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DOCUMENT TITLE:  COLLABORATION AND LICENSE AGREEMENT .
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Clause Heading
2.1 - Collaboration Overview.
(a) - Formation and Role.
(b) - Guiding Principles.
2.4 - JSC Membership.
(a) - Meetings.
(b) - Decision Making.
(c) - Disputes.
2.6 - Subcommittees.
2.7 - Alliance Representative.
2.8 - Royalty Territory Information Sharing.
3.1 - Overview.
3.4 - Development Expenses.
3.5 - Performance; Diligence.
3.6 - Records, Reports and Information.
3.7 - Backup Research Agreement.
3.8 - Replacement Products.
3.9 - Right of First Negotiation to Backup Compounds.
(a) - Proposal.
(b) - Joint Development.
(c) - Rejection; Failure to Agree.
(a) - Duties.
(b) - Costs.
(c) - Comparator Drugs.
(a) - Existing Data.
(b) - Future Data.
(c) - Clarification.
(a) - In General.
(b) - Costs and Expenses.
(c) - Rights of Reference to Regulatory Materials.
(a) - Preparation.
(b) - Compliance.
(c) - Meetings.
(d) - Ownership.
(c) - Ownership.
(d) - Meetings.
4.5 - Consultation, Reporting and Review.
4.6 - Communications.
4.7 - Adverse Event Reporting and Safety Data Exchange.
4.8 - Regulatory Authority Communications Received by a Party.
(a) - Audit of Takeda.
(b) - Audit of Affymax.
(c) - Audit Procedures.
4.10 - Recalls and Voluntary Withdrawals.
5.1 - Commercialization in the Licensed Territory.
(b) - Royalty Territory.
5.2 - Commercialization Plans.
(b) - For the Royalty Territory.
5.3 - Product Labeling; Promotional Materials.
5.4 - Pricing Approvals; Pricing.
5.5 - Sales and Distribution.
5.6 - Takeda Performance; Diligence.
(b) - Time to Launch Product.
(c) - Royalty Territory Reports.
5.9 - Compliance.
5.11 - Trademarks.
(b) - Filing; Maintenance.
(d) - Registration of Exclusive License.
(e) - Compliance with Guidelines.
6.1 - Licenses to Takeda under Affymax Technology.
6.2 - Limited License for Product Trademarks and Affymax House Marks.
6.3 - License to Affymax under Takeda Technology.
6.4 - Negative Covenant.
6.5 - No Implied Licenses.
6.6 - Parallel Programs.
6.7 - Third Party Licenses.
6.8 - Amendment to Japan Agreement.
7.1 - Roles of the Parties.
7.2 - Preclinical and Clinical Supply.
7.3 - Commercial Supply Agreement.
7.4 - Cost Audit.
7.5 - Facility Audits.
7.6 - Quality Agreement.
8.1 - License Fee.
8.2 - Development Milestone Payments.
(a) - Existing Agreements.
8.3 - Sales Milestone Payments.
(a) - Royalty Rate.
(b) - Royalty Rate Step Down.
(c) - Royalty Payments and Reports.
(b) - Future Agreements.
(c) - Reimbursement Procedures.
(a) - Cooperation and Coordination.
(b) - Payment of Tax.
(c) - Tax Residence Certificate.
(d) - Assessment.
8.8 - Blocked Currency.
8.9 - Foreign Exchange.
8.10 - Late Payments.
8.11 - Records; Audits.
9.1 - Ownership of Inventions.
9.2 - Disclosure of Inventions.
(a) - Affymax Patents Other than Joint Patents.
(b) - Takeda Patents Other Than Joint Patents.
(c) - Joint Patents.
(d) - Cooperation in Prosecution.
9.4 - Patent Term Extensions in the Licensed Territory.
(a) - Notification.
(b) - Infringement of Affymax or Joint Patents in the Licensed Territory.
(d) - Settlement.
(a) - Notice.
(b) - Defense.
(c) - Settlement.
(d) - Settlement Payment.
9.7 - Patent Marking.
9.8 - Infringement of Trademarks by Third Parties.
(a) - Corporate Existence and Power.
(b) - Authority and Binding Agreement.
9.9 - Patent Oppositions and Other Proceedings.
9.10 - Parties Patent Rights.
9.11 - Orange Book Listing, Compendial Listing.
9.12 - Registration of Exclusive License.
9.13 - Certain Patent Matters.
10.1 - Mutual Representations and Warranties.
(c) - No Conflict.
(d) - No Debarment.
10.2 - Additional Representations, Warranties and Covenants of Affymax.
(a) - Regulatory Materials and Studies.
(c) - Patent/House Mark/Trademark Matters in the Licensed Territory.
(d) - Supply of Bulk API or Finished Product by Affymax.
(e) - Listing of Backup Compounds.
(f) - Cross-License Agreement.
(b) - Sufficiency of License Grants.
10.3 - Additional Representation of Takeda.
10.4 - Disclaimer.
10.5 - No Other Representations or Warranties.
11.1 - Indemnification by Affymax.
11.2 - Indemnification by Takeda.
11.4 - Indemnification Procedures.
11.5 - Limitation of Liability.
11.6 - Insurance.
12.1 - Confidentiality.
12.2 - Authorized Disclosure.
12.3 - Publicity; Terms of Agreement.
12.4 - Publications.
12.5 - Injunction.
13.1 - Term.
(a) - Withdrawal by Takeda.
(b) - Termination for Breach.
13.3 - Other Remedies for Affymax Breach.
(a) - Supply.
(b) - Regulatory.
(c) - Continuing Right to Additional Product.
13.4 - Effect of Termination of the Agreement.
(a) - Partial Termination.
(b) - Regulatory Materials.
(c) - Takeda License.
(d) - Transition Assistance.
(e) - Remaining Inventories.
(f) - Termination of Licenses.
(g) - Restriction on Licensing of Compounds.
13.5 - Effects of Expiration.
13.6 - Other Remedies.
13.7 - Rights in Bankruptcy.
13.8 - Survival.
14.1 - English Language; Governing Law.
14.2 - Disputes.
15.1 - Entire Agreement; Amendment.
15.2 - Force Majeure.
15.3 - Notices.
15.4 - No Strict Construction; Headings.
15.11 - Counterparts.
15.5 - Assignment.
15.6 - Performance by Affiliates.
15.7 - Further Actions.
15.8 - Severability.
15.9 - No Waiver.
15.10 - Independent Contractors.
15.12 - Construction.
1 - COST OF GOODS SOLD
2 - MANUFACTURING COSTS
3 - PRE-MARKETING AND MARKETING EXPENSES
4 - DISTRIBUTION EXPENSES
5 - CLINICAL PHASE IV AND RELATED EXPENSES
6 - MEDICAL SCIENCE LIAISON EXPENSES
7 - REGULATORY EXPENSES
8 - LAUNCH EXPENSE ALLOWANCE
9 - ALLOCATION OF COSTS OF FINISHED PRODUCT.