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DOCUMENT TITLE:
COLLABORATION AND LICENSE AGREEMENT
.
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.
Clause Heading
(a) - Formation and Role.
2.2 - Joint Committee Membership
(a) - Meetings.
(b) - Meeting Agendas.
(a) - Decision Making.
(b) - Dispute.
(c) - Excepted Development Matters.
2.5 - Project Coordinators.
2.6 - Collaboration Guidelines.
3.1 - Overview.
3.2 - Development Plan.
3.3 - Principles of Product Development.
3.4 - Collaborators Performance.
3.5 - Records, Reports and Information.
3.6 - Right of First Refusal to Backup Product Developed in the Field.
(a) - Data Generated by Affymax.
(b) - Audited Data Generated by Third Parties on Behalf of Affymax; Requests for Additional Data by Collaborator.
(c) - Data Generated by or on Behalf of Collaborator.
(d) - Use of Collaborator Data.
(e) - Clarification.
(a) - In General.
(b) - Rights of Reference to Regulatory Materials.
(c) - Collaborator Rights and Obligations.
(d) - Consultation, Reporting and Review.
4.3 - Filings for Regulatory Exclusivity.
4.4 - Regulatory Costs.
4.5 - Communications.
4.6 - Collaborator Regulatory Filings.
4.7 - No Harmful Actions.
4.8 - Adverse Event Reporting and Safety Data Exchange.
(a) - General.
(b) - Collaborator Disclosures to Affymax.
4.10 - Regulatory Inspection or Audit.
(b) - Audit of Product Manufacturer.
4.11 - Recalls and Voluntary Withdrawals.
5.1 - Commercialization in the Licensed Territory.
5.2 - Pricing Approvals in the Licensed Territory.
5.3 - Pricing of the Product in the Licensed Territory.
(a) - Level of Efforts.
(b) - Time to Launch Product.
(c) - Reports.
5.5 - Compliance.
(a) - Product Trademark.
(b) - Affymax House Marks.
6.1 - Licenses to Collaborator under Affymax Technology.
6.2 - Limited License for Affymax House Marks.
(b) - Standards for Using Affymax House Marks.
6.3 - License to Affymax under Collaborator Technology.
6.4 - Negative Covenant.
6.5 - No Implied Licenses.
6.6 - Exclusivity.
6.7 - Third Party Licenses.
7.1 - Roles of the Parties.
7.4 - Finished Product.
7.5 - Comparator Drugs.
7.2 - Preclinical and Clinical Supply of Bulk Hematide.
7.3 - Commercial Supply of Bulk Hematide.
7.6 - Audit.
(a) - Rate for Patented Products.
7.7 - Collaborator Audit Right of Bulk Hematide Facility.
7.8 - Quality Agreement.
8.1 - License Fee.
8.2 - Clinical Milestone Payments.
(b) - Royalty Rate Step Down; Term of Obligation.
(c) - Royalty Payments and Reports.
8.4 - Existing and Future Third Party Royalties.
(a) - Cooperation and Coordination.
(b) - Payment of Tax.
(c) - Tax Residence Certificate.
(d) - Assessment.
8.6 - Foreign Exchange.
8.7 - Late Payments.
8.8 - Records; Audits.
9.1 - Ownership of Inventions.
9.2 - Disclosure of Inventions.
9.4 - Patent Term Extensions in the Licensed Territory.
(a) - Notification.
(a) - Affymax Patents Other than Joint Patents.
(b) - Collaborator Patents Other Than Joint Patents.
(c) - Joint Patents.
(d) - Cooperation in Prosecution.
(b) - Infringement of Affymax Patents or Joint Patents in the Licensed Territory.
(c) - Infringement of Affymax Patents or Joint Patents in the Affymax Territory.
(f) - Settlement.
(g) - Allocation of Proceeds.
(a) - Notice.
(b) - Defense.
(c) - Settlement.
9.7 - Patent Marking.
9.8 - Infringement of Trademarks by Third Parties.
(a) - Third-Party Patent Rights.
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.
(a) - Corporate Existence and Power.
