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FCPA Compliance Report

FCPA Compliance Report – Frank Orlowski on Navigating Challenges in Operating in Emerging Markets

Welcome to the award-winning FCPA Compliance Report, the longest-running podcast in compliance. In this episode, Tom Fox welcomes Frank Orlowski.

Frank Orlowski is a seasoned professional with a wealth of experience in managing emerging markets in the pharmaceutical industry, having spent over 25 years at Pfizer Pharmaceuticals. His extensive knowledge, particularly in South America, Middle East Asia, and Eastern Europe, where he faced difficulties in compliance, controls, and adhering to US accounting regulations, has shaped his perspective on managing emerging markets. Orlowski emphasizes the importance of understanding different cultures, regulations, and geopolitical issues when working in these markets. After retiring from Pfizer, he founded the Ation Advisory Group, where he leverages his expertise to assist companies in commercializing products in the life science industry. Join Tom Fox and Frank Orlowski on this episode of the FCPA Compliance Report podcast to gain more insights into managing emerging markets in the pharmaceutical industry.

Key Highlight:

  • Frank Orlowski’s Global Financial Expertise
  • Navigating Unique Obstacles in Emerging Markets
  • Navigating Cultural Differences in Emerging Market Compliance
  • Creative Employee Rewards and Engagement Strategies
  • Enhancing Healthcare Through Medtech Innovations
  • The Integrated Legal Division at Pfizer

Resources:

Frank Orlowski on LinkedIn

Tom Fox

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Daily Compliance News

Daily Compliance News: January 8, 2024 – The Unwarranted Embarrassment Edition

Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance, brings you compliance-related stories to start your day. Sit back, enjoy a cup of morning coffee, and listen to the Daily Compliance News. All from the Compliance Podcast Network. Each day, we consider four stories from the business world: compliance, ethics, risk management, leadership, or general interest for the compliance professional.

In today’s edition of Daily Compliance News:

  • Fat when de-risking leads to more risks, or at least newer risks. (WSJ)
  • The state of Florida can now import drugs from Canada. (WaPo)
  • Africa’s richest man accuses Nigeria’s anti-corruption watchdog of seeking to cause “unwarranted embarrassment.”. (FT)
  • Musk’s drug use concerns executives. (Bloomberg)
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Adventures in Compliance

The Memoirs of Sherlock Holmes – The Final Problem

Welcome to a review of all the Sherlock Holmes stories that are collected in the work “The Memoirs of Sherlock Holmes.” They appeared in Strand Magazine from December 1892 to December 1893. Over the past 12 episodes, I have reviewed each story and mined them for leadership, compliance, and ethical lessons.  In this, we begin a two-part series looking at the last story from The Memoirs of Sherlock Holmes.

The intriguing concept of applying Sherlock Holmes’ methods to the work of compliance professionals is the focus of our discussion today. Tom Fox, a seasoned compliance professional, believes that the principles embodied by the iconic detective, such as ethical behavior, problem-solving abilities, continuous learning, and persistence, can greatly enhance the effectiveness of compliance professionals. Fox’s perspective is shaped by his extensive experience in the field, where he has seen the value of attention to detail, deductive reasoning, thorough research, collaboration, risk assessment, and discretion. Join Tom Fox in this episode of the Adventures in Compliance podcast as he delves deeper into how the methods of Sherlock Holmes can be applied to uphold ethical and legal standards in the world of compliance.

Key Highlights:

  • The Story
  • Reichenbach Falls Showdown
  • Lessons for Compliance Professionals

Resources:

The New Annotated Sherlock Holmes

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Blog

New DOJ M&A Safe Harbor Policy

We continue our review of DOJ initiatives from 2023 and what they may portend for the compliance professional in 2024 and beyond. In October 2023, Deputy Attorney General Lisa Monaco announced a new policy regarding M&A. It is a Mergers & Acquisitions Safe Harbor policy that encourages companies to self-disclose criminal misconduct discovered by an acquiring company during the acquisition of a target company. Under the policy, the acquiring party will receive a presumption of criminal declination if it promptly and voluntarily discloses criminal misconduct, cooperates with any ensuing investigation, and engages in appropriate remediation, restitution and disgorgement.

