responsibilities:
|
(a) |
manage the overall strategic alignment between the Parties under this Agreement and maintain the relationship between the Parties;
|
(b) |
oversee, review, monitor, and coordinate, and, where specified in this Section 8.2.3 (Specific Responsibilities of the Europe JSC), approve the Parties’ Development, Manufacturing, Medical Affairs, and Commercialization
activities under this Agreement for the Licensed Products in the Territory (excluding the Asia Territory to the extent within the responsibilities of the Asia JSC);
|
(c) |
review, discuss, and determine whether to [***];
|
(d) |
review, discuss, and determine (at a joint meeting with the Asia JSC) whether [***];
|
(e) |
review, discuss, and determine whether [***];
|
(f) |
review, discuss, and determine whether [***];
|
(g) |
review, discuss and determine whether [***];
|
(h) |
review, discuss, and determine whether to approve any updates to the Shared Development Budget, as described in Section 4.4.2(a) (Shared Development Budget);
|
(i) |
review, discuss, and determine whether to approve [***] and the Shared Development Budget, as described in Section 4.4.4(a) (Shared Costs);
|
(j) |
share information related to, and review and discuss activities and progress of each Party (A) in connection with the Development of Licensed Products in the Europe Territory and Ionis Territory and (B) under the Cross-Territory Clinical
Development Plan, including through updates from each Party of the status of Development for the Licensed Products in each such Territory, as described in Section 4.5 (Development Reports);
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31
(k) |
share information related to, and review and discuss activities and progress under the Europe Territory-Specific Development Plan, and the Non-Clinical Europe HAE Development Plan, as described in Section 4.5 (Development
Reports);
|
(l) |
review and discuss any matters related to the Development of the Licensed Products applicable to the Europe Territory referred to the Europe JSC by either Party’s representatives, including matters related to the Development of the
Licensed Products applicable to both the Europe Territory and the Asia Territory that are referred to a joint meeting of the Europe JSC and the Asia JSC by either Party’s representatives;
|
(m) |
discuss any concerns raised by either Party regarding any action that the other Party is taking or intends to take with respect to a Licensed Product that is [***], as described in Section 5.8 (No Harmful Actions);
|
(n) |
discuss [***];
|
(o) |
review, discuss, and determine whether to approve [***];
|
(p) |
review, discuss, and determine whether to approve [***];
|
(q) |
review, discuss, and determine whether to approve [***];
|
(r) |
review, discuss and determine whether to approve [***];
|
(s) |
review and discuss any matters related to the Commercialization of the Licensed Products applicable to the Europe Territory that are referred to the Europe JSC by either Party’s representatives, including matters related to the
Commercialization of the Licensed Products applicable to both the Europe Territory and the Asia Territory that are referred to a joint meeting of the Europe JSC and the Asia JSC by either Party’s representatives;
|
(t) |
establish and delegate specifically defined duties to any Subcommittees, as described in Section 8.3.1 (Formation; Authority);
|
(u) |
review, discuss and determine whether to approve [***];
|
(v) |
discuss the inclusion of Ionis’ logo, name, and housemark on the packaging for the Licensed Products in the Europe Territory, as described in Section 10.10.6 (Housemarks);
|
(w) |
attempt to resolve any disputes or disagreements arising from matters within the jurisdiction of the Europe Regulatory Subcommittee or any other Subcommittee established by the Europe JSC; and
|
(x) |
perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.
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32
8.2.4 |
Specific Responsibilities of the Asia JSC. The Asia JSC will have the following responsibilities:
|
(a) |
oversee, review, monitor, and coordinate, and, where specified in this Section 8.2.4 (Specific Responsibilities of the Asia JSC), approve the Parties’ Development, Manufacturing, Medical Affairs, and Commercialization activities
under this Agreement for the Licensed Products in the Asia Territory;
|
(b) |
review, discuss, and determine whether to [***];
|
(c) |
review, discuss, and determine (at a joint meeting with the Europe JSC) whether [***];
|
(d) |
review, discuss, and determine whether [***];
|
(e) |
review, discuss and determine whether [***];
|
(f) |
share information related to, and review and discuss activities and progress under the Asia Territory-Specific Development Plan and the Non-Clinical Asia HAE Development Plan, as described in Section 4.5 (Development Reports);
|
(g) |
review and discuss any matters related to the Development of the Licensed Products applicable to the Asia Territory that are referred to the Asia JSC by either Party’s representatives, including matters related to the Development of the
Licensed Products applicable to both the Europe Territory and the Asia Territory that are referred to a joint meeting of the Europe JSC and the Asia JSC by either Party’s representatives;
|
(h) |
discuss any concerns raised by either Party regarding any action that the other Party is taking or intends to take with respect to a Licensed Product that is [***], as described in Section 5.8 (No Harmful Actions);
|
(i) |
review, discuss, and determine whether to [***];
|
(j) |
review, discuss and determine whether to [***];
|
(k) |
review and discuss any matters related to the Commercialization of the Licensed Products applicable to the Asia Territory that are referred to the Asia JSC by either Party’s representatives, including matters related to the
Commercialization of the Licensed Products applicable to both the Europe Territory and the Asia Territory that are referred to a joint meeting of the Europe JSC and the Asia JSC by either Party’s representatives;
|
(l) |
establish and delegate specifically defined duties to any Subcommittees, as described in Section 8.3.1 (Formation; Authority);
|
(m) |
review, discuss and determine whether to [***];
|
(n) |
discuss the inclusion of Ionis’ logo, name, and housemark on the packaging for the Licensed Products in the Asia Territory, as described in Section 10.10.6 (Housemarks);
|
(o) |
attempt to resolve any disputes or disagreements arising from matters within the jurisdiction of any Subcommittee established by the Asia JSC; and
|
(p) |
perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.
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33
8.3 |
8.3.1 |
|
8.3.2 |
|
34
8.4 |
Additional Participants. Employees of a Party or any of its Affiliates involved in the Exploitation of the Licensed Products may attend meetings of the Executive Committee, a JSC, or any other
Subcommittee as non-voting participants. In addition, with the prior consent of each Party, consultants, representatives, or advisors involved in the same activities and under written obligations of confidentiality and non-use applicable to
the Confidential Information of each Party that are at least as stringent as those set forth in Article 12 (Confidentiality) may attend meetings of the Executive Committee, a JSC or any other Subcommittee as non-voting observers.
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8.5 |
8.5.1 |
General Decision-Making Process. Each Party’s representatives on the Executive Committee, each JSC, and each other Subcommittee will, collectively, have one vote (the “Party Vote”) on all matters brought before such committee for a decision by consensus. The Executive Committee, each JSC, and each other Subcommittee will make decisions as to matters within its
jurisdiction by unanimous Party Vote, which may be reflected in the minutes of the committee meeting or by an action by written consent signed by the Executive Committee Co-Chairpersons or the Subcommittee Co-Chairpersons, as applicable, or
their designees identified in writing. Except as otherwise expressly set forth in this Agreement, the phrase “determine,” “designate,” “approve,” or “determine whether to approve” by the Executive Committee, either JSC or any other
Subcommittee and similar phrases used in this Agreement will mean approval in accordance with this Section 8.5 (Decision‑Making) or Section 8.6 (Resolution of Committee Disputes), including the escalation and tie‑breaking
provisions herein. For the avoidance of doubt, matters that are specified in Section 8.2.3 (Specific Responsibilities of the Europe JSC) or Section 8.2.4 (Specific Responsibilities of the Asia JSC) to be reviewed and
discussed (as opposed to reviewed, discussed, and approved) do not require any agreement or decision by either Party and are not subject to the voting and decision-making procedures set forth in this Section 8.5 (Decision‑Making) or
Section 8.6 (Resolution of Committee Disputes).
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8.5.2 |
Decisions of the Subcommittees. If any Subcommittee cannot reach unanimous agreement using good faith efforts on any matter within their respective scope of authority within [***] of the meeting at
which such matter was discussed, then a Party may refer such matter to the applicable Establishing Committee for resolution in accordance with Section 8.5.3 (Decisions of Establishing Committees).
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35
8.5.3 |
Decisions of Establishing Committees. If any Subcommittee established by a JSC is unable to reach a consensus decision on a matter within the scope of such Subcommittee’s authority in accordance
with Section 8.5.2 (Decisions of the Subcommittees), then, at either Party’s request, each Party will submit in writing its respective positions with respect to such unresolved matter to the applicable JSC and if such JSC, after the
use of good faith efforts, including reasonable discussion and good faith consideration of each Party’s view on a particular matter, is unable to resolve such matter within a period of [***] after each Party submits in writing its
respective position with respect to such matter, then either Party may refer such matter to the Executive Committee. If a JSC or other Subcommittee established by the Executive Committee is unable to reach a consensus decision on a matter
within the scope of such JSC’s or other Subcommittee’s authority in accordance with Section 8.5.2 (Decisions of the Subcommittees) or a JSC is unable to reach a consensus decision on a Subcommittee-related matter submitted to such
JSC pursuant to the first sentence of this Section 8.5.3 (Decisions of Establishing Committees), then, [***].
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8.6 |
8.6.1 |
Final Decision-Making Authority. For any matter referred to the Executive Committee in accordance with Section 8.5.3 (Decisions of Establishing Committees), if the Executive Committee is
unable to reach a consensus decision on such matter, then, with respect to any matter set forth in clauses (b) and (c) of this Section 8.6.1 (Final Decision-Making Authority), the applicable Executive Committee Co-Chairperson
appointed by the Party with final-decision making authority over such matter will make a final decision on such matter in accordance with this Section 8.6.1 (Final Decision-Making Authority) and subject to Section 8.6.2
(Limitations on Decision Making). Any matter set forth in clause (a) of this Section 8.6.1 (Final Decision-Making Authority) shall be subject to the mutual agreement of both Parties and, unless and until such mutual agreement is
reached (by consensus decision of the applicable JSC or Executive Committee), the status quo will be maintained.
|
(a) |
No Change; Status Quo. Neither Party’s Executive Committee Co-Chairperson will have final decision-making authority with respect to the final resolution of any disagreement related to: (i) [***];
(ii) [***]; (iii) [***]; (iv) [***]; (v) [***]; (vi) [***]; (vii) [***]; (viii) [***]; and (ix) [***].
|
(b) |
Ionis Final Decision-Making Authority. The Executive Committee Co-Chairperson for Xxxxx will have final decision-making authority over (i) [***], (ii) [***], (iii) [***], (iv) [***], (v) [***], and
(vi) [***]. Notwithstanding the foregoing, [***].
|
(c) |
Otsuka Final Decision-Making Authority. The Executive Committee Co-Chairperson for Otsuka will have final decision making authority over
(i) [***], (ii) [***], (iii) [***], (iv) [***], (iv) [***], and (v) [***].
|
8.6.2 |
Limitations on Decision Making. Notwithstanding anything to the contrary set forth in this Agreement, without the other Party’s prior written consent, no decision of the Executive Committee, either
JSC, any other Subcommittee, or a Party’s Executive Committee Co-Chairperson (in the exercise of a Party’s decision‑making authority on any such matters), in each case may, without the other Party’s prior written consent, (a) be likely to
[***], (b) impose any requirements that the other Party take or decline to take any action that a Party reasonably believes would result in a violation of any Applicable Law, the requirements of any Regulatory Authority, or any agreement
with any Third Party (including any Collaboration In-License) or the infringement or misappropriation of intellectual property rights of any Third Party, or (c) conflict with, amend, interpret, modify, or waive compliance under this
Agreement.
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36
8.7 |
Day-to-Day Responsibilities. Each Party will: (a) be responsible for day-to-day implementation and conduct of the activities hereunder for which it has or is otherwise assigned responsibility under
this Agreement, provided that such implementation is consistent with the express terms of this Agreement or the decisions of the Executive Committee, either JSC, or any other Subcommittee, in each
case, within the scope of its authority as provided herein; and (b) provide the other Party with information about material events related to the progress of such activities, as may be reasonably requested by the other Party from time to
time.
|
8.8 |
Alliance Managers. As of the Restatement Date, each of the Parties has appointed a representative of such Party to act as its alliance manager under this Agreement for the Europe Territory and,
within [***] after the Restatement Date, each Party will appoint a representative to act as its alliance manager under this Agreement for the Asia Territory (each, an “Alliance Manager”).
The role of the Alliance Managers is to act as a single point of contact between the Parties to ensure a successful relationship under this Agreement. All of the Alliance Managers will attend all Executive Committee meetings and joint
meetings of the JSCs, the Alliance Managers for each Region shall attend the applicable JSC meetings, and the Alliance Managers or their respective designees will attend all other Subcommittee meetings and will support the Executive
Committee Co-Chairpersons and any Subcommittee Co-Chairpersons in the discharge of their responsibilities. Alliance Managers will be non-voting participants in all Executive Committee and Subcommittee meetings, but an Alliance Manager may
bring any matter to the attention of the Executive Committee or any Subcommittee if such Alliance Manager reasonably believes that such matter warrants such attention. Each Party may change its designated Alliance Manager(s) at any time
upon written notice to the other Party. Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager by written notice to the other Party. Each Alliance Manager, with respect to each Region,
or all Alliance Managers with respect to the Territory, will also: (a) be the point of first referral in all matters of conflict resolution; (b) provide a single point of communication for seeking consensus between the Parties regarding key
strategy and plan issues; (c) identify and bring disputes to the attention of the JSCs or Executive Committee in a timely manner; (d) plan and coordinate cooperative efforts and internal and external communications; and (e) take
responsibility for ensuring that governance activities, such as the conduct of required Executive Committee and any Subcommittee meetings and production of meeting minutes, occur as set forth in this Agreement, and that the relevant action
items resulting from such meetings are appropriately carried out or otherwise addressed.
|
ARTICLE 9
9.1 |
|
9.2 |
9.2.1 |
Regulatory Milestones. Subject to Section 9.2.1(a) (Europe Territory Regulatory Milestone Adjustment), after the first achievement of each regulatory milestone event set forth in Table
9.2.1 below by Otsuka or its Affiliates or Sublicensees for the first Licensed Product, Otsuka will pay to Ionis the corresponding regulatory milestone payment set forth in Table 9.2.1 (the regulatory milestone events set forth in Table
9.2.1, the “Regulatory Milestone Events” and the regulatory milestone payments set forth in Table 9.2.1, the “Regulatory
Milestone Payments”).
|
37
Table 9.2.1 – Regulatory Milestones
|
|||
Regulatory Milestone Event
|
Regulatory Milestone
Payment (in U.S.
Dollars)
|
||
1.
|
[***] |
$[***]
|
|
2.
|
[***] |
$[***]
|
|
3.
|
[***] |
$[***]
|
|
4.
|
[***] |
(a) $[***]
or
(b) $[***]
|
|
5.
|
[***] |
$[***]
|
(a) |
Europe Territory Regulatory Milestone Adjustment. If any [***], then the Regulatory Milestone Payments for the Europe Territory [***].
|
(b) |
|
9.2.2 |
Sales Milestones. After each sales milestone event set forth in Table 9.2.2 below is achieved by Otsuka or its Affiliates or Sublicensees for the Licensed Products in the Europe Territory or the
Asia Territory, as applicable, Otsuka will pay to Ionis the corresponding sales milestone payment, as set forth below (the sales milestone events set forth in Table 9.2.2, the “Sales
Milestone Events” and the sales milestone payments set forth in Table 9.2.2, the “Sales Milestone Payments”).
|
38
Table 9.2.1 – Regulatory Milestones
|
|||
Regulatory Milestone Event
|
Regulatory Milestone
Payment (in U.S.
Dollars)
|
||
1.
|
[***] |
$[***]
|
|
2.
|
[***] |
$[***]
|
|
3.
|
[***] |
$[***]
|
|
4.
|
[***] |
(a) $[***]
or
(b) $[***]
|
|
5.
|
[***] |
$[***]
|
(a) |
Notice and Payment. Otsuka will notify Ionis in writing of the achievement of each Sales Milestone Event no later than (i) [***] or (ii) [***]. However, in no event will a failure or delay by
Otsuka to deliver such notice of achievement of a Sales Milestone Event relieve Otsuka of its obligation to pay Ionis the corresponding Sales Milestone Payment for achievement of
such Sale Milestone Event. Following receipt of such notice, Ionis will send Otsuka an invoice (and, if there has been any change to a Payment Form previously submitted, or if a previously submitted Payment Form has expired, then an updated
Payment Form) for the applicable Sales Milestone Payment, and Otsuka shall pay such Sales Milestone Payment within [***] after receipt of such invoice (and Payment Forms, if applicable). If more than one of the Sales Milestone Events is
achieved for the first time in a given Calendar Quarter during the Term, then Otsuka will pay to Ionis a separate Sales Milestone Payment with respect to each such Sales Milestone Event. Each Sales Milestone Payment is payable only once, regardless of the number of times the corresponding Sales Milestone Event is achieved. If Otsuka or its Affiliates or Sublicensees achieve all of the Sales Milestone Events, then the Sales Milestone
Payments payable by Otsuka under this Section 9.2.2 (Sales Milestones) will not exceed $[***].
|
9.3 |
9.3.1 |
Royalty Payments During the Initial Royalty Term. Subject to the provisions of Section 9.3.2 (Royalty Reductions), Otsuka will pay to Ionis royalties based on the Net Sales of a Licensed
Product by Otsuka and its Affiliates and Sublicensees in the Otsuka Territory at the rates set forth in Table 9.3.1 below (the “Initial Royalties”), on a Licensed
Product-by-Licensed Product and country-by-country basis, commencing on the first sale of such Licensed Product that results in Net Sales of such Licensed Product in such country and ending on the latest to occur of (a) the [***]
anniversary of the First Commercial Sale of such Licensed Product in such country, (b) the expiration of the last Valid Claim in the [***] that Cover such Licensed Product in such country [***], and (c) loss of Regulatory Exclusivity of
such Licensed Product in such country (the “Initial Royalty Term”).
|
39
Table 9.3.1– Royalty Rates for the Licensed Products
|
||
Europe Territory
|
||
Portion of annual Net Sales of all Licensed Products in the Europe Territory that is [***]
|
[***]%
|
|
Portion of annual Net Sales of all Licensed Products in the Europe Territory that is greater than [***]
|
[***]%
|
|
Portion of annual Net Sales of all Licensed Products in the Europe Territory that is [***]
|
[***]%
|
|
[***]
|
||
Portion of annual Net Sales of all Licensed Products in [***] that is [***]
|
[***]%
|
|
Portion of annual Net Sales of all Licensed Products in [***] that is [***]
|
[***]%
|
|
Portion of annual Net Sales of all Licensed Products in [***] that is [***]
|
[***]%
|
|
Portion of annual Net Sales of all Licensed Products in [***] that is [***]
|
[***]%
|
|
[***]
|
||
Portion of annual Net Sales of all Licensed Products in [***] that is [***]
|
[***]%
|
|
Portion of annual Net Sales of all Licensed Products in [***] that is [***]
|
[***]%
|
|
Portion of annual Net Sales of all Licensed Products in [***] that is [***]
|
[***]%
|
|
Portion of annual Net Sales of all Licensed Products in [***] that is [***]
|
[***]%
|
|
Portion of annual Net Sales of all Licensed Products in [***] that is [***]
|
[***]%
|
By way of example only, if Otsuka receives [***] in Net Sales of all Licensed Products during a given Calendar Year in the Europe Territory, then Otsuka would owe Ionis a royalty of [***] (as
converted into U.S. Dollars in accordance with Section 9.8 (Method of Payment; Exchange Rate)).
9.3.2 |
(a) |
Generic Approval. On a country-by-country and Licensed Product-by-Licensed Product basis, if at any time during the Initial Royalty Term a Generic Product receives Regulatory Approval in a country
in the Otsuka Territory, then, subject to Section 9.3.2(e) (Royalty Reductions Floor), the royalty rates set forth in Table 9.3.1 will be reduced by [***] for such Licensed Product in such country.
|
(b) |
Third Party Payments. Subject to Section 9.3.2(e) (Royalty Reductions Floor), Otsuka may credit [***] of [***] in a country in the Otsuka Territory in a Calendar Quarter during the
Royalty Term against the Royalties due and payable by Otsuka to Ionis on the Net Sales for such Licensed Product in such country in such Calendar Quarter; provided that the terms of this Section 9.3.2(b) (Third Party Payments) will not apply to any license agreement entered into without Ionis’ prior written consent in violation of the terms of Section 10.5.3
(Settlement). For clarity, Otsuka will not have the right to offset any Third Party Payments arising out of, or allocable to, the Manufacture of a Licensed Product.
|
40
(c) |
[***]. Subject to Section 9.3.2(e) (Royalty Reductions Floor), on a Licensed Product-by-Licensed Product and country-by-country basis, if during any
Calendar Quarter during the Initial Royalty Term for such Licensed Product in such country, (i) [***], and (ii) [***], then, commencing [***]; provided that, if [***], then [***].
|
(d) |
[***]. Subject to Section 9.3.2(e) (Royalty Reductions Floor), on a Licensed Product-by-Licensed Product and country-by-country basis, during the
Initial Royalty Term for such Licensed Product in such country, if, [***].
|
(e) |
Royalty Reductions Floor. In no event will the Royalties due to Ionis for a Licensed Product in a country in the Otsuka Territory [***] set forth in this Section 9.3.2 (Royalty
Reductions). Notwithstanding the foregoing, [***].
|
9.3.3 |
Reduced Royalty Term. On a Licensed Product-by-Licensed Product, country-by-country and Region-by-Region basis in the Otsuka Territory, following expiration of the Initial Royalty Term for a
Licensed Product in a given country in a Region, Otsuka will pay Ionis a [***] royalty on the Net Sales of such Licensed Product by Otsuka and its Affiliates and Sublicensees in such country (the “Reduced Royalties” and together with the Initial Royalties, the “Royalties”) until the later of (a) [***], and (b) [***] (the “Reduced Royalty Term” and together with the Initial Royalty Term, the “Royalty Term”). For clarity, on a Licensed Product-by-Licensed Product and
country-by-country basis, [***].
|
9.3.4 |
(a) |
[***]. Commencing with the Calendar Quarter during which the first sale of a Licensed Product is made that results in Net Sales anywhere in the Otsuka
Territory, [***].
|
(b) |
Royalty Report. Commencing with the Calendar Quarter during which the first sale of a Licensed Product is made that results in Net Sales anywhere in the Otsuka Territory, within [***] after the end
of each Calendar Quarter, Otsuka will provide to Ionis a written report (each, a “Royalty Report”) setting forth in reasonable detail: (i) the gross sales of the Licensed Products
sold by Otsuka or its Affiliate or Sublicensee in each of the Europe Territory, [***] in such Calendar Quarter; (ii) the aggregate Net Sales of the Licensed Products sold by Otsuka or its Affiliates or Sublicensees in each of the Europe
Territory, [***] in such Calendar Quarter; (iii) all deductions and reductions used to determine the Net Sales of the Licensed Products for such Calendar Quarter or the Royalties payable with respect to the Licensed Products for such
Calendar Quarter, including any reduction pursuant to Section 9.3.2 (Royalty Reductions) (if applicable); (iv) the exchange rates used to calculate the Royalties payable in U.S. Dollars; (v) any withholding taxes required to be made
from such Royalties; and (vi) the quantity and description of the Licensed Products sold by Otsuka or its Affiliate or Sublicensee in each of the Europe Territory, [***] during such Calendar Quarter comprising such Net Sales. The Parties
will seek to resolve any questions or issues related to a Royalty Report within [***] following receipt by Ionis of each Royalty Report.
|
(c) |
Royalty Payments. The information contained in each Royalty Report will be considered the Confidential Information of Otsuka. Following receipt of each Royalty Report, Ionis will [***] and, [***],
Otsuka will pay the Royalties due hereunder for the Calendar Quarter covered by the applicable Royalty Report.
|
41
9.4 |
Other Amounts Payable. With respect to any amounts owed under this Agreement by one Party to the other for which no other invoicing and payment procedure is specified hereunder, within [***] after
the end of each Calendar Quarter, each Party will provide an invoice, together with reasonable supporting documentation, to the other Party for such amounts owed in respect of such Calendar Quarter. The owing Party will pay any undisputed
invoiced amounts within [***] after the date of the invoice, and any disputed amounts owed by a Party will be paid within [***] following resolution of the dispute.
|
9.5 |
Financial Records and Audits. Each Party will, and will require its Sublicensees and Subcontractors to, maintain complete and accurate records in accordance with such Party’s Accounting Standards
in sufficient detail to permit the other Party to confirm the accuracy of any amounts payable under this Agreement for at least the preceding [***] (provided that, with respect to Internal Costs,
such records may be based on estimates as long as the method of calculating such estimates is consistently applied), including (as applicable) any External Costs incurred in
connection with the performance of the Asia-Specific Non-Clinical HAE Development Activities, Eligible Cross-Territory Development Costs, Milestone Payments, Royalties, and sales of the Licensed Products (including all calculations of Net
Sales). Upon reasonable prior notice, each Party agrees to permit such records to be open during regular business hours for examination by an independent certified public accountant selected by the auditing Party and reasonably acceptable
to the audited Party for the sole purpose of verifying the accuracy of the financial reports furnished by the audited Party pursuant to this Agreement or of any payments made, or required to be made, by the audited Party pursuant to this
Agreement; provided that such independent accounting firm is subject to written obligations of confidentiality and non-use applicable to each Party’s
Confidential Information that are at least as stringent as those set forth in Article 12 (Confidentiality). Such audit will not be (a) performed more frequently than [***], or (b) repeated for any Calendar Year or with respect to
the same set of records (in each case, except for cause). Such auditor will not disclose the audited Party’s Confidential Information to the auditing Party or to any Third Party, except to the extent such disclosure is necessary to verify
the accuracy of the financial reports furnished by the audited Party or the amount of payments by the audited Party under this Agreement. The audited Party will pay any amounts shown to be owed to the auditing Party but unpaid within [***]
after the accountant’s report, plus interest (as set forth in Section 9.11 (Late Payments; Disputed Payments)) from the original due date solely if the audited Party is responsible for the
discrepancy. If such examination of records reveals any overpayment by Xxxxx, then Otsuka will reimburse Ionis for the amount overpaid within [***] after the accountant’s report, plus interest (as
set forth in Section 9.11 (Late Payments; Disputed Payments)) from the original due date [***]. If such examination of records reveals any overpayment by Otsuka, then [***]. The auditing Party will bear the full cost of such audit
unless such audit reveals an underpayment by the audited Party of more than [***] of the amount actually due for the time period being audited, in which case the audited Party will reimburse the auditing Party for the reasonable audit fees
for such examination.
|
9.6 |
No Refunds. Except as expressly provided herein, all payments under this Agreement will be irrevocable, non-refundable, and non-creditable.
|
9.7 |
Accounting Standards. If a Party changes its general accounting principles from its then-current Accounting Standard (e.g., from GAAP to IFRS) at any time
during the Term, then at least [***] prior to adopting such change in principles, such Party will provide written notice to the other Party of such change. A Party may not change its general accounting principles to any accounting standard
other than GAAP or IFRS without the prior written approval of the other Party.
|
42
9.8 |
Method of Payment; Exchange Rate. All amounts to be paid pursuant to this Agreement will be made in U.S. Dollars and will be paid by wire transfer in immediately available funds to a bank account
designated by the receiving Party. The rate of exchange to be used in computing the amount of currency equivalent in U.S. Dollars owed to a Party under this Agreement will be the Selling Party’s then-current standard exchange rate
methodology employed for the translation of foreign currency sales into U.S. Dollars in accordance with its Accounting Standards and consistently applied during the period.
|
9.9 |
Blocked Payments. If by reason of Applicable Law in any country or jurisdiction, it becomes impossible or illegal for a Party to transfer, or have transferred on its behalf, payments owed the other
Party hereunder, then such Party will promptly notify the other Party of the conditions preventing such transfer and use reasonable efforts to deposit such payments in U.S. Dollars. If, after using reasonable efforts, such Party is not able
to deposit such payments in U.S. Dollars, then such payments will be deposited in local currency in the relevant country to the credit of the other Party in a recognized banking institution designated by the other Party or, if none is
designated by the other Party within [***], in a recognized banking institution selected by the transferring Party, as the case may be, and identified in a written notice given to the other Party.
|
9.10 |
9.10.1 |
Taxes on Income. Each Party will be solely responsible for the payment of any and all income Taxes levied on account of all payments it receives under this Agreement.
|
9.10.2 |
Withholding Tax. Any and all payments made pursuant to this Agreement will be paid without deduction or withholding for any Taxes, except as required by Applicable Law. To the extent a Party is
required by Applicable Law to deduct or withhold Taxes on any payment to the other Party (the “Withheld Amount”), such Party will remit such Withheld Amount to the proper
Governmental Authority in a timely manner and promptly transmit to the other Party an official Tax certificate or other evidence of any withholding sufficient to enable the other Party to claim available credits for such Withheld Amount.
