COLLABORATION AND LICENSE AGREEMENT
between
NOVO NORDISK A/S
and
SEPTERNA, INC.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SEPTERNA, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO SEPTERNA, INC. IF PUBLICLY DISCLOSED.
COLLABORATION AND LICENSE AGREEMENT
between
NOVO NORDISK A/S
and
SEPTERNA, INC.
Table of Contents
1. |
DEFINITIONS |
1 |
2. |
RESEARCH AND DEVELOPMENT PROGRAMS; TECH TRANSFER |
32 |
2.1 |
R&D Overview and Purpose |
32 |
2.2 |
R&D Collaboration Term |
32 |
2.3 |
R&D Plans and Budgets |
33 |
2.4 |
R&D Program Stages |
34 |
2.5 |
Reports |
36 |
2.6 |
New R&D Programs. |
37 |
2.7 |
Technology Transfer |
38 |
2.8 |
Materials Transfer |
38 |
2.9 |
R&D Program Costs |
39 |
2.10 |
Standards Applicable to the R&D Programs |
40 |
3. |
DEVELOPMENT; COMMERCIALIZATION; MANUFACTURING; SEPTERNA PROFIT SHARE OPTION |
41 |
3.1 |
Development by Novo Nordisk |
41 |
3.2 |
Commercialization by Novo Nordisk |
46 |
3.3 |
Manufacture and Supply |
46 |
3.4 |
Manufacturing Technology and Material Transfer |
47 |
3.5 |
Septerna Manufacturing Support |
48 |
3.6 |
Septerna Profit Share Option |
48 |
4. |
REGULATORY MATTERS |
54 |
4.1 |
Regulatory Decision Power |
54 |
4.2 |
Assistance |
54 |
4.3 |
Adverse Event Reporting |
54 |
4.4 |
Recalls, Suspensions or Withdrawals |
55 |
5. |
RECORDS |
55 |
5.1 |
Development Records – Maintenance |
55 |
5.2 |
Recordkeeping – Duration |
55 |
5.3 |
Development Records – Inspections |
55 |
5.4 |
[***] – Audits |
56 |
5.5 |
Information Security |
56 |
6. |
EXCLUSIVITY |
57 |
6.1 |
Collaboration Target Exclusivity |
57 |
6.2 |
[***]; [***] |
58 |
1
6.3 |
Change of Control Exceptions |
61 |
6.4 |
Acquired Programs |
63 |
6.5 |
Acknowledgement |
63 |
6.6 |
Novo Restrictions |
63 |
7. |
GOVERNANCE |
64 |
7.1 |
Joint Steering Committee |
64 |
7.2 |
Membership |
64 |
7.3 |
Alliance Managers |
65 |
7.4 |
Discontinuation of JSC |
65 |
7.5 |
Joint Profit Share Committee |
65 |
7.6 |
Scientific Project Leaders |
65 |
7.7 |
JSC Meetings |
66 |
7.8 |
Emergency JSC Meetings |
66 |
7.9 |
JSC Meetings – Agenda |
66 |
7.10 |
JSC Minutes |
66 |
7.11 |
JSC Responsibilities |
66 |
7.12 |
Subcommittees |
68 |
7.13 |
Quorum and Decision Making |
68 |
7.14 |
JSC Cannot Reach Agreement |
68 |
7.15 |
Alternatives to Meeting |
69 |
8. |
LICENSE GRANT |
69 |
8.1 |
Research License |
69 |
8.2 |
Licenses to Novo Nordisk |
70 |
8.3 |
Sublicenses |
70 |
8.4 |
Right to Subcontract |
71 |
8.5 |
No Implied Licenses |
71 |
9. |
FINANCIAL PROVISIONS |
72 |
9.1 |
Upfront Payment |
72 |
9.2 |
Milestone Payments |
72 |
9.3 |
Royalty Rate |
78 |
9.4 |
Royalty Term |
79 |
9.5 |
Payment Step-Downs |
79 |
9.6 |
Septerna Third Party Payments |
82 |
9.7 |
Research Funding |
82 |
9.8 |
Other Costs |
83 |
9.9 |
Payment Terms |
83 |
9.10 |
Mode of Payment |
83 |
9.11 |
Royalty Reports and Payments |
83 |
9.12 |
Profit & Loss Share for the Profit Share Product |
83 |
9.13 |
Audit Right |
84 |
9.14 |
Taxes |
85 |
2
9.15 |
Reimbursement |
87 |
10. |
INTELLECTUAL PROPERTY |
87 |
10.1 |
Disclosure of R&D Plan Inventions |
87 |
10.2 |
Inventorship |
87 |
10.3 |
Ownership |
88 |
10.4 |
Patent Prosecution and Maintenance |
90 |
10.5 |
Enforcement of Patents |
93 |
10.6 |
Infringement of Third Party Rights in the Territory |
95 |
10.7 |
Other Invalidity or Unenforceability Proceedings |
97 |
10.8 |
Orange Book Listing |
98 |
10.9 |
Cost and Expenses |
98 |
11. |
REPRESENTATIONS, WARRANTIES AND COVENANTS |
98 |
11.1 |
Mutual Representations and Warranties |
98 |
11.2 |
Additional Representations and Warranties by Septerna |
99 |
11.3 |
Additional Disclosures |
103 |
11.4 |
Covenants by Septerna |
105 |
11.5 |
No Other Representations and Warranties |
107 |
11.6 |
Antitrust Clearance |
107 |
12. |
INDEMNIFICATION AND LIMITATION OF LIABILITY |
108 |
12.1 |
Indemnification by Novo Nordisk |
108 |
12.2 |
Indemnification by Septerna |
109 |
12.3 |
Indemnification Procedure |
109 |
12.4 |
Third Party Claims for Profit Share Products |
111 |
12.5 |
Effect of Investigation |
111 |
12.6 |
Insurance |
111 |
12.7 |
Limitation of Liability |
112 |
13. |
CONFIDENTIALITY |
112 |
13.1 |
Duty of Confidence |
112 |
13.2 |
Exceptions |
113 |
13.3 |
Authorized Disclosure |
114 |
13.4 |
Confidential Treatment |
116 |
13.5 |
Breaches of Confidentiality |
117 |
13.6 |
Relationship to Confidentiality Agreement |
117 |
13.7 |
Security |
117 |
13.8 |
Return of Confidential Information |
117 |
13.9 |
Residual Knowledge Exception |
117 |
13.10 |
Attorney-Client Privilege |
118 |
14. |
PUBLICATIONS AND PUBLICITY |
118 |
3
14.1 |
Public Announcements |
118 |
14.2 |
Publications Generally |
119 |
14.3 |
Use of Name |
119 |
15. |
TERM AND TERMINATION |
119 |
15.1 |
Term |
119 |
15.2 |
Termination |
120 |
16. |
EFFECTS OF TERMINATION |
122 |
16.1 |
General |
122 |
16.2 |
Effects of Termination Generally |
123 |
16.3 |
Additional Effects of Certain Terminations |
124 |
16.4 |
Alternative Remedies in Lieu of Termination |
126 |
16.5 |
Survival |
127 |
16.6 |
Remedies |
129 |
16.7 |
Bankruptcy Code |
129 |
17. |
DISPUTE RESOLUTION |
130 |
17.1 |
Dispute Resolution Mechanism |
130 |
17.2 |
Resolution by Executive Officers |
130 |
17.3 |
Arbitration |
131 |
17.4 |
Excluded Claims |
132 |
17.5 |
Injunctive Relief |
132 |
17.6 |
Continued Performance |
132 |
18. |
MISCELLANEOUS |
132 |
18.1 |
Assignment |
132 |
18.2 |
Designees |
133 |
18.3 |
Change of Control of Septerna |
133 |
18.4 |
Entire Agreement; Amendments |
134 |
18.5 |
Severability |
134 |
18.6 |
No Waiver and Non-Exclusion of Remedies |
135 |
18.7 |
Relationship of the Parties |
135 |
18.8 |
No Third Party Beneficiary Rights |
135 |
18.9 |
Compliance with Law |
135 |
18.10 |
Force Majeure |
135 |
18.11 |
Governing Law |
136 |
18.12 |
Notices |
136 |
18.13 |
Further Assurance |
137 |
18.14 |
Export Control |
137 |
18.15 |
Binding Effect |
137 |
18.16 |
English Language |
137 |
18.17 |
Construction |
138 |
18.18 |
Expenses |
138 |
4
18.19 |
Counterparts |
138 |
SCHEDULES
Schedule 1.22 Collaboration Targets
Schedule 1.29 [***]
Schedule 1.64 [***]
Schedule 1.65 [***]
Schedule 1.112 Program Compounds
Schedule 1.130 Septerna Patents
Schedule 2.1 Collaboration Target(s) for R&D Programs
Schedule 2.3.1 Initial R&D Plan(s)
Schedule 2.10.2 Use of Human Biosamples and Informed Consent
Schedule 2.10.3 Novo Nordisk Principles for the Use of Animals
Schedule 3.6.8 Profit Share Agreement Terms
Schedule 5.5 Information Security Requirement
Schedule 8.4 Permitted Subcontractors and Permitted Activities
Schedule 9.9 Novo Nordisk’s Invoicing Instructions
Schedule 10.4.4 Patent Expert Dispute Procedures
Schedule 11.2 Initial Disclosure Schedule
Schedule 14.1 Press Release
Schedule 16.3.2 [***]
THIS COLLABORATION AND LICENSE AGREEMENT (this “Agreement”) is entered into as of May 13, 2025 (the “Execution Date”) by and between Novo Nordisk A/S, a corporation organized and existing under the laws of Denmark, having an address at Novo Nordisk Allé, 2880 Bagsvaerd, Denmark, CVR No. 24 25 67 90 (“Novo Nordisk”), on the one hand, and Septerna, Inc., a Delaware corporation, with its principal place of business at 250 East Grand Avenue, South San Francisco, CA 94080 (“Septerna”), on the other hand. Septerna and Novo Nordisk are each referred to individually as a “Party” and together as the “Parties”.
BACKGROUND
WHEREAS, Novo Nordisk is a leading global healthcare company engaged in the research, development and commercialization of pharmaceutical products useful in the amelioration, treatment or prevention of human diseases and conditions;
WHEREAS, Septerna has developed the Septerna Platform (as defined below) and has expertise in discovering and generating new chemical entities;
WHEREAS, Novo Nordisk and Septerna desire to enter into this Agreement to allow the Parties to collaborate on the discovery, selection, research and development of novel and existing chemical entities against multiple G-protein coupled receptor (“GPCR”) drug targets utilizing the Septerna Platform;
5
WHEREAS, such collaboration will include R&D Programs (as defined below) relating to one (1) or more specified GPCR drug targets, all in accordance with the terms and conditions of this Agreement; and
WHEREAS, in connection with the foregoing, Novo Nordisk desires to obtain from Septerna an exclusive license to Develop, Manufacture and Commercialize Licensed Compounds and Licensed Products in the Field in the Territory (with each capitalized term as respectively defined below), and Septerna is hereby willing to grant such license to Novo Nordisk, all in accordance with the terms and conditions set forth in this Agreement.
NOW THEREFORE, in consideration of the mutual covenants and agreements contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by both Parties, the Parties, intending to be legally bound, agree as follows:
Capitalized terms used in this Agreement shall have the meanings specified in this Article 1 or as defined elsewhere in this Agreement.
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Term |
Section |
Acquiree |
1.145 |
Acquirer |
1.20 |
Additional R&D Program Optimization Activities |
2.4.4 |
[***] |
[***] |
Agreement |
Preamble |
Alliance Manager |
7.3 |
[***] |
[***] |
Audited Party |
9.13 |
Auditor |
9.13 |
Bankruptcy Laws |
16.7 |
Breaching Party |
15.2.2 |
Budget Overrun |
2.9.2 |
Claim |
12.1 |
Collaboration Data |
5.5 |
Collaboration Personnel |
1.48 |
[***] |
[***] |
Collaboration Target Exclusivity Term |
6.1 |
Collaboration Target Milestone Event |
9.2.1 |
Collaboration Target Milestone Payment |
9.2.1 |
[***] |
[***] |
[***] |
[***] |
Commercial Milestone Event |
9.2.3 |
Commercial Milestone Payment |
9.2.3 |
[***] |
[***] |
Competing Infringement |
10.5.1 |
Confidentiality Agreement |
13.6 |
[***] |
[***] |
21
Term |
Section |
[***] |
[***] |
Cure Period |
15.2.2 |
[***] |
[***] |
DEL |
1.131 |
Development Cost and Profit/Loss Split |
3.6.7 |
[***] |
[***] |
Development Records |
5.1 |
Development to G1 Activities |
2.4.2 |
Development Update |
3.1.1 |
[***] |
[***] |
Disclosing Party |
13.1 |
Dispute |
17.1 |
ERC |
6.2.1 |
Excluded Claim |
17.4 |
Execution Date |
Preamble |
Exempt Program |
6.3 |
[***] |
[***] |
Extensions |
10.4.6 |
Final Report |
2.4.3(a) |
Final Report Acceptance Date |
2.4.3(a) |
Final Report Delivery Date |
11.2 |
Final Report Disclosure Schedule |
11.3.2 |
[***] |
[***] |
[***] |
[***] |
Force Majeure |
18.10 |
GPCR |
Recitals |
G0 Data Package |
2.4.1 |
ICC |
17.3.1 |
ICH |
1.58 |
[***] |
[***] |
Indemnified Party |
12.3.1 |
Indemnifying Party |
12.3.1 |
Indirect Taxes |
9.14.3 |
Infringement Action |
10.5.2(a) |
Initial Disclosure Schedule |
11.2 |
Joint Know-How |
10.3.1 |
Joint IP |
10.3.1 |
Joint Patents |
10.3.1 |
JPSC |
7.5 |
JSC |
7.1 |
Losses |
12.1 |
Manufacturing Technology and Material Transfer |
3.4 |
Manufacturing Transition Plan |
3.4 |
Materials |
2.8 |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
22
Term |
Section |
Native Complex |
1.131 |
Necessary Third Party Right |
10.6.4(b) |
New R&D Program |
2.6.2 |
[***] |
[***] |
Non-breaching Party |
15.2.2 |
[***] |
[***] |
[***] |
1.108 |
Novo Nordisk |
Preamble |
[***] |
[***] |
Novo Nordisk Indemnitee |
12.2 |
Novo Studies |
2.4.5 |
Novo Third Party Agreement |
10.6.4(a) |
Ongoing Programs Limitation |
2.1 |
[***] |
[***] |
Other Components |
1.23 |
[***] |
[***] |
Owed Party |
9.15 |
Owing Party |
9.15 |
Other Third Party Right |
10.6.4(c) |
Parent Compound |
1.39 |
Party |
Preamble |
Patent Challenge |
15.2.6 |
Patent Challenging Party |
15.2.6 |
[***] |
[***] |
[***] |
[***] |
Paying Party |
9.14.2 |
Permitted Budget Overruns |
2.9.3 |
Permitted Subcontractors |
8.4 |
Product Information |
13.1 |
[***] |
[***] |
Profit Share Agreement |
3.6.8 |
[***] |
[***] |
Profit Share Exercise Notice |
3.6.4 |
Profit Share Information Request |
3.6.6 |
Profit Share Negotiation Period |
3.6.8 |
Profit Share Option |
3.6.1 |
Profit Share Option Period |
3.6.4 |
Profit Share Option Trigger Threshold Notice |
3.6.2 |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
Project Leader |
7.6 |
Proposed New Program Plan |
2.6.2 |
Prosecution and Maintenance |
10.4.2 |
Qualified Licensed Product |
3.6.1 |
R&D Budget |
2.3.2 |
R&D Collaboration Term |
2.2 |
R&D Plan |
2.3.1 |
R&D Plan Activities |
2.3.1 |
R&D Program |
2.1 |
23
Term |
Section |
R&D Program Modification Right |
2.6.1 |
[***] |
[***] |
Receiving Party |
13.1 |
Recipient |
9.14.2 |
Redacted Agreement |
13.4.2 |
Research and Development Milestone Event |
9.2.2 |
Research and Development Milestone Payment |
9.2.2 |
Residual Knowledge |
13.9 |
Restricted Information |
1.48 |
Restricted Personnel |
1.48 |
[***] |
[***] |
[***] |
[***] |
Reverted Product |
16.3.2 |
Royalty Payments |
9.3 |
SEC |
13.4.2 |
Second Generation Product Patents |
10.4.1 |
[***] |
[***] |
[***] |
[***] |
Septerna |
Preamble |
Septerna Indemnitee |
12.1 |
Septerna Other Patent |
10.4.2 |
Shared Claim |
12.4 |
Shared Losses |
12.4 |
Shared Septerna Patent Matter |
10.4.4 |
Subsequent Disclosure Schedule |
11.3.1 |
[***] |
[***] |
Supervisory Executives |
1.48 |
Supply Agreement |
3.3.3 |
[***] |
[***] |
Term |
15.1 |
[***] |
[***] |
Third Party Action |
10.6.1 |
Third Party IP Notice |
10.6.4(c) |
Third Party Patent Challenge |
10.7.2 |
Third Party Right |
10.6.4(a) |
[***] |
[***] |
[***] |
[***] |
24
2.3.1 Creation of R&D Plans. The scope and specific terms governing each R&D Program, including all Development activities with respect to the Collaboration Target(s), Program Compounds and Licensed Compounds for such R&D Program and the timelines and budget for such activities, shall be set forth in one (1) or more mutually agreed upon research and development plans for each R&D Program (each, an “R&D Plan”). As of the Execution Date, the initial R&D Plan for each R&D Program is set forth in Schedule 2.3.1. Each R&D Plan will include [***].
2.3.2 R&D Budgets. Each R&D Plan shall include a detailed written budget [***] for Septerna’s R&D Plan Activities or Additional R&D Program Optimization Activities set forth therein, which will include [***](for each R&D Plan, a “R&D Budget”).
2.3.3 Review of R&D Plans. Each R&D Plan (including the R&D Budget included therein) shall be reviewed, updated and amended by the Parties, through the JSC, on [***]; provided that either Party shall have the right to propose any additional update or amendment to an R&D Plan (including the R&D Budget included therein) in connection with the progress of the applicable R&D Program, by submitting such proposed amendment in writing to the JSC for review and approval; provided, further, [***]). With respect to any R&D Budget or amendment thereto, the JSC shall review and agree to a recommended R&D Budget, which Novo Nordisk shall submit for internal governance approval. If Novo Nordisk receives such approval, the JSC shall approve such recommended R&D Budget. If Novo Nordisk does not receive such approval, the JSC shall further review, update and agree to a revised recommended R&D Budget, which revised R&D Budget shall be submitted for Novo Nordisk internal governance approval in accordance with the foregoing. In case of a conflict between the terms and conditions of this Agreement and any provision in an R&D Plan, the terms and conditions of this Agreement shall prevail.
25
2.4.1 Development to G0. On an R&D Program-by-R&D Program basis, Septerna will, [***], conduct initial screening, hit confirmation, hit validation, high resolution structure analysis, and hit-to-lead optimization activities for each Collaboration Target included in such R&D Program as described in the applicable R&D Plan. [***] Following [***] leading to the discovery of Licensed Compound(s) meeting the G0 Criteria for an R&D Program in accordance with the applicable R&D Plan, Septerna will deliver to Novo Nordisk a data package for such R&D Program, containing the data and information generated in the performance of such activities and any other information in its possession or control that is necessary or useful to select Licensed Compounds to progress to Development to G1 Activities (each, a “G0 Data Package”).
2.4.2 Development to G1. On an R&D Program-by-R&D Program basis, no later than [***] after Novo Nordisk’s receipt of the G0 Data Package for an R&D Program, the JSC will meet to review the G0 Data Package and determine whether to progress existing Licensed Compounds with respect to such R&D Program to further research and pre-clinical Development activities up to [***] (such activities, the “Development to G1 Activities”) or to continue R&D Plan Activities as described in Section 2.4.1 (Development to G0) to advance additional Program Compounds toward the G0 Criteria under such R&D Program.
