Business Case Development Key Components : Company Analysis – Decision Process on Launching New Products or Product Expansion (J spend most time here…v key) Business Case Development Key Components : Product concept details – how this fits within a company overarching strategy Total market potential Development, testing, and regulatory approval costs Manufacturing and supply chain costs – any capital investment needed? Ongoing cost of goods (COGs)? Probability of success – approvals and general freedom to operate considerations How to go to market – direct vs. distribution model; what infrastructure and resources are required? Return on Investment (ROI) – How long will it take to break even, then start making a profit? Net Present Value (NPV) – What is the potential total value of the product over an estimated lifecycle (e.g., 30 – 40 yrs)? Company approvals – Go or No Go Decision

Maintenance of Business Company Planning and Investment – Launching New Products or Product Expansion Commercial Launch R&D Expense Development Regulatory Approvals Manufacturing Planning Supply Chain Planning Marketing, Portfolio, Sales, Go to Market Planning Maintenance of Business Approvals Sales Force and other Headcount Local Infrastructure Distribution Agreements & Programs Customer Claims General Freedom to Operate