The withholding Party will have the right to deduct such Withheld Amount from payment due to the other Party. For the avoidance of doubt, to the extent such Withheld Amount is so withheld and remitted in accordance with this Section
9.10.2 (Withholding Tax), such Withheld Amount will be treated for all purposes of this Agreement as having been paid to the other Party.
|
9.10.3 |
Tax Cooperation. The Parties agree to cooperate with one another in accordance with Applicable Law and use reasonable efforts to [***] in respect of payments made by each Party to the other Party
under this Agreement. Without limiting the generality of the foregoing, each Party will provide the other with any Tax forms and other information that may be reasonably necessary to [***] based on an applicable treaty or otherwise,
including a properly completed Internal Revenue Service (“IRS”) Form W-9 or appropriate IRS Form W-8, as applicable, before a payment is made. If any Tax form or other information
a Party previously delivered expires or becomes obsolete or inaccurate in any respect, then such Party will provide the other Party with an updated version of such form or certification or promptly notify the other Party in writing of its
legal inability to do so. Each Party will provide the other Party with reasonable assistance to enable the recovery, as permitted by Applicable Law, of withholding Taxes or similar obligations resulting from payments made under this
Agreement, such recovery to be for the benefit of the Party bearing such withholding Tax.
|
43
9.10.4 |
Changes in Domicile. Notwithstanding any provision to the contrary in this Agreement, including Section 9.10.2 (Withholding Tax), if as a result of a Party assigning, transferring, or
conveying rights under this Agreement to an Affiliate or changing its domicile, additional Taxes become due that would not otherwise have been due hereunder with respect to payments under this Agreement, then such Party will be responsible
for all such additional withholding Taxes.
|
9.11 |
Late Payments; Disputed Payments. Any undisputed payments or portions thereof due hereunder that are not paid on or before the date such payments are due under this Agreement will bear interest
from the due date until the date of payment at a per-annum rate equal to the lesser of: (a) [***] percentage points above the prime rate as published by The Wall Street Journal or any successor
thereto; or (b) the maximum rate permitted by Applicable Law. If a Party disputes an invoice or other payment obligation under this Agreement, then such Party will timely pay the undisputed amount of the invoice or other payment obligation,
and the Parties will resolve such dispute in accordance with Article 15 (Dispute Resolution; Governing Law).
|
ARTICLE 10
10.1 |
10.1.1 |
Ownership of Background Intellectual Property. As between the Parties, and subject to the licenses granted under this Agreement, each Party retains all rights, title, and interests in and to all
Patent Rights and Know-How that such Party owns or Controls as of the Original Effective Date or that it develops or otherwise acquires after the Original Effective Date outside the performance of the activities under the Original Agreement
during the Original Agreement Term or under this Agreement.
|
10.1.2 |
Ownership of Arising Intellectual Property. As between the Parties, ownership of all Collaboration Know-How will be as follows:
|
(a) |
Ionis will be the sole owner of any (i) Collaboration Know-How that is developed or invented solely by Representatives of Ionis or its Affiliates or its or their licensees (other than Otsuka), Sublicensees, or Subcontractors, or any
Persons contractually required to assign or license such Collaboration Know-How to Ionis or any Affiliate of Ionis (“Ionis Collaboration Know-How”), and (ii) Patent Rights that
Cover the Ionis Collaboration Know-How (“Ionis Collaboration Patent Rights”), and will retain all of its rights thereto, subject to any rights or licenses expressly granted by
Xxxxx to Otsuka under this Agreement.
|
(b) |
Otsuka will be the sole owner of any (i) Collaboration Know-How that is developed or invented solely by Representatives of Otsuka or its Affiliates or its or their licensees (other than Ionis), Sublicensees, or Subcontractors, or any
Persons contractually required to assign or license such Collaboration Know-How to Otsuka or any Affiliate of Otsuka (“Otsuka Collaboration Know-How”), and (ii) Patent Rights that
Cover the Otsuka Collaboration Know-How (“Otsuka Collaboration Patent Rights”), and will retain all of its rights thereto, subject to any rights or licenses expressly granted by
Otsuka to Ionis under this Agreement.
|
(c) |
Each Party will own an equal, undivided share of all Joint Collaboration Technology.
|
44
10.1.3 |
(a) |
Invention Disclosure. Each Party will promptly disclose to the other Party all Inventions within the Collaboration Know-How developed or invented during the Original Agreement Term or during the
Term by or on behalf of such Party, in each case, as soon as practicable prior to an intended public disclosure of such Invention and prior to the filing of a patent application thereon. Each Party will also promptly respond to reasonable
requests from the other Party for additional information relating thereto.
|
(b) |
Inventions by a Party. Inventorship for Inventions and discoveries (including Know-How) first invented or developed during the course of the performance of activities under the Original Agreement
and this Agreement will be determined in accordance with United States Patent Laws for determining inventorship.
|
(c) |
Joint Research Agreement under the Xxxxx-Xxxxx America Invents Act. If a Party intends to invoke its rights under 35 U.S.C. § 102(c) of the Xxxxx-Xxxxx America Invents Act, then it will notify the
other Party and neither Party will make an election under such provision when exercising its rights under this Article 10 (Intellectual Property) without the prior written consent of the other Party (such consent not to be
unreasonably withheld, conditioned, or delayed), and the Parties will use reasonable efforts to cooperate and coordinate their activities with respect to any submissions, filings or other activities in support thereof. The Parties
acknowledge and agree that the Original Agreement and this Agreement is a “joint research agreement” as defined in 35 U.S.C. § 100(h).
|
10.1.4 |
|
10.1.5 |
Representative Assignment. Each Party and its Affiliates will, and will cause its licensees, Sublicensees and Subcontractors to, enter into an agreement or employment policy with each of its
Representatives performing activities related to Development, Manufacture, or Commercialization of a Licensed Product that (a) compels prompt disclosure to such Party (or its Affiliate, licensee, Sublicensee or Subcontractor, as applicable)
of all Collaboration Know-How and Collaboration Patent Rights discovered, developed, invented, or filed by such Representative during any performance of such Development, Manufacture or Commercialization activities; and (b) automatically
assigns to such Party (or its Affiliate, licensee, Sublicensee or Subcontractor, as applicable) all rights, title, and interests in and to all Collaboration Know-How and Collaboration Patent Rights, and requires each Representative to
execute all documents and take such other actions as may be necessary to effectuate such assignment (or, if such assignment is not feasible, provides for such Party’s (or its Affiliate’s, licensee’s, Sublicensee’s or Subcontractor’s, as
applicable) joint ownership of, or an irrevocable, royalty-free license to such Party (or its Affiliate, licensee, Sublicensee or Subcontractor, as applicable) under, all Collaboration Know-How and Collaboration Patent Rights, with the
right to sublicense to the other Party as contemplated in this Agreement), provided that the foregoing will not apply with respect to improvements to background technology of a Subcontractor.
|
45
10.2 |
10.2.1 |
(a) |
Right to Prosecute. As between the Parties, Ionis will have the (i) first right, in its sole discretion, to control the Patent Prosecution of all Ionis Product-Specific Patents in the Otsuka
Territory and all Joint Collaboration Patent Rights worldwide, and (ii) sole right, in its sole discretion, to control the Patent Prosecution of all (A) Ionis Product-Specific Patents in the Ionis Territory, and (B) Ionis Core Technology
Patents and Ionis Manufacturing and Analytical Patents, in each case, worldwide (collectively, ((i) and (ii)), the “Ionis Prosecuted Patent Rights”). Upon Xxxxx’ request, Otsuka
will obtain any necessary assignment documents for Ionis with respect to the Patent Prosecution of Ionis Prosecuted Patent Rights, will render all signatures that will be necessary for such patent filings, and will assist Ionis in all other
reasonable ways that are necessary for the issuance of Ionis Prosecuted Patent Rights as well as for the Patent Prosecution of Ionis Prosecuted Patent Rights, and Xxxxx will reimburse Otsuka’s reasonable External Costs incurred in
connection therewith. Ionis will be responsible for [***] of the costs and expenses incurred with respect to the Patent Prosecution of all Ionis Product-Specific Patents, Ionis Core Technology Patents and Ionis Manufacturing and Analytical
Patents throughout the world and for [***] of the costs and expenses incurred with respect to the Patent Prosecution of Joint Collaboration Patent Rights in the Ionis Territory. Otsuka will be responsible for [***] of the reasonable
out-of-pocket costs incurred by or on behalf of Ionis with respect to the Patent Prosecution of the Joint Collaboration Patent Rights in the Otsuka Territory (including any maintenance fees owed to local patent offices for the Joint
Collaboration Patent Rights in the Otsuka Territory), and Otsuka will reimburse Ionis for such costs within [***] after receiving an invoice with reasonable supporting documentation for such costs.
|
(b) |
Review and Consult. Ionis will consult with Otsuka and keep Otsuka reasonably informed regarding the Patent Prosecution of the Ionis Product-Specific Patents in the Otsuka Territory and the Patent
Prosecution of the Joint Collaboration Patent Rights worldwide and will provide Otsuka with all substantive correspondence received from any patent authority in connection therewith no later than [***] after receipt thereof. In addition,
Xxxxx will provide Otsuka with drafts of proposed substantive filings in the Otsuka Territory and correspondence to any patent authority in the Otsuka Territory in connection with the Patent Prosecution of the Ionis Product-Specific Patents
and with drafts of proposed substantive filings in the Territory and correspondence to any patent authority in the Territory in connection with the Patent Prosecution of Joint Collaboration Patent Rights, in each case for Otsuka’s review
and comment at least [***] prior to the submission of such proposed filings and correspondence, which comments (if any) Otsuka must provide no later than [***] after receipt of the applicable filing or correspondence. Xxxxx will consider in
good xxxxx Xxxxxx’x reasonable comments on the Patent Prosecution of the Ionis Product-Specific Patents in the Otsuka Territory and the Joint Collaboration Patent Rights in the Territory, but Xxxxx will have final decision-making authority
regarding Patent Prosecution of such Patent Rights under this Section 10.2.1(b) (Review and Consult).
|
46
(c) |
Abandonment. If, at any time during the Term, Xxxxx decides to cease the Patent Prosecution of a particular Ionis Product-Specific Patent in the Otsuka Territory, or a particular Joint
Collaboration Patent Right in the Territory, then Xxxxx will provide written notice to Otsuka of such decision at least [***] prior to the date that such applicable Patent Right will become abandoned. Unless such written notice includes a
reasonable strategic reason for ceasing such Patent Prosecution (e.g., continuing such Patent Prosecution would adversely affect Xxxxx’ Patent Prosecution or litigation strategy), Otsuka may, upon
written notice to Xxxxx, assume the Patent Prosecution of any such Patent Right at Otsuka’s sole cost and expense. Without limiting the foregoing, with respect to any such Joint Collaboration Patent Right abandoned by Xxxxx, Ionis shall
assign, and hereby does assign, to Otsuka all of its rights, title and interests in and to such Joint Collaboration Patent Right, and upon such assignment, such Joint Collaboration Patent Right shall be deemed an Otsuka Patent Right for all
purposes of this Agreement.
|
10.2.2 |
(a) |
Right to Prosecute. As between the Parties, Otsuka will have the first right to control the Patent Prosecution of all Otsuka Patent Rights throughout the world. Otsuka will be responsible for [***]
of the costs and expenses incurred with respect to the Patent Prosecution of such Patent Rights throughout the world.
|
(b) |
Review and Consult. Otsuka will consult with Xxxxx and keep Ionis reasonably informed regarding the Patent Prosecution of the Otsuka Patent Rights and will provide Ionis with all substantive
correspondence received from any patent authority in connection therewith no later than [***] after receipt thereof. In addition, Otsuka will provide Ionis with drafts of all proposed substantive filings and correspondence to any patent
authority in connection with the Patent Prosecution of the Otsuka Patent Rights for Xxxxx’ review and comment at least [***] prior to the submission of such proposed filings and correspondence, which comments (if any) Ionis must provide no
later than [***] after receipt of the applicable filing or correspondence. Otsuka will consider in good xxxxx Xxxxx’ reasonable comments on the Patent Prosecution of the Otsuka Patent Rights, but will have final decision-making authority
regarding Patent Prosecution of such Patent Rights under this Section 10.2.2(b) (Review and Consult).
|
(c) |
Abandonment. If, at any time during the Term, Otsuka ceases the Patent Prosecution of a particular Otsuka Patent Right, then Otsuka will provide written notice to Ionis of such decision at least
[***] prior to the date on which such Patent Right will become abandoned. Unless such written notice includes a reasonable strategic reason for ceasing such Patent Prosecution (e.g., continuing such
Patent Prosecution would adversely affect Otsuka’s Patent Prosecution or litigation strategy), Ionis may, upon written notice to Otsuka, assume the Patent Prosecution of any such Patent Right at Ionis’ sole cost and expense.
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47
10.3 |
10.3.1 |
Notice of Infringement or Misappropriation. Each Party will promptly notify the other of any apparent, threatened, or actual Competitive Infringement of which it becomes aware.
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10.3.2 |
Otsuka’s Enforcement Right. Otsuka will have the first right, but not the obligation, to enforce [***] against any Competitive Infringement in the Otsuka Territory and at its own cost and expense
and using counsel of its own choice; provided that, (a) [***], Ionis will be entitled to attend any substantive meetings, hearings, or other proceedings related to such infringement or
misappropriation suit (together with its own counsel, at its own expense) and to review and comment on all substantive documents related to such infringement or misappropriation suit prior to filing or submission of such documents, and (b)
with respect to [***], Otsuka shall keep Ionis reasonably informed of the status of any substantive meetings, hearings, or other proceedings related to such infringement or misappropriation suit. If Otsuka fails to initiate a suit or take
other action to xxxxx any such Competitive Infringement within the earlier of: (i) [***] and (ii) [***], then, in either case, Ionis will have the second right, but not the obligation, to attempt to resolve such Competitive Infringement, at
its own expense, including the filing of an infringement or misappropriation suit, as applicable, to enforce the applicable Patent Rights or Know-How using counsel of its own choice; provided that,
if Otsuka notifies Ionis during [***] that it is electing not to take steps to enforce the applicable Patent Rights against such Competitive Infringement [***].
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10.3.3 |
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10.3.4 |
Allocation of Recoveries. Any recoveries resulting from an enforcement action relating to a claim of Competitive Infringement in the Territory will be first applied against payment of each Party’s
costs and expenses in connection therewith. Any such recoveries in excess of such costs and expenses will be [***]; provided that [***].
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48
10.3.5 |
Cooperation; Procedures. At the request and expense of the Party bringing an infringement or misappropriation action under this Section 10.3 (Enforcement Against Third Party Infringement or
Misappropriation), the other Party will provide reasonable assistance and cooperation in any such action (including entering into a common interest agreement if reasonably deemed necessary by any Party) and agrees to be joined as a party to
the suit if necessary for the initiating Party to bring or continue an infringement or misappropriation action hereunder. In addition, the Party bringing an infringement or misappropriation action under this Section 10.3
(Enforcement Against Third Party Infringement or Misappropriation) will provide the other Party with copies of all pleadings and other documents in advance of filing with the court and will consider reasonable input from the other Party
during the course of the action. For clarity, the Party bringing an infringement or misappropriation action under this Section 10.3 (Enforcement Against Third Party Infringement or Misappropriation) will control such infringement or
misappropriation action subject to the terms of this Section 10.3 (Enforcement Against Third Party Infringement or Misappropriation). Neither Party may settle any action or proceeding brought under this Section 10.3
(Enforcement Against Third Party Infringement or Misappropriation) or knowingly take any other action in the course thereof that disclaims, limits the scope of, admits the invalidity or unenforceability of, or grants a license, covenant not
to sue or similar immunity under a Patent Right Controlled by the other Party without first obtaining the written consent of the Party that Controls the relevant Patent Right. Furthermore, Ionis may not [***]. The Parties will reasonably
assist each other and cooperate with each other, at their own expense, in any such investigation, pre-litigation preparation, or litigation to ensure that there is an aligned global litigation and enforcement strategy.
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10.4 |
Defense of Third-Party Patent Challenges. Each Party will promptly notify the other Party in writing after becoming aware of an actual or threatened Patent Challenge by a Third Party of any Ionis
Patent Right, Otsuka Patent Right, and Joint Collaboration Patent Right (each, a “Third Party Patent Challenge”).
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10.4.1 |
Otsuka’s Right to Defend. Subject to the terms of Section 10.4.3 (Cooperation; Procedures), and except as may be otherwise agreed by the Parties, Otsuka will have the first right, but not
the obligation, to control the defense of any Third Party Patent Challenge relating to an Otsuka Patent Right or Joint Collaboration Patent Right in the Otsuka Territory, and to compromise, litigate, settle, or otherwise dispose of any such
challenge, in each case at its own expense using counsel of its own choice; provided that (a) with respect to a Joint Collaboration Patent Right, Ionis will be entitled to attend any substantive
meetings, hearings, or other proceedings related to such Third Party Patent Challenge (together with its own counsel, at its own expense) and to review and comment on all substantive documents related to such Third Party Patent Challenge,
and (b) with respect to an Otsuka Patent Right, Otsuka shall keep Ionis reasonably informed of the status of any substantive meetings, hearings, or other proceedings related to such Third Party
Patent Challenge, and if Otsuka fails to initiate the defense of such Third Party Patent Challenge of a Patent Right in the Otsuka Territory within [***] after the notice provided under Section 10.4 (Defense of Third Party Patent
Challenges), or otherwise abandons or elects not to continue any such defense once initiated, then Xxxxx will have the second right, but not the obligation, to control the defense of such Third Party Patent Challenge at its own expense
using counsel of its own choice.
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49
10.4.2 |
Ionis’ Right to Defend. Ionis will have the sole right, but not the obligation, to control the defense of any Third Party Patent Challenge relating to an (a) Ionis Product-Specific Patent in the
Ionis Territory or (b) Ionis Core Technology Patent or Ionis Manufacturing and Analytical Patent in the Territory, and to compromise, litigate, settle, or otherwise dispose of any such challenge, in each case, at its own expense using
counsel of its own choice. Subject to the terms of Section 10.4.3 (Cooperation; Procedures), Ionis will have the first right, but not the obligation, to control the defense of any Third Party Patent Challenge relating to an (i)
Otsuka Patent Right or Joint Collaboration Patent Right in the Ionis Territory or (ii) Ionis Product-Specific Patent in the Otsuka Territory and to compromise, litigate, settle, or otherwise dispose of any such challenge, at its own expense
using counsel of its own choice; provided that Otsuka will be entitled to attend any substantive meetings, hearings, or other proceedings related to such Third Party Patent Challenge (together with
its own counsel, at its own expense) and to review and comment on all substantive documents related to such Third Party Patent Challenge. If Xxxxx fails to initiate the defense of such Third Party Patent Challenge of an Otsuka Patent Right
or Joint Collaboration Patent Right in the Ionis Territory or an Ionis Product-Specific Patent in the Otsuka Territory, in each case, within [***] after the notice provided under Section 10.4 (Defense of Third Party Patent
Challenges), or otherwise abandons or elects not to continue any such defense once initiated, then Otsuka will have the second right, but not the obligation, to control the defense of such Third Party Patent Challenge at its own expense
using counsel of its own choice.
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10.4.3 |
Cooperation; Procedures. At the request and expense of the Party controlling the defense of any Third Party Patent Challenge under this Section 10.4 (Defense of Third Party Patent
Challenges), the other Party will provide reasonable assistance and cooperation in any such action. In addition, the Party controlling the defense of any Third Party Patent Challenge under this Section 10.4 (Defense of Third Party
Patent Challenges) will provide the other Party with copies of all pleadings and other documents to be filed with the court and will consider reasonable input from the other Party during the course of the action. Otsuka may not settle any
action or proceeding brought or defended under this Section 10.4 (Defense of Third-Party Patent Challenges) or knowingly take any other action in the course thereof without Xxxxx’ prior written consent, unless such action or
proceeding solely concerns the Otsuka Patent Rights. Ionis may not settle any action or proceeding brought or defended under this Section 10.4 (Defense of Third-Party Patent Challenges) or knowingly take any other action in the
course thereof with respect to the Ionis Product-Specific Patents or Joint Collaboration Patent Rights in the Otsuka Territory, without Otsuka’s prior written consent not to be unreasonably withheld, conditioned or delayed. The Parties will
reasonably assist each other and cooperate with each other, at their own expense, in any such investigation, pre-litigation preparation, or litigation to ensure that there is an aligned global litigation strategy. Notwithstanding the above,
in the case of any invalidity or unenforceability claims arising in an enforcement action under Section 10.3 (Enforcement Against Third Party Infringement or Misappropriation), the Party controlling the enforcement action pursuant
to Section 10.3 (Enforcement Against Third Party Infringement or Misappropriation) shall control the response to such invalidity or unenforceability claims, provided such Party may not admit
invalidity or unenforceability of any Patent Right Controlled by the other Party without the prior written consent of the other Party.
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50
10.5 |
10.5.1 |
Infringement Claim; Patent Challenges of Third-Party IP. If a Third Party asserts that a Patent Right controlled by it is, or will be, infringed by the Exploitation of a Licensed Product in the
Territory in accordance with this Agreement, then the Party first obtaining knowledge of such claim will promptly provide the other Party with prompt written notice thereof and the related facts in reasonable detail.
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10.5.2 |
Responsibility to Defend. During the Term of this Agreement, if a Third Party asserts that a Patent Right controlled by such Third Party is infringed, or will be infringed, by the Exploitation of a
Licensed Product, then the Parties will promptly discuss the matter and the appropriate course of action. If the Parties cannot agree on a course of action within [***] following the date on which the Parties receive notice of such Third
Party claim, then, subject to Article 13 (Indemnification): (a) Ionis will have the sole right, but not the obligation, to defend such claim in the Ionis Territory using counsel of its own choosing, and (b) Otsuka will have the
first right, but not the obligation, to defend such claim in the Otsuka Territory using counsel of its own choosing. If Otsuka does not take affirmative steps to defend such claim in the Otsuka Territory within [***] (or such shorter period
of time as is legally required to answer to such claim) and does not inform Ionis within such [***] period that it is electing not to defend such claim for strategic reasons intended to maintain the commercial value of the relevant Patent
Rights or any product or subject matter Covered thereby or relating thereto, then Ionis may defend such claim in the Otsuka Territory. The Party defending such claim in the Otsuka Territory will (i) keep the other Party reasonably informed
regarding any such assertion, including by providing the other Party with copies of all pleadings and other documents filed in any proceeding relating to such claim, (ii) consider reasonable input from the other Party during the course of
the claim, and (iii) provide the other Party with the opportunity to attend any substantive meetings, hearings, or other proceedings related to such claim (together with its own counsel, at its own expense) and to review and comment on all
substantive documents related to such claim prior to filing or submission of such documents. The Parties will reasonably assist each other and cooperate and share information with respect to any such claim. Each Party will bear its own
costs and expenses with respect to any such claim.