(b) - Authority and Binding Agreement.
(c) - No Conflict.
(d) - No Debarment.
10.2 - Additional Representations, Warranties and Covenants of Affymax.
(a) - Regulatory Materials and Studies.
10.3 - Disclaimer.
10.4 - No Other Representations or Warranties.
(b) - Sufficiency of License Grants; Affymax Patents.
(c) - Patent Matters in the Licensed Territory.
(d) - Supply of Bulk Hematide by Affymax.
11.1 - Indemnification by Affymax.
11.2 - Indemnification by Collaborator.
11.3 - Indemnification Procedures.
11.4 - Limitation of Liability.
11.5 - 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 Collaborator.
(b) - Termination for Breach.
13.3 - Effect of Termination of the Agreement.
(a) - Regulatory Materials.
(b) - Collaborator License.
(c) - Transition Assistance.
(d) - Remaining Inventories.
13.4 - Other Remedies.
13.5 - Rights in Bankruptcy.
13.6 - Survival.
14.1 - English Language; Governing Law.
14.2 - Disputes.
(a) - Referred From Joint Committee.
(b) - Arising Between the Parties.
14.3 - Patent and Trademark Dispute Resolution.
15.1 - Entire Agreement; Amendment.
15.2 - Force Majeure.
15.3 - Notices.
15.4 - No Strict Construction; Headings.
15.5 - Assignment.
15.6 - Performance by Affiliates.
15.7 - Further Actions.
15.8 - Severability.
15.9 - No Waiver.
15.10 - Independent Contractors.
15.11 - Counterparts.
1.1 - Sale and Issuance of Series E Preferred Stock.
1.2 - Closing.
2 - REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
2.1 - Organization, Good Standing and Qualification.
2.2 - Capitalization and Voting Rights.
(i) - Preferred Stock.
(ii) - Common Stock; Options; Reserved Shares.
2.3 - Authorization.
2.4 - Valid Issuance of Series E Preferred Stock.
2.5 - Governmental Consents.
2.6 - Offering.
2.9 - Permits.
2.10 - Title to Properties and Assets; Liens, Etc.
3 - REPRESENTATIONS AND WARRANTIES OF THE INVESTORS.
2.7 - Litigation.
2.8 - Financial Statements.
3.1 - Authorization.
3.2 - Purchase Entirely for Own Account.
3.3 - Disclosure of Information.
3.4 - Further Limitations on Disposition.
3.5 - Legends.
3.6 - Reliance by Company.
3.7 - No Reliance on Others.
3.8 - Accredited Investor.
4 - CONDITIONS OF INVESTORS OBLIGATIONS AT CLOSING.
4.1 - Representations and Warranties True; Performance of Obligations.
4.2 - Consents, Permits, and Waivers.
4.3 - Filing of Restated Charter.
4.4 - Corporate Documents.
4.5 - Reservation of Conversion Shares.
4.6 - Compliance Certificate.
4.7 - Secretarys Certificate.
4.8 - Investors Rights Agreement.
4.9 - Co-Sale Agreement.
4.10 - Voting Agreement.
5 - CONDITIONS OF THE COMPANYS OBLIGATIONS AT CLOSING.
5.1 - Representations and Warranties True.
5.2 - Performance of Obligations.
5.3 - Filing of Restated Charter.
5.4 - Investors Rights Agreement.
5.5 - Co-Sale Agreement.
5.6 - Voting Agreement.
5.7 - Consents, Permits, and Waivers.
6.1 - Survival of Representations and Warranties.
7.1 - Amendment, Waiver.
8.1 - Notices.
8.2 - Interpretation.
8.3 - Counterparts; Facsimile Delivery.
8.4 - Attorneys Fees.
8.5 - Entire Agreement; Nonassignability; Parties in Interest.
8.6 - Severability.
8.7 - Remedies Cumulative.
8.8 - Governing Law.
8.9 - Rules of Construction.
8.10 - Finders Fee.
8.11 - Expenses.
8.12 - Aggregation of Stock.
8.13 - Delays or Omissions.