GAP & NPP Initiatives 3 GNH USA Overview GNH USA delivers strategic market access programmes designed to accelerate pharmaceutical product launches whilst ensuring full regulatory compliance. Our GAP (Global Access Programme) and NPP (Named Patient Programme) initiatives enable pharmaceutical companies to generate revenue and gather critical market intelligence before formal product registration is complete. Initiative Business Objective Where Applied Value Delivered GAP (Global Access Programme) Early market entry and revenue generation through compassionate use frameworks Markets with established access pathways; pre-registration phase in target territories Revenue stream 12324 months before registration; real-world evidence collection; market demand validation NPP (Named Patient Programme) Patient-specific access for medicines not yet approved locally Individual physician requests; specific patient cases requiring urgent treatment access Physician relationship building; patient outcomes data; regulatory goodwill; early brand awareness

Data & Ecosystem Supporting GAP and NPP GNH USA's competitive advantage lies in our comprehensive data infrastructure and established import partnerships. We combine proprietary market intelligence with verified regulatory channels to ensure compliant, efficient programme execution across multiple jurisdictions. Our ecosystem integrates real-time pricing analytics, competitive positioning data, and regulatory pathway mapping. This enables pharmaceutical partners to make informed decisions about market entry timing, pricing strategy, and distribution approaches before committing to full registration investments. Comprehensive Data Foundation Our platform aggregates over 50 data sources including wholesale acquisition costs, retail pricing benchmarks, and reimbursement frameworks across 40+ markets, updated quarterly to reflect dynamic market conditions. Data / Enabler Type Source How GNH USA Uses It Benefit to Client Real-World Pricing Data Proprietary databases; wholesale distributors; pharmacy networks Competitive pricing analysis; market positioning recommendations; value- based pricing models Optimal pricing strategy; maximised margin potential; competitive market positioning Regulatory Pathway Intelligence Government agencies; regulatory consultants; legal advisers Compliance roadmap creation; documentation requirements mapping; timeline forecasting Reduced regulatory risk; accelerated approval timelines; complete documentation accuracy Import & Logistics Partners Certified import brokers; customs specialists; cold chain providers End-to-end supply chain management; temperature-controlled distribution; customs clearance Guaranteed product integrity; on-time delivery; full chain-of- custody documentation Market Access Data Physician networks; hospital formularies; insurance databases Demand forecasting; prescriber targeting; reimbursement strategy development Accurate volume predictions; targeted market development; optimised reimbursement outcomes

Measurable Benefits of GAP & NPP GNH USA's initiatives deliver tangible business outcomes that directly impact pharmaceutical companies' market entry success and financial performance. These benefits extend beyond revenue generation to include strategic advantages in regulatory relationships, market intelligence, and competitive positioning. 18 Average Months Earlier revenue generation vs traditional registration pathway $2.4M Average Revenue Generated per product during pre-registration phase 94% Compliance Rate Successful regulatory approvals following GAP/NPP programmes Benefit Area Description Business Impact Early Revenue Generation Monetisation of products 12324 months befor e full registration, creating positive cash flow during typically cost-intensive development phases Offset R&D costs; fund additional clinical trials; improve investment attractiveness; demonstrate commercial viability to stakeholders Real-World Evidence Collection Systematic gathering of patient outc omes, safety profiles, and efficacy data in authentic clinical settings outside controlled trial environments Strengthen regulatory submissions; identify optimal patient populations; refine clinical protocols; support pricing negotiations Market Intelligence Direct insights into prescriber behaviour, pa tient demand patterns, competitive responses, and reimbursement challenges before full market commitment Inform launch strategy; optimise marketing spend; identify key opinion leaders; anticipate competitive threats Regulatory Relationships Established credibility with health autho rities through compliant early access programmes, demonstrating commitment to patient needs and regulatory standards Expedited review processes; collaborative problem-solving; favourable consideration during formal approval; reduced scrutiny Legal & Import Support Comprehensive management of complex cross-border regulations, import documentation, customs clearance, and supply chain compliance requirements Eliminated compliance risk; guaranteed product integrity; predictable timelines; reduced internal resource burden Competitive Advantage First-mover positioning in target markets, e stablishing physician relationships and patient access ahead of competitors' registration completion Market share capture; brand awareness; prescriber loyalty; patient advocacy; barrier creation for competitors

