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DOCUMENT TITLE:  CO-DEVELOPMENT/CO-PROMOTION AND LICENSE AGREEMENT RELATING TO TYPE-3 INTERFERON FAMILY .
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Clause Heading
1.1 - Definitions
1.2 - Terminology
2.1 - General
2.2 - No Competing Program or Competing Product during Exclusivity Term
2.3 - Competing Product Due to a Change of Control
2.4 - Acquisition of Hepatitis C Program Due to a Change of Control
3.1.1 - Formation; Composition; JEC Action
3.1.2 - Role and Responsibilities
(c) - Approval of any Combination Studies.
3.1.3 - Meetings and Communications
3.2.1 - Project Leaders; Appointment; Role and Responsibilities
3.2.2 - Formation of Joint Development Committee
3.2.3 - Roles and Responsibilities
(iii) - Formulate and propose to the JEC go/no go criteria for a Decision to Proceed to Phase II and Decision to Proceed to Phase III.
3.2.4 - Meetings and Communications
3.2.5 - Decision Making; Formalities
3.3.1 - Commercialization Leaders; Appointment; Role and Responsibilities
3.3.2 - Formation of Joint Commercialization Committee for a Licensed Product
3.3.3 - Roles and Responsibilities
3.3.4 - Meetings and Communications
3.3.5 - Decision Making; Formalities
3.4.1 - Appointment
3.4.2 - Responsibilities
3.5 - Finance Contacts
3.6 - Working Groups
3.7 - Allocation of Party Development Tasks and Party Commercialization Tasks
(a) - Develop each Licensed Product for Regulatory Approval in the Joint Development Territory in accordance with the Joint Development Plan;
3.8 - Operational Decisions
3.9 - Escalation to Joint Executive Committee
4.1 - Initial Joint Development Project; Collaborative Development Efforts for the Joint Development Project
4.2.1 - Initial Transfer
4.2.2 - Continuing Exchange of Technology
4.3 - Party Development Tasks
4.4.1 - Clinical Trial Data
4.4.3 - Rights of Reference
4.4.4 - Regulatory Meetings and Communications
4.4.2 - Regulatory Submissions
4.4.5 - Regulatory Inspection Right
4.4.6 - Clinical Trial Disclosures
4.5.1 - Adverse Event Reporting
4.5.2 - Global Safety Database and Pharmacovigilance
4.5.3 - Recalls
4.6.1 - Combination Studies; BMS Molecules
4.6.2 - New Indications
4.7.1 - Cost Sharing of Joint Development Costs
4.7.2 - Accounting and Reconciliation
4.8 - Joint Development Costs Paid to Third Parties
4.9 - BMS Efforts Outside the Joint Development Project
5.1 - Commercialization in the USA
5.2 - USA Co-Promotion Agreement
5.4 - USA Commercialization Costs Paid to Third Parties
5.5 - BMS Sole and Primary Roles in Commercialization
5.6 - Reports of Sales in the USA
5.7 - Accounting and Reconciliation
(v) - Sales Costs
5.8 - Commercialization in the ROW
5.9 - Reporting
6.2 - Commercial Manufacture
7.1.1 - Zymos Option
7.1.2 - Failure to File BLA
6.1 - Preclinical and Clinical Supplies
7.1.3 - Zymos Financial Condition
7.1.4 - Effective Date of Conversion
7.2.1 - Joint Development Costs and USA Commercialization Costs
7.2.2 - Wind Down of Activities
7.3.1 - Governance; Responsibility for Development and Commercialization
7.3.2 - Termination of USA Co-Promotion Agreement
7.3.3 - No Other Changes
7.4.1 - Zymos Option
7.4.2 - Effective Date of Election to Co-Fund Only
7.5.1 - Joint Development Costs and USA Commercialization Costs
7.5.2 - Wind Down of Activities
7.6.1 - Governance; Responsibility for Development and Commercialization
7.6.2 - Termination of USA Co-Promotion Agreement
7.6.3 - No Other Changes
7.7 - Combined Conversion and Election to Co-Fund Only
8.1 - Licensing Fees
8.2 - Milestone Payments
8.3 - Reporting of Milestone Events; Payment of Milestone Payments
9.1 - Payments on Net Profits in the USA
9.2.1 - Rate for Protection by Core Patent
9.2.2 - Royalty for Protection by Other Patents and Without Applicable Patent Rights
9.2.3 - Royalties on Follow On Products
9.2.4 - Royalties upon Conversion
9.2.5 - No Cumulative Royalties; Aggregation and Allocation of Net Sales for Determining Royalty Rate Breakpoints
