Please answer the following questions based on the case below

i) what activities/plans/initiatives could potentially constitute a legal violation? (e.g., ad board, speaker program, research grant, etc);

(ii) for each activity/plan/initiative identified, what specific facts contribute to making it a violation and explain your reasoning (e.g., ad board has 100 members which is far greater than needed, therefore intent seems to be to provide kickback to HCPs rather than gain needed advice).

(iii) for each activity/plan/initiative identified, what type of violation/problem is at issue (e.g, kickback, off-label promotion, performance pressure, privacy violation, bad governance, etc)?

The case

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Commercial Assets:

You are the Global Chief Commercial Officer of SuperTech, a mid-sized pharmaceutical company with revenues of $4 billion and a market cap of about $35 billion. You have an approved product, Super X which is used to treat Bad Disease. Super X is approved and marketed in the US, Europe, Japan, Canada, and Australia. In addition, marketing applications for Super X have been submitted in all major LATAM countries as well as in China, with expected approval dates ranging from the next 1 to 5 months. Third party distributors have been acting on your behalf in LATAM and China for the past year, ostensibly conducting disease awareness activities and market research to gauge the size of the respective country markets. You also submitted marketing applications for Super X in Russia and India, with expected approval within the next 6 to 8 months in those countries. Contracts have just been signed with distributors for those markets. In addition to Super X, you have a second product - MiracleCure - that has completed phase III trials. MiracleCure is used to treat Terrible Disease. While there is already a treatment on the market for Terrible Disease, it is common knowledge that it is not very effective. Marketing applications for MiracleCure have been submitted in the US and Europe, with approval expected first in the US in 3 months and then in the EU in 6 months.

Market Conditions, Targets, & Governance:

Reporting to you globally are Sales, Sales Operations, Marketing, Market Access, Patient Service HUBs (US only), Medical Affairs, and Patient Advocacy. You, in turn, report to the Chief Operating Officer, who reports to the Chief Executive Officer. You've divided the world into 4 regions, each led by a general manager reporting to you. The regions are: (i) North America (US and Canada), (ii) EuroPlus (Europe, Australia, and Russia), (iii) Asia (Japan, China, and India), and (iv) LATAM (Brazil, Argentina, Columbia, and Chile). It is a new year and to be successful you will need significant sales in each region's largest market. This means keeping a laser focus on the US, Europe, Japan, and Brazil. It won't be easy. The Board of Directors has set this year's target at $5 Billion, which is $1 Billion more than last year's target of $4 Billion. The problem is that Super X is somewhat saturated in the approved markets, with a further penetration potential of about 15% ($150,000M), leaving a shortfall of $850,000M.

To hit this target, which has already been communicated to the Street, you will need to squeeze more than 15% from the approved markets, and find opportunities elsewhere. You schedule a meeting with your leadership team, comprised of the General Managers of each of the four regions, the VP Global Marketing, VP Sales Operations, VP Global Medical Affairs, and VP Patient Advocacy, to figure out how to hit target. It is agreed that to grow the market from $4 billion to $5 billion, the approved markets for Super X will need to generate at least $200,000 million. In addition, each Regional General Manager is assigned the following product-specific country-level targets: (i) $250,000 million for the launch of MiracleCure in the US, (ii) $200,000 million for the launch of MiracleCure in the EU, (iii) $150,000 million for the launch of Super X in China, (iv) $100,000 million for the launch of Super X in Brazil and Argentina, (v) $50,000 million

for the launch of Super X in Columbia and Chile, and (vi) $50,000 million for the launch of Super X in Russia and India.

Because these targets are aggressive and will stretch your team to perform at its very best, you tell the team that you have modified their bonus structure. This year hitting target will result in a 125% payout (rather than 100%). Additionally, every $100,000 million in revenue above target will result in an additional 5% payout. However, every $50,000 million below target will reduce the payout by 10%, and if global revenues are below $4.8 billion, the payout will be zero. You advise your leadership team to develop incentive compensation plans for each of their teams that will heavily drive performance and give them wide latitude to be innovative