2.4.3 Final Report; Program Transition.
(a) On an R&D Program-by-R&D Program basis, following completion of Development to G1 Activities with respect to a Licensed Compound for such R&D Program in accordance with the applicable R&D Plan, Septerna will present to Novo Nordisk a final report containing all data and information generated in the conduct of such R&D Program, including such data set forth in the R&D Plan for such R&D Program (for each R&D Program, a “Final Report”). Following Novo Nordisk’s receipt of a Final Report, Novo Nordisk will, within [***], either notify Septerna (i) that such Final Report has been accepted by Novo Nordisk or (ii) that Novo Nordisk in good faith believes such Final Report does not include all of the data and information therefor, in which case Septerna will discuss with Novo Nordisk to determine the completeness of such Final Report and, if any such data or information is missing, Septerna will address Novo Nordisk’s concerns by delivering to Novo Nordisk a revised Final Report [***]; provided that Septerna shall not be required to perform additional Development activities to generate any such additional data or information that are not otherwise required pursuant to the applicable R&D Plan or Section 2.4.4 (Additional R&D Program Optimization Activities). In the event that Novo Nordisk fails to notify Septerna within such [***] period in accordance with clause (i) or clause (ii) above, the Final Report will be deemed to have been accepted by Novo Nordisk (the date of such acceptance or deemed acceptance of the Final Report, the “Final Report Acceptance Date”). For clarity, following the first Final Report Acceptance Date for an R&D Program, Novo Nordisk will not, via the JSC, revise the applicable R&D Plan to require Septerna to perform additional Research activities, unless pursuant to Section 2.4.4 (Additional R&D Program Optimization Activities) or Section 2.4.3(b). Following the first Final Report Acceptance Date with respect to an R&D Program, (A) as between the Parties, Novo Nordisk will have the sole right (subject to Section 2.4.4 (Additional R&D Program Optimization Activities) and Section 2.4.3(b)) to conduct or have conducted further Development, Manufacturing, Commercialization
26
and other Exploitation activities with respect to any Licensed Compounds and Licensed Products with respect to such R&D Program in accordance with Articles 3 and 4, and (B) Septerna will complete a technology transfer with respect to such R&D Program in accordance with Section 2.7 (Technology Transfer) and Section 3.4 (Manufacturing Technology and Material Transfer).
(b) With respect to each R&D Program, within [***] after the first Final Report Acceptance Date for such R&D Program, Novo Nordisk shall have the right to amend the R&D Plan for such R&D Program to include additional R&D Plan Activities with respect to additional back-up or follow-on Licensed Compounds, subject to the JSC’s review and approval as set forth in Section 2.3.3 (Review of R&D Plans) and Section 7.14 (JSC Cannot Reach Agreement) (which review and approval may occur after such [***] period). Upon approval by the JSC, such additional R&D Plan Activities may be performed after the first Final Report Acceptance Date for such R&D Program but in no event shall Septerna be required to perform any R&D Plan Activities after the end of the R&D Program Term for such R&D Program. Upon completion of such R&D Plan Activities, Septerna shall provide a Final Report with respect thereto and the procedures set forth above shall apply mutatis mutandis with respect to the Final Report Acceptance Date for such additional R&D Plan Activities.
2.4.4 Additional R&D Program Optimization Activities. With respect to an R&D Program, upon Novo Nordisk’s reasonable written request (including by email to Septerna’s Alliance Manager) during the R&D Program Term for such R&D Program, the JSC will discuss additional Development activities for such R&D Program following the Final Report Acceptance Date for such R&D Program (“Additional R&D Program Optimization Activities”), which, for clarity, shall not include Development activities for additional back-up or follow-on Licensed Compounds, and shall be limited to additional assays or experiments to be performed with respect to Licensed Compounds to support Development following the Final Report Acceptance Date. Following the JSC’s approval, Septerna will perform such Additional R&D Program Optimization Activities; provided that, subject to Section 7.14 (JSC Cannot Reach Agreement), Septerna shall not be required to perform any Additional R&D Program Optimization Activities that would reasonably be anticipated to take more than [***] to complete if Septerna were to use [***] to perform such Additional R&D Program Optimization Activities. Novo Nordisk will prepare an amendment to the applicable R&D Plan (including to the applicable R&D Budget) reflecting such Additional R&D Program Optimization Activities for the applicable R&D Program and will submit such amendment and budget to the JSC to review, discuss and approve, and Septerna will perform such Additional R&D Program Optimization Activities in accordance with Section 2.10.1 (Applicable Laws and Standards; Performance Obligations). Promptly following completion of such Additional R&D Program Optimization Activities, Septerna will provide and transfer to Novo Nordisk copies of all data and information and other Septerna Know-How resulting from such Additional R&D Program Optimization Activities. For clarity, Additional R&D Program Optimization Activities are not R&D Plan Activities.
2.4.5 Novo Studies. At any time prior to the completion of the technology transfer with respect to an R&D Program in accordance with Section 2.7 (Technology Transfer), Novo Nordisk will have the right to conduct studies with respect to any Licensed Compound or Licensed Product for such R&D Program that Novo Nordisk deems necessary or useful to advance such R&D Program or otherwise support the goals of such R&D Program or evaluate such Licensed Compound or Licensed Product for further Development, such as biological profiling
27
studies, in each case, as set forth in the applicable R&D Plan for such R&D Program (the “Novo Studies”). Septerna will, at Novo Nordisk’s cost and expense, provide to Novo Nordisk, in accordance with Section 2.8 (Materials Transfer), any Septerna Know-How and reasonable quantities of the applicable Licensed Compounds, Licensed Products and Materials, as applicable, requested by Novo Nordisk for the conduct of the Novo Studies; provided that Novo Nordisk informs Septerna of the overall objective of the Novo Studies that include such Licensed Compounds, Licensed Products or Materials. Novo Nordisk will keep Septerna reasonably informed through the JSC via high-level summaries of the Novo Studies that Novo Nordisk conducts and high-level results of such Novo Studies.
2.4.6 Infeasible R&D Programs. If Septerna reasonably believes that any R&D Plan Activity in an R&D Plan is technically infeasible to complete, it will notify Novo Nordisk, and either Party may propose an amendment to such R&D Plan to address such concerns in accordance with Section 2.3.3 (Review of R&D Plans). The JSC will meet within [***] after such request to discuss Septerna’s concerns and whether to approve any proposed amendment to such R&D Plan, terminate the relevant R&D Program or substitute or initiate a new R&D Program in accordance with Section 2.6 (New R&D Programs).
2.5.1 R&D Plan Activities Reports. Within [***] following the end of each [***] during which Septerna performs any R&D Plan Activities or Additional R&D Program Optimization Activities, Septerna shall provide to Novo Nordisk a reasonably detailed report of such activities it has performed, or caused to be performed, since the preceding report, its activities in process and the future activities it expects to initiate during the then-current [***]. Without limiting the foregoing, Septerna shall promptly make available to Novo Nordisk all material Know-How (including all results and data) from R&D Plan Activities or Additional R&D Program Optimization Activities performed under the R&D Plans (and excluding, for clarity, any such Know-How or information specifically related to the Septerna Platform that does not constitute Product Information), and, at Novo Nordisk’s request, shall meet with Novo Nordisk to discuss the Licensed Compounds and Licensed Products.
2.5.2 [***] Reports. Within [***] following the end of each [***] during which Septerna performs any activities with respect to any [***] in accordance with Section 8.1.2, Septerna shall provide to Novo Nordisk a high-level report of (a) the identity of any such [***] for which Septerna has performed such activities and (b) any Licensed Compound that is identified or generated under or in connection with such activities (including whether any such Licensed Compound is an [***]).
2.6.1 R&D Program Modification Right. During the Programs Modification Term, Novo Nordisk will have the right to substitute new R&D Programs for any ongoing R&D Programs at any time or initiate a new R&D Program at any time after the first Final Report Acceptance Date for each R&D Program, subject to the Ongoing Programs Limitation (such rights,
28
the “R&D Program Modification Right”). For avoidance of doubt, the number of R&D Programs that are subject to ongoing R&D Plan Activities at any given time may not exceed [***] R&D Programs unless otherwise agreed by Septerna in writing.
2.6.2 New R&D Programs Proposal. Subject to the Ongoing Programs Limitation, Novo Nordisk may exercise its R&D Program Modification Right in accordance with Section 2.6.1 (R&D Program Modification Right) by providing written notice to Septerna, which written notice shall include (a) the proposed Collaboration Target(s) that Novo Nordisk desires to include in as a new R&D Program (the “New R&D Program”), and (b) if applicable, any existing R&D Program that Novo Nordisk intends to be replaced and terminated. Within [***] after Septerna’s receipt of such notice, Novo Nordisk shall prepare (and Septerna will provide support with respect thereto as reasonably requested by Novo Nordisk) and present to the JSC a proposed R&D Plan for such New R&D Program, including an R&D Budget for such New R&D Program (the “Proposed New Program Plan”).
2.6.3 New R&D Plan. Upon receiving the Proposed New Program Plan, the Parties shall, via the JSC, discuss in good faith and approve the Proposed New Program Plan (and, for clarity, such approval by the JSC shall be subject to Section 7.14.2). Once approved by the JSC, the Proposed New Program Plan shall be deemed to be an R&D Plan for the New R&D Program for purposes of this Agreement.
2.6.4 Effect of Exercise of R&D Program Modification Right. Effective upon Septerna’s receipt of written notice that Novo Nordisk wishes to exercise its R&D Program Modification Right: (a) the New R&D Program will be an R&D Program; and (b) any R&D Program that is terminated and substituted in Novo Nordisk’s exercise of such R&D Program Modification Right (but not, for clarity, any R&D Program for which a Final Report Acceptance Date has occurred) will cease to be an R&D Program, and neither Party will have any obligation to perform further R&D Plan Activities with respect to such terminated and substituted R&D Program.
2.6.5 New R&D Program for [***]. If Novo Nordisk fails to exercise its R&D Program Modification Right to establish an R&D Program that includes [***] as a Collaboration Target prior to the date that is [***] after the last Final Report Acceptance Date and completion of the Additional R&D Program Optimization Activities, if any, for an R&D Program (or, if earlier, upon the first substitution or initiation of a new R&D Program for an ongoing R&D Program pursuant to Section 2.6.1 (R&D Program Modification Right)), [***] will be a Dropped Target and will cease to be a Collaboration Target for purposes of this Agreement.
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2.9.1 Unless otherwise agreed to in writing by the Parties, (a) except as set forth in clause (b) with respect to Septerna and in Section 2.4.5 (Novo Studies) with respect to Septerna’s provision of Licensed Compounds, Licensed Products or Materials, each Party will be responsible for all of the costs and expenses incurred by it or its respective Affiliates in the performance of its activities under each R&D Program and, with respect to Novo Nordisk, the Novo Studies and (b) Novo Nordisk shall make payments to Septerna in accordance with and pursuant to Section 9.7 (Research Funding) for documented Septerna Research Costs.
2.9.2 In the event that Septerna Research FTE Costs and Out-of-Pocket Costs for any R&D Program at any time during an applicable Calendar Year are expected to be greater than, on a cumulative annual basis, the aggregate amounts set forth in the then-current R&D Budget for such R&D Program or the Additional R&D Program Optimization Activities for an R&D Program for such Calendar Year by [***] or more (such excess amount above [***] of the then-current R&D Budget, a “Budget Overrun”), then further Novo Nordisk internal governance committee review and approval will be required but is not guaranteed for any such Budget Overrun. Septerna shall provide Novo Nordisk with reasonable advance written notice of any anticipated Budget Overruns through the JSC, accompanied by, as applicable, (a) a detailed, line-item breakdown of all such anticipated increased Septerna Research FTE Costs and Out-of-Pocket Costs relating to such Budget Overrun, (b) an overall impact assessment of the requested changes, including impact on the overall R&D Budget and current or future obligations to perform the R&D Plan Activities or Additional R&D Program Optimization Activities for such R&D Program and (c) [***] forecasted estimates of performance against the then-current R&D Budget for such R&D Program, and with the foregoing ((a)-(c)), seek Novo Nordisk’s approval for such requested amounts that represent such additional Septerna Research FTE Costs and Out-of-Pocket Costs to be actually incurred.
2.9.3 To the extent any Budget Overrun amount is subsequently approved by Novo Nordisk according to the foregoing, (a) such additional Septerna Research FTE Costs and Out-of-Pocket Costs shall constitute Septerna Research Costs and shall be used solely by Septerna for the R&D Program for which such Septerna Research Costs were approved, and (b) Novo Nordisk shall make payments to Septerna in accordance with and pursuant to Section 9.6 (Research Funding), during each remaining applicable [***] for such Calendar Year (such approved amounts, “Permitted Budget Overruns”). [***]
2.10.1 Applicable Laws and Standards; Performance Obligations. All Development activities conducted by either Party under or in connection with each R&D Program shall be conducted in a good scientific manner and in accordance with the applicable R&D Plan and all Applicable Laws. Septerna shall use [***] to (a) complete all R&D Plan Activities or Additional R&D Program Optimization Activities for which it is responsible under the R&D Plans, (b) complete such R&D Plan Activities or Additional R&D Program Optimization Activities in accordance with the timelines and R&D Budget set forth in the applicable R&D Plan and (c) with respect to each R&D Program, Develop a Licensed Compound that satisfies applicable [***] for such R&D Program; provided that, with respect to any such activities for which Septerna is required to use [***], in no event shall such efforts and resources be less than those used by Septerna and its Affiliates for any of its or their other programs. Except as set forth in Section 2.4.5
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(Novo Studies) and Section 2.8 (Materials Transfer), each Party shall provide all materials, facilities and resources necessary for it to perform its Development activities set forth in each R&D Plan and shall devote the efforts of suitably qualified and trained employees and personnel capable of carrying out such Development activities to perform such Development activities in a professional and workmanlike manner, with reasonable care and skill, and consistent with sound and ethical business and scientific practices.
2.10.2 Human Biosamples. If applicable, in the event that Septerna wishes to use or source any human biosamples for use to perform any activities to be conducted pursuant to an R&D Plan, including from a Third Party supplier, Septerna will only do so after receiving prior approval of the JSC with respect thereto; provided, however, [***]. Each Party represents and warrants that, in performing its obligations under the R&D Plans, it shall adhere to and comply with the obligations related to the use of human biosamples set forth in Schedule 2.10.2 and shall use [***] to ensure that all future subcontractors (including CROs) adhere to and comply with these obligations. The decision to use human biosamples in the activities to be conducted pursuant to an R&D Plan shall be made by the JSC.
2.10.3 Use of Animals. Prior to the use of animals in connection with the activities to be conducted pursuant to the R&D Plans by Septerna, Septerna shall obtain Novo Nordisk’s prior written approval therefor, including with respect to facilities to be used in connection therewith. If animals are so used, the Parties agree to ensure high welfare standards for experimental animals used in any activities to be conducted pursuant to the R&D Plans. Septerna acknowledges that it has read and understood Novo Nordisk’s Principles for the Use of Animals attached hereto in Schedule 2.10.3 and agrees to adhere to and comply with these obligations. Septerna must promptly notify Novo Nordisk in the event of any material unexpected issues in relation to animal welfare or bioethical concerns that occur under an R&D Plan. The Parties agree to reasonably collaborate to address any such issues and concerns to the extent such issues and concerns relate to more than local legal requirements. Septerna must report to Novo Nordisk the number of experimental animals having been (and if applicable, plan to be) used by or on behalf of Septerna under each R&D Plan in a Calendar Year (if any) no later than [***] of such Calendar Year. Septerna acknowledges that initiation of activities involving the use of animals under the R&D Plans is subject to Novo Nordisk’s approval of the R&D Plans. Novo Nordisk (i) will review the R&D Plans and the protocol(s) with respect to anticipated animal use and (ii) may require an on-site animal welfare inspection prior to initiation of any experimental animal activities to be conducted pursuant to the R&D Plans. If Novo Nordisk wishes to perform such animal welfare inspection during the R&D Collaboration Term, Septerna shall give Novo Nordisk access to the relevant areas of its site (or, to the extent such activities are conducted at a Third Party site, the relevant areas of such Third Party site) upon reasonable notice of no less than [***]; provided that any such audit shall not be conducted more than [***] (except in the event that an audit identifies any issues, in which case Novo Nordisk shall be permitted to undertake a follow-up audit) and shall be conducted during normal business hours, subject to customary confidentiality obligations and security measures reasonably required by Septerna (or such Third Party, as applicable) and in a manner intended to minimize any disruptions to Septerna’s (or such Third Party’s, as applicable) day-to-day business.
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3.1.1 General. Following the first Final Report Acceptance Date with respect to an R&D Program, as between the Parties, except for any Additional R&D Program Optimization Activities or Research activities performed pursuant to Section 2.4.3(b), Novo Nordisk shall have the sole right, itself or through its Affiliates or Sublicensees or Permitted Subcontractors, to further Develop, including to seek Regulatory Approval for, any Licensed Products with respect to such R&D Program in the Field in the Territory, at its sole cost and expense (except with respect to Development Costs for the Profit Share Product, which shall be shared in accordance with the Profit Share Agreement). Novo Nordisk will use [***] to Develop, including to seek Regulatory Approval for, in [***] for [***]Indication, [***]; provided that the foregoing shall only apply to [***] to the extent that a Final Report is delivered [***] and [***] has satisfied the G1 Criteria or has otherwise been advanced by Novo Nordisk to IND-Enabling Studies. At least [***] (and, with respect to [***]) during [***], Novo Nordisk shall prepare, update and share with Septerna a high-level written development status update (the “Development Update”), which shall be summary in nature and which shall outline material Development activities performed since the preceding report and in process or anticipated to be performed during the [***] (or [***] period with respect to [***]). Novo Nordisk may update and amend, as Novo Nordisk deems appropriate, the then-current Development Update from time to time and shall submit such updates or amendments to Septerna.
3.1.2 [***]
(a) [***].
(b) [***].
(c) [***].
3.1.3 [***]
(a) [***].
(b) [***].
(c) [***].
(d) [***].
(e) [***].
(f) [***].
(g) [***].
3.1.4 [***].
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3.3.1 Unless otherwise mutually agreed by the Parties, as between the Parties, (a) [***] will be responsible for the Manufacture and supply of Licensed Compounds until completion of Development to G1 Activities for any R&D Program; provided that, [***] (itself or through its Affiliate(s) or Sublicensee(s)) will have the sole right to perform, and sole control over and decision-making authority with respect to, all Manufacturing activities for the Manufacture of Licensed Compounds and Licensed Products, at [***].
3.3.2 Septerna shall Manufacture (or have Manufactured) all such Licensed Compounds ([***]) and Licensed Product(s) in accordance with Applicable Laws and any applicable manufacturing and quality agreements and, for purposes of supply to Novo Nordisk, shall only use contract manufacturers reasonably acceptable to Novo Nordisk in accordance with terms reasonably acceptable to Novo Nordisk. Septerna represents and warrants that each Licensed Compound, [***] and Licensed Product supplied to Novo Nordisk (a) will be Manufactured in accordance with Applicable Laws, including, with respect to any clinical supply of [***] and Licensed Product(s), current Good Manufacturing Practices, (b) will not be adulterated or misbranded under the FD&C Act and may be introduced into interstate commerce pursuant to the FD&C Act and (c) complies with the applicable specifications with respect thereto in the then-current IND for such Licensed Product, if applicable.
3.3.3 Novo Nordisk and Septerna will negotiate in good faith the terms of an agreement for the Manufacture and supply to Novo Nordisk of the Licensed Compounds, [***] and Licensed Product(s) (and any components thereof) as set forth above (the “Supply Agreement”), which Supply Agreement will include customary terms for supply of material to a collaboration partner for development, including a related quality agreement if necessary. Novo Nordisk and Septerna shall use good faith efforts to execute such Supply Agreement (and any quality agreement) [***]. The Supply Agreement (and any quality agreement) will be subordinate to this Agreement.
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3.6.1 Overview. Subject to the remainder of this Section 3.6 (Septerna Profit Share Option), Novo Nordisk hereby grants to Septerna the one-time option to share in the global Development Costs and Operating Profits or Losses with respect to one (1) Licensed Product (other than any Combination Product) that has met a Profit Share Option Trigger Threshold (each, a “Qualified Licensed Product”) of Septerna’s election [***]) in accordance with the proportions set forth in Section 3.6.7 (Expense and Profits and Loss Sharing[***]) and the applicable Profit Share Agreement (the “Profit Share Option”), which option will be exercisable solely during the applicable Profit Share Option Period. For the avoidance of doubt, [***], in no event will Septerna be entitled to elect more than [***] Profit Share Option, whether with respect to the same R&D Program or a different R&D Program. [***].
3.6.2 Notice. With respect to [***] Qualified Licensed Product, Novo Nordisk shall deliver to Septerna written notice that such Qualified Licensed Product has achieved a Profit Share Option Trigger Threshold within [***] after the achievement thereof (such notice, a “Profit
35
Share Option Trigger Threshold Notice”); provided that, following Septerna’s exercise of a Profit Share Option ([***]), Novo Nordisk shall no longer be required to provide the foregoing notice with respect to any Licensed Product under this Agreement.
3.6.3 Profit Share Option Data Package. At any time during the [***] period following Septerna’s receipt of a Profit Share Option Trigger Threshold Notice for a Qualified Licensed Product, Septerna may request (and Novo Nordisk shall provide to Septerna within a reasonable period of time thereafter) the Profit Share Option Data Package therefor. If Septerna does not request a Profit Share Option Data Package within such [***] period, Septerna’s Profit Share Option with respect to such Qualified Licensed Product shall terminate. Septerna shall use the Profit Share Option Data Package (and any additional information provided by Novo Nordisk pursuant to this Section 3.6 (Septerna Profit Share Option)) solely for purposes of determining whether to exercise its Profit Share Option with respect to such Qualified Licensed Product, and the Profit Share Option Data Package and any other accompanying information provided by Novo Nordisk shall remain Novo Nordisk’s Confidential Information. Notwithstanding Article 13, Septerna shall not have the right to use such information for any purpose other than to determine whether to exercise its Profit Share Option with respect to the applicable Qualified Licensed Product.