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10.5.3 |
Settlement. Subject to Article 13 (Indemnification), neither Party will pursue or enter into any settlement or license agreement with any Third Party with respect to the Patent Rights that
are the subject of a claim brought by a Third Party that a Patent Right controlled by such Third Party is infringed by the Exploitation of a Licensed Product in the Otsuka Territory without the other Party’s prior written consent, not to be
unreasonably withheld, conditioned, or delayed. Subject to Article 13 (Indemnification), Otsuka will bear the costs of any amounts paid in settlement or to satisfy a judgment of a claim that the Exploitation of a Licensed Product
infringes any Third Party Patent Right in the Otsuka Territory, except to the extent such costs [***].
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10.6 |
10.6.1 |
Notice of Third-Party Patent Right. If either Party becomes aware of a Third Party Patent Right that might form the basis for a claim that the Exploitation of a Licensed Product anywhere in the
world infringes, or will infringe, such Patent Right, then the Party first obtaining knowledge of such Patent Right will promptly provide the other Party with written notice thereof and the related facts in reasonable detail, and the
Parties will promptly meet to discuss the matter.
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51
10.6.2 |
Patent Challenges of Third-Party Patents. Xxxxx will have the sole right, but not the obligation, to initiate a Patent Challenge of any such Third Party Patent Right in the Ionis Territory using
counsel of its own choosing. Otsuka will have the first right, but not the obligation, to initiate a Patent Challenge of such Third Party Patent Right in the Otsuka Territory, and if Otsuka notifies Ionis that it does not intend to initiate
such a Patent Challenge, Xxxxx will have the second right, but not the obligation, to do so; provided that, [***]. The Party initiating such Patent Challenge will (a) keep the other Party
reasonably informed regarding any such Patent Challenge, including by providing the other Party with copies of all pleadings and other documents filed in any proceeding relating to such Patent Challenge, (b) consider reasonable input from
the other Party during the course of the Patent Challenge, and (c) provide the other Party with the opportunity to attend any substantive meetings, hearings, or other proceedings related to such Patent Challenge (together with its own
counsel, at its own expense) and to review and comment on all substantive documents related to such Patent Challenge prior to filing or submission of such documents. The Parties will reasonably assist each other and cooperate and share
information with respect to any such Patent Challenge. Each Party will bear its own costs and expenses with respect to any such Patent Challenge; provided, however, that the Parties will each bear
[***] of the reasonable out-of-pocket costs incurred with respect to any such Patent Challenge in the Otsuka Territory, and the non-controlling Party will reimburse the Party initiating such Patent Challenge in the Otsuka Territory for such
costs within [***] after receiving an invoice with reasonable supporting documentation for such costs.
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10.6.3 |
Restrictions on Settlement. Neither Party nor its Affiliates will pursue or enter into any settlement or license agreement with any Third Party with respect to the Patent Rights that are the
subject of such Patent Challenge in the Otsuka Territory without the other Party’s prior written consent.
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10.7 |
Patent Term Extensions. With respect to any system for extending the term of Patent Rights in the Otsuka Territory established by any applicable Regulatory Authority or patent office during the
Term that is similar to the patent term extension system in the U.S., [***] for making all decisions regarding patent term extensions of the Ionis Patent Rights or Joint Collaboration Patent Rights in the Otsuka Territory, including
supplementary protection certificates and any other extensions that are now or become available in the future, that are applicable to the Ionis Patent Rights or Joint Collaboration Patent Rights licensed hereunder and that become available
directly as a result of the Regulatory Approval of a Licensed Product in the Otsuka Territory; provided that Otsuka will consult with Ionis with respect to such decisions and consider in good faith
the reasonable comments and concerns of Ionis.
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10.8 |
10.8.1 |
Otsuka will be solely responsible for making all decisions regarding the opting-out or opting-in of existing Patent Rights into the jurisdiction of the Unified Patent Court or the registration of Patent Rights with Unitary Effect; provided that Otsuka will consult with Ionis with respect to such decisions and will [***].
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10.8.2 |
Otsuka will be solely responsible for making all decisions regarding the patent linkage listings (or other listings similar to the Orange Book listings in the U.S.) in the Otsuka Territory; provided that
Otsuka will consult with Ionis with respect to such decisions and will [***].
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52
10.9 |
Common Interest. The Parties stipulate and agree that, with regard to such prosecution, maintenance, enforcement, and defense the interests of the Parties as collaborators and licensor and licensee
are to obtain the strongest patent protection possible, and as such, are aligned and are legal in nature. The Parties stipulate and agree that they have not waived, and nothing in this Agreement constitutes a waiver of, any legal privilege
concerning the Patent Rights under this Article 10 (Intellectual Property), including privilege under the common interest doctrine and similar or related doctrines. Notwithstanding any provision to the contrary set forth in this
Agreement, to the extent a Party has a good faith belief that any information required to be disclosed by such Party to the other Party under this Article 10 (Intellectual Property) is protected by attorney-client privilege or any
other applicable legal privilege or immunity, such Party will not be required to disclose such information and the Parties will in good faith cooperate to agree upon a procedure (including entering into a specific common interest agreement,
disclosing such information on a “for counsel eyes only” basis or similar procedure) under which such information may be disclosed without waiving or breaching such privilege or immunity.
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10.10 |
10.10.1 |
(a) |
Unitary Product Trademarks. Ionis shall, at its sole cost and expense, develop, and shall use Commercially Reasonable Efforts to obtain and maintain, a unitary Trademark (and back-up Trademarks
thereof) to be used for the Licensed Products worldwide (each, a “Unitary Product Trademark”); provided however, [***]. If Otsuka believes
it is necessary or reasonably useful to develop Trademarks in local languages in the Otsuka Territory (such as a katakana Trademark, which is a Japanese notation of a Trademark to be used for Exploitation of Licensed Products in Japan),
Otsuka will [***] (each, a “Local Unitary Product Trademark”) will be deemed to be a Unitary Product Trademark for all purposes of this Agreement (including, for clarity, [***]).
For clarity, it would be [***]. Ionis will own all right, title, and interest in and to each Unitary Product Trademark (including each Local Unitary Product Trademark). Otsuka will use the Unitary Product Trademarks in the Otsuka Territory
to the extent required by and in accordance with the Otsuka Territory Brand Strategy, subject to Section 6.4.1 (Global Brand Strategy and American Commercialization Operating Plan) and Section 6.4.2 (Otsuka Territory Brand
Strategy and Commercialization Operating Plans).
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(b) |
Ownership of Otsuka Product Trademarks. As between the Parties, Otsuka will have the sole right to determine and will own all right, title, and interest in and to any Trademarks, other than the
Unitary Product Trademarks, to be created or used by Otsuka or its Affiliates or its or their Sublicensees for the Exploitation of Licensed Product in the Otsuka Territory excluding any trademarks, service marks, names, or logos that
include any corporate name or logo of the Parties or their Affiliates or its or their Sublicensees (“Otsuka Product Trademarks”); provided that
such Otsuka Product Trademarks are consistent with the Global Brand Strategy, except to the extent such inconsistency is (i) [***], or (ii) [***]. Ionis will not [***]. Ionis will not [***].
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53
(c) |
Ownership of Ionis Product Trademarks. As between the Parties, Ionis will have the sole right to determine and will own all right, title, and interest in and to the Trademarks (other than the
Unitary Product Trademarks) to be used by Ionis or its Affiliates or its or their Sublicensees or licensees for the Exploitation of Licensed Product in the Ionis Territory excluding any trademarks, service marks, names, or logos that
include any corporate name or logo of the Parties or their Affiliates or its or their Sublicensees or licensees (“Ionis Product Trademarks”); provided
that such Ionis Product Trademarks are consistent with the Global Brand Strategy. Otsuka will not [***]. Otsuka will not [***].
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10.10.2 |
Notice. Each Party will provide to the other Party prompt written notice of any actual or threatened infringement of the Otsuka Product Trademarks or Ionis Product Trademarks in the Territory and
of any actual or threatened claim that the use of the Otsuka Product Trademarks or Ionis Product Trademarks in the Territory violates the rights of any Third Party, in each case, of which such Party becomes aware.
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10.10.3 |
(a) |
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(b) |
Otsuka Product Trademarks. Otsuka will have the sole right to register, prosecute and maintain the Otsuka Product Trademarks in the Territory using counsel of its own choice. All costs and expenses
of registering, prosecuting, and maintaining the Otsuka Product Trademarks in the Territory will be borne solely by Otsuka.
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(c) |
Ionis Product Trademarks. Ionis will have the sole right to register, prosecute and maintain the Ionis Product Trademarks in the Territory using counsel of its own choice. All costs and expenses of
registering, prosecuting, and maintaining the Ionis Product Trademarks in the Territory will be borne solely by Ionis.
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10.10.4 |
(a) |
Unitary Product Trademarks. During the Term, each Party will promptly notify the other Party in writing of any alleged, threatened, or actual infringement,
dilution, misappropriation or other violation of or unfair trade practices or any other like offense by a Third Party relating to any Unitary Product Trademark (including any Local Unitary Product Trademark) in the Otsuka Territory (“Otsuka Territory Trademark Infringement”). Otsuka will have the first right, but not the obligation, to take any reasonable measures it deems appropriate with respect to any Otsuka
Territory Trademark Infringement, using counsel of its own choice, and at its own cost and expense, including initiating or prosecuting an infringement, misappropriation or other appropriate suit or action to enforce the Unitary Product
Trademarks in the Otsuka Territory and, if requested by Otsuka, Ionis shall (i) join as a party to such suit or action and execute and cause its Affiliates to execute all documents necessary for Otsuka to initiate and maintain such suit or
action and (ii) provide reasonable assistance to Otsuka in connection with such suit or action. Notwithstanding the foregoing, if Otsuka does not inform Xxxxx that it intends to initiate a suit or take other action against an Otsuka
Territory Trademark Infringement within [***] after Otsuka becoming aware of such Otsuka Territory Trademark Infringement and does not [***] within such [***], then Ionis will have the second right, but not the obligation, to initiate a
suit or take other action against such Otsuka Territory Trademark Infringement at its own cost and expense. Any recoveries resulting from such suit or other action will be first applied against payment of each Party’s costs and expenses in
connection therewith. Any such recoveries in excess of such costs and expenses will be [***].
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54
(b) |
Otsuka Product Trademarks. Otsuka will have the sole right to take such action as Otsuka deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution,
misappropriation or other violation of or unfair trade practices or any other like offense relating to, the Otsuka Product Trademarks by a Third Party in the Territory, at its sole cost and expense and using counsel of its own choice.
Otsuka will retain any damages or other amounts collected in connection therewith.
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(c) |
Ionis Product Trademarks. Ionis will have the sole right to take such action as Xxxxx xxxxx necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution,
misappropriation or other violation of or unfair trade practices or any other like offense relating to, the Ionis Product Trademarks by a Third Party in the Territory, at its sole cost and expense and using counsel of its own choice. Ionis
will retain any damages or other amounts collected in connection therewith.
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10.10.5 |
(a) |
Unitary Product Trademarks. If a Third Party brings suit alleging that Otsuka’s or its Affiliate’s or Sublicensee’s Exploitation of a Licensed Product in the Otsuka Territory infringes or will
infringe such Third Party’s Trademarks or that the use or registration of any Unitary Product Trademark (including any Local Unitary Product Trademark) in the Otsuka Territory infringes, dilutes, misappropriates or otherwise violates any
Trademark or other right of such Third Party (“Trademark Infringement Suit”), then the Party against whom such suit is brought will promptly notify the other Party of such
Trademark Infringement Suit and Otsuka will have the first right, but not the obligation, to defend such Trademark Infringement Suit using counsel of its own choice. If Otsuka does not take affirmative steps to defend such Trademark
Infringement Suit within [***] (or such shorter period of time as is legally required to answer to such suit) and does not [***], then Ionis may defend such Trademark Infringement Suit. The Party defending such Trademark Infringement Suit
will (i) keep the other Party reasonably informed regarding such suit, including by providing the other Party with copies of all pleadings and other documents filed in any proceeding relating to such suit, (ii) consider reasonable input
from the other Party during the course of the suit, and (iii) provide the other Party with the opportunity to attend any substantive meetings, hearings, or other proceedings related to such suit (together with its own counsel, at its own
expense) and to review and comment on all substantive documents related to such suit prior to filing or submission of such documents. The Parties will reasonably assist each other and cooperate and share information with respect to any such
suit. The Parties will [***] all of the costs incurred by either Party in defending a Trademark Infringement Suit and any and all damages paid in settlement or to satisfy a judgment in a Trademark Infringement Suit. Neither Party will enter
into any settlement of a Trademark Infringement Suit that is instituted or threatened to be instituted against the other Party without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed; provided that such consent will not be required if such settlement includes a release of all liability in favor of, and does not impose any obligation on, the other Party and contains no admission of
liability by such settling Party. Further, neither Party shall settle or compromise any Trademark Infringement Suit, or knowingly take any other action in the course thereof, in a manner that materially adversely affects the other Party’s
rights or interests, without the other Party’s prior written consent.
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55
(b) |
Otsuka Product Trademarks. Otsuka will have the sole right to defend against and settle any alleged, threatened or actual claim by a Third Party that the use or registration of the Otsuka Product
Trademarks in the Territory infringes, dilutes, misappropriates or otherwise violates any Trademark or other right of that Third Party or constitutes unfair trade practices or any other like offense or any other claims as may be brought by
a Third Party against a Party in connection with the use of the Otsuka Product Trademarks with respect to the Licensed Products in the Otsuka Territory, at its sole cost and expense and using counsel of its own choice. Otsuka will retain
any damages or other amounts collected in connection therewith.
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(c) |
Ionis Product Trademarks. Ionis will have the sole right to defend against and settle any alleged, threatened or actual claim by a Third Party that the use or registration of the Ionis Product
Trademarks in the Territory infringes, dilutes, misappropriates or otherwise violates any Trademark or other right of that Third Party or constitutes unfair trade practices or any other like offense or any other claims as may be brought by
a Third Party against a Party in connection with the use of the Ionis Product Trademarks with respect to the Licensed Products in the Ionis Territory, at its sole cost and expense and using counsel of its own choice. Ionis will retain any
damages or other amounts collected in connection therewith.
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10.10.6 |
Housemarks. The Parties, through the Europe JSC or the Asia JSC, in consultation with regulatory experts, will [***].
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10.10.7 |
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56
ARTICLE 11
11.1 |
Mutual Representations and Warranties. Each of Otsuka and Ionis hereby represents and warrants to the other Party as of the Restatement Date that:
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11.1.1 |
It is a corporation or limited company duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and it has the full right, power, and authority to enter into this Agreement and to
perform its obligations hereunder.
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11.1.2 |
All consents, approvals, and authorizations from all Governmental Authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained.
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11.1.3 |
The execution, delivery, and performance of this Agreement by it has been duly authorized by all requisite corporate action.
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11.1.4 |
The execution and delivery of this Agreement and the performance of its obligations hereunder (a) do not conflict with or violate any requirement of Applicable Law or any provision of its articles of incorporation, bylaws, limited
partnership agreement, or any similar instrument, as applicable, in any material way, and (b) do not conflict with, violate, or breach or constitute a default or require any consent under, any Applicable Law or any contractual
obligation or court or administrative order by which it is bound.
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11.1.5 |
It has not been debarred or suspended under 21 U.S.C. §335(a) or (b), is not the subject of a conviction described in Section 306 of the FD&C Act,
has not been and is not excluded from a federal or governmental health care program, debarred from federal contracting, convicted of or pled nolo contendere to any felony, or to any federal or
state legal violation (including misdemeanors) relating to prescription drug products or fraud, is not subject to OFAC sanctions or on the OFAC list of specially designated nationals, and is not
subject to any similar sanction of any Governmental Authority in the Territory (“Debarred/Excluded”), and no proceeding that could
result in it being Debarred/Excluded is pending, and neither it nor any of its Affiliates has used, in any capacity in the performance of obligations relating to the Licensed Products, any employee, subcontractor, consultant, agent, representative, or other Person who has been Debarred/Excluded.
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11.2 |
Additional Ionis Representations and Warranties. Ionis hereby represents and warrants as of the Restatement Date to Otsuka that:
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11.2.1 |
It has the right under the Ionis Technology to grant to Otsuka the licenses in the Asia Territory set forth in this Agreement, and it has not granted any license or other right under the Ionis Technology that is inconsistent with the
licenses granted to Otsuka in the Asia Territory hereunder.
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11.2.2 |
Schedule 1.111 (Ionis Core Technology Patents), Schedule 1.117
(Ionis Manufacturing and Analytical Patents), and Schedule 1.124 (Ionis Product-Specific Patents), collectively, list all Ionis Patent Rights existing as of the Restatement Date.
With respect to any such Ionis Patent Right identified as being solely owned by Xxxxx, Xxxxx owns all rights, title, and interests in and to such Ionis Patent Rights.
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57
11.2.3 |
As of the Restatement Date, all issued Patent Rights in the Asia Territory within the Ionis Patent Rights are in full force and effect and, to Ionis’ Knowledge, are valid and enforceable. To Ionis’ Knowledge, all Ionis Patent Rights
in the Asia Territory are being diligently prosecuted in the respective patent offices in the Asia Territory in accordance with Applicable Law and have been filed, prosecuted, and maintained
properly and correctly, and all applicable fees have been paid on or before the due date for payment.
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11.2.4 |
There is no pending or, to Ionis’ Knowledge, threatened litigation, nor has Ionis received any written notice from any Third Party, asserting or alleging that the Exploitation of the Licensed Products in the Asia Territory prior to
the Restatement Date infringed or misappropriated the Patent Rights, Know-How or other intellectual property rights of such Third Party or that the disclosing, copying, making, assigning, licensing or use of the Ionis Technology in the
Asia Territory infringes or misappropriates any Patent Right, Know-How or other intellectual property rights of such Third Party.
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11.2.5 |
To Ionis’ Knowledge, the practice by Otsuka of the Ionis Technology in the Asia Territory and the Exploitation by Otsuka or its Affiliates or Sublicensee of the Licensed Products in the Asia Territory in the form existing as of the
Restatement Date for the treatment of HAE, in each case, does not and will not infringe, misappropriate, or otherwise violate any Patent Rights, Know-How or other intellectual property rights of any Third Party.
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11.2.6 |
To Ionis’ Knowledge, there are no Third Party Know-How or Patent Rights that are necessary for the Exploitation of Licensed Products in the form existing as of the Restatement Date for the treatment of HAE in the Asia Territory,
other than the Know-How and Patent Rights licensed to Ionis pursuant to the Existing Third-Party IP Agreements. To Ionis’ Knowledge, other than the Patent Rights and Know-How licensed to Ionis pursuant to the Existing Third-Party IP
Agreements, there are no Third Party Patent Rights in the Asia Territory that Cover the composition of matter of Licensed Compound or Licensed Products or any Third Party Patent Rights or Know-How in the Asia Territory that are used in
the Manufacture of the Licensed Product in the form existing as of the Restatement Date.
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11.2.7 |
There are no pending or, to Ionis’ Knowledge, threatened, adverse actions, suits, or proceedings against Ionis in the Asia Territory involving the Ionis Technology.
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11.2.8 |
To Ionis’ Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate any Ionis Technology in the Asia Territory.
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11.2.9 |
There are no legal claims, judgments, or settlements against or owed by Ionis or any of its Affiliates, or pending or, to Ionis’ Knowledge, threatened, legal claims or litigation, in each case, relating to antitrust,
anti-competition, or anti-corruption law violations in the Asia Territory.
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11.2.10 |
Schedule 1.69 (Existing Third-Party IP Agreements) sets forth all Existing Third-Party IP Agreements in effect as of the Restatement Date, redacted copies of which have
been provided to Otsuka prior to the date hereof. Other than the Existing Third-Party IP Agreements set forth in Schedule 1.69 (Existing Third-Party IP Agreements), as of the
Restatement Date there are no agreements between Ionis and any Third Party pursuant to which Ionis Controls any Know-How or Patent Rights in the Asia Territory within the Ionis Technology.
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11.2.11 |
Except for Existing Third-Party IP Agreements, Ionis is not obligated under any contract or other agreement with a Third Party as of the Restatement Date to make any payments to any owner or licensor of, or other claimant to, any
Patent Right, Know-How or other intellectual property or proprietary right with respect to the Exploitation of the Licensed Product in the Asia Territory in the form existing as of the Restatement Date for the treatment of HAE.
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11.2.12 |
With respect to the Existing Third-Party IP Agreements, Ionis represents and warrants to Otsuka, as of the Restatement Date, that: (a) it is in full force and effect; (b) neither Ionis nor any of its Affiliates is in material breach
thereof; (c) neither Ionis nor any of its Affiliates has received any notice from any counterparties thereto of any material breach or notice of threatened material breach thereof; (d) neither Ionis nor any of its Affiliates has
received any notice from any counterparties thereto of any intent to reduce the scope of the field thereunder or render any of the licenses thereunder non-exclusive or otherwise terminate such Existing Third-Party IP Agreements, and, to
Ionis’ Knowledge no event, act or omission has occurred which would reasonably give rise to the right of any counterparties thereto to reduce the scope of the field thereof or render any of the licenses thereunder non-exclusive or
otherwise terminate such agreement or any licenses thereunder (including with respect to any particular Patent Rights or other intellectual property); (e) neither Ionis nor any of its Affiliates have waived or relinquished any rights
thereunder; (f) entering into this Agreement and granting the rights and licenses granted (or purported to be granted) to Otsuka hereunder complies with and will not result in a breach of the terms and conditions of any Existing
Third-Party IP Agreement; and (g) Ionis has the right to grant sublicenses to Otsuka under the Existing Third-Party IP Agreements as contemplated herein, including to Develop, Manufacture, Commercialize and conduct Medical Affairs for
the Licensed Products in the Field in the Asia Territory.
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11.2.13 |
Neither Ionis nor any counterparty to any Existing Third-Party IP Agreement has in writing alleged or threatened that the other party has breached an Existing Third-Party IP Agreement (which has not been cured) or, to Ionis’
Knowledge, threatened in writing to terminate an Existing Third-Party IP Agreement.
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11.2.14 |
Each [***].
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11.2.15 |
to Ionis’ Knowledge: (a) [***]; and (b) [***].
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11.2.16 |
All preclinical and clinical studies necessary for Regulatory Approval in the Asia Territory of the Licensed Products sponsored by Ionis or its Affiliates have been and as of the Restatement Date are being conducted in material
compliance with Applicable Law, including [***]. Neither Ionis nor its Affiliates has received any written notice from the PMDA or any other Regulatory Authority in the Asia Territory performing functions similar to those performed by
those with respect to any ongoing clinical or pre-clinical studies or tests of the Licensed Products requiring the termination, suspension, or material modification of such ongoing studies or tests, and no Governmental Authority in the
Asia Territory has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing Clinical Trial of the Licensed Products conducted by or on behalf of Ionis or its Affiliates necessary for
Regulatory Approval in the Asia Territory as of the Restatement Date.
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11.2.17 |
As of the Restatement Date, neither Ionis nor any of its Affiliates, and, to Ionis’ Knowledge, none of its or their respective officers, employees, or agents, has made an untrue statement of material fact or fraudulent statement to
the PMDA or any other Regulatory Authority in the Asia Territory with respect to the Development of the Licensed Compounds or the Licensed Products in the Asia Territory, failed to disclose a material fact required to be disclosed to
the PMDA or any other Regulatory Authority in the Asia Territory with respect to the Development of the Licensed Compounds or the Licensed Products in the Asia Territory, or committed an act, made a statement, or failed to make a
statement with respect to the Development of the Licensed Compounds or the Licensed Products in the Asia Territory that could reasonably be expected to provide a basis for the PMDA to invoke any laws or policies in the Asia Territory
analogous to the FDA policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991).
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11.2.18 |
As of the Restatement Date, Ionis has no Knowledge of [***] in the Asia Territory in the form existing as of the Restatement Date for the treatment of HAE.
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11.3 |
11.3.1 |
Otsuka represents and warrants to Ionis as of the Restatement Date that there are no Patent Rights Controlled by Otsuka or any of its Affiliates that are necessary to Exploit a Licensed Product in the Asia Territory.
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11.3.2 |
Ionis’ representations and warranties set forth in Section 11.2 of the Original Agreement are hereby incorporated by reference in this Agreement in their entirety (with all such defined terms contained therein having the applicable
meanings set forth in the Original Agreement), with such representations and warranties being effective as of the Original Effective Date.
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11.4 |
Additional Covenants. Each of Otsuka and Ionis hereby covenant to the other:
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11.4.1 |
Assignment of Inventions. Each Party will require all of its and its Affiliates’ employees and consultants to assign all Inventions that are developed or invented by such employees according to
the ownership principles described in Section 10.1 (Inventions).
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11.4.2 |
Compliance with Law. It will, and will ensure that its Affiliates, comply with all Applicable Law and, to the extent applicable, Professional Requirements, with respect to the performance of
its obligations under this Agreement, including, as applicable, the Approved Labeling, the European Data Protection Directive 95/46/EC, the European General Data Protection Regulation (Regulation (EU)
2016/679), and any other applicable national data protection legislation.
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11.4.3 |
No Bribery. It will not in the future offer, promise, pay, authorize, or give, money or anything of value, directly or indirectly, to any Government Official or Other Covered Party for the
purpose, pertaining to this Agreement, of: (a) influencing any act or decision of the Government Official or Other Covered Party; (b) inducing the Government Official or Other Covered Party to do or omit to do an act in violation of a
lawful duty; (c) securing any improper advantage; or (d) inducing the Government Official or Other Covered Party to influence the act or decision of a government or government instrumentality, in order to obtain or retain business, or
direct business to, any Person, in each case, in any way related to this Agreement.
