Expanded Access Programmes (GAP) 3 Strategic Initiative Positioning GNH India as a trusted partner for compassionate access to investigational therapies

STRATEGIC OVERVIEW Executive Summary What is GAP? Expanded Access Programmes, also known as compassionate use programmes, provide investigational medicines to patients with serious or life-threatening conditions outside of clinical trials. These programmes bridge the gap between regulatory approval and urgent patient need whilst maintaining rigorous compliance standards. Why GNH India? Our established capabilities in regulatory affairs, global pharmaceutical distribution, and cold chain logistics across 180+ countries position us uniquely to deliver GAP services. This initiative strengthens relationships with innovative biotech sponsors whilst building foundations for future Managed Access Programmes. Strategic Alignment Leverages existing GNH strengths in named patient supply and regulatory expertise Reputation Building Establishes credibility with global innovators and regulatory authorities Future Growth Creates pathway to higher-value Managed Access Programme opportunities

MARKET ANAL YSIS The GAP Market Opportunity The global landscape for expanded access continues to evolve rapidly, driven by patient advocacy, regulatory encouragement, and pharmaceutical innovation in rare disease and oncology therapeutics. Growing Patient Demand Increasing awareness and advocacy for access to orphan drugs and breakthrough therapies creates sustained demand for compliant GAP pathways, particularly in underserved emerging markets where clinical trial infrastructure remains limited. Regulatory Support Health authorities worldwide are establishing clearer frameworks for compassionate use programmes. Regulatory bodies increasingly encourage sponsors to provide investigational products when no alternative treatments exist, creating a more favourable environment for GAP operations. Emerging Market Gap LATAM, MENA, Africa, and Asia remain significantly underserved by existing GAP providers. These regions present substantial opportunities for partners with proven regulatory intelligence, local expertise, and established distribution networks capable of navigating complex country-specific requirements.

GNH India's Existing Capabilities Our established infrastructure and proven expertise provide the foundation for excellence in GAP delivery. Named Patient Supply Extensive experience managing individual patient programmes across diverse regulatory environments. Our track record demonstrates operational excellence in compassionate use scenarios with complete documentation and compliance adherence. Regulatory Expertise Deep knowledge of country-specific submission requirements, ethics committee processes, and import licensing across 180+ jurisdictions. Our regulatory intelligence spans complex and emerging markets where guidance may be limited or evolving. Cold Chain Logistics Validated temperature-controlled supply chain with real-time monitoring, customs clearance expertise, and final-mile delivery capabilities. Our infrastructure supports biologics, cell therapies, and other temperature- sensitive investigational products. PV Integration Potential Established relationships with certified pharmacovigilance partners enable seamless integration of adverse event reporting, safety data collection, and sponsor communication throughout the patient treatment journey.

PROCESS FRAMEWORK GAP Execution Model A systematic, compliance-first approach ensures programme integrity from feasibility through closure. Feasibility Assessment Evaluate country regulations, import pathways, and operational requirements Regulatory Submission Ethics committee approval, import licences, and authority notifications Supply & Distribution Product procurement, cold chain logistics, and patient delivery PV & Safety Monitoring Adverse event reporting, safety data collection, sponsor communication Programme Closure Final reporting, documentation archival, audit readiness Audit-Ready at Every Stage: Complete documentation, validated processes, and quality checkpoints ensure inspection readiness and regulatory compliance throughout the programme lifecycle.

Compliance Framework Regulatory & Ethical Principles Country-specific regulatory pathway validation Ethics committee approval for all patient enrolments Informed consent documentation Import licensing and customs compliance Non-commercial product handling Full traceability and chain of custody Quality & Safety Controls GDP-compliant storage and distribution Temperature monitoring with validated systems Batch documentation and product verification Adverse event reporting within 24 hours SAE communication to sponsor PV team Periodic safety update reporting

  1. Pre-Programme Feasibility Regulatory pathway confirmation and operational capability assessment
  2. Regulatory Approval Gate No product movement until all approvals secured and documented
  3. Supply Chain Validation Temperature qualification and logistics provider certification
  4. Patient Treatment Monitoring Continuous safety surveillance and compliance documentation
  5. Programme Close-Out Review Final audit readiness check and documentation archival

