[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
ARTICLE 1 DEFINITIONS1
ARTICLE 2 GOVERNANCE29
2.1Joint Research Committee.29
2.2Joint Development Committee.29
2.3Joint Finance Committee.30
2.4Meetings and Minutes.30
2.5Decision-Making.31
2.6Subcommittees.34
2.7Alliance Managers.34
ARTICLE 3 RESEARCH PROGRAM FOR LICENSED CD28 ANTIBODIES AND LICENSED CD28 PRODUCTS34
3.1Overview.34
3.2Research Plan.35
3.3Conduct of Research Program Activities.35
3.4Binding Domains.35
3.5Research Program Costs.36
3.6Records; Reports.36
3.7Candidate Selection; Antigen Selection.36
3.8Materials.38
ARTICLE 4 DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF LICENSED CD28 ANTIBODIES AND LICENSED CD28 PRODUCTS39
4.1General – Licensed CD28 Products.39
4.2Xencor Assistance for Licensed CD28 Products.39
4.3[Reserved].39
4.4Conduct of Licensed CD28 Product Activities.39
ARTICLE 5 DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF PLAMOTAMAB AND PLAMOTAMAB PRODUCTS40
5.1Development of Plamotamab Products.40
5.2Commercialization of Plamotamab Products.55
5.3Manufacturing of Plamotamab Products.56
i
ARTICLE 6 XENCOR OPTION RIGHTS FOR LICENSED CD28 PRODUCTS; DILIGENCE57
6.1General.57
6.2CD28 Co-Funding Option.57
6.3CD28 Co-Detailing Option.69
6.4Diligence Obligations.71
6.5Preliminary Licensed CD28 Products Diligence.77
ARTICLE 7 FINANCIAL PROVISIONS77
7.1Upfront Payment.77
7.2Development and Regulatory Milestones.77
7.3Sales Milestones.89
7.4Royalties.91
7.5Payment Terms.103
7.6Records; Audits.104
7.7Taxes.105
ARTICLE 8 LICENSE GRANTS; EXCLUSIVITY106
8.1Grants.106
8.2Sublicensing.108
8.3No Implied Licenses.109
8.4Exclusivity.109
ARTICLE 9 INTELLECTUAL PROPERTY113
9.1Patent Representatives.113
9.2Inventions.113
9.3Prosecution of Patents.115
9.4Patent Enforcement.119
9.5Patent Term Extensions.123
9.6Regulatory Data Protection.123
9.7Patent Invalidity Claims.123
9.8Claimed Infringement.124
9.9Acquirer Intellectual Property.124
9.10Trademarks.125
ARTICLE 10 CONFIDENTIALITY AND PUBLICITY125
10.1Non-Disclosure and Non-Use.125
10.2Exceptions.126
ii
10.3Authorized Disclosure.127
10.4Terms of Agreement.128
10.5Publicity.128
10.6Prior Non-Disclosure Agreement.128
10.7Equitable Relief.129
10.8Publications.129
ARTICLE 11 REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS130
11.1Representations of Authority.130
11.2Consents.130
11.3No Conflict.130
11.4Enforceability.130
11.5Additional Representations and Warranties of Xencor for Licensed CD28 Products.130
11.6Additional Representations and Warranties of Xencor for Plamotamab Products. 133
11.7No Warranties.135
11.8No Debarment or Exclusion.136
11.9Compliance with Anti-Corruption Laws.136
11.10Additional Third Party Technology.139
11.11[***]139
ARTICLE 12 INDEMNIFICATION; INSURANCE140
12.1Indemnification by Janssen.140
12.2Indemnification by Xencor.140
12.3Indemnification Procedures.141
12.4Insurance.142
ARTICLE 13 TERM AND TERMINATION142
13.1Term.142
13.2Termination for Material Breach.143
13.3Other Rights of Termination.143
13.4Provisions for Insolvency.145
13.5Effects of Termination or Expiration.146
ARTICLE 14 EFFORTS TO OBTAIN CLEARANCES154
14.1Commercially Reasonable Efforts.154
14.2Antitrust Filing.154
iii
ARTICLE 15 DISPUTE RESOLUTION156
15.1Exclusive Dispute Resolution Mechanism.156
15.2Referral to Executive Officers.156
15.3Mediation.156
15.4Arbitration.156
15.5Waiver.158
ARTICLE 16 MISCELLANEOUS158
16.1Assignment; Successors.158
16.2Performance by Affiliates.158
16.3Subcontracting.159
16.4No Consequential or Punitive Damages.159
16.5Choice of Law.159
16.6Submission to Jurisdiction.159
16.7Notices.160
16.8Severability.161
16.9Captions.162
16.10Further Actions.162
16.11Amendment; No Waiver.162
16.12Integration.162
16.13Independent Contractors; No Agency.162
16.14Force Majeure.162
16.15Counterparts; Signatures.163
16.16Construction.163
iv
COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (the “Agreement”) is made and effective as of October 1, 2021 (the “Execution Date”) by and between Xencor, Inc., a Delaware corporation (“Xencor”), on the one hand, and Janssen Biotech, Inc., a Pennsylvania company (“Janssen”), on the other hand. Xencor and Janssen are referred to herein each individually as a “Party” and collectively as the “Parties.”