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11.4.4 |
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11.4.5 |
FCPA Compliance. In performing under this Agreement, it and its Affiliates agree to comply with all applicable anti-corruption laws, including the Foreign Corrupt Practices Act of 1977 and the UK Bribery Act 2010, as amended from time-to-time; the anti-corruption laws of the Territory; and all laws enacted to implement the Organization for Economic Co-operation and Development
Convention on Combating Bribery of Foreign Officials in International Business Transactions.
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11.4.6 |
Debarred/Excluded Persons. It will not engage, in any capacity in connection with this Agreement or any ancillary agreements, any officer, employee, contractor, consultant, agent,
representative, or other Person who has been Debarred/Excluded. Each Party will inform the other Party in writing promptly if it or any Person engaged by it or any of its Affiliates who is performing any obligations under this Agreement
or any ancillary agreements is Debarred/Excluded, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or, to each Party’s Knowledge, is threatened, pursuant to which a Party, any of its
Affiliates or any such Person performing obligations hereunder or thereunder may become Debarred/Excluded.
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11.5 |
Disclaimer. EXCEPT AS EXPRESSLY SET FORTH HEREIN, THE INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY ARE PROVIDED “AS IS” AND WITHOUT WARRANTY. EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH
OF THE PARTIES EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY, OR ENFORCEABILITY OF THEIR RESPECTIVE
INTELLECTUAL PROPERTY RIGHTS, AND NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO.
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11.6 |
Limitation of Liability. NEITHER OF THE PARTIES WILL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL, OR PUNITIVE DAMAGES OR DAMAGES FOR LOSS OF
PROFIT, LOSS OF REVENUE, OR LOST OPPORTUNITY IN CONNECTION WITH THIS AGREEMENT, ITS PERFORMANCE OR LACK OF PERFORMANCE HEREUNDER, OR ANY LICENSE GRANTED HEREUNDER, EXCEPT TO THE EXTENT THE DAMAGES RESULT FROM A BREACH OF THE OBLIGATIONS
OF A PARTY UNDER ARTICLE 12 (CONFIDENTIALITY) OR BREACH OF SECTION 2.5.2 (NEGATIVE COVENANT) BY IONIS, MISAPPROPRIATION OR INFRINGEMENT OF INTELLECTUAL PROPERTY OWNED OR CONTROLLED BY THE OTHER PARTY, OR AMOUNTS REQUIRED
TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER ARTICLE 13 (INDEMNIFICATION).
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ARTICLE 12
12.1 |
Duty of Confidence. Subject to the other provisions of this Article 12 (Confidentiality):
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12.1.1 |
except to the extent expressly authorized by this Agreement, the Receiving Party shall maintain in confidence and otherwise safeguard, and not publish or otherwise disclosed, all Confidential Information of the Disclosing Party;
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12.1.2 |
the Receiving Party will treat all Confidential Information provided by the Disclosing Party, at a minimum, with the same degree of care as the Receiving Party uses for its own similar information, but in no event less than a
reasonable degree of care;
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12.1.3 |
the Receiving Party may only use any Confidential Information of the Disclosing Party for the purposes of performing its obligations or exercising its rights under this Agreement;
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12.1.4 |
a Receiving Party may only disclose Confidential Information of the Disclosing Party to: (a) such Receiving Party’s Affiliates, licensees, and Sublicensees; and (b) employees, directors, officers, agents, contractors, attorneys,
accountants and consultants, of the Receiving Party and its Affiliates, licensees, and Sublicensees, in each case ((a) and (b)), to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this
Agreement; provided that such Persons are bound by legally enforceable obligations of confidentiality and non-use with respect to the Disclosing Party’s Confidential Information, no less
stringent than the confidentiality and non-use obligations set forth in this Agreement, except that the term of such obligation will be customary for such recipient of Confidential Information. Each Party will remain responsible for any
failure by its Affiliates, licensees, and Sublicensees, and its and its Affiliates’, licensees’, and Sublicensees’ respective employees, directors, officers, agents, consultants, attorneys, accountants and contractors, in each case, to
treat such Confidential Information as required under this Section 12.1 (Duty of Confidence) (as if such Persons were Parties directly bound to the requirements of this Section 12.1 (Duty of Confidence)); and
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12.1.5 |
each Party will promptly notify the other Party of any misuse or unauthorized disclosure of the other Party’s Confidential Information.
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12.1.6 |
The confidentiality, non-use, and non-disclosure obligations set forth in this Section 12.1 (Duty of Confidence) will be in full force and effect from the Restatement Date until [***] after expiration or termination of this
Agreement, provided that, with respect to any Know-How that is a trade secret and is identified as such by the Disclosing Party at the time of disclosure, the obligations of this Section
12.1 (Duty of Confidence) will continue for so long as such Know-How remains a trade secret.
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12.2 |
Confidential Information. Notwithstanding anything to the contrary in the definition of “Confidential Information” set forth in Appendix 1 (Definitions), the Ionis Product-Specific
Know-How, any ROFN Exercise Notice, the Joint Collaboration Know-How and the terms of this Agreement will be the Confidential Information of both Parties, with each Party deemed to be the Receiving Party of such information; provided that Ionis Product-Specific Know-How will be deemed the Confidential Information of Ionis following any termination (but not expiration) of this Agreement. The Ionis Core Technology Know-How
and the Ionis Manufacturing and Analytical Know-How will be the Confidential Information of Ionis. The Otsuka Know-How will be the Confidential Information of Otsuka. Except as provided in Section 12.4 (Authorized Disclosures)
and Section 12.6 (Publicity; Use of Names), neither Party nor its Affiliates may disclose the existence or the terms of this Agreement.
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12.3 |
Exemptions. Information of a Disclosing Party will not be Confidential Information of such Disclosing Party to the extent that the Receiving Party can demonstrate through competent evidence
that such information:
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12.3.1 |
was already known by the Receiving Party or any of its Affiliates without an obligation of confidentiality at the time of its receipt from the Disclosing Party, and not through a prior disclosure by or on behalf of the Disclosing
Party, as documented by the Receiving Party’s business records;
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12.3.2 |
was generally available to the public or otherwise part of the public domain before its receipt from the Disclosing Party;
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12.3.3 |
became generally available to the public or otherwise part of the public domain after its disclosure by the Disclosing Party other than through any act or omission of the Receiving Party or any of its Affiliates or disclosees in
breach of this Agreement;
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12.3.4 |
is subsequently disclosed to the Receiving Party or any of its Affiliates without obligation of confidentiality by a Third Party who may rightfully do so and is not under a conflicting obligation of confidentiality to the Disclosing
Party; or
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12.3.5 |
is developed by the Receiving Party or any of its Affiliates independently and without use of or reference to any Confidential Information received from the Disclosing Party, as documented by the Receiving Party’s business records.
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No combination of features or disclosures will be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the
rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
12.4 |
12.4.1 |
Permitted Circumstances. Notwithstanding the obligations set forth in Section 12.1 (Duty of Confidence), a Party may disclose the other Party’s Confidential Information (including this
Agreement and the terms herein) to the extent such disclosure is reasonably necessary in the following situations:
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(a) |
the prosecution or enforcement of Ionis Patent Rights, Collaboration Patent Rights, or Otsuka Patent Rights, in each case, as contemplated by this Agreement;
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(b) |
Regulatory Submissions and other filings or communications with Governmental Authorities (including Regulatory Authorities), as necessary for the Exploitation of the Licensed Products in connection with the exercise of the rights and
the performance of the obligations of the applicable Party under this Agreement;
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63
(c) |
disclosure of this Agreement, its terms, and the status and results of Exploitation of the Licensed Products to actual or bona fide potential investors, acquirors, (sub)licensees (including
any counterparty to a Collaboration In-License), lenders, and other financial or commercial partners (including in connection with any royalty financing transaction), and their respective attorneys, accountants, banks, investors, and
advisors, solely for the purpose of evaluating or carrying out an actual or bona fide potential investment, acquisition, (sub)license, debt transaction, or collaboration transaction; provided that, in each such case, (i) such Persons are bound by obligations of confidentiality and non-use, or subject to professional ethical obligations of
confidentiality, at least as stringent as those set forth Article 12 (Confidentiality), except that the term of such obligation will be customary for such recipient of Confidential Information and such type of transaction and
(ii) the scope of any such disclosure is limited to the maximum extent practicable for the particular context in which it is being disclosed;
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(d) |
such disclosure is required to comply with Applicable Law (whether generally or in pursuit of an application for listing of securities) including the United States Securities and Exchange Commission or equivalent foreign agency or
regulatory body, or otherwise required by judicial or administrative process, provided that in each such event, as promptly as reasonably practicable and to the extent not prohibited by
Applicable Law or judicial or administrative process, such Party will notify the other Party of such required disclosure and provide a draft of the disclosure to the other Party reasonably in advance of such filing or disclosure for the
other Party’s review and comment. The non-disclosing Party will provide any comments as soon as practicable, and the disclosing Party will consider in good faith any timely comments provided by the non-disclosing Party; provided that the disclosing Party may or may not accept such comments in its reasonable discretion. Confidential Information that is disclosed in order to comply with Applicable Law or by judicial
or administrative process pursuant to this Section 12.4.1(d) (Permitted Circumstances), in each case, will remain otherwise subject to the confidentiality and non-use provisions of this Article 12 (Confidentiality) with
respect to the Party disclosing such Confidential Information, and such Party will take all steps reasonably necessary, including seeking of confidential treatment or a protective order to the maximum extent permitted by Applicable Law
or Governmental Authority, to ensure the continued confidential treatment of such Confidential Information, and each Party will be responsible for its own legal and other external costs in connection with any such filing or disclosure
pursuant to this Section 12.4.1(d) (Permitted Circumstances); or
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(e) |
disclosure pursuant to Section 12.6 (Publicity; Use of Names).
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(f) |
If and whenever any Confidential Information is disclosed in accordance with this Section 12.4 (Authorized Disclosures), such disclosure will not cause any such information to cease to be Confidential Information except to
the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement).
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12.5 |
12.5.1 |
Otsuka’s Right to Publish. Otsuka will have the right to publicly present or publish any Clinical Trial data, non-clinical or preclinical data, or any associated results or conclusions
generated by or on behalf of Ionis or Otsuka pursuant to this Agreement (each such proposed presentation or publication, an “Otsuka Publication”), [***]. If Otsuka desires to
publicly present or publish an Otsuka Publication in accordance with the foregoing sentence, then Otsuka will provide Ionis (including Ionis’ Alliance Manager and all Ionis members of the JSC) with a copy of such proposed Otsuka
Publication as early as practicable but at least [***] prior to the earlier of its presentation or intended submission for publication (such applicable period, the “Review Period”).
[***]. Notwithstanding any provision to contrary set forth in this Agreement, Otsuka will [***]. Otsuka will provide Ionis a copy of any Otsuka Publication at the time of the submission or presentation thereof. Otsuka agrees to
determine the authorship of all Otsuka Publications in accordance with all applicable International Committee of Medical Journal Editors (ICMJE) guidelines. Otsuka will require its Affiliates and Sublicensees to comply with the
obligations of this Section 12.5 (Publications) as if they were Otsuka, and Otsuka will be liable for any non-compliance of such Persons.
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12.5.2 |
Ionis’ Right to Publish. Ionis will have the right to publicly present or publish any Clinical Trial data, non-clinical or preclinical data, or any associated results or conclusions generated
by or on behalf of Ionis pursuant to this Agreement (each such proposed presentation or publication, a “Ionis Publication”) [***]. If Ionis desires to publicly present or
publish an Ionis Publication in accordance with the foregoing sentence, then Ionis will provide Otsuka (including Otsuka’s Alliance Manager and all Otsuka members of the JSC) with a copy of such proposed Ionis Publication for review
during the applicable Review Period. [***]. Notwithstanding any provision to contrary set forth in this Agreement, Ionis will [***]. Ionis will provide Otsuka a copy of any Ionis Publication at the time of the submission or presentation
thereof. Xxxxx agrees to determine the authorship of all Ionis Publications in accordance with all applicable International Committee of Medical Journal Editors (ICMJE) guidelines. Ionis will require its Affiliates to comply with the
obligations of this Section 12.5 (Publications) as if they were Ionis, and Ionis will be liable for any non-compliance of such Persons.
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12.5.3 |
Subsequent Publications. After any Otsuka Publication or Ionis Publication has been published or publicly presented in accordance with Section 12.5.1 (Otsuka’s Right to Publish) or Section
12.5.2 (Xxxxx’ Right to Publish), as applicable, either Party may make subsequent publications or presentations of the content of such previously published Otsuka Publication or Ionis Publication without further approval or review
by the other Party; provided, that such subsequent publication or presentation does not include any new data, information or conclusions, or present the content in a form or manner that
materially alters the conclusion or subject matter of the previous publication or public presentation.
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12.6 |
12.6.1 |
Press Release. The Parties may issue a press release announcing this Agreement, on such date and time and in such form, in each case, as may be agreed by the Parties. Other than such press release and the public disclosures permitted by this Section 12.6.1 (Press Release) and Section 12.4 (Authorized Disclosures), the Parties agree that the
portions of any other news release or other public announcement relating to this Agreement or the performance hereunder that would disclose information other than that already in the public domain will require prior review and approval
by both Parties (with such approval not to be unreasonably withheld, conditioned, or delayed). However, the Parties agree that after (a) a disclosure pursuant to this Section 12.6 (Publicity; Use of Names) or Section 12.4
(Authorized Disclosures) or (b) the issuance of a press release (including the initial press release) or other public announcement pursuant to this Section 12.6.1 (Press Release) that has been reviewed and approved by the other
Party, the disclosing Party may make subsequent public disclosures reiterating such information without having to obtain the other Party’s prior consent and approval so long as the information in such press release or other public
announcement remains true, correct, and such disclosure is consistent with prior disclosures approved by the other Party pursuant to this Section 12.6 (Publicity; Use of Names) and which do not reveal non‑public information
about the other Party. Similarly, after a Publication has been made available to the public, each Party may post such Publication or a link to it on its corporate website or social media platforms (or any website managed by such Party
in connection with a Clinical Trial for the Licensed Products, as appropriate) without the prior written consent of the other Party, so long as the information in such Publication remains true, correct, and the most current information
with respect to the subject matters set forth therein.
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65
12.6.2 |
Disclosures by Xxxxx. Notwithstanding any provision to the contrary set forth in this Agreement, Xxxxx has the right to publicly disclose (in written, oral, or other form): (a) the achievement
of any Regulatory Milestone Event or Sales Milestone Event under this Agreement (including the timing of achievement of any such milestone event but without disclosing the amount of such milestone payment unless permitted pursuant to Section
12.4.1(d) (Permitted Circumstances)); (b) the commencement, completion, material data, or key results of any Clinical Trials for the Licensed Products conducted by or on behalf of Ionis; and (c) the achievement of Regulatory
Approval for any Licensed Product throughout the world; provided that, subject to Section 12.4.1(d) (Permitted Circumstances), [***].
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12.6.3 |
Use of Names. Each Party will have the right to use the other Party’s name and logo in presentations, its website, collateral materials, and corporate overviews to describe the collaboration
relationship, as well as in taglines of press releases issued pursuant to this Section 12.6 (Publicity; Use of Names); provided that neither Party will [***], and each Party will [***].
Except as permitted under this Section 12.6 (Publicity; Use of Names) or with the prior express written permission of the other Party, neither Party will use the name, trademark, trade name, or logo of the other Party or its
Affiliates or their respective employees in any publicity, promotion, news release, or disclosure relating to this Agreement or its subject matter except as may be required by Applicable Law.
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12.7 |
12.7.1 |
To the extent permitted under Applicable Law in the Otsuka Territory, Otsuka will acknowledge in any press release, public presentation, or publication regarding a Licensed Product Ionis’ role in discovering and developing the
Licensed Products, that the Licensed Products are under license from Ionis, and [***].
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12.7.2 |
Otsuka agrees that it will acknowledge Xxxxx’ role in the discovery of a Licensed Product in any scientific, medical, and other Licensed Product-related communications [***], by including the words “Discovered by Ionis” or equivalent language (collectively, the “Ionis Attribution Language”) in any such communications; provided,
however, that [***].
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ARTICLE 13
13.1 |
Indemnification by Xxxxx. Ionis will indemnify, hold harmless, and defend Otsuka and its Affiliates and their respective directors, officers, employees, and agents (each, an “Otsuka Indemnitee”) from and against any and all Third Party suits, claims, actions, or demands (“Third Party Claims”)
and all liabilities, expenses, or losses (including reasonable attorneys’ fees, court costs, witness fees, damages, judgments, fines, and amounts paid in settlement) (“Losses”)
arising therefrom to the extent that the applicable Third Party Claims and such Losses arise out of (a) a breach of this Agreement by Ionis, (b) the Exploitation of the Licensed Products by or on behalf of Ionis or any of its
Affiliates, licensees (not including Otsuka or its Affiliates, Sublicensees, or its Subcontractors), Sublicensees, or Subcontractors, or (c) the negligence or willful misconduct of any Ionis Indemnitee. Notwithstanding the foregoing,
Xxxxx will not have any obligation to indemnify Otsuka Indemnitees to the extent that any Losses arise out of any Third Party Claim for which Otsuka is responsible for indemnifying Ionis pursuant to Section 13.2 (Indemnification
by Otsuka).
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13.2 |
Indemnification by Otsuka. Otsuka will indemnify, hold harmless, and defend Ionis and its Affiliates, and their respective directors, officers, employees, and agents (each, an “Ionis Indemnitee”) from and against any and all Third Party Claims and all Losses arising therefrom, to the extent that the applicable Third Party Claims and such Losses arise out
of (a) a breach of this Agreement by Otsuka, (b) the Exploitation of the Licensed Products by or on behalf of Otsuka or any of its Affiliates, Sublicensees, or Subcontractors, or (c) the negligence or willful misconduct of any Otsuka
Indemnitee. Notwithstanding any provision to the contrary set forth in this Agreement, Otsuka will not have any obligation to indemnify the Ionis Indemnitees
to the extent that any Losses arise out of any Third Party Claim for which Xxxxx is responsible for indemnifying Otsuka pursuant to Section 13.1 (Indemnification by Xxxxx).
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13.3 |
Indemnification Procedure. If either Party is seeking indemnification under Section 13.1 (Indemnification by Ionis) or Section 13.2 (Indemnification by Otsuka) (the “Indemnified Party”), then it will inform the other Party (the “Indemnifying Party”) of the Third Party Claim giving rise
to such indemnification obligations within [***] after receiving written notice of the Third Party Claim (it being understood and agreed, however, that the failure or delay by an Indemnified Party to give such notice of a Third Party
Claim will not affect the Indemnifying Party’s indemnification obligations hereunder except to the extent the Indemnifying Party will have been actually prejudiced as a result of such failure or delay to give notice). The Indemnifying
Party will have the right to assume the defense of any such Third Party Claim for which it is obligated to indemnify the Indemnified Party. The Indemnified Party will cooperate with the Indemnifying Party and the Indemnifying Party’s
insurer as the Indemnifying Party may reasonably request, and at the Indemnifying Party’s cost and expense. The Indemnified Party will have the right to participate, with counsel of its choice, in the defense of any Third Party that has
been assumed by the Indemnifying Party, which participation will be at the Indemnified Party’s expense unless (a) the Indemnifying Party has agreed to pay such fees and expenses, or (b) the Indemnified Party has been advised by counsel
that there are actual or potential conflicting interests between the Indemnifying Party and the Indemnified Party, including situations in which there are one or more legal defenses available to the Indemnified Party that are different
from or additional to those available to the Indemnifying Party. Neither Party will have the obligation to indemnify the other Party in connection with any settlement made without the Indemnifying Party’s written consent, which consent
will not be unreasonably withheld, conditioned, or delayed. The Indemnifying Party will not admit any fault or negligence on the part of the Indemnified Party, or impose any obligation on, or otherwise adversely affect, the Indemnified
Party, without the Indemnified Party’s prior written consent, which consent will not be unreasonably withheld, conditioned, or delayed. If the Parties cannot agree as to the application of Section 13.1 (Indemnification by
Ionis) or Section 13.2 (Indemnification by Otsuka) as to any Third Party Claim, then, pending resolution of the dispute pursuant to Article 15 (Dispute Resolution; Governing Law), then the Parties may conduct separate
defenses of such Third Party Claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Section 13.1 (Indemnification by Ionis) or Section 13.2 (Indemnification by
Otsuka), as applicable, upon resolution of the underlying Third Party Claim.
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13.4 |
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ARTICLE 14
14.1 |
Term. The term of this Agreement will begin on the Restatement Date and, unless earlier terminated in accordance with this Article 14 (Term and Termination), will continue until Otsuka,
its Affiliates, and its Sublicensees are no longer Commercializing any Licensed Product in any country in the Otsuka Territory (the “Term”).
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14.2 |
14.2.1 |
Material Breach. If either Party believes in good faith that the other Party is in material breach of its obligations under this Agreement with respect to a given Region, then the non-breaching
Party may deliver notice of such breach to the other Party stating the cause and proposed remedy (“Breach Notification”). For any breach alleged in any Breach Notification
arising from a failure to make a payment set forth in this Agreement, the allegedly breaching Party will have [***] from the receipt of the applicable Breach Notification to cure such breach. For all breaches other than a failure to
make a payment as set forth in this Agreement, the allegedly breaching Party will have [***] from the date of the Breach Notification to cure such breach. If the allegedly breaching Party fails to cure the applicable breach within the
applicable period set forth above, then the Party originally delivering the Breach Notification may terminate this Agreement with respect to the applicable Region effective on written notice of termination to such allegedly breaching
Party. For clarity, if the material breach relates to this Agreement as a whole, then the non-breaching Party will have the right to terminate this Agreement in its entirety in accordance with this Section 14.2.1 (Material
Breach).
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14.2.2 |
Disagreement as to Material Breach. Notwithstanding Section 14.2.1 (Material Breach), if the Parties, reasonably and in good faith, disagree as to whether there has been a material
breach of this Agreement, then: (a) the Party that disputes whether there has been a material breach may contest the allegation by referring such matter, within the cure period applicable to such alleged material breach, for resolution
in accordance with Article 15 (Dispute Resolution; Governing Law); (b) the relevant cure period with respect to such alleged material breach will be tolled from the date on which the Party that disputes whether there has been a
material breach notifies the other Party of such dispute and through the resolution of such dispute in accordance with Article 15 (Dispute Resolution; Governing Law); and (c) during the pendency of such dispute, all of the terms
and conditions of this Agreement will remain in effect and the Parties will continue to perform all of their respective obligations hereunder.
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68
14.3 |
Termination by Otsuka for Convenience. At any time during the Term, Otsuka will have the right to terminate this Agreement (a) ***] or (b) [***].
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14.4 |
Discontinuation of Development and Commercialization. If Otsuka and its Affiliates and Sublicensees have not conducted any material Development or Commercialization activities with respect to
the Licensed Products in any country in the Otsuka Territory for a continuous period of [***], and such discontinuation of activity is not: (a) by written agreement of the Parties, (b) due to [***], or (c) due to a Force Majeure, then Ionis may, at its election, terminate this Agreement in its entirety upon [***] prior written notice to Otsuka. For purposes of this Section 14.4 (Discontinuation of
Development and Commercialization), the use of reasonable efforts, to the extent possible, by Otsuka or its Affiliates or Sublicensees (as applicable) to resolve a Force Majeure, clinical hold or other action or inaction of a Regulatory
Authority, or any scientific or technical issues, Manufacturing or supply interruption or other material adverse event outside of Otsuka’s control for the Licensed Product will, in each case, be considered material Development or
Commercialization activities.
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14.5 |
Termination for Patent Challenge. Except to the extent unenforceable under Applicable Law, Ionis may terminate this Agreement in its entirety upon [***] prior written notice of termination to
Otsuka if Otsuka or its Affiliates or Sublicensees (individually or in association with any Person) commences or assists a Third Party in commencing or conducting a Patent Challenge with respect to any Ionis Patent Right, provided that, Ionis shall not have the right to terminate this Agreement on account of such Patent Challenge (a) if, within [***] after receipt by Otsuka of the written notice from Ionis as set
forth above in this Section 14.5 (Termination for Patent Challenge), Otsuka or its Affiliate, as applicable, rescinds such Patent Challenge (or in the case of any ex-parte proceeding, multi-party proceeding, or other Patent
Challenge that Otsuka or such Affiliate does not have the power to unilaterally withdraw or cause to be withdrawn, Otsuka and its Affiliate, as applicable, knowingly ceases providing any direction to any Person with respect to such
Patent Challenge and, to the extent Otsuka or any of its Affiliates is a party to such Patent Challenge and to the extent permitted by the applicable tribunal, it withdraws from such Patent Challenge) and provided that neither Otsuka nor any of its Affiliates thereafter continues such Patent Challenge or, knowingly provides any direction to any Person in respect of the same or (b) in the case of any Patent Challenge
commenced by a Sublicensee of Otsuka or its Affiliate, if Otsuka or its Affiliate, as applicable, terminates such Sublicensee’s sublicense under any Ionis Technology within [***] after receipt by Otsuka of the applicable written notice
from Ionis as set forth above in this Section 14.5 (Termination for Patent Challenge). If Xxxxx has the right to terminate this Agreement in accordance with this Section 14.5 (Termination for Patent Challenge) but such
termination is prohibited under Applicable Law, then in lieu of such termination, [***]. If Ionis [***], then [***]. Notwithstanding the foregoing, Ionis shall not have the right to terminate this Agreement pursuant to this Section
14.5 (Termination for Patent Challenge) if Otsuka or any of its Affiliates or its or their Sublicensees commences a Patent Challenge (i) in a proceeding involving an Ionis Patent Right in which Otsuka or any of its Affiliates or
its or their Sublicensees has been compelled to participate in the proceeding by a court, patent office, or Third Party or (ii) that is necessary or reasonably required to assert a cross-claim or a counterclaim or to respond to a court
request or order or administrative law request or order, including asserting any defense or counterclaim in, or otherwise responding to, an action for infringement of intellectual property asserted, filed or threatened to be filed
against Otsuka or any of its Affiliates or its or their Sublicensees by Ionis or any of its Affiliates or its or their Sublicensees.