FINANCIAL MODEL Pricing & Cost-Recovery Model Transparent, non-commercial pricing ensures programme sustainability whilst maintaining regulatory compliance. Sponsors pay only for operational support4never product mark-up. Cost Component Unit Pricing (USD) Notes Regulatory Submission $1,00032,000 Per country, one-time Import & Customs Clearance $50031,500 Per shipment, country variable Cold Chain Logistics $1,000 Includes temperature monitoring Pharmacovigilance Handling $2003500 Per patient, SAE reporting Programme Management $300 Per patient coordination Contingency Reserve 5310% Risk buffer for excursions $2,500 Entry-Level Per-Patient Cost Single-country, standard temperature product with straightforward regulatory pathway $5,000 Complex Per-Patient Cost Multi-country, ultra-cold chain, or complex regulatory submission requirements Optional Enhancement: Multi-country programme management available at 10315% flat fee for coordinated project-level oversight across multiple jurisdictions.

Business Development & Market Entry Strategy Target Sponsor Profile We focus on innovative biotech companies developing breakthrough therapies in oncology, rare diseases, and cell/gene therapy. These sponsors value operational excellence, regulatory expertise, and compliant access solutions in markets where they lack local presence. Decision-makers include Heads of Regulatory Affairs, Clinical Operations Directors, and Market Access Leaders evaluating GAP partnership models. Pilot Programme Approach Launch with 132 carefully selected countries where GNH demonstrates proven capabilities and regulatory relationships. Initial pilots establish operational excellence, generate case studies, and build sponsor confidence before scaling to additional markets. Success metrics include regulatory approval timelines, adverse event reporting accuracy, and audit inspection outcomes. Initial Awareness Campaign Targeted email outreach introducing GNH capabilities, regulatory expertise, and operational infrastructure for expanded access programmes Capability Presentations Discovery calls and capability presentations demonstrating end-to- end GAP support, country-specific intelligence, and compliance framework Pilot Programme Engagement Structured pilot proposals with defined scope, pricing transparency, and clear success metrics for initial sponsor partnerships Scale & Expand Case study development, sponsor testimonials, and expanded country coverage based on proven pilot programme success

ORGANISATIONAL STRUCTURE Team & Governance Framework Cross-functional expertise ensures programme quality, regulatory compliance, and operational excellence. GAP Programme Lead Overall accountability for programme delivery, sponsor relationships, and strategic direction. Coordinates cross- functional teams and ensures alignment with compliance framework. Regulatory Affairs Country-specific submissions, ethics committee coordination, import licensing, and ongoing regulatory intelligence. Maintains relationships with health authorities and consultants. Quality Assurance SOP development, documentation review, audit readiness, and CAPA management. Ensures GDP compliance and maintains quality management system integration. Supply Chain & Logistics Product procurement, cold chain management, customs clearance, and final-mile delivery. Manages temperature excursion protocols and distribution validation. Pharmacovigilance Partner External certified PV partner providing adverse event intake, SAE reporting, safety database management, and sponsor communication for all patient safety data. Governance Structure Fortnightly programme review meetings assess ongoing GAP initiatives, regulatory developments, and operational performance. Quarterly sponsor business reviews provide transparency and continuous improvement opportunities. An independent Quality Oversight Committee conducts periodic audits and compliance assessments.

90-Day Implementation Roadmap

  1. Days 1330: Foundation Develop core GAP SOPs Finalise PV partner agreement Create country capability matrix Establish quality oversight Define pricing model
  2. Days 31360: System Build Team training programmes Mock GAP dry runs Regulatory pathway validation Documentation templates Sponsor presentation materials
  3. Days 61390: Market Entry Launch BD email campaign Sponsor discovery meetings First pilot programme proposal Country-specific feasibility Operational readiness review This phased approach ensures thorough preparation before market engagement whilst maintaining momentum towards operational launch. Each phase includes defined deliverables, quality checkpoints, and leadership review gates.

STRATEGIC VALUE Key Benefits for GNH India Build Credibility with Global Innovators Establishing GAP capabilities positions GNH India as a strategic partner for innovative biotech companies. Successful programme delivery demonstrates operational sophistication, regulatory competence, and quality commitment 4attributes that differentiate us in competitive sponsor evaluations for larger opportunities. Foundation for Managed Access Programmes GAP excellence creates natural progression to higher-value Managed Access Programme (MAP) partnerships. Sponsors comfortable with our expanded access capabilities increasingly engage us for post-approval early access, bridging programmes, and complex market entry strategies across emerging markets. Sustainable Revenue Through Cost- Recovery Transparent operational pricing generates revenue whilst maintaining non-commercial compliance. The model proves financially sustainable as programme volume scales, with predictable per- patient economics and opportunity for efficiency improvements as processes mature and country coverage expands.