INTRODUCTION
WHEREAS, Xencor is engaged in the research of pharmaceutical products and controls certain patents, know-how and other rights related to the Licensed CD28 Antibodies, Licensed CD28 Products, Plamotamab and Plamotamab Products (as defined below);
WHEREAS, Janssen has considerable knowledge and experience in developing and commercializing products in the oncology field throughout the world;
WHEREAS, the Parties believe that a collaboration arrangement between the Parties regarding the research of the Licensed CD28 Antibodies would be desirable and Xencor desires to grant to Janssen, and Janssen desires to obtain from Xencor, an exclusive, worldwide license to develop, manufacture and commercialize Licensed CD28 Antibodies, Licensed CD28 Products, Plamotamab and Plamotamab Products; and
WHEREAS, the Parties therefore desire to provide for such research collaboration and license on and subject to the terms and conditions set forth herein.
NOW, THEREFORE, for and in consideration of the mutual covenants contained herein, the Parties agree as follows:
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
For purposes of this definition, a Person will be deemed the “Beneficial Owner” of, and will be deemed to “beneficially own,” and will be deemed to have “Beneficial Ownership” of, any securities:
4
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5
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
6
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Notwithstanding the foregoing, Development excludes any Research activities conducted under the Research Program and any Commercialization activities.
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8
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
9
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
10
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
11
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
All aforementioned deductions will only be allowable to the extent they are commercially reasonable by Janssen and will be determined, on a country-by-country basis, as incurred in the ordinary course of business in type and amount verifiable based on Janssen’s and Affiliates’ reporting system. All such discounts, allowances, credits, rebates, and other deductions will be fairly and equitably allocated to the applicable Product and other products of Janssen and its Affiliates and sublicensees such that the applicable Product does not bear a disproportionate portion of such deductions.
Sales of a Product by and between Janssen and its Affiliates and sublicensees, in each case, unless the Affiliate, sublicensee, or Party is the end purchaser, are not sales to Third Parties and will be excluded from Net Sales calculations for all purposes; provided, however, that if such Product is subsequently resold to a Third-Party end user such resale shall be included in the determination of Net Sales.
Sales of a Product for the use in conducting Clinical Studies of the Product (including Included Medical Affairs Studies) in a country at or below cost, or in a ‘cost-plus a percentage’ scenario where the ‘percentage’ covers Janssen’s tax considerations, and in order to obtain the regulatory approval of the Product (including for use in a Combination Regimen) in such country will be excluded from Net Sales calculations for all purposes.
Compassionate use and “named patient sales” will be excluded from Net Sales calculations for all purposes.
Any disposition of a Product as free samples, donations, or patient assistance will be excluded from Net Sales calculations for all purposes.
If the applicable product is a Combination Product that is not a Solely CD28/Plamotamab Combination Product, the Parties will negotiate in good faith, at the latest [***] before the expected launch of such Combination Product, an allocation of Net Sales of such Combination Product to the respective active pharmaceutical ingredient (“API”) components, as the case may be, based on the fair market value of such components for the purposes of determining a product-specific or licensed-API-specific allocated Net Sales. Payments related to such Combination Product under this Agreement, including royalty payments, will be calculated, due and payable based only on such allocated Net Sales.
