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and TRIUMPH PHARMACEUTICALS

TPP Trans-pacific partnership. and TRIUMPH PHARMACEUTICALS. Anjali Chhajed | Atulya Kumari | Julian Hartman | Manik Malhotra | Rathish Palikuzhi. TPP and Triumph. TPP TPP provides Triumph incentives to diversify its supply chain Decreases trade barriers between member countries

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and TRIUMPH PHARMACEUTICALS

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  1. TPP Trans-pacific partnership and TRIUMPH PHARMACEUTICALS Anjali Chhajed | Atulya Kumari | Julian Hartman | Manik Malhotra | Rathish Palikuzhi

  2. TPP and Triumph 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

  3. Ensure IP Protection Triumph has three options to secure IP protection Composition of Matter Patent Data Protection Process Patent

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

  5. Ensure IP Protection Composition of Matter Patent • With TPP • Data protection increases from 5 years to 10 years • Component of Matter Patent is forgone Process Patent Data Protection

  6. Ensure IP Protection Composition of Matter Patent Data Protection • With TPP • It is easier to enforce process patent Process Patent

  7. Ensure IP Protection • 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. Data Protection Process Patent

  8. The NPV of investing in a new API-I process is positive ExpectedCosts and Returns over time Discounted Return in 10 years % of annual revenue (2015) % of annual revenue (2015) Investment Return Year

  9. Objective Supply Chain Partners • Analysis • Implementation • Risk • Summary Malaysia – Vietnam – Malaysia – New Zealand Malaysia – Singapore – Singapore – New Zealand U.S.A – U.S.A – Mexico – New Zealand

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

  11. Objective A diversified supply chain provides cheap and reliable sourcing • Analysis • Implementation • Risk • Summary • 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

  12. Objective Implementation Strategy • Analysis • Implementation • Risk • Summary • Supplier selection 7 Months 0 1 5 6 3 Exclusive Contracts Global sourcing team Triumph Supplier committee Communication Network • 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

  13. Objective Global Sourcing : Risks & Mitigation • Analysis • Implementation • Risk • Summary

  14. Objective Summary • Analysis • Implementation • Risk • 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

  15. Q & A

  16. Appendix

  17. Triumph’s Asian supply routes are flexible and resilient to deliver low cost materials while mitigating disruption Unfavorable *Exclusive Contract raises cost by 20% **After development of new API-I Favorable Moderate Cumulative shipping costs between the countries amount to $0.80/kg Source – worldfreightrates.com

  18. Before establishing supplier relationships, conduct a multilevel comprehensive risk-assessment

  19. 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.

  20. Management Operating Framework Preparedness Partnership Governance IP Protection Quality Control • Tiered Relationship Management • Vendor Performance Scorecard • Contract Enforcement • Pilot to Long-term Collaboration • 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 • Safety, Health & Environment Compliance • Annual Product Reviews • Statistical Process Control • Planned Corrective Actions • Supply Chain Risk Mitigation • Guardrails – Absorb Supply Chain Shocks • Lead Time Management • Sourcing Flexibility Plan

  21. Operationalizing Primary Route • Steering Management Team • Exclusive Contract- ensure steady supply • 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

  22. Operationalizing Secondary Route • As supplier will be in USA we can have an Intercompany Management Team to have quality control • 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

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