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14.6 |
Termination for Insolvency. Each Party will have the right to terminate this Agreement upon delivery of written notice to the other Party if (a) such other Party files in any court or agency
pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other
Party or its assets, (b) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within [***] of its filing, or (c) such other Party
makes an assignment of substantially all of its assets for the benefit of its creditors.
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14.7 |
Rights in Bankruptcy. The Parties intend to take advantage of the protections of Section 365(n) (or any successor provision) of the U.S. Bankruptcy Code or any analogous provisions in any other
country or jurisdiction to the maximum extent permitted by Applicable Law. All rights and licenses granted under or pursuant to this Agreement shall be deemed to be “intellectual property” for the purposes of Section 365(n) or any
analogous provisions in any other country or jurisdiction. The Parties shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code or any analogous provisions in any other country or
jurisdiction, including the right to obtain the intellectual property from another entity. In the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions
in any other country or jurisdiction, the Party that is not subject to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) all such intellectual property (including all embodiments of
such intellectual property), which, if not already in the non-subject Party’s possession, shall be promptly delivered to it upon the non-subject Party’s written request (a) upon commencement of a bankruptcy proceeding, unless the Party
subject to such proceeding continues to perform all of its obligations under this Agreement, or (b) if not delivered pursuant to clause (a) above because the subject Party continues to perform, upon the rejection of this Agreement by or
on behalf of the subject Party. Unless and until the subject Party rejects this Agreement, the subject Party shall perform this Agreement or provide the intellectual property (including all embodiments of such intellectual property) to
the non-subject Party, and shall not interfere with the rights of the non-subject Party to such intellectual property, including the right to obtain the intellectual property from another entity.
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14.8 |
Full Force and Effect During Notice Period. This Agreement will remain in full force and effect until the expiration of the applicable termination notice period. For clarity, if Otsuka or any
of its Affiliates or Sublicensees achieve any Milestone Events during the termination notice period, then the corresponding Milestone Payment is accrued and Otsuka will remain responsible for the payment of such Milestone Payment even
if the due date of such Milestone Payment occurs after the effective date of the termination.
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14.9 |
Effects of Termination. If this Agreement is terminated by either Party pursuant to Section 14.2 (Termination for Material Breach) or Section 14.6 (Termination for Insolvency),
by Otsuka pursuant to Section 14.3 (Termination by Otsuka for Convenience), or by Ionis pursuant to Section 14.4 (Discontinuation of Development and Commercialization), or Section 14.5 (Termination for Patent
Challenge), then all rights in the Licensed Products in the Terminated Regions will revert to Ionis, and the following will apply with respect to the Licensed Products in the Terminated Regions:
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14.9.1 |
Termination of Licenses. As of the effective date of termination of this Agreement, all rights licensed to Otsuka under Section 2.1 (License Grants to Otsuka) or otherwise under this
Agreement (except for the licenses granted under Section 2.4 (Collaboration Technology Enabling License)), in each case, will each terminate with respect to the Terminated Region, but each Party will retain its joint ownership
interests in the Joint Collaboration Technology.
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70
14.9.2 |
(a) |
License Grant. Ionis will have, and Otsuka hereby grants to Ionis, effective upon such termination, a worldwide, [***] license under any Patent Rights and Know-How Controlled by Otsuka as of
the effective date of such termination, other than any Otsuka Technology, that, in each case, are used by Otsuka or its Affiliates in the Exploitation of any Licensed Product in the Terminated Region(s) prior to or as of the effective
date of such termination solely to Exploit the Licensed Products in the Terminated Region(s) (the “Reversion License”). Except as otherwise provided in Section 14.9.8
(Sell-Off), Otsuka will not have the right to Commercialize any Licensed Product in the Terminated Region(s) upon and following the effective date of termination of this Agreement with respect to such Terminated Region(s).
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(b) |
Reversion Royalty. Ionis will pay, on a Calendar Quarter basis during the applicable Royalty Term (defined mutatis mutandis with respect to the
Reversion License except that, for clarity, references to the Ionis Patent Rights in such definition will instead refer to any Patent Rights licensed by Otsuka to Ionis under the Reversion License) a [***] royalty on Ionis’ Net Sales
(defined mutatis mutandis with respect to the Reversion License) of each Licensed Product in the Terminated Region(s). The provisions of Section 9.3.4 (Royalty Payments and Reports)
through Section 9.11 (Late Payments; Disputed Payments) will apply to such payment obligation mutatis mutandis. Notwithstanding the foregoing, in no event will the total amount of the
reversion royalty payments under this Section 14.9.2(b) (Reversion Royalty) exceed [***].
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14.9.3 |
(a) |
Scope. Xxxxx may request that Otsuka perform transition activities with respect to any Licensed Products in the Terminated Region(s) that are necessary to transition the responsibilities under
all Regulatory Approvals for the Licensed Products in the Terminated Region(s) and ongoing Clinical Trials in the Terminated Region(s) for Licensed Products to Ionis or its designee. If Ionis requests that Otsuka perform any such
transition activities, then the Parties will enter into a transition agreement containing a plan for Otsuka to perform the transition services listed in Schedule 14.9.3
(Transition Services), to the extent applicable at the time of termination, and such other transition services that the Parties mutually agree to (such plan, the “Transition Plan”
and such activities, the “Transition Services”).
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(b) |
Transition Plan. Ionis may elect to have Otsuka perform the Transition Services by providing written notice to Otsuka no later than [***] following the effective date of the termination in the
Terminated Region(s). If Xxxxx requests that Otsuka perform the Transition Services, then Xxxxx will propose a draft of the Transition Plan setting forth the Transition Services to be performed by Otsuka and the Parties will negotiate
and enter into the Transition Plan, which will be consistent with this Section 14.9.3 (Transition Services) and will include, to the extent applicable, the services listed on Schedule
14.9.3 (Transition Services), within [***] after such request. In addition, the Parties will, within [***] after such request, establish a transition committee consisting of at least each Party’s Alliance Managers, a
representative from each Party’s CMC group who was responsible for the Licensed Product prior to the termination in the Terminated Region(s), and up to two additional representatives from each Party who are from other relevant
functional groups to facilitate a smooth transition. While Otsuka is providing Transition Services, Otsuka and Xxxxx will mutually agree on talking points and a communication plan to customers, specialty pharmacies, physicians,
Regulatory Authorities, patient advocacy groups, and clinical study investigators, in each case, in the Terminated Region(s), and Otsuka will make all such communication to such entities in accordance with the mutually agreed talking
points.
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(c) |
Costs. Ionis will pay Otsuka for [***]. In addition, Ionis will reimburse Otsuka for [***]. Otsuka will submit an invoice, together with supporting documentation of [***], to Ionis quarterly
for the foregoing costs incurred by or on behalf of Otsuka in such Calendar Quarter, and Ionis will pay the undisputed invoiced amounts within [***] after the date of such invoice (and will pay any disputed amounts within [***]
following resolution of the dispute and determination that such amounts are owed).
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14.9.4 |
Return of Confidential Information. Each Party will return or destroy (at the other Party’s election) all Confidential Information of the other Party to the extent relating to the Terminated
Region(s) in its possession upon termination of this Agreement in such Terminated Region(s) and, if applicable, the Receiving Party will provide a written confirmation of such destruction within [***] of such request. Notwithstanding
the foregoing or any provision to the contrary set forth in this Agreement: (a) the foregoing terms of this Section 14.9.4 (Return of Confidential Information) will not apply to any Confidential Information that is necessary to
allow the Receiving Party to perform its obligations or exercise any of its rights that expressly survive the applicable termination of this Agreement in such Terminated Region(s), and the Receiving Party may retain one copy of such
Confidential Information for its legal archives; and (b) the Receiving Party will not be required to destroy electronic files containing such Confidential Information that are made in the ordinary course of its business information
back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information.
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14.9.5 |
Sublicenses. If this Agreement is terminated prior to expiration, then Ionis shall grant to each Sublicensee of Otsuka with respect to one or more Terminated Regions, at each such Sublicensee’s
written request to Ionis within [***] of the effective date of termination in such Terminated Region(s), a direct license, provided that such Sublicensee (a) is not then in default of its
sublicense agreement or this Agreement, (b) agrees in writing to comply with the terms of this Agreement to the extent applicable to the rights originally sublicensed to such Sublicensee by Otsuka, and (c) agrees to pay directly to
Ionis such Sublicensee’s payments under such sublicense agreement. The scope of such direct license shall be no less than the scope of the license granted herein and sublicensed to such Sublicensee, and Ionis shall have no obligation to
perform any task for such Sublicensee beyond the obligations owed to Otsuka hereunder. Each Sublicensee will be an intended Third Party beneficiary of this Section 14.9.5 (Sublicenses) with the right to enforce the same against
Xxxxx.
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14.9.6 |
Assignment. To the extent requested by Xxxxx in writing following the date that a Party provides notice of termination of this Agreement in the Terminated Region(s), Otsuka will promptly (and
in any event no later than [***] after the effective date of termination in the Terminated Region(s) unless agreed otherwise in the Transition Plan or expressly specified otherwise below):
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72
(a) |
provide to Ionis for its review unredacted copies of all clinical trial agreements and distribution agreements with respect to one or more Terminated Regions (to the extent assignable, not cancelled, and solely related to the
Licensed Products), in each case, that are necessary or reasonably useful for the Exploitation of the Licensed Products in the Terminated Region(s), and, following such review, upon Xxxxx’ written request within [***] after entering
into a Transition Plan or [***] after the effective date of termination in the Terminated Region(s) if Ionis does not elect to enter into a Transition Plan, assign and transfer to Ionis or its designee all of Otsuka’s rights, title, and
interests in and to any such agreements;
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(b) |
assign to Ionis any Potential In-Licenses with respect to one or more Terminated Regions entered into by Otsuka pursuant to Section 2.7.2 (Potential In-Licenses);
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(c) |
assign any agreements or arrangements with Third Party vendors (including distributors) with respect to one or more Terminated Regions solely related to the Licensed Products or, to the extent any such Third Party agreement or
arrangement is not assignable to Ionis, reasonably cooperate with Ionis to arrange to continue to provide such services for a reasonable time after termination of this Agreement in the Terminated Region(s) to facilitate the orderly
transition of all Commercialization and other activities then being performed by or on behalf of Otsuka or its Affiliates or Sublicensees for the Licensed Products in the Terminated Region(s) to Ionis or its designee;
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(d) |
assign and transfer to Ionis or its designee, as of the effective date of termination in the Terminated Region(s), all of Otsuka’s rights, title, and interests in and to the Otsuka Product Trademarks in the Terminated Region(s) and
any domain names associated with the Otsuka Product Trademarks (to the extent that Otsuka or its Affiliates has any) in the Terminated Region(s) and promptly provide to Ionis all information necessary to maintain such domain names;
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(e) |
assign and transfer to Ionis or its designee, as of the effective date of termination in the Terminated Region(s), all of Otsuka’s rights, title, and interests in and to any Product Materials in the Terminated Region(s) specifically
related to the Licensed Products, and copyrights and any registrations for the foregoing (to the extent that Otsuka or its Affiliates has any); and
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(f) |
within [***] after entering into a Transition Plan or [***] after the effective date of termination in the Terminated Region(s) if Ionis does not elect to enter into a Transition Plan, disclose to Ionis or its designee all documents,
records, and materials that embody any of the foregoing and that are Controlled by Otsuka.
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To the extent that any agreement or other asset described in this Section 14.9.6 (Assignment) is not assignable by Otsuka, then such agreement or other asset will not be assigned,
and upon the request of Ionis, Otsuka will take such steps as may be necessary to allow Ionis to obtain and to enjoy the benefits of such agreement or other asset, in the form of a license or other right to the extent Otsuka has the right and
ability to do so; provided that such steps will not require Otsuka to [***] in order to obtain and enjoy such benefits. For clarity, Ionis will have the right to request that Otsuka take any or all of
the foregoing actions in whole or in part, or with respect to all or any portion of the assets set forth in the foregoing provisions.
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14.9.7 |
Regulatory Submissions and Regulatory Approvals. Otsuka will and hereby does, and will cause its Affiliates and Sublicensees to, (a) no later than [***] after the effective date of termination
of this Agreement in the Terminated Region(s), at Ionis’ request either (i) assign and transfer to Ionis or its designee all of Otsuka’s rights, title, and interests in and to all Regulatory Submissions, Regulatory Approvals, and
Reimbursement Approvals in the Terminated Region(s) or (ii) solely with respect to any Terminated Region(s) in the Asia Territory, withdraw all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in such Terminated
Region(s), in each case ((i) or (ii)), solely for the Licensed Products in the Terminated Region(s) then Controlled by Otsuka or any of its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis
pursuant to Section 14.9.5 (Sublicenses)), and (b) to the extent any assignment requested pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Ionis to cross-reference and rely
upon any such Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals filed by Otsuka or any of its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section
14.9.5 (Sublicenses)). Otsuka will execute and deliver, or will cause to be executed and delivered, to Ionis or its designee such endorsements, assignments, commitments, acknowledgements, and other documents as may be necessary to
effect the foregoing assignment, including submitting to each applicable Regulatory Authority or other Governmental Authority a letter or other necessary documentation (with copy to Ionis) notifying such Regulatory Authority or other
Governmental Authority of, or otherwise giving effect to, the transfer of ownership to Ionis of all such assigned Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals in the Terminated Region(s). In addition, upon
Xxxxx’ written request, Otsuka will, [***] (other than in the event of termination of this Agreement by Otsuka pursuant to Section 14.2 (Termination for Material Breach) or Section 14.6 (Termination for Insolvency), in
which case Ionis shall [***]), provide to Ionis copies of all material related documentation, including material non-clinical, preclinical, and clinical data related to the Licensed Products in the Terminated Region(s) that are held by
or reasonably available to Otsuka or its Affiliates or Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis pursuant to Section 14.9.5 (Sublicenses)).
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14.9.8 |
Sell-Off. If Otsuka is Commercializing any Licensed Product in any country in the Terminated Region(s) as of the applicable effective date of termination in such Terminated Region(s), then,
[***], either (a) Otsuka will appoint Ionis or its designee as its exclusive distributor of such Licensed Product in such country and xxxxx Xxxxx or its designee the right to appoint sub-distributors, to the extent not prohibited by any
written agreement between Otsuka or any of its Affiliates and a Third Party or (b) Otsuka will have the continued right to sell the Licensed Products in the Terminated Region(s) from its inventory; provided,
however, that Otsuka’s obligations under this Agreement with respect to the Licensed Products that Otsuka sells in the Terminated Region(s), including the obligation to pay Royalties to Ionis
hereunder, will continue in full force and effect during such period. If Xxxxx elects to be appointed as the exclusive distributor pursuant to the foregoing clause (a), then the Parties will enter into a distribution agreement with
respect to such appointment and Xxxxx will use good faith efforts to distribute such Licensed Product in such country, or otherwise distribute such Licensed Product in such country, in accordance with the terms of the distribution
agreement.
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14.9.9 |
Inventory. [***].
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14.9.10 |
Wind Down and Transition. Otsuka will be responsible, [***] (other than in the event of termination of this Agreement by Otsuka pursuant to Section 14.2 (Termination for Material
Breach) or Section 14.6 (Termination for Insolvency), in which case Ionis shall [***]), for the wind-down of Otsuka’s and its Affiliates’ and Sublicensees (for any Sublicensees that do not become a direct licensee of Ionis
pursuant to Section 14.9.5 (Sublicenses)) activities with respect to the Licensed Products in the Terminated Region(s). Otsuka will, and will cause its Affiliates and such Sublicensees to, reasonably cooperate with Ionis to
facilitate orderly transition to Ionis or its designee of all Commercialization and other activities then being performed by or on behalf of Otsuka or its Affiliates for the Licensed Products in the Terminated Region(s).
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14.9.11 |
Cost of Transition Activities. Notwithstanding any provision to the contrary in this Section 14.9 (Effects of Termination), but without limiting Section 14.9.3(c) (Costs), if
Otsuka terminates this Agreement pursuant to Section 14.2 (Termination for Material Breach) or Section 14.6 (Termination for Insolvency), Ionis will be responsible for, and will pay Otsuka, [***]. Otsuka will submit an
invoice, together with supporting documentation of [***], to Ionis quarterly for the foregoing costs incurred by or on behalf of Otsuka in such Calendar Quarter, and Ionis will pay the undisputed invoiced amounts within [***] after the
date of any such invoice (and will pay any disputed amounts within [***] following resolution of the dispute and determination that such amounts are owed).
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14.9.12 |
Other Assistance; Further Assurances. Otsuka will provide any other assistance reasonably requested by Xxxxx for the purpose of allowing Ionis or its designee to proceed expeditiously with the
Exploitation of the Licensed Products in the Terminated Region(s) for a period of [***] after the effective date of termination of this Agreement in such Terminated Region(s). Otsuka will execute all documents, and take all such further
actions as may be reasonably requested by Xxxxx in order to give effect to the requirements in this Section 14.9 (Effects of Termination).
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14.10 |
Survival; Accrued Rights. Expiration or termination of this Agreement with respect to Terminated Region(s) will not relieve the Parties of any liability that accrued hereunder prior to the
effective date of such expiration or termination in such Terminated Region(s) nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor
prejudice either Party’s right to obtain performance of any obligation. Without limiting the foregoing, the following provisions of this Agreement will survive the expiration or termination of this Agreement with respect to Terminated
Region(s): Section 2.2 (License Grant to Ionis); Section 2.4 (Collaboration Technology Enabling License); Section 4.6 (Development Records; Cooperation) (solely with respect to the obligation to maintain records
for at least [***] after the end of the Term or for such longer period as may be required by Applicable Law); Article 9 (Payments) (solely with respect to amounts that accrued prior to the effective date of termination and, with
respect to Section 9.5 (Financial Records and Audits), solely for [***] after the effective date of termination), Section 10.1 (Inventions); Section 11.5 (Disclaimer); Section 11.6 (Limitation of
Liability); Article 12 (Confidentiality, excluding Section 12.5 (Publications)); Article 13 (Indemnification); Section 14.9 (Effects of Termination); this Section 14.10 (Survival; Accrued Rights);
Article 15 (Dispute Resolution; Governing Law); Article 16 (Miscellaneous); and Appendix 1 (Definitions).
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ARTICLE 15
15.1 |
Executive Officers; Disputes. Each Party will ensure that an Executive Officer is designated for such Party at all times during the Term for dispute resolution purposes, and will promptly
notify the other Party of any change in its designated Executive Officer. In the event of a dispute, controversy or claim arising under, relating to, or in connection with this Agreement (except for disputes arising at the Executive
Committee, any JSC, or any other Subcommittee, which will be resolved in accordance with Section 8.5 (Decision-Making) and Section 8.6 (Resolution of Committee Disputes)) (a “Disputed Matter”), then the Parties will refer such dispute to their respective Executive Officer, and such Executive Officers or designees will attempt in good faith to resolve such dispute. If the
Parties are unable to resolve any such dispute within [***] after both Parties have referred such dispute to their designated Executive Officers pursuant to this Section 15.1 (Executive Officers; Disputes), then either Party
will have the right to pursue any and all remedies available at law or equity, as set forth in Section 15.2 (Arbitration) or Section 15.3 (Intellectual Property Disputes), as applicable.
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15.2 |
15.2.1 |
If the Parties are unable to resolve a Disputed Matter using the process described in Section 15.1 (Executive Officers; Disputes) and Section 15.3 (Intellectual Property Disputes)
does not apply, then a Party seeking further resolution of the Disputed Matter will submit the Disputed Matter to resolution by final and binding arbitration in accordance with this Section 15.2 (Arbitration).
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15.2.2 |
The seat, or legal place, of arbitration will be New York, New York. The arbitration will be administered by the International Chamber of Commerce pursuant to its Rules of Arbitration in effect at
the time of the arbitration, (the “Rules”), except they may be modified as set forth herein, and applying the
substantive law specified in Section 15.5 (Governing Law; English Language). The language of the arbitration will be English.
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15.2.3 |
Unless a Party elects for application of the ICC’s Expedited Procedure Rules pursuant to Section 15.2.4 (Arbitration) or the Expedited Procedure Rules otherwise apply because of the amount
in dispute, the arbitration will be conducted by a tribunal of three arbitrators. The claimant will nominate an arbitrator in its request for arbitration; the respondent will nominate an arbitrator within [***] of receipt of the request for arbitration; and the two-party nominated arbitrators will nominate the third, who will serve as chair of the tribunal, within [***]
of the second arbitrator’s appointment. If any of the three arbitrators are not nominated within the time prescribed above, then the ICC will appoint the arbitrator(s). Within [***] of the
commencement of arbitration, the Parties will attempt in good faith to reach agreement upon and thereafter follow procedures directed at assuring that the arbitration will be concluded and the award rendered within no more than [***] from the date the ICC Secretariat transmits the file to the arbitral tribunal. Failing such agreement, the arbitral tribunal will design and the Parties will follow procedures directed at meeting such
a time schedule. Each arbitrator must have at least [***] of business or legal experience in the pharmaceutical industry. An arbitrator will be deemed to meet these qualifications unless a
Party objects within [***] after the arbitrator is nominated.
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15.2.4 |
Notwithstanding Section 15.2.3 (Arbitration), if the Disputed Matter involves the dispute of a Breach Notification for any default other than a determination of an alleged failure to use
Commercially Reasonable Efforts to Develop or Commercialize the Licensed Product, the non-breaching Party may elect on notice to the breaching Party to apply the ICC Expedited Procedure Rules to the arbitration and, if such election
is made, the number of arbitrators will be one and the period for the rendering of the final award will be [***] from the date of the case management conference.
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15.2.5 |
The Parties agree that any dispute concerning the propriety of the commencement of the arbitration or the scope and applicability of the agreement to arbitrate will be determined by the arbitrator(s).
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15.2.6 |
No tribunal of arbitrators will have the power to award damages excluded pursuant to Section 11.6 (Limitation of Liability).
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15.2.7 |
Article 38 of the Rules will apply with respect to the costs of the arbitration.
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15.2.8 |
Except as may be required by Applicable Law, neither a Party nor any arbitrator may disclose the existence, content, or results of any arbitration hereunder without the prior written consent of both
Parties, unless to protect or pursue a legal right. The arbitral award will be final and binding on the Parties and the Parties will carry out the award without delay. Judgment on the award so rendered may be entered in any court of
competent jurisdiction. No award or procedural order made in the arbitration shall be published.
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15.3 |
Intellectual Property Disputes. Notwithstanding any provision to the contrary set forth in this Agreement, if a dispute arises under this Agreement with respect to the validity, scope,
enforceability, or ownership of any Patent Right or other intellectual property rights, and such dispute is not resolved in accordance with Section 15.1 (Executive Officers; Disputes), then such dispute will be submitted to a
court of competent jurisdiction in the jurisdiction in which such Patent Right or other intellectual property right was granted or arose.
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15.4 |
Equitable Remedies. Notwithstanding any provision to the contrary set forth in this Agreement, the Parties each stipulate and agree that (a) the other Party’s Confidential Information
includes highly sensitive trade secret information such that a breach of Article 12 (Confidentiality) by a Party will cause irrevocable harm for which monetary damages would not provide a sufficient remedy; and (b) in such
case of such breach of Article 12 (Confidentiality), the non-breaching Party will be entitled to seek equitable relief, including specific performance, temporary or permanent restraining orders, preliminary injunction,
permanent injunction, or other equitable relief without the posting of any bond or other security. In addition, and notwithstanding any provision to the contrary set forth in this Agreement, in the event of any other actual or
threatened breach hereunder, the aggrieved Party may seek interim equitable relief (including temporary restraining orders, or other provisional equitable relief) from any court of competent jurisdiction without first submitting to
the dispute resolution procedures set forth in Article 15 (Dispute Resolution; Governing Law) and shall retain that right after the appointment of the arbitrator(s).
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15.5 |
Governing Law; English Language. This Agreement and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties, will be construed under and governed by
the laws of the State of New York, United States, exclusive of its conflicts of laws principles. This Agreement has been prepared in the English language and the English language will control its interpretation. All consents, notices,
reports, and other written documents to be delivered or provided by a Party under this Agreement will be in the English language, and in the event of any conflict between the provisions of any document and the English language
translation thereof, the terms of the English language translation will control.
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ARTICLE 16
16.1 |
Assignment. This Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the prior written
consent of the other Party. Notwithstanding the foregoing, (a) Ionis may assign its rights to receive payments under this Agreement to one or more Persons (including as part of a royalty monetization transaction) (a “Payment Assignment”) without consent of Otsuka; provided that Ionis shall give prompt written notice to Otsuka upon making a Payment
Assignment, and any assignee of a Payment Assignment shall not have any rights, including any audit rights, hereunder (other than the right to receive payments under this Agreement) unless Otsuka provides express prior written
consent, which Otsuka may grant or withhold in its discretion, and (b) either Party may, without consent of the other Party, assign this Agreement and its rights and
obligations hereunder (i) in whole or in part to an Affiliate of such Party (for so long as such Affiliate remains an Affiliate), or (ii) in whole to its successor-in-interest in connection with the sale of all or substantially all of
its assets, whether in a merger, acquisition, or similar transaction or series of related transactions. If there is an assignment pursuant to the foregoing clauses (b)(i) or (b)(ii), then such assignment will only be effective if the
Person to whom this Agreement is assigned agrees in writing to assume all of the assigning Party’s obligations under this Agreement and the assigning Party provides written notice of such assignment to the non-assigning Party within
[***] after the effective date of such assignment. Any attempted assignment of this Agreement in violation of this Section 16.1 (Assignment) will be null, void, and of no legal effect. Any permitted assignee will assume all
assigned obligations of its assignor under this Agreement. This Agreement will be binding on and will inure to the benefit of the permitted successors and assigns of the Parties.