9.2.6 - Third Party Commercial Use Fees Paid by Zymo
9.3.1 - Credit for Third Party Commercial Use Fees Paid by BMS
9.3.2 - Credit for Generic Products
9.3.3 - Cumulative Credits
9.4 - Reporting and Payment
9.5 - Acknowledgment Regarding Compensation
10.1 - Form of Payment; Currency Conversion
10.2 - Late Payment
10.3 - Records
10.4 - Audits
10.5 - Payments Based on Audit Results
10.6 - Withholding
11.1 - Ownership of Patent Rights
11.2 - Core Patents
11.3.1 - Grant
11.3.2 - Exclusions
11.3.3 - Reservation
11.4 - License to Zymo
11.5 - Rights Upon Bankruptcy
11.6 - Grant of Sublicenses
11.7 - Sublicense to Contractors
11.8 - No Other Rights
11.9 - Use of Names, Trade Names and Trademarks
12.1 - Patent Contacts
12.2.1 - Core Patents
12.2.2 - BMS IP
12.2.3 - Zymo IP
12.2.4 - Joint Patents and Core Patents
12.2.5 - Patent Prosecution Partys Efforts
12.2.6 - Discontinued Patent
12.3 - Defense of Third Party Infringement Claims
12.4.1 - Licensed Product related Infringement
12.4.2 - Non-Licensed Product related Infringement
12.4.3 - Enforcement of Joint Patent Rights
12.4.4 - General Provisions Relating to Enforcement of Patents
12.4.5 - Sharing of Awards
12.5 - No Action in Violation of Law
12.6 - Data Exclusivity and Regulatory Listings
12.7 - Notification of Allegation of Invalidity
12.8 - Patent Term Extensions
12.9 - Protection of the Licensed Product Trademarks
12.10 - Copyright Registrations
13.1 - Confidentiality and Non-Use
13.2 - Exceptions
13.3 - Permitted Disclosures
13.4 - Materials; Permitted Uses
13.5 - Press Releases
13.6 - Publications
13.7 - Obligations of Confidentiality to Third Parties
14.1 - Representations and Warranties of Zymo
14.1.1 - Organization and Good Standing
14.1.2 - Enforceability; Authority and No Current Conflicts
14.1.3 - Invention Agreements and Obligations to Assign
14.1.4 - Third Party Agreements
14.1.5 - Authority to License; Ownership of Zymo Enabling Technology
14.1.6 - No Notice of Invalidity or Unenforceability
14.1.7 - Third Party Patent on IFN-Lambda
14.1.8 - Compliance With Applicable Laws
14.1.9 - No Debarment Proceedings
14.1.11 - Regulatory Filings
14.2 - Representations and Warranties of BMS
14.2.1 - Organization and Good Standing
14.2.2 - Enforceability; Authority and No Current Conflicts
14.2.3 - Invention Agreements with Personnel and Contractors
14.2.4 - Third Party Agreements
14.2.5 - Authority to License
14.2.6 - No Notice of Invalidity or Unenforceability
14.3.1 - No Future Conflicts
14.3.2 - Compliance With Laws
14.3.3 - No Debarment Proceedings
14.3.4 - Third Party Agreements
14.4 - Materials
14.5 - Warranty Disclaimer
15.1.1 - Matters Covered
15.1.2 - Exclusions
15.2.1 - Provision of Attorney
15.2.2 - Notice
15.2.3 - Tender of Defense
15.2.4 - Assistance
15.3 - Insurance
16.1 - HSR Act Filing; Effective Date
16.2 - Term
16.3 - Termination by Mutual Consent
16.4 - Termination for Material Breach
16.5 - Termination by BMS for Convenience
16.6 - Bankruptcy
16.8 - Transfer of Project Following Termination
16.10 - Exception for Termination for Safety Reasons
16.11.1 - Accrued Rights
16.11.2 - Sale of Inventory
16.11.3 - Surviving Provisions
16.11.4 - Cumulative Remedies
17.1 - Goal; Cooperative Decision-Making
17.2 - Procedure
17.4.1 - Matters to be Arbitrated
17.4.2 - Venue and Rules
17.4.3 - Composition of Tribunal
17.4.4 - Tribunals Jurisdiction
17.4.5 - Costs
17.4.6 - Continuing Performance
17.4.7 - Equitable Remedies
17.5 - Disputes Relating to Patents
17.6 - Governing Law
18.1 - Entire Agreement
18.2 - No Strict Construction
18.3 - Notices
18.4 - Force Majeure
18.7 - Amendments and Waivers
18.8 - Severability
18.9 - Counterparts
(a) - Except an assignment:
18.6 - Non-Solicitation
18.10 - Relationship
18.11 - Affiliates
1.37 - Cost of Goods Sold means the Manufacturing Costs for the Licensed Products sold.
(b) - Trademark Costs
(d) - Write-offs of obsolete inventory
(ii) - Project Technology;