Risk Assessment & Mitigation Strategies Proactive risk management ensures programme success and protects organisational reputation. Risk Category Potential Impact Mitigation Strategy Regulatory Delays Extended timelines frustrate sponsors and delay patient access Comprehensive country matrix with realistic timelines; local regulatory consultant network; parallel submission strategies where permitted Pharmacovigilance Gaps Inadequate safety reporting creates compliance failures and sponsor liability Certified PV partner with proven capabilities; clear SOP for AE intake and SAE reporting; regular sponsor communication protocols Supply Chain Failures Temperature excursions or delivery failures compromise product integrity Validated cold chain with redundancy; real- time monitoring; contingency stock strategies; qualified backup courier relationships Audit Inspection Failures Regulatory findings damage reputation and sponsor confidence Comprehensive documentation from day one; internal audit programme; mock inspection readiness; continuous training and CAPA follow-up Operational Cost Overruns Unprofitable programmes threaten busines s sustainability Detailed cost modelling per country; contingency reserves; quarterly pricing review; transparent sponsor communication on scope changes Risk Governance: Monthly risk register review by programme leadership identifies emerging concerns early. Escalation protocols ensure senior management visibility for critical risks requiring strategic decisions or resource allocation.

Competitive Positioning GNH India Differentiators Emerging Market Expertise

Deep operational experience in LATAM, MENA, Africa, and Asia where competitors have limited presence Integrated Capabilities: Regulatory, logistics, and PV support under unified management reduces sponsor coordination burden Transparent Pricing: Clear cost-recovery model with no hidden fees builds sponsor trust Established Infrastructure: Existing country networks and supplier relationships enable faster programme launch Quality Focus: Compliance-first culture and audit readiness from programme inception Market Landscape The GAP services market includes global specialty distributors, regional access providers, and CRO-affiliated operations. Many competitors focus primarily on North America and Western Europe, leaving emerging markets underserved. Sponsors increasingly seek partners offering integrated regulatory and operational capabilities rather than coordinating multiple vendors. This trend favours GNH India's comprehensive service model and geographic coverage in high-growth regions.

FINANCIAL PROJECTIONS Three-Year Business Case Conservative growth assumptions demonstrate programme viability whilst establishing foundation for MAP expansion. $0.00 $250,000.00 $500,000.00 $750,000.00 Revenue Direct Costs Operating Expenses Year

  1. Year
  2. Year 3
  3. Year
  4. Target Pilot programmes across 2 countries, establishing operational excellence
  5. Year
  6. Target Programme patients with expanded sponsor relationships 20 Year
  7. Target Patients annually across multiple sponsors and geographies Key Assumptions: Average programme value $3,500 per patient; 60% gross margin on operational services; team expansion from
  8. FTE to
  9. FTE by Year 3; break-even achieved in Year 2 with positive contribution by Year 3 supporting MAP investment.

Board Decision & Next Steps

  1. Approve GAP as Formal Business Line Authorise establishment of Expanded Access Programmes as strategic service offering within GNH India's portfolio, with dedicated resources and operational independence
  2. Allocate Team & Budget Approve hiring of GAP Programme Lead and supporting resources; allocate £120,000 Year 1 budget for system development, training, and pilot programme operations
  3. Endorse Compliance-First Approach Affirm organisational commitment to regulatory excellence, quality standards, and ethical programme delivery as non- negotiable principles for all GAP activities Immediate Actions Following Board Approval Initiate recruitment for GAP Programme Lead position Finalise pharmacovigilance partnership agreement Commence SOP development and quality system integration Begin sponsor target identification and outreach planning Establish programme governance and oversight structures "This initiative represents a natural evolution of GNH India's capabilities, positioning us as a comprehensive partner for innovative sponsors seeking compliant patient access solutions in underserved markets. Board approval enables us to capture first-mover advantage in a growing segment whilst building foundations for long-term strategic value."