Relating to the establishment of a consortium to conduct United States Food and Drug Administration's drug development clinical trials with ibogaine to secure the administration's approval of the medication's use for treatment of opioid use disorder, co-occurring substance use disorder, and any other neurological or mental health conditions for which ibogaine demonstrates efficacy and to the administration of that treatment.

Contracts

• Consortium MOU: You must execute a binding Memorandum of Understanding between a Texas university (Lead Institution), a hospital with cardiac intensive care capabilities, and a drug developer. This document must designate the Lead Institution and define liability sharing.
• IP Assignment Amendments: Existing IP agreements must be amended to acknowledge the State of Texas as a 20% stakeholder in all revenue generated from patents, treatment models, and data resulting from these trials.
• State Interagency Contract: The Lead Institution must prepare to sign a performance-based contract with HHSC that ties funding disbursements to specific clinical milestones.

Hiring/Training

• Cardiac Care Staffing: Participating hospitals must verify staffing levels for cardiac intensive care units, as the statute explicitly mandates this capability for trial sites due to Ibogaine’s risk profile.
• Data Integrity Officer: The consortium must designate personnel responsible for the statutory "Data Integrity Plan" to manage patient data and trial results in compliance with both HHSC and FDA standards.

Reporting & Record-Keeping

• Segregated Accounting: Finance departments must establish separate ledgers for "Matching Funds." You must prove the 1:1 match with non-state sources before HHSC releases any grant money.
• Quarterly Financials: The Lead Institution is required to submit quarterly reports to HHSC detailing expenditures and verifying the continued status of matching funds.
• Revenue Tracking: Systems must be implemented to track "revenue attributable to intellectual property" distinct from general operating revenue to calculate the 20% state remittance.

Fees & Costs

• 1:1 Matching Requirement: The consortium must provide dollar-for-dollar funding from non-state sources.
• 20% Revenue Remittance: The law requires the consortium to return 20% of all revenue from commercialization and IP to the State General Revenue Fund. This is a permanent royalty, not a one-time fee.