GNH Early Access Programme

Operating Model for Nivolumab Biosimilar Operates under High Court permission and DCGI approval. Features a structured, physician-led Early Access Programme (EAP). Ensures non-commercial, named-patient access. Maintains strict separation from Zydus's commercial marketing and launch activities. Physician Request Oncologist requests EAP for named patient with clinical justification. Medical Review Independent committee reviews clinical appropriateness and label consistency. Patient Approval Compliance verified, consent obtained, patient enrolled with documentation. Controlled Supply Product supplied via traceable channel to designated facility. Safety Monitoring Adverse events tracked and reported per regulatory requirements. Programme Sunset Program terminates automatically upon Zydus's commercial launch. Defined Responsibilities Limited Distribution Restricted Access High Compliance India-Only Supply Clear Role Separation Non-Commercial PositioningNamed-Patient Access

Early Access Programme Risk Landscape

Inherent Risks Before Mitigation Early Access Programmes (EAPs) address legitimate medical needs. However, EAPs inherently carry legal, regulatory, and commercial risks. These risks exist prior to implementing structural safeguards. Robust governance and controls are essential for mitigation. De-facto Commercialisation Likelihood: High | Impact: Critical Perceived as commercial launch, undermining approvals, creating liability. Export / Cross-Border Leakage Likelihood: Medium | Impact: High Uncontrolled supply, unauthorized territories, violating IP/regulations. Inducement / Promotion Allegations Likelihood: Medium | Impact: High Programme design, promotional activity, regulatory enforcement. Continuity Expectation Likelihood: High | Impact: Medium Patient/physician expectation, ongoing supply, ethical/legal issues. Regulatory Non-Compliance Likelihood: Medium | Impact: Critical Failure to adhere to DCGI conditions, pharmacovigilance, sanctions. Litigation Optics Likelihood: Medium | Impact: High IP litigation scrutiny, commercial intent, undermining legal defense. These inherent risks are typical for EAPs lacking robust governance and safeguards.

GNH Risk Mitigation & Governance Framework

Structural Controls Three-layered architecture Addresses inherent EAP risks Ensures compliance and protects commercial interests Layer 1: Design Controls Structural safeguards Layer 2: Governance & Oversight Active monitoring Layer 3: Audit & Evidence Documentation & traceability Audit & Evidence Documentation, Traceability, Reporting Governance & Oversight Medical Review, Compliance Check, Stop- Triggers Programme Design Named-Patient, Label-Locked, Auto-Sunset This framework creates a layered defense, moving from intrinsic program rules to active management, and finally to robust verification, ensuring comprehensive risk mitigation.

Residual Risk Assessment & Assurance to Zydus Lifesciences Residual risk substantially reduced Three-layer framework effectiveness demonstrated Risk moved from high to low zones High Risk Mitigation Applied Residual Low Risk