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16.2 |
16.2.1 |
This Agreement and the Ancillary Agreements, together with all exhibits and schedules attached hereto, is in effect from and after the Restatement Date. This Agreement constitutes the entire agreement between the Parties with
respect to the subject matter hereof, and supersedes and merges all prior and contemporaneous negotiations, representations, and understandings regarding the same except, with respect to the
Original Agreement, as set forth in Section 16.2.2 (Entire Agreement; Amendment) (including that certain mutual confidential disclosure agreement between the Parties dated [***] (“Confidential Disclosure Agreement”)). All information shared by the Parties pursuant to the Confidential Disclosure Agreement and the Original Agreement will be Confidential Information under this Agreement from and
after the Restatement Date, and the use and disclosure thereof will be governed by Article 12 (Confidentiality). This Agreement may not be modified or amended, except by another agreement in writing executed by duly authorized
signatories of each Party.
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16.2.2 |
The Original Agreement is amended and restated in its entirety and superseded as of the Restatement Date by this Agreement; provided that such amendment and restatement of the Original
Agreement does not relieve the Parties of any liability that accrued under the Original Agreement prior to the Restatement Date nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in
equity with respect to any breach of the Original Agreement, nor prejudice either Party’s right to obtain performance of any obligation that was due during the Original Agreement Term. Notwithstanding any provision to the contrary in
the Original Agreement, including Section 14.10 (Survival; Accrued Rights), the following provisions of the Original Agreement will survive the amendment and restatement of the Original Agreement: Section 4.6
(Development Records; Cooperation) (solely with respect to the obligation to maintain records for at least three years after the end of the Original Agreement Term or for such longer period as may be required by Applicable Law); Article
9 (Payments) (solely with respect to amounts that accrued prior to the Restatement Date and, with respect to Section 9.5 (Financial Records and Audits), solely for 36 months after the Restatement Date); Section 11.5
(Disclaimer); Section 11.6 (Limitation of Liability); Article 13 (Indemnification); Article 15 (Dispute Resolution; Governing Law); Article 16 (Miscellaneous) (solely to extent applicable to other
surviving provisions); and Appendix 1 (Definitions) (solely to the extent applicable to other surviving provisions).
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78
16.3 |
No Strict Construction; Interpretation. This Agreement has been prepared jointly and will not be strictly construed against either Party. Ambiguities, if any, in this Agreement will not be
construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. Except where the context expressly requires otherwise, (a) whenever any provision of this Agreement uses the term
“including” (or “includes”), such term will be deemed to mean “including without limitation” and “including but not limited to” (or “includes without limitations” and “includes but is not limited to”) regardless of whether the words
“without limitation” or “but not limited to” actually follow the term “including” (or “includes”); (b) “herein,” “hereby,” “hereunder,” “hereof,” and other equivalent words will refer to this Agreement in its entirety and not solely
to the particular portion of this Agreement in which any such word is used; (c) all definitions set forth herein will be deemed applicable whether the words defined are used herein in the singular or the plural; (d) wherever used
herein, any pronoun or pronouns will be deemed to include both the singular and plural and to cover all genders; (e) the schedules and exhibits to this Agreement, and the terms and conditions incorporated in such schedules and
exhibits will be deemed integral parts of this Agreement and all references in this Agreement to this Agreement will encompass such schedules and exhibits and the terms and conditions incorporated in such schedules and exhibits; provided that if there is a conflict between the terms and conditions of this Agreement and any terms and conditions set forth in the schedules, or exhibits, then the terms of this Agreement will
control; (f) in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions that may be set forth on any order, invoice, or verbal agreement by the Parties pursuant to this Agreement, the
terms and conditions of this Agreement will govern; (g) unless otherwise provided, all references to Sections, Articles, and Schedules in this Agreement are to Sections, Articles, and Schedules of and to this Agreement; (h) any
reference to any federal, national, state, local, or foreign statute or law will be deemed to also refer to all rules and regulations promulgated thereunder, and any reference to any law, rule, or regulation will be deemed to include
the then‑current amendments thereto or any replacement or successor law, rule, or regulation thereof; (i) wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are
interchangeable with one another; (j) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or”; (k) references to a particular Person include such Person’s successors and assigns to the
extent not prohibited by this Agreement; (l) the section headings and captions used herein are inserted for convenience of reference only and will not be construed to create obligations, benefits, or limitations; (m) any definition of
or reference to any agreement, instrument, or other document herein will be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented, or otherwise modified (subject to any
restrictions on such amendments, supplements, or modifications set forth herein); (n) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals, and other written
communications contemplated under this Agreement; and (o) provisions that require that a Party, the Parties, or any committee hereunder “agree,” “consent,” or “approve” or the like will require that such agreement, consent, or
approval be specific and in writing, whether by written agreement, letter, approved minutes, or otherwise (but excluding email and instant messaging).
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79
16.4 |
Severability. If any provision of this Agreement is declared invalid by a court of last resort or by any court or other governmental body the decision of which an appeal is not taken within
the time provided by law, then and in such event, this Agreement will be deemed to have been terminated only as to the portion thereof that relates to the provision invalidated by that decision and only in the relevant jurisdiction,
but this Agreement will remain in force, in all other respects and all other jurisdictions; provided, however, that if the provision so invalidated is essential to this Agreement as a whole,
then the Parties will negotiate in good faith to amend the terms hereof as nearly as practical to carry out the original intent of the Parties, and, failing such amendment, either Party may submit the matter for resolution pursuant to
Article 15 (Dispute Resolution; Governing Law).
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16.5 |
Force Majeure. Neither Party will be held liable or responsible to the other Party nor be deemed to be in default under, or in breach of any provision of, this Agreement for failure or delay
in fulfilling or performing any obligation of this Agreement when such failure or delay is due to Force Majeure. For purposes of this Agreement, “Force Majeure” is defined as
any cause beyond the control of the affected Party and without the fault or negligence of such Party, which may include acts of God; material changes in Applicable Law; war; civil commotion; destruction of production facilities or
materials by fire, flood, earthquake, explosion, or storm; labor disturbances; epidemic; pandemic; quarantine; and failure of public utilities or common carriers. Notwithstanding the foregoing, a Party will not be excused from making
payments owed hereunder due to any such Force Majeure circumstances affecting such Party. The Party affected by Force Majeure will immediately notify the other Party of such inability and of the period for which such inability is
expected to continue. The Party giving such notice will thereupon be excused from such of its obligations under this Agreement as it is thereby disabled from performing for so long as it is so disabled for up to [***], after which
time the Parties will promptly meet to discuss in good faith how to best proceed in a manner that maintains and abides by this Agreement. To the extent possible, each Party will use reasonable efforts to minimize the duration of any
Force Majeure.
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16.6 |
Notices. All notices that are required or permitted hereunder will be in writing and sufficient if delivered by internationally recognized overnight courier or sent by registered or certified
mail, postage prepaid, return receipt requested, and in each case, addressed as follows (with a courtesy copy sent by email, which will not constitute notice):
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If to Ionis:
Ionis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxx
Carlsbad, CA 92010
Attention: Chief Business Officer
With a copy (which will not constitute notice for purposes of this Agreement) to:
[***]
Attention: General Counsel
80
If to Otsuka:
Otsuka Pharmaceutical Co., Ltd.
Shinagawa Grand Central Tower
2-16-4 Xxxxx, Xxxxxx-ku
Tokyo, 108-8242 Japan
Attn: Director, Global Business Development
Email: [***]
With a copy (which will not constitute notice for purposes of this Agreement) to:
Otsuka Pharmaceutical Co., Ltd.
Shinagawa Grand Central Tower
2-16-4 Xxxxx, Xxxxxx-ku
Tokyo, 108-8242 Japan
Attn: Director, Legal Affairs Department
Email: [***]
Otsuka Pharmaceutical Europe Ltd.
0 Xxxxxxx Xxxxx, Xxxxxx Xxxx,
Windsor, SL4 1RS, United Kingdom
Attn: General Counsel
Email: [***]
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice will be deemed to have been given:
(a) on the Business Day after dispatch if sent by internationally recognized overnight courier; or (b) on the fifth Business Day after dispatch if sent by registered or certified mail, postage prepaid, return receipt requested.
16.7 |
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16.8 |
Performance by Affiliates. Notwithstanding any provision to the contrary set forth in this Agreement, either Party will have the right to perform any or all of its obligations and exercise
any or all of its rights under this Agreement through any Affiliate. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement and will cause its Affiliates to comply with the
provisions of this Agreement in connection with such performance.
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16.9 |
Agency. Neither Party is, nor will be deemed to be an employee, agent, or representative of the other Party for any purpose. Each Party is an independent contractor, not an employee or
partner of the other Party. Neither Party will have the authority to speak for, represent, or obligate the other Party in any way without prior written authority from the other Party.
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81
16.10 |
Binding Effect; No Third-Party Beneficiaries or Obligors. As of the Restatement Date, this Agreement will be binding upon and inure to the benefit of the Parties and their respective
permitted successors and assigns. Except as set forth in Article 13 (Indemnification), no Person other than Xxxxx, Otsuka, and their respective permitted successors and assigns hereunder will be deemed an intended beneficiary
hereunder, nor have any right to enforce any obligation of any Party to this Agreement, nor will any Person other than Ionis and Otsuka and their respective permitted successors and assigns have any obligations to any Party under this
Agreement.
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16.11 |
No Waiver. Any omission or delay by either Party at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants, or provisions hereof, by
the other Party, will not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement. Any waiver by a Party of a particular breach or default by the other Party will not operate or be
construed as a waiver of any subsequent breach or default by the other Party.
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16.12 |
Cumulative Remedies. No remedy referred to in this Agreement, including termination of this Agreement, is intended to be exclusive, but each will be cumulative and in addition to any other
remedy referred to in this Agreement or otherwise available under law.
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16.13 |
Counterparts. This Agreement may be executed in one or more counterparts, all of which taken together will be regarded as one and the same instrument. Each Party may execute this Agreement in
Adobe™ Portable Document Format (PDF) sent by electronic mail. PDF signatures of authorized signatories of the Parties will be deemed to be original signatures, will be valid and binding upon the Parties, and, upon delivery, will
constitute due execution of this Agreement.
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[Remainder of page intentionally left blank; Signature page follows.]
82
IN WITNESS WHEREOF, the Parties have executed this Agreement through their duly authorized representatives to be effective as of the Restatement Date.
Ionis Pharmaceuticals, Inc.
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Otsuka Pharmaceutical Co., Ltd.
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By: |
/s/ Xxxxx Xxxxx, PhD
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By: |
/s/ Xxxxxx Xxxxx
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Name: Xxxxx Xxxxx, PhD
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Name: Xxxxxx Xxxxx
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Title: Chief Executive Officer
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Title: President and Representative Director
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Otsuka Pharmaceutical Co., Ltd. | ||||
By: |
/s/ Xxxxxxx Xxxxxxxx
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Name: Xxxxxxx Xxxxxxxx, PhD, MBA
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||||
Title: VP, Global Head of Business Development
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[Signature Page to Amended and Restated License Agreement]
Appendix 1
For purposes of this Agreement, whether used in the singular or plural, the following terms will have the meanings set forth below:
1.1 |
“Accounting Standards” means, with respect to a Party or its Affiliate or Sublicensee, GAAP or IFRS, as such Person uses for its financial reporting standards from time to
time, in each case, as consistently applied.
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1.2 |
“Affiliate” means, with respect to a Person, any corporation or other business entity controlled by, controlling, or under common control with such Person, with “control”
meaning (a) direct or indirect beneficial ownership of more than 50% of the voting stock or other ownership interest of, or more than 50% interest in the income of, the applicable entity, or (b) the possession, directly or indirectly,
of the power to direct the management or policies of the applicable entity, whether through the ownership of voting securities or other equity rights, by contract relating to voting rights or corporate governance, or otherwise.
Notwithstanding the foregoing, for purposes of this Agreement, “Affiliates” will not include, (a) with respect to an entity, bona fide venture capital investors in such entity or bona fide institutional investors in such entity, in each case, that routinely make venture capital investments for the potential financial return on such investments and not with any view to
acquisition or for other strategic purpose, or Affiliates of such venture capital or institutional investors, or (b) with respect to Otsuka, any entities that are controlled by Otsuka Holdings Co., Ltd. but are not subsidiaries of
Otsuka.
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1.3 |
“Alliance Manager” has the meaning set forth in Section 8.8 (Alliance Managers).
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1.4 |
“[***]” means any [***].
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1.5 |
“American Commercialization Operating Plan” has the meaning set forth in Section 6.4.1 (Global Brand Strategy and American Commercialization Operating Plan).
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1.6 |
“American Medical Affairs Operating Plan” has the meaning set forth in Section 6.6.1 (Global Medical Affairs Strategy and American Medical Affairs Operating Plan).
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1.7 |
“Ancillary Agreements” means the Pharmacovigilance Agreement, each Supply Agreement, and each Quality Agreement.
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1.8 |
“Applicable Law” means applicable (with respect to the particular activity, task, or obligation under this Agreement to which such term applies) laws, statutes, rules,
regulations, and other pronouncements having the effect of law of any Governmental Authority that may be in effect from time to time, including for clarity any applicable rules, regulations, guidelines, or other requirements of any
Regulatory Authority that may be in effect from time to time.
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1.9 |
“Approved Labeling” means, with respect to a Licensed Product and a jurisdiction: (a) the applicable Regulatory Authority-approved full prescribing information for such
Licensed Product in such jurisdiction; and (b) the applicable Regulatory Authority-approved labels and any other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such
Licensed Product in such jurisdiction.
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1.10 |
“Asia JSC” has the meaning set forth in Section 8.2.1 (Formation and Purposes of the Joint Steering Committees).
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1.11 |
“Asia ROFN Period” has the meaning set forth in Section 2.8.1 (ROFN Exercise).
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1.12 |
“Asia-Specific Non-Clinical HAE Development Activities” has the meaning set forth in Section 4.2.2(b) (Asia Territory).
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1.13 |
“Asia Territory” means, individually, each of the Major Asian Countries, Australia, Egypt, Hong Kong, Indonesia, Malaysia, Myanmar, New Zealand, Pakistan, the Philippines,
Singapore, Taiwan, Thailand, Turkey, and Vietnam, excluding all countries in any Terminated Region.
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1.14 |
“Asia Territory Brand Strategy” has the meaning set forth in Section 6.4.2 (Otsuka Territory Brand Strategy and Commercialization Operating Plans).
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1.15 |
“Asia Territory Commercialization Operating Plan” has the meaning set forth in Section 6.4.2 (Otsuka Territory Brand Strategy and Commercialization Operating
Plans).
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1.16 |
“Asia Territory Medical Affairs Plan” has the meaning set forth in Section 6.6.2 (Otsuka Territory Medical Affairs Plans).
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1.17 |
“Asia Territory-Specific Development Plan” has the meaning set forth in Section 4.3.2 (Asia Territory-Specific Development Plan).
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1.18 |
“ASMF” has the meaning set forth in Section 5.3 (Correspondences with Regulatory Authorities).
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1.19 |
“Blocking Identified Rights” has the meaning set forth in Section 2.7.2(a)(ii) (Acquisition of Potential In-Licenses).
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1.20 |
“Breach Notification” has the meaning set forth in Section 14.2.1 (Material Breach).
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1.21 |
“Business Day” means a day other than (a) a Saturday, Sunday, (b) a day on which banking institutions in California, Tokyo, Japan, or London, England are required by
Applicable Law to remain closed or (c) the nine consecutive days beginning on December 24 and continuing through January 1, to the extent not already covered in clause (a) or clause (b).
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1.22 |
“Calendar Quarter” means, with respect to the first Calendar Quarter during the Term, the period beginning on the Restatement Date and ending on the last day of the
Calendar Quarter within which the Restatement Date falls, and thereafter each successive period of three calendar months ending on (and including) each of March 31, June 30, September 30, and December 31; except that the last Calendar
Quarter during the Term will end upon the expiration of the Term.
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1.23 |
“Calendar Year” means the period of 12 consecutive calendar months beginning on January 1 and ending on December 31; except that (a) the first Calendar Year during the
Term will begin on the Restatement Date and end on December 31 of the Calendar Year within which the Restatement Date falls, and (b) the last Calendar Year during the Term will end upon expiration of the Term.
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1.24 |
“Change of Control” means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such
Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such
Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than 50% of the total voting power of all of the then outstanding voting securities of such Party; (b) a merger, consolidation,
recapitalization, or reorganization of such Party is consummated that would result in shareholders or equity holders of such Party immediately prior to such transaction owning 50% or less of the outstanding voting securities of the
surviving entity (or its parent entity) immediately following such transaction; or (c) the sale or transfer to a Third Party, in one or more related transactions, of all or substantially all of such Party’s consolidated assets taken
as a whole.
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1.25 |
“Clinical Supply Agreement” has the meaning set forth in Section 7.2.1 (Clinical Supply Agreement).
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1.26 |
“Clinical Trial” means any clinical trial in humans.
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1.27 |
“CMC” means chemistry, manufacturing, and controls.
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1.28 |
“CMO” has the meaning set forth in Section 7.3.1 (By Otsuka).
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1.29 |
“Collaboration In-License” means (a) any Potential In-License that [***] in accordance with Section 2.7.2(b) (Collaboration In-Licenses) and (b) any Existing
Third-Party IP Agreement.
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1.30 |
“Collaboration Know-How” means all Know-How developed or invented by a Party’s or its Affiliates’, licensees’, Sublicensees’, or Subcontractors’ employees, agents, or
independent contractors, or any Persons contractually required to assign or license such Know-How to such Party or any Affiliate of such Party, either alone or jointly with the other Party’s or its Affiliates’, licensees’,
Sublicensees’, or Subcontractors’ employees, agents, or independent contractors, or any Persons contractually required to assign or license such Know-How to such other Party or any Affiliate of such other Party, in each case, in the
performance of activities under the Original Agreement during the Original Agreement Term or under this Agreement during the Term.
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1.31 |
“Collaboration Patent Rights” means any Patent Right that (a) has a priority date after the Original Effective Date and (b) Covers any Invention included in the
Collaboration Know-How.
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1.32 |
“Combination Product” has the meaning set forth in Section 1.158 of this Appendix 1 (Definitions).
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1.33 |
“Combination Product Net Sales” has the meaning set forth in Section 1.158 of this Appendix 1 (Definitions).
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1.34 |
“Commercial Supply Agreement” has the meaning set forth in Section 7.2.2 (Commercial Supply Agreement).
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1.35 |
“Commercialization” means any and all activities directed to the marketing, promotion, distribution, pricing, reimbursement, offering for sale, and sale of a
pharmaceutical or biologic product and interacting with Regulatory Authorities following receipt of Regulatory Approval in the applicable country or region for such pharmaceutical or biologic product regarding the foregoing, including
seeking and maintaining any required Reimbursement Approval, but excluding activities directed to Manufacturing or Development. “Commercialize,” “Commercializing,” and “Commercialized” will be construed accordingly.
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1.36 |
“Commercially Reasonable Efforts” means, with respect to the Exploitation of a Licensed Product by a Party, [***].
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1.37 |
“Competitive Infringement” means any infringement, unauthorized use, misappropriation or threatened infringement or misappropriation by a Third Party with respect to any
Ionis Technology, Otsuka Technology, or Joint Collaboration Technology by reason of the making, using, offering to sell, selling, or importing of a compound, product, method, or process that would be competitive with a Licensed
Product then being Developed or Commercialized in the Field.
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1.38 |
“Confidential Disclosure Agreement” has the meaning set forth in Section 16.2 (Entire Agreement; Amendment).
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1.39 |
“Confidential Information” means, subject to Section 12.3 (Exemptions), (a) Know-How and any technical, scientific, trade, research, Manufacturing, business,
financial, marketing, product, supplier, intellectual property, and other non-public or proprietary data or information (including unpublished patent applications) that may be disclosed by one Party (the “Disclosing Party”) or its Affiliates to the other Party (the “Receiving Party”) or its Affiliates pursuant to this Agreement (including
information disclosed prior to the Restatement Date pursuant to the Confidential Disclosure Agreement or the Original Agreement), regardless of whether such information is specifically marked or designated as confidential and
regardless of whether such information is in written, oral, electronic, or other form, and (b) the terms of this Agreement.
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1.40 |
“Continuing Know-How Transfer” has the meaning set forth in Section 3.1 (Initial Know-How Transfer).
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1.41 |
“Control” or “Controlled” means the possession by a Party (whether by
ownership, license, or otherwise other than pursuant to this Agreement) of, (a) with respect to any materials or other tangible Know-How, the legal authority or right to physical possession of such materials or tangible Know-How, with
the right to provide such materials or tangible Know-How to the other Party on the terms set forth herein, (b) with respect to Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other intellectual
property, the legal authority or right to grant a license, sublicense, access, or right to use (as applicable) to the other Party under such Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other
intellectual property on the terms set forth herein, in each case ((a) and (b)), without breaching or otherwise violating the terms of any arrangement or agreement with a Third Party in existence as of the time such Party or its
Affiliates would first be required hereunder to grant the other Party such access, right to use, licenses, or sublicense or incurring any additional payment obligations to a Third Party that would not be incurred but for such access,
right to use, licenses, or sublicense, other than payment obligations incurred under a Collaboration In-License, and (c) with respect to any product, the possession by a Party of the ability (whether by sole or joint ownership,
license, or otherwise, other than pursuant to the licenses granted under this Agreement) to grant an exclusive license or sublicense of Patent Rights that Cover such product or proprietary Know-How that is used in connection with the
Exploitation of such product. Notwithstanding the foregoing, [***].
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1.42 |
“Core or Manufacturing Identified Rights” has the meaning set forth in Section 2.7.2(a)(i) (Acquisition of Potential In-Licenses).
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1.43 |
“Core or Manufacturing Potential In-License” has the meaning set forth in Section 2.7.2(a)(i) (Acquisition of Potential In-Licenses).
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1.44 |
“Cost Overrun” has the meaning set forth in Section 4.4.2(b) (Cost Overruns).
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1.45 |
“Cover” means, with respect to a particular subject matter at issue and a relevant Patent Right or individual claim in such Patent Right, as applicable, that the
manufacture, use, sale, offer for sale, or importation of such subject matter would fall within the scope of one or more claims in such Patent Right.
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1.46 |
“Cross-Territory Clinical Development Plan” has the meaning set forth in Section 4.2.1 (Cross-Territory Clinical Development Plan).
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1.47 |
“Cross-Territory Clinical Studies” has the meaning set forth in Section 4.2.1 (Cross-Territory Clinical Development Plan).
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1.48 |
“Debarred/Excluded” has the meaning set forth in Section 11.1.5 (Mutual Representations and Warranties).
