Driving Compliant Early Access through GNH GAP/MAP Bridging patient need and global scientific innovation with structured, compliant early- access programmes. Leveraging GNH's regulatory expertise, global network, and operational excellence to expand responsible access in priority markets. STRUCTURED ACCESS SCIENTIFIC RIGOUR GLOBAL REACH

Key Outcomes Minutes of Meeting 3 Strategic Alignment Discussion Controlled International Access GNH ensures early-access delivery without impacting pricing strategy, brand positioning, or planned commercial launches. Our approach maintains complete control over market entry whilst meeting urgent patient needs. Operational Capabilities Experience supporting pre-commercial and early-access programmes across selected markets, in alignment with applicable regulatory frameworks. Real-World Evidence Generation Integrated pharmacovigilance systems capture actionable safety data prior to broader launch. Structured reporting mechanisms ensure comprehensive documentation for regulatory submissions. Programme Structure Institution-based access with medical justification ensuring scientific credibility Physician-led programmes with documented clinical rationale Compliant framework leveraging GNH's distribution and regulatory network End-to-end management: GMP, CoPP, CoA, PV systems, audit-ready documentation Ethical Foundation GAP/NPP execution without retail promotion ensures ethical, case-by- case access with structured safety reporting. Risk management through comprehensive screening, verification, and traceability protocols.

GNH GAP/MAP 3 Enabling Controlled Access to ZRC-3276 Purpose for Zydus Enable structured, pre-commercial access to ZRC-3276 (Nivolumab) whilst protecting pricing integrity, brand strategy, and commercial roadmap. Bridge urgent patient need with compliant international access before broader market expansion, maintaining complete control over therapeutic positioning. Why GNH India Proven expertise in GAP/MAP delivery, regulatory affairs, and global distribution across 180+ countries. Ability to generate comprehensive pharmacovigilance data and real-world evidence to support Zydus' scientific positioning whilst building relationships with global oncologists, institutions, and regulatory authorities. Strategic Alignment Leverages GNH strengths in Named Patient Supply and Regulatory Intelligence. Strengthens Zydus' reputation in global early-access and limited-launch scenarios, creating a pathway for higher-value Managed Access Programmes (MAPs) with sustained commercial impact.

Global GAP/MAP Potential 3 Focus on ZRC-3276 Patient Access Demand Growing need for early access to immuno- oncology therapies, particularly in emerging markets including Latin America, MENA, Africa, and Asia-Pacific regions. Supports Zydus' mission to expand access to critical therapies responsibly whilst building market presence in underserved geographies. Regulatory Environment Health authorities increasingly encourage provision of investigational or early-access products for patients with high unmet medical need. GNH navigates country- specific regulatory approvals, ethics committee processes, and import licensing requirements to ensure compliant, timely supply. Emerging Market Gap Limited existing GAP/MAP programmes for biosimilar oncology therapies in key regions. Significant opportunity for Zydus to leverage GNH's established international network for controlled, institution-led access programmes that meet both patient need and regulatory standards.

Operational Excellence GNH GAP/MAP Capabilities & NPP Expertise Core GNH Capabilities for Zydus

1. Named Patient Supply Case-by-case supply for ZRC-3276 through verified institutions with complete documentation and compliance adherence. Each request undergoes rigorous verification ensuring medical justification.
2. Regulatory Expertise Deep expertise in approvals, ethics committee processes, and import licences across many countries. Navigate complex regulatory landscapes efficiently.
3. Cold Chain Logistics Validated temperature-controlled supply with real-time monitoring, customs clearance, and final-mile delivery for biologics. Ensures product integrity throughout distribution.
4. PV Integration Real-time adverse event reporting and safety data collection with certified pharmacovigilance partners. Comprehensive documentation for regulatory submissions. NPP in India Supporting ZRC-3276 Access: Provides early access to unapproved or not-yet-registered medicines for patients with high unmet medical need. GNH acts as local agent, handling import, distribution, regulatory coordination, and PV support whilst ensuring patient selection meets clinical criteria. Molecule under NPP Selected Molecules: Oncology/Biologics: Olaratumab (Lartruvo), Rituximab, Trastuzumab, Pembrolizumab Haematology/Immunotherapy: Interferon Alfa-2b Demonstrates proven experience in structured, ethical early-access programmes similar to ZRC-3276 requirements.

Integrating Compliant Real-World Evidence into Named Patient Programmes Generating decision-useful, compliant clinical insights during early access via Form 12B in India without affecting regulatory classification or compromising future approval pathways. The Challenge Capturing meaningful real-world data whilst maintaining complete regulatory compliance for NPP/Form 12B programmes. Traditional approaches risk regulatory reclassification or compromise compliance integrity, creating unnecessary risk for sponsors. The key challenge lies in designing data collection that remains genuinely non-interventional whilst providing actionable clinical insights for internal learning and future regulatory strategy development. The Solution Implement a structured RWD overlay that preserves the non-interventional nature of Form 12B access programmes. This approach ensures complete CDSCO alignment whilst providing valuable clinical insights. The solution incorporates functional separation between access provision and data collection, with voluntary physician participation, appropriate patient consent under DPDP Act requirements, and retrospective data capture that avoids research-like protocols. This methodology has been validated through successful implementation in multiple therapeutic areas, demonstrating both regulatory acceptability and clinical utility.