The Safe Harbor policy is a clear continuation of the DOJ’s push for corporate voluntary self-disclosure. Monaco outlined efforts by DOJ to increase the benefits to companies that voluntary disclose corporate misconduct rather than those companies that decide not to disclose misconduct. The key for the acquirer company to  obtain the “carrot” DOJ is dangling and poses questions as to the “stick” the DOJ might wield if a self-disclosure does not achieve safe harbor, or more broadly, if an acquirer fails to identify criminal misconduct in the acquisition process, either pre or post-closing. This new Mergers & Acquisitions Safe Harbor Policy clearly demonstrates the DOJ’s interest is to avoid discouraging companies with strong compliance programs from acquiring companies with ineffective compliance programs and/or a history of misconduct.  To the contrary, DOJ is seeking to incentivize an acquiring company to timely disclose misconduct uncovered during the M&A process.

The Key Policy Takeaways are as follows:

  • The acquiring company must disclose criminal misconduct within six months of the transaction closing date.
  • The acquiring company has one year from the closing date to fully remediate the misconduct, including remediation, restitution and disgorgement, where appropriate.
  • Both deadlines are subject to reasonableness and may be extended by prosecutors due to deal complexity and other factors.
  • Misconduct that threatens national security or involves ongoing imminent harm must be immediately disclosed.
  • Misconduct disclosed under the policy will not factor into present or future recidivist analysis for the acquiring company.
  • The acquiring company’s eligibility for a criminal declination will not be impacted by the presence of aggravating factors at the acquired company.
  • The target company can also qualify for self-disclosure benefits, potentially including a declination, if there are no aggravating factors at the target company.
  • The policy does not impact civil merger enforcement.
  • The policy does not apply to misconduct that is otherwise required to be disclosed, already public or otherwise known to the DOJ.

Under this new Mergers & Acquisitions Safe Harbor, which applies across the Department of Justice, companies that promptly and voluntarily disclose criminal misconduct with the Safe Harbor period, and then cooperate with the resulting investigation, engage in timely and appropriate remediation and pay applicable restitution and disgorgement, will receive a presumption of a declination. Once again, the key deadlines are as follows:

  • Companies must disclose misconduct discovered (whether pre-or post-acquisition) at the acquired entity within six (6) months from the date of closing.
  • Companies will then have one year from the date of closing to fully remediate the misconduct.

The 6 month and one-year deadlines are subject to modification depending on the specific circumstances and complexity of the transaction.  The acquired company can also qualify under the Mergers & Acquisition Safe Harbor Policy for voluntary self-disclosure benefits.  Interestingly, DOJ clarified that any misconduct disclosed under the Safe Harbor Policy will not implicate or be counted in any future potential recidivist analysis.

As with most new DOJ policy initiatives, these concepts have been around for some time. As far back as 2008, the DOJ in Opinion Release 08-02 laid out safe harbor concepts in mergers and acquisitions. This Opinion Release was followed by the FCPA Resource Guide, 1st edition, released in 2012 which brought these concepts forward. However, many defense counsel decried the lack of certainty in both of these initiatives. Now under this new Mergers & Acquisition Safe Harbor Policy, the benefits are laid out in black and white.

The DOJ has made clear that under this new Mergers & Acquisition Safe Harbor Policy organizations that do not perform effective due diligence or self-disclose misconduct at an acquired entity will be subject to full successor liability. DOJ’s objective is clear — they do not want to penalize companies with strong compliance programs from acquiring companies with weak compliance programs when they conduct proper due diligence and discover and self-disclose misconduct. With this new policy, the DOJ is encouraging companies to conduct robust pre-acquisition due diligence and post-acquisition integration. Compliance must have a prominent seat at the deal table if an acquiring company wishes to effectively de-risk a transaction.

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Sunday Book Review

Sunday Book Review: January 7, 2024 The Four Business Books for 2024 Edition

In the Sunday Book Review, I consider books that would interest the compliance professional, the business executive, or anyone who might be curious. It could be books about business, compliance, history, leadership, current events, or anything else that might interest me. Over the month of December, we will review some of the best books reported by the Financial Times in various categories. In today’s edition of the Sunday Book Review, we look at 4 business books you should read in 2024.