12
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Without limiting the foregoing and following negotiation, the Parties anticipate that allocated Net Sales will be calculated according to one of the following paradigms, with the calculation approach in clause (i) being more preferable:
If the Parties do not agree on an allocation of Net Sales of such Combination Product to the respective API components or Product components thereof before launch, then the calculation approach described in clause (i) above will be used. Where the foregoing refers to “subject to reasonable estimation” such estimation shall be made by the selling Party and promptly provided to the other Party. If the other Party disagrees with such estimation, it shall notify the other Party (“Component Allocation Notice”) and the JFC shall convene to reasonably determine the proper allocation between the applicable components. If the JFC does not agree on such allocation within [***] of the Component Allocation Notice, then [***]. For clarity, the selling Party may launch such Combination Product and use its reasonable estimation of the average net selling price of each component while such matter is being discussed and until it is resolved in accordance with this Section or Section 2.5.1.5.
13
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[***].
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15
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
in each case ((a), (b) and (c)), including those Inventions assigned to Xencor pursuant to Section 9.2.2.2(a) and Xencor’s interest in Joint Inventions.
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Defined Term | Section |
---|---|
[***] Notice Period | 3.7.2 |
1974 Convention | |
Acquired Competing Product | |
Acquirer Competing Product | |
Acquirer Intellectual Property | |
Acquiring Party | |
Adjusted Combination Net Sales Amount | |
Agreement | the Introduction |
Alliance Manager | |
Alternative Plamotamab Formulation | 5.3.3 |
Anti-Corruption Laws | |
Antigen Selection | 3.7.3 |
Antigen Selection Date | 3.7.3 |
Antigen Selection Milestone Events | 7.2.4.2 |
Antigen Selection Outside Date | |
API | |
Applied Janssen Technology | |
Backup | |
B-Cell Antigen Variant Specific Patent | |
Beneficial Owner | |
Beneficial Ownership | |
Biosimilar Application | |
Bispecific Competing Product | |
BLA | |
Breaching Party | |
Business Combination | |
Candidate Selection | |
Candidate Selection Date | |
Category A Net Sales | |
Category A Sales Milestone Event | |
Category A Sales Milestone Payment | |
Category B Net Sales | |
Category B Sales Milestone Event | |
Category B Sales Milestone Payment | |
CD28 Co-Detailing Option |
18
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Defined Term | Section |
---|---|
CD28 Co-Funding Option | |
CD28 Co-Funding Option Exercise Date | |
CD28 Co-Funding Opt-Out | |
CD28 Co-Funding Opt-Out Effective Date | |
CD28 Co-Funding Opt-Out Notice | |
CD28 Co-Funding Wind-down Period | |
CD28 Component | |
CD28 Development Budget | |
CD28 Development Plan | |
CD28 Included Medical Affairs Studies Costs Limit | |
CD28 Milestone Event | |
CD28 Milestone Payment | |
CD28 Royalty Term | |
CD28 Royalty-Bearing Patent | |
CD28 Unit Price | |
CD28/Plamotamab Combination Royalty Term | |
CD28/Plamotamab Combination Royalty-Bearing Patent | |
CD28/Plamotamab Combination Sales | |
CDR | |
Claim Basis | |
Clinical Reverted Product | |
CMC Development Activities | |
Co-Chair | |
Co-Detailing Data Package | |
Co-Detailing Data Package Delivery Date | |
Co-Detailing Option Exercise Date | |
Co-Detailing Plan | |
Combination Copack | |
Committee Matters | |
Competing Product | |
[***] | [***] |
Confidential Information | |
Contemplated Transactions | |
Cost Report |
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Defined Term | Section |
---|---|
Cost Variances | |
CPR Mediation Procedure | |
CPR Rules | |
Create Act | |
Cure Period | |
Data Package | |
Data Package Delivery Date | |
Derived Competing Product | |
Detail | |
Detailing | |
Development Decision Milestone Event | |
Development Decision Milestone Payment | |
Development FTE | |
Development FTE Costs | |
Development FTE Rate | |
Development Reconciliation Procedures | |
Disclosing Party | |
Dispute | |
Effective Royalty Rate | |
Execution Date | the Introduction |
Executive Officers | |
Existing Xencor Intellectual Property | |
Expert | |
Expert Panel | |
First CD28/Plamotamab Marketing Approval | 6.4.1.4(a) |
First CD28 Product Marketing Approval | 6.4.2.2(a) |
First Exclusivity Period | |
First Milestone Product | |
Force Majeure | |
Hatch-Waxman Act | |
Included Medical Affairs Studies | |
Included Medical Affairs Studies Costs | |
Incompletion Notice | 3.7 |
Incumbent Board | |
Indemnification Claim | |
Indemnitee | |
Indemnitor | |
Independent Plamotamab/Tafa Study |
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Defined Term | Section |
---|---|
Independent Plamotamab/Tafa Study Opt-In Payment | |
Independent Plamotamab/Tafa Study Safety Data | 5.1.3.5(i) |
Infringement Action | |
