1. Objective Recommendation Analysis Implementation andTRIUMPHPHARMACEUTICALS TPP Trans-pacific partnership Anjali Chhajed | Atulya Kumari | Julian Hartman | Manik Malhotra | Rathish Palikuzhi

2. Objective Recommendation Analysis Implementation TPP TPP provides Triumph incentives to diversify its supply chain – Decreases trade barriers between member countries – Increases IP enforcement tools in TPP area – Access to cheaper manufacturing areas Objectives With supply chain diversification Triumph must 1) Ensure IP protection 2) Reduce supply chain risk TPP and Triumph ObjectiveAnalysisImplementationRiskSummary

3. Objective Recommendation Analysis Implementation Composition of Matter Patent Process Patent Data Protection Triumph has three options to secure IP protection Ensure IP Protection ObjectiveAnalysisImplementationRiskSummary

4. Objective Recommendation Analysis Implementation Ensure IP Protection 5 years of patent protection Patent covers molecule and process variants Difficult to enforce outside USA Composition of Matter Patent Process Patent Data Protection Triumph currently has a Composition of Matter Patent ObjectiveAnalysisImplementationRiskSummary

5. Objective Recommendation Analysis Implementation Ensure IP Protection Composition of Matter Patent Process Patent Data Protection With TPP Data protection increases from 5 years to 10 years Component of Matter Patent is forgone ObjectiveAnalysisImplementationRiskSummary

6. Objective Recommendation Analysis Implementation Composition of Matter Patent Process Patent Data Protection With TPP It is easier to enforce process patent Ensure IP Protection ObjectiveAnalysisImplementationRiskSummary

7. Objective Recommendation Analysis Implementation Process Patent Data Protection Ensure IP Protection ObjectiveAnalysisImplementationRiskSummary Process Patent will be acquired for both old as well as new process. Competitors will have to significantly invest if new process is to be developed. Combining Process Patent for API-I stage and Data Protection will ensure safeguarding the drug from generic versions for 10 years. The new unique process will help in cost reduction.

8. Objective Recommendation Analysis Implementation The NPV of investing in a new API-I process is positive InvestmentReturn Year % of annual revenue (2015) Discounted Return in 10 yearsExpected Costs and Returns over time % of annual revenue (2015) ObjectiveAnalysisImplementationRiskSummary

9. Objective Recommendation Analysis Implementation Supply Chain Partners Malaysia – Vietnam – Malaysia – New Zealand Malaysia – Singapore – Singapore – New Zealand U.S.A – U.S.A – Mexico – New Zealand ObjectiveAnalysisImplementationRiskSummary

10. Objective Recommendation Analysis Implementation Supply Chain Partners Malaysia – Vietnam – Malaysia – New Zealand Malaysia – Singapore – Singapore – New Zealand U.S.A – U.S.A – Mexico – New Zealand Sourcing by route ObjectiveAnalysisImplementationRiskSummary

11. Objective Recommendation Analysis Implementation A diversified supply chain provides cheap and reliable sourcing Dual sourcing of alpha raw materials mitigates disruption risk – Exclusive contract in Malaysia increases costs but ensures supply Asian supply chains—cheaper materials, greater risk – Emphasis on redundancy and flexibility American supply chain—medium price, low disruption Price ($/kg) Disruption Probability 260073% 280084% 285060% ObjectiveAnalysisImplementationRiskSummary

12. Objective Recommendation Analysis Implementation Exclusive Contracts Supplier selection Global sourcing team Communication Network Triumph Supplier committee Months01 3 5 6 7 Supplier Quality Management Strategic partnership for TQM and continuous supplier process improvement Ensuring quality compliance by reviews, site visits Gather data and leveraging predictive data analytics Supplier Quality Management Strategic partnership for TQM and continuous supplier process improvement Ensuring quality compliance by reviews, site visits Gather data and leveraging predictive data analytics ObjectiveAnalysisImplementationRiskSummary Implementation Strategy

