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DOCUMENT TITLE:  DEVELOPMENT AND COMMERCIALIZATION AGREEMENT .
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ARTICLE I - DEFINITIONS
2.1 - License.
2.2 - Sublicensees.
(a) - BioMarin CF Rights Limited.
(b) - Territorial Integrity.
2.4 - Asia-Pacific Matching Right.
(f) - No Implied Obligations.
(g) - Audit Rights.
(h) - Right to Share Information.
(a) - Establishment.
(b) - Duties.
3.2 - Establishment of Working Group.
3.3 - JSC Membership.
3.4 - JSC Meetings.
3.5 - Decision-Making.
3.6 - Scope of Governance.
4.1 - Overall Efforts in Development.
(c) - ASPEN Study.
(d) - Development Costs.
(e) - Dosing Study.
(a) - General.
(b) - Initial Operating Plan/Budget.
(c) - Amendments.
(d) - Timing and Process for Annual Amendments.
(e) - Operating Plan/Budget Content.
(a) - By Either Party.
(b) - Provision of Data to JSC.
4.4 - Term of Ongoing Obligations.
5.1 - Regulatory Responsibilities.
(a) - ASPEN Study and Dosing Study.
(b) - NDA Regulatory Responsibilities.
(c) - Other Regulatory Responsibilities.
(d) - Costs.
(a) - Regulatory Filings and Correspondence.
(b) - Regulatory Interactions.
(c) - Role of JSC.
(d) - Other Regulatory Matters.
5.3 - Regulatory Inspections.
5.4 - Audit Rights.
5.5 - Adverse Event Management.
(b) - Territorial Allocation.
(i) - United States.
(ii) - Countries of the Territory Outside the Unites States.
(iii) - Promotion of the Products.
(iv) - Activities Prior to Full Participation Point.
(a) - Exercise of Option.
(i) - La Jolla FTEs.
(ii) - Sales Activities.
(b) - Role of the Joint Steering Committee.
(c) - Joint Promotion Plan.
(d) - Performance Standards.
(e) - BioMarin CF Practices and Procedures.
(i) - Sales Efforts of the Parties.
(ii) - Costs.
(iii) - Sales Representative Compensation Weighting.
(g) - Timing.
6.3 - Right to Seek to Change Structure to Royalties on Net Sales.
6.4 - Booking Sales.
6.5 - Commercialization Activities Outside the Territory.
7.1 - Commencement Payments.
7.2 - Payments in Connection with First Interim Efficacy Analysis.
7.3 - Payments in Connection with Second Interim Efficacy Analysis.
7.4 - Payment in Connection with 128 Flare Topline Data.
7.5 - Partial Payments in Equity.
7.6 - Certain Terms.
7.7 - Notice by La Jolla.
7.8 - Termination.
7.9 - Regulatory Milestones.
7.10 - Net Sales Milestones.
7.11 - Milestone Reporting and Payments.
7.12 - Cost-Profit Sharing.
(a) - Adverse Outcome.
(b) - Rights Relating to Approval of the NDA without P-Value Achievement.
(a) - Payments Non-Refundable.
(b) - Payment Method.
(c) - Currency Conversion.
7.15 - Withholding Taxes.
7.16 - Books and Records.
(a) - Request.
(b) - Discrepancies.
7.18 - Restriction on Certain Equity Investments.
8.1 - General Communications.
8.2 - Conduct of Activities.
9.1 - Manufacturing.
9.2 - Funding for La Jolla Facility.
9.3 - Cooperation.
(a) - Materials Produced by Third Party Contractors.
(b) - Materials Produced by BioMarin CF.
9.4 - Shortage of Supply.
(a) - Procedures.
(b) - Allocation.
9.5 - BioMarin CF Manufacturing.
9.6 - Restrictions on Manufacturing Locations.
10.1 - Confidential Information.
10.4 - Publication of Product Information.
(a) - Initial Release.
10.2 - Permitted Disclosures.
10.3 - Confidential Terms.
(b) - Further Publicity.
(c) - Certain Events.
10.6 - Prior Non-Disclosure Agreements.
(a) - General Principles.
(b) - Joint Ownership.
(c) - Grant-Back License.
(a) - Control of Prosecution Prior to Full Participation.
(b) - Control of Prosecution After Full Participation.
(c) - Scope of Activities.
(d) - Cooperation.
(e) - Prosecution and Maintenance Costs.
(a) - Notice.
(b) - Enforcement Actions.
(c) - Cooperation.
(d) - Recoveries.
11.4 - Third Party Infringement Claims.
11.5 - Patent Marking.
(a) - Existing Third Party Technology.
(b) - Provisions of Existing In-License.
(c) - New Technology.
12.1 - Display.
12.2 - Title.
12.3 - Grant of License.
12.4 - Registration of Trade Marks.
12.5 - Certain Covenants.
12.6 - Recordation of Licenses.
12.7 - Approval of Packaging and Promotional Materials.
12.8 - Enforcement.
12.9 - Termination of Trade Mark License.
12.10 - Trademark Costs.
13.1 - Term.
13.2 - Breach.
13.3 - Convenience.
14.1 - Accrued Obligations.
14.2.1 - Right of Sale.
14.2.2 - Right of Purchase.
14.3 - Procedure.
(i) - Development.
(ii) - Commercialization.
(iii) - Manufacturing.
(b) - Assignment of Regulatory Filings and Marketing Approvals.
(c) - Data and Know-How Disclosure.
(d) - Transition.
(e) - Licenses.
(f) - Sublicensees.
(g) - Return of Materials.
14.5 - Expiration of Term.
14.6 - Surviving Sections and Articles.
15.1 - General Representations.
(a) - Duly Organized.
(b) - Due Execution; Binding Agreement.
(c) - Authorizations.
(d) - No Other Affiliates.
15.3 - Representations and Warranties of BioMarin CF.
15.4 - DISCLAIMER.
16.1 - Indemnification of La Jolla.
15.2 - Representations and Warranties of La Jolla.
16.2 - Indemnification of BioMarin CF.
16.3 - Procedure.
(a) - Voluntary and Mandatory Recalls; Decision-Making.
(b) - Costs of Recall.
16.5 - Products Liability Claims.
16.6 - WAIVER OF CERTAIN CLAIMS.
ARTICLE XVII - DISPUTE RESOLUTION
17.2 - Arbitration Proceedings.
(a) - General Provisions.
(b) - Decision of Arbitrator.
(c) - Location; Costs.
ARTICLE X - VIII
18.1 - Force Majeure.
18.2 - Governing Law; Venue.
18.3 - Waiver of Breach.
18.4 - Modification.
18.5 - Severability.
18.6 - Entire Agreement.
18.7 - Notices.
18.8 - Assignment.
18.9 - No Partnership or Joint Venture.
18.10 - Interpretation.
18.11 - Export Laws.
18.12 - Counterparts; Facsimile Signatures.
2 - Finish patent No.