Infringement Claim | |
Initial Development Activities | |
Insolvency Event | |
Invalidity Claim | |
Inventions | |
Janssen | the Introduction |
Janssen Assigned Inventions | |
Janssen B-Cell Antigen Variant | |
Janssen B-Cell Antigen Variant Binding Domain | |
Janssen Indemnitees | |
JDC | |
JFC | |
JMT | |
Joint CD28 Patents | |
[***] | [***] |
Joint Inventions | |
Joint Patent Costs | |
Joint Patents | |
Joint Plamotamab Patents | |
[***] | [***] |
[***] | [***] |
JRC | |
JRD | |
Losses | |
MAA | |
Manufacturing Cost of Clinical Supply | |
Materials | |
Milestone Event | |
Milestone Payment | |
Minimal Development Activity | 6.4.1.4(a) |
MTD | |
No Plamotamab Development Election | |
Non-breaching Party |
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Defined Term | Section |
---|---|
Notice of 6.4.1 Application | 6.4.2 |
Notice of 6.4.2 Application | 6.4.1.4(a) |
[***] | [***] |
[***] | [***] |
Notice of Development Election Without CD28 | |
Notice of Plamotamab POC Study After Successful Exploration | 5.1.2.1(a)(iii) |
Notice of Plamotamab POC Study After Unsuccessful Exploration | |
Novartis | |
Number of CD28 Units | |
Number of Plamotamab Units | |
Other Costs Not Included in Standard | |
Other Plamotamab Product Royalty Term | |
Other Plamotamab Product Royalty-Bearing Patent | |
Out-of-Pocket Expenses | |
Outstanding Common Stock | |
Outstanding Voting Securities | |
Party | the Introduction |
Patent Representative | |
PDE | |
[***] | [***] |
Phase 1 Exploration Study | |
PHSA | |
Plamotamab Antibody Patents | |
Plamotamab Co-Detailing Option | |
Plamotamab Component | |
Plamotamab Cure Period | |
Plamotamab Development Budget | |
Plamotamab Development Election | |
Plamotamab Development Notice | |
Plamotamab Development Plan | |
Plamotamab Included Medical Affairs Studies Costs Limit | |
Plamotamab Milestone Event | |
Plamotamab Milestone Payment | |
Plamotamab POC Study | |
Plamotamab Safety Concerns |
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Defined Term | Section |
---|---|
Plamotamab/Tafa Combination Regimen | |
POC Data Package | |
POC Data Package Delivery Date | |
Post-POC Decision Notice | 5.1.2.1(b)(ii) |
Pre-POC Decision Development Activity | 5.1.2.2 |
Primary Antibody | |
Primary Plamotamab | |
Primary Plamotamab Products | |
Product Infringement | |
Product Marks | |
Proof-of-Concept | |
Proof-of-Concept Date | |
Proposal Delivery Date | |
Proposal Review Period | |
Proposed Plamotamab/Tafa Study | |
Prosecute | |
Prosecution | |
Protocol | |
Public Official | |
Purple Book | |
Quarterly Net Sales | |
Receiving Party | |
Regulatory Documentation and Filings | |
Remaining Net Sales Amount | |
Research Clone Banking | |
Research Competing Product | |
Research License | |
Research Plan | |
Research Program | |
Research Program Results | |
Research Program Term | |
Reversion Royalty Rate | |
Reverted CD28 Antibody | |
Reverted CD28 Derivative | |
Reverted CD28 Product | |
Reverted CD28 Product Derivative | |
Reverted CD28 Variant | |
Reverted CD28/Plamotamab Combination Product |
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Defined Term | Section |
---|---|
Reverted Plamotamab Product | |
Reverted Product | |
Royalty Term | |
Royalty-Bearing Patent | |
Royalty-Bearing Plamotamab Formulation Patent | 7.4.2.2(a) |
Sales Milestone Event | |
Sales Milestone Payment | |
Scale-Up | |
Second Exclusivity Period | |
[***] | [***] |
Selected B-Cell Antigen | |
Selected B-Cell Antigen Binding Domain | |
Selected CD28 Antibody | |
Shared Development Costs | |
Specified Person | |
Standard Cost of Goods Manufactured | |
Subcontract | |
Subcontractor | |
Supplemental Application | |
Tafa/len Safety Run-in | |
Target B-Cell Antigens | |
Target Criteria | |
Target Phase 1 Exploration Study Completion Date | 5.1.2.1(a) |
Term | |
Third Party Compensation | |
Third Party Competitive Product | |
Third Party License | |
Total CD28/Plamotamab Net Sales | |
Unadjusted Quarterly Royalties | |
Xencor | the Introduction |
Xencor B-Cell Antigen x CD28 Patents | |
Xencor CD28 Inventions | |
[***] | [***] |
Xencor Indemnitees | |
[***] | [***] |
[***] | [***] |
24
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25
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26
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
27
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28
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29
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
30
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
31
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
32
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
33
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF LICENSED CD28 ANTIBODIES AND LICENSED CD28 PRODUCTS
34
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
35
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
36
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
An initial Plamotamab Development Budget with non-binding cost estimates for the Initial Development Activities is attached as Exhibit 5.1.1.2.