13. Objective Recommendation Analysis Implementation Close monitoring & data analytics Increase in lead time & volatility Hedging & contracts in home currency Rapid exchange rate fluctuations Education & training Understanding foreign culture & practices Transportation & storage facilities Logistics & infrastructure ObjectiveAnalysisImplementationRiskSummary Global Sourcing : Risks & Mitigation

14. Objective Recommendation Analysis Implementation Summary Objective – Sustainable Supply Chain by exploiting the benefits of TPP for Triumph Recommendation – Diversify supply chain – Implement unique process for API Intermediary – 10 years data protection & process patent Effect – Risk Mitigation – Protection of intellectual property – Reduced material cost & tariffs – 10% return on investments ObjectiveAnalysisImplementationRiskSummary

15. Objective Recommendation Analysis Implementation Q & A

16. Objective Recommendation Analysis Implementation Appendix

17. Objective Recommendation Analysis Implementation Triumph’s Asian supply routes are flexible and resilient to deliver low cost materials while mitigating disruption Primary Route Cost ($/kg) Disruption Prob. Malaysia* (alpha raw material) 150- Vietnam (reaction intermediate) 2000.20 Malaysia (API-SM) 12500.20 New Zealand** (API intermediate) 10000.58 Total 26000.73 Cumulative shipping costs between the countries amount to $0.80/kg Source – worldfreightrates.com *Exclusive Contract raises cost by 20% **After development of new API-I Unfavorable Favorable Moderate Secondary Route Cost ($/kg) Disruption Prob. Malaysia* (alpha raw material) 150- Singapore (reaction intermediate) 3000.30 Singapore (API-SM) 12500.44 New Zealand** (API intermediate) 10000.58 Total 28000.84 ObjectiveAnalysisImplementationRiskSummary

18. Objective Recommendation Analysis Implementation Before establishing supplier relationships, conduct a multilevel comprehensive risk-assessment Geopolitical Risk Industry Risk Manufacturer Risk Potential international disputes and conflicts National political disruption Labor supply disruption Natural disaster Scale and growth potential of industry Financial environment Viability and profitability Quality and control Intellectual Property

19. Objective Recommendation Analysis Implementation Supplier Relations & Trans Pacific Partnership The Trans-Pacific Partnership (TPP) is a trade agreement among twelve Pacific Rim countries to "promote economic growth by lowering trade barriers such as tariffs and establishing investor-state dispute settlement mechanism. Decreases risk of IP Theft IP complaints will be routed through international tribunals IP and Data Protection Ensures better information sharing between companies Has provisions to reduce red tape Transparency and Anti Corruption Develops and strengths supply chains in order to integrate production and facilitate trade Explores ways to take advantage of trade and investment opportunities Increase in Business Facilitation

20. Objective Recommendation Analysis Implementation Management Operating Framework Safety, Health & Environment Compliance Annual Product Reviews Statistical Process Control Planned Corrective Actions IP Protection Controls Frequent Internal Audits TPP Data Protection Adherence Continuous Monitoring Joint Management Team Quarterly Progress Reviews Standard Operating Procedures Cross-Industry Best Practices Tiered Relationship Management Vendor Performance Scorecard Contract Enforcement Pilot to Long-term Collaboration Supply Chain Risk Mitigation Guardrails – Absorb Supply Chain Shocks Lead Time Management Sourcing Flexibility Plan Quality Control IP ProtectionGovernance PartnershipPreparedness

21. Objective Recommendation Analysis Implementation Operationalizing Primary Route Alpha raw material Malaysia Reaction Intermediate Vietnam API Starting Material Singapore API Intermediate New Zealand Intercompany Management Team Stringent contract for IP Protection Joint Management Team Quality Control support program to ensure GMP Compliance Joint Management Team Quality Control support program to ensure GMP Compliance Steering Management Team Exclusive Contract- ensure steady supply

22. Objective Recommendation Analysis Implementation Operationalizing Secondary Route Alpha raw material USA Reaction Intermediate USA API Starting Material Mexico API Intermediate Australia As supplier will be in USA we can have an Intercompany Management Team to have quality control Joint Management Team Quality Control support program to ensure GMP Compliance Joint Management Team Quality Control support program to ensure GMP Compliance As supplier will be in USA we can have an Intercompany Management Team to have quality control