Pharm Corp is a publicly-traded, multinational pharmaceutical company that engages in research, manufacturing, and sales of pharmaceutical products.Corp has $15 billion in annual sales.In early 2010, it had a "modest" kickback settlement with the Boston U.S. Attorney's Office for $75M, and a 5year Corporate Integrity Agreement (CIA). Due to the CIA, the company developed a robust global compliance program. The HHSOIG forced Corp to separate its compliance and legal departments, with the CCO reporting directly to the CEO (rather than GC). The CIA expired approximately six months ago. Brimming with confidence and relief that the CIA has expired, Pharm Corp is in the midst of returning to the preCIA compliance organization structure, with the CCO positioned under GC, a very prominent figure in the company. Also, the Board is quite happy to reduce many of the burdensome obligations it had committed to in the CIA relating to Board oversight.

Identify and explain key regulatory and compliance consideration

analytical framework to address the identified issues

Recognize any nuances/complexities and thoughtfully address them

Reach conclusions, while recognizing aspects that are open/unresolved

Identify pertinent follow-up questions and/or recommendations