3.6.4 Exercise. Subject to the remainder of this Section 3.6.4 (Exercise) and Section 3.6.5 ([***]), Septerna may exercise its Profit Share Option with respect to a Qualified Licensed Product by providing to Novo Nordisk written notice (the “Profit Share Exercise Notice”) of such exercise no later than the date that is the earlier of [***]; provided that (x) [***] and (y) such time period may be otherwise mutually extended by the Parties in writing (such period between the receipt of the Profit Share Option Trigger Threshold Notice and the end-time set forth in the foregoing, subject to the last sentence of Section 3.6.6 (Requests for Additional Information), the “Profit Share Option Period”).
3.6.5 [***].
3.6.6 Requests for Additional Information. From time to time during the Profit Share Option Period, and solely to the extent reasonably necessary for Septerna to decide whether to exercise its Profit Share Option, Septerna may provide Novo Nordisk with written notice requesting from Novo Nordisk reasonable additional information (including, as reasonable, any additional information regarding the [***]) with respect to, or the ability to reasonably discuss with Novo Nordisk representative(s) who have knowledge of, in each case, such Qualified Licensed Product (each, a “Profit Share Information Request”). Novo Nordisk shall use [***] to provide such information or hold any such discussion as promptly as practicable but in any event within [***] after receipt of such Profit Share Information Request so long as such requested information is in Novo Nordisk’s or any of its Affiliates’ Control and its provision does not require the expenditure of additional funds or the performance of additional studies to generate. Additionally, at any time during the Profit Share Option Period, Septerna may request an updated estimated accounting of all previously incurred [***] since the Effective Date for the applicable Qualified Licensed Product, which Novo Nordisk will provide within [***] after such request. With respect to any Profit Share Information Request submitted by Septerna during the [***] of the Profit Share Option Period, to the extent that Novo Nordisk has not provided such information in any material respect or has failed to hold such requested discussion, the Profit Share Option
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Period shall be extended by a period corresponding to the number of Calendar Days between the expiration of [***] period following Novo Nordisk’s receipt of such Profit Share Information Request and the date such requested information is provided by Novo Nordisk to Septerna or such requested discussion is held between the Parties.
3.6.7 Expense and Profits and Loss Sharing; [***]. Unless otherwise mutually agreed by the Parties, the initial percentage of Development Costs and Operating Profits or Losses to be borne by each Party with respect to the Profit Share Term for the Profit Share Product (the “Development Cost and Profit/Loss Split”) shall be [***] to be borne and received by Septerna and [***] to be borne and received by Novo Nordisk. [***].
3.6.8 Profit Share Agreement. If Septerna exercises the Profit Share Option with respect to a Qualified Licensed Product ([***]), the Parties shall negotiate in good faith the terms of a definitive profit share agreement for such Licensed Product (a “Profit Share Agreement”) within [***] after Novo Nordisk’s receipt of the Profit Share Exercise Notice (“Profit Share Negotiation Period”). The Profit Share Agreement shall include the terms set forth in Schedule 3.6.8 and such other terms that the Parties may in good faith agree, which in any event shall be customary for those provisions found in an agreement that governs parties’ co-funding of pharmaceutical product Development and Commercialization and otherwise be consistent with the provisions of this Agreement; provided that the Parties hereby agree to at least the following: [***].
3.6.9 [***].
3.6.10 Financial Products. Upon the execution of the Profit Share Agreement, the corresponding Qualified Licensed Product shall be deemed the Profit Share Product hereunder and shall not be deemed a Financial Product or Covered Financial Product for purposes of Article 9. For clarity, with respect to such Qualified Licensed Product, upon such execution of the Profit Share Agreement, subject to Section 3.6.12 (Termination of Profit Share Term), Septerna shall not be eligible to receive payments under Section 9.2.1 (Collaboration Target Milestones) Section 9.2.2 (Research and Development Milestones), Section 9.2.3 (Commercial Milestones) or Section 9.3 (Royalty Rate) for such Qualified Licensed Product for Research and Development Milestone Events, Commercial Milestone Events and Net Sales occurring and achieved during the Profit Share Term. For clarity, any such payment owed but not paid by Novo Nordisk by the date of execution of such Profit Share Agreement shall not be paid by Novo Nordisk unless otherwise provided in Section 3.6.12 (Termination of Profit Share).
3.6.11 Initial Profit Share Payment. Within [***] after the execution of the Profit Share Agreement, Septerna shall pay to Novo Nordisk, in cash, (a) an amount equal to its percentage of the Development Cost and Profit/Loss Split multiplied by (i) [***] (in the event Septerna is exercising the Profit Share Option in accordance with clause (a) of the definition of “Profit Share Option Trigger Threshold”) or (ii) [***] (in the event Septerna is exercising the Profit Share Option in accordance with clause (b) of the definition of “Profit Share Option Trigger Threshold”) [***]. Thereafter, Septerna shall pay to Novo Nordisk its share of Development Costs and each Party shall pay to the other Party its share of Operating Profits or Losses for the Profit Share Product, as allocated pursuant to the Development Cost and Profit/Loss Split, in accordance with the Profit Share Agreement.
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3.6.12 Termination of Profit Share Term. Septerna’s Profit Share Option or, if executed by the Parties, the Profit Share Agreement (and the Development Costs and Profit/Loss Split), as applicable, shall continue in full force and effect until the earliest of: [***] With respect to the Profit Share Product, in the event that the Profit Share Agreement is terminated, as of the effective date of such termination, (x) the Profit Share Product shall no longer be deemed a “Profit Share Product” but shall remain a “Licensed Product” hereunder and (y) such Profit Share Product shall automatically become a Financial Product hereunder, and such Financial Product shall be thereafter eligible for payments under Sections 9.2.2 (Research and Development Milestones), 9.2.3 (Commercial Milestones) and 9.3 (Royalty Rate) (as and if applicable) solely with respect to Research and Development Milestone Events, Commercial Milestone Events and Net Sales occurring and achieved after such Profit Share Agreement termination; provided that, for clarity, Septerna shall remain responsible for its share of any Development Costs, Cost of Sales and Commercialization Costs, in each case, attributable to Development or Commercialization of the Profit Share Product during the Profit Share Term. In the event of any termination of the Profit Share Agreement, unless it is terminated by Novo Nordisk pursuant to Section 3.6.12(a)(ii), [***]. For clarity, upon the termination of the Profit Share Agreement, Septerna’s rights and obligations to share in the Development Costs and Operating Profits or Losses with respect to the corresponding Licensed Product after the Profit Share Term shall immediately cease (provided that Septerna shall remain responsible for its share of any Development Costs, Cost of Sales and Commercialization Costs, in each case, attributable to the Development or Commercialization of the Profit Share Product during the Profit Share Term), and Septerna shall not have the right to exercise a Profit Share Option for any other Licensed Product. For further clarity, in the event that Septerna undergoes a Change of Control and Septerna previously exercised its Profit Share Option ([***]) but the Parties have not yet executed a Profit Share Agreement, and Novo Nordisk elects to terminate Septerna’s Profit Share Option, the applicable Qualified Licensed Product shall not become a Profit Share Product, Septerna’s Profit Share Option will terminate, and the Parties shall cease negotiations with respect to the Profit Share Agreement.
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5.5.1 Responsibilities. Each Party is responsible for protecting against unauthorized use or disclosure, and ensuring data availability, of Collaboration Data. Each Party
40
will comply with Privacy and Data Security Laws and maintain reasonable information security systems (as further defined in Schedule 5.5 attached hereto) with administrative, physical, organizational and technical controls sufficient to protect against material risks towards Collaboration Data. If Collaboration Data generated or possessed by Septerna hereunder will be managed by a Third Party, the information security requirements herein should be provided for and stated clearly in the IT contract with such Third Party, or such IT contract shall provide for in all material respects equivalent requirements as hereof, and such contract may be assessed by Novo Nordisk upon request.
5.5.2 Notification. Each Party shall notify the other Party without delay after discovering any unauthorized access to, or unpermitted use or disclosure of, any Collaboration Data in its or its Affiliates’, subcontractors’ or (sub)licensees’ possession or any other type of security incident that could potentially impact the other Party. Upon occurrence of such incident, the affected Party shall use [***] to remedy such incident, including conducting root cause analysis and implementing procedures to mitigate the impact of such incident, and shall provide the other Party a reasonably detailed summary with respect thereto.
5.5.3 Information Security Audit. Septerna shall permit Novo Nordisk to audit, upon reasonable notice and no more frequently than [***], under customary confidentiality obligations, Septerna’s compliance with industry standard information technology requirements, which audit may be conducted by an independent Third Party expert appointed by Novo Nordisk reasonably acceptable to Septerna, at Novo Nordisk’s cost and expense, and subject to customary confidentiality and securities measures as may be reasonably implemented by Septerna. Such Third Party expert shall have [***]. For clarity, if required by such audit Septerna shall grant such independent Third Party expert [***].
6.1.1 [***].
6.1.2 [***].
6.2.1 [***].
6.2.2 [***].
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6.2.3 [***].
6.3.1 [***]
6.3.2 [***]
6.3.3 [***].
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6.6.1 [***].
6.6.2 [***].
6.6.3 For the avoidance of doubt, nothing herein will limit or restrict Novo Nordisk’s Research, Development, Manufacturing, Commercialization or other Exploitation of any Compound or product outside this Agreement, subject to the terms set forth in Article 13.
43
44
(a) to discuss and decide the strategic direction of each R&D Program;
(b) to allocate any unassigned activities under an R&D Plan;
(c) to monitor, review and discuss the progress and results of all activities undertaken by the Parties under each R&D Plan and the allocation of resources among such activities;
(d) to facilitate the exchange of information between the Parties in accordance with the R&D Plan;
(e) to discuss, recommend updates for, amend and approve each R&D Plan (including the applicable R&D Budget) on an [***] (or at any other time in accordance with Section 2.3.3 (Review of R&D Plans)) (including in the event Septerna reasonably believes that
45
any R&D Plan Activity in such R&D Plan is technically infeasible to complete in accordance with Section 2.4.6 (Infeasible R&D Programs), to include additional R&D Plan Activities with respect to additional back-up or follow-on Program Compounds in accordance with Section 2.4.3(b) or Additional R&D Program Optimization Activities to be performed by Septerna in accordance with Section 2.4.4 (Additional R&D Program Optimization Activities), and to engage different subcontractors and update the R&D Budget accordingly in accordance with Section 2.9.3); provided that Novo Nordisk’s representatives on the JSC shall not have the right to approve any R&D Budget or amendment thereto without first receiving required internal governance approval of Novo Nordisk (outside of the purview of the JSC);
(f) to (i) [***] and (ii) review and discuss the G0 Data Package(s) for each R&D Program and determine whether to progress existing Licensed Compounds under such R&D Program to Development to G1 Activities or to continue R&D Plan Activities to advance additional Program Compound(s) toward the G0 Criteria under such R&D Program, in each case, in accordance with Section 2.4.2 (Optimization Activities);
(g) to discuss and review the results of Novo Studies as described in Section 2.4.5 (Novo Studies);
(h) to discuss and approve a Proposed New Program Plan in accordance with Section 2.6 (R&D Program Creation and Replacement Right);
(i) if requested by Novo Nordisk, to develop a plan outlining key transition activities to be carried out by Parties with respect to an R&D Program in accordance with Section 2.7 (Technology Transfer);
(j) to receive, review and discuss the [***] Septerna Research FTE Costs and Out-of-Pocket Costs incurred and expected to be incurred by or on behalf of Septerna or any of its Affiliates with respect to each R&D Plan (including any anticipated Budget Overruns in accordance with Section 2.9.2);
(k) to review, discuss and determine whether to use human biosamples in the activities to be conducted pursuant to an R&D Plan as described in Section 2.10.2 (Human Biosamples);
(l) to review and determine whether activities under each Manufacturing Transition Plan are completed as described in Section 3.4 (Manufacturing Technology and Material Transfer);
(m) to decide matters and resolve disputes referred to the JSC which the JSC has authority to decide or resolve under this Agreement; and
(n) to perform other responsibilities specifically assigned to the JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties in writing from time to time.
46
7.14.1 [***]
7.14.2 [***]
7.14.3 [***].
For clarity, any amendment or modification to the terms and conditions of this Agreement or any Party’s contractual rights hereunder shall not be under the purview of the JSC and shall require the mutual written agreement of the Parties.
8.1.1 On an R&D Program-by-R&D Program basis, during the R&D Collaboration Term, Novo Nordisk hereby grants to Septerna and its Affiliates a non-exclusive, non-sublicensable (except through Section 8.4 (Right to Subcontract)), non-transferable (except in accordance with Section 18.1 (Assignment)), royalty-free, fully paid-up, limited license under (a) the Septerna Technology licensed to Novo Nordisk pursuant to Section 8.2.1 and Section 8.2.2, and (b) any Know-How, Patent Rights or other intellectual property rights Controlled by Novo
47
Nordisk or any of its Affiliates that are (i) necessary or reasonably useful for Septerna to conduct activities under the R&D Plan and (ii) specifically identified in the R&D Plan or actually provided by Novo Nordisk for use in such R&D Program, in each case ((a) and (b)), to perform Septerna’s obligations under the R&D Plan for such R&D Program in the Field in the Territory.
8.1.2 Subject to Section 6.1 (Collaboration Target Exclusivity) and Section 6.2.3 ([***]), Novo Nordisk hereby grants to Septerna and its Affiliates, a non-exclusive, non-sublicensable (except through Section 8.4 (Right to Subcontract)), non-transferable (except in accordance with Section 18.1 (Assignment)), royalty-free, fully paid-up, limited license under the Septerna Technology licensed to Novo Nordisk pursuant to Section 8.2.2 [***].
8.2.1 Septerna hereby grants to Novo Nordisk a sublicensable (including through multiple tiers, subject to Sections 8.3 (Sublicenses) and 8.4 (Right to Subcontract), as applicable), non-transferable (except in accordance with Section 18.1 (Assignment)), royalty-free, fully paid-up (a) non-exclusive, limited license under the Septerna Technology to Research (but not Develop or Commercialize) any Program Compounds with respect to each R&D Program during the R&D Program Term for such R&D Program (and any additional period during which Additional R&D Program Optimization Activities are being conducted in accordance with Section 2.4.4 (Additional R&D Program Optimization Activities)) in the Field in the Territory solely in furtherance of such R&D Program and (b) non-exclusive, perpetual and irrevocable license, with the right to sublicense through multiple tiers, under the [***] for any and all purposes.
8.2.2 Septerna hereby grants to Novo Nordisk an exclusive, sublicensable (including through multiple tiers, subject to Sections 8.3 (Sublicenses) and 8.4 (Right to Subcontract), as applicable), non-transferable (except in accordance with Section 18.1 (Assignment)), royalty-bearing license under the Septerna Technology to (a) conduct the R&D Plan for each R&D Program, and (b) Research, Develop, Manufacture, Commercialize and otherwise Exploit any Licensed Compound or Licensed Product in the Field in the Territory.
48
49
9.2.1 Collaboration Target Milestones. In further consideration for the rights and licenses granted to Novo Nordisk hereunder, upon the first achievement of each of the following milestone events by Novo Nordisk or its Affiliates or Sublicensees with respect to the applicable Collaboration Target (“Collaboration Target Milestone Event”), subject to the first paragraph of Section 9.2 (Milestone Payments) and the rest of this Section 9.2.1 (Collaboration Target Milestones), Novo Nordisk shall pay to Septerna the corresponding one-time milestone payments set forth below (each, “Collaboration Target Milestone Payment”). Each Collaboration Target Milestone Payment shall be payable only once, and shall be payable only for the first achievement of the corresponding Collaboration Target Milestone Event, regardless of the repeated achievement of the Collaboration Target Milestone Event for the applicable Collaboration Target. [***].
|
Collaboration Target Milestone Event |
Collaboration Target Milestone Payment |
1. |
[***] |
[***] |
2. |
[***] |
[***] |
3. |
[***] |
[***] |
4. |
[***] |
[***] |
5. |
[***] |
[***] |
9.2.2 Research and Development Milestones. In further consideration for the rights and licenses granted to Novo Nordisk hereunder, on an R&D Program-by-R&D Program basis, upon the first achievement of each of the following milestone events (each, a “Research and Development Milestone Event”) by a Licensed Compound, Licensed Product or Covered
50
Financial Product, as applicable, with respect to such R&D Program (for clarity, other than an R&D Program with respect to which a Profit Share Product exists at the time of achievement of such milestone event), subject to the first paragraph of Section 9.2 (Milestone Payments), and the rest of this Section 9.2.2 (Research and Development Milestones), Novo Nordisk shall pay to Septerna the one-time milestone payments below (“Research and Development Milestone Payment”); provided, however, [***]. The Research and Development Milestone Payments shall be payable only once for the first Licensed Compound or Covered Financial Product, as applicable, with respect to an R&D Program to achieve the specified Research and Development Milestone Event, regardless of the repeated achievement of the Research and Development Milestone Event by the same Licensed Compound, Covered Financial Product or other Licensed Products with respect to such R&D Program, and irrespective of how many Indications for which such Licensed Compound or Covered Financial Product, as applicable, is Developed.
|
Research and Development Milestone Event |
Research and Development Milestone Payment |
1. |
[***] |
[***] |
2. |
[***] |
[***] |
3. |
[***] |
[***] |
4. |
[***] |
[***] |
5. |
[***] |
[***] |
6. |
[***] |
[***] |
7. |
[***] |
[***] |
8. |
[***] |
[***] |
9. |
[***] |
[***] |
10. |
[***] |
[***] |
11. |
[***] |
[***] |
12. |
[***] |
[***] |
13. |
[***] |
[***] |
|
Total Possible Research and Development Milestone Payments Per R&D Program |
[***] |
51
On an R&D Program-by-R&D Program basis, each Research and Development Milestone Payment set forth above shall be payable only once for the first achievement (including any deemed achievement in accordance with the rest of this paragraph) of the specified milestone event with respect to the first Licensed Compound or Covered Financial Product, as applicable, with respect to such R&D Program (other than any R&D Program with respect to which any Profit Share Product exists at the time of achievement of such Research and Development Milestone Event), regardless of the number of Licensed Compounds or Covered Financial Products that achieve the applicable milestone event with respect to such R&D Program, and in no event will the Research and Development Milestone Payments set forth in this Section 9.2.2 (Research and Development Milestones) exceed [***]. Notwithstanding the foregoing, [***]. In addition, [***]. For clarity, [***].
9.2.3 Commercial Milestones. In further consideration for the rights and licenses granted to Novo Nordisk hereunder, on an R&D Program-by-R&D Program basis, upon the first achievement of each of the following milestone events (“Commercial Milestone Event”) by a Covered Financial Product with respect to such R&D Program (for clarity, other than an R&D Program with respect to which a Profit Share Product exists at the time of achievement of such milestone event), subject to the first paragraph of Section 9.2 (Milestone Payments), the rest of this Section 9.2.3 (Commercial Milestones) and Section 9.5.3 (Third Party Payments), Novo Nordisk shall pay to Septerna the one-time milestone payments below (“Commercial Milestone Payment”). Each Commercial Milestone Payment shall be payable only once per R&D Program, irrespective of how many Indications for which the applicable Covered Financial Product with respect to such R&D Program is Commercialized, upon the first time during the Term that the Annual Net Sales of a Covered Financial Product with respect to such R&D Program in any Calendar Year by Novo Nordisk, its Affiliates or its Sublicensees in the Territory exceed the amounts set forth in the following table (subject to the rest of this Section 9.2.3 (Commercial Milestones)), and irrespective of how many times the same or another Covered Financial Product with respect to such R&D Program achieves the corresponding Commercial Milestone Event.
|
Commercial Milestone Events |
Commercial Milestone Payments |
1. |
[***] |
[***] |
2. |
[***] |
[***] |
3. |
[***] |
[***] |
4. |
[***] |
[***] |
5. |
[***] |
[***] |
|
Total Possible Commercial Milestone Payments Per R&D Program |
$[***] |
Notwithstanding the foregoing, [***]. In no event will the Commercial Milestone Payments set forth in this Section 9.2.3 (Commercial Milestones) exceed [***] If more than one (1) Commercial Milestone Event described in this Section 9.2.3 (Commercial Milestones) occurs during the same
52
Calendar Year with respect to an R&D Program, Novo Nordisk shall pay only the highest applicable Commercial Milestone Payment during such Calendar Year and any lower Commercial Milestone Payment(s) that is not paid during such Calendar Year shall become payable only if [***]. For illustrative purposes only, [***].