Live Case Execution by GNH USA GNH USA has successfully executed GAP and NPP programmes across diverse therapeutic areas and geographical markets. The following anonymised cases demonstrate our capability to deliver measurable results whilst maintaining full regulatory compliance and supply chain integrity. Case Initiative Used Execution Highlights Outcome (Indexed) Imported Kuvan, 'Rare Life Medicine,' to India NPP Special Import Pathway to Import products under GAP/NPP. Form 12B route to apply for Import. A total of 28 patients have been treated, resulting in a 96% physician satisfaction rate. Revenue generated prior to the product's official registration in the Indian market. Exporting product from GNH USA NPP Kybernin P 500- Exported to a patient in Brazil in full compliance with all applicable legal and regulatory requirements. 27 patients accessed treatment; 100% regulatory approval success. Dacilon Export to the Brazilian Market (business- focused) NPP Exported to Brazil for patient use via authorized import partners responsible for all legal and regulatory compliance. Revenue index: 210; 1,240 patients enrolled; generated $3.8M pre-registration revenue; in process of supporting successful pricing negotiations post-launch. All cases maintained 100% regulatory compliance, zero product quality incidents, and complete supply chain traceability. Data indexed to protect commercial confidentiality whilst demonstrating programme effectiveness.

What This Means for LUPIN USA LUPIN USA operates in an increasingly competitive pharmaceutical landscape where speed to market and strategic differentiation are critical success factors. GNH USA's GAP and NPP programmes offer LUPIN a proven pathway to accelerate market entry, generate early revenue, and build market intelligence before competitors complete traditional registration processes. Our programmes are particularly valuable for LUPIN's portfolio spanning generic formulations, specialty products, and complex therapeutic areas where early physician relationships and real-world evidence can significantly influence market adoption and reimbursement outcomes. LUPIN USA Objective GAP / NPP Application Expected Outcome Accelerate time-to-revenue for pipeline products Launch GAP programmes 18324 months before anticipated FDA approval in key international markets; establish early access pathways in territories with compassionate use frameworks Generate $235M revenue per product during pre-approval period; offset development costs; demonstrate commercial viability to investors; create positive cash flow De-risk market entry for specialty portfolio Implement NPP programmes to test market receptivity, gather real-world outcomes data, and identify optimal patient populations before full commercial launch commitment Validate market assumptions with real clinical data; refine target patient profiles; optimise pricing strategy; reduce commercial launch risk by 60370% Build relationships with key opinion leaders Provide early product access to influential prescribers through structured GAP/NPP programmes; offer training and clinical support; co-develop treatment protocols Establish 50+ key opinion leader relationships per therapeutic area; generate publication opportunities; create physician advocacy network; accelerate post-launch adoption Generate regulatory-grade real-world evidence Design GAP/NPP programmes with robust data collection protocols; capture patient outcomes, safety profiles, and comparative effectiveness data in routine clinical practice Strengthen regulatory submissions with real- world evidence; support health technology assessments; enable value-based contracting; differentiate from competitors Navigate complex international regulatory landscapes Leverage GNH USA's established import partnerships, legal expertise, and regulatory pathway knowledge across 40+ markets to ensure compliant product access Eliminate regulatory compliance risk; reduce internal resource requirements by 70%; guarantee supply chain integrity; accelerate market entry timelines by 12318 months Create competitive barriers in target markets Establish first-mover advantage through early market presence; capture market share before competitors complete registration; build physician and patient loyalty Achieve 25340% market share advantage vs later entrants; establish brand recognition; create switching costs; defend market position against biosimilar or generic competition