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1.49 |
“Development” means all internal and external research, development and regulatory activities regarding pharmaceutical or biologic products, including (a) research,
process development, non-clinical testing, toxicology, non-clinical activities, IND-enabling studies, and Clinical Trials, and (b) preparation, submission, review, and development of data or information for the purpose of submission
to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of a pharmaceutical or biologic product, but excluding activities directed to Manufacturing or
Commercialization. Development will include development and regulatory activities for additional presentations or indications for a product after receipt of Regulatory Approval of such product, including Post-Approval Mandatory
Studies. “Develop,” “Developing,” and “Developed” will
be construed accordingly.
|
1.50 |
“Disclosing Party” has the meaning set forth in Section 1.39 (Confidential Information) of this Appendix 1 (Definitions).
|
1.51 |
“Disputed Matter” has the meaning set forth in Section 15.1 (Executive Officers; Disputes).
|
1.52 |
“Eligible Cross-Territory Development Costs” has the meaning set forth in Section 4.4.3 (Shared Cross-Territory Development Costs).
|
1.53 |
“EMA” means the European Medicines Agency or any successor agency thereto.
|
1.54 |
“Establishing Committee” has the meaning set forth in Section 8.3.1 (Formation; Authority).
|
1.55 |
“Europe JSC” has the meaning set forth in Section 8.2.1 (Formation and Purposes of the Joint Steering Committees).
|
1.56 |
“Europe Regulatory Subcommittee” has the meaning set forth in Section 5.2 (Europe Regulatory Subcommittee).
|
1.57 |
“Europe ROFN Period” has the meaning set forth in Section 2.8.1 (ROFN Exercise).
|
1.58 |
“Europe Territory” means (a) all members of the European Union or the European Economic Area (EEA) as of the Original Effective Date, and (b) the following countries:
Iceland, Liechtenstein, Norway, Switzerland, and the United Kingdom, excluding all countries in any Terminated Region.
|
1.59 |
“Europe Territory Brand Strategy” has the meaning set forth in Section 6.4.2 (Otsuka Territory Brand Strategy and Commercialization Operating Plans).
|
1.60 |
“Europe Territory Commercialization Operating Plan” has the meaning set forth in Section 6.4.2 (Otsuka Territory Brand Strategy and Commercialization Operating
Plans).
|
1.61 |
“Europe Territory Medical Affairs Plan” has the meaning set forth in Section 6.6.2 (Otsuka Territory Medical Affairs Plans).
|
1.62 |
“Europe Territory-Specific Development Plan” has the meaning set forth in Section 4.3.1 (Europe Territory-Specific Development Plan).
|
1.63 |
“European Union” or “E.U.” means the economic, scientific, and political organization of member states of the European Union as it
may be constituted from time to time.
|
1.64 |
1.65 |
“[***]” has the meaning set forth in Section 7.2.6 ([***]).
|
1.66 |
“Executive Committee” has the meaning set forth in Section 8.1.1 (Formation and Purpose of the Executive Committee).
|
1.67 |
“Executive Committee Co-Chairperson” has the meaning set forth in Section 8.1.2 (Membership).
|
1.68 |
“Executive Officer” means (a) with respect to Otsuka, its President and Representative Director or their designee and (b) with respect to Xxxxx, the Chief Executive
Officer or their designee.
|
1.69 |
“Existing Third-Party IP Agreement” means any agreement between Ionis (or any of its Affiliates) and any Third Party entered into prior to the Original Effective Date or
any time during the Original Agreement Term under which Ionis (or any of its Affiliates) obtained a license or other right to any of such Third Party’s Know-How or Patent Rights that fall within the definition of any of the Ionis
Technology.
|
1.70 |
“Exploit” means to make, have made, use, offer to sell, sell, Develop, Manufacture, Commercialize, or otherwise exploit. “Exploitation” will be construed accordingly.
|
1.71 |
“External Costs” mean, with respect to a Party, the documented actual expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with such
Party’s Accounting Standards) by such Party (or its Affiliate) in consideration of the performance of activities under this Agreement, without mark-up, and excluding any costs or expenses included under the FTE Rate.
|
1.72 |
“FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as amended from time-to-time, together with any rules, regulations, and requirements
promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
|
1.73 |
“FDA” means the U.S. Food and Drug Administration or any successor agency thereto.
|
1.74 |
“Field” means for the treatment or prevention of any diseases and conditions in humans.
|
1.75 |
“Filing Party” has the meaning set forth in Section 5.5 (Regulatory Submissions).
|
1.76 |
“First Commercial Sale” means, with respect to a Licensed Product in a country, the first sale for end use or consumption to a Third Party of such Licensed Product in such
country by a Party, or its Affiliates or Sublicensees after the receipt of Regulatory Approval and Reimbursement Approval in the Field for such Licensed Product by the relevant Regulatory Authority in such country. First Commercial
Sale excludes any sale or other distribution for use in a Clinical Trial or other Development activity or for compassionate use, named-patient use, or expanded access, indigent or other patient
access programs when sold or distributed at or below the applicable Selling Party’s costs.
|
1.77 |
“[***]” has the meaning set forth in Section 9.3.4(a) ([***]).
|
1.78 |
“Follow-On Product” has the meaning set forth in Section 2.8.1 (ROFN Exercise).
|
1.79 |
“Follow-On Product Activities” has the meaning set forth in Section 2.8.3 (Follow-On Product Activities).
|
1.80 |
“Force Majeure” has the meaning set forth in Section 16.5 (Force Majeure).
|
1.81 |
“FTE” means the equivalent of the work of one duly qualified employee of a Party full time for one year (consisting of a total of [***] hours per year) directly carrying
out [***] activities under this Agreement. Overtime, and work on weekends, holidays and the like will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number
of hours that are used to calculate the FTE contribution, and no individual may be charged at greater than one FTE, regardless of that individual’s hours worked during that year. The portion of an FTE billable by a Party for one
employee during a given accounting period will be determined by dividing the number of hours worked directly by such employee on the work to be conducted under this Agreement during such accounting period by the number of FTE hours
applicable for such accounting period based on [***] working hours per Calendar Year. For clarity, travel time spent by an employee, unless also spent working directly on activities under this Agreement, will not be included in the
number of hours used to calculate the FTE contribution.
|
1.82 |
“FTE Rate” means ***] per FTE per hour. For the avoidance of doubt, such FTE Rate will be [***].
|
1.83 |
“Future Cross-Territory Studies” has the meaning set forth in Section 4.2.1 (Cross-Territory Clinical Development Plan).
|
1.84 |
“GAAP” means the generally accepted accounting principles in the United States.
|
1.85 |
“Generic Product” means, with respect to a Licensed Product in a country, a pharmaceutical product (other than such Licensed Product) that (a) is expected to be sold by a
Third Party other than a Sublicensee under license from Otsuka in such country, (b) is authorized for use in such country in one or more of the indications for which such Licensed Product has Regulatory Approval in such country; and
(c) contains the same active pharmaceutical ingredient(s) as such Licensed Product. A product will not be considered to be a Generic Product if (i) Otsuka or any of its Affiliates or Sublicensees was involved in or authorized the
Development or Commercialization of such product, (ii) Otsuka or any of its Affiliates or Sublicensees has granted a license to such Third Party in respect of such product, or (iii) such product is Commercialized by any Person who
obtained such product in a chain of distribution that included Otsuka or any of its Affiliates or Sublicensees.
|
1.86 |
“Global Brand Strategy” has the meaning set forth in Section 6.4.1 (Global Brand Strategy and American Commercialization Operating Plan).
|
1.87 |
“Global Medical Affairs Strategy” has the meaning set forth in Section 6.6.1 (Global Medical Affairs Strategy and American Medical Affairs Operating Plan).
|
1.88 |
“Global Trade Control Laws” means the U.S. Export Administration Regulations, the U.S. International Traffic in Arms Regulations, the economic sanctions regulations
administered by the U.S. Treasury Department’s Office of Foreign Assets Control, E.U. Council Regulations on export controls, including Nos. 428/2009, 267/2012, other E.U. Council sanctions regulations, as implemented in the E.U.
member states, United Nations sanctions policies, and all relevant regulations made under any of the foregoing.
|
1.89 |
“Good Clinical Practices” or “GCP” means the then-current good clinical practice standards, practices, and
procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time.
|
1.90 |
“Good Laboratory Practices” or “GLP” means the then-current good laboratory practice standards, practices, and
procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time.
|
1.91 |
“Good Manufacturing Practices” or “GMP” means the then-current good manufacturing practice standards,
practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time.
|
1.92 |
“Government Official” means any official, officer, employee, or representative of: (a) any federal, state, provincial, administrative division, county, or municipal
government or any department or agency thereof; (b) any public international organization or any department or agency thereof; or (c) any company or other entity owned or controlled by any government or Governmental Authority.
|
1.93 |
“Governmental Authority” means any court, agency, department, authority, tribunal, or other instrumentality of any supra-national, national, state, provincial, county,
city, or other political subdivision. For clarity, Governmental Authorities include all Regulatory Authorities.
|
1.94 |
“HAE” means hereditary angioedema.
|
1.95 |
“Identified Rights” has the meaning set forth in Section 2.7.1 (Identification of New In-License Agreements).
|
1.96 |
“IFRS” means International Financial Reporting Standards, consistently applied.
|
1.97 |
“IND” means an Investigational New Drug application required pursuant to 21 C.F.R. Part 312 or any comparable filings outside of the U.S. required to commence human
clinical trials in such country or region (such as an application for a Clinical Trial Authorization in the E.U.), and all supplements or amendments that may be filed with respect to the foregoing.
|
1.98 |
“Indemnified Party” has the meaning set forth in Section 13.3 (Indemnification Procedure).
|
1.99 |
“Indemnifying Party” has the meaning set forth in Section 13.3 (Indemnification Procedure).
|
1.100 |
“Initial Know-How Transfer” has the meaning set forth in Section 3.1 (Initial Know-How Transfer).
|
1.101 |
“Initial Royalties” has the meaning set forth in Section 9.3.1 (Royalty Payments During the Initial Royalty Term).
|
1.102 |
“Initial Royalty Term” has the meaning set forth in Section 9.3.1 (Royalty Payments During the Initial Royalty Term).
|
1.103 |
“Initiation” means dosing of the first patient in a Clinical Trial.
|
1.104 |
“Internal Costs” means, for any period of time, the product obtained by multiplying (a) the total FTEs (or portion thereof) devoted to the performance of activity under
this Agreement during such period, by (b) the applicable FTE Rate for such period; provided that [***].
|
1.105 |
“Invention” means any process, method, composition of matter, article of manufacture, discovery, or finding that is conceived or reduced to practice (whether or not
patentable).
|
1.106 |
“Ionis Attribution Language” has the meaning set forth in Section 12.7.2 (Acknowledgement).
|
1.107 |
“Ionis Collaboration Know-How” has the meaning set forth in Section 10.1.2(a) (Ownership of Arising Intellectual Property).
|
1.108 |
“Ionis Collaboration Patent Rights” has the meaning set forth in Section 10.1.2(a) (Ownership of Arising Intellectual Property).
|
1.109 |
“Ionis Core Technology” means Ionis Core Technology Know-How and the Ionis Core Technology Patents.
|
1.110 |
“Ionis Core Technology Know-How” means, subject to Section 4.4.4(b) ([***] by Ionis), all Know-How, including Ionis Collaboration Know-How but excluding Ionis
Product-Specific Know-How, Ionis Manufacturing and Analytical Know-How and Ionis’ interest in any Joint Collaboration Know-How, that (a) is Controlled by Ionis or its Affiliates as of the Original Effective Date or at any time during
the Original Agreement Term or the Term, (b) is necessary or reasonably useful to Exploit a Licensed Product, and (c) relates generally to oligonucleotide.
|
1.111 |
“Ionis Core Technology Patents” means, subject to Section 4.4.4(b) ([***] by Xxxxx), any Patent Rights, including Ionis Collaboration Patent Rights but excluding
Ionis Product-Specific Patents, Ionis Manufacturing and Analytical Patents and Ionis’ interest in any Joint Collaboration Patent Rights, that (a) are Controlled by Ionis or its Affiliates as of the Original Effective Date or at any
time during the Original Agreement Term or the Term, (b) are necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) to
Exploit a Licensed Product and (c) Cover subject matter generally applicable to oligonucleotides. A list of the Ionis Core Technology Patents as of the
Restatement Date is set forth on Schedule 1.111 (Ionis Core Technology
Patents); provided that, any Patent Right existing as of the Restatement Date that otherwise would be included in the definition of Ionis Core Technology Patents but is not included
on Schedule 1.111 (Ionis Core Technology Patents) will still be considered an Ionis Core Technology Patent.
|
1.112 |
“Ionis Incurred Development Costs” has the meaning set forth in Section 4.4.1(c)(ii) (Shared Development Costs).
|
1.113 |
“Ionis Indemnitee” has the meaning set forth in Section 13.2 (Indemnification by Otsuka).
|
1.114 |
“Ionis Internal Oligonucleotide Safety Database” has the meaning set forth in Section 5.12.1 (Ionis Internal Oligonucleotide Safety Database).
|
1.115 |
“Ionis Know-How” means the Ionis Core Technology Know-How, Ionis Manufacturing and Analytical Know-How, and Ionis Product-Specific Know-How.
|
1.116 |
“Ionis Manufacturing and Analytical Know-How” means, subject to Section 4.4.4(b) ([***] by Ionis), Know-How, including Ionis Collaboration Know-How but excluding
Xxxxx’ interest in any Joint Collaboration Know-How, that (a) is Controlled by Ionis or its Affiliates as of the Original Effective Date or at any time during the Original Agreement Term or the Term, (b) is necessary or reasonably
useful to Exploit a Licensed Product, and (c) relates to any Manufacturing Technology.
|
1.117 |
“Ionis Manufacturing and Analytical Patents” means, subject to Section 4.4.4(b) ([***] by Xxxxx), Patent Rights, including Ionis Collaboration Patent Rights but
excluding Xxxxx’ interest in any Joint Collaboration Patent Rights, that (a) are Controlled by Ionis or its Affiliates as of the Original Effective Date or at any time during the Original Agreement Term or the Term, (b) are necessary
or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) to Exploit a Licensed Product, and (c) Cover Manufacturing Technology. A list
of Ionis Manufacturing and Analytical Patents as of the Restatement Date is set forth on Schedule 1.117 (Ionis Manufacturing and Analytical Patents); provided that, any Patent Right existing as of the Restatement Date that otherwise would be included in the definition of Ionis Manufacturing and Analytical Patent but is not included on Schedule 1.117 (Ionis Manufacturing and Analytical Patents) will still be considered an Ionis Manufacturing and Analytical Patent.
|
1.118 |
“Ionis Manufacturing and Analytical Technology” means Ionis Manufacturing and Analytical Know-How and Ionis Manufacturing and Analytical Patents.
|
1.119 |
“Ionis [***] Costs” has the meaning set forth in Section 4.4.4(c) (Otsuka Opt-In).
|
1.120 |
“Ionis [***] Development” has the meaning set forth in Section 4.4.4(b) ([***] by Xxxxx).
|
1.121 |
“Ionis [***]” means [***] generated by or on behalf of Ionis in the [***] in accordance with Section
4.4.4(b) ([***] by Xxxxx).
|
1.122 |
“Ionis Patent Rights” means the Ionis Core Technology Patents, Ionis Manufacturing and Analytical Patents, and Ionis Product-Specific Patents.
|
1.123 |
“Ionis Product-Specific Know-How” means, subject to Section 4.4.4(b) ([***] by Xxxxx), all Know-How, including Ionis Collaboration Know-How but excluding Ionis’
interest in any Joint Collaboration Know-How, that is (a) Controlled by Ionis or its Affiliates as of the Original Effective Date or at any time during the Original Agreement Term or the Term, (b) necessary or reasonably useful to
Exploit a Licensed Product in the Field, and (c) specifically relating to (i) the composition of matter of a Licensed Product or (ii) methods of using a Licensed Product for the Field; provided
however, Know-How that (i) consists of subject matter applicable to oligonucleotide compounds or products in general or (ii) relates to an oligonucleotide compound that does not specifically modulate expression of PKK via the
binding, partially or wholly, of such compound to RNA that encodes PKK, will not be considered Ionis Product-Specific Know-How, and in each case of (i) and (ii), such Know-How will be considered Ionis Core Technology Know-How.
|
1.124 |
“Ionis Product-Specific Patents” means, subject to Section 4.4.4(b) ([***] by Ionis), all Product-Specific Patents, excluding Ionis’ interest in any Joint
Collaboration Patent Rights, that are (a) Controlled by Ionis or its Affiliates as of the Original Effective Date or at any time during the Original Agreement Term or the Term and (b) necessary or reasonably useful (or, with respect
to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) to Exploit a Licensed Product; provided, however, that Patent Rights that include only claims that are directed to (i) subject matter applicable to oligonucleotide compounds or products in general or (ii) an oligonucleotide compound that does not
specifically modulate expression of PKK via the binding, partially or wholly, of such compound to RNA that encodes PKK, will not be considered Ionis Product-Specific Patents, and in each case of (i) and (ii), such Patent Rights will
be considered Ionis Core Technology Patents. A list of Ionis Product-Specific Patents as of the Restatement Date is set forth on Schedule 1.124 (Ionis Product-Specific Patents); provided that, any Patent Right existing as of the
Restatement Date that otherwise would be included in the definition of Ionis Product-Specific Patent but is not included on Schedule 1.124 (Ionis Product-Specific Patents) will
still be considered an Ionis Product-Specific Patent.
|
1.125 |
“Ionis Product-Specific Technology” means Ionis Product-Specific Know-How and Ionis Product-Specific Patents.
|
1.126 |
“Ionis Product Trademarks” has the meaning set forth in Section 10.10.1(c) (Ownership of Ionis Product Trademarks).
|
1.127 |
“Ionis Prosecuted Patent Rights” has the meaning set forth in Section 10.2.1(a) (Right to Prosecute).
|
1.128 |
“Ionis Publication” has the meaning set forth in Section 12.5.2 (Ionis’ Right to Publish).
|
1.129 |
“Ionis Regulatory Activities” has the meaning set forth in Section 5.1 (Regulatory Responsible Party).
|
1.130 |
“Ionis Technology” means the Ionis Know-How, the Ionis Patent Rights, and Xxxxx’ interest in the Joint Collaboration Technology.
|
1.131 |
“Ionis Territory” means worldwide, except for the Otsuka Territory.
|
1.132 |
“IRS” has the meaning set forth in Section 9.10.3 (Tax Cooperation).
|
1.133 |
“Joint Collaboration Know-How” means all Collaboration Know-How that is developed or invented jointly by a Party’s or its Affiliates’, licensees’, Sublicensees’, or
Subcontractors’ employees, agents, or independent contractors, or any Persons contractually required to assign or license such Collaboration Know-How to such Party or any Affiliate of such Party, on the one hand, and the other Party’s
or its Affiliates’, licensees’, Sublicensees’, or Subcontractors’ employees, agents, or independent contractors, or any Persons contractually required to assign or license such Collaboration Know-How to such Party or any Affiliate of
such Party, on the other hand.
|
1.134 |
“Joint Collaboration Patent Rights” means all Collaboration Patent Rights that Cover Joint Collaboration Know-How.
|
1.135 |
“Joint Collaboration Technology” means the Joint Collaboration Know-How and the Joint Collaboration Patent Rights.
|
1.136 |
“JSCs” has the meaning set forth in Section 8.2.1 (Formation and Purposes of the Joint Steering Committees) and “JSC” means the Europe JSC or the Asia JSC, as the case may be.
|
1.137 |
“Know-How” means proprietary Inventions, discoveries, trade secrets, materials, information, experience, data, formulas, procedures, technology, and results (whether or
not patentable), including practices, knowledge, know-how, experience and test data (including physical, chemical, biological, toxicological, pharmacological, clinical and
veterinary data), dosage regimens, assays, diagnostics, product specifications, manufacturing techniques and costs, analytical and quality control data and marketing, pricing and distribution costs, and sales practices, methods, data,
and descriptions.
|
1.138 |
“Knowledge” means the actual knowledge, without any inquiry or investigation, of (a) with respect to Ionis, its [***]; and (b) with respect to Otsuka, its [***].
|
1.139 |
“Licensed Compound” means the GaINAc-conjugated antisense oligonucleotide compound known as donidalorsen.
|
1.140 |
“Licensed Product” means any pharmaceutical product that contains, comprises, or incorporates the Licensed Compound, in all current and future formulations and in any
dosage strengths, presentations, or package configuration, and for any mode of administration. For clarity, any combination product comprised of an autoinjector pre-filled with the Licensed Compound is considered a Licensed Product.
All products containing or comprising the same Licensed Compound, regardless of the formulation, indication, line extension or otherwise, will be considered the same Licensed Product for all purposes of this Agreement.
|
1.141 |
“Local Unitary Product Trademark” has the meaning set forth in Section 10.10.1(a) (Unitary Product Trademarks).
|
1.142 |
“Losses” has the meaning set forth in Section 13.1 (Indemnification by Xxxxx).
|
1.143 |
“MAA” or “Marketing Authorization Application” means any (a) New Drug Application as defined in the FD&C
Act, (b) a marketing authorization application filed with (i) the EMA under the centralized EMA filing procedure to gain approval to market a biopharmaceutical in the E.U., or (ii) a Regulatory Authority in any country in the E.U. if
the centralized EMA filing procedure is not used to gain approval to market a biopharmaceutical in the E.U., or (c) a marketing authorization application filed with the PMDA in Japan, or (d) substantially similar application or
submission to those set forth in the foregoing clauses filed with a Regulatory Authority in a country or group of countries to obtain Regulatory Approval to Commercialize a biopharmaceutical or diagnostic product in that country or in
that group of countries, in each case ((a) through (d)), including any amendments thereto, and supplemental applications, but excluding Reimbursement Approval applications.
|
1.144 |
“MAA Acceptance” means, with respect to a Marketing Authorization Application filed for a Licensed Product, the receipt of written notice of acceptance by the EMA of such
Marketing Authorization Application for filing under the centralized filing procedure.
|
1.145 |
“[***]” means, [***].
|
1.146 |
“[***]” means, [***].
|
1.147 |
“Manufacture” means activities directed to manufacturing, processing, packaging, labeling, filling, finishing, assembly, quality assurance, quality control, testing, and
release, shipping, or storage of any pharmaceutical or biologic product (or any components or process steps involving any product or any companion diagnostic), placebo, or comparator agent, as the case may be, including qualification,
validation, and scale-up, pre-clinical, clinical, and commercial manufacture and analytic development, product characterization, and stability testing, but excluding activities directed to Development, or Commercialization. “Manufacturing” and “Manufactured” will be construed accordingly.
|
1.148 |
“Manufacturing Costs” means, with respect to a Licensed Product [***].
|
1.149 |
“Manufacturing Handover Date” has the meaning set forth in Section 7.1.2 (Otsuka Manufacturing).
|
1.150 |
“Manufacturing Handover Notice” has the meaning set forth in Section 7.1.2 (Otsuka Manufacturing).
|
1.151 |
“Manufacturing Technology” means any or all of (a) methods or materials used in the synthesis or analysis of an oligonucleotide or a Licensed Product regardless of
sequence or chemical modification, (b) methods of manufacturing components of an oligonucleotide, and (c) methods or materials used in Manufacturing a Licensed Product.
|
1.152 |
“Manufacturing Technology Transfer” has the meaning set forth in Section 7.4 (Manufacturing Technology Transfer).
|
1.153 |
“Manufacturing Technology Transfer Agreement” has the meaning set forth in Section 7.4 (Manufacturing Technology Transfer).
|
1.154 |
“Medical Affairs” means activities conducted by a Party’s medical affairs department (or, if a Party does not have a medical affairs department, the equivalent function
thereof), including real world evidence, communications with key opinion leaders, continuing medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), activities performed in
connection with patient registries, review and approval of materials consistent with a Party’s or its Affiliate’s internal SOPs and Applicable Law, interactions and engagements with patient advocacy groups and other key stakeholders,
and other similar medical programs and communications.
|
1.155 |
“Milestone Events” means the Regulatory Milestone Events and the Sales Milestone Events.
|
1.156 |
“Milestone Payments” means the Regulatory Milestone Payments and the Sales Milestone Payments.
|
1.157 |
“[***]” has the meaning set forth in Section 2.7.2(a) (Acquisition of Potential In-Licenses).
|
1.158 |
“Net Sales” means, with respect to any Licensed Product, the amount invoiced by Otsuka or its Affiliates or Sublicensees (each a “Selling Party”) for sales of such Licensed Product in arm’s length transactions to Third Parties in all countries in the Otsuka Territory, less deduction (if not already deducted in the amount invoiced)
of the following items with respect to sales of such Licensed Product:
|
(a) |
Normal and customary trade, quantity, or cash discounts to non-affiliated brokers, agents or customers to the extent actually allowed and taken, provided that such discounts are not applied
disproportionately to the Licensed Products when compared to the other products of the Selling Party, as applicable;
|
(b) |
Actual amounts repaid or credited by reason of rejections, returns, defects, price adjustments, billing errors, or trial prescriptions, including amounts repaid, discounted or credited by reason of risk sharing schemes with respect
to the Licensed Product with any Governmental Authority;
|
(c) |
To the extent separately stated on purchase orders, invoices, or other documents of sale, any taxes, tariffs, duties, excises or other governmental charges (including any value added tax, sales tax, consumption tax or similar tax,
other than any taxes based on income) imposed or levied on the production, sale, transportation, delivery, or use, exportation or importation of the Licensed Products;
|
(d) |
Rebates, reimbursements, fees, clawbacks, discounts or chargeback payments paid, granted or credited to managed health care organizations, pharmacy
benefit managers (or equivalent thereof), national, state/provincial, local, and other governments or Governmental Authorities, their agencies/purchasers/reimbursement providers (including those requested by any Governmental Authority
any time after the actual sale of a Licensed Product), or to any Third Party payor, administrator, contractee or purchaser, including trade customers, including any fees levied by any Governmental Authority as a result of healthcare
reform policies, and including those offered as a result of the clinical or real-world performance of the Licensed Product after it is marketed and sold;
|
(e) |
Outbound transportation costs prepaid or allowed and costs of insurance in transit, with the exclusion of storage and warehousing costs;
|
(f) |
Any invoiced amounts that are not collected, including bad debts; and
|
(g) |
Any other deductions that are consistent with the Selling Party’s Accounting Standards and are not duplicative of the above deductions;
|
provided that the following deductions are not allowed in the calculation of Net Sales: (i) co-payment assistance; (ii) discounts offered to insurers
to facilitate patient access to the product; (iii) program and data management fees paid to wholesalers/distributors; (iv) commissions paid to third-party logistics (3PL) providers; and (v) product samples shipped to indirect customers.
If a Selling Party makes any adjustments to such deductions after the associated Net Sales have been reported pursuant to this Agreement, then the adjustments will be
reported and reconciled with the next report and payment of any royalties due.
Net Sales will not include (i) any payments among Selling Parties, unless such paying party is the end user of the relevant Licensed Product, (ii) any payments in
consideration of supplies of the applicable Licensed Product for use in Clinical Trials, or (iii) payments for promotional samples, compassionate use, named-patient use, or expanded access, indigent or other patient access programs, in each
case when sold or distributed at or below the applicable Selling Party’s costs (including supply price paid).