Portion of Annual Net Sales, on a Financial Product-by-Financial Product basis |
Royalty Rate |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
By way of example, [***].
9.5.1 No Valid Claim. Notwithstanding Section 9.3 (Royalty Rate), on a country-by-country and Financial Product-by-Financial Product basis, if at any time during the applicable Royalty Term in a country, such Financial Product is not Covered by [***], then the
53
applicable royalty rates set forth in Section 9.3 (Royalty Rate) for such Financial Product in such country shall be reduced by [***].
9.5.2 Generic Competition. On a country-by-country and Financial Product-by-Financial Product basis, if at any time during the Royalty Term for such Financial Product in such country, [***] or more applicable Generic Product(s) are introduced into the market in such country and [***], then [***].
9.5.3 Third Party Payments.
(a) On a country-by-country and Financial Product-by-Financial Product basis, if Novo Nordisk enters into a Novo Third Party Agreement with respect to a Financial Product (or Licensed Compound contained therein), [***], Novo Nordisk shall have the right to deduct [***].
(b) If Novo Nordisk or any of its Affiliates or its or their Sublicensees [***] with respect to a Financial Product under a Novo Third Party Agreement that it believes are a result of a breach by Septerna of this Agreement, then, Novo Nordisk may elect to [***] by providing a written notice to Septerna, in which case, the following shall apply:
(i) Novo Nordisk will provide Septerna with written notice of [***].
(ii) Novo Nordisk shall not [***] that is [***] by Novo Nordisk [***];
(iii) If Septerna notifies Novo Nordisk in writing that it disputes Novo Nordisk’s assertion that Septerna is in breach of this Agreement or Novo Nordisk’s [***], then, unless the Parties resolve such dispute pursuant to Section 17.2 (Resolution by Executive Officers), (A) either Party shall have the right to initiate the dispute resolution process in accordance with Section 17.3 (Arbitration) and (B) pending such dispute resolution, [***]. In the event that it is finally determined pursuant to Section 17.3 (Arbitration) that: (X) Septerna is in breach of this Agreement and Novo Nordisk is entitled to [***], then, Novo shall have the right to [***]; (Y) Septerna is in breach of this Agreement but [***] as a result of such breach, then Novo Nordisk will [***] and thereafter, Novo Nordisk shall have the right to [***]; or (Z) Septerna is not in breach of this Agreement, then Novo Nordisk will [***]. For clarity, this Section 9.5.3 (Third Party Payments) applies only with respect to [***].
(iv) If it is finally determined pursuant to Section 17.3 (Arbitration) that Septerna has committed an uncured material breach of this Agreement and Novo Nordisk is entitled to invoke its right under Section 16.4 (Alternative Remedies in Lieu of Termination) and as a result of such uncured material breach, Novo Nordisk or any of its Affiliates or its or their Sublicensees enters (or has entered) into a Novo Third Party Agreement, then, notwithstanding Section 9.5.3(b)(iii), if Novo Nordisk exercises its right under Section 16.4 (Alternative Remedies in Lieu of Termination) for such uncured material breach, Novo Nordisk shall [***]. After Novo Nordisk exercises its right under Section 16.4 (Alternative Remedies in Lieu of Termination), Novo Nordisk shall [***].
9.5.4 Inflation Reduction Act Deductions. If, during the Royalty Term for a Financial Product, such Financial Product is designated as a Selected Drug by the Secretary of the
54
U.S. Department of Health and Human Services, and Novo Nordisk is required to negotiate a Maximum Fair Price that will apply to sales of such Financial Product, then, commencing on the date that the Maximum Fair Price is made public for such Financial Product in the United States, the applicable royalty rates set forth in Section 9.3 (Royalty Rate) for such Financial Product in the United States shall be reduced by [***]. The foregoing provision will not be subject to the royalty reduction floor set forth in Section 9.5.5 (Payment Floor).
9.5.5 Payments Floor. The payment reductions set forth in this Section 9.5 (Payment Step-Downs) shall be applied [***].
9.5.6 Carry Forward. [***].
55
9.13.1 the Party requesting such audit shall give the Audited Party at least [***] prior written notice specifying when its Auditor shall visit the Audited Party;
56
9.13.2 at least [***] prior to inspecting any records, the Auditor must have executed a confidentiality agreement with the Audited Party in a form that is reasonably satisfactory to the Audited Party;
9.13.3 the Audited Party shall make its books and records available for review by the Auditor solely to the extent necessary to verify that the payments made by the Audited Party under this Agreement were correctly determined;
9.13.4 all books and records made available for inspection or audit hereunder shall be deemed to be the Confidential Information of the Audited Party;
9.13.5 the Audited Party shall provide the foregoing access to the Auditor during the regular business hours of the place(s) where the applicable books and records are usually kept; while inspecting such books and records, the Auditor must abide by all of the Audited Party’s applicable standard rules and regulations;
9.13.6 at the conclusion of such audit, the Auditor shall prepare and deliver to each Party a report solely setting out whether the payments made by the Audited Party under this Agreement were correctly determined and, only if not, the specific details concerning any discrepancies thereof, which report shall be delivered no later than [***] after the audit has been completed; provided that the Auditor shall share its findings with the Audited Party prior to delivering such report in order for the Audited Party to discuss in good faith with the Auditor any discrepancies therein; provided, further that, for clarity, no other information will be provided to the auditing Party without the prior written consent of the Audited Party;
9.13.7 any report provided by the Auditor in connection with an audit under this Section 9.13 (Audit Right) shall be deemed Confidential Information of the Audited Party, and the auditing Party shall keep confidential such report and any other information received or learnt in connection with the audit;
9.13.8 no Calendar Year will be subject to audit under this Section 9.13 (Audit Right) more than [***] and no audit may cover any period that is more than [***] prior to the date of such requested audit;
9.13.9 should any Auditor report reveal an Audited Party payment discrepancy to the detriment of the Party requesting the audit, the Audited Party will, within [***] after receipt of such report from the Auditor, pay any undisputed amount of such discrepancy, and should any Auditor report reveal an Audited Party payment discrepancy to the Audited Party’s detriment, the Audited Party may, at its sole discretion, require the Party requesting the audit to repay the Audited Party such amount of the discrepancy within [***] after receipt of such report from the Auditor or credit and offset such amount of the discrepancy against future payments payable to the Party requesting the audit under this Agreement; and
9.13.10 the Party requesting the audit will pay the full cost of any audit pursued under this Section 9.13 (Audit Right) unless there is an undisputed underpayment of amounts due to the Party requesting the audit that is greater than [***], in which case, the Audited Party will pay the cost charged by the Auditor for such audit.
57
9.14.1 Income Tax. Each Party shall be solely responsible for the payment of any and all Taxes levied on the payments such Party receives under this Agreement.
9.14.2 Withholding Tax. The Parties agree to use reasonable efforts to avoid double taxation or similar obligations in respect of upfront, royalties, milestone payments and other payments made by each Party to the other Party under this Agreement. To the extent either Party (the “Paying Party”) is required under Applicable Law to deduct and withhold Taxes on any payment to the other Party (the “Recipient”) under this Agreement, the Paying Party shall (a) deduct those withholding Taxes and any applicable interest and penalties from the applicable payment or from any other payment owed by the Paying Party; (b) pay the amount of such withholding taxes, interest and penalties to the appropriate Governmental Authority in a timely manner; and (c) send to the Recipient evidence of such payment and related Governmental Authority receipt or certificate, to the extent available. The Paying Party will use reasonable efforts to provide the Recipient with advance notice prior to withholding any Taxes from payments payable to the Recipient. The Recipient will provide the Paying Party any tax forms that may be reasonably necessary in order for the Paying Party to withhold Tax at a reduced rate under an applicable bilateral income tax treaty, to the extent the Paying Party is legally able to do so. Each Party will provide the other Party with reasonable assistance to enable the recovery or reduction, as permitted by Applicable Law, of appropriate amounts from withholding taxes or similar obligations in connection with payments made under this Agreement. [***].
9.14.3 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar Taxes (the “Indirect Taxes”). If any Indirect Taxes are chargeable in respect of any payments under Applicable Law, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an invoice in the appropriate form issued by the receiving Party in respect of those payments and indicating applicable Indirect Taxes. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by the receiving Party to receive a refund of these undue Indirect Taxes from the applicable Governmental Authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to the receiving Party will be transferred to the paying Party within [***] of receipt.
9.14.4 Tax Responsibilities. Any Tax resulting from the execution and performance of this Agreement will be borne by the Parties in accordance with Applicable Laws. Septerna has provided or will provide to Novo Nordisk a copy of its current Form 6166 (or a substantially similar form that demonstrates taxable entity status).
9.14.5 Tax Benefits. The Parties will use reasonable efforts to provide, and to cause their respective Affiliates, subcontractors, (sub)licensees/Sublicensees, customers and other applicable Third Parties to provide, any information and documentation reasonably requested by the other Party, at such other Party’s cost and expense, to obtain the benefits of any current or
58
future tax legislation (e.g. Section 250 of the Internal Revenue Code of 1986, as amended and the applicable Treasury Regulations) that could provide a material tax benefit to either Party.
10.3.1 General. As between the Parties, subject to the terms and conditions of this Agreement, including the licenses granted under Section 8.2 (Licenses to Novo Nordisk) and, with respect to Septerna, its exclusivity obligations under Article 6 (Exclusivity), (a) each Party will own the entire right, title and interest in, to and under the intellectual property rights (i) owned or Controlled by such Party at the Effective Date (including Compounds from such Party’s chemical libraries) or (ii) first developed, created, conceived or reduced to practice solely by or on behalf of such Party independently of this Agreement, without the direct or indirect use of or access to any the other Party’s Confidential Information, (b) Septerna shall own and retain all right, title and interest in and to any and all Know-How first developed, created, conceived or reduced to practice solely by or on behalf of Septerna or its Affiliates in the course of activities conducted under or in connection with this Agreement, and any and all Patent Rights to the extent Covering such Know-How and other intellectual property rights with respect thereto; (c) Novo Nordisk shall own and retain all right, title and interest in and to any and all Know-How first developed, created, conceived or reduced to practice solely by or on behalf of Novo Nordisk or its Affiliates in the course of activities conducted under or in connection with this Agreement, and any and all Patent
59
Rights to the extent Covering such Know-How and other intellectual property rights with respect thereto; and (d) the Parties shall each own and retain an equal, undivided interest in all right, title and interest in and to any and all Know-How first developed, created, conceived or reduced to practice jointly by Novo Nordisk or its Affiliates, on the one hand, and by Septerna or its Affiliates, on the other hand, in the course of activities conducted under or in connection with this Agreement (“Joint Know-How”) and any and all Patent Rights to the extent Covering the Joint Know-How (“Joint Patents”) and other intellectual property rights with respect to the Joint Know-How (collectively, together with the Joint Know-How and Joint Patents, “Joint IP”); provided that, [***]. The Parties acknowledge and agree that this Agreement will be understood to be a “joint research agreement” (as defined in 35 U.S.C. § 100(h)) for the purposes of 35 U.S.C. §102(c) entered into for the purpose of researching, identifying and developing Licensed Compounds or Licensed Products under the terms set forth herein. Subject to the terms and conditions of this Agreement, including the licenses granted under Section 8.2 (Licenses to Novo Nordisk), Article 13 and, in the case of Septerna, its exclusivity obligations hereunder, each Party shall have the right to Exploit the Joint IP without a duty of seeking consent or accounting to the other Party and each Party shall grant and hereby does grant to the other Party all further permissions, consents and waivers with respect to, and all licenses under, any Joint IP throughout the world necessary to provide the other Party with full rights of use and Exploitation of such Joint IP subject to the foregoing. For clarity, for the purpose of Article 10, neither Party or its Affiliates, or its or their (sub)licensees/Sublicensees, shall be considered a (sub)licensee (or, with respect to Novo Nordisk, a Sublicensee) of the other Party or its Affiliates.
10.3.2 Assignment. Each Party shall, and does hereby, assign to the other Party and will cause each of its (and its Affiliates’ and (sub)licensees/Sublicensees’) officers, directors, employees, agents and contractors to assign to the other Party, in each case free and clear of all restrictions, liens or other encumbrances and without additional compensation, all such right, title and interest in and to any Know-How (including inventions) developed, created, conceived or reduced to practice hereunder as is necessary to fully effect the sole or joint ownership, as applicable, provided for in Section 10.3.1(b) through Section 10.3.1(d) (General) (including in the event that U.S. law does not apply to the development, creation, conception or reduction to practice of any Know-How (including inventions) hereunder or any intellectual property rights therein).
10.3.3 Covenants in Support of Assignment. Each Party shall take (and cause its Affiliates and its and their (sub)licensees/Sublicensees, and their respective officers, directors, employees, agents and contractors to take) such further actions reasonably requested by the other Party, at the requesting Party’s cost and expense (except as provided in Section 10.3.5 ([***])), to evidence such assignment set forth in Section 10.3.2 (Assignment) and to assist the other Party in obtaining Patent Rights and other intellectual property protection with respect to Know-How first developed, created, conceived or reduced to practice under or in connection with this Agreement, and, [***], including executing further assignments, consents, releases and other commercially reasonable documentation and providing good faith testimony by affidavit, declaration, in-person or other proper means in support of any effort by the other Party to establish, perfect, defend or enforce its rights in any such Know-How or Patent Rights Covering such Know-How through prosecution of governmental filings, regulatory proceedings, litigation and other means, including through the filing, prosecution and maintenance of Patent Rights. Without limiting the foregoing, each Party will cooperate with the other Party, at such other Party’s cost and expense ([***])), if the other Party applies for U.S. or foreign patent protection for inventions within such Know-How
60
in accordance herewith and will use its reasonable efforts to obtain the cooperation of the individual inventors of any such inventions. If a Party is unable to assign the applicable interest in any Know-How or Patent Rights to the other Party as required by Section 10.3.2 (Assignment), then such Party hereby grants and agrees to grant (and shall cause its Affiliates and (sub)licensees/Sublicensees to grant) to the other Party a royalty-free, fully paid-up, worldwide, perpetual, irrevocable license (with the right to grant sublicenses through multiple tiers) under such Know-How and Patent Rights, which license shall be exclusive (even as to such granting Party) with respect to Know-How and Patent Rights that are solely owned by the other Party as set forth in Section 10.3.1(b) and non-exclusive with respect to the Know-How and Patent Rights that are jointly owned by the Parties as set forth in Section 10.3.1(c), in each case, for any and all purposes.
10.3.4 Control of Intellectual Property. Each Party shall not, and shall cause its Affiliates not to, enter into or amend any agreement with a Third Party, or include in any such agreement or amendment any restrictive provisions, with an intent to limit its Control of, or to not Control, any Know-How, Patent Right or other intellectual property right that would otherwise be subject to the license grants in this Agreement or would constitute R&D Plan Technology in the absence of such agreement, amendment or restrictive provisions. Further, when entering into any agreement or amendment with a Third Party relating to any Know-How, Patent Rights or other intellectual property rights that, if Controlled by a Party or its Affiliates, would be subject to the license grants in this Agreement or would constitute R&D Plan Technology, such Party shall and shall cause its Affiliates to use good faith efforts to obtain Control of such Know-How, Patent Rights and other intellectual property rights.
10.3.5 [***].
10.4.1 Second Generation Product Patents. Following the Effective Date, Septerna shall have the right and authority to prepare, file, prosecute and maintain any Existing Septerna Patents (excluding the Shared Septerna Patents, which are subject to Section 10.4.4 (Shared Septerna Patents)) and will consult with Novo Nordisk to identify Existing Septerna Patents that Cover one (1) or more Licensed Compound(s), and, following such consultation, shall coordinate with Novo Nordisk to file, prosecute and maintain (until transfer of such prosecution to Novo Nordisk) continuation, continuation-in-part or divisional applications claiming priority to any such Existing Septerna Patent, which continuation, continuation-in-part or divisional applications (a) specifically Cover the composition of, formulations containing, or any methods of using a Licensed Compound or Licensed Product containing such Licensed Compound and (b) do not Cover the composition of, formulations containing, or any methods of using, any Compounds Directed Against [***] that are not Licensed Compounds (including, for clarity, any [***]) (“Second Generation Product Patents”). Septerna shall take all reasonable steps to file Second Generation Product Patents with the objective of maximizing patent protection with respect to the Licensed Compounds and Licensed Products in the Field in the Territory. If, with respect to any Licensed Compound and an Existing Septerna Patent Covering such Licensed Compound in a country in the Territory, Septerna is unable to secure any such Second Generation Product Patent that Covers as a composition of matter such Licensed Compound and there is no New Product Patent in such country that Covers as a composition of matter such Licensed Compound, then such
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Existing Septerna Patent will constitute a Shared Septerna Patent and the provisions of Section 10.4.4 (Shared Septerna Patents) will apply with respect thereto.
10.4.2 Septerna’s Rights. As between the Parties, Septerna shall have the sole right and authority, but not the obligation, to prepare, file, prosecute and maintain all Septerna Patents (other than Product Patents and [***]) (each, a “Septerna Other Patent”) on a worldwide basis, and to be responsible for any related interference, re-issuance, re-examination, inter partes review, opposition proceeding or other action challenging any such patent in any patent office of competent jurisdiction (collectively, “Prosecution and Maintenance” and the term “Prosecute and Maintain” shall have the corollary meaning), in each case, at Septerna’s sole cost and expense; provided that Septerna shall not, without Novo Nordisk’s prior written consent (not to be unreasonably withheld, conditioned or delayed), Prosecute and Maintain any Patent Right (other than an Existing Septerna Patent or a Product Patent solely as permitted by and in accordance with this Agreement) that Covers any Licensed Compound published, in the public domain or otherwise known to Septerna or any of its Affiliates. In undertaking such activities, Septerna shall keep Novo Nordisk reasonably informed of material communications with the relevant patent offices with respect to any such Septerna Other Patents, and provide Novo Nordisk a reasonable opportunity to comment thereon (which Novo Nordisk shall do promptly) and consider Novo Nordisk’s comments in good faith.
10.4.3 Novo Nordisk’s Rights. As between the Parties, Novo Nordisk shall have the first right and authority, but not the obligation, to Prosecute and Maintain all Product Patents (excluding the Shared Septerna Patents, which are subject to Section 10.4.4 (Shared Septerna Patents)), [***] and Joint Patents on a worldwide basis, at Novo Nordisk’s sole cost and expense (except to the extent shared as Operating Profits or Losses for the Profit Share Product, if any). In undertaking such activities, Novo Nordisk shall keep Septerna reasonably informed of material communications with the relevant patent offices, and provide Septerna a reasonable opportunity to comment thereon (which Septerna shall do promptly) and consider Septerna’s comments in good faith. If Novo Nordisk decides, in its sole discretion, to allow any such Product Patent, [***] or Joint Patent to lapse, then Novo Nordisk shall notify Septerna in writing and Septerna shall have the right to take over the Prosecution and Maintenance of such Product Patent, [***] or Joint Patent, as applicable, at its sole cost and expense; provided that Septerna may not exercise its right to pursue or continue Prosecution and Maintenance of such Product Patents, [***] or Joint Patents without Novo Nordisk’s prior written consent (not to be unreasonably withheld, conditioned or delayed). The foregoing shall not prevent Septerna from filing divisionals or continuations of Product Patents, [***] or Joint Patents that only Cover [***].
10.4.4 Shared Septerna Patents. With respect to each Shared Septerna Patent in a country, the Parties shall jointly determine the Prosecution and Maintenance strategy for such Shared Septerna Patent with the goal of maximizing protection thereunder for both the Licensed Compounds and Licensed Products, on the one hand, and [***] Covered by such Shared Septerna Patent that are not Licensed Compounds or Licensed Products, on the other hand, in such country. The Parties may, by mutual agreement, designate [***] of the Parties to lead the Prosecution and Maintenance of each Shared Septerna Patent in such country as an administrative matter, provided that all substantive decisions with respect to such Prosecution and Maintenance will be subject to mutual agreement of the Parties, and, provided, further, that, in undertaking such activities, the lead Party shall keep the other Party reasonably informed of material communications with the
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relevant patent offices, and provide the other Party a reasonable opportunity to comment thereon (which the other Party shall do promptly) and incorporate the other Party’s comments thereto. Any disputes with respect to the Prosecution and Maintenance of any such Shared Septerna Patent (each, a “Shared Septerna Patent Matter”) may be submitted by either Party to a Third Party Patent Expert for binding resolution in accordance with Schedule 10.4.4.
