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DOCUMENT TITLE:  PRODUCT DEVELOPMENT AND LICENSE AGREEMENT .
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Clause Heading
2.1 - Joint Steering Committee.
2.2 - Working Groups.
2.3 - Membership.
2.4 - Decision-Making.
2.5 - Meetings of the JSC and Working Groups.
2.6 - Alliance Managers.
2.7 - Third Party Performance of Agreement Activities.
3.1 - Dyax Grants.
3.2 - Grant Back License.
3.3 - Retained Rights.
3.5 - Scope of Agreement; Activities in the Dyax Territory.
3.6 - Right of Second Offer; China.
4.1 - HAE Development Plan.
4.2 - Development Plan for Other Angioedema Indications.
4.3 - Roles and Responsibilities.
4.4 - Diligent Development Efforts
4.5 - Manner of Performance; Reports.
4.6 - Exchange of Development Information.
4.7 - Regulatory Submissions and Regulatory Approvals.
4.8 - Complaints; Adverse Event Reporting Procedures; Notice of Adverse Events Affecting Compound.
4.9 - Audits.
5.2 - Advertising and Promotional Materials.
5.3 - Sales and Distribution.
5.4 - Cross-Territory and Cross-Field Sales.
5.5 - Recalls and Market Withdrawals.
6.1 - Manufacture of Drug Substance and Drug Product.
6.2 - Quality.
6.3 - Responsibility for Product Manufacturing Process.
6.4 - Step-in Rights.
6.5 - Supply and Quality Agreements.
7.1 - License Fee.
7.3 - Ongoing Costs.
7.4 - Sales Milestones.
7.5 - Royalties.
7.6 - Net Sales Reports and Royalty Payments.
7.7 - Audits.
7.8 - Taxes; Deductions and Set-Offs.
7.9 - United States Dollars.
7.10 - Currency Exchange.
7.11 - Blocked Payments.
7.12 - Late Payments.
8.1 - Ownership of Inventions.
(d) - Inventorship; Implementation of Joint Ownership.
8.2 - Prosecution and Maintenance of Patent Rights.
8.3 - Third Party Infringement.
8.4 - Claimed Infringement; Patent Invalidity Claims.
8.5 - Patent Term Extensions.
8.6 - Non-Patent Regulatory Exclusivity.
8.7 - Patent Marking.
8.8 - Trademarks.
9.1 - Confidential Information.
9.2 - Related Party, Employee, Consultant and Advisor Obligations.
9.3 - Publicity; Terms of Agreement.
9.4 - Publications.
10.1 - Representations of Authority.
10.2 - Consents.
10.3 - No Conflict.
10.4 - Enforceability.
10.5 - No Debarment.
10.6 - Additional Representations and Warranties of Dyax.
10.7 - No Warranties.
11.1 - By CMIC.
11.2 - By Dyax.
11.4 - No Consequential or Punitive Damages.
11.5 - Product Liability Insurance.
12.1 - Term.
12.2 - Termination Rights.
12.3 - Consequences of Termination.
12.4 - Survival.
13.1 - Referral to Executive Officers.
13.2 - Final Decision-Making Authority Allocated to a Single Party.
13.3 - Arbitration.
14.1 - Choice of Law; Jurisdiction.
14.2 - Notices.
14.3 - Construction.
14.4 - Severability.
14.5 - Captions.
14.6 - Integration.
14.7 - Independent Contractors; No Agency.
14.8 - Assignment; Successors.
14.9 - Execution in Counterparts; Facsimile Signatures.
14.10 - Waiver.
14.11 - Performance by Affiliates.
14.12 - Force Majeure.
14.13 - Export Control.
14.14 - Costs.