If a Selling Party sells a Licensed Product in the Otsuka Territory as part of a therapy or product in combination with other pharmaceutical or biologic products,
diagnostic products, ingredients, delivery devices or other components other than the Licensed Compound (each, an “Other Product”) whether combined in a single formulation or
package, formulated or packaged separately but sold under a single label approved by a Regulatory Authority, packaged together for sale or shipment as a single unit, or marketed or sold collectively as a single product, but, in all cases,
sold together for a single price (a “Combination Product”), Net Sales of such Combination Product for the purposes of determining payments based on Net Sales hereunder will be
calculated by multiplying actual Net Sales of such Combination Product as determined in the first paragraph of this Net Sales definition (“Combination Product Net Sales”) by the
fraction A/(A+B) where A is the average selling price of the Licensed Compound sold separately in such country during the applicable reporting period, and B is the sum of the average selling price(s) of the Other Product(s) in the Combination
Product in such country during the same reporting period. If the Licensed Compound is sold separately in an applicable reporting period in a country in the Otsuka Territory, but the Other Product(s) are not sold separately in the same country
in the same reporting period, then Net Sales of such Combination Product will be calculated by multiplying the Combination Product Net Sales by the fraction A/C where A is the average selling price of the Licensed Compound sold separately in
such country during such reporting period, and C is the average selling price of the Combination Product in such country during such reporting period. If neither the Licensed Compound nor the Other Product(s) are sold separately in the same
country in the same reporting period, then Net Sales of such Combination Product will be calculated by multiplying the Combination Product Net Sales by a fraction that reflects the value of the Licensed Compound relative to the value of the
Other Product(s) in such Combination Product, which fraction shall be determined by Otsuka in its reasonable judgment, and reasonably acceptable to Ionis, and in such event, Otsuka shall provide Ionis with supporting documentation for such
determination. Notwithstanding the foregoing, the Parties agree that the Licensed Product Manufactured and supplied by Ionis pursuant to the Supply Agreements in the form of an autoinjector pre-filled with Licensed Compound will not be
subject to the terms of this paragraph, and such autoinjector will not be deemed an Other Product for purposes of calculating Net Sales.
1.159 |
“[***]” has the meaning set forth in Section 4.4.4(a) (Shared Costs).
|
1.160 |
“[***]” has the meaning set forth in Section 4.4.4(a) (Shared Costs).
|
1.161 |
“Non-Clinical Asia HAE Development Plan” has the meaning set forth in Section 4.2.2(b) (Asia Territory).
|
1.162 |
“Non-Clinical Europe HAE Development Plan” has the meaning set forth in Section 4.2.2(a) (Europe Territory).
|
1.163 |
“Non-Clinical HAE Development Plans” means the Non-Clinical Asia HAE Development Plan and the Non-Clinical Europe HAE Development Plan.
|
1.164 |
“OFAC” means the Office of Foreign Assets Control of the United States Department of the Treasury or any successor agency thereto.
|
1.165 |
“Ongoing Cross-Territory Studies” has the meaning set forth in Section 4.2.1 (Cross-Territory Clinical Development Plan).
|
1.166 |
“Opt-In Fee” has the meaning set forth in Section 4.4.4(c) (Otsuka Opt-In).
|
1.167 |
“Opt-In Notice” has the meaning set forth in Section 4.4.4(c) (Otsuka Opt-In).
|
1.168 |
“Original Agreement” has the meaning set forth in the Recitals.
|
1.169 |
“Original Agreement Term” means the period of time commencing on the Original Effective Date and continuing until the Restatement Date.
|
1.170 |
“Original Effective Date” has the meaning set forth in the Recitals.
|
1.171 |
“Other Covered Party” means any political party or party official, or any candidate for political office.
|
1.172 |
“[***]” has the meaning set forth in Section 2.7.2(c) ([***] Potential In-Licenses).
|
1.173 |
“Other Product” has the meaning set forth in Section 1.158 of this Appendix 1 (Definitions).
|
1.174 |
“Otsuka Collaboration Know-How” has the meaning set forth in Section 10.1.2(b) (Ownership of Arising Intellectual Property).
|
1.175 |
“Otsuka Collaboration Patent Rights” has the meaning set forth in Section 10.1.2(b) (Ownership of Arising Intellectual Property).
|
1.176 |
“Otsuka Indemnitee” has the meaning set forth in Section 13.1 (Indemnification by Xxxxx).
|
1.177 |
“Otsuka Know-How” means all Collaboration Know-How (excluding Otsuka’s interest in Joint Collaboration Know-How) that is (a) Controlled by Otsuka or any of its Affiliates
during the Term and (b) necessary or reasonably useful to Exploit a Licensed Product.
|
1.178 |
“Otsuka Patent Rights” means all Collaboration Patent Rights (excluding Otsuka’s interest in Joint Collaboration Patent Rights) that are (a) Controlled by Otsuka or any of
its Affiliates during the Term and (b) necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) to Exploit a Licensed
Product.
|
1.179 |
“Otsuka Product Trademarks” has the meaning set forth in Section 10.10.1(b) (Ownership of Otsuka Product Trademarks).
|
1.180 |
“Otsuka Publication” has the meaning set forth in Section 12.5.1 (Otsuka’s Right to Publish).
|
1.181 |
“Otsuka Technology” means Otsuka Know-How, Otsuka Patent Rights, and Otsuka’s interest in the Joint Collaboration Technology.
|
1.182 |
“Otsuka Territory” means the Asia Territory and the Europe Territory.
|
1.183 |
“Otsuka Territory Brand Strategy” has the meaning set forth in Section 6.4.2 (Otsuka Territory Brand Strategy and Commercialization Operating Plans).
|
1.184 |
“Otsuka Territory Commercialization Operating Plans” has the meaning set forth in Section 6.4.2 (Otsuka Territory Brand Strategy and Commercialization Operating
Plans).
|
1.185 |
“Otsuka Territory Medical Affairs Plans” has the meaning set forth in Section 6.6.2 (Otsuka Territory Medical Affairs Plans).
|
1.186 |
“Otsuka Territory-Specific Development Plans” has the meaning set forth in Section 4.3.2 (Asia Territory-Specific Development Plan).
|
1.187 |
“Otsuka Territory Trademark Infringement” has the meaning set forth in Section 10.10.4(a) (Unitary Product Trademark).
|
1.188 |
“Packaging and Labeling” means primary, secondary, or tertiary packaging and labeling of a Licensed Product (in its commercial packaging presentation) for sale or use in a
country, including the Approved Labeling and insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed, or graphic materials accompanying such Licensed Product
and any brand security or anti-counterfeiting measures included in the packaging elements for such Licensed Product considered to be part of the finished packaged Licensed Product, and all testing and release thereof.
|
1.189 |
“Party Vote” has the meaning set forth in Section 8.5.1 (General Decision-Making Process).
|
1.190 |
“Patent Challenge” means, with respect to a Person, that such Person contests or assists a Third Party in contesting the scope, validity, or enforceability of a Patent
Right or any foreign counterpart thereof anywhere in the world in any court, tribunal, arbitration proceeding, or other proceeding, including the U.S. Patent and Trademark Office and the U.S. International Trade Commission. A Patent
Challenge includes: (a) filing an action under 28 U.S.C. §§ 2201-2202 seeking a declaration of invalidity or unenforceability of any such Patent Right; (b) filing, or joining in, a petition under 35 U.S.C. § 311 to institute inter partes review of any such Patent Right; (c) filing, or joining in, a petition under 35 U.S.C. § 321 to institute post-grant review of any such Patent Right or any portion thereof; (d) filing
or commencing any opposition, nullity, or similar proceedings challenging the validity of any such Patent Right in the Territory; or (e) any foreign equivalent of clauses (a), (b), (c), or (d), including any proceeding in any country
or patent office in any country or region in the Otsuka Territory.
|
1.191 |
“Patent Prosecution” means activities directed to (a) preparing, filing, and prosecuting applications (of all types) for any Patent Right, (b) maintaining any Patent
Right, and (c) deciding whether to abandon or maintain any Patent Right.
|
1.192 |
“Patent Rights” means (a) all patents, patent applications, and utility models in any country or jurisdiction, including provisional applications, priority applications,
and international applications, (b) all patent applications filed either from such patents or patent applications or from an application claiming priority from any of these, including divisionals, continuations, and
continuations-in-part, (c) any and all patents that have issued or in the future issue from the foregoing patent applications, (d) any and all substitutions, renewals, registrations, confirmations, revalidations, reissues, and
re-examinations of the foregoing patents or patent applications, and (e) extensions, restorations, supplemental protection certificates, and the like based on any of the foregoing patents or patent applications.
|
1.193 |
“Payment Assignment” has the meaning set forth in Section 16.1 (Assignment).
|
1.194 |
“Payment Forms” means one copy of each of the following documents which, at the time Ionis provides such documents to Otsuka, must be currently effective (un-expired),
completed and signed: the United States Internal Revenue Service Form 6166 (United States Residency Certification) as received from the United States Internal Revenue Service; Form 3 (Application Form for Income Tax Convention); and
Form 17 (Attachment Form for Limitation on Benefits Article).
|
1.195 |
“Person” means any corporation, limited or general partnership, limited liability company, joint venture, trust, unincorporated association, governmental body, authority,
bureau, or agency, or any other entity or body, or an individual.
|
1.196 |
“Pharmacovigilance Agreement” means an agreement regarding receipt, investigation, and reporting of product complaints, adverse events, product recalls, and any other
information related to the safety of the Licensed Products in the Territory.
|
1.197 |
“Phase 3 Clinical Trial” means a Clinical Trial of a Licensed Product that satisfies the requirements for a Phase 3 study as defined in 21 CFR § 312.21(c) (or any amended
or successor regulations) or that satisfies the requirements of similar laws or regulations outside the United States.
|
1.198 |
“[***]” means the [***].
|
1.199 |
“PMDA” means the Pharmaceuticals and Medical Devices Agency or any successor agency thereto.
|
1.200 |
“Post-Approval Cross-Territory Mandatory Studies” has the meaning set forth in Section 4.2.1 (Cross-Territory Clinical Development Plan).
|
1.201 |
“Post-Approval Mandatory Study” means any Clinical Trial or other study of a pharmaceutical or biologic product initiated following receipt of Regulatory Approval or to be
conducted after receipt of Regulatory Approval, in each case, that was mandated by the applicable Regulatory Authority in any country in the Territory as a condition of receiving or maintaining a Regulatory Approval for a product with
respect to a particular indication in such country (such as post-marketing approval studies and observational studies, if required by any Regulatory Authority in any country in the Territory to support or maintain Regulatory Approval
for a product in such country) or that is required for a label extension for a product in such country. For clarity, a [***] is a Post-Approval Mandatory Study.
|
1.202 |
“Potential In-License” has the meaning set forth in Section 2.7.2(a) (Acquisition of Potential In-Licenses).
|
1.203 |
“Product Materials” has the meaning set forth in Section 6.8 (Product Materials).
|
1.204 |
“Product-Specific Patents” means Patent Rights Controlled by a Party or any of its Affiliates as of or after the Original Effective Date claiming: (a) the composition of
matter of a Licensed Product, or (b) methods of using a Licensed Product.
|
1.205 |
“Professional Requirements” means (a) the codes and standards of the European Accreditation Council for Continuing Medical Education (EACCME) and the European Federation
of Pharmaceutical Industries and Associations (EFPIA), (b) the codes of the Prescription Medicines Code of Practice Authority (PMCPA) and the Association of the British Pharmaceutical Industry (ABPI), (c) FDA’s regulations, guidance,
and enforcement letters concerning the advertising of prescription drug products, (d) the American Medical Association’s Guidelines on Gifts to Physicians from Industry, (e) the Accreditation Council for Continuing Medical Education
(ACCME) Standards for Commercial Support of Continuing Medical Education, (f) the Pharmaceutical Supply Chain Initiative (PSCI) and Pharmaceutical Industry Principles for Responsible Supply Chain Management, (g) the Code on
Interactions with Healthcare Professionals promulgated by the Pharmaceutical Research and Manufacturers of America (PhRMA Code), (h) the Department of Health and Human Services Office of Inspector General Compliance Program Guidance
for Pharmaceutical Manufacturers (OIG Compliance Guidance), and (i) all other accepted national and international pharmaceutical industry codes of practice in and for the relevant countries in the Territory, as any of the foregoing
may be amended from time-to-time.
|
1.206 |
“Publication” has the meaning set forth in Section 12.5 (Publications).
|
1.207 |
“PV Subcommittee” has the meaning set forth in Section 5.11 (Pharmacovigilance Subcommittee).
|
1.208 |
“[***]” means [***].
|
1.209 |
“Quality Agreement” has the meaning set forth in Section 7.2.3 (Quality Agreements).
|
1.210 |
“Receiving Party” has the meaning set forth in Section 1.39 (Confidential Information) of this Appendix 1 (Definitions).
|
1.211 |
“Reduced Royalties” has the meaning set forth in Section 9.3.3 (Reduced Royalty Term).
|
1.212 |
“Reduced Royalty Term” has the meaning set forth in Section 9.3.3 (Reduced Royalty Term).
|
1.213 |
“[***]” has the meaning set forth in Section 9.3.2(c) ([***]).
|
1.214 |
“Region” means each of the (a) Asia Territory and (b) the Europe Territory.
|
1.215 |
“Regulatory Approval” means, with respect to a particular country or other regulatory jurisdiction, any approval of an MAA or other approval, product, or establishment
license, registration, or authorization of any Regulatory Authority necessary for the commercial sale of a pharmaceutical, diagnostic, or biologic product in such country or other regulatory jurisdiction, excluding, in each case,
Reimbursement Approval.
|
1.216 |
“Regulatory Authority” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or
jurisdiction, including (a) in the U.S., the FDA and any other applicable Governmental Authority in the U.S. having jurisdiction over any pharmaceutical, diagnostic, or biologic product, (b) in the E.U., the EMA and any other
applicable Governmental Authority in the E.U. having jurisdiction over any pharmaceutical, diagnostic, or biologic product, (c) in Japan, the PMDA and any other applicable Governmental Authority in Japan having jurisdiction over any
pharmaceutical, diagnostic, or biologic product, and (d) in other countries, other analogous Governmental Authorities having jurisdiction over any pharmaceutical, diagnostic, or biologic product.
|
1.217 |
“Regulatory Exclusivity” means, with respect to a Licensed Product in a country in the Otsuka Territory, the period of time during which: (a) Otsuka or its Affiliate or
Sublicensee has been granted the exclusive legal right by a Regulatory Authority (or is otherwise entitled to the exclusive legal right by operation of Applicable Law) in such country to market and sell such Licensed Product, and such
right precludes a Third Party from making such Licensed Product available for purchase for any indication; or (b) the data and information submitted by Otsuka or its Affiliate or Sublicensee to the relevant Regulatory Authority in
such country for purposes of obtaining Regulatory Approval of such Licensed Product may not be referenced, or relied upon in any way by a Third Party or such Regulatory Authority to support the Regulatory Approval or marketing of any
product by a Third Party in such country, or if such data and information is referenced, or relied upon to support a Regulatory Approval granted to a Third Party in such country, the product may not be placed on the market for any
indication.
|
1.218 |
“Regulatory Milestone Events” has the meaning set forth in Section 9.2.1 (Regulatory Milestones).
|
1.219 |
“Regulatory Milestone Payments” has the meaning set forth in Section 9.2.1 (Regulatory Milestones).
|
1.220 |
“Regulatory Responsible Party” means the Party designated under Section 5.1 (Regulatory Responsible Party).
|
1.221 |
“Regulatory Submission” means any filing, application, or submission with any Regulatory Authority in support of the Development, Manufacture, Commercialization, or other
Exploitation of a pharmaceutical, diagnostic, or biologic product (including to obtain, support, or maintain Regulatory Approval from that Regulatory Authority), and all written or electronic correspondence or communication with or
from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences, or discussions with the relevant Regulatory Authority. Regulatory Submissions include all INDs, XXXx, and other applications
for Regulatory Approval and their equivalents.
|
1.222 |
“Regulatory Support” has the meaning set forth in Section 5.6 (Cooperation).
|
1.223 |
“Reimbursed Manufacturing Tech Transfer Costs” has the meaning set forth in Section 7.4 (Manufacturing Technology Transfer).
|
1.224 |
“Reimbursement Approval” means, as applicable, (a) the Governmental Authority approval, agreement, determination, or other decision establishing prices that can be charged
for a product in regulatory jurisdictions where the applicable Governmental Authority approves or determines the prices charged to end-users for pharmaceutical, diagnostic, or biologic products, or (b) the Governmental Authority
approval, agreement, determination or decision establishing the prices at which a product will be reimbursed in regulatory jurisdictions where the applicable Governmental Authority approves, determines or recommends the reimbursement
or use of pharmaceutical, diagnostic, or biologic products.
|
1.225 |
“Remedial Action” has the meaning set forth in Section 5.13.1 (Notification and Determination).
|
1.226 |
“Representatives” means, with respect to a Person, such Person’s employees, officers, directors, consultants, contractors, Subcontractors, and agents, in each case, who
are authorized to act on behalf of such Person.
|
1.227 |
“Requested Assistance” has the meaning set forth in Section 3.2 (Technology Transfer Costs).
|
1.228 |
“Restatement Date” has the meaning set forth in the Preamble.
|
1.229 |
“Restatement Upfront Payment” has the meaning set forth in Section 9.1 (Upfront Payment).
|
1.230 |
“Restricted Party” means any individual or entity on one or more of the Restricted Party Lists.
|
1.231 |
“Restricted Party List” means the list of sanctioned entities maintained by the United Nations; the Specially Designated Nationals and Blocked Persons List, the Foreign
Sanctions Evaders List and the Sectoral Sanctions Identifications List, all administered by OFAC; the U.S. Denied Persons List, the U.S. Entity List, and the U.S. Unverified List, all administered by the U.S. Department of Commerce;
and the entities subject to restrictive measures and the consolidated list of Persons, Groups, and Entities Subject to E.U. Financial Sanctions, as implemented by the E.U. Common Foreign & Security Policy; and similar lists of
restricted parties maintained by the Governmental Authorities of the countries that have jurisdiction over the activities conducted under this Agreement.
|
1.232 |
“Reversion License” has the meaning set forth in Section 14.9.2(a) (License Grant).
|
1.233 |
“Review Period” has the meaning set forth in Section 12.5.1 (Otsuka’s Right to Publish).
|
1.234 |
“ROFN Exercise Notice” has the meaning set forth in Section 2.8.1 (ROFN Exercise).
|
1.235 |
“ROFN Negotiation Period” has the meaning set forth in Section 2.8.2 (Negotiation).
|
1.236 |
“ROFN Notice and Package” has the meaning set forth in Section 2.8.1 (ROFN Exercise).
|
1.237 |
“ROFN Territory” has the meaning set forth in Section 2.8.1 (ROFN Exercise).
|
1.238 |
“Royalties” has the meaning set forth in Section 9.3.3 (Reduced Royalty Term).
|
1.239 |
“Royalty Report” has the meaning set forth in Section 9.3.4(b) (Royalty Report).
|
1.240 |
“Royalty Term” has the meaning set forth in Section 9.3.3 (Reduced Royalty Term).
|
1.241 |
“[***]” has the meaning set forth in Section 9.3.1 (Royalty Payments During the Initial Royalty Term).
|
1.242 |
“Rules” has the meaning set forth in Section 15.2.2 (Arbitration).
|
1.243 |
“Sales Milestone Events” has the meaning set forth in Section 9.2.2 (Sales Milestones).
|
1.244 |
“Sales Milestone Payments” has the meaning set forth in Section 9.2.2 (Sales Milestones).
|
1.245 |
“Selling Party” has the meaning set forth in Section 1.158 of this Appendix 1 (Definitions).
|
1.246 |
“[***]” has the meaning [set forth in Section 4.4.1(c) (Shared Development Costs)].
|
1.247 |
“Shared Cross-Territory Development Costs” has the meaning set forth in Section 4.4.1(c) (Shared Development Costs).
|
1.248 |
“Shared Development Budget” has the meaning set forth in Section 4.4.2(a) (Shared Development Budget).
|
1.249 |
“Subcommittee” has the meaning set forth in Section 8.3.1 (Formation; Authority).
|
1.250 |
“Subcommittee Co-Chairperson” has the meaning set forth in Section 8.3.2 (Subcommittee Leadership and Meetings).
|
1.251 |
“Subcontractors” has the meaning set forth in Section 2.3.2 (Right to Subcontract).
|
1.252 |
“Sublicensee” means, with respect to a Party, any Third Party to which such Party or its Affiliate grants a sublicense under any of the rights licensed to the applicable
Party under this Agreement other than a Subcontractor.
|
1.253 |
“Supply Agreements” has the meaning set forth in Section 7.2.2 (Commercial Supply Agreement).
|
1.254 |
“Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of
any nature (including any interest thereon), including value add, sales, excise or similar taxes.
|
1.255 |
“Technology Transfer” has the meaning set forth in Section 3.1 (Initial Know-How Transfer).
|
1.256 |
“Term” has the meaning set forth in Section 14.1 (Term).
|
1.257 |
“Terminated Region” means (a) any Region pursuant to which the non-breaching Party terminates this Agreement pursuant to Section 14.2 (Termination for Material
Breach), (b) the Europe Territory, the Asia Territory, or any country other than Japan in the Asia Territory, in each case, for which Otsuka terminates this Agreement pursuant to Section 14.3 (Termination by Otsuka for
Convenience), or (c) all countries in the Territory if either Party terminates this Agreement in its entirety pursuant to Section 14.2 (Termination for Material Breach), Section 14.4 (Discontinuation of Development and
Commercialization), Section 14.5 (Termination for Patent Challenge), or Section 14.6 (Termination for Insolvency).
|
1.258 |
“Territory” means (a) the Otsuka Territory, with respect to Otsuka, (b) the Ionis Territory, with respect to Ionis, and (c) collectively, worldwide.
|
1.259 |
“Third Party” means any Person other than a Party or its Affiliates.
|
1.260 |
“Third Party Claims” has the meaning set forth in Section 13.1 (Indemnification by Xxxxx).
|
1.261 |
“[***]” has the meaning set forth in Section 2.8.2 (Negotiation).
|
1.262 |
“Third Party Patent Challenge” has the meaning set forth in Section 10.4 (Defense of Third Party Patent Challenges).
|
1.263 |
“Third Party Payments” means, with respect to a Licensed Product, any (a) payments (including upfront payments, milestone payments, license fees, royalties and monetary
damages) made by Otsuka or its Affiliate to a Third Party (i) pursuant to an agreement between Otsuka or its Affiliate and such Third Party entered into following the Original Effective Date in accordance with Section 2.7.2
(Potential In-Licenses) to obtain rights to Patent Rights or Know-How from such Third Party that would be infringed or misappropriated by the Exploitation of a Licensed Product in the Otsuka Territory or (ii) pursuant to an agreement
between Otsuka or its Affiliate and such Third Party, or otherwise, as part of a settlement or to satisfy a judgment in accordance with Section 10.5.3 (Settlement), or (b) amounts for which Otsuka reimburses Ionis under a
Collaboration In-License, in each case ((a) or (b)), that are directly in consideration for or reasonably allocable to a license or sublicense (as applicable) to Otsuka or its Affiliate under, or are paid in settlement or to satisfy a
judgment of a claim relating to, Patent Rights or Know-How Controlled by such Third Party that would, but for a license thereunder, be infringed or misappropriated by the Exploitation of such Licensed Product.
|
1.264 |
“Trademark” means any word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand
name, domain name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design or business symbol, that functions as an identifier of source or origin,
whether or not registered and all statutory and common law rights therein and all registrations and applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.
|
1.265 |
“Trademark Infringement Suit” has the meaning set forth in Section 10.10.5(a) (Unitary Product Trademarks).
|
1.266 |
“Transition Plan” has the meaning set forth in Section 14.9.3(a) (Scope).
|
1.267 |
“Transition Services” has the meaning set forth in Section 14.9.3(a) (Scope).
|
1.268 |
“Unitary Product Trademark” has the meaning set forth in Section 10.10.1(a) (Unitary Product Trademarks).
|
1.269 |
“U.S.” means the United States of America (including all possessions and territories thereof, including Puerto Rico).
|
1.270 |
“U.S. Dollars” or “$” means the legal tender of the U.S.
|
1.271 |
“Valid Claim” means a claim of an issued and unexpired patent (as may be adjusted through a patent term adjustment or extended through supplementary protection certificate
or patent term extension or the like) that has not been revoked, held invalid, or held unenforceable by a patent office or other Governmental Authority of competent jurisdiction in a final and non-appealable judgment (or judgment from
which no appeal was taken within the allowable time period), and [***].
|
1.272 |
“Withheld Amount” has the meaning set forth in Section 9.10.2 (Withholding Tax).
|
CONFIDENTIAL
Schedule 1.69
Existing Third-Party IP Agreements
[***]
CONFIDENTIAL
Schedule 1.111
Ionis Core Technology Patents
Ionis File No.
|
Country/Treaty
|
Application No./
Patent No.
|
Filing Date
|
Grant Date
|
Title
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
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[***]
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[***]
|
[***]
|
CONFIDENTIAL
Schedule 1.117
Ionis Manufacturing and Analytical Patents
Ionis File No.
|
Country
|
Application No./
Patent No.
|
Filing Date
|
Grant Date
|
Title
|
[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
|
|
[***]
|
CONFIDENTIAL
Schedule 1.124
Ionis Product-Specific Patents
Ionis File No.
|
Country/
Treaty
|
Status
|
Application No./
Patent No.
|
Filing Date
|
Grant Date
|
Title
|
[***]
|
[***]
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[***]
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[***]
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[***]
|
[***]
|
Ionis File No.
|
Country/
Treaty
|
Status
|
Application No./
Patent No.
|
Filing Date
|
Grant Date
|
Title
|
[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
|
[***] | [***] | [***] | [***] | [***] | [***] |
Ionis File No.
|
Country/
Treaty
|
Status
|
Application No./
Patent No.
|
Filing Date
|
Grant Date
|
Title
|
[***]
|
[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
|
[***]
|
Ionis File No.
|
Country/
Treaty
|
Status
|
Application No./
Patent No.
|
Filing Date
|
Grant Date
|
Title
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
CONFIDENTIAL
Schedule 4.2.1
Cross-Territory Clinical Development Plan
[***]
CONFIDENTIAL
Schedule 4.2.2
Non-Clinical Europe HAE Development Plan
[***]
CONFIDENTIAL
Schedule 4.4.2
Shared Development Budget
[***]
Schedule 14.9.3
Transition Services
[***]