10.4.5 Cooperation. The non-Prosecuting Party shall, and shall cause its Affiliates to, assist and cooperate with the Prosecuting Party, as such Prosecuting Party may reasonably request from time to time and at the Prosecuting Party’s cost and expense, in connection with its activities set forth in this Section 10.4 (Patent Prosecution and Maintenance) or otherwise with respect to Prosecution and Maintenance by Novo Nordisk (or its Affiliate or its or their Sublicensee) of any other Patent Right that Covers a Licensed Compound or Licensed Product or the Exploitation thereof under this Agreement (and in which case, Novo Nordisk shall be deemed to be a Prosecuting Party), including to (a) obtain and deliver to the Prosecuting Party any records, documents (including laboratory notebooks) and other evidence, in each case, to the extent reasonable necessary for the Prosecuting Party to prosecute its applicable Patent Rights; provided that in no event shall the foregoing require Septerna to deliver any records, documents or other evidence that are unrelated to Licensed Compounds or Licensed Products or the Exploitation thereof, including any records, documents or other evidence embodying the Septerna Platform that do not contain any information related to any Licensed Compounds or Licensed Products or the Exploitation thereof; (b) make the inventor(s) and its other employees available at reasonable business hours, (c) render all signatures that will be necessary in connection with all such patent filings and (d) assist the Prosecuting Party in all other reasonable ways that are necessary or reasonably useful for the issuance of such Patent Rights, as well as for the Prosecution and Maintenance of such Patent Rights. For clarity, unless otherwise set forth above, as between the Parties, each Party will control, at its sole cost and expense (except to the extent shared as Operating Profits or Losses for the Profit Share Product, if any), and in its sole discretion, the Prosecution and Maintenance of Patent Rights owned or controlled by such Party. Without limiting the last sentence of Section 10.4.1 (Septerna’s Rights), the Parties will, and will cause their Affiliates to, cooperate and implement reasonable patent filing and prosecution strategies (including filing divisionals, continuations or otherwise) so that, to the extent reasonable and feasible, (x) Product Patents, on the one hand, and (y) other Septerna Patents Covering compounds and products that are not Licensed Compounds or Licensed Products, on the other hand, are pursued in mutually exclusive patent applications (which may be simultaneously filed) where reasonably practicable.
10.4.6 Patent Term Extension and Supplementary Protection Certificate. As between the Parties, in relation to the Licensed Products, Novo Nordisk shall have the sole right to make decisions regarding, and to apply for, at Novo Nordisk’s sole cost and expense (except to the extent shared as Operating Profits or Losses for the Profit Share Product, if any), patent term extensions in the Territory, including the U.S. with respect to extensions pursuant to 35 U.S.C. §156 et. seq. and in other jurisdictions pursuant to supplementary protection certificates, and in all jurisdictions with respect to any other extensions that are now or become available in the future, wherever applicable (collectively, the “Extensions”), in each case including whether or not to do so; provided that Novo Nordisk shall not apply for any Extension with respect to a Septerna Other Patent without Septerna’s prior written consent. Septerna shall provide prompt and reasonable assistance with respect thereto, as requested by Novo Nordisk and at Novo Nordisk’s cost and
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expense, including by taking such action as patent holder as is required under any Applicable Laws to obtain such Extensions. [***]. For clarity, this Section 10.4.6 (Patent Term Extension and Supplementary Protection Certificate) only applies to Extensions relating to a Licensed Product.
10.5.1 Notice. During the Term, the Parties will promptly notify each other in writing if either Party becomes aware of any suspected, threatened or actual infringement by any Third Party of any Septerna Patents, [***] or Joint Patents arising from the making, using, offering to sell, selling or importing a product in the Field in the Territory that is Directed Against one (1) or more Collaboration Target(s), including a Generic Product (a “Competing Infringement”). Each Party will provide any available evidence of such Competing Infringement with such notification.
10.5.2 Enforcement Rights.
(a) Novo Nordisk’s Rights. As between the Parties, Novo Nordisk shall have the first right, but not the obligation, to initiate and control an infringement, misappropriation or other appropriate suit or action (and “Infringement Action”) against any Competing Infringement with respect to the Septerna Patents, [***] and Joint Patents, at Novo Nordisk’s sole discretion and at Novo Nordisk’s sole cost and expense (except to the extent shared as Operating Profits or Losses for the Profit Share Product, if any); provided that, Novo Nordisk shall not [***]). Without limiting the foregoing, Novo Nordisk shall keep Septerna reasonably informed of such Infringement Action and shall consider Septerna’s comments in good faith.
(b) Septerna Step-In Rights. During the Term, if Novo Nordisk fails to initiate an Infringement Action against, and is not engaged in settlement discussions with respect to, any Competing Infringement with respect to any Septerna Patents, [***] or Joint Patents within [***] after written notice of such Competing Infringement is first provided by a Party under Section 10.5.1 (Notice), or elects not to continue to pursue an Infringement Action or any settlement with respect thereto, then Septerna will have the right to initiate and control an Infringement Action with respect to such Competing Infringement by counsel of its own choice, at its own discretion and at Septerna’s sole cost and expense, and Novo Nordisk will have the right, at its sole cost and expense, to be represented in any such action by counsel of its own choice; provided that if Novo Nordisk notifies Septerna during such [***] period that it is electing in good faith not to institute any Infringement Action against such Competing Infringement for strategic reasons, then Septerna will not have the right to initiate and control any Infringement Action with respect to such Competing Infringement.
(c) Settlement. The Party controlling an Infringement Action in accordance with this Section 10.5.2 (Enforcement Rights) shall have the right to settle such claim; provided that neither Party shall settle an Infringement Action in a manner that has a material adverse effect on the rights or interests of the other Party (including any of its Patent Rights) or in a manner that imposes any costs or liability on or involves any admission by, the other Party, without the express written consent of such other Party (which consent will not be unreasonably withheld, conditioned or delayed); and provided, further, that (i) Septerna’s consent will not be required under the foregoing proviso (and, if such consent is otherwise required, it will be deemed
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unreasonable for Septerna to withhold such consent) solely on the grounds that such settlement permits a Generic Product to commercially launch in any country(ies) in the Territory and (ii) the foregoing limitation shall not be deemed to require the consent of such other Party in connection with a settlement of any action that would or may result in reduced payments hereunder as permitted under Article 9 (Financial Provisions) or that would or may impose an obligation on Septerna after termination of this Agreement with respect to the applicable Reverted Product in the applicable country pursuant to Section 16.3.2.
(d) Recoveries. If either Party recovers monetary damages from any Third Party in an Infringement Action brought under this Section 10.5.2 (Enforcement Rights), or any royalties, milestones or other payments from a license agreement with a Third Party related to such Competing Infringement, then such recovery shall be allocated first [***], and any remaining amounts shall thereafter be (i) if Novo Nordisk is the controlling Party, [***], or (ii) if Septerna is the controlling Party, [***].
10.5.3 Procedures. Each Party shall bear all of its own internal costs and expenses incurred in connection with its activities under this Section 10.5 (Enforcement of Patents) (except to the extent shared as Operating Profits or Losses for the Profit Share Product, if any). In the event that the Parties are joined in suit or action against a Competing Infringement or the non-enforcing Party elects to join such suit or action and, in either case, elects to be represented by the same outside counsel as the enforcing Party, then the enforcing Party shall be responsible for all expenses arising from such outside counsel; provided that the enforcing Party consents to such joint representation by outside counsel, such consent not to be unreasonably withheld, delayed or conditioned. For clarity, the enforcing Party may reasonably withhold consent where such Party has a good faith basis to believe there is a conflict with the non-enforcing Party. The Party not bringing an action with respect to the infringement in the Territory under this Section 10.5 (Enforcement of Patents) shall be entitled to separate representation in such matter by counsel of its own choice and at its sole cost and expense, but such Party shall at all times cooperate fully with the Party bringing such action. Unless otherwise set forth herein, the Party entitled to bring any Infringement Action in accordance with this Section 10.5 (Enforcement of Patents) shall have the right to settle such Infringement Action; provided that Septerna shall not have the right to settle any Competing Infringement under this Section 10.5 (Enforcement of Patents) without the express written consent of Novo Nordisk (which consent shall not be unreasonably withheld, conditioned or delayed).
10.5.4 Cooperation. If a Party controls an action for infringement, including an Infringement Action, arising from the making, using, offering to sell, selling or importing a product in the Field in the Territory that is Directed Against one (1) or more Collaboration Target(s), including a Generic Product, the other Party shall, and shall cause its Affiliates to, reasonably assist and cooperate with the controlling Party, at the controlling Party’s cost and expense, as such controlling Party may reasonably request from time to time, in connection with its activities in such action, including where necessary, furnishing a power of attorney solely for such purpose or joining in, or being named as a necessary party to, such action, providing access to relevant documents (including laboratory notebooks) and other evidence and making the inventors and its other employees available at reasonable business hours.
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10.6.1 Notice. If the Exploitation of a Licensed Compound or Licensed Product in the Territory pursuant to this Agreement results in, or is reasonably expected to result in, any claim, suit or proceeding by a Third Party alleging infringement by a Party or any of its Affiliates or its or their (sub)licensees/Sublicensees, distributors or customers (“Third Party Action”), including any defense or counterclaim in connection with an enforcement action initiated pursuant to Section 10.5 (Enforcement of Patents), the Party first having notice of such Third Party Action shall promptly notify the other Party.
10.6.2 Defense. As between the Parties, [***] shall have the first right, but not the obligation, to defend any such Third Party Action, at [***] sole cost and expense (except to the extent shared as Operating Profits or Losses for the Profit Share Product, if any). If [***] does not take any steps to defend or settle a Third Party Action within [***] from any notice of such Third Party Action, then [***] shall have the right and option to do so at its sole cost and expense upon providing a written notice to [***]; provided that any action by [***] to eliminate the Third Party Action under this Section 10.6 (Infringement of Third Party Rights in the Territory) shall not be inconsistent with [***] global patent defense strategy. Where a Party controls a Third Party Action, the other Party shall, and shall cause its Affiliates to, reasonably assist and cooperate with the controlling Party, as such controlling Party may reasonably request from time to time, in connection with its activities set forth in this Section 10.6 (Infringement of Third Party Rights in the Territory), including furnishing a power of attorney solely for such purpose or joining in, or being named as a necessary party to, such action, providing access to relevant records, documents (including laboratory notebooks) and other evidence and making inventors and other of its employees available at reasonable business hours.
10.6.3 Settlement. The Party entitled to defend a Third Party Action in accordance with this Section 10.6 (Infringement of Third Party Rights in the Territory) shall have the right to settle such claim; provided that neither Party shall settle a Third Party Action in a manner that has a material adverse effect on the rights or interests of the other Party (including any of its Patent Rights) or in a manner that imposes any costs or liability on or involves any admission by, the other Party, without the express written consent of such other Party (which consent will not be unreasonably withheld, conditioned or delayed); and provided, further, that the foregoing limitation shall not be deemed to require the consent of such other Party in connection with a settlement of any action that would or may result in reduced payments hereunder as permitted under Article 9 (Financial Provisions) or that would or may impose an obligation on Septerna after termination of this Agreement with respect to the applicable Reverted Product in the applicable country pursuant to Section 16.3.2.
10.6.4 Third Party Agreements.
(a) If Novo Nordisk determines that it is necessary or reasonably useful for Novo Nordisk or its Affiliates or its or their Sublicensees to acquire any Know-How, Patent Rights or other intellectual property right from a Third Party, or, [***], in either case, in connection with the Development, Manufacture, Commercialization or other Exploitation of a Licensed Compound or Licensed Product in the Territory (such right, a “Third Party Right”), then, as between the Parties, except with respect to agreements entered into by Septerna in accordance with Section 10.6.4(b), Novo Nordisk or its Affiliates or its or their Sublicensees shall have the sole right (but not the obligation) in its sole discretion to obtain a license or other rights to, or acquire
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(whether by license, exercise of option, acquisition or otherwise) from such Third Party, such Know-How, Patent Right or other intellectual property right with respect to Development, Manufacture, Commercialization or other Exploitation of a Licensed Compound or Licensed Product in the Territory. In the event that Novo Nordisk, any of its Affiliates or any of its or their Sublicensees negotiates and obtains any such license or other right to, or acquires (whether by license, exercise of option, acquisition or otherwise) from a Third Party any Know-How, Patent Right or other intellectual property right, in each case, necessary or reasonably useful to Develop, Manufacture, Commercialize or otherwise Exploit Licensed Compounds or Licensed Products in the Territory (each, a “Novo Third Party Agreement”), Novo Nordisk shall be entitled to deduct amounts payable to such Third Party from payments to Septerna hereunder in accordance with Section 9.5.3 (Third Party Payments).
(b) Notwithstanding the foregoing, Septerna or its Affiliates shall have the sole right to negotiate with a Third Party a Third Party Right that is specific to the Septerna Platform and is not limited to or specific to compounds or products Directed Against one (1) or more Collaboration Targets. If Septerna obtains any such Third Party Right with respect to the Septerna Platform that (1) is actually used in, or otherwise necessary or reasonably useful to conduct, an R&D Program or (2) is necessary to Exploit a Licensed Compound (each of (1) and (2), a “Necessary Third Party Right”), then (i) such Necessary Third Party Right shall automatically be deemed to be “Controlled” by Septerna and included in the licenses granted to Novo Nordisk under Section 8.2 (Licenses to Novo Nordisk), (ii) any license with respect to such Necessary Third Party Right shall be fully consistent with this Agreement (including that any such license shall not impose any additional obligations on Novo Nordisk), and (iii) Septerna shall be responsible for all payments to any such Third Party with respect to such Necessary Third Party Right.
(c) If Septerna obtains rights to any Third Party Right that is useful to Exploit any Licensed Compound, but is not a Necessary Third Party Right (a “Other Third Party Right”), then, to the extent such rights are sublicensable to Novo Nordisk, (i) following the effectiveness of the applicable Third Party agreement pursuant to which Septerna has obtained such Other Third Party Right, Septerna will provide prompt written notice to Novo Nordisk disclosing the existence of such agreement, the Other Third Party Right covered by such agreement and any additional obligations (including payment obligations) under such agreement that would apply to Novo Nordisk as a sublicensee thereunder if Novo Nordisk were to receive a sublicense under such Other Third Party Right (a “Third Party IP Notice”) and (ii) Novo Nordisk may elect, by written notice to Septerna, to receive a sublicense under such Other Third Party Right, in which case, effective as of such notice, (A) such Other Third Party Right shall automatically be deemed to be “Controlled” by Septerna and included in the licenses granted to Novo Nordisk under Section 8.2 (Licenses to Novo Nordisk), (B) Novo Nordisk will comply with those obligations (excluding payment obligations, which are addressed in clause (C)) of Novo Nordisk as a sublicensee under such agreement expressly set forth in the applicable Third Party IP Notice or otherwise disclosed by Septerna to Novo Nordisk in writing in connection with such Third Party IP Notice, and (C) as between the Parties, Septerna will remain solely responsible for payments under such Third Party agreement, except that, solely to the extent the applicable payment obligations are disclosed to Novo Nordisk in writing in, or in connection with, such Third Party IP Notice, Novo Nordisk will be responsible for (1) any royalties payable to such Third Party under such agreement in respect of Net Sales of any Licensed Products that are subject to such sublicense, (2) solely in the case of
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any milestone payment obligations that apply to all products licensed under such Third Party agreement, any milestone payment in respect of any milestone event achieved by Novo Nordisk or any of its Affiliates or Sublicensees with respect to a Licensed Compound or Licensed Product that is subject to such sublicense, and (3) any other payments that are reasonably allocable to a Licensed Compound or Licensed Product and payable to such Third Party under such agreement as a result of Novo Nordisk, its Affiliates or Sublicensees Exploitation of a Licensed Compound or Licensed Product, provided, in the case of this clause (3), that such payment obligations with respect to a Licensed Compound or Licensed Product are no greater than payment obligations with respect to any other compounds or products that are subject to such agreement, in each case ((1)-(3)), on a pass-through basis without any markup. Novo Nordisk shall be entitled to deduct all such amounts paid by Novo Nordisk under the preceding sentence from payments to Septerna hereunder in accordance with Section 9.5.3 (Third Party Payments), as if Novo Nordisk had entered into such Third Party agreement directly. For the avoidance of doubt, if Novo Nordisk does not so elect to receive a sublicense under any Other Third Party Right as set forth in this Section 10.6.4(c), then such Other Third Party Right will not be deemed to be “Controlled” by Septerna or included in the licenses granted to Novo Nordisk under Section 8.2 (Licenses to Novo Nordisk) and Novo Nordisk will not be responsible for any payments with respect thereto.
(d) Notwithstanding anything to the contrary in this Section 10.6.4, neither Septerna nor any of its Affiliates shall enter into an agreement with a Third Party with respect to a Third Party Right (except with respect to Necessary Third Party Rights that are Controlled by Septerna as provided in Section 10.6.4(b)) on terms that would prevent Novo Nordisk from obtaining a license with respect to such Third Party Right directly from such Third Party to Develop, Manufacture, Commercialize or otherwise Exploit Licensed Compounds and Licensed Products.
10.7.1 Third Party Patents. As between the Parties, Novo Nordisk shall have the sole right, at Novo Nordisk’s sole cost and expense (except to the extent shared as Operating Profits or Losses for the Profit Share Product, if any), to bring an opposition, action for declaratory judgment, nullity action, interference, declaration for non-infringement, reexamination, post-grant proceedings or other attack upon the validity, title or enforceability of a Patent Right owned or controlled by a Third Party and having one (1) or more claims that Cover a Licensed Product, or the use, sale, offer for sale or importation of a Licensed Product (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, a Third Party’s claim or assertion of infringement under Section 10.6 (Infringement of Third Party Rights in the Territory), in which case the provisions of Section 10.6 (Infringement of Third Party Rights in the Territory) shall govern). Any awards or amounts received in bringing any such action shall be first allocated to reimburse Novo Nordisk’s costs and expenses in such action, and any remaining amounts shall be allocated between the Parties in accordance with the principles set forth in Section 10.5.2(d) (Recoveries).
10.7.2 Third Party Patent Challenge. If any [***], Joint Patent or Septerna Patent becomes the subject of any proceeding commenced by a Third Party within the Territory in connection with an opposition, reexamination request, post-grant proceeding, action for declaratory judgment, nullity action, interference or other attack upon the validity, title or
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enforceability thereof (a “Third Party Patent Challenge”) (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, an action for infringement against a Third Party under Section 10.5 (Enforcement of Patents), in which case the provisions of Section 10.5 (Enforcement of Patents) shall govern), then the Prosecuting Party for the applicable Patent Rights shall control such defense at its sole cost and expense (except to the extent shared as Operating Profits or Losses for the Profit Share Product, if any). The Prosecuting Party shall permit the non-Prosecuting Party to participate in the proceeding to the extent permissible under Applicable Laws, and to be represented by its own counsel in such proceeding, at the non-Prosecuting Party’s sole cost and expense. If the Prosecuting Party decides that it does not wish to defend against a Third Party Patent Challenge, then the other Party shall have a backup right to assume defense of such Third Party Patent Challenge at its sole cost and expense. Any awards or amounts received in defending any such Third Party Patent Challenge shall be allocated between the Parties in accordance with the principles set forth in Section 10.5.2(d) (Recoveries).
11.1.1 Organization. It is a corporation duly organized, validly existing and in good standing, and is a tax resident, under Applicable Laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement.
11.1.2 Binding Agreement. This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms, subject to the effects of bankruptcy, insolvency or other Applicable Laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity).
11.1.3 Authorization. The execution, delivery and performance of this Agreement by such Party have been duly authorized by all necessary corporate actions and do not conflict with such Party’s charter documents, bylaws or other organizational documents or any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any Applicable Law or any order, writ, judgment, injunction, decree, determination or
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award of any court, governmental body or administrative or other agency, presently in effect applicable to such Party.
11.1.4 No Further Approval. Except for any filings that may be required to comply with Antitrust Laws, it is not aware of any government authorization, consent, approval, license or exemption of or filing or registration with any court or Governmental Authority, domestic or foreign, under any Applicable Law, currently in effect, necessary for, or in connection with, the transactions contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements (save for Regulatory Approvals and similar authorizations from Governmental Authorities necessary for the Research, Development, Commercialization or Exploitation of any Licensed Products as contemplated hereunder).
11.1.5 No Inconsistent Obligations. Neither Party is under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfilment of its obligations hereunder.
11.2.1 Septerna is the sole and exclusive owner of the full legal or beneficial rights, title and interests in the intellectual property and other rights licensed to Novo Nordisk under Section 8.2 (Licenses to Novo Nordisk), and Septerna has the rights necessary to perform the R&D Plans and, to Septerna’s Knowledge, to grant such licenses to Novo Nordisk for the Research, Development, Commercialization, Manufacture and Exploitation of the Licensed Compounds and Licensed Products without additional payment or other consideration for such intellectual property or other rights (other than in accordance with Article 9).
