RealDealDocs - Find thousands of real agreements and clauses from top US law firms

View Clause Headings                                                                                                                                               HelpHelp
DOCUMENT TITLE:  CO-DEVELOPMENT/CO-PROMOTION AND LICENSE AGREEMENT RELATING TO TYPE-3 INTERFERON FAMILY .
ACTIONS: Here are the clause headings in the document. To view the clause, click the clause heading.To view the full document, click the "View Document" button.

View Document Back
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;