37
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
38
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
39
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
40
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
41
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
42
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
43
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
44
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
45
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
46
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
47
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
48
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
49
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
50
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
51
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
52
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
53
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
54
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
55
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
For clarity, Shared Development Costs for CD28/Plamotamab Combinations will be included in the Plamotamab Development Budget and will be treated as Shared Development Costs for the Plamotamab Products.
Notwithstanding anything to the contrary in this Agreement, Shared Development Costs do not include [***] (the “CD28 Included Medical Affairs Studies Costs Limit”). Shared Development Costs for the Plamotamab Products do not include [***] (the “Plamotamab Included Medical Affairs Studies Costs Limit”).
56
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
57
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
58
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
���
59
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
60
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
61
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
62
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
For clarity, (x) Xencor’s exercise of the CD28 Co-Funding Opt-Out is irrevocable as of the date of the CD28 Co-Funding Opt-Out Notice and (y) Xencor’s exercise of the CD28 Co-Funding Opt-Out will have no effect on Xencor’s rights and obligations under ARTICLE 5 and Section 6.2.3.4 with respect to CD28/Plamotamab Combinations. Except as provided in this Section 6.2.4, this ARTICLE 6 and Section 7.4.1.3 will be of no further force and effect after the CD28 Co-Funding Opt-Out Effective Date.
63
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
64
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
65
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
66
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
67
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
68
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
69
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
70
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Category A Sales Milestone Event | Category A Sales Milestone Payment |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Category B Sales Milestone Event | Category B Sales Milestone Payment |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
71
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Annual Aggregate Category A Net Sales in the Territory | Royalty Rate |
---|---|
For that portion of annual Category A Net Sales in the Territory in such Calendar Year less than US$[***] | [***] |
For that portion of annual Category A Net Sales in the Territory in such Calendar Year greater than or equal to US$[***] and less than US$[***] | [***] |
72
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Annual Aggregate Category A Net Sales in the Territory | Royalty Rate |
---|---|
For that portion of annual Category A Net Sales in the Territory in such Calendar Year greater than or equal to US$[***] | [***] |
[***].
Annual Aggregate Category A Net Sales in the Territory | Co-Funding Royalty Rate |
---|---|
For that portion of annual Category A Net Sales in the Territory in such Calendar Year less than US$[***] | [***] |
For that portion of annual Category A Net Sales in the Territory in such Calendar Year greater than or equal to US$[***] and less than US$[***] | [***] |
For that portion of annual Category A Net Sales in the Territory in such Calendar Year greater than or equal to US$[***] | [***] |
[***].
73
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Annual Aggregate Category B Net Sales in the U.S. | Royalty Rate |
---|---|
For that portion of annual Category B Net Sales in the U.S. in such Calendar Year less than US$[***] | [***] |
For that portion of annual Category B Net Sales in the U.S. in such Calendar Year greater than or equal to US$[***] and less than US$[***] | [***] |
For that portion of annual Category B Net Sales in the U.S. in such Calendar Year greater than or equal to US$[***] | [***] |
Annual Aggregate Category B Net Sales in the OUS Territory | Royalty Rate |
---|---|
For that portion of annual Category B Net Sales in the OUS Territory in such Calendar Year less than US$[***] | [***] |
For that portion of annual Category B Net Sales in the OUS Territory in such Calendar Year greater than or equal to US$[***]and less than US$[***] | [***] |
For that portion of annual Category B Net Sales in the OUS Territory in such Calendar Year greater than or equal to US$[***] | [***] |
Net Sales of a particular Product or combination in a particular country occurring after expiration of the applicable Royalty Term for such Product or combination in such country will be disregarded in the calculation of royalties pursuant to Section 7.4.1.4 and Section 7.4.1.5.