11.2.2 Septerna has not licensed the Septerna Technology (or any component thereof) from any Third Party. Septerna and its Affiliates have not entered into any licensing, option, transfer or similar agreements or arrangements that relate to the ownership or granting rights with respect to (a) the Septerna Platform or Septerna Technology, in each case, in a manner that would conflict with the licenses and rights purported to be granted to Novo Nordisk herein in any material respect or (b) the Regulatory Documentation, Collaboration Targets, Licensed Compounds or Licensed Products (including by granting any covenant not to sue with respect thereto). To Septerna’s Knowledge, the use of the Septerna Platform as contemplated by the R&D Plans and the Development, Manufacture, Commercialization or Exploitation of the Licensed Compounds or Licensed Products as contemplated herein will not be subject to any other license or agreement to which Septerna or any of its Affiliates is a party (other than agreements entered
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into by Septerna or any of its Affiliates pursuant to Section 8.4 (Right to Subcontract) with a Third Party contractor performing for or on behalf of Septerna or its Affiliates, including any contract research organizations or contract manufacturing organizations).
11.2.3 Septerna Controls all Compounds in its or its Affiliates’ ownership or control that are Directed Against one (1) or more Collaboration Targets.
11.2.4 [***].
11.2.5 To Septerna’s Knowledge, Schedule 1.112 sets forth all Compounds Controlled by Septerna or its Affiliates as of the Effective Date that are Directed Against one (1) or more Collaboration Targets (other than [***]). [***].
11.2.6 The intellectual property and other rights licensed to Novo Nordisk under Section 8.2 (Licenses to Novo Nordisk) are not subject to any restrictions, liens or encumbrances that would limit the rights granted or to be granted to Novo Nordisk under this Agreement.
11.2.7 Septerna and its Affiliates have provided or made available to Novo Nordisk (or its designated patent counsel) in all material respects: (a) the file wrapper and other documents and materials relating to the prosecution, defense, maintenance, validity and enforceability of Septerna Patents, (b) all Regulatory Documentation, if any, and (c) except for Septerna Platform, copies of all material and relevant Know-How in its possession regarding the Licensed Compounds and Licensed Products (and, in each case, Exploitation thereof), and the intellectual property and other rights to be licensed to Novo Nordisk under Section 8.2 (Licenses to Novo Nordisk) that would be material to Novo Nordisk’s decision to enter into this Agreement or to continue to Exploit Licensed Compounds and Licensed Products with respect to the applicable R&D Program(s), and to Septerna’s Knowledge, such documents, materials, Regulatory Documentation and Know-How are true, correct and complete in all material respects.
11.2.8 The Patent Rights set forth in Schedule 1.130 represent all Patent Rights that Septerna or any of its Affiliates owns or controls that Cover or disclose any invention that is necessary or reasonably useful for carrying out each R&D Program according to the applicable R&D Plan and for the Research, Development, Commercialization, Manufacture and Exploitation of the Licensed Compounds or Licensed Products in the Territory in the Field with respect to such R&D Program. Such Septerna Patents are subsisting and have not been declared invalid or unenforceable, in whole or in part. Such Septerna Patents are being diligently prosecuted in patent offices in the Territory in accordance with Applicable Laws. Such Septerna Patents have been filed and maintained properly and correctly in all material respects, and all applicable fees have been paid on or before the due date for payment. In respect of the pending patent applications included in such Septerna Patents, in jurisdictions where required, Septerna has presented all relevant references, documents and information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office. Each of such Septerna Patents properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Septerna Patent is issued or such application is pending.
11.2.9 There is no Know-How owned or controlled by Septerna or any of its Affiliates that relates to the Septerna Platform, Licensed Compounds or Licensed Products that is
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not within the Septerna Know-How. The Septerna Know-How has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality. To the Knowledge of Septerna, no breach of such confidentiality has been committed by any Third Party.
11.2.10 Septerna or its Affiliates own or otherwise have the right to use or access all intellectual property or other rights necessary (a) for carrying out the anticipated R&D Plans as of the Execution Date and the Effective Date, and (b) to Septerna’s Knowledge, (i) for the Research, Development, Commercialization and Exploitation of the Licensed Compounds and Licensed Products as contemplated as of the Execution Date, the Effective Date or each Final Report Acceptance Date, as applicable, in accordance with this Agreement and (ii) for granting the licenses under Section 8.2 (Licenses to Novo Nordisk), in each case ((a) and (b)), without additional payment or other consideration for such intellectual property or other rights (other than in accordance with Article 9).
11.2.11 Septerna or its Affiliates have not received any notification of infringement or misappropriation of the Septerna Technology or of any threatened claims or litigation seeking to invalidate or otherwise challenge the Septerna Patents by any Person in the Territory, and there is no pending or, to Septerna’s Knowledge, threatened infringement or misappropriation of the Septerna Technology by any Person in the Territory.
11.2.12 To Septerna’s Knowledge, neither Septerna nor any of its Affiliates, sublicensees or subcontractors have taken any action that would render any invention claimed (or to be claimed) in Septerna Patents unpatentable.
11.2.13 To Septerna’s Knowledge, (a) neither Septerna nor any of its Affiliates, sublicensees or subcontractors, or their respective current or former employees, have misappropriated any of the Septerna Know-How from any Third Party, and Septerna is not aware of any claim by a Third Party that such misappropriation has occurred and (b) no Person has misappropriated or is misappropriating or threatening to misappropriate Septerna Know-How.
11.2.14 Septerna or its Affiliates have not received any notification of, and do not have other Knowledge of, actual claims, disputes, proceedings, challenges or allegations regarding or relating to improper inventorship or ownership of the Septerna Patents.
11.2.15 There are no actual, pending, alleged or threatened adverse actions, suits, administrative proceedings, claims, re-examinations, oppositions, interferences or formal governmental investigations, and Septerna has no Knowledge of any such action, whether or not pending, alleged or threatened, involving the Septerna Platform, Septerna Technology, Regulatory Documentation, Licensed Compounds or Licensed Products in or before any court, Governmental Authority or Regulatory Authority.
11.2.16 (a) Septerna and its Affiliates have not received any notice from any Third Party asserting or alleging that the Research, Development, Commercialization, Manufacture or Exploitation of any Licensed Compound or Licensed Product or the use of the Septerna Platform infringes or misappropriates the intellectual property rights of such Third Party, and (b) to Septerna’s Knowledge, the Research, Development, Commercialization, Manufacture and Exploitation of the Licensed Compounds or Licensed Products in the Field in the Territory
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and the use of the Septerna Platform in accordance with the terms of this Agreement will not infringe or misappropriate the Patent Rights or any other intellectual property or proprietary rights of any Third Party in the Territory.
11.2.17 All employees, agents and subcontractors of, and consultants to, Septerna or its Affiliates are obligated to assign to Septerna or its Affiliate their rights in and to any inventions arising out of their work for Septerna or its Affiliate, either pursuant to written agreement or by operation of Applicable Law, and all current and former officers, employees, agents, advisors, consultants, contractors or other representatives of Septerna or any of its Affiliates who are inventors of or have otherwise contributed in a material manner to the creation or development of any Know-How, Patent Rights or other intellectual property rights that are necessary or reasonably useful to Exploit the Licensed Compounds or Licensed Products, including the Septerna Platform or any Septerna Technology, have executed and delivered to Septerna or any such Affiliate an assignment or other agreement regarding the protection of proprietary information and the assignment to Septerna or any such Affiliate of any such Know-How, Patent Rights or other intellectual property rights. Novo Nordisk shall have no obligation to contribute to any remuneration of any inventor employed or engaged or previously employed or engaged by Septerna or any of its Affiliates in respect of any such inventions, information and discoveries and intellectual property rights thereof that are so assigned to Septerna or its Affiliate(s).
11.2.18 Neither Septerna nor any of its Affiliates, nor any of its or their respective officers, employees or agents has made an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Development of the Licensed Products, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority with respect to the Development of the Licensed Products, or committed an act, made a statement, or failed to make a statement with respect to the Development of the Licensed Products that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory.
11.2.19 Neither Septerna nor any of its Affiliates has been debarred by the FDA, is not subject to any similar sanction of other Governmental Authorities in the Territory, and, to Septerna’s Knowledge, neither it nor any of its Affiliates has used, in any capacity, in connection with the Exploitation of Licensed Compounds or Licensed Products, any Person who either has been debarred by such a Regulatory Authority, or is the subject of a conviction described in Section 306 of the FD&C Act. Septerna is not aware of any conduct or activity that could lead to such debarment actions.
11.2.20 Septerna and its Affiliates and their respective (sub)contractors and consultants have conducted all Development with respect to the Licensed Compounds and Licensed Products (including the generation, preparation, maintenance and retention of all Regulatory Documentation) in accordance with Applicable Laws, including current Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices where applicable. Septerna and its Affiliates have employed Persons with appropriate education, knowledge and experience to conduct, and to oversee the conduct of, such studies and activities.
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11.2.21 The inventions claimed by the Septerna Patents: (a) were not developed, created, conceived or reduced to practice in connection with any Research activities funded, in whole or in part, by the federal government of the United States of America or any agency thereof, (b) are not a “subject invention” as that term is described in 35 U.S.C. Section 201(e) and (c) are not otherwise subject to the provisions of the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401.
11.2.22 Septerna is a taxable Person in the United States and is liable for and subject to U.S. federal taxation in the United States.
11.2.23 Solely as of the applicable Final Report Delivery Date, the applicable Final Report is complete and correct in all material respects.
11.3.1 Within [***] after the Antitrust Clearance Date, Septerna shall provide to Novo Nordisk either (a) an updated Schedule 1.112, an updated Schedule 1.130 and a list of any exceptions to any of the representations and warranties in Section 11.2 (Additional Representations and Warranties by Septerna) existing as of the Effective Date (the “Subsequent Disclosure Schedule”); or (b) a written statement that no such updates are required and all such schedules and representations and warranties, as qualified by the Initial Disclosure Schedule, remain true and correct as of the Effective Date. If (x) any act, omission or event occurring on or after the Execution Date causes any of the representations or warranties in Section 11.2 (Additional Representations and Warranties by Septerna) to be untrue or misleading as of the Effective Date but for any disclosure that Septerna provides in the Subsequent Disclosure Schedule pursuant to this Section 11.3.1; (y) any of the representations or warranties in Section 11.2 (Additional Representations and Warranties by Septerna) were untrue or misleading as of the Effective Date or (z) Septerna or any of its Affiliates breached the covenant set forth in Section 11.4.9, and, in any case ((x) through (z)), such occurrence fundamentally frustrates the purpose of this Agreement for Novo Nordisk, or materially undermines the benefits reasonably expected to be realized under this Agreement by Novo Nordisk, then Novo Nordisk may terminate this Agreement upon written notice to Septerna not later than [***] after Septerna’s delivery of the Subsequent Disclosure Schedule in accordance with this Section 11.3.1; provided that any decision by Novo Nordisk to not terminate this Agreement in accordance with this Section 11.3.1 shall not constitute a waiver with respect to the foregoing clauses (x) through (z) or with respect to any claim that Novo Nordisk may otherwise have in respect of any breach by Septerna of its representations, warranties or covenants. In the event Novo Nordisk terminates this Agreement pursuant to this Section 11.3.1, this Agreement shall terminate and become void and of no further effect as of the date of such notice.
11.3.2 On the Final Report Delivery Date with respect to an R&D Program, Septerna shall provide to Novo Nordisk [***].
11.3.3 For all representations and warranties for which Septerna [***] with respect to such R&D Program to Novo Nordisk as of such Final Report Delivery Date without additional qualification. For the avoidance of doubt, [***]. Septerna acknowledges and agrees that [***].
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11.4.1 Without Novo Nordisk’s prior written consent, Septerna and its Affiliates will not, after the Execution Date, enter into any written or oral contractual obligation with a Third Party that would be inconsistent with its obligations under this Agreement or that would encumber or deprive Novo Nordisk’s benefits or rights granted under this Agreement.
11.4.2 Septerna will not amend, modify, terminate or waive any rights or fail to meet any obligations under any Third Party Services Agreements in a manner that would adversely affect Novo Nordisk’s rights or obligations under this Agreement without Novo Nordisk’s prior written consent. Septerna will not commit any acts or permit the occurrence of any omissions that would cause or result in the termination of any Third Party Services Agreement in its entirety or with respect to any rights under such agreement for which such termination would adversely affect Novo Nordisk’s rights or obligations under this Agreement. Septerna will notify Novo Nordisk of any notification received under any Third Party Services Agreement that would or could be reasonably expected to affect Novo Nordisk’s rights or obligations under this Agreement. Septerna will notify Novo Nordisk in writing (a) within [***] after any termination of any Third Party Services Agreement, and (b) within [***] after any expiration of any Third Party Services Agreement.
11.4.3 Septerna will not amend, modify, terminate or waive any rights or fail to meet any obligations with respect to any intellectual property or other rights (including with respect to any Patent Rights) that are Controlled by Septerna or its Affiliates at any time during the Term and necessary or reasonably useful (a) for carrying out Research and other Development activities according to each R&D Plan and (b) (i) for the Research, Development, Manufacture, Commercialization or Exploitation of Licensed Compounds or Licensed Products in accordance with this Agreement and (ii) for granting the licenses under Section 8.2 (Licenses to Novo Nordisk), in each case ((a) and (b)), in a manner that would adversely affect Novo Nordisk’s rights or obligations under this Agreement (including by incurring additional payment or other costs for such intellectual property or other rights (other than in accordance with Article 9)) without Novo Nordisk’s prior written consent.
11.4.4 Septerna will maintain the rights necessary to grant, and continue to grant (and otherwise take all actions required to so grant, including via obtaining appropriate sublicenses), the licenses to intellectual property and other rights licensed to Novo Nordisk under Section 8.2 (Licenses to Novo Nordisk) (including with respect to any Patent Rights) for the Research, Development, Manufacture, Commercialization and Exploitation of Licensed Compounds and Licensed Products in accordance with Article 8, without additional payment or other consideration for such intellectual property or other rights (other than in accordance with Article 9).
11.4.5 Septerna will not remove or otherwise screen off, or restrict, from use in the R&D Programs any hits identified from, or Compounds included in, the Screening Libraries.
11.4.6 All officers, employees, agents, advisors, consultants, contractors and other representatives of Septerna or its Affiliates will assign to Septerna or its Affiliate their rights in and to any inventions arising out of their work for Septerna or its Affiliate, either pursuant to
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written agreement or by operation of Applicable Laws, and all current and former officers, employees, agents, advisors, consultants, contractors or other representatives of Septerna or any of its Affiliates who are or will be inventors of or have otherwise contributed or will otherwise contribute in a material manner to the creation or development of any Licensed Compounds or Licensed Products or any Septerna Technology or R&D Plan Technology will execute and deliver to Septerna or any such Affiliate an assignment or other agreement regarding the protection of proprietary information and the assignment to Septerna or any such Affiliate of any Septerna Technology or R&D Plan Technology.
11.4.7 Septerna and its Affiliates will perform their obligations under this Agreement, including all activities under the R&D Programs, in a good scientific manner and in accordance with all Applicable Laws, including, to the extent applicable, current Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices and any applicable Privacy and Data Security Laws. All studies to be conducted for any Licensed Compounds or Licensed Products by or on behalf of Septerna will be conducted by Persons with appropriate education, knowledge and experience and in accordance with Applicable Laws, including current Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices where applicable.
11.4.8 Septerna will not use or engage, in any capacity, in connection with this Agreement, any Person who either has been debarred by a Regulatory Authority, or is the subject of a conviction described in Section 306 of the FD&C Act or similar provisions of the laws of other countries. Septerna will inform Novo Nordisk in writing promptly if it or any Person engaged by it or any of its Affiliates who is performing services under this Agreement becomes debarred or is the subject of a conviction described in Section 306 of the FD&C Act, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Septerna’s Knowledge, is threatened, relating to the debarment or conviction of Septerna or any of its Affiliates or any such Person performing services hereunder.
11.4.9 Between the Execution Date and the Effective Date, Septerna shall, and shall cause its Affiliates to (a) conduct its business with respect to the Septerna Platform, Licensed Compounds and Licensed Products and the intellectual property rights to be granted hereunder in the ordinary course consistent with past practice and in accordance with all Applicable Laws, (b) refrain from taking any action or omitting to take any action that would have the effect of restricting or impairing the rights to be granted to Novo Nordisk hereunder or preventing either Party’s ability to perform its obligations under this Agreement, including (i) licensing, transferring, assigning or otherwise disposing of any Septerna Know-How or Septerna Patent, (ii) entering into, modifying, extending, renewing or amending any contract related to the Licensed Compounds or Licensed Products or the intellectual property rights to be granted hereunder or (iii) incurring, creating, assuming or permitting the incurrence, creation or assumption of any encumbrance, lien or claim of ownership by any Third Party with respect to any of the foregoing, in each case ((i)-(iii)), in a manner that would materially limit or impair Novo Nordisk’s rights under this Agreement, (c) not commit any act or permit the occurrence of any omission that would cause any of the representations and warranties of Septerna in Section 11.2 (Additional Representations and Warranties by Septerna) to be untrue or misleading as of the Effective Date and (d) promptly notify Novo Nordisk if it becomes aware that any of the representations or warranties in Section 11.2 (Additional Representations and Warranties by Septerna) are untrue or misleading.
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11.6.1 Antitrust Filing. If Novo Nordisk reasonably determines in good faith that the activities and licenses contemplated under this Agreement require an HSR filing, each of Novo Nordisk and Septerna shall make any such HSR filing in such jurisdiction within [***] (or within such other period as mutually agreed in writing by the Parties) after the Execution Date. If the activities and licenses contemplated under this Agreement require any Antitrust Filings in any other jurisdiction, each of Novo Nordisk and Septerna shall make any such Antitrust filings in such jurisdiction as soon as reasonably practicable. The Parties shall cooperate with one another to the extent necessary in the preparation of any such filings. Each Party shall be responsible for its own costs and expenses associated with any such filings.
11.6.2 Antitrust Clearance. In connection with obtaining Antitrust Clearance, Novo Nordisk and Septerna shall use their respective commercially reasonable efforts to resolve as promptly as practicable any objections that may be asserted by any Antitrust Authority with respect to the transactions notified in the applicable Antitrust Filing. The term “commercially reasonable efforts” as used in this Section 11.6.2 (Antitrust Clearance) shall not require Novo Nordisk or Septerna to (a) agree to any remedy or consent decree with any Governmental Authority, including (i) any remedy to sell, divest (including through a license or a reversion of licensed or assigned rights), hold separate, transfer or dispose of any assets, operations, rights, product lines or businesses, or interests therein, of itself or any of its Affiliates (or consent to any of the foregoing actions) or (ii) any behavioral remedy or (b) litigate or otherwise formally oppose any determination (whether judicial or administrative in nature) by a Governmental Authority seeking to impose any of the restrictions referenced in clause (a) above. Notwithstanding anything to the contrary in this Section 11.6.2 (Antitrust Clearance), Novo Nordisk shall have the principal responsibility for determining and implementing the strategy for obtaining any necessary clearance, consents or approvals under any Antitrust Law (including with respect to timing and potential ways to address any concerns that may be raised) and shall control, lead and direct all submissions to, meetings, negotiations and communications with any Governmental Authority (or other Third Party) in connection therewith; provided that Novo Nordisk shall keep Septerna reasonably informed of summaries of such submissions, meetings, negotiations or communications.
11.6.3 Cooperation. In connection with obtaining Antitrust Clearance, each of Novo Nordisk and Septerna shall (a) cooperate with each other in connection with any
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investigation or other inquiry relating to an Antitrust Filing and the transactions contemplated by this Agreement; (b) keep the other Party or its counsel informed of any communication received from or given to an Antitrust Authority where Antitrust Filings are required, relating to the applicable Antitrust Filing and the transactions contemplated by this Agreement (and provide a copy to the other Party if such communication is in writing); (c) reasonably consult with each other in advance of any meeting or conference with an Antitrust Authority where Antitrust Filings are required, and, to the extent permitted by such Antitrust Authority, give the other Party or its counsel the opportunity to attend and participate in such meetings and conferences; and (d) permit the other Party or its counsel to review in advance, and in good faith consider the views of the other Party or its counsel concerning, any submission, filing or communication (and documents submitted therewith) intended to be given to the applicable Antitrust Authority.
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12.3.1 All indemnification claims in respect of any Septerna Indemnitee or Novo Nordisk Indemnitee seeking indemnification hereunder shall be made solely by such Party to this Agreement (“Indemnified Party”), and the Indemnified Party shall notify the Party against whom indemnification is sought (“Indemnifying Party”) in writing reasonably promptly after the assertion against the Septerna Indemnitee or Novo Nordisk Indemnitee, as applicable, describing, to the extent known, the facts of any Claim in respect of which the Indemnified Party intends to base a claim for indemnification hereunder, but the failure or delay so to notify the Indemnifying Party shall not relieve the Indemnifying Party of any obligation or liability that it may have to the Indemnified Party, except and only to the extent that the Indemnifying Party demonstrates that its ability to defend or resolve such Claim is adversely affected thereby. The Indemnified Party shall furnish promptly to the Indemnifying Party copies of all papers and official documents received in respect of any Losses and Claims.