Compliance Framework GNH RWD Overlay

1. Three-Layer Structural Model Named Patient Import Form 12B, prescription-based access only. Access is completely independent from data collection activities. Patient receives treatment based purely on medical need and physician prescription. Pharmacovigilance Mandatory ADR reporting and SAE timelines. Regulatory requirement that is non-negotiable. Ensures patient safety monitoring and regulatory compliance throughout treatment. Observational RWD/Registry Optional, physician-led, voluntary, de- identified. Strictly separated from access programme, preserving non-interventional nature. Data collection never impacts treatment access decisions. Critical Principle Access b Data Collection Data collection is optional, independent, and compliant. Treatment access decisions remain completely separate from research activities. Operational Design
2. Collecting RWD Compliantly Physician Engagement: Independent clinical judgement with voluntary data-sharing agreements and no financial incentives Patient Consent: Separate consent under Indian DPDP Act; documentation avoids references to clinical research or study participation Data Capture Tools: Simplified eCRF with 30-50 essential fields, retrospective entry only, no mandated timelines or follow-up schedules Decision Framework Strategic Approach Recommendation Implement NPP with RWD overlay using strict functional separation and governance controls. Access & Revenue: Use Form 12B for patient access and early revenue generation whilst building market presence 1. Learning & Confidence: Use RWD overlay for internal insights, safety signals, and regulatory strategy refinement 2. Registration Integrity: Maintain complete CDSCO registration pathway, ensuring no compromise to future approval processes 3.

Extending Controlled Access to Priority International Markets Leverage Zydus' existing India access framework and GNH's regulatory expertise with global network capabilities to enable compliant early-access programmes in selected international markets. A structured, phased approach ensures regulatory alignment whilst maintaining operational momentum. Market Prioritisation & Feasibility Focus on countries with clear regulatory pathways for early-access or GAP programmes. Selection based on regulatory alignment, local infrastructure, and operational readiness, ensuring a responsible, risk-aware approach to international programme expansion. Pilot Programme Approach Launch in carefully selected priority markets where GNH has proven regulatory relationships. Initial pilots demonstrate operational readiness, compliance, and generate case studies. Success metrics include regulatory approval timelines, AE reporting quality, and audit inspection outcomes. Awareness & Engagement Targeted communications introducing GNH capabilities and compliance framework. Capability presentations through discovery calls demonstrate end-to-end GAP support and country-specific intelligence. Structured proposals with transparent scope and success metrics lead to scalable expansion.

Implementation Roadmap Proposed 90-Day Programme Launch Timeline Foundation Days 1-30: prepare governance Market Entry Days 61-90: launch and monitor System Build Days 31-60: develop core systems A phased, structured approach ensures careful preparation and regulatory alignment whilst maintaining momentum for early operational launch. Each phase incorporates specific deliverables, quality checkpoints, and leadership reviews to ensure programme readiness and compliance.

1. Foundation (Days 1330) Finalise core GAP standard operating procedures, PV partner agreement, country capability matrix, pricing framework, and quality oversight mechanisms. Establish governance structure and documentation standards.
2. System Build (Days 31360) Complete team training programmes, conduct mock GAP dry runs, obtain regulatory validation, develop documentation templates, and prepare sponsor materials. Validate all operational systems and compliance processes.
3. Market Entry (Days 61390) Launch targeted outreach campaign, initiate sponsor discovery meetings, develop first pilot programme proposal, complete feasibility assessment, and conduct operational readiness review. Begin controlled market entry.

Partnering for Responsible Global Access GNH GAP/MAP represents a strategic partnership opportunity to expand patient access responsibly whilst building real-world evidence, strengthening scientific positioning, and supporting future regulatory expansion across global markets. Trusted Execution Proven experience in GAP, NPP for oncology and biologics across multiple markets and therapeutic areas. Compliance & Credibility Fully aligned with regulatory frameworks, ensuring ethical, institution-led access with comprehensive documentation and audit readiness. Global Reach Operational excellence and regulatory intelligence across countries with established distribution networks and local partnerships. Strategic Value Builds real-world evidence, strengthens scientific positioning, and supports future regulatory expansion whilst generating early market insights. Next Steps Explore pilot programme design for priority markets 1. Define operational scope and success metrics 2. Collaboratively plan phased international access strategy 3. Establish governance framework and compliance oversight 4. Initiate stakeholder engagement and capability presentations 5. Partnership Vision Enabling patient access responsibly. Driving global scientific impact. Together, we can bridge the gap between patient need and innovative therapies whilst maintaining the highest standards of regulatory compliance and scientific rigour.