74
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
75
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
76
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
(i) a CD28/Plamotamab Combination Regimen has received Marketing Approval in a country;
(ii) the same Licensed CD28 Product that is a component of such CD28/Plamotamab Combination Regimen (the “CD28 Component”) has received Marketing Approval in such country for use either in a Combination Regimen that is not a CD28/Plamotamab Combination Regimen, or for use as a single agent; and
77
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
(iii) the Plamotamab Product that is a component of such CD28/Plamotamab Combination Regimen (the “Plamotamab Component”) has not received Marketing Approval in such country for any other use or Indication;
then the aggregate Net Sales of the CD28 Component and the aggregate Net Sales of the Plamotamab Component (the “Total CD28/Plamotamab Net Sales”) in such country in such period will be allocated between Category A Net Sales and Category B Net Sales as follows:
78
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
(i) a CD28/Plamotamab Combination Regimen has received Marketing Approval in a country; and
(ii) the CD28 Component of such CD28/Plamotamab Combination Regimen has received Marketing Approval in such country for use either in a Combination Regimen that is not a CD28/Plamotamab Combination Regimen, or for use as a single agent; and
(iii) the Plamotamab Component of such CD28/Plamotamab Combination Regimen has received Marketing Approval in such country for use either in a Combination Regimen that is not a CD28/Plamotamab Combination Regimen, or for use as a single agent.
then Janssen will fairly and equitably allocate Net Sales of the CD28 Component and Plamotamab Component among the approved uses. Janssen will submit its allocation methodology to the JFC and if the JFC does not agree with such methodology, then the JFC will discuss and approve an alternate methodology. If the JFC does not approve an alternate methodology within [***], then either Party may refer the matter for resolution by an Expert Panel in accordance with the procedures set forth in Section 2.5.1.5 [***].
79
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
80
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
81
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
82
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Example royalty calculations are attached hereto as Exhibit 7.4.3.4.
83
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
84
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Each Party will keep, and cause its Affiliates and sublicensees to keep, complete and accurate records of the items underlying Shared Development Costs, Net Sales and any other elements required to prepare the reports or calculate payments required by under this Agreement. Such records must be retained for a period of [***] following the relevant reporting period.
85
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
86
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
87
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
88
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
89
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
90
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
91
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
During any period in which the Acquiring Party is permitted to continue Researching, Developing, Manufacturing or Commercializing such Acquired Competing Product in accordance with clause (a) or (b) above, the applicable prohibition under Section 8.4.2 or Section 8.4.3 will not apply with respect to such Acquired Competing Product, and the Acquiring Party will [***].
92
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Each Party hereby makes all assignments necessary to accomplish the foregoing ownership.
93
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
94
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
95
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
96
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
97
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
98
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
99
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
100
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
101
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
The obligations in Section 10.1 will not apply to the extent of any portion of the Confidential Information that the Receiving Party can show by competent written evidence:
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If and whenever any Confidential Information is disclosed in accordance with this Section 10.3, such disclosure will not cause such information to cease to be Confidential Information for purposes of this Agreement, 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, if a Party intends to make a disclosure of the other Party’s Confidential Information pursuant to Section 10.3(c) or Section 10.3(d), it will, except where impracticable or not legally permitted, give [***] advance notice (or, if [***] notice is not possible under the circumstances, reasonable advance notice) to the other Party of such disclosure and use not less than the same efforts to secure confidential treatment of such information as it would to protect its own confidential information from disclosure (but no less than reasonable efforts).
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105
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
106
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
107
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
108
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Notwithstanding the foregoing, Xencor makes no representations or warranties (and none of the foregoing representations and warranties shall apply) with respect to any Licensed CD28 Antibody disclosed in Schedule 1.64 or any activities with respect thereto except to the extent the breach of such representation or warranty relates to Xencor’s use or incorporation of a Xencor Binding Domain or Xencor Research Intellectual Property in such antibody or to Janssen’s use or incorporation of a Xencor Binding Domain in such antibody.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
111
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
112
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
113
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
114
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
except, in each case, to the extent such Losses arise out of or relate to the negligence of Xencor or any of the other Xencor Indemnitees or to the extent otherwise arising out of or relating to clause (a) or clause (b) of Section 12.2.
except, in each case, to the extent such Losses arise out of or relate to the negligence of Janssen or any of the other Janssen Indemnitees or to the extent otherwise arising out of or relating to clause (a) or clause (b) of Section 12.1.