12.3.2 Subject to the provisions of Section 10.5 (Enforcement of Patents), Section 10.6 (Infringement of Third Party Rights in the Territory), Section 10.7 (Other Invalidity or Unenforceability Proceedings) and Section 12.3.3, the Indemnifying Party shall have the right, upon providing notice to the Indemnified Party of its intent to do so within [***]after receipt of the notice from the Indemnified Party of any Claim, to assume the defense and handling of such Claim, at the Indemnifying Party’s sole cost and expense. If the Indemnifying Party does not assume control of such defense or does not comply with its obligations under Section 12.3.3, the Indemnified Party shall be entitled to control the defense and handling of the Claim at the Indemnifying Party’s sole cost and expense. The assumption of the defense of a Claim by the Indemnifying Party shall not be construed as an acknowledgment that the Indemnifying Party is liable to indemnify the Indemnified Party in respect of the Claim, nor shall it constitute a waiver
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by the Indemnifying Party of any defenses it may assert against the Indemnified Party’s claim for indemnification. If the Indemnifying Party assumes the defense of a Claim, except as provided in Section 12.3.4, the Indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Claim unless specifically requested in writing by the Indemnifying Party. In the event that it is ultimately determined that the Indemnifying Party is not obligated to indemnify, defend or hold harmless the Indemnified Party from and against the Claim, the Indemnified Party shall reimburse the Indemnifying Party for any Losses incurred by the Indemnifying Party in its defense of the Claim. For clarity, if a Claim, or the events giving rise to or resulting in such Claim, are subject to Article 10 and Section 12.1 (Indemnification by Novo Nordisk) or Section 12.2 (Indemnification by Septerna), then Article 10 shall apply with respect to the defense of such Claim and Section 12.1 (Indemnification by Novo Nordisk) or Section 12.2 (Indemnification by Septerna), as applicable, shall apply with respect to the allocation of financial responsibility for the related Losses.
12.3.3 If the Indemnifying Party does not assume control of such defense or does not comply with its obligations under Section 12.3.4, the Indemnified Party shall be entitled to control the defense and handling of the Claim at the Indemnifying Party’s sole expense. If national procedural rules prevent the Indemnifying Party from managing and controlling the defense of a Claim and its settlement, the Indemnified Party shall to the extent necessary cooperate with the Indemnifying Party to manage and control the defense of such Claim and its settlement; provided, however, that the Indemnifying Party shall have the right to make all decisions relevant for the defense of such Claim and its settlement.
12.3.4 If the Indemnifying Party elects to assume the defense and handling of the Claim: (a) the Indemnifying Party shall select competent counsel in connection with conducting the defense and handling of such Claim, and the Indemnifying Party shall defend or handle the same in consultation with the Indemnified Party, and shall keep the Indemnified Party timely apprised of the status of, and material developments with respect to, such Claim and shall consider in good faith the recommendations made by the Indemnified Party with respect to such Claim; (b) the Indemnifying Party shall not, without the prior written consent of the Indemnified Party, agree to a settlement of any Claim that could lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnifying Party does not expressly agree to provide indemnification hereunder, or would involve any admission of wrongdoing on the part of the Indemnified Party; and (c) the Indemnified Party shall cooperate with the Indemnifying Party at the request and expense of the Indemnifying Party, and shall be entitled to participate in (but, for clarity, except as provided in Section 12.3.3, not lead or have final decision-making authority over) the defense and handling of such Claim with its own counsel and at its sole cost and expense. Regardless of whether the Indemnifying Party elects to assume the defense and handling of a Claim, the Indemnified Party shall not agree to any settlement of a Claim without the prior written consent of the Indemnifying Party if there is any liability or any financial or other obligation on the part of the Indemnifying Party or if it would adversely affect the Indemnifying Party. Notwithstanding the foregoing, if the Indemnifying Party believes that any of the exceptions to its obligation of indemnification of the Indemnified Party set forth in this Article 12 may apply, the Indemnifying Party will promptly notify the Indemnified Party, who shall then have the right to be represented in any such action or proceeding by separate counsel at its sole cost and expense; provided that the Indemnifying Party will be responsible for payment of such expenses if the
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Indemnified Party is ultimately determined to be entitled to indemnification from the Indemnifying Party.
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13.2.1 was known to, or was otherwise in the possession of, the Receiving Party or its Affiliates prior to the time of disclosure by the Disclosing Party under this Agreement; provided that the foregoing exception will not apply (a) with respect to Septerna, to Product Information prior to termination (but not expiration) of this Agreement or (b) with respect to either Party, Joint Know-How;
13.2.2 is (at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through no breach of this Agreement by the Receiving Party or any of its Affiliates;
13.2.3 is disclosed to the Receiving Party or its Affiliate by a Third Party on a non-confidential basis that has a legal right to make such disclosure without breaching any confidentiality or non-use obligation with respect to such information; or
13.2.4 is independently developed by or on behalf of the Receiving Party or its Affiliates without the use of or reference to the Confidential Information disclosed by the Disclosing Party or its Affiliates under this Agreement; provided that the foregoing exception will not apply (a) with respect to Septerna, to Product Information prior to termination (but not expiration) of this Agreement or (b) with respect to either Party, Joint Know-How.
Specific aspects or details of Confidential Information will not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information will not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.
13.3.1 to a Governmental Authority or other Regulatory Authority in order to file, prosecute, defend or enforce Patent Rights (or register license rights thereunder) as permitted by this Agreement, and, except with respect to Novo Nordisk’s activities under and as permitted by Article 10 with respect to Product Patents and [***] after consultation with and approval by the Disclosing Party (except that with respect to Septerna’s activities under and as permitted by Section 10.3.1 (Patent Prosecution and Maintenance) to the extent reasonably necessary to comply with applicable patent laws or rules of the applicable patent offices, such approval not to be unreasonably withheld, conditioned or delayed);
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13.3.2 in the case of Novo Nordisk as the Receiving Party, to a Governmental Authority or other Regulatory Authority as reasonably required in generating Regulatory Documentation and obtaining Regulatory Approvals;
13.3.3 in the case of Novo Nordisk as the Receiving Party, initiating, prosecuting or defending litigation, including responding to a subpoena in a Third Party litigation, in connection with the Licensed Products;
13.3.4 to the extent required in connection with complying with Applicable Laws or court or administrative orders, including as may be required in connection with any filings made with, or by the disclosure policies of a major stock exchange, subject in each case to Section 13.4 (Confidential Treatment) and Section 14.1 (Public Announcements);
13.3.5 to such Party’s attorneys, independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the Receiving Party, on the condition that such attorneys, independent accountants and financial advisors are either bound under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, with obligations substantially as protective as the confidentiality provisions of this Agreement as they apply to the Receiving Party;
13.3.6 to such Party’s actual or prospective bona fide acquirers, underwriters, investors (excluding investors that are, or are an Affiliate of, any biotechnology, pharmaceutical or other similar company), lenders or other financing partners (excluding financing partners that are, or are an Affiliate of, any biotechnology, pharmaceutical or other similar company) of such Party or its Affiliates and their professional advisors to the extent reasonably necessary in connection with their evaluation of such bona fide potential or actual acquisition, underwriting, investment, lending or other financing transactions, and limited to a reasonably redacted version of this Agreement; provided that in any such case, unless such redacted version of the Agreement is publicly available as permitted by this Agreement, the Receiving Party shall permit the Disclosing Party to review and comment upon a redacted version of this Agreement for such purpose at least [***] in advance of its disclosure and shall implement any additional redactions such Disclosing Party reasonably requests; provided, further, that such actual or prospective bona fide acquirers, underwriters, investors, lenders or financing partners are under written agreements of confidentiality and non-use, in each case, with obligations substantially as protective as the confidentiality provisions of this Agreement as they apply to the Receiving Party (but with reasonable and customary period of such confidentiality obligations that is no less than [***] from the date of disclosure);
13.3.7 to such Party’s actual or prospective bona fide collaborators (including investors and financing partners that are, or are an Affiliate of, any biotechnology, pharmaceutical or other similar company) and their professional advisors to the extent reasonably necessary in connection with their evaluation of such bona fide potential or actual collaboration and limited to a redacted version of this Agreement; provided that in any such case, such redacted version will be consistent with the Redacted Agreement under Section 13.4.2, [***], and the Receiving Party shall permit the Disclosing Party to review and comment upon such redacted version of this Agreement for such purpose at least [***] in advance of its disclosure and shall implement any
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additional redactions such Disclosing Party requests; provided, further, that such actual or prospective bona fide collaborators are under written agreements of confidentiality and non-use, in each case, with obligations substantially as protective as the confidentiality provisions of this Agreement as they apply to the Receiving Party; and
13.3.8 to its and its Affiliates’ employees, sublicensees or prospective sublicensees, or subcontractors or prospective subcontractors, in each case, on a strict “need-to-know” basis in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, each of whom prior to disclosure must be bound by written obligations of confidentiality and restrictions on use of such Confidential Information that are at least as stringent as the obligations applicable to the Receiving Party under this Agreement; provided, however, that: (a) the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Section 13.3.8 to treat such Confidential Information as required under this Article 13 and (b) the financial terms of this Agreement shall be redacted from any such disclosure of the terms of this Agreement.
If and whenever any Confidential Information is disclosed in accordance with this Section 13.3 (Authorized Disclosure), such disclosure shall 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). Notwithstanding the foregoing, in the event that a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to this Section 13.3 (Authorized Disclosure), it will use not less than the same efforts to secure confidential treatment of such information when available as it would to protect its own confidential information from disclosure.
13.4.1 Notwithstanding any provision to the contrary set forth in this Agreement, if a Party is required to make a disclosure of the other Party’s Confidential Information as described in Section 13.3.4, then it will (a) to the extent not prohibited by Applicable Law or judicial or administrative process, give reasonable advance notice to the other Party of such proposed disclosure and use [***] to quash such order or to obtain a protective order or secure confidential treatment of such information requiring that the Confidential Information and documents that are the subject of such disclosure be held in confidence by the applicable court or Governmental Authority or, if disclosed, be used only for the purposes for which the order was issued or such disclosure was required by law and (b) only disclose that portion of Confidential Information that is legally required or advisable to be disclosed as advised by its legal counsel. In any event, each Party agrees to take reasonable action to avoid any disclosure of Confidential Information of the other Party hereunder.
13.4.2 In addition, the Parties acknowledge that either or both Parties may be obligated to file a copy of this Agreement (or portions of this Agreement or an abstract of the terms of this Agreement) with the United States Securities and Exchange Commission (“SEC”) or other Governmental Authorities. Each Party will be entitled to make such a required filing; provided that it initially files a redacted copy of this Agreement (or portions of this Agreement or an abstract of the terms of this Agreement) and requests confidential treatment of the terms redacted from this Agreement for a reasonable period of time, in each case, as further described in the remainder of
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this Section 13.4.2 (“Redacted Agreement”). In the event of any such filing, each Party will (a) permit the other Party to review and comment upon a Redacted Agreement at least [***] in advance of its submission to the SEC or such other Governmental Authorities, (b) cooperate in good faith with and reasonably consider the other Party’s reasonable comments thereon to seek confidential treatment of the terms and conditions of this Agreement that such other Party requests to be kept confidential or otherwise afforded confidential treatment, to the extent consistent with the then-current legal requirements governing redaction of information from material agreements (as determined based on the advice of such Party’s outside counsel) that must be publicly filed in the applicable country, (c) only disclose Confidential Information that counsel reasonably advises is legally required to be disclosed, (d) [***] advise the other Party of any other substantive communications between it or its representatives with such Governmental Authority with respect to such confidential treatment request, (e) upon the written request of the other Party, request an appropriate extension of the term of the confidential treatment period upon the expiration thereof, where available, and (f) if such Governmental Authority requests any changes to the redactions set forth in the Redacted Agreement, use [***] to support the redactions in the Redacted Agreement as originally filed (to the extent consistent with the then-current legal requirements governing redaction of information from material agreements that must be publicly filed) and, to the extent reasonably practicable, before agreeing to any changes to the redactions proposed in the Redacted Agreement, first discuss any changes to the redactions proposed in the Redacted Agreement with the other Party and consider in good faith the other Party’s comments when deciding whether to agree to such changes. Each Party will be responsible for its own legal and other costs and expenses in connection with any such filing, registration or notification.
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15.2.1 Termination without Cause. Novo Nordisk shall have the right to terminate this Agreement in its entirety, or with respect to an R&D Program, Collaboration Target, Licensed Product or Region, in its sole discretion, at any time and for any or no reason, as follows:
(a) prior to [***] of the Effective Date, upon [***] prior written notice to Septerna; or
(b) on or after [***] of the Effective Date, upon [***] prior written notice to Septerna.
15.2.2 Termination for Material Breach. Either Party (the “Non-breaching Party”) may terminate this Agreement in its entirety, or with respect to an R&D Program, Collaboration Target, Licensed Product or Region, in the event that the other Party (the “Breaching Party”) has materially breached this Agreement in its entirety or with respect to such R&D Program, Collaboration Target, Licensed Product or Region and such material breach has not been cured within [***] (or [***] with respect to any undisputed payment-related breach) after receipt of written notice of such breach by the Breaching Party from the Non-breaching Party or, if such breach is not reasonably curable within such [***] period (or [***] with respect to any undisputed payment-related breach) but is curable, such longer period as reasonably necessary for the Breaching Party to cure such material breach (the “Cure Period”); provided that: (a) the Breaching Party has initiated and continues to use Commercially Reasonable Efforts to cure such material breach and (b) [***]. The written notice describing the alleged material breach shall provide sufficient detail to put the Breaching Party on notice of such material breach. Except as set forth in the following sentence, any termination of this Agreement pursuant to this Section 15.2.2 (Termination for Material Breach) shall become effective at the end of the Cure Period, unless the Breaching Party has cured any such material breach prior to the expiration of such Cure Period. If the allegedly Breaching Party in good faith disputes such material breach or the failure to cure or remedy such material breach, such Party shall have the right during the Cure Period to bring such dispute in accordance with Section 17.3 (Arbitration), in which case, such termination and the Cure Period shall be tolled during the pendency of such arbitration. Notwithstanding anything to the contrary in the foregoing, if the Breaching Party is Novo Nordisk and the alleged material breach only relates to a particular R&D Program, Collaboration Target, Licensed Product or Region, Septerna shall only have a right to terminate this Agreement with respect to such R&D Program, Collaboration Target, Licensed Product or Region; provided, however, that [***].
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15.2.3 Termination for Bankruptcy. Either Party may terminate this Agreement immediately upon written notice to the other Party if, at any time: (a) the other Party files in any court or with any Governmental Authority pursuant to any Applicable Laws a petition in bankruptcy or insolvency or for reorganization, or for an arrangement or appointment of a receiver or trustee of such Party or of substantially all of its assets; (b) the other Party proposes a written agreement of composition or extension of its debts with respect to substantial assets of such Party; (c) the other Party is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition is not dismissed within [***] after the filing thereof; (d) the other Party proposes or is a Party to any dissolution or liquidation; or (e) the other Party makes an assignment for the benefit of its creditors. For purposes of this Section 15.2.3 (Termination for Bankruptcy), references to “the other Party” shall include any controlling Affiliate of such other Party.
15.2.4 Termination for Safety Reasons. Novo Nordisk may terminate this Agreement in its entirety or on an R&D Program-by-R&D Program, Collaboration Target-by-Collaboration Target or Licensed Product-by-Licensed Product basis at any time upon [***] prior written notice to Septerna if senior executives responsible for Novo Nordisk’s pharmacovigilance or clinical science functions determine in good faith that the risk/benefit profile of an R&D Program, Collaboration Target or Licensed Product, as applicable, is such that Development or Commercialization of Licensed Products with respect to such R&D Program, Licensed Products Directed Against such Collaboration Target, or such Licensed Product, respectively, cannot be continued safely, including in connection with (a) the receipt of a material adverse regulatory determination by a Regulatory Authority in a country regarding a Licensed Product (such as a suspension of Regulatory Approval) or (b) the occurrence of serious Adverse Events related to the use of a Licensed Product. In connection with such termination, Novo Nordisk will provide reasonable documentation to Septerna of the rationale for making any such determination.
15.2.5 Termination for Failure or Delay to Obtain Antitrust Clearance. This Agreement shall terminate (a) upon written notice given by [***] if [***] receives a second request for additional information under the HSR Act and [***] delivers such notice of termination within [***] after receipt of such second request or (b) upon written notice given by [***] if the Effective Date has not occurred within [***] after the date on which the last Antitrust Filing is made and [***] delivers notice of termination within [***] after the end of such [***] period. In each case ((a) or (b)), this Agreement shall terminate and become void and of no further effect as of the date of such notice.
15.2.6 Termination for Patent Challenge. Except to the extent that this Section 15.2.6 (Termination for Patent Challenge) is unenforceable under Applicable Laws of the applicable jurisdiction where the applicable Royalty-Bearing Patents are pending or issued, Septerna will have the right to terminate this Agreement in its entirety, upon [***] written notice to Novo Nordisk in the event that Novo Nordisk or any of its Affiliates or its or their Sublicensees (each, a “Patent Challenging Party”) commences or knowingly and voluntarily participates in any proceeding as a party before a Governmental Authority to challenge the validity or enforceability of any Royalty-Bearing Patent (a “Patent Challenge”); provided that:
(a) this Section 15.2.6 (Termination for Patent Challenge) shall not apply to any Patent Challenge that is (i) first made by a Patent Challenging Party as a cross-claim
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or a counterclaim, including asserting any defense or counterclaim in, or otherwise responding to, a claim of patent infringement under the applicable Royalty-Bearing Patent, (ii) made in ordinary course patent prosecution or maintenance activities to distinguish the inventions claimed in any Patent Right Controlled by Novo Nordisk or its Affiliate from those claimed or disclosed in any Royalty-Bearing Patent or to respond to citation of any Royalty-Bearing Patent by a patent office in a rejection against any Patent Right Controlled by Novo Nordisk or its Affiliate or (iii) in a proceeding involving a Royalty-Bearing Patent that covers another product that Novo Nordisk or its Affiliate or Sublicensee is exploiting outside the scope of this Agreement at the time of such Patent Challenge;
(b) Septerna shall not have the right to terminate this Agreement under this Section 15.2.6 (Termination for Patent Challenge) if Novo Nordisk (i) causes the Patent Challenge to be terminated, withdrawn or dismissed (or in the case of ex-parte proceedings, multi-party proceedings or other Patent Challenges in which the Patent Challenging Party does not have the power to unilaterally cause the Patent Challenge to be terminated, withdrawn or dismissed, such Patent Challenging Party withdraws as a party from such Patent Challenge (if the Patent Challenging Party is a party to such Patent Challenge) and ceases actively assisting any other party to such Patent Challenge in connection with such Patent Challenge), or (ii) in the case of a Patent Challenge brought by a Sublicensee, terminates such Sublicensee’s sublicense to the Royalty-Bearing Patents being challenged by the Sublicensee, in each case ((i) and (ii)), within [***] after Septerna’s notice to Novo Nordisk under this Section 15.2.6 (Termination for Patent Challenge), and
(c) this Section 15.2.6 (Termination for Patent Challenge) shall not apply to any Patent Challenge that is due to the Patent Challenging Party responding to a court request, subpoena or order, or an administrative agency request or order, or the applicable proceeding is initiated by a patent office and not at the instigation of the Patent Challenging Party.
In addition, notwithstanding the foregoing, Septerna shall not have the right to terminate this Agreement pursuant to this Section 15.2.6 (Termination for Patent Challenge) if any Affiliate that first becomes an Affiliate of Novo Nordisk after the Effective Date was undertaking activities in connection with a Patent Challenge prior to such Affiliate first becoming an Affiliate of Novo Nordisk.
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16.2.1 the licenses and rights granted by Septerna to Novo Nordisk under Section 8.2.1(a) and Section 8.2.2 shall automatically terminate; provided, however, that (a) if this Agreement is terminated with respect to [***] Regions but not the entire Territory, the rights and licenses granted to Novo Nordisk under Section 8.2.1(a) and Section 8.2.2 shall not terminate but Section 8.2.2 shall automatically be deemed to be amended with respect to the Terminated Region(s) to be non-exclusive and only to include the right to Develop (other than clinically Develop, except with respect to any Clinical Trials being conducted by Novo Nordisk or its Affiliates as of the effective date of termination to the extent they cannot be terminated in a manner consistent with Applicable Law and standards of ethical conduct) and Manufacture Licensed Compounds and Licensed Products in the Terminated Region(s) solely for the purposes of supporting Regulatory Approval or Commercialization of the Licensed Products in the surviving countries in the Territory; and (b) Novo Nordisk shall have the right to sell off any remaining inventory of all Licensed Products that exists as of the date of such termination, and the proceeds of such sales of such Licensed Products shall remain subject to the applicable provisions of Article 9 hereunder; provided, further, that such licenses and rights will continue as necessary for Novo Nordisk to complete the orderly wind-down of its activities under this Agreement in accordance with Applicable Law;
16.2.2 Septerna shall submit a final invoice for all Septerna Research Costs incurred up to the effective date of termination (but not including any amounts incurred after or extending past the effective date of termination, whether non-cancelable commitments or otherwise, except as set forth in the below proviso), and Novo Nordisk shall pay any such undisputed invoice within [***] after receipt thereof; provided that in the event of any termination by Novo Nordisk of this Agreement under Section 15.2.1(a) (Termination without Cause), Novo Nordisk shall additionally reimburse any non-cancelable commitments comprising Septerna Research Costs incurred in accordance with the applicable R&D Plan during the Term;
16.2.3 each Party shall be relieved of all its future obligations under the Agreement, except as explicitly stated otherwise in this Section 16.2 (Effects of Termination Generally), Section 16.3 (Additional Effects of Certain Terminations), if applicable, and Section 16.5 (Survival);
16.2.4 the Parties shall cease all activities under this Agreement as soon as reasonably practicable (including activities under the R&D Program(s) and the Development and Commercialization of any Licensed Compounds and Licensed Products); provided that such activities will continue as necessary for the Parties to complete the orderly wind-down of their activities under this Agreement in accordance with Applicable Law;
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16.2.5 the JSC shall coordinate the wind-down of each Party’s efforts under this Agreement and then shall be dissolved (and any subcommittees thereof shall be dissolved), and the JPSC (if applicable) shall be dissolved;
16.2.6 the Parties shall retain their ownership interests in the applicable Patent Rights and Know-How (in accordance with Article 10) without any restrictions on the practice and exploitation of such Patent Rights and Know-How subject to the license granted by Novo Nordisk to Septerna pursuant to Section 16.3.2, if applicable;
16.2.7 Section 13.8 (Return of Confidential Information) shall apply to the Parties’ Confidential Information; and
16.2.8 if this Agreement is terminated with respect to [***] Regions but not the entire Territory, each Party shall not, and shall cause its Affiliates and any of its and their licensees, sublicensees or distributors not to, distribute, market, promote, offer for sale or sell the terminated Licensed Products directly or indirectly (a) to any Person for use in the other Party’s territory (i.e., with respect to Septerna, the surviving countries in the Territory and with respect to Novo Nordisk, the Terminated Region(s)) or (b) to any Person in the other Party’s territory that such Party or any of its Affiliates knows is likely to distribute, market, promote, offer for sale or sell any Licensed Product for use in the other Party’s territory or assist another Person to do so. If a Party or any of its Affiliates receives or becomes aware of the receipt by a licensee, sublicensee or distributor of any orders for any Licensed Product for use in the other Party’s territory, it shall use commercially reasonable efforts to ensure that such Person refers such orders to the other Party, to the extent possible and contractually and legally permissible. Each Party shall cause its Affiliates and shall use commercially reasonable efforts to cause its and their licensees, sublicensees and distributors to notify it of any receipt of any orders for any Licensed Product for use in the other Party’s territory and shall upon receipt of such notification notify the other Party accordingly.
16.3.1 [***];
16.3.2 Novo Nordisk shall, upon Septerna’s request made no later than [***] after the effective date of termination, discuss in good faith, for a period of up to [***] from such notice by Septerna (unless extended by mutual agreement of the Parties), (a) [***], “Reverted Products”, which, for clarity, shall no longer be deemed to be Licensed Products for purposes of this Agreement), and (b) [***]; provided [***].
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16.4.1 the licenses and rights granted by Septerna to Novo Nordisk under Section 8.2 (Licenses to Novo Nordisk) shall [***];
16.4.2 with respect to any R&D Program for which Septerna has not fulfilled and completed its obligations in Section 2.7 (Technology Transfer) or Section 3.4 (Manufacturing Technology and Material Transfer), Section 2.7 (Technology Transfer) and Section 3.4 (Manufacturing Technology and Material Transfer) shall apply to such R&D Program as of the effective date of termination;
16.4.3 notwithstanding anything to the contrary under Section 3.6 (Septerna Profit Share Option), (a) Septerna will [***] and (b) if there is an active Profit Share Product at the time of such notice, the Profit Share Agreement shall automatically terminate as of the date of such notice, and the Profit Share Term shall end on the date of such notice. For clarity, such Profit Share Product shall thereafter be a Financial Product;
16.4.4 Novo Nordisk shall continue to pay Septerna upon achievement of a milestone event pursuant to Section 9.2.1 (Collaboration Target Milestones), Section 9.2.2 (Research and Development Milestones) and Section 9.2.3 (Commercial Milestones) and Royalty Payments pursuant to Section 9.3 (Royalty Rate) but, in each case, at a [***] reduction, with any applicable payment step-downs set forth in Section 9.5 (Payment Step-Downs) to be additionally applied against such reduced amounts;
16.4.5 the JSC (and any subcommittees thereof) and JPSC (if applicable) shall be dissolved;
16.4.6 Novo Nordisk’s diligence obligations pursuant to Section 3.1 (Development by Novo Nordisk) and Section 3.2 (Commercialization by Novo Nordisk) shall all terminate;
16.4.7 Septerna shall, at the request of and as directed by Novo Nordisk, return or destroy any Confidential Information of Novo Nordisk and any other information and data related to the Development, Commercialization or Exploitation of any Licensed Compound or Licensed Product in Septerna’s possession and all copies thereof; provided, however, that Septerna may keep one (1) copy of Novo Nordisk’s Confidential Information in its confidential files for recordkeeping purposes and such copy shall remain subject to Article 13 of this Agreement; and
16.4.8 all other provisions of this Agreement shall remain in full force and effect without change.
Notwithstanding anything to the contrary in the foregoing, if (a) the alleged uncured material breach by Septerna only relates to a particular R&D Program, Collaboration Target or Licensed Product and (b) subject to dispute resolution in accordance with Section 17.3 (Arbitration), as provided in Section 15.2.2 (Termination for Material Breach), Novo Nordisk has the right to terminate this Agreement pursuant to Section 15.2.2 (Termination for Material Breach), then, Novo Nordisk shall have the right to elect to invoke this Section 16.4 (Alternative Remedies in Lieu of Termination) only with respect to such R&D Program, Collaboration Target or Licensed Product, as applicable.
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16.5.1 [***]; and
16.5.2 [***].
All other rights and obligations will terminate upon termination or expiration of this Agreement. If this Agreement is terminated with respect to one (1) or more Licensed Products, R&D Programs or Regions but not in its entirety, then following such termination, the foregoing provisions of this Agreement shall remain in effect with respect to the terminated Licensed Product(s), R&D Programs or Regions (to the extent they would survive and apply in the event this Agreement is terminated in its entirety or as otherwise necessary for any of Novo Nordisk and its Affiliates and its and their Sublicensees to exercise their rights for the other Licensed Products, R&D Programs and Regions) and all provisions not surviving in accordance with the foregoing shall terminate upon termination of this Agreement and be of no further force and effect with respect to the terminated Licensed Product(s), R&D Programs and Regions (and for the avoidance of doubt all provisions of this Agreement shall remain in effect with respect to all non-terminated Licensed Products, R&D Programs and Regions).
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17.3.1 Any unresolved Dispute that had been subject to, and exhausted the procedures of, Section 17.2 (Resolution by Executive Officers) and that is not an Excluded Claim shall be finally resolved by binding arbitration by the International Chamber of Commerce (“ICC”) administered in accordance with the Rules of ICC in effect on the Execution Date, and applying the substantive law specified in Section 18.11 (Governing Law). Judgment on the arbitration award may be entered in any court having jurisdiction thereof. The obligation to arbitrate under this Section 17.3 (Arbitration) shall extend to any claims by or against the Parties and their respective Affiliates and any agents, principals, officers, directors or employees of either of the Parties or their respective Affiliates.
17.3.2 The Dispute arbitration shall be conducted by [***] experienced in the business of pharmaceuticals. If the issues in dispute involve scientific, technical or commercial matters, the arbitrators chosen hereunder shall engage experts that have educational training or industry experience sufficient to demonstrate a reasonable level of relevant scientific, technical and commercial knowledge, as necessary to resolve such dispute. Within [***] after initiation of arbitration, the Parties shall select the arbitrators. Novo Nordisk, on the one hand, shall select [***] arbitrator and Septerna, on the other hand, shall select [***] arbitrator (or, if either Party fails to make a choice, the ICC shall select [***] arbitrator on behalf of such Party) and the [***] arbitrators selected by the Parties will mutually select a third arbitrator (or, if they fail to make or agree on a choice, the ICC shall select a third arbitrator). In making their Dispute resolution determination, the arbitrators shall not have the authority to modify any term or provision of this Agreement. A majority consensus decision by any [***] of the arbitrators shall be final, conclusive and binding on the Parties. The place of arbitration shall be New York City, New York, United States, and all proceedings and communications shall be in English.
17.3.3 Prior to the arbitrators being selected, either Party, without waiving any remedy under this Agreement, may seek a temporary restraining order or preliminary injunction pursuant to Section 17.5 (Injunctive Relief) prior to final resolution of the Dispute by the arbitrators or other resolution of the controversy between the Parties. Once the arbitrators are in place, either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved, and either Party may apply to a court of competent jurisdiction to enforce such interim injunctive relief granted by the arbitrators. Any final award by the arbitrators may be entered by either Party in any court having appropriate jurisdiction for a judicial recognition of the decision and applicable orders of enforcement. The arbitrators may render early or summary disposition of some or all Dispute issues, after the Parties have had a reasonable opportunity to make submissions on those issues. The arbitrators shall have no authority to award punitive or any other type of damages not directly measured by a Party’s compensatory damages.
17.3.4 Except to the extent necessary to confirm an award or as may be required by Applicable Law, neither a Party nor an arbitrator may disclose the existence, content or results
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of a Dispute arbitration without the prior written consent of both Parties. In no event may a Dispute arbitration be initiated after the date when commencement of a legal or equitable proceeding based on such Dispute’s dispute, controversy or claim would have been barred by the applicable statute of limitations under Applicable Laws.
17.3.5 Notwithstanding Section 15.2.2 (Termination for Material Breach), if a Dispute relates to a material breach by a Party for which the other Party asserts a right to terminate this Agreement pursuant to Section 15.2.2 (Termination for Material Breach), then the arbitrators will be instructed that, if they render an award finding such first Party in material breach, they shall include in such an award an explanation of what specific steps such first Party would be required to follow in order to cure such material breach.
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18.3.1 Effects of Change of Control on Profit Share. Notwithstanding anything to the contrary under Section 3.6 (Septerna Profit Share Option), after Septerna undergoes a Change of Control, Septerna (and the Acquirer or the assignee) will [***]. In the event that Septerna undergoes a Change of Control and there is an active Profit Share Product, regardless of whether Novo Nordisk exercises its right to terminate the Profit Share Agreement pursuant to Section 3.6.12 (Termination of Profit Share Term), all information sharing requirements of Novo Nordisk with respect to the Profit Share Product, including in connection with the Profit Share Summary Development Plan and Profit Share Summary Commercialization Plan, shall cease and Novo Nordisk shall no longer have any such informational obligations except, (a) if Novo Nordisk does not exercise its right to terminate the Profit Share Agreement pursuant to Section 3.6.12 (Termination of Profit Share Term), those requirements to report Development Costs and Operating Profits or Losses as set forth in the Profit Share Agreement and (b) if Novo Nordisk exercises its right to terminate the Profit Share Agreement pursuant to Section 3.6.12 (Termination of Profit Share Term), the royalty reporting requirements set forth in Section 9.11 (Royalty and Sales Reports).
18.3.2 Change of Control to Novo Nordisk Competitor. Without limiting Section 18.3.1 (Effects of Change of Control on Profit Share), in the event that the Acquirer is deemed a Novo Nordisk Competitor in Novo Nordisk’s reasonable discretion, Novo Nordisk shall in its sole discretion have the option to, upon written notice to Septerna or the Acquirer:
(a) require that Septerna separate and create a Firewall as provided in Section 6.3.3;
(b) notwithstanding anything to the contrary under this Agreement, terminate its obligations to provide any information or reporting hereunder [***]; provided that Novo Nordisk shall continue to provide reports necessary to verify royalties and any Development Cost and Profit/Loss Split in accordance with Section 9.11 (Royalty and Sales Reports) and the Profit Share Agreement;
(c) disband the JSC (and any subcommittees thereof) and JPSC; provided that the Parties acknowledge and agree that in the event of any such disbanding, the rights and obligations of the Parties set forth in Sections 7.13 (Quorum and Decision Making) and 7.14 (JSC Cannot Reach Agreement) shall remain in effect; and
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(d) require that any disclosure and other informational sharing obligations pursuant Article 10 shall be made only by and through an external law firm intellectual property counsel representing Septerna or Acquirer.
18.3.3 Post-Change of Control Covenant. From and after any Change of Control of Septerna, Septerna shall not, and shall cause its Affiliates (including its successors, assigns and transferees for the applicable Patent Rights) not to, institute or prosecute any claim, demand, action or other proceeding alleging that the Exploitation of any Licensed Compound or Licensed Product in the Field in the Territory by or on behalf of Novo Nordisk or any of its Affiliates or its or their Sublicensees in accordance with the terms of this Agreement infringes any [***]; provided that the foregoing covenant (a) excludes any [***] to the extent that it Covers (i) any [***] other than the Licensed Compound [***]) and (ii) any proprietary [***] as of the date of such Change of Control, (b) shall not apply to any [***] that [***] and (c) shall not apply with respect to any litigation initiated by the Acquirer against Novo Nordisk or any of its Affiliates or Sublicensee prior to the date of such Change of Control.
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If to Novo Nordisk:
Novo Nordisk A/S
Novo Nordisk Allé 1
Bagsvaerd
Denmark
Attention: External Innovation, Outreach & Alliances
with a copy to:
Novo Nordisk A/S
Novo Nordisk Alle 1
2880 Bagsvaerd
Denmark
Attention: General Counsel
with a copy to:
Covington & Burling LLP
One CityCenter, 850 Tenth Street, NW
Washington, DC 20001-4956
United States
Attention: John Hurvitz
If to Septerna:
Septerna, Inc.
250 East Grand Avenue
South San Francisco, CA 94080
Attention: Gil Labrucherie, Chief Financial Officer
with a copy to:
Goodwin Procter LLP
The New York Times Building
620 Eighth Avenue
New York, NY 10018-1405
Attention: Noelle Dubiansky
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[Remainder of page left blank intentionally; signature page follows.]
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IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives.
SEPTERNA, INC.
By:/s/ Jeffrey Finer
Name: Jeffrey Finer
Title: CEO
NOVO NORDISK A/S
By: /s/ Karsten Munk Knudsen
Name: Karsten Munk Knudsen
Title: EVP & CFO
By: /s/ Marcus Schindler
Name: Marcus Schindler
Title: EVP R&ED and CSO
[Signature Page to Collaboration and License Agreement]
Collaboration Targets
[***]
[***]
[***]
[***]
Program Compounds
[***]
Septerna Patents
[***]
Collaboration Target(s) for R&D Programs
[***]
Initial R&D Plan(s)
[***]
Use of Human Biosamples and Informed Consent
[***]
Novo Nordisk Principles for the Use of Animals
[***]
Profit Share Agreement Terms
[***]
Information Security Requirements
[***]
Schedule 8.4
Permitted Subcontractors and Permitted Activities
[***]
Novo Nordisk’s Invoicing Instructions
[***]
Patent Expert Dispute Procedures
Initial Disclosure Schedule
[***]
Press Release
Septerna and Novo Nordisk to collaborate on oral small molecule medicines for obesity and other cardiometabolic diseases
Collaboration combines Novo Nordisk’s scientific leadership in obesity and cardiometabolic diseases with Septerna’s expertise in G protein-coupled receptor (GPCR) drug discovery
Goal is to develop multiple oral small molecule therapies for key GPCR targets, including GLP-1, GIP and glucagon receptors
Septerna is eligible to receive approximately 2.2 billion US dollars, including more than 200 million dollars in upfront and near-term payments
South San Francisco, California, US and Bagsværd, Denmark, 14 May 2025 – Septerna, Inc. (Nasdaq: SEPN) and Novo Nordisk today announced an exclusive global collaboration and license agreement to discover, develop and commercialise oral small molecule medicines for obesity, type 2 diabetes and other cardiometabolic diseases.
The companies will initially commence four development programmes for potential small molecule therapies directed to one or more select G protein-coupled receptor (GPCR) targets, including the GLP-1, GIP and glucagon receptors.
“Novo Nordisk has a rich history of innovation in obesity and diabetes. We are building on our scientific leadership in this space and developing a broad pipeline across various targets and modalities, including peptides and small molecules. Leveraging different modalities creates important optionality in our pipeline in terms of potential targets, dosing regimens and scalability,” said Marcus Schindler, executive vice president and chief scientific officer of Novo Nordisk. “Septerna has demonstrated strong capabilities in GPCR drug discovery, and we are excited about the opportunity to develop oral small molecule medicines directed at multiple targets.”
GPCRs represent the largest and most diverse family of cell membrane receptors, with hundreds of different GPCRs regulating physiological processes in nearly every organ system of the human body. Using its proprietary Native Complex Platform, Septerna aims to unlock the full potential of GPCR therapies. The company is focused on the discovery and development of a pipeline of oral small molecules for multiple therapeutic areas, initially focused on endocrinology, immunology and inflammation, and metabolic diseases.
“Novo Nordisk has a long-standing track record of bringing transformative therapies to market, particularly in the field of metabolic disease, which makes them the ideal partner to advance a suite of programmes targeting critical GPCRs for treating obesity, type 2 diabetes and other related conditions,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “This collaboration provides a significant opportunity to create multiple potentially groundbreaking oral medicines, while also providing Septerna with the operational flexibility and resources to advance our diverse portfolio of other GPCR-targeted programmes.”
Under the terms of the agreement, Septerna is eligible to receive approximately 2.2 billion US dollars from Novo Nordisk across an upfront payment and research, development and commercial milestone payments. This includes more than 200 million dollars in upfront and near-term milestone payments. Septerna is also eligible to receive tiered royalties on global net sales of marketed products. Novo Nordisk will cover all research and development expenses for partnered programs under the collaboration.
The companies will jointly conduct research activities from discovery through development candidate selection. Starting at IND-enabling activities, Novo Nordisk will have sole responsibility for all global development and commercialisation activities. In addition, Septerna has the right to opt in to a worldwide profit share for one program in the collaboration in lieu of future milestones and royalties for that product candidate.
The agreement is subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Closing is expected to occur in the second quarter of 2025.
About GPCRs and Septerna’s Native Complex Platform
G protein-coupled receptors (GPCRs) represent the largest and most diverse family of cell membrane receptors, with hundreds of different GPCRs regulating physiological processes in nearly every organ system of the human body. They have been the most productive target class in drug discovery history, accounting for approximately one-third of all FDA-approved drugs. However, around 75% of potential GPCR therapeutic targets remain undrugged, representing a substantial untapped opportunity for future drug discovery.
Septerna has developed proprietary technologies to isolate, purify, and reconstitute GPCRs outside of cells into complexes with ligands, transducer proteins, and lipid bilayers which mimic cell membranes. These reconstituted assemblies are called Native Complexes because they replicate the natural structure, function, and dynamics of GPCRs in purified biochemical formats.
The Native Complex Platform is powered by a suite of tools and technologies that allow screening of billions of candidate molecules. It is designed to target specific GPCRs, uncover novel binding pockets for validated receptors, and pursue a wide spectrum of pharmacologies, including agonists (which activate GPCR signalling), antagonists (which inhibit GPCR signalling), and allosteric modulators (which either increase or decrease the degree of GPCR activation by endogenous ligands), to affect GPCR signalling in different ways to achieve desired therapeutic effects.
About Septerna
Septerna, Inc. is a biotechnology company pioneering a new era of GPCR drug discovery powered by its proprietary Native Complex Platform. Its industrial-scale platform aims to unlock the full potential of GPCR therapies and has led to the discovery and development of its deep pipeline of oral small molecule product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases. Septerna was launched by preeminent drug discovery company builders and scientific leaders in the biochemistry, structural biology, and pharmacology of GPCRs. For more information, please visit www.septerna.com.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, X, LinkedIn and YouTube.
Contacts for further information
Novo Nordisk Media: |
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Ambre James-Brown +45 3079 9289
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Liz Skrbkova (US) |
Novo Nordisk investors: |
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Jacob Martin Wiborg Rode
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Ida Schaap Melvold +45 3077 5649
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Sina Meyer +45 3079 6656
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Max Ung +45 3077 6414 mxun@novonordisk.com |
Frederik Taylor Pitter +1 609 613 0568
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Septerna Media: Carly Scaduto carly@carlyscadutoconsulting.com |
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Septerna Investors: Renee Leck renee@thrustsc.com |
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