  • Poor Charlie’s Almanack: The Essential Wit and Wisdom of Charles T. Munger by Charlie Munger
  • Possible: How We Survive (and Thrive) in the Age of Conflict by William Ury
  • Strategic: The Skill to Set Direction, Create Advantage, and Achieve Executive Excellence by Rick Horwath
  • Career Forward: Strategies From Women Who’ve Made it by Grace Puma and Christiana Smith Shi

Resource:

Four Must Read Business Books to Kick of 2024 (Inc.com)

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31 Days to More Effective Compliance Programs

31 Days to a More Effective Compliance Program: Day 7 – Compliance Program Use of Data Analytics

Matt Galvin, Counsel, Compliance & Data Analytics at the DOJ and one of the experts leading the DOJ’s data analytics initiative, highlighted in another talk the proactive use of data to generate cases related to the FCPA and emphasized that this is just the beginning. The DOJ expects companies to adopt a similar data-driven approach to compliance. In her speech, Argentieri stated, “Just as we are upping our game when it comes to data analytics, we expect companies to do the same.” This expectation extends beyond simply tracking trainings, policies, and investigations. The DOJ’s focus is on monitoring third parties throughout the lifespan of the relationship, not just during the onboarding process.

The DOJ’s increasing use of data analytics for proactive enforcement signifies a significant shift in their approach to combating white-collar crime. Companies must embrace this data-driven approach to compliance, continuously monitor high-risk transactions, and invest in the necessary resources and technology. By doing so, they can demonstrate effective compliance programs, uncover hidden financial irregularities, and improve overall efficiency.

Three key takeaways:

1. This also means that data analytics in the compliance function has moved from cutting edge to best practice. It soon may simply mean table stakes for compliance.

2. The DOJ is seeking to incentivize an acquiring company to timely disclose misconduct uncovered during the M&A process.

3. The DOJ has made it clear that under this new Mergers & Acquisitions Safe Harbor Policy, organizations that do not perform effective due diligence or self-disclose misconduct at an acquired entity will be subject to full successor liability.

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Kerrville Weekly News Roundup

Kerrville Weekly News Roundup: January 6, 2024

Welcome to the Kerrville Weekly News Roundup. Each week, veteran podcaster Tom Fox and his colleagues Andrew Gay and Gilbert Paiz get together to go over a couple of their favorite stories from the past week from Kerrville and the greater Hill Country. Sit back, enjoy a cup of morning coffee, and listen in to get a wrap-up of the Kerrville Weekly News. We each consider two of our favorite stories and talk about the upcoming weekend’s events, which we will enjoy or participate in this weekend.

In this episode, Tom and Andrew discuss the following stories that caught their attention over the past week:.

  • Tom discusses the increase in Kerrville sales tax revenue and congratulates Axel Benitez-Chavez for being Kerrville’s first new arrival in 2024. He is looking forward to the Symphony of Hills performance of A Night at the Movies at the Cailloux Theater on Saturday.
  • Andrew discusses the 80th annual Kerr County Stock Show occurring this weekend and the new Eucharistic Adoration Chapel under construction at Notre Dame Catholic Church. He and his wife are looking forward to enjoying some sunshine this weekend.

Resources:

Tom Fox on LinkedIn

Gilbert Paiz on LinkedIn

Andrew Gay on LinkedIn

Texas Hill Country Podcast Network

The Lead

Kerrville Daily Times

Categories
31 Days to More Effective Compliance Programs

31 Days to a More Effective Compliance Program: Day 6 – DOJ M&A Safe Harbor

In October 2023, Deputy Attorney General Lisa Monaco announced a new policy regarding M&A. It is a Mergers & Acquisitions Safe Harbor policy that encourages companies to self-disclose criminal misconduct discovered by an acquiring company during the acquisition of a target company. Under the policy, the acquiring party will receive a presumption of criminal declination if it promptly and voluntarily discloses criminal misconduct, cooperates with any ensuing investigation, and engages in appropriate remediation, restitution, and disgorgement.

Under this new Mergers & Acquisitions Safe Harbor, which applies across the Department of Justice, companies that promptly and voluntarily disclose criminal misconduct during the Safe Harbor period and then cooperate with the resulting investigation, engage in timely and appropriate remediation, and pay applicable restitution and disgorgement will receive a presumption of a declination. Once again, the key deadlines are as follows:

  • Companies must disclose misconduct discovered (whether pre-or post-acquisition) at the acquired entity within six (6) months from the date of closing.
  • Companies will then have one year from the date of closing to fully remediate the misconduct.

The 6 month and one-year deadlines are subject to modification depending on the specific circumstances and complexity of the transaction. The acquired company can also qualify under the Mergers & Acquisitions Safe Harbor Policy for voluntary self-disclosure benefits. Interestingly, the DOJ clarified that any misconduct disclosed under the Safe Harbor Policy will not implicate or be counted in any future potential recidivist analysis.

Three key takeaways:

1. The DOJ Mergers & Acquisitions Safe Harbor policy encourages companies to self-disclose criminal misconduct discovered by an acquiring company during the acquisition of a target company.

2. The DOJ is seeking to incentivize an acquiring company to timely disclose misconduct uncovered during the M&A process.

3. The DOJ has made it clear that under this new Mergers & Acquisitions Safe Harbor Policy, organizations that do not perform effective due diligence or self-disclose misconduct at an acquired entity will be subject to full successor liability.

Categories
10 For 10

10 For 10: Top Compliance Stories For The Week Ending January 6, 2024

Welcome to 10 For 10, the podcast that brings you the week’s Top 10 compliance stories in one podcast each week. Tom Fox, the Voice of Compliance, brings to you, the compliance professional, the compliance stories you need to be aware of to end your busy week. Sit back, and in 10 minutes, hear about the stories every compliance professional should be aware of from the prior week. Every Saturday, 10 For 10 highlights the most important news, insights, and analysis for the compliance professional, all curated by the Voice of Compliance, Tom Fox. Get your weekly filling of compliance stories with 10 for 10, a podcast produced by the Compliance Podcast Network.

  1. Senator Menendez draws more charges. (CNN)
  2. Political protests are a compliance risk. (WSJ)
  3. Can the Big 4 ever govern themselves? (FT)
  4. SpaceX illegally fired workers for protected conduct. (NYT)
  5. Broader DEI fights are coming to the Boardroom. (NYT)
  6. Trump companies took in $7.8 in payments from foreign governments and officials. (WSJ)
  7. A suspended Altice office leaves the company. (Bloomberg)
  8. AML whistleblower programs will help in greater ABC efforts. (Bloomberg)
  9. Taking on the banking culture of drive fast, crash.(WSJ)
  10. How FEPA will change ACP enforcement.(WSJ)

You can check out the Daily Compliance News for four curated compliance and ethics-related stories each day here.

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31 Days to More Effective Compliance Programs

31 Days to a More Effective Compliance Program: Day 5 – Kenneth Polite on Clawbacks

Assistant Attorney General Kenneth A. Polite, Jr. began his speech on clawback policy developed by the DOJ to promote “innovative approaches to compensation,” which would “shift the burden of corporate malfeasance away from uninvolved shareholders onto those more directly responsible.” She believes “Companies should ensure that executives and employees are personally invested in promoting compliance,” as “nothing grabs attention or demands personal investment like having skin in the game, through direct and tangible financial incentives.” This led the Criminal Division to “develop guidance, guidance on how to reward corporations with compliance-promoting compensation programs.”

The clawback initiative has two parts. “First, every corporate resolution involving the Criminal Division will now include a requirement that the resolving company develop compliance-promoting criteria within its compensation and bonus system. Second is the creation of a 3-year pilot program under which the “Criminal Division will provide fine reductions to companies who seek to claw back compensation from corporate wrongdoers.”

Three key takeaways:

1. The clawback policy was developed to promote “innovative approaches to compensation.

2. Clawbacks will include those who had supervisory authority over the employees or business area engaged in the misconduct and knew of, or were willfully blind to, the misconduct.

3. How far will the DOJ push companies to move for clawbacks, and how far down the chain will it go?