117
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
118
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
119
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
120
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
121
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
If Xencor or any of its successors or assigns provides to Janssen any of the intellectual property licensed hereunder (or any embodiment thereof) under this Section 13.4.2, Janssen will have the right to perform Xencor’s obligations under ARTICLE 3 with respect to such intellectual property, but neither such provision nor such performance by Janssen will release Xencor from liability resulting from rejection of the license or failure to perform such obligations.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
123
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
125
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
126
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Until the effective date of termination, the costs of such Clinical Study will be shared by the Parties as Shared Development Costs to the extent such costs are to be shared pursuant to Section 6.2.3. After the effective date of termination: (x) costs incurred in the winding down of such Clinical Study in accordance with clause (a) above will be shared by the Parties as Shared Development Costs to the extent such costs are to be shared pursuant to Section 6.2.3; and (y) costs incurred to conduct any Clinical Study that Xencor elects to have transferred to Xencor in accordance with clause (b) above will be borne solely by Xencor. If Xencor fails to notify Janssen which option ((a) or (b)) it chooses within the [***] time period, then Xencor will be deemed to have elected to have Janssen wind down the Clinical Study. If this Agreement is terminated solely with respect to Plamotamab and the Plamotamab Products, or solely with respect to Licensed CD28 Antibodies and Licensed CD28 Products, this Section will not apply to any Clinical Study of a CD28/Plamotamab Combination (and, instead, Section 13.5.1.3 will apply to such Clinical Study).
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
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If to Xencor:
[***]
If to Janssen:
[***]
All such notices, requests, demands, waivers and other communications will be deemed to have been received, if by personal delivery or overnight courier, on the day delivered or, if by facsimile, on the next Business Day following the day on which such facsimile was sent; provided, in each case that a copy is also sent by electronic mail in accordance with the first sentence of this Section 16.7.
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[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties have caused this Collaboration and License Agreement to be executed by their respective duly authorized officers as of the Execution Date.
Xencor, Inc. By: Name: Title: ___________________ | Janssen Biotech, Inc. By: Name: Title: ___________________ |
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
LIST OF EXHIBITS AND SCHEDULES
Johnson & Johnson Universal Calendar | |
Schedule 1.42 | Existing Third Party Agreements |
| |
Schedule 1.64 | Certain Licensed CD28 Antibodies |
Schedule 1.84 | Plamotamab |
| |
Exhibit 1.88 | Pre-Approved Study |
| |
Research Plan | |
Initial Plamotamab Development Budget | |
Exhibit 7.4.3.4 | Examples of Royalty Calculations |
| |
Schedule 8.4.8 | Certain Provisions of Existing Third Party Agreements |
| |
Schedule 9.2.2.4 | Certain Inventions |
| |
Initial Press Release | |
CD28 Binding Domains | |
| |
CD28 Patents of Xencor | |
| |
Schedule 11.6.1 | Certain Existing Third Party Agreements |
| |
Schedule 11.6.10 | Plamotamab Patents of Xencor |
| |
Schedule 11.6.11 | Plamotamab Regulatory Documentation and Licenses |
| |
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Existing Third Party Agreements
[***]Collaboration and License Agreement entered into by and between Xencor, Inc. and Novartis Institutes for Biomedical Research, Inc. as of June 26, 2016, as amended (the “Novartis Collaboration Agreement”) and that certain Side Letter regarding “Disposition of Intellectual Property Assets after the Termination of the THG338 (CD20xCD3 bispecific antibody) project” dated around September 2019 (the “Novartis Side Letter”) (collectively, the “Novartis Agreements”).
[***]
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Schedule 1.64
Certain Licensed CD28 Antibodies
See attached.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Schedule 1.84
Plamotamab
See attached.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Schedule 9.2.2.4
Certain Inventions
See attached.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Schedule 11.6.10
Plamotamab Patents of Xencor
See attached.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.
Schedule 11.6.11
Plamotamab Regulatory Documentation and Licenses
See attached.
[***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE.