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Corporate Compliance Answer Book 2012-13
 by Holland & Knight LLP
 
 Copyright: 2012

 Product Details >> 

Product Details

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  • ISBN Number: 9781402418389
  • Page Count: 1638
  • Number of Volumes: 2
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Covering the full spectrum of heavily regulated industries and corporate activities in a convenient Q&A format, the Corporate Compliance Answer Book 2012-13 helps you develop, implement, and enforce compliance programs that detect and prevent wrongdoing. You’ll learn how to use risk assessment to pinpoint and reduce your company’s areas of legal exposure • apply gap analyses to detect and eliminate flaws in your compliance programs • conduct internal investigations that prevent legal problems from becoming major crises • develop records management programs that prepare you for the e-discovery involved in investigations and litigation • satisfy labor and employment mandates, environmental rules, lobbying and campaign finance laws, export control regulations, and FCPA anti-bribery standards • make voluntary disclosures of illegalities as a major step toward reducing penalties and sanctions • and cooperate with federal agencies during investigations in ways that mitigate the legal and financial damage done by wrongdoing.

Corporate Compliance Answer Book 2012-13 features a number of recently revised chapters, covering • The Culture of Compliance • Witness Preparation • Procuring Computer Resources • Intellectual Property Licensing, Outsourcing, and Cloud Computing • Institutions of Higher Education • and the Consumer Product Safety Act.

Featuring dozens of real-world case studies, compliance checklists, and best practice tips, Corporate Compliance Answer Book 2012-13 pays for itself over and over again by helping you avoid major legal and financial burdens.

Essential reading at a time when your legal and regulatory burdens continue to mount, Corporate Compliance Answer Book 2012-13 minimizes the risk of litigation, penalties, sanctions, company turmoil, and lost revenue due to noncompliance.

  Introduction
Chapter 1: The Business Case for Compliance Programs Michael R Manthei ~ Holland & Knight LLP
Christopher A Myers ~ Holland & Knight
  • Q 1.1 : What is a compliance program?2
    • Q 1.1.1 : What does the Federal Sentencing Guidelines’ definition mean by “due diligence”?3
    • Q 1.1.2 : Should the primary focus of a compliance program be on criminal conduct?4
  • Q 1.2 : What makes a compliance program “effective”?4
  • Q 1.3 : How does a compliance program help prevent unethical or illegal conduct from occurring?6
    • Q 1.3.1 : How can a program change a corporate culture?6
  • Q 1.4 : Why does my organization need a compliance and ethics program?7
    • Q 1.4.1 : Can’t we just start a compliance program after we get hit with a government investigation?8
    • Q 1.4.2 : What happens if we don’t have a compliance program, learn of a government investigation, and still don’t implement a program?9
  • Q 1.5 : Does the law require businesses to have compliance and ethics programs?10
    • Q 1.5.1 : Are there state law requirements related to compliance and ethics programs?11
    • Q 1.5.2 : Do some agencies require (rather than recommend) compliance programs?11
    • Q 1.5.3 : What have the courts said about compliance programs?13
  • Q 1.6 : Can our business afford a program?14
  • Q 1.7 : What are the potential costs of an investigation?15
    • Q 1.7.1 : Why not just pay the fine and move on?17
    • Q 1.7.2 : Shouldn’t compliance programs be viewed as cost centers?17
  • Q 1.8 : What other benefits does an effective compliance program provide?18
    • Q 1.8.1 : What is the proof that there is a link between corporate governance and corporate performance?20
    • Q 1.8.2 : What if I have a program and wrongdoing still occurs?23
  • Q 1.9 : How do I tell if my company already has a compliance program?24
    • Q 1.9.1 : If we do not already have a functioning compliance program in place, how do we start from “zero” to build one?24
    • Q 1.9.2 : What happens as my business grows and changes over time?28
Chapter 2: Implementation of Effective Compliance and Ethics Programs and the Federal Sentencing Guidelines Steven D Gordon ~ Holland & Knight LLP
  • Q 2.1 : What are the Federal Sentencing Guidelines?34
  • Q 2.2 : How do the Sentencing Guidelines relate to an effective compliance program?35
    • Q 2.2.1 : Why should my company care about the Sentencing Guidelines if it conducts business honestly and is unlikely ever to face criminal prosecution?35
  • Q 2.3 : What policies and procedures should my company implement to meet the Sentencing Guidelines’ requirements?36
    • Q 2.3.1 : What are the elements of an effective compliance program that will satisfy the Sentencing Guidelines?36
    • Q 2.3.2 : What specific steps must our company take to create an effective compliance program?36
    • Q 2.3.3 : Is there a standard compliance program that most companies can use?38
  • Q 2.4 : Are industry practice and standards considered in assessing the effectiveness of a compliance program?38
    • Q 2.4.1 : Does the company size matter?39
    • Q 2.4.2 : What are the differences between compliance programs for large companies and small companies?39
  • Q 2.5 : When it comes to putting a compliance program together, where do we start?39
    • Q 2.5.1 : What are the most common risk areas that we may need to address in our compliance program?40
  • Q 2.6 : Is a code of conduct a required part of a compliance program?45
    • Q 2.6.1 : What are the legal requirements for a code of conduct?46
    • Q 2.6.2 : What are the elements of a good code of conduct?46
    • Q 2.6.3 : How many codes of conduct should a company have?48
  • Q 2.7 : How do we administer and enforce a compliance program?48
    • Q 2.7.1 : Who should administer the compliance program?50
    • Q 2.7.2 : Which senior executive(s) should be placed in charge of the compliance program?50
    • Q 2.7.3 : What role does top management have in administering a compliance program?51
    • Q 2.7.4 : What is meant by a “culture” of compliance?53
    • Q 2.7.5 : How can we demonstrate a culture of ethics and compliance?53
    • Q 2.7.6 : What are reasonable efforts to exclude bad actors?53
  • Q 2.8 : What is required in the way of training and communication?54
    • Q 2.8.1 : Who within our organization needs to be trained?55
    • Q 2.8.2 : Do we need to educate every employee about every policy?55
    • Q 2.8.3 : We hold a training session for new employees.Is a thorough, one-time training session on our code and policies enough?55
  • Q 2.9 : How can my company maintain the compliance program’s effectiveness?56
    • Q 2.9.1 : What should an audit of the program be examining?56
    • Q 2.9.2 : What is internal auditing?57
    • Q 2.9.3 : Why should an organization have internal auditing?57
    • Q 2.9.4 : What is internal auditing’s role in preventing, detecting, and investigating fraud?58
    • Q 2.9.5 : What is the appropriate relationship between the internal audit activity and the audit committee of the board of directors?58
  • Q 2.10 : What type of reporting system does my company need to have?58
    • Q 2.10.1 : What is a non-retaliation policy?59
  • Q 2.11 : How can my company effectively enforce the compliance program?60
    • Q 2.11.1 : Despite our best efforts to promote a culture of honesty and integrity, some criminal or unethical conduct has occurred. How should the company respond?60
Chapter 3: Assessing and Managing an Ethical Culture David Gebler ~ Skout Group LLC
  • Q 3.1 : If a company has a compliance program and employees know they must act in accordance with those standards, why does misconduct still occur?67
  • Q 3.2 : Why should compliance officers focus on culture?68
  • Q 3.3 : How do we know if our implementation of the elements of the Federal Sentencing Guidelines is sufficient?69
    • Q 3.3.1 : What do regulators and prosecutors think about culture?70
    • Q 3.3.2 : How can an organization evaluate behavior as part of its compliance program?71
  • Q 3.4 : What are the elements of an ethical culture/a culture of compliance?72
  • Q 3.5 : How do individual and organizational goals help create an ethical cultural framework?74
    • Q 3.5.1 : How are goals rewarded?75
    • Q 3.5.2 : How are business goals and ethics linked?75
    • Q 3.5.3 : Can challenges to business goals be safely raised?76
  • Q 3.6 : What is organizational tone, and what is its role in supporting a culture of ethics and compliance?77
    • Q 3.6.1 : What is the role of top management and organizational leaders in setting the appropriate tone?77
    • Q 3.6.2 : What is the role of middle management in setting the appropriate tone?77
    • Q 3.6.3 : What is the role of regular employees in setting the appropriate tone?78
    • Q 3.6.4 : Is the organizational tone always set from the top down?78
  • Q 3.7 : Which values are important to an ethical culture framework?78
    • Q 3.7.1 : What is the role of collective/shared values in an ethical culture framework?79
  • Q 3.8 : How do the elements of the ethical culture framework work together?81
    • Q 3.8.1 : How do you align goals and values?81
    • Q 3.8.2 : … goals and behaviors?82
    • Q 3.8.3 : … behaviors and values?82
  • Q 3.9 : What are the barriers to an ethical culture?82
    • Q 3.9.1 : What risk factors exist, and how should they be addressed?83
  • Q 3.10 : How do we know if our culture creates ethics and compliance risks?87
    • Q 3.10.1 : Can’t we use our existing employee survey data to assess our compliance risk?88
    • Q 3.10.2 : What is the goal of a culture risk assessment?88
    • Q 3.10.3 : What information are we looking for in a culture risk assessment?89
  • Q 3.11 : How do we reduce risks to an ethical culture?90
    • Q 3.11.1 : What are our top ethics issues?90
    • Q 3.11.2 : What are the risk factors?90
    • Q 3.11.3 : Why are these risk factors permitted to flourish?93
    • Q 3.11.4 : What’s needed to address the root cause problem?94
    • Q 3.11.5 : How can we link the solution back to the ethics issues?95
  • Q 3.12 : What is the easiest first step in addressing culture issues?96
Chapter 4: Risk Assessments and Gap Analyses Jennifer Dure ~ Interior Department, Office of Inspector General
  • Q 4.1 : What are the goals of a risk assessment?102
    • Q 4.1.1 : Why should our company perform a “risk assessment”?102
    • Q 4.1.2 : What is senior management’s role in a risk assessment?103
    • Q 4.1.3 : Who should perform the risk assessment?103
  • Q 4.2 : What risk areas should my company be assessing in the first place?103
    • Q 4.2.1 : What do we do once we have identified the company’s potential risk areas?104
  • Q 4.3 : What are the different methods we should use to gather the data?104
    • Q 4.3.1 : What documents should we review as part of the risk assessment?105
    • Q 4.3.2 : How much data is enough? When can we stop gathering data and start using it?105
  • Q 4.4 : What do we do with the data we have gathered?105
    • Q 4.4.1 : What is a compliance matrix?107
    • Q 4.4.2 : Is a matrix the only way to catalog the risk assessment information?107
    • Q 4.4.3 : Once we identify the various risks facing the organization, how can we prioritize the organizational response to those risk areas?107
    • Q 4.4.4 : Once the risk areas have been prioritized, what do we do with this information?108
  • Q 4.5 : What is the purpose of a compliance “gap analysis,” and how does it differ from a risk assessment?108
    • Q 4.5.1 : How do we perform a gap analysis?108
Chapter 5: Records Management Ieuan G Mahony ~ Holland & Knight LLP
  • Q 5.1 : What are the benefits of a records management program?112
    • Q 5.1.1 : What are the constituent parts of a records management program?113
    • Q 5.1.2 : Our organization already has a records “destruction” program; do we still need a records “management” program?114
    • Q 5.1.3 : When it comes to designing a records management program, where should we begin?116
    • Q 5.1.4 : What role should senior management play?116
  • Q 5.2 : What is meant by a “record” in “records management”?117
    • Q 5.2.1 : Does our records management program need to apply to all of our records?118
  • Q 5.3 : Should our records management program cover electronic information?118
    • Q 5.3.1 : What is metadata and how is it relevant to a records management policy?119
    • Q 5.3.2 : How can ESI be used to support a records management program?120
    • Q 5.3.3 : For management purposes, should all records be treated the same?122
    • Q 5.3.4 : How should we handle duplicate records?122
  • Q 5.4 : What do we do once we have determined the lifecycle for each record type?123
    • Q 5.4.1 : What specific goals should an effective records management policy accomplish?123
  • Q 5.5 : What should a retention schedule look like?127
    • Q 5.5.1 : How should we determine retention periods for a particular category of records?129
    • Q 5.5.2 : Should we retain metadata?129
    • Q 5.5.3 : Does the statute of limitations play a role in setting retention periods?131
    • Q 5.5.4 : When a retention period expires for a record, is the record destroyed?131
  • Q 5.6 : What if we make mistakes here and there in following our records management policy?132
    • Q 5.6.1 : Should we have a training program?132
    • Q 5.6.2 : Should we consider sanctions for noncompliance?132
  • Q 5.7 : How is our organization’s Disaster Recovery Plan different from a records management program?133
    • Q 5.7.1 : Can’t we just rely on our Disaster Recovery Plan’s backup system for records management?133
  • Q 5.8 : How do ESI rules affect policy?134
    • Q 5.8.1 : How can we be best prepared to respond to requests for ESI?135
    • Q 5.8.2 : How should concerns about litigation inform our retention of records?138
    • Q 5.8.3 : What if requested records have already been destroyed in accordance with our retention schedule?138
  • Q 5.9 : What is a litigation hold?139
    • Q 5.9.1 : How do we put a litigation hold in place?140
    • Q 5.9.2 : How long should a litigation hold last?140
Chapter 6: Internal Investigations Gregory Baldwin ~ Holland & Knight LLP
  • Q 6.1 : What triggers an internal investigation?147
    • Q 6.1.1 : What kinds of allegations trigger an investigation?148
    • Q 6.1.2 : Are all allegations of wrongdoing subject to investigation?148
  • Q 6.2 : What determines the type of internal investigation to conduct?149
    • Q 6.2.1 : How is the decision about the appropriate type of internal investigation made?149
  • Q 6.3 : How should low-risk allegations of misconduct be investigated?150
    • Q 6.3.1 : How should high-risk allegations of misconduct be investigated?151
    • Q 6.3.2 : How do internal allegations affect the investigation?152
    • Q 6.3.3 : How do external allegations from government authorities affect the investigation?152
    • Q 6.3.4 : When subject to a government investigation, how does a company determine the scope of the government’s inquiry and its own investigative response?152
    • Q 6.3.5 : What does the issuance of a search warrant tell us about the government’s intentions?153
    • Q 6.3.6 : What does the service of a grand jury subpoena or CID say about the intended scope of the government’s investigation?153
    • Q 6.3.7 : What information can a government agent or attorney provide?154
    • Q 6.3.8 : How do allegations from external nongovernment sources affect the type of investigation to be pursued?155
  • Q 6.4 : What steps does the company need to take once a decision to investigate is reached?156
    • Q 6.4.1 : How does the company determine the logistical needs of and methods to be used in an investigation?156
  • Q 6.5 : When should a company initiate an investigation?157
    • Q 6.5.1 : Is it beneficial to commence an investigation immediately?158
  • Q 6.6 : What kinds of inquiries will be involved in an investigation?158
    • Q 6.6.1 : What factors should the company consider in determining the scope of an investigation?159
    • Q 6.6.2 : When should the scope of the investigation be determined?160
  • Q 6.7 : Who should be in charge of an internal investigation?161
    • Q 6.7.1 : How does legal counsel maintain the confidentiality of the investigation?161
    • Q 6.7.2 : Who is in charge of the investigation—inside counsel or outside counsel?162
  • Q 6.8 : How are an investigation’s staffing needs determined?163
    • Q 6.8.1 : What circumstances warrant the services of professional investigators?164
    • Q 6.8.2 : Is the work of a professional investigator protected?164
    • Q 6.8.3 : What circumstances warrant the services of forensic experts?164
    • Q 6.8.4 : Is the work of a forensic expert protected?165
  • Q 6.9 : How are the facts in an investigation determined?165
  • Q 6.10 : How should a company approach its documents and e-data at the initiation of an investigation?166
    • Q 6.10.1 : How does an investigation affect a company’s routine document destruction policies?166
    • Q 6.10.2 : Is e-data subject to the same ban on destruction?167
    • Q 6.10.3 : Is the e-data preservation directive confined to the on-site locations?167
    • Q 6.10.4 : How can documents/data be classified as relevant?168
    • Q 6.10.5 : Where can we look for guidance in identifying relevant documents/data in external allegations of criminal misconduct?168
    • Q 6.10.6 : What steps should the company take to collect relevant documents for review by counsel?169
    • Q 6.10.7 : What is a “litigation hold”?170
    • Q 6.10.8 : When should a litigation hold be imposed?170
    • Q 6.10.9 : What are the responsibilities of the “records custodian”?171
  • Q 6.11 : Who must be interviewed?171
    • Q 6.11.1 : When should interviews take place?172
    • Q 6.11.2 : Who should conduct the interviews?172
    • Q 6.11.3 : Who do the interviewers represent?173
    • Q 6.11.4 : What should the interviewers tell persons who are interviewed?173
    • Q 6.11.5 : How are Upjohn warnings given to a witness?173
    • Q 6.11.6 : What should be included in the Upjohn warnings?174
    • Q 6.11.7 : Is there a standard form for Upjohn warnings?175
    • Q 6.11.8 : Is a witness allowed to have separate counsel?176
    • Q 6.11.9 : What happens if the witness refuses to cooperate?176
    • Q 6.11.10 : Is the interview privileged?176
    • Q 6.11.11 : Is the witness covered by the privilege?177
    • Q 6.11.12 : Can the confidentiality of the information disclosed during an interview be waived?177
  • Q 6.12 : Should notice be given to the entire company that an internal investigation is underway?178
    • Q 6.12.1 : Should the notice identify the investigated employees or group of employees?178
    • Q 6.12.2 : How should the notice be circulated?179
    • Q 6.12.3 : Should a notice include a statement in defense of the company?179
    • Q 6.12.4 : What information should be included in the notice?179
    • Q 6.12.5 : What information should be included in a notice if the company is under a criminal investigation?180
    • Q 6.12.6 : What are an employee’s rights if he is approached by law enforcement agents for an interview?180
    • Q 6.12.7 : Should the company obtain and pay for legal representation for officers, directors, or employees who may be interviewed by law enforcement agents?181
    • Q 6.12.8 : If the company obtains counsel for officers, directors, or employees, should it enter into a joint defense agreement with that counsel?181
    • Q 6.12.9 : What if an officer, director, or employee is named as a subject or target of a criminal investigation?182
    • Q 6.12.10 : What other information should be contained in the notice to employees?182
  • Q 6.13 : Should internal investigations be kept confidential?184
    • Q 6.13.1 : How are internal investigations protected?185
  • Q 6.14 : When does the attorney-client privilege attach?185
    • Q 6.14.1 : Does the privilege apply to communications with former employees?186
    • Q 6.14.2 : Does the privilege apply to communications with third parties?186
    • Q 6.14.3 : Is the attorney-client privilege absolute?187
    • Q 6.14.4 : Does the crime-fraud exception apply to all disclosures of criminal activity?187
    • Q 6.14.5 : May a disclosing witness prevent a company from disclosing their admission of past criminal conduct?187
  • Q 6.15 : What is protected under the work-product doctrine?188
    • Q 6.15.1 : How does the scope of the work-product doctrine compare to that of the attorney–client privilege?188
    • Q 6.15.2 : Must a company release its entire work product upon a third party’s showing of substantial need and undue hardship?188
  • Q 6.16 : Can the attorney-client privilege and work-product protection be waived?189
    • Q 6.16.1 : What motivates companies to waive their privileges?189
    • Q 6.16.2 : What is required under a voluntary disclosure?190
    • Q 6.16.3 : What is the scope of a waiver of the attorney-client privilege or work-product protection?190
  • Q 6.17 : What guidelines do federal prosecutors follow when seeking a waiver of the attorney-client privilege and the attorney work-product protection?190
    • Q 6.17.1 : What is the Holder Memorandum?191
    • Q 6.17.2 : What is the Thompson Memorandum?191
    • Q 6.17.3 : What is the McNulty Memorandum?192
    • Q 6.17.4 : What is the Filip Memorandum?193
    • Q 6.17.5 : What is the current policy?194
Chapter 7: Electronic Discovery Sonya Strnad ~ Holland & Knight LLP
  • Q 7.1 : Why is electronic data so significant?202
  • Q 7.2 : What is e-discovery?203
    • Q 7.2.1 : In what context does e-discovery usually occur?204
  • Q 7.3 : What can our company do now so that we are in a better position if we are ever sued?205
  • Q 7.4 : What data should be preserved?206
    • Q 7.4.1 : How is ESI preserved?206
    • Q 7.4.2 : How do we prevent data from being unintentionally deleted or altered?207
  • Q 7.5 : When is the duty to preserve or issue a “litigation hold” triggered?207
    • Q 7.5.1 : In what format should a litigation hold be issued?208
    • Q 7.5.2 : Who should receive the litigation hold notice?208
    • Q 7.5.3 : How do we determine who the “key players” are?208
    • Q 7.5.4 : What should the litigation hold cover?209
    • Q 7.5.5 : What are in-house counsel’s or upper management’s obligations with respect to implementing and maintaining a litigation hold?210
    • Q 7.5.6 : What are outside counsel’s obligations?211
  • Q 7.6 : What can happen if I fail to take reasonable steps to preserve data?212
    • Q 7.6.1 : What is spoliation?212
    • Q 7.6.2 : What are some of the hazards to be aware of in trying to implement a litigation hold?212
    • Q 7.6.3 : What kinds of sanctions can result from a failure to preserve data?213
    • Q 7.6.4 : When can we lift the litigation hold?213
  • Q 7.7 : How soon after preservation will we need to start collecting documents?215
    • Q 7.7.1 : How should we begin collecting the internal documents that our litigation counsel will need?216
    • Q 7.7.2 : Is keyword searching an effective way to collect ESI?216
    • Q 7.7.3 : What is “imaging”?217
  • Q 7.8 : What is an e-discovery vendor?217
    • Q 7.8.1 : When should I consider hiring one?218
    • Q 7.8.2 : Are there any special concerns with regard to using an e-discovery vendor for data collection?218
    • Q 7.8.3 : Do I have to collect data from backup tapes?219
  • Q 7.9 : What are some of the document collection hazards I should be aware of?219
    • Q 7.9.1 : What can happen if data that the other side wants in the litigation was destroyed?220
    • Q 7.9.2 : Are there special considerations for collecting data outside the United States?220
  • Q 7.10 : In what format should my data be produced?221
    • Q 7.10.1 : What are my options regarding data production format?221
  • Q 7.11 : How much does it all cost?222
Chapter 8: Voluntary Disclosure of Wrongdoing Michael R Manthei ~ Holland & Knight LLP
  • Q 8.1 : What is a voluntary disclosure of wrongdoing?228
    • Q 8.1.1 : Why would a corporation disclose wrongdoing rather than simply fix the problem?228
    • Q 8.1.2 : Does voluntary disclosure of wrongdoing preclude criminal prosecution?229
  • Q 8.2 : What are the basic elements of a voluntary disclosure?230
    • Q 8.2.1 : What information should be included in the initial disclosure?230
  • Q 8.3 : What happens after the initial disclosure?231
    • Q 8.3.1 : What should an internal investigation cover?231
    • Q 8.3.2 : What information should be reported regarding the scope of the activity?232
    • Q 8.3.3 : What information should be reported regarding the discovery and response to the problem?232
    • Q 8.3.4 : How does the company assess the financial impact of the disclosed activities?233
    • Q 8.3.5 : What happens after the company submits its disclosure and self-assessment reports?234
  • Q 8.4 : How does voluntary disclosure affect the attorney-client and work-product privileges?235
  • Q 8.5 : When are requests for privileged information permitted?235
    • Q 8.5.1 : What is the Holder Memorandum?236
    • Q 8.5.2 : What is the Thompson Memorandum?236
    • Q 8.5.3 : What is the McNulty Memorandum?237
    • Q 8.5.4 : What is the Filip Memorandum?237
    • Q 8.5.5 : What is the current policy?238
  • Q 8.6 : What happens if I change my mind after disclosure?239
  • Q 8.7 : How are voluntary disclosures finally resolved?239
Chapter 9: Witness Preparation Daniel I. Small ~ Holland & Knight
  • Q 9.1 : Why is witness preparation important?244
    • Q 9.1.1 : Is witness preparation unethical?245
    • Q 9.1.2 : Isn’t witness preparation expensive?246
  • Q 9.2 : What can a company do in advance?246
  • Q 9.3 : Why do our own employees need counsel for an internal investigation?247
  • Q 9.4 : Is it more efficient for in-house counsel to represent company employees?248
    • Q 9.4.1 : Don’t the Upjohn warnings protect company counsel?249
  • Q 9.5 : What is the process for obtaining outside counsel for witnesses in an internal investigation?250
  • Q 9.6 : What is the difference between witness preparation and witness coaching?250
  • Q 9.7 : What is “real” witness preparation?251
    • Q 9.7.1 : How can effective witness preparation help “level the playing field”?252
  • Q 9.8 : What are the ten most important rules for witnesses?253
Chapter 10: Settling with the Government Jennifer Short ~ Holland & Knight
  • Q 10.1 : What role does compliance play in settling with the government?258
  • Q 10.2 : What kinds of compliance provisions can settlement agreements impose?259
    • Q 10.2.1 : How does the government ensure ongoing compliance monitoring?260
    • Q 10.2.2 : Who selects the monitor and who pays for it?260
  • Q 10.3 : How are settlements affected by parallel proceedings?261
    • Q 10.3.1 : What is a global resolution?261
  • Q 10.4 : How do settlements with an administrative agency differ from those with an enforcement agency?262
    • Q 10.4.1 : What compliance-related provisions might an administrative agency seek to include in a settlement agreement?262
    • Q 10.4.2 : What are some common types of settlement agreements?263
    • Q 10.4.3 : What is a corporate integrity agreement?263
    • Q 10.4.4 : What compliance-related provisions can a CIA mandate?264
    • Q 10.4.5 : What is a certification of compliance agreement?265
    • Q 10.4.6 : What is an administrative compliance agreement?265
    • Q 10.4.7 : What does an administrative compliance agreement specifically require?266
  • Q 10.5 : How are settlements with the SEC different from those with other administrative agencies?267
    • Q 10.5.1 : What are the mechanisms for settling with the SEC?267
    • Q 10.5.2 : What kinds of sanctions may be imposed?267
  • Q 10.6 : Can a civil settlement agreement include compliance and reporting provisions?268
    • Q 10.6.1 : What happens when an agency joins a civil settlement agreement?269
    • Q 10.6.2 : Will an administrative agency always join in a civil settlement agreement?270
  • Q 10.7 : Do plea agreements contain compliance and reporting provisions?270
    • Q 10.7.1 : What is a deferred prosecution agreement?271
    • Q 10.7.2 : What are the advantages of a deferred prosecution agreement?271
    • Q 10.7.3 : What are the drawbacks of a deferred prosecution agreement?271
Chapter 11: The False Claims Act Jennifer Short ~ Holland & Knight
  • Q 11.1 : What kinds of actions are typically brought under the False Claims Act?277
  • Q 11.2 : What specifically does the FCA prohibit?278
    • Q 11.2.1 : What is a “claim” for purposes of the FCA?279
    • Q 11.2.2 : When is a claim “false”?280
  • Q 11.3 : What does it mean to present a false claim “knowingly”?280
  • Q 11.4 : What are the penalties for violating the FCA?281
  • Q 11.5 : What conduct most commonly leads to FCA liability?283
  • Q 11.6 : What is a “whistleblower” or “relator”?286
  • Q 11.7 : Who can be a whistleblower?286
  • Q 11.8 : How much can the whistleblower make?287
  • Q 11.9 : What is the procedure for filing a qui tam action?288
    • Q 11.9.1 : How long does the complaint remain under seal?288
    • Q 11.9.2 : How and when does the government become involved in the prosecution of a qui tam action?289
    • Q 11.9.3 : How does a defendant learn that an FCA action is pending?289
  • Q 11.10 : What happens after the defendant learns that an FCA case has been filed?290
  • Q 11.11 : Our company has just received a subpoena that indicates the government is investigating a potential FCA violation; what should we do?291
    • Q 11.11.1 : The government refuses to narrow the scope of its broad requests; what can we do?291
    • Q 11.11.2 : The government has narrowed the scope of its requests; what do we do?291
    • Q 11.11.3 : What use can the government make of our documents once produced?292
  • Q 11.12 : Why should we conduct an internal investigation?293
    • Q 11.12.1 : Would we ever choose to disclose our findings to the government attorneys?293
  • Q 11.13 : Who should be interviewed during an internal investigation?294
    • Q 11.13.1 : What should we do if, during the course of our investigation, we discover that an employee has engaged in illegal or unethical conduct?295
  • Q 11.14 : What kind of information can we get from the government, and how should we go about getting it?295
  • Q 11.15 : When is it in our interest to share information with the government?296
  • Q 11.16 : What happens once the complaint is unsealed?297
  • Q 11.17 : How are damages and penalties calculated under the FCA?297
    • Q 11.17.1 : How should we approach damages in the context of settlement?297
  • Q 11.18 : Is the process of negotiating a settlement in an FCA case different from that in any other litigation?298
  • Q 11.19 : What should we do if we learn that the whistleblower is a current employee of our company?298
    • Q 11.19.1 : What should we do if we learn that the whistleblower works for one of our contracting partners?299
  • Q 11.20 : What are the most common defenses to an FCA claim?300
  • Q 11.21 : What is the statute of limitations for an FCA violation?302
  • Q 11.22 : Can a compliance program prevent FCA claims?303
  • Q 11.23 : Does the lack of a compliance program pose an FCA risk?304
  • Q 11.24 : What is the Deficit Reduction Act of 2005 and how does it affect the FCA and compliance programs?304
  • Q 11.25 : Do states have false claims act statutes?305
Chapter 12: Conflicts of Interest Kwamina T. Williford ~ Holland & Knight LLP
  • Q 12.1 : What is a conflict of interest?316
    • Q 12.1.1 : What concerns do conflicts of interest raise?317
  • Q 12.2 : How do conflicts of interest arise?317
    • Q 12.2.1 : Why should my business be concerned if an individual employee has a conflict of interest?318
  • Q 12.3 : What concerns arise if an employee has an interest in a competitor’s business?318
    • Q 12.3.1 : What can a company do to avoid conflicts of interest related to an ownership interest in a competitor company?318
    • Q 12.3.2 : What concerns arise if an employee works for a competitor while also working for you?319
    • Q 12.3.3 : What can a company do to avoid such conflicts of interest related to employment in a competitor company?319
  • Q 12.4 : Can conflicts arise if an employee has a relationship with a non-competitor company?319
    • Q 12.4.1 : What can a company do to avoid conflicts of interest related to vendors or customers?320
  • Q 12.5 : If my employees have access to confidential or business-sensitive information, what kinds of policies should I have in place?320
  • Q 12.6 : How can I reduce the risk that an employee may divert corporate opportunities to his personal benefit?321
  • Q 12.7 : What conflict-of-interest issues are raised by doing business with the government?321
    • Q 12.7.1 : If my business’s work involves interaction with government officials, what kinds of policies should I have in place?322
    • Q 12.7.2 : If my business contracts with the government, what kinds of policies should I have in place?322
    • Q 12.7.3 : What other industries create special concerns regarding conflicts of interest?323
  • Q 12.8 : Am I required to have a conflicts of interest policy?323
    • Q 12.8.1 : What should be included within a conflicts of interest policy?324
  • Q 12.9 : What should be done if a potential conflict of interest arises?325
Chapter 13: Privacy and Security of Personal Information Ieuan G Mahony ~ Holland & Knight LLP
Maximilliam J Bodoin ~ Holland & Knight LLP
Peter I Sanborn ~ Holland & Knight LLP
  • Q 13.1 : What are the particular concerns that drive privacy law?333
    • Q 13.1.1 : What is the legal definition of “personal information”?336
    • Q 13.1.2 : What steps should our organization take to ensure compliance with data protection laws?338
  • Q 13.2 : Should we implement a privacy policy?341
    • Q 13.2.1 : Where should our organization place its privacy policy?341
    • Q 13.2.2 : What principles should inform our privacy policy?341
    • Q 13.2.3 : What types of choices should data subjects be allowed?343
    • Q 13.2.4 : How should my organization administer its privacy policy?343
    • Q 13.2.5 : What happens if we modify the privacy policy?343
    • Q 13.2.6 : Should our organization display any third-party seals of approval?343
  • Q 13.3 : What privacy rules apply to our organization’s employees?344
    • Q 13.3.1 : What criminal sanctions does the ECPA provide for?344
    • Q 13.3.2 : Are we allowed to monitor our employees’ email?344
    • Q 13.3.3 : Do we need a written email policy?344
  • Q 13.4 : What is identity theft?345
    • Q 13.4.1 : Are states taking actions to require organizations to protect individuals against identity theft?346
    • Q 13.4.2 : Are there federal regulations that require organizations to protect individuals against identity theft?346
    • Q 13.4.3 : What should our identity theft prevention program include?347
    • Q 13.4.4 : Do we need an identity theft prevention program for our service providers?349
  • Q 13.5 : What security protections should we have in place?349
  • Q 13.6 : What should our privacy and security program look like?352
  • Q 13.7 : Are public companies required to take additional steps in terms of compliance with privacy obligations?352
  • Q 13.8 : Do we need to be concerned in our compliance program about class action cases seeking to enforce privacy obligations?353
Chapter 14: Procuring Computing Resources: IP Licensing, Outsourcing, and Cloud Computing Ieuan G Mahony ~ Holland & Knight LLP
  • Q 14.1 : What are “computing resources”?359
  • Q 14.2 : What alternatives are generally available to my organization for procuring computing resources?359
    • Q 14.2.1 : What is the “in-house model” for obtaining computing resources?360
    • Q 14.2.2 : What is the “outsourcing model” for obtaining computing resources?360
    • Q 14.2.3 : How does “cloud computing” relate to my organization’s computing resources?361
  • Q 14.3 : What are the key considerations when comparing the options for obtaining computing resources?362
  • Q 14.4 : In these transactions, what vendor intellectual property rights, if any, should my organization be concerned with?363
  • Q 14.5 : Should my organization be concerned about its own intellectual property rights?364
    • Q 14.5.1 : My organization engages a range of other vendors in connection with its computing resources. Do we need to address system access by these third parties?366
    • Q 14.5.2 : A vendor proposes to develop software for my organization using an “agile development” methodology. What does this mean for us?366
  • Q 14.6 : Are there any special considerations our organization should be aware of when integrating the new computing resource within our existing systems?368
    • Q 14.6.1 : What are “rights in interfaces”?368
    • Q 14.6.2 : What is open-source software?369
    • Q 14.6.3 : What open-source software considerations may affect our system?369
    • Q 14.6.4 : What concerns are raised by legacy data?370
  • Q 14.7 : What factors affect maintenance of our computing resource assets and monitoring of performance?371
    • Q 14.7.1 : What role do SLAs and SLOs play in maintaining computing resources?371
    • Q 14.7.2 : How can we use audit requirements to enhance maintenance of our system?372
    • Q 14.7.3 : Can company policies enhance system maintenance?373
  • Q 14.8 : How do computing resources relate to our compliance obligations?373
    • Q 14.8.1 : Can an organization procuring computing resources be held responsible for actions of a service provider?374
    • Q 14.8.2 : How do we address conflicting regulatory requirements for cross-border operations?374
  • Q 14.9 : What compliance risks are raised by storing data with a third party?375
    • Q 14.9.1 : What data security protections should be in place?376
  • Q 14.10 : How do we disengage from a licensor or service provider?377
  • Q 14.11 : How can an organization seeking to terminate its relationship with a vendor reduce the threat of vendor lock-in?377
    • Q 14.11.1 : How do we get unconditional access to portable data?377
    • Q 14.11.2 : What is transition assistance?378
    • Q 14.11.3 : What are escrow agreements?379
Chapter 15: Government Contractors Oliya Zamaray ~ Holland & Knight LLP
Thomas Brownell ~ Holland & Knight LLP
David Black ~ Holland & Knight LLP
Allison Feierabend ~ Holland & Knight LLP
  • Q 15.1 : What are the benefits to contractors of developing, implementing, and maintaining a compliance program?385
  • Q 15.2 : Generally speaking, what should a government contractor’s compliance program aim to do?386
  • Q 15.3 : Does the Federal Acquisition Regulation (FAR) include provisions requiring compliance programs?387
    • Q 15.3.1 : Who is subject to these rules?388
    • Q 15.3.2 : How must contractors fulfill the code of conduct requirement?389
    • Q 15.3.3 : What is required in an internal controls system and training program?389
    • Q 15.3.4 : Who should participate in a training program?390
    • Q 15.3.5 : What is required for an internal reporting system and hotline poster?391
    • Q 15.3.6 : What are the mandatory disclosure requirements?391
    • Q 15.3.7 : What is the time frame for disclosure?392
    • Q 15.3.8 : How is disclosure made?393
    • Q 15.3.9 : To whom is disclosure made?393
    • Q 15.3.10 : What must be disclosed?393
    • Q 15.3.11 : What is “knowing” failure to disclose?393
    • Q 15.3.12 : What is required for “full cooperation”?393
    • Q 15.3.13 : What are the implications of suspension and debarment for knowing failure to make mandatory disclosures?394
    • Q 15.3.14 : What constitutes failure to report “significant overpayments”?395
  • Q 15.4 : Are contractors required to flow-down the clauses into subcontracts?395
  • Q 15.5 : Will a contractor’s compliance program be considered in performance evaluations?395
  • Q 15.6 : What does a government contractor risk by not having a compliance program?396
    • Q 15.6.1 : Can a contractor be found liable for the acts of its employees?396
    • Q 15.6.2 : What types of liability might government contractors incur?397
  • Q 15.7 : What criminal and civil penalties may government contractors face?397
    • Q 15.7.1 : What makes a case criminal rather than civil?398
    • Q 15.7.2 : How are criminal fines determined?398
    • Q 15.7.3 : How can contractors be held liable under the False Claims Act?398
    • Q 15.7.4 : What constitutes a false statements violation?399
    • Q 15.7.5 : What constitutes criminal mail fraud violations?399
    • Q 15.7.6 : What constitutes wire fraud violations?400
    • Q 15.7.7 : What constitutes a major fraud violation?400
    • Q 15.7.8 : How can the conspiracy statute affect government contractors?401
    • Q 15.7.9 : How can the Racketeer Influenced Corrupt Organizations Act affect government contractors?401
    • Q 15.7.10 : What behaviors can subject a government contractor to obstruction of justice liability?402
    • Q 15.7.11 : What is required to avoid liability under the Truth in Negotiations Act?402
    • Q 15.7.12 : What are “cost or pricing data”?402
    • Q 15.7.13 : What are the requirements for providing cost or pricing data to the government?403
    • Q 15.7.14 : How might a contractor incur liability?403
    • Q 15.7.15 : What civil remedies can the government seek for such violations?404
    • Q 15.7.16 : What are the civil penalties for violations of the Program Fraud Civil Remedies Act?404
    • Q 15.7.17 : What are the civil penalties for violations of the Foreign Assistance Act?404
    • Q 15.7.18 : What other civil penalties might government contractors be subject to?405
  • Q 15.8 : What administrative penalties may government contractors face?405
    • Q 15.8.1 : What are the implications of suspension?405
    • Q 15.8.2 : What are the implications of debarment?405
    • Q 15.8.3 : What kinds of contractor acts can result in suspension and/or debarment?405
    • Q 15.8.4 : What administrative penalties are available under the Program Fraud Civil Remedies Act?406
  • Q 15.9 : What other contractual clauses might trigger penalties in government contracts?407
    • Q 15.9.1 : What penalties are triggered by “unallowable costs”?407
    • Q 15.9.2 : How can defective cost or pricing data result in price reduction?407
  • Q 15.10 : What compliance issues may arise when preparing bids on government contracts?408
    • Q 15.10.1 : What kinds of certifications might contractors be required to make?408
    • Q 15.10.2 : When is a contractor eligible to bid on a government contract?410
    • Q 15.10.3 : What makes a contractor “responsible”?410
    • Q 15.10.4 : What are “organizational conflicts of interest”?411
    • Q 15.10.5 : Under what circumstances might an OCI arise?411
    • Q 15.10.6 : What can a government contractor do to identify OCIs?413
    • Q 15.10.7 : How can the impact of organizational conflicts of interest be mitigated?414
    • Q 15.10.8 : What recent changes and developments in the field of OCIs should contractors keep track of over the coming year?415
    • Q 15.10.9 : What are a federal contractor’s compliance responsibilities regarding accounting for costs?417
    • Q 15.10.10 : How must a contractor comply with the FAR’s “cost principles”?417
    • Q 15.10.11 : How must a contractor comply with the FAR’s Cost Accounting Standards?417
    • Q 15.10.12 : What are the compliance requirements of the Truth in Negotiations Act for government contractors?419
    • Q 15.10.13 : What requirements regarding anticompetitive behavior must a contractor comply with?420
  • Q 15.11 : What potential improper business practice violations occur during contract performance?421
    • Q 15.11.1 : What are the statutes/regulations dealing with disclosure of procurement information with which a government contractor must comply?422
    • Q 15.11.2 : What compliance issues does gift-giving raise?423
    • Q 15.11.3 : What is the difference between a bribe and a gratuity?423
    • Q 15.11.4 : What are acceptable gifts?424
    • Q 15.11.5 : What are the penalties for illegal giving of “things of value”?424
    • Q 15.11.6 : What are a federal contractor’s compliance obligations regarding kickbacks?425
    • Q 15.11.7 : What is a contingent fee?425
    • Q 15.11.8 : What compliance considerations regarding contingent fees should a federal contractor be aware of?426
    • Q 15.11.9 : What compliance issues should contractors engaging in foreign business activities be aware of?426
    • Q 15.11.10 : Are there any kinds of payments to officials that are permitted?427
    • Q 15.11.11 : What are the penalties for violations?427
    • Q 15.11.12 : What kinds of relationships may create personal conflicts of interest?428
    • Q 15.11.13 : What are the restrictions on current government employees seeking employment from government contractors?428
    • Q 15.11.14 : What are the restrictions on former government employees currently working for government contractors?429
    • Q 15.11.15 : What are the restrictions on government employees who previously worked for government contractors?432
    • Q 15.11.16 : What can a contractor considering hiring a government employee do to avoid liability?433
    • Q 15.11.17 : Under what circumstances might an organizational conflict of interest arise after the procurement of a government contract?434
    • Q 15.11.18 : What kinds of lobbying activities are restricted?434
    • Q 15.11.19 : What kinds of lobbying requirements must federal contractors comply with?435
  • Q 15.12 : What are a contractor’s ethical obligations in relation to subcontractors?435
  • Q 15.13 : What wage-and-hour statutes and regulations should a compliance program account for?436
    • Q 15.13.1 : What are a government contractor’s obligations regarding compliance with the Davis-Bacon Act?436
    • Q 15.13.2 : … with the Service Contract Act?437
    • Q 15.13.3 : … with the Walsh-Healey Public Contracts Act?438
    • Q 15.13.4 : … with the Copeland Act?438
    • Q 15.13.5 : … with the Contract Work Hours and Safety Standards Act?439
    • Q 15.13.6 : … with Equal Employment Opportunity requirements?439
    • Q 15.13.7 : … with the Drug-Free Workplace Act?440
  • Q 15.14 : Are government contractors subject to any special employment verification requirements?440
  • Q 15.15 : What is E-Verify?441
    • Q 15.15.1 : Are there E-Verify exemptions?441
    • Q 15.15.2 : Must a contractor verify its entire workforce?441
    • Q 15.15.3 : When must a contractor enroll and use E-Verify?442
  • Q 15.16 : What proprietary intellectual property concerns should a compliance program account for?442
    • Q 15.16.1 : What technical data and computer software rights should a government contractor be concerned with?443
    • Q 15.16.2 : What copyright protections should a government contractor be concerned with?446
    • Q 15.16.3 : What rights in patented inventions should a government contractor be concerned with?446
  • Q 15.17 : What are a government contractor’s obligations regarding the products/components and services it uses?447
    • Q 15.17.1 : What domestic and foreign preference statutes and regulations should a compliance program account for?448
    • Q 15.17.2 : What are a government contractor’s obligations regarding compliance with the Buy American Act?448
    • Q 15.17.3 : Are there any exemptions to the Buy American Act?449
    • Q 15.17.4 : What remedies may be sought for violations of the Buy American Act?451
    • Q 15.17.5 : What are a government contractor’s obligations regarding compliance with the Trade Agreements Act?451
    • Q 15.17.6 : … with the Berry Amendment?452
    • Q 15.17.7 : … with the Fly American Act?453
    • Q 15.17.8 : … with the Arms Export Control Act?453
    • Q 15.17.9 : What are the Arms Export Control Act’s licensing requirements?454
    • Q 15.17.10 : What are the penalties for violations of the Arms Export Control Act?455
    • Q 15.17.11 : What are a government contractor’s obligations regarding compliance with the Foreign Military Sales Program?455
  • Q 15.18 : What compliance obligations exist regarding tracking expenditures under government contracts?456
  • Q 15.19 : What particular types of government contracts raise special compliance issues?457
    • Q 15.19.1 : What special issues should a small business compliance plan address?457
    • Q 15.19.2 : What issues may arise in GSA contracts?458
  • Q 15.20 : How does the Sarbanes-Oxley Act affect government contractors?461
    • Q 15.20.1 : What advantages do government contractors have in dealing with Sarbanes-Oxley?461
    • Q 15.20.2 : What obligations do officers of government contractors have under Sarbanes-Oxley?462
    • Q 15.20.3 : What obligations do program managers and product line executives have?462
    • Q 15.20.4 : What are in-house lawyers’ obligations?463
  • Q 15.21 : What compliance issues may arise under the Freedom of Information Act?463
Chapter 16: International Investigations Steven D Gordon ~ Holland & Knight LLP
  • Q 16.1 : What is an international investigation?478
  • Q 16.2 : What are some of the special issues raised by international investigations?479
  • Q 16.3 : What kinds of considerations are raised by special issues related to document collection and review?479
  • Q 16.4 : What special issues exist relating to witness interviews?480
    • Q 16.4.1 : Can telephone interviews be used?481
  • Q 16.5 : Does the attorney-client privilege apply in an international investigation?481
  • Q 16.6 : When do U.S. courts have jurisdiction over a company’s foreign activities?482
    • Q 16.6.1 : Do U.S. laws apply to conduct outside the United States?482
  • Q 16.7 : Does travel to the United States by foreign officers raise any special issues?483
  • Q 16.8 : What are some of the major practice areas where international investigations typically occur?484
    • Q 16.8.1 : How frequent and significant are government investigations of suspected international cartels?484
    • Q 16.8.2 : Does the government face special problems in investigating and prosecuting international cartels?485
    • Q 16.8.3 : Why has the government been so successful in prosecuting international cartels?485
    • Q 16.8.4 : What are investigation “triggers” in the area of noncartel anticompetitive and unfair business practices?486
    • Q 16.8.5 : What laws address bribery in an international context?486
    • Q 16.8.6 : Who is subject to the Foreign Corrupt Practices Act?487
    • Q 16.8.7 : Is there an international consensus on anti-bribery regulation?487
    • Q 16.8.8 : Why do export controls trigger international investigations?487
    • Q 16.8.9 : Is there a particular industry significantly affected by U.S. export controls?487
    • Q 16.8.10 : What sorts of issues commonly arise in international investigations of export control issues?488
    • Q 16.8.11 : What failures in corporate governance trigger an investigation?488
    • Q 16.8.12 : Are there external triggers for a corporate governance investigation?489
    • Q 16.8.13 : What industries are vulnerable to international intellectual property rights infringement?489
    • Q 16.8.14 : What legal actions are available to a party whose IP rights are being infringed abroad?489
  • Q 16.9 : What preliminary considerations are necessary prior to carrying out an international investigation?490
    • Q 16.9.1 : Who will conduct the investigation?491
Chapter 17: The Foreign Corrupt Practices Act; And Appendix 17A: Foreign Payments Provisions Under the FCPA Don Zarin ~ Holland & Knight, LLP
  • Q 17.1 : What do the foreign payments provisions of the FCPA prohibit?496
  • Q 17.2 : Who is subject to prosecution under the FCPA?497
    • Q 17.2.1 : Which “issuers” are subject to the FCPA?498
    • Q 17.2.2 : What is a “domestic concern”?498
    • Q 17.2.3 : What other jurisdictional requirements are there for potential liability under the FCPA?499
  • Q 17.3 : What is the scope of the requirement that a payment be made “corruptly”?500
  • Q 17.4 : What is the scope of “foreign official”?500
  • Q 17.5 : What is the meaning of “anything of value”?501
  • Q 17.6 : How can U.S. companies be held liable for illicit payments made indirectly through intermediary third parties, such as agents or consultants?502
  • Q 17.7 : What is the “knowledge” standard under the FCPA?502
  • Q 17.8 : What is the standard for “authorization” of illicit payments made by a third party?503
  • Q 17.9 : Is the FCPA limited to payments designed to influence a foreign official’s acts or decisions?504
  • Q 17.10 : What is the business purpose test under the FCPA? What is its scope?505
  • Appendix 17A : Foreign Payments Provisions Under the FCPA511
Chapter 18: Export Controls Ronald A. Oleynik ~ Holland & Knight LLP
Jonathan M Epstein ~ Holland & Knight LLP
Antonia Tzinova ~ Holland & Knight LLP
  • Q 18.1 : Generally speaking, what do U.S. export laws and regulations aim to achieve?572
    • Q 18.1.1 : How do export controls seek to achieve those objectives?572
    • Q 18.1.2 : Which U.S. agencies regulate exports from the United States?572
  • Q 18.2 : How are defense exports regulated?573
  • Q 18.3 : What is the scope of the ITAR?573
    • Q 18.3.1 : What is a defense article?575
    • Q 18.3.2 : What is technical data?575
    • Q 18.3.3 : What are defense services?575
    • Q 18.3.4 : What is “look through” treatment under the ITAR?575
    • Q 18.3.5 : What does the USML cover?576
    • Q 18.3.6 : How can an exporter determine that an item is ITAR-controlled?576
  • Q 18.4 : What constitutes an export under the ITAR?576
    • Q 18.4.1 : What are re-exports and retransfers?577
    • Q 18.4.2 : How can a company obtain DDTC authorization to export?577
    • Q 18.4.3 : Are there exemptions to ITAR licensing?578
    • Q 18.4.4 : Who is a broker?578
    • Q 18.4.5 : What is brokering?579
  • Q 18.5 : How are commercial goods and technology exports regulated?580
    • Q 18.5.1 : What is the scope of the EAR?580
    • Q 18.5.2 : What categories of items and technology require a license to export under the EAR?581
    • Q 18.5.3 : What are the CCL categories?581
    • Q 18.5.4 : What constitutes an export or re-export?583
    • Q 18.5.5 : How does an exporter determine if it needs a license to export dual-use goods and technology?583
    • Q 18.5.6 : How can a license be obtained?584
  • Q 18.6 : What activities are prohibited by U.S. economic sanctions programs?584
    • Q 18.6.1 : Are there exceptions to the prohibition on exportation to embargoed countries?585
    • Q 18.6.2 : What are terrorist and other barred entity lists?585
    • Q 18.6.3 : Who administers economic sanctions programs?586
    • Q 18.6.4 : Who is a “U.S. person”?587
    • Q 18.6.5 : What are the jurisdictional limits of OFAC embargo programs?587
  • Q 18.7 : What are the penalties for violation of the controls on defense exports?587
    • Q 18.7.1 : What are the penalties for violation of the controls on dual-use item exports?588
    • Q 18.7.2 : What are the penalties for exporting to an embargoed country?588
    • Q 18.7.3 : Who is subject to penalties for export violations?589
    • Q 18.7.4 : How are penalties determined?589
    • Q 18.7.5 : What factors do the DDTC, BIS, and OFAC take into account in assessing penalties?590
  • Q 18.8 : What are the industry best practices related to export compliance?593
    • Q 18.8.1 : What is the role of management?594
    • Q 18.8.2 : What are the roles of those groups recognized as “compliance personnel”?594
    • Q 18.8.3 : How important is an export compliance program manual?594
    • Q 18.8.4 : What role should training play?595
    • Q 18.8.5 : What are a company’s record-keeping obligations?595
    • Q 18.8.6 : What is the importance of internal audits?598
    • Q 18.8.7 : How should suspected violations be reported?598
    • Q 18.8.8 : Why does a company need clear disciplinary procedures?598
  • Q 18.9 : What are the first steps a company should take when drafting a compliance program?599
    • Q 18.9.1 : Isn’t there a one-size-fits-all program we can adopt?599
    • Q 18.9.2 : What are the pitfalls to avoid in designing an export compliance program?600
    • Q 18.9.3 : What key questions should be posed when designing an export compliance program?600
  • Q 18.10 : Why should universities be concerned about export controls?604
  • Q 18.11 : What do export controls concerns related to the defense and high-technology sectors have to do with institutions of higher education?604
    • Q 18.11.1 : Who is a “foreign student” for purposes of export controls?605
    • Q 18.11.2 : Can an institution’s treatment of foreign students differ from that of U.S. students?606
  • Q 18.12 : What institution activities may fall under the export controls?606
  • Q 18.13 : Is all information taught at universities subject to export controls?606
    • Q 18.13.1 : What information qualifies as “publicly available” and thus not subject to export controls?607
    • Q 18.13.2 : How is educational information subject to export controls?608
  • Q 18.14 : Are the results of fundamental research subject to export controls?609
    • Q 18.14.1 : How does an institution apply the fundamental research exception in practice?609
    • Q 18.14.2 : What are the limitations on publication or dissemination of the research results?610
    • Q 18.14.3 : What are some pitfalls to avoid in negotiating research grants or funding?610
  • Q 18.15 : Can a U.S. university professor teach abroad?611
  • Q 18.16 : Are there limitations on setting up a foreign campus?611
  • Q 18.17 : How can an institution set up successful screening and compliance procedures?612
Chapter 19: Corporate Political Activity Christopher DeLacy ~ Holland & Knight LLP
  • Q 19.1 : May a corporation contribute to a candidate directly out of its treasury?621
  • Q 19.2 : How may corporations participate in the federal political process?621
  • Q 19.3 : May a corporation expend any resources in relation to a federal election?622
  • Q 19.4 : What is a PAC?622
    • Q 19.4.1 : Are there restrictions on who can participate in a PAC/SSF?622
    • Q 19.4.2 : Are there limits and restrictions on how a corporation can support an SSF?623
    • Q 19.4.3 : What kinds of restrictions are there on solicitation of contributions to SSFs?623
    • Q 19.4.4 : Who makes up the “restricted class”?624
  • Q 19.5 : How does a corporation form a PAC?624
    • Q 19.5.1 : What are the disclosure requirements for a PAC?625
    • Q 19.5.2 : What are contribution limits for PACs?626
    • Q 19.5.3 : How can a corporation ensure PAC compliance?626
  • Q 19.6 : What is express advocacy?627
  • Q 19.7 : What is issue advocacy?627
  • Q 19.8 : What is an electioneering communication?627
  • Q 19.9 : What is an independent expenditure?627
  • Q 19.10 : What is coordination?627
  • Q 19.11 : What may a corporation communicate about a federal candidate to its employees?628
    • Q 19.11.1 : What may a corporation communicate about a federal candidate outside its restricted class?628
    • Q 19.11.2 : How is express advocacy regulated?629
    • Q 19.11.3 : Is issue advocacy regulated?630
    • Q 19.11.4 : How are electioneering communications regulated?630
    • Q 19.11.5 : Is coordination permitted?630
    • Q 19.11.6 : What disclosure requirements apply to corporate communications?630
  • Q 19.12 : What is a Super PAC?632
    • Q 19.12.1 : Who can make contributions to a Super PAC?633
    • Q 19.12.2 : Who is prohibited from making contributions to a Super PAC?633
    • Q 19.12.3 : What kinds of limitations and restrictions are placed on a Super PAC’s activities?633
  • Q 19.13 : How are Super PACs regulated?633
    • Q 19.13.1 : Are Super PACs required to disclose who their donors are?634
    • Q 19.13.2 : What steps can a corporation take to vet contributions to third parties?635
  • Q 19.14 : How much can individual employees contribute to federal candidates?636
    • Q 19.14.1 : What other limitations and conditions exist for contributions from individuals?636
  • Q 19.15 : What is “bundling”?637
    • Q 19.15.1 : May corporate employees “bundle” contributions to federal candidates?637
  • Q 19.16 : May corporate employees engage in political activity related to a federal election while at work?638
  • Q 19.17 : May corporate resources or facilities be used in conjunction with a federal election?638
    • Q 19.17.1 : May a corporation invite a federal candidate to its facility?638
    • Q 19.17.2 : May a corporation allow a federal candidate to fly on its private aircraft?639
  • Q 19.18 : What is the Lobbying Disclosure Act of 1995?640
    • Q 19.18.1 : Who must register under the LDA?640
    • Q 19.18.2 : What are the penalties for violating the LDA?641
    • Q 19.18.3 : What is a “lobbying contact”?641
    • Q 19.18.4 : What is not a “lobbying contact”?641
    • Q 19.18.5 : What are “lobbying activities”?641
    • Q 19.18.6 : Who is a “lobbyist”?642
    • Q 19.18.7 : Who is a “covered official”?642
  • Q 19.19 : What is the process for registering under the LDA?643
    • Q 19.19.1 : What are the contents of the LDA registration?643
    • Q 19.19.2 : What are the contents of the LDA quarterly reports?644
    • Q 19.19.3 : What are the contents of the LDA semi-annual report and certification?644
    • Q 19.19.4 : What is the filing schedule under the LDA?646
    • Q 19.19.5 : What if my corporation only lobbied the executive branch?646
    • Q 19.19.6 : Does an in-house lobbyist for a foreign corporation also need to register under the Foreign Agents Registration Act?647
  • Q 19.20 : Has anyone ever been prosecuted for an LDA violation?647
  • Q 19.21 : Will my LDA reports be audited by GAO?647
  • Q 19.22 : What should an LDA compliance program include?648
  • Q 19.23 : Does the executive branch have any lobbying restrictions?649
  • Q 19.24 : Who is subject to the House and Senate gift and travel rules?651
    • Q 19.24.1 : Do other government entities have their own rules?651
    • Q 19.24.2 : Are House and Senate rules the same?651
    • Q 19.24.3 : How can a corporation obtain information about House and Senate rules?652
  • Q 19.25 : What House and Senate rules should a corporation be aware of?652
  • Q 19.26 : What is the gift rule?652
    • Q 19.26.1 : What is a “gift”?652
    • Q 19.26.2 : What gifts are acceptable?653
    • Q 19.26.3 : What are some relevant exceptions to the gift rule?653
    • Q 19.26.4 : May a lobbyist provide a gift?653
    • Q 19.26.5 : What is the “personal friendship” exception?653
    • Q 19.26.6 : What is the “widely attended event” exception to the gift rule?654
    • Q 19.26.7 : What is the “charitable event” exception?655
    • Q 19.26.8 : What is the “commemorative item” exception to the gift rule?655
    • Q 19.26.9 : What is the “food or drink of a nominal value” exception to the gift rule?655
  • Q 19.27 : What are the rules for travel?656
    • Q 19.27.1 : What is “officially connected” travel?656
    • Q 19.27.2 : What are “necessary expenses”?656
    • Q 19.27.3 : Who may pay for officially connected travel?657
    • Q 19.27.4 : What are the new rules for “One-Day Event Trips”?657
  • Q 19.28 : What are the House and Senate rules for travel on private aircraft?657
  • Q 19.29 : What do corporations need to know about state and local laws and regulations?658
  • Q 19.30 : What are pay-to-play laws?659
    • Q 19.30.1 : Does the federal government have pay-to-play laws?659
    • Q 19.30.2 : Which states have pay-to-play laws?660
    • Q 19.30.3 : Which localities have pay-to-play laws?660
    • Q 19.30.4 : Do any other entities have pay-to-play laws?661
  • Q 19.31 : How does pay-to-play disclosure work?661
  • Q 19.32 : What should a pay-to-play compliance program include?661
Chapter 20: Healthcare Organizations and Providers Lisa Sterneck ~ Holland & Knight LLP
Jonathan E. Anderman ~ Holland & Knight LLP
Reetu Dua ~ Holland & Knight LLC
  • Q 20.1 : Why do healthcare organizations need compliance and ethics programs?676
    • Q 20.1.1 : Are there financial incentives for having an effective compliance program?676
    • Q 20.1.2 : Is having an effective compliance program a guarantee that we won’t be investigated?677
    • Q 20.1.3 : How can I anticipate federal government enforcement actions?677
  • Q 20.2 : How do I begin to create a compliance and ethics program?678
    • Q 20.2.1 : What industries does the OIG guidance cover?678
    • Q 20.2.2 : What kind of resources/guidance does the OIG offer that might be of value?679
    • Q 20.2.3 : Is the OIG guidance mandatory?679
  • Q 20.3 : What makes a compliance program effective?680
    • Q 20.3.1 : What specific things does an effective compliance program need?680
    • Q 20.3.2 : What is the OIG’s role in investigations of healthcare organizations and providers?682
    • Q 20.3.3 : What are Corporate Integrity Agreements and Certification of Compliance Agreements?683
    • Q 20.3.4 : What new enforcement initiatives have come out of the current administration and the Congress?684
    • Q 20.3.5 : What additional enforcement provisions were included in healthcare reform legislation?685
  • Q 20.4 : In what areas might healthcare violations/investigations typically occur?686
  • Q 20.5 : What are the government sources of payment for healthcare services?686
    • Q 20.5.1 : What is Medicare?686
    • Q 20.5.2 : What is Medicaid?687
    • Q 20.5.3 : What are employee benefit programs?687
  • Q 20.6 : Which statutes and regulations govern the areas of healthcare typically subject to government investigation and enforcement?688
  • Q 20.7 : What is the False Claims Act?688
    • Q 20.7.1 : What constitutes a violation of the FCA?689
    • Q 20.7.2 : What are some risk areas under the FCA particular to healthcare entities?689
  • Q 20.8 : What is the federal anti-kickback statute?691
    • Q 20.8.1 : What does the federal anti-kickback statute mean by “remuneration”?691
    • Q 20.8.2 : How is “knowing and willfully” defined?691
    • Q 20.8.3 : What if there are other good purposes for the arrangement?692
    • Q 20.8.4 : What are the penalties for violating the AKS?692
    • Q 20.8.5 : Are there exceptions to the AKS?693
    • Q 20.8.6 : What are AKS safe harbors?693
    • Q 20.8.7 : How does a business arrangement qualify for safe-harbor protection?694
    • Q 20.8.8 : What is an OIG advisory opinion?695
  • Q 20.9 : What are the Stark rules and regulations?695
    • Q 20.9.1 : Can a party self-disclose actual or potential Stark violations?697
  • Q 20.10 : What is HIPAA?698
  • Q 20.11 : What is EMTALA?699
    • Q 20.11.1 : What are EMTALA’s key requirements?699
    • Q 20.11.2 : How is EMTALA enforced and what are the penalties for an EMTALA violation?700
  • Q 20.12 : What is the Deficit Reduction Act?700
    • Q 20.12.1 : Who may be affected by the DRA?700
    • Q 20.12.2 : What types of companies does the DRA apply to?701
    • Q 20.12.3 : What does the DRA require?701
    • Q 20.12.4 : Do the policies required by the DRA have to be on paper?702
    • Q 20.12.5 : What if my company does not have a document called an “employee handbook”? Do we need to create one?702
    • Q 20.12.6 : What are the penalties for noncompliance with the DRA?702
  • Q 20.13 : What is the HITECH Act?703
    • Q 20.13.1 : What are the rules and requirements of the HITECH Act?703
Chapter 21: Medicare Part D Jeffrey Mittleman ~ Holland & Knight LLP
Elizabeth Sanghavi ~ Holland & Knight LLP
Jonathan E. Anderman ~ Holland & Knight LLP
  • Q 21.1 : What is Medicare Part D?711
    • Q 21.1.1 : Is Medicare Part D mandatory?711
    • Q 21.1.2 : What benefits are provided under Part D?712
  • Q 21.2 : Why does my company need a compliance program for Medicare Part D?712
  • Q 21.3 : What is MIPPA and how does it impact Part D?712
  • Q 21.4 : Generally, what kinds of risks does a Medicare D compliance program aim to mitigate?713
  • Q 21.5 : How are pharmacies and manufacturers at risk of violating the AKS?713
  • Q 21.6 : What is a patient assistance program?714
    • Q 21.6.1 : What are the AKS implications associated with a manufacturer-affiliated PAP?714
    • Q 21.6.2 : What is TrOOP?714
    • Q 21.6.3 : What are the AKS implications for PAPs affiliated with independent charities?715
  • Q 21.7 : What are the AKS implications for PAPs operating outside of Part D?715
    • Q 21.7.1 : Do PAPs run any risk of violating the AKS by offering services to uninsured patients?716
  • Q 21.8 : How are waiver of coinsurance and deductible amounts regulated by the AKS?716
  • Q 21.9 : How can pharmacies offer free or discounted drugs without violating the AKS?717
  • Q 21.10 : How should pharmacies handle manufacturer rebates or other price concessions?717
  • Q 21.11 : What is co-branding?718
  • Q 21.12 : How does patient steering pose a risk?719
  • Q 21.13 : What is the electronic prescribing safe harbor?719
  • Q 21.14 : What is the electronic health records safe harbor?720
  • Q 21.15 : What is the waiver or reduction of cost-sharing exception to the AKS?721
  • Q 21.16 : What are the elements of an effective Medicare Part D compliance program?721
    • Q 21.16.1 : What should our written policies and procedures say?722
    • Q 21.16.2 : What requirements must be met to have an effective compliance officer and compliance committee?723
    • Q 21.16.3 : What do we need to do for training and education?723
    • Q 21.16.4 : How can we develop effective lines of communication between individuals involved with compliance?724
    • Q 21.16.5 : How do we enforce our compliance standards?724
    • Q 21.16.6 : How do we effectively monitor and audit our program?724
    • Q 21.16.7 : What should our fraud and abuse plan look like?724
    • Q 21.16.8 : Is self-reporting mandatory?725
  • Q 21.17 : Can compliance duties under a Part D contract be delegated?725
  • Q 21.18 : Can CMS audit plans?725
  • Q 21.19 : Has OIG audited plans?725
Chapter 22: Managed Care Organizations Jeffrey Mittleman ~ Holland & Knight LLP
Jonathan E. Anderman ~ Holland & Knight LLP
  • Q 22.1 : What are the areas of focus in monitoring MCOs for fraud and abuse?732
  • Q 22.2 : Do MCOs need to be concerned with fraud and abuse areas that do not involve under-utilization?734
  • Q 22.3 : What have states done to enforce regulations for MCOs?734
  • Q 22.4 : Why does our MCO need to adopt a compliance program?735
  • Q 22.5 : Can our MCO implement the same compliance program as an FFS plan?735
  • Q 22.6 : What are the CMS requirements for a compliance program?735
    • Q 22.6.1 : What is required of a compliance plan’s written policies, procedures, and standards?736
    • Q 22.6.2 : What are the functions of the compliance officer and committee?737
    • Q 22.6.3 : What kind of training should our MCO have?738
    • Q 22.6.4 : What is meant by “effective lines of communication”?738
    • Q 22.6.5 : What are the required procedures for internal monitoring and auditing?739
    • Q 22.6.6 : How should standards be enforced through disciplinary guidelines?739
    • Q 22.6.7 : What procedures for corrective action should an MCO implement?739
    • Q 22.6.8 : What specific requirements are there for MAPD plan compliance programs?740
  • Q 22.7 : What are the consequences of failing to comply with CMS’s mandates?740
  • Q 22.8 : Why should MCOs be concerned about the False Claims Act?740
  • Q 22.9 : Who, in a managed care context, can liability be imposed on?741
    • Q 22.9.1 : What is required for liability under the FCA?741
    • Q 22.9.2 : What penalties does the FCA provide for?741
  • Q 22.10 : What other statutes might pose liability issues for MCOs?741
  • Q 22.11 : How are MA MCOs vulnerable to false claims liability?742
  • Q 22.12 : What liability issues can an MCO face related to Physician Incentive Plans?742
  • Q 22.13 : What are CMS’s prompt payment requirements?743
    • Q 22.13.1 : What is a “clean” claim?743
    • Q 22.13.2 : What are potential consequences of failure to make prompt payments?743
  • Q 22.14 : When does denial or unavailability of care by an MCO constitute fraud and abuse?744
    • Q 22.14.1 : What are potential consequences for denial of care?744
  • Q 22.15 : What are Medicare MCOs required to do in their marketing practices?744
Chapter 23: Pharmaceutical and Medical Device Manufacturers Michael R Manthei ~ Holland & Knight LLP
Jenna C Phipps ~ Holland + Knight LLP
William F Gould ~ Holland & Knight LLP
Patrick C O'Brien ~ Holland & Knight LLP
  • Q 23.1 : What are the major risk areas in the pharmaceutical and medical device industry?752
  • Q 23.2 : What is labeling?752
    • Q 23.2.1 : What must a prescription drug label include?753
    • Q 23.2.2 : What must an over-the-counter drug label include?753
    • Q 23.2.3 : What must a medical device label include?754
    • Q 23.2.4 : What happens if labeling does not comply with FDA requirements?754
    • Q 23.2.5 : What are the potential consequences of noncompliance with label requirements?754
  • Q 23.3 : Generally speaking, how important is advertising/labeling compliance?755
  • Q 23.4 : What is “advertising”?755
    • Q 23.4.1 : What are prescription drug advertisements required to include?756
    • Q 23.4.2 : What is the “brief summary” of side effects, contraindications, and effectiveness?756
    • Q 23.4.3 : Must a broadcast advertisement contain the “brief summary” of side effects, contraindications, and effectiveness?757
    • Q 23.4.4 : What does the FDA consider true, balanced, and not-misleading advertising?757
    • Q 23.4.5 : Are there exceptions to these advertising requirements?758
    • Q 23.4.6 : Does the FDA pre-approve advertising?764
    • Q 23.4.7 : Is pre-approval of advertising ever mandatory?764
    • Q 23.4.8 : Must advertisements be filed with the FDA?765
    • Q 23.4.9 : What happens if drug/device advertising does not comply with FDA requirements?765
    • Q 23.4.10 : What are the possible consequences of a misbranding violation?766
  • Q 23.5 : What is meant by “off-label”?767
    • Q 23.5.1 : Is it illegal for a physician to prescribe a drug “off-label”?767
    • Q 23.5.2 : Is advertising or promotion of off-label uses permitted?767
    • Q 23.5.3 : How might off-label promotion constitute misbranding?768
    • Q 23.5.4 : How might off-label promotion constitute the introduction of an unapproved new drug?769
    • Q 23.5.5 : How does FDA determine the “intended use” of a regulated product?769
  • Q 23.6 : What laws and other guidance apply to the sale and marketing of pharmaceuticals and medical devices?770
    • Q 23.6.1 : How do the states regulate sales and marketing practices?771
  • Q 23.7 : What is the federal anti-kickback statute?772
    • Q 23.7.1 : What are some of the key risk areas implicating the AKS?772
    • Q 23.7.2 : What are the primary AKS considerations with regard to discounts?773
    • Q 23.7.3 : … product support services?773
    • Q 23.7.4 : … educational grants?773
    • Q 23.7.5 : … research or other charitable organizations?774
    • Q 23.7.6 : … equipment lease and storage agreements?775
    • Q 23.7.7 : … price reporting?775
    • Q 23.7.8 : … consultant training, education, and sales meetings?776
    • Q 23.7.9 : … gifts?776
    • Q 23.7.10 : … “switching arrangements”?776
    • Q 23.7.11 : … consulting arrangements?777
  • Q 23.8 : What is the federal False Claims Act?778
    • Q 23.8.1 : How does the marketing of drugs and devices implicate the False Claims Act?778
  • Q 23.9 : What is the Prescription Drug Marketing Act of 1987?778
    • Q 23.9.1 : Is it still permissible to provide free samples?779
  • Q 23.10 : What are the major compliance risks arising from the conduct of biomedical research?779
  • Q 23.11 : What rules and regulations govern conflicts of interest in clinical trials?779
  • Q 23.12 : What are the Public Health Service Rules?781
    • Q 23.12.1 : To whom do the PHS Rules apply?781
    • Q 23.12.2 : What do the PHS Rules require?781
    • Q 23.12.3 : What is a “significant financial interest” under the PHS Rules?782
    • Q 23.12.4 : What types of remuneration do not constitute a significant financial interest?782
    • Q 23.12.5 : Who is considered an “investigator” to whom the significant financial interest disclosure and other requirements apply under the PHS Rules?783
    • Q 23.12.6 : What are the responsibilities of the designated institutional official?783
    • Q 23.12.7 : What is a “conflict of interest” for purposes of the PHS Rules?783
    • Q 23.12.8 : What mechanisms are available to “manage” conflicts of interest as required by the PHS Rules?784
    • Q 23.12.9 : What are the consequences for failing to comply with the PHS Rules?784
    • Q 23.12.10 : Beyond suspension of funding or imposition of additional corrective action, what other consequences might there be for a failure to comply with the PHS Rules?785
  • Q 23.13 : What are the National Science Foundation requirements?786
    • Q 23.13.1 : To whom do the NSF requirements apply?786
  • Q 23.14 : What are the National Institutes of Health Guidelines?786
    • Q 23.14.1 : What are the main “considerations” for sponsored research agreements?787
  • Q 23.15 : What is the Bayh-Dole Act?787
    • Q 23.15.1 : What are the considerations for nonprofit grantees?788
    • Q 23.15.2 : What considerations require “heightened scrutiny”?789
  • Q 23.16 : What are the FDA Financial Disclosure Requirements?790
    • Q 23.16.1 : What is a “disclosable” financial arrangement?790
    • Q 23.16.2 : What are the obligations of the investigator?791
    • Q 23.16.3 : What factors will the FDA consider in assessing the potential of a disclosable financial interest to bias a study?791
    • Q 23.16.4 : What actions may the FDA take if it believes that the integrity of the research data may have been compromised by an investigator’s financial interest?791
  • Q 23.17 : What rules govern the protection of human subjects?792
    • Q 23.17.1 : What is the Common Rule?792
    • Q 23.17.2 : What are the FDA regulations concerning human-subject research?793
    • Q 23.17.3 : What are the HHS regulations concerning human-subject research?794
    • Q 23.17.4 : What is the ICH Guidance?794
    • Q 23.17.5 : What is the World Medical Association Declaration of Helsinki?795
  • Q 23.18 : What are the general requirements for informed consent?796
    • Q 23.18.1 : Are there exceptions to the informed consent requirements?797
    • Q 23.18.2 : What are the “emergency exceptions” to the FDA’s informed consent regulations?797
    • Q 23.18.3 : What are the exceptions to the Common Rule’s informed consent regulations?799
    • Q 23.18.4 : What are the membership requirements for IRBs?800
    • Q 23.18.5 : What are the operational requirements for IRBs?801
    • Q 23.18.6 : What are the criteria for IRB approval of research?802
    • Q 23.18.7 : What is “expedited review”?803
    • Q 23.18.8 : What is “minimal risk”?803
    • Q 23.18.9 : What is an “assurance of compliance” with the Common Rule?803
  • Q 23.19 : Is it appropriate to charge for investigational drugs?804
    • Q 23.19.1 : What is a “treatment IND”?804
    • Q 23.19.2 : Is it appropriate to charge for the study drug under a treatment IND?804
  • Q 23.20 : Will Medicare pay for the healthcare services given to Medicare beneficiaries participating in clinical trials?805
    • Q 23.20.1 : What does Medicare consider “routine costs”?806
    • Q 23.20.2 : What is a “qualifying” clinical trial?806
    • Q 23.20.3 : What types of clinical trials are deemed to automatically qualify for reimbursement of routine costs?807
    • Q 23.20.4 : Does Medicare cover the costs of treating complications arising from the study?808
Chapter 24: HIPAA Security and Privacy Shannon Hartsfield-Salimone ~ Holland + Knight LLP
  • Q 24.1 : Who must comply with HIPAA?817
    • Q 24.1.1 : What is meant by “health plan”?817
    • Q 24.1.2 : Are employers considered covered entities?817
    • Q 24.1.3 : What is a business associate?817
    • Q 24.1.4 : Does HIPAA apply to business associates?818
  • Q 24.2 : What is the Privacy Rule?819
    • Q 24.2.1 : What is PHI?819
    • Q 24.2.2 : How are use and disclosure of PHI restricted by the Privacy Rule?820
  • Q 24.3 : What is the Security Rule?820
    • Q 24.3.1 : What is considered ePHI?820
    • Q 24.3.2 : What are covered entities required to do under the Security Rule?820
  • Q 24.4 : As a covered entity or a business associate, where do we begin when approaching compliance measures?821
    • Q 24.4.1 : What does a risk analysis involve?821
    • Q 24.4.2 : Who is responsible for these compliance tasks?822
  • Q 24.5 : What are some of the key documents that a covered entity or business associate needs?822
  • Q 24.6 : As a covered entity, we implemented a compliance program when the Rules became effective back in 2003, so we’re all set; right?823
  • Q 24.7 : Do we need to be concerned about state law?824
  • Q 24.8 : As a covered entity, how should we handle subpoenas?824
  • Q 24.9 : What should happen if there is an improper disclosure?824
Chapter 25: Ethical Conduct in Banking and Finance Aaron Cohn ~ Holland & Knight LLP
Cameron G. Stout ~ Holland & Knight LLP
  • Q 25.1 : Why does my institution need a compliance and ethics program?835
    • Q 25.1.1 : What are the consequences of ethics breaches?835
  • Q 25.2 : What is compliance risk?835
    • Q 25.2.1 : What are the consequences of noncompliance?836
    • Q 25.2.2 : What is the difference between informal and formal sanctions?836
  • Q 25.3 : What is the best structure for a compliance and ethics program?837
    • Q 25.3.1 : What specific policies should banks adopt?838
  • Q 25.4 : What are some of the most important federal regulations to consider?839
    • Q 25.4.1 : What agencies regulate banks?839
    • Q 25.4.2 : Is a separate policy that covers each and every regulation required?840
    • Q 25.4.3 : Should policies for state laws and regulations also be included?843
  • Q 25.5 : How do nonbanking activities and affiliates fit into a compliance program?843
    • Q 25.5.1 : What kinds of special compliance considerations do affiliates raise?843
  • Q 25.6 : Are audits and examinations sufficient?845
    • Q 25.6.1 : How often should independent testing be done?845
    • Q 25.6.2 : What is the current emphasis in bank compliance?846
    • Q 25.6.3 : How can an institution remain current with the frequent, significant changes to the plethora of laws and regulations?846
    • Q 25.6.4 : What are the implications of Dodd-Frank on a financial institution’s compliance program?847
    • Q 25.6.5 : Who should keep track of all the legal, legislative, and regulatory developments?848
    • Q 25.6.6 : What is the value of immediate self-reporting and cooperation with regulators?848
    • Q 25.6.7 : How can employees be incentivized to embrace and fully participate in the firm’s compliance program?849
Chapter 26: Anti-Money Laundering Gregory Baldwin ~ Holland & Knight LLP
  • Q 26.1 : What are the goals of money laundering?857
    • Q 26.1.1 : How does money laundering work?857
    • Q 26.1.2 : What is placement?858
    • Q 26.1.3 : What is layering?858
    • Q 26.1.4 : What is integration?858
    • Q 26.1.5 : What forms aside from cash can funds for laundering take?859
  • Q 26.2 : What are the federal anti-money laundering statutes?859
    • Q 26.2.1 : To whom do these AML laws apply?860
  • Q 26.3 : What does the MLCA provide?861
    • Q 26.3.1 : What does “some form of unlawful activity” mean under the MLCA?861
    • Q 26.3.2 : What constitutes “knowledge” under the MLCA?862
    • Q 26.3.3 : What is a “specified unlawful activity” for purposes of the MLCA?862
    • Q 26.3.4 : What are “financial transactions”?863
    • Q 26.3.5 : What are “monetary instruments”?863
    • Q 26.3.6 : What are “financial institutions”?863
  • Q 26.4 : What does section 1956 of the MLCA prohibit?864
    • Q 26.4.1 : What is “transaction money laundering”?864
    • Q 26.4.2 : What is “transportation money laundering”?864
    • Q 26.4.3 : What are the prohibitions related to “sting” operations?865
    • Q 26.4.4 : What are the MLCA penalties for violation of section 1956?865
    • Q 26.4.5 : What extraterritorial jurisdiction does section 1956 of the MLCA have?866
  • Q 26.5 : What does section 1957 of the MLCA provide?867
    • Q 26.5.1 : What is a “monetary transaction”?867
    • Q 26.5.2 : What is “criminally derived property”?868
    • Q 26.5.3 : Does the government have extraterritorial jurisdiction to prosecute violations of section 1957 of the MLCA?868
    • Q 26.5.4 : What are the penalties for violations of section 1957 of the MLCA?868
  • Q 26.6 : What is the Bank Secrecy Act?868
    • Q 26.6.1 : To whom does the BSA apply?869
    • Q 26.6.2 : What is the definition of “financial institutions” for purposes of the BSA?869
  • Q 26.7 : Which financial institutions must implement AML compliance programs, and which are exempted?870
    • Q 26.7.1 : What are the general regulatory requirements for subject financial institutions?871
    • Q 26.7.2 : What are the BSA’s requirements for anti–money laundering programs?872
    • Q 26.7.3 : What is a “risk-based” anti-money laundering program?872
  • Q 26.8 : What are the BSA’s requirements regarding CIPs?872
  • Q 26.9 : What is a “suspicious transaction”?873
    • Q 26.9.1 : Who must report suspicious transactions?874
    • Q 26.9.2 : Doesn’t reporting a suspicious transaction expose me and/or my company to legal risk?875
    • Q 26.9.3 : What are the filing requirements for reports of suspicious transactions?875
  • Q 26.10 : What is “information sharing”?875
    • Q 26.10.1 : What is section 314(a) mandatory information sharing?876
    • Q 26.10.2 : Who is subject to section 314(a) mandatory information sharing?876
    • Q 26.10.3 : What must a financial institution do upon receipt of a section 314(a) mandatory information sharing request?876
    • Q 26.10.4 : Should a positive response to a section 314(a) mandatory information sharing request include records?878
    • Q 26.10.5 : Are section 314(a) mandatory information sharing requests and responses confidential?878
    • Q 26.10.6 : Should a section 314(a) mandatory information sharing request trigger the filing of a suspicious activity report if there is a positive match?878
    • Q 26.10.7 : What is section 314(b) voluntary information sharing?879
    • Q 26.10.8 : What information may be shared among financial institutions under section 314(b) voluntary information sharing?879
    • Q 26.10.9 : Who may share information under section 314(b)?879
    • Q 26.10.10 : How does one participate in section 314(b) voluntary information sharing?879
    • Q 26.10.11 : Who may information be shared with?880
    • Q 26.10.12 : Is information shared under 314(b) confidential?880
    • Q 26.10.13 : Should a section 314(b) voluntary information sharing request trigger the filing of a SAR?880
    • Q 26.10.14 : May a financial institution that shares information under section 314(b) be sued civilly by the subject of the information?880
  • Q 26.11 : Why does the government require large cash transactions to be reported?880
    • Q 26.11.1 : What forms are used to report large cash transactions?881
    • Q 26.11.2 : What are the requirements for filing a Currency Transaction Report (CTR)?881
    • Q 26.11.3 : What are the requirements for filing an IRS Form 8300?882
    • Q 26.11.4 : What constitutes “currency” for purposes of Form 8300?883
    • Q 26.11.5 : What is a reportable transaction?883
    • Q 26.11.6 : When are transactions considered “related”?884
    • Q 26.11.7 : How are multiple-payment transactions handled?884
  • Q 26.12 : What records must be made and kept under the BSA?884
  • Q 26.13 : What is “bulk cash smuggling”?886
    • Q 26.13.1 : What are the filing requirements for FinCEN Form 105?887
    • Q 26.13.2 : What are the consequences of bulk cash smuggling?887
    • Q 26.13.3 : For purposes of bulk cash smuggling, what are “currency” and “monetary instruments”?887
    • Q 26.13.4 : Are there any exceptions to this reporting requirement?888
  • Q 26.14 : What is structuring?888
    • Q 26.14.1 : What are the penalties for structuring violations?888
  • Q 26.15 : Who are the “specially designated persons” that federal AML statutes prohibit transactions with?889
    • Q 26.15.1 : Who is considered a “United States person”?889
  • Q 26.16 : What kinds of transactions with SDNs are prohibited?890
    • Q 26.16.1 : What are the consequences of conducting business with an SDN?890
  • Q 26.17 : What are the AML requirements for Money Services Businesses?890
  • Q 26.18 : What are the AML requirements for foreign Money Services Businesses?891
  • Q 26.19 : Why should my company care about having an anti-money laundering compliance program?892
    • Q 26.19.1 : Our institution is currently exempted from anti–money laundering compliance program requirements. How can we keep track of changing regulations should our status change?893
    • Q 26.19.2 : What are the elements of an effective anti-money laundering compliance program?894
    • Q 26.19.3 : What are the key considerations in appointing a compliance officer?895
    • Q 26.19.4 : What are the key considerations when approaching employee training?895
    • Q 26.19.5 : What are the key considerations regarding independent audits?896
    • Q 26.19.6 : How can we confirm a customer’s identity?897
    • Q 26.19.7 : What if verifying a customer’s identity is not possible?897
    • Q 26.19.8 : What are the actual steps a company must take to create an effective anti-money laundering compliance program?898
    • Q 26.19.9 : What is the relationship between a compliance program under the U.S. Sentencing Guidelines and an anti-money laundering compliance program?899
    • Q 26.19.10 : Is there a standard anti-money laundering compliance program that my company can effectively use?900
    • Q 26.19.11 : How do we go about designing an anti-money laundering compliance program?900
    • Q 26.19.12 : What are the basic considerations for the ongoing administration and enforcement of an anti-money laundering compliance program?903
    • Q 26.19.13 : Who should administer the anti-money laundering compliance program?904
    • Q 26.19.14 : What role does top management have in administering the program?904
Chapter 27: The Troubled Asset Relief Program Tom Morante ~ Holland & Knight LLP
Michelle T. Hess ~ Holland & Knight LLP
  • Q 27.1 : What is TARP?917
  • Q 27.2 : What are the TARP programs?917
    • Q 27.2.1 : What is the Capital Purchase Program?917
    • Q 27.2.2 : … Capital Assistance Program?918
    • Q 27.2.3 : … Investment in AIG Program?918
    • Q 27.2.4 : … Targeted Investment Program?918
    • Q 27.2.5 : … Asset Guarantee Program?919
    • Q 27.2.6 : … Term Asset-Backed Securities Loan Facility?919
    • Q 27.2.7 : … Public-Private Investment Program?919
    • Q 27.2.8 : … SBA 7(a) Securities Purchase Program?920
    • Q 27.2.9 : … Automotive Industry Financing Program?920
    • Q 27.2.10 : … Auto Supplier Support Program?920
    • Q 27.2.11 : … Auto Warranty Commitment Program?921
    • Q 27.2.12 : … Making Home Affordable Program?921
  • Q 27.3 : Who oversees the EESA and, as a result, monitors TARP funding?921
    • Q 27.3.1 : What are the oversight and enforcement responsibilities of the Financial Stability Oversight Board?922
    • Q 27.3.2 : … Office of the Special Investigator General TARP?922
    • Q 27.3.3 : … Congressional Oversight Panel?922
    • Q 27.3.4 : … Government Accountability Office?923
  • Q 27.4 : What legal, compliance, and enforcement risks does a company face by participating in TARP?923
  • Q 27.5 : What is the best way for my organization to manage the risks associated with participating in TARP?924
Chapter 28: Sarbanes-Oxley Act of 2002 Richard T Williams ~ Holland & Knight
Jerome Hoffman ~ Holland & Knight
  • Q 28.1 : To whom does SOX apply?933
  • Q 28.2 : Which companies are “issuers”?934
  • Q 28.3 : Generally, what does SOX require?934
  • Q 28.4 : What should a company put in its code of ethics?934
    • Q 28.4.1 : What does a company do with its code of ethics once it is adopted by the board?935
  • Q 28.5 : How does SOX affect boards of directors?935
    • Q 28.5.1 : Do boards have to act in a manner different from the way they did before SOX?936
  • Q 28.6 : What does an audit committee do?936
    • Q 28.6.1 : How does SOX affect the make-up of the audit committee?936
    • Q 28.6.2 : What if no one in the company is an independent financial expert?937
    • Q 28.6.3 : Does SOX change the audit committee’s responsibilities?937
  • Q 28.7 : What are the new requirements for officers and directors?938
  • Q 28.8 : What are the SEC’s penalties for officers and directors if they violate SOX?938
    • Q 28.8.1 : Do officers and directors face any penalties beyond those imposed by the SEC?938
    • Q 28.8.2 : Have the SEC and law enforcement actually used these new powers?939
  • Q 28.9 : Are violations of SOX by officers and directors generally covered by liability insurance?939
    • Q 28.9.1 : Other than insurers, who else is concerned with the effect SOX could have on officers and directors?939
  • Q 28.10 : How does SOX protect whistleblowers?940
    • Q 28.10.1 : What does a whistleblower employee need to show to prove that the company is taking retaliatory action against him or her?940
    • Q 28.10.2 : What procedures should be in place to help stave off successful legal action by whisteblowers?940
    • Q 28.10.3 : What should the company do once a complaint is filed?941
    • Q 28.10.4 : What happens if the whistleblower wins the case?942
    • Q 28.10.5 : Are there any repercussions beyond what is owed to the whistleblower?942
    • Q 28.10.6 : Do states have similar protections for whistleblowers?942
  • Q 28.11 : The landscape has changed for public companies, but what about for accounting firms?942
  • Q 28.12 : Has SOX affected the relationship between the companies and auditors?943
    • Q 28.12.1 : What about “one-stop shopping” for financial and accounting services?943
  • Q 28.13 : What is the relationship between the audit committees and the auditors?944
    • Q 28.13.1 : Can a company keep using audit partners with whom it has an established relationship?944
  • Q 28.14 : What are new procedures that auditors must follow?944
  • Q 28.15 : What powers does the PCAOB have over the auditors?946
    • Q 28.15.1 : What can the PCAOB do if it uncovers a violation?946
    • Q 28.15.2 : How have the new PCAOB rules changed audits?946
  • Q 28.16 : What effect does SOX have on foreign auditors?947
    • Q 28.16.1 : What if a U.S. accounting firm relies in part upon a foreign accounting firm?947
  • Q 28.17 : How does SOX affect lawyers for issuers?947
    • Q 28.17.1 : What responsibilities does the SEC impose upon lawyers under SOX?948
    • Q 28.17.2 : Which lawyers are affected by SOX?948
    • Q 28.17.3 : Are there any limitations on the applicability of the SEC rules on attorney conduct?949
  • Q 28.18 : What is “up-the-ladder” reporting?949
    • Q 28.18.1 : Do the requirements depend on whether the attorney is in a supervisory position?949
    • Q 28.18.2 : What if an attorney has reason to believe that reporting to the CEO or CLO would be futile?950
    • Q 28.18.3 : How do these requirements apply to outside counsel?950
  • Q 28.19 : Who is a “supervisory attorney”?950
  • Q 28.20 : Who is a “subordinate attorney”?950
    • Q 28.20.1 : As long as there is an attorney above you on the chain, are you a subordinate attorney?951
    • Q 28.20.2 : Are the definitions of supervisory and subordinate attorney static?951
  • Q 28.21 : What do SOX and the SEC require of a lawyer?951
    • Q 28.21.1 : How does this affect the attorney-client relationship?952
    • Q 28.21.2 : What sanctions are there for violations by an attorney of the SEC rules under SOX?952
  • Q 28.22 : What does “becoming aware of credible evidence” actually mean?952
    • Q 28.22.1 : How should companies define “credible evidence”?953
  • Q 28.23 : What constitutes a “material violation”?953
  • Q 28.24 : At what stage must a future possible violation be reported?954
  • Q 28.25 : What is a qualified legal compliance committee (QLCC)?954
    • Q 28.25.1 : How is a QLCC established?954
    • Q 28.25.2 : How does the QLCC operate?955
  • Q 28.26 : What steps must a CLO take when presented with a report of evidence of material violation?955
    • Q 28.26.1 : What kind of paper trail should the inquiry have?956
    • Q 28.26.2 : What would be considered an “appropriate response”?956
    • Q 28.26.3 : How does a reporting attorney determine whether the response was appropriate?956
    • Q 28.26.4 : What does a reporting attorney do after the company has responded?957
    • Q 28.26.5 : In the absence of an appropriate response to a report of a material violation, what should a conscientious counsel do?957
    • Q 28.26.6 : What options do lawyers currently have when a SOX violation may be occurring?957
  • Q 28.27 : Does SOX also apply to foreign lawyers?957
  • Q 28.28 : How do the SEC rules compare with American Bar Association and state rules?958
    • Q 28.28.1 : What is the difference between the SEC and ABA and state rules?958
    • Q 28.28.2 : What is the relationship between the SEC and state rules?959
  • Q 28.29 : How should law firms and lawyers adjust to the new standards?959
    • Q 28.29.1 : What should the training entail?959
  • Q 28.30 : Has the SEC punished lawyers for misconduct?960
    • Q 28.30.1 : How has the SEC punished lawyers?960
  • Q 28.31 : How do the new SEC rules affect insurance for lawyers?960
  • Q 28.32 : What should the role of the general counsel be in the new environment?961
    • Q 28.32.1 : How have the SEC rules changed the relations among general counsel, directors, and management?961
    • Q 28.32.2 : How does the new environment affect the CEO vis à vis the general counsel?962
    • Q 28.32.3 : How has SOX changed the role of the general counsel?962
    • Q 28.32.4 : What new tasks does the general counsel have under SOX?962
    • Q 28.32.5 : How do the new SOX requirements interact with the need to protect privileged communications?963
    • Q 28.32.6 : What organizational steps and tools are out there to assist the general counsel?964
    • Q 28.32.7 : How does a general counsel determine the best interests of the corporation?965
  • Q 28.33 : What factors are relevant to the SEC in the course of an investigation?966
    • Q 28.33.1 : Has the SEC indicated the areas of greatest concern?968
    • Q 28.33.2 : What are the biggest obstacles to cooperation?968
  • Q 28.34 : What are SOX’s certification requirements?969
    • Q 28.34.1 : What must the SOX section 906 certificate contain?969
    • Q 28.34.2 : What is the test for liability under the financial certificate requirements?970
    • Q 28.34.3 : What else must the CEO and CFO do under SOX section 302?970
    • Q 28.34.4 : What must the CEO and CFO actually certify under SOX section 302?970
    • Q 28.34.5 : Does the CEO have to sign the company’s federal tax returns?971
    • Q 28.34.6 : What should the CEO and CFO do prior to certifying a report under SOX?972
  • Q 28.35 : What is non-GAAP reporting?973
    • Q 28.35.1 : How must a company report a non-GAAP financial measure?973
  • Q 28.36 : What enforcement action can the SEC take upon discovery of false certifications?974
  • Q 28.37 : What internal controls does SOX require?974
    • Q 28.37.1 : What is the scope of internal controls over financial reporting?975
    • Q 28.37.2 : What are the elements and scope of internal controls?976
    • Q 28.37.3 : Is there a specified process for designing, monitoring, or testing internal controls?976
    • Q 28.37.4 : What can be expected from internal controls?976
    • Q 28.37.5 : What is a “reasonable assurance”?976
    • Q 28.37.6 : Whose responsibility is it to design and develop internal controls?977
    • Q 28.37.7 : How do auditors advise on internal controls without violating the stringent requirements of auditor independence?977
    • Q 28.37.8 : What are the processes for developing internal controls for financial reporting?977
  • Q 28.38 : What areas of financial reporting appear to be most vulnerable to manipulation?978
    • Q 28.38.1 : What aspects of revenue recognition should be considered in particular?978
    • Q 28.38.2 : What aspects of expense accounting should be considered in particular?979
    • Q 28.38.3 : What aspects of asset valuations should be considered in particular?980
    • Q 28.38.4 : What aspects of contingent liability valuations should particularly be considered?980
    • Q 28.38.5 : What aspects of special-purpose entities should particularly be considered?980
    • Q 28.38.6 : How should companies document internal controls?981
    • Q 28.38.7 : What else is management required to do beyond developing, documenting, putting into operation, and using internal controls?981
    • Q 28.38.8 : What should management use to assess their internal controls?982
  • Q 28.39 : What are the auditing standards?982
    • Q 28.39.1 : What should testing encompass?983
    • Q 28.39.2 : What other inquiries should be made?983
  • Q 28.40 : What should management do if it finds problems with the internal controls?984
    • Q 28.40.1 : What is a “control deficiency”?984
    • Q 28.40.2 : What is a “significant deficiency”?984
    • Q 28.40.3 : What is a “material weakness”?985
    • Q 28.40.4 : What factors should be considered in categorizing a shortcoming?985
    • Q 28.40.5 : What kinds of deficiencies are least likely to be considered significant?986
    • Q 28.40.6 : What kinds of deficiencies are likely to be considered material?987
    • Q 28.40.7 : What should accompany the disclosure of material weaknesses?987
  • Q 28.41 : What is the PCAOB’s auditing standard?987
    • Q 28.41.1 : How important is documentation to an audit?988
  • Q 28.42 : What is the proper standard for documentation?988
    • Q 28.42.1 : What are the relevant subjects for which management’s records should be retained?989
  • Q 28.43 : What should a company do to sustain SOX compliance?989
    • Q 28.43.1 : What specific expectations does the SEC have regarding companies’ ongoing compliance efforts?990
    • Q 28.43.2 : What approach should a company take to achieve “optimization”?991
    • Q 28.43.3 : What is the advantage of a top-down approach?991
    • Q 28.43.4 : What can a company use to augment the top–down approach?991
    • Q 28.43.5 : What kinds of risk analysis should be used?992
  • Q 28.44 : What are disclosure controls?992
    • Q 28.44.1 : What are the certification requirements related to disclosure controls?992
    • Q 28.44.2 : What exactly must the CEO and CFO certify about the disclosure controls?993
    • Q 28.44.3 : What is the purpose of disclosure controls?993
    • Q 28.44.4 : Is the procedure for disclosure important?994
    • Q 28.44.5 : What should the disclosure contain?994
    • Q 28.44.6 : How should a company handle disclosure?994
    • Q 28.44.7 : What should the disclosure controls consist of?995
    • Q 28.44.8 : How should a company sustain and enhance disclosure controls and enterprise risk management?995
  • Q 28.45 : How has SOX enhanced the powers of the SEC?996
    • Q 28.45.1 : How much has the SEC grown under SOX?996
    • Q 28.45.2 : How has the increased budget affected enforcement?997
    • Q 28.45.3 : Has the SEC expanded into any new areas?997
  • Q 28.46 : Are there any express private rights of action under SOX?998
    • Q 28.46.1 : Did SOX enhance any existing private rights of action?999
    • Q 28.46.2 : Does SOX have any effect on private 10b–5 litigation?999
    • Q 28.46.3 : Does SOX create a private right under which investors can file claims against the issuer’s attorneys?1000
  • Q 28.47 : What are the SOX penalty provisions that apply to also-private companies?1000
  • Q 28.48 : What are the SOX record retention requirements that apply to all companies and persons?1001
  • Q 28.49 : What are SOX’s requirements for ERISA and notice of pension-fund blackout periods?1001
  • Q 28.50 : Does SOX apply to almost-public companies?1001
    • Q 28.50.1 : How does SOX affect almost-public companies?1002
  • Q 28.51 : Does SOX cover non-public banks?1002
  • Q 28.52 : Does SOX affect non-public insurance companies?1002
  • Q 28.53 : What problems has SOX caused for international companies?1003
    • Q 28.53.1 : Has the EU responded to SOX with a law of its own?1003
    • Q 28.53.2 : How has the EU coped with SOX?1004
    • Q 28.53.3 : Is there any hope for a convergence of EU and SEC standards?1004
  • Q 28.54 : How are non-profit governmental organizations treated under SOX?1005
  • Q 28.55 : Does SOX apply to colleges and universities?1005
Chapter 29: The Law and Accounting: The Convergence of Sarbanes-Oxley, COSO, the Federal Sentencing Guidelines, and Caremark Duties James D Wing ~ Holland & Knight LLP
  • Q 29.1 : Is the Sarbanes-Oxley Act of 2002 (SOX) primarily aimed at improving corporate governance and legal compliance?1012
    • Q 29.1.1 : How did SOX try to accomplish its goal?1012
    • Q 29.1.2 : What prompted Congress to act?1013
    • Q 29.1.3 : What was the precise mechanism Congress used?1013
  • Q 29.2 : What is COSO?1014
    • Q 29.2.1 : Does the COSO report relate only to details of financial reporting and concepts of accounting?1014
    • Q 29.2.2 : Have there been any subsequent developments since the first COSO report?1015
    • Q 29.2.3 : Is COSO II mandated by law?1016
    • Q 29.2.4 : What does COSO II’s integrated framework recommend?1016
    • Q 29.2.5 : What are the specific components of COSO II?1016
    • Q 29.2.6 : What other principles guide risk management?1017
  • Q 29.3 : Are these principles exclusively applicable to public companies, or do they have broader implications?1017
    • Q 29.3.1 : Isn’t there a massive political reaction against this, particularly given the huge cost to companies for instituting these programs?1018
  • Q 29.4 : Has the financial collapse of 2007–2008 interrupted recent developments in audits and compliance?1019
Chapter 30: SEC Investigations of Public Companies Mitchell Herr ~ Holland and Knight LLP
  • Q 30.1 : What does the SEC investigate?1023
    • Q 30.1.1 : What individuals are subject to investigation?1023
    • Q 30.1.2 : Who at the SEC is responsible for conducting investigations?1024
    • Q 30.1.3 : What triggers an SEC investigation?1025
    • Q 30.1.4 : What is the difference between a “preliminary” investigation and a “formal” investigation?1026
    • Q 30.1.5 : Are all SEC investigations private?1027
  • Q 30.2 : What are a company’s obligations to its SEC defense counsel?1027
  • Q 30.3 : What role does cooperation play in SEC enforcement investigations?1028
  • Q 30.4 : What are the potential benefits of cooperation with the SEC?1029
  • Q 30.5 : What are the potential benefits to an individual of cooperation with the SEC?1030
    • Q 30.5.1 : What is a proffer agreement?1031
    • Q 30.5.2 : … a cooperation agreement?1031
    • Q 30.5.3 : … a deferred prosecution agreement?1032
    • Q 30.5.4 : … a non-prosecution agreement?1032
    • Q 30.5.5 : … an immunity request?1032
  • Q 30.6 : Does the SEC coordinate investigations with other law enforcement authorities?1035
    • Q 30.6.1 : Do parallel civil and criminal investigations present additional risks?1036
    • Q 30.6.2 : Must the government disclose that there are parallel civil and criminal investigations?1037
    • Q 30.6.3 : Will both the criminal and civil proceedings proceed simultaneously?1038
  • Q 30.7 : Can we rely on directors’ and officers’ policies to cover the costs of responding to an SEC investigation?1039
    • Q 30.7.1 : What kinds of expenses related to an enforcement action might not be covered by a D&O policy?1040
    • Q 30.7.2 : What other D&O policy issues/considerations are raised by SEC investigations?1040
    • Q 30.7.3 : How can we mitigate the risks of rescission of our D&O policy?1041
  • Q 30.8 : How is an SEC investigation conducted?1041
    • Q 30.8.1 : Has the SEC disclosed how it conducts its investigations?1042
  • Q 30.9 : What are a company’s obligations regarding documents?1043
    • Q 30.9.1 : Are there special considerations for preserving electronic documents?1043
    • Q 30.9.2 : What are the consequences of inadequate document preservation?1044
    • Q 30.9.3 : What can our company do to make sure that it meets its preservation obligations?1044
    • Q 30.9.4 : Should we preserve everything or only those documents we think the SEC will want produced?1045
  • Q 30.10 : What can we expect from the document request process?1046
  • Q 30.11 : Can we negotiate with the SEC about our document production?1048
  • Q 30.12 : What are the advantages of hiring an outside e–discovery vendor?1048
  • Q 30.13 : Why is the question of selective disclosure of information in SEC investigations important?1049
  • Q 30.14 : Can privileged information be selectively disclosed to the SEC?1049
    • Q 30.14.1 : What is the outlook for selective disclosure?1050
    • Q 30.14.2 : Should we consider disclosing privileged information?1051
  • Q 30.15 : From whom is sworn testimony likely to be requested?1051
    • Q 30.15.1 : Should witnesses speak informally with SEC enforcement staff?1052
  • Q 30.16 : How should we respond after a request for sworn witness testimony has been made?1053
  • Q 30.17 : What can we expect from an SEC witness examination?1053
  • Q 30.18 : What rights do witnesses have?1053
    • Q 30.18.1 : Can a witness refuse to testify?1054
    • Q 30.18.2 : What are some important considerations in deciding whether or not to refuse to testify?1054
    • Q 30.18.3 : What is a witness’s counsel permitted to do during an examination?1054
  • Q 30.19 : What other important considerations should we keep in mind when anticipating a witness examination?1055
  • Q 30.20 : Should the same counsel represent the company and its employees?1055
    • Q 30.20.1 : What are the advantages of using the same counsel?1055
    • Q 30.20.2 : Are there any limitations or provisions to using the same counsel?1056
  • Q 30.21 : What if an employee decides to retain separate personal counsel?1056
  • Q 30.22 : What are the opportunities for informal advocacy during the investigation?1057
  • Q 30.23 : What is a Wells Notice?1058
  • Q 30.24 : What is a Wells Submission?1058
    • Q 30.24.1 : Should a Wells Submission automatically follow a Wells Notice?1059
  • Q 30.25 : What kind of charges can the SEC bring?1059
  • Q 30.26 : What remedies can the SEC obtain against a company?1060
    • Q 30.26.1 : How large are civil monetary penalties?1060
    • Q 30.26.2 : What factors does the SEC consider in deciding on whether or not to assess a penalty on a company?1062
    • Q 30.26.3 : Does the SEC ever seek other remedies?1064
  • Q 30.27 : What remedies can the SEC seek against directors and officers?1064
    • Q 30.27.1 : What monetary penalties can the SEC seek against directors and officers?1065
    • Q 30.27.2 : What other kinds of relief can the SEC seek against directors and officers?1065
  • Q 30.28 : How does the SEC approach settlements?1067
Chapter 31: Executive Compensation Robert J Friedman ~ Holland & Knight LLP
Richard Hindlian ~ Holland & Knight LLP
David G O'Leary ~ Holland & Knight LLC
  • Q 31.1 : How do employers generally provide and document executive compensation arrangements?1079
  • Q 31.2 : What types of compensation are usually provided by an employment agreement?1079
    • Q 31.2.1 : What types of compensation are generally provided by a “plan”?1079
    • Q 31.2.2 : What types of compensation arrangements are not considered “plans”?1080
    • Q 31.2.3 : What is severance pay?1081
    • Q 31.2.4 : What is a change-in-control agreement or plan?1081
  • Q 31.3 : What are the general rules that apply to taxation of executive compensation?1082
    • Q 31.3.1 : What are gross-up covenants?1083
    • Q 31.3.2 : What is an incentive stock option (ISO)?1084
    • Q 31.3.3 : What is the AMT?1085
    • Q 31.3.4 : How should an executive prepare for the AMT?1085
  • Q 31.4 : What is the general rule for the taxation of non-qualified deferred compensation?1086
    • Q 31.4.1 : Does a rabbi trust affect the treatment of a deferred compensation plan under the Code or ERISA?1086
    • Q 31.4.2 : How does Code section 83, concerning transfers of property as compensation for services, affect executive compensation?1086
    • Q 31.4.3 : How does Code section 422, concerning ISOs, affect executive compensation?1087
    • Q 31.4.4 : What are the general tax rules for non-qualified stock options?1088
    • Q 31.4.5 : Are there adverse tax consequences from mispriced stock options?1088
  • Q 31.5 : What is deferred compensation?1089
  • Q 31.6 : What are the general attributes of a non–qualified deferred compensation plan?1090
    • Q 31.6.1 : What types of non-qualified deferred compensation plans are there?1090
    • Q 31.6.2 : How does an excess plan work?1090
    • Q 31.6.3 : Are there any requirements with respect to SERP?1091
    • Q 31.6.4 : What is a select group of management and highly compensated employees?1091
    • Q 31.6.5 : May a deferred compensation plan be funded?1092
    • Q 31.6.6 : What is split-dollar insurance?1093
    • Q 31.6.7 : How is split-dollar insurance taxed?1093
  • Q 31.7 : What rules does Code section 409A impose?1093
    • Q 31.7.1 : What is a non-qualified deferred compensation plan for purposes of Code section 409A?1094
    • Q 31.7.2 : What is a deferral of compensation?1094
    • Q 31.7.3 : What is a “service provider”?1095
    • Q 31.7.4 : What is a “service recipient”?1095
    • Q 31.7.5 : Which non-qualified deferred compensation plans are subject to Code section 409A?1095
  • Q 31.8 : What types of plans and arrangements are generally exempt from the requirements of Code section 409A?1096
    • Q 31.8.1 : What are short-term deferrals?1096
    • Q 31.8.2 : What are statutory stock options and employee stock purchase plans?1097
    • Q 31.8.3 : What non-statutory stock options are exempt from the section 409A requirements?1097
    • Q 31.8.4 : What kinds of stock appreciation rights are exempt from the section 409A requirements?1097
    • Q 31.8.5 : What are restricted property and stock plans covered by Code section 83?1098
    • Q 31.8.6 : What are qualified employer plans?1098
    • Q 31.8.7 : What are welfare benefit plans and arrangements?1098
    • Q 31.8.8 : What kinds of foreign plans are exempt from the section 409A requirements?1099
    • Q 31.8.9 : What kinds of severance payments are exempt from section 409A requirements?1099
    • Q 31.8.10 : What happens if the service provider uses the accrual method of accounting?1099
    • Q 31.8.11 : What if the service provider is actively engaged in the trade or business of providing substantial services?1099
    • Q 31.8.12 : Why is fair market value of stock important and how is it determined?1100
    • Q 31.8.13 : If a deferred compensation plan or arrangement is not exempt from section 409A, what restrictions are necessary to prevent immediate taxation to the service provider?1101
    • Q 31.8.14 : What constitutes a “substantial risk of forfeiture”?1101
    • Q 31.8.15 : If there is no substantial risk of forfeiture, what requirements must be satisfied?1101
    • Q 31.8.16 : Does section 409A restrict the time and form of payments of deferred compensation?1102
  • Q 31.9 : What are permitted “distributable events” under Code section 409A?1102
    • Q 31.9.1 : When has an employee separated from service?1102
    • Q 31.9.2 : When is a service recipient considered disabled?1103
    • Q 31.9.3 : What are the requirements for specified-time or fixed-schedule payments?1103
    • Q 31.9.4 : What constitutes a change in control?1103
    • Q 31.9.5 : How is an “unforeseeable emergency” defined?1103
  • Q 31.10 : When can deferred compensation be paid?1104
    • Q 31.10.1 : When must payments to key employees of a public company be delayed?1104
    • Q 31.10.2 : Under what conditions may a plan permit the acceleration of the time or schedule of any payments under the plan?1105
    • Q 31.10.3 : Under what circumstances can payments be delayed?1105
    • Q 31.10.4 : Does section 409A provide rules affecting initial and subsequent deferral elections?1106
    • Q 31.10.5 : When must an initial deferral election be made?1106
    • Q 31.10.6 : What are the special rules for an initial deferral election related to performance-based compensation?1106
    • Q 31.10.7 : What is the effect of changes to an existing election?1106
    • Q 31.10.8 : What effects does Code section 409A have on the use of rabbi trusts?1107
  • Q 31.11 : What are the penalties for failure to comply with Code section 409A?1107
    • Q 31.11.1 : What are the reporting requirements?1108
    • Q 31.11.2 : What is the effective date of Code section 409A?1108
    • Q 31.11.3 : What is a “material modification” of a plan?1109
    • Q 31.11.4 : What relief from section 409A violations can be sought under the IRS “Voluntary Compliance Program”?1109
  • Q 31.12 : Are there any special rules that apply to offshore non-qualified deferred compensation plans?1110
    • Q 31.12.1 : What is a “nonqualified deferred compensation plan” under section 457?1110
    • Q 31.12.2 : What is a “nonqualified entity”?1110
    • Q 31.12.3 : What is a substantial risk of forfeiture?1111
    • Q 31.12.4 : What rules does section 457A impose?1111
    • Q 31.12.5 : Are there any exceptions to the requirements of section 457A?1112
  • Q 31.13 : What are golden parachute payments?1112
    • Q 31.13.1 : What types of payments are considered parachute payments?1112
    • Q 31.13.2 : What types of payments are exempt?1113
    • Q 31.13.3 : What are “excess parachute payments”?1113
    • Q 31.13.4 : What is an executive’s “base amount”?1113
    • Q 31.13.5 : Which executives are “disqualified individuals”?1114
    • Q 31.13.6 : What are “payments in the nature of compensation”?1114
    • Q 31.13.7 : What payments are considered “contingent on a change in ownership or control”?1114
    • Q 31.13.8 : Is there a minimum “threshold” for change-in-control payments to be considered excess parachute payments?1115
    • Q 31.13.9 : How are excess parachute payments taxed?1115
  • Q 31.14 : What are the advantages of equity-based compensation?1115
    • Q 31.14.1 : What are the different types of equity compensation plans?1116
    • Q 31.14.2 : Do equity awards have to be issued pursuant to a plan?1116
    • Q 31.14.3 : What are the main differences between granting an ISO and a non-qualified stock option?1116
    • Q 31.14.4 : What are the rules with respect to ISOs?1117
    • Q 31.14.5 : What are the rules with respect to non–qualified options?1117
    • Q 31.14.6 : What is a grant of restricted stock?1117
    • Q 31.14.7 : What is a stock appreciation right (SAR) and how do SARs work?1117
    • Q 31.14.8 : What is phantom stock?1118
    • Q 31.14.9 : Can a company reissue stock options if the price goes down?1118
    • Q 31.14.10 : What are the concerns about backdated stock options?1119
  • Q 31.15 : What are the general rules about accounting for options?1120
    • Q 31.15.1 : How are SARs and phantom stock accounted for?1121
  • Q 31.16 : What kinds of obligations and limits do the securities laws place upon companies and executives?1121
    • Q 31.16.1 : How do the SEC’s 2006 Proxy Disclosure Rules affect the company’s disclosure obligations with respect to executive compensation?1122
    • Q 31.16.2 : Are there special rules for small business issuers?1122
    • Q 31.16.3 : Are there other classes of companies that are subject to special disclosure rules?1123
    • Q 31.16.4 : What is the Compensation Discussion and Analysis?1123
    • Q 31.16.5 : What period does the CDA cover?1125
    • Q 31.16.6 : Which executives are covered by the Proxy Disclosure Rules?1125
    • Q 31.16.7 : What if compensation policies differ among the NEOs?1125
    • Q 31.16.8 : What if performance targets/goals contain sensitive information?1126
    • Q 31.16.9 : What are the “tabular disclosures” that must accompany the CDA?1126
    • Q 31.16.10 : Are narratives required with respect to the tabular disclosures?1126
    • Q 31.16.11 : What is a perquisite or personal benefit?1127
    • Q 31.16.12 : Must perquisites and personal benefits be disclosed?1127
    • Q 31.16.13 : What disclosures are required for grants of stock options and stock appreciation rights?1127
    • Q 31.16.14 : What disclosures are required for director compensation?1129
    • Q 31.16.15 : Are there other SEC-required disclosure rules that relate to executives and directors?1129
    • Q 31.16.16 : What are the disclosure requirements regarding related-party transactions?1129
    • Q 31.16.17 : What are the disclosure requirements regarding other corporate governance matters?1130
    • Q 31.16.18 : Are company disclosures required to include a Compensation Committee Report?1130
    • Q 31.16.19 : Do the CEO and CFO certifications apply to the CDA and the CCR?1131
  • Q 31.17 : For purposes of registration requirements under the Securities Act of 1933, what is a “security”?1131
    • Q 31.17.1 : Is an interest in a non-qualified deferred compensation plan treated as a “security” under federal securities law?1131
    • Q 31.17.2 : When might a participant’s interest in a NQDC plan be treated as a “security” under federal securities law?1132
    • Q 31.17.3 : Does the Securities Act of 1933 require registration of sales of stock in connection with employee stock plans?1133
    • Q 31.17.4 : Does the Securities Exchange Act of 1934 require registration of sales of stock in connection with employee stock plans?1133
  • Q 31.18 : Are there any exemptions from the registration requirements of the Securities Act of 1933 that apply to interests in a NQDC plan or the stock sold to a participant in connection with an employee stock plan?1133
    • Q 31.18.1 : What form should be used to register interests in NQDC plans and the stock sold pursuant to employee stock plans?1134
    • Q 31.18.2 : If a NQDC plan or employee stock plan is registered, what disclosures must be made to plan participants?1135
    • Q 31.18.3 : If a NQDC plan or employee stock plan is not registered, are there any disclosure requirements?1135
    • Q 31.18.4 : Do the anti-fraud provisions of federal securities law apply to disclosures in connection with NQDC plans and employee stock plans?1135
    • Q 31.18.5 : Are there other disclosures to the SEC required in connection with NQDC plans and employee stock plans?1135
    • Q 31.18.6 : What plans must be approved by shareholders pursuant to stock exchange requirements?1136
    • Q 31.18.7 : What plans are exempt from the shareholder approval requirements of the stock markets?1136
    • Q 31.18.8 : What is the profit recovery rule of section 16(b) of the Securities Exchange Act of 1934?1137
    • Q 31.18.9 : Who are “insiders” under section 16(b)?1137
    • Q 31.18.10 : What happens if a person becomes an insider within six months of a stock purchase or sale transaction?1137
    • Q 31.18.11 : What filings are required by an insider under section 16(a) of the 1934 Act?1138
    • Q 31.18.12 : What transactions are exempt under Rule 16(b)-3 from the profit recovery rule of section 16(b)?1138
    • Q 31.18.13 : Under what circumstances and conditions can a plan participant resell public company securities purchased or otherwise received through an employee benefit plan?1139
    • Q 31.18.14 : Who is an affiliate for purposes of resales?1140
    • Q 31.18.15 : What are the conditions that must be met under Rule 144?1140
    • Q 31.18.16 : Does Sarbanes-Oxley prohibit trading by executives of a company stock during pension blackout periods?1140
    • Q 31.18.17 : Does Regulation BTR provide any exemptions to the trading prohibition?1141
    • Q 31.18.18 : Is there a notice requirement relating to the trading prohibition?1141
    • Q 31.18.19 : What remedies apply to a violation of the trading prohibition?1141
    • Q 31.18.20 : Does Sarbanes-Oxley impose any other restrictions impacting executive compensation?1142
Chapter 32: Institutions of Higher Education Paul Lannon ~ Holland & Knight LLP
Nathan Adams ~ Holland & Knight LLP
Kwamina T. Williford ~ Holland & Knight LLP
  • Q 32.1 : Is it necessary for an institution to have a compliance program?1149
    • Q 32.1.1 : What should a compliance program for a higher education institution entail?1151
    • Q 32.1.2 : Who should be involved in the implementation of a compliance program at institutions of higher education?1152
  • Q 32.2 : What are the greatest areas of risk for institutions?1154
  • Q 32.3 : May academic institutions take race and gender into account when making admissions decisions?1154
    • Q 32.3.1 : When do institutions have a compelling interest to consider race in admissions?1155
    • Q 32.3.2 : When is an institution’s implementation of a race-conscious admissions policy narrowly tailored?1156
    • Q 32.3.3 : In what circumstances may the consideration of gender in admissions be constitutional?1157
  • Q 32.4 : What are the consequences of a noncompliant admissions policy?1158
  • Q 32.5 : What obligations regarding disability should an institution be aware of?1158
    • Q 32.5.1 : How should institutions respond to the ADAAA?1159
  • Q 32.6 : What are the eligibility requirements for an institution to participate in federal student aid (FSA) programs?1160
  • Q 32.7 : What are the requirements for an academic program to be eligible for FSA?1161
  • Q 32.8 : What requirements must an institution comply with in order to participate in FSA programs?1163
    • Q 32.8.1 : What limitations are there on the compensation of student recruiters?1164
    • Q 32.8.2 : What types of compensation plans are permitted for student recruiters under Title IV?1164
    • Q 32.8.3 : What requirements and limitations are there on institutions providing students with a list of preferred lenders?1165
    • Q 32.8.4 : What are an institution’s obligations regarding a code of conduct?1166
    • Q 32.8.5 : What are an institution’s disclosure and notification obligations regarding student loan information?1167
    • Q 32.8.6 : What obligations does an institution have regarding financial counseling for students?1168
    • Q 32.8.7 : What requirements and limitations are there on the activities of private lenders?1169
    • Q 32.8.8 : What are the penalties for violating Title IV student aid regulations?1169
  • Q 32.9 : What liability does an institution have for violence on campus?1170
    • Q 32.9.1 : What are the requirements of the Clery Act?1171
    • Q 32.9.2 : What are the repercussions for failing to comply with the Clery Act?1172
    • Q 32.9.3 : What are some best practices for preventing and responding to campus violence?1173
    • Q 32.9.4 : What is the role of legal counsel in improving campus security?1175
  • Q 32.10 : What is FERPA?1175
    • Q 32.10.1 : What are the privacy rights students have under FERPA?1176
    • Q 32.10.2 : Who enforces FERPA?1176
    • Q 32.10.3 : Can a student bring a lawsuit against an institution for FERPA violations?1176
    • Q 32.10.4 : What is the process for FERPA investigations by the FPCO?1177
  • Q 32.11 : What are the consequences of a FERPA violation?1177
  • Q 32.12 : How does an institution determine what constitutes “education records” covered by FERPA?1178
    • Q 32.12.1 : What information is excluded from the definition of “education records”?1178
  • Q 32.13 : When must an institution allow a student to view his or her education records?1180
    • Q 32.13.1 : Are there any limits on a student’s rights to access to his or her education records?1180
    • Q 32.13.2 : Can students amend their education records after inspecting them?1181
  • Q 32.14 : When is student consent not required for disclosure?1181
    • Q 32.14.1 : What is disclosable “directory information”?1182
    • Q 32.14.2 : When can parents view education records without the student’s consent?1183
    • Q 32.14.3 : Does FERPA allow a student’s former high school to send records to a university or college?1183
    • Q 32.14.4 : What types of outside institutions can access student education records?1184
    • Q 32.14.5 : Can college and university officials share information in the education record with each other?1186
    • Q 32.14.6 : What if there is a court order or subpoena for information in a student’s education record?1186
    • Q 32.14.7 : What happens to protected records when there is a legal action between the student and the educational institution?1186
    • Q 32.14.8 : What is the health or safety emergency exception?1187
    • Q 32.14.9 : To whom may institutions disclose information in case of health or safety emergency?1188
  • Q 32.15 : When does FERPA allow outsourcing of information in student education records?1189
    • Q 32.15.1 : What steps must be taken to comply with FERPA when student education records are outsourced?1189
  • Q 32.16 : What guidance does the DOE provide for protecting access to student records within an institution?1190
  • Q 32.17 : What records does FERPA require an institution to keep after it discloses information in a student education record?1191
    • Q 32.17.1 : What should the institution include in its annual FERPA notice?1191
  • Q 32.18 : How are student health/medical records protected by institutions?1192
    • Q 32.18.1 : How does FERPA interact with HIPAA?1193
    • Q 32.18.2 : When are student records protected under HIPAA?1194
  • Q 32.19 : What does the Copyright Act protect?1194
    • Q 32.19.1 : How is a copyright created?1194
    • Q 32.19.2 : What benefits does a copyright holder enjoy?1195
  • Q 32.20 : Who owns the copyright in faculty-produced work?1196
    • Q 32.20.1 : Are there any exceptions to the work-for-hire doctrine?1197
    • Q 32.20.2 : Can a faculty member use copyrighted materials without permission from the copyright owner?1199
  • Q 32.21 : What is “fair use,” and does it apply to institutions of higher education?1200
  • Q 32.22 : Should an institution implement a copyright policy?1201
  • Q 32.23 : What exposure does an institution face if found liable for copyright infringement?1202
    • Q 32.23.1 : Can an institution be liable for copyright infringement based on the acts of its students or faculty?1203
    • Q 32.23.2 : Can an institution limit its exposure from students who use the institution’s computer network to commit copyright infringement?1204
    • Q 32.23.3 : Does the DMCA address copyright infringement by faculty and graduate students?1206
  • Q 32.24 : Why should U.S. institutions of higher education be concerned with export controls?1207
  • Q 32.25 : What specific requirements pertaining to research sponsored by a federal grant or contract should institutions be aware of?1208
    • Q 32.25.1 : What are an institution’s obligations regarding time and effort reporting?1209
    • Q 32.25.2 : … summer salary calculations and reporting?1209
    • Q 32.25.3 : … cost transfers?1210
    • Q 32.25.4 : … cost sharing?1210
    • Q 32.25.5 : … human-subject research?1211
    • Q 32.25.6 : … receiving American Recovery and Reinvestment Act funding?1212
    • Q 32.25.7 : … patentable inventions created with federal money?1213
  • Q 32.26 : How does False Claims Act liability affect institutions?1214
    • Q 32.26.1 : How does improper medical billing expose institutions to False Claims Act liability?1215
    • Q 32.26.2 : How do certification requirements regarding adherence to federal and state laws expose institutions to False Claims Act liability?1217
    • Q 32.26.3 : How has federally sponsored research exposed institutions to False Claims Act liability?1219
    • Q 32.26.4 : Are public institutions immune from claims under the False Claims Act?1222
  • Q 32.27 : How can an institution limit its exposure to False Claims Act liability?1223
Chapter 33: Environmental Law Bonni Kaufman ~ Holland & Knight LLP
Stacy Watson May ~ Holland & Knight LLP
  • Q 33.1 : How are environmental issues regulated in the United States?1249
  • Q 33.2 : What are the major federal environmental laws with general application to business operations that we need to be aware of and comply with?1249
  • Q 33.3 : What is the Resource Conservation and Recovery Act?1250
    • Q 33.3.1 : What is “hazardous waste”?1250
    • Q 33.3.2 : How does a generator properly manage and dispose of hazardous waste?1251
    • Q 33.3.3 : What are the reporting requirements for hazardous waste generators?1251
    • Q 33.3.4 : What are the allowances for hazardous waste storage?1252
    • Q 33.3.5 : How are underground storage tanks (USTs) for hazardous waste regulated?1252
    • Q 33.3.6 : What am I required to do if I release hazardous waste?1253
    • Q 33.3.7 : Is used oil subject to RCRA regulation?1254
    • Q 33.3.8 : Is lead-based paint subject to RCRA regulation?1254
    • Q 33.3.9 : What are the penalties for RCRA violations?1254
  • Q 33.4 : What does CERCLA provide?1255
    • Q 33.4.1 : What are CERCLA’s hazardous substance release reporting requirements?1255
    • Q 33.4.2 : How does CERCLA govern cleanup of property containing hazardous substances?1256
    • Q 33.4.3 : Who is subject to CERCLA liability for release of a hazardous substance?1256
    • Q 33.4.4 : Is anyone exempted from liability?1257
  • Q 33.5 : What is the Superfund Recycling Equity Act?1257
    • Q 33.5.1 : What is “recyclable material”?1257
    • Q 33.5.2 : What does the SREA consider “recycling”?1257
    • Q 33.5.3 : What are some defenses to CERCLA liability?1258
  • Q 33.6 : What is the EPCRA?1259
    • Q 33.6.1 : How does the EPCRA regulate hazardous chemicals?1259
    • Q 33.6.2 : What are the penalties for noncompliance with EPCRA?1260
  • Q 33.7 : What is the intent of the Clear Air Act?1261
    • Q 33.7.1 : What kinds of air pollutants does the CAA aim to clean up?1261
    • Q 33.7.2 : How does the CAA regulate criteria pollutants?1261
    • Q 33.7.3 : What are some of the ways the CAA regulates HAPs?1262
    • Q 33.7.4 : How does the CAA regulate greenhouse gas emissions?1262
    • Q 33.7.5 : What kinds of CAA reporting/compliance requirements should businesses be aware of?1263
    • Q 33.7.6 : What constitutes a violation of the CAA?1265
    • Q 33.7.7 : What are the penalties for CAA violations?1265
  • Q 33.8 : What is the aim of the Clean Water Act?1265
    • Q 33.8.1 : What kinds of pollutants are regulated by the CWA?1266
    • Q 33.8.2 : How does the CWA protect the nation’s waters?1266
    • Q 33.8.3 : What are point source discharges?1266
    • Q 33.8.4 : What are nonpoint sources?1266
    • Q 33.8.5 : What is an NPDES permit required for?1266
    • Q 33.8.6 : What are the requirements for a discharging facility to be issued an NPDES permit?1267
    • Q 33.8.7 : Which kinds of storm water discharges require an NPDES permit?1267
    • Q 33.8.8 : What kind of permits are required for municipal sewage treatment plants?1268
    • Q 33.8.9 : What other permits are required by the CWA?1269
    • Q 33.8.10 : What regulations should facilities dealing with oil be aware of?1269
    • Q 33.8.11 : What does the SPCC consider “oil”?1270
    • Q 33.8.12 : What must an SPCC plan include?1270
    • Q 33.8.13 : What other requirements do the SPCC regulations impose?1271
    • Q 33.8.14 : What are the penalties for CWA violations?1271
  • Q 33.9 : What is the intent of the Toxic Substances Control Act?1272
    • Q 33.9.1 : What substances does the TSCA address?1272
    • Q 33.9.2 : Are all substances not on the inventory of existing chemicals banned?1273
    • Q 33.9.3 : What reporting requirements does TSCA impose?1273
  • Q 33.10 : How is asbestos regulated?1274
  • Q 33.11 : How is lead-based paint regulated?1274
  • Q 33.12 : How are PCBs regulated?1275
    • Q 33.12.1 : What uses of PCB-containing materials/equipment are permitted?1275
    • Q 33.12.2 : What are some of the requirements for permitted uses of PCBs?1275
  • Q 33.13 : What are the penalties for violations of the TSCA?1277
  • Q 33.14 : What other federal regulations should businesses be aware of when considering environmental issues and compliance?1277
    • Q 33.14.1 : What are covered facilities required to do under CFATS?1277
    • Q 33.14.2 : How does DHS enforce these standards?1278
  • Q 33.15 : What other compliance obligations related to environmental issues should businesses be aware of?1278
    • Q 33.15.1 : What are Contingent Remediation Liabilities?1279
    • Q 33.15.2 : What kinds of environmental legal proceedings must be disclosed?1279
    • Q 33.15.3 : What are “Description of Business” disclosures?1280
    • Q 33.15.4 : What are MD&A disclosures?1280
    • Q 33.15.5 : What are “Conditional Asset Retirement Obligations” disclosures?1280
  • Q 33.16 : What does the SEC require companies to report with respect to the impact of climate change?1281
Chapter 34: Labor and Employment Law Mark Baker ~ Holland & Knight LLP
  • Q 34.1 : What are an employer’s obligations regarding documentation of an employee’s legal authorization to work in the United States?1288
    • Q 34.1.1 : What are the Form I-9 filing requirements?1288
    • Q 34.1.2 : What are the consequences of failure to file?1288
    • Q 34.1.3 : What federal laws/regulations governing employment background checks must an employer comply with?1289
    • Q 34.1.4 : What does the FCRA require?1289
  • Q 34.2 : What federal laws govern employment discrimination?1290
  • Q 34.3 : What types of discrimination are prohibited?1290
  • Q 34.4 : How does Title VII protect against discrimination?1290
    • Q 34.4.1 : What is “disparate impact” discrimination?1291
    • Q 34.4.2 : What is “association” discrimination?1291
    • Q 34.4.3 : How must an employer protect an employee’s rights regarding religion?1292
    • Q 34.4.4 : What are the rules regarding a pregnant employee?1292
    • Q 34.4.5 : What are indications of discrimination based on national origin?1293
    • Q 34.4.6 : Can an employer insist that English be spoken in the workplace?1293
  • Q 34.5 : What are an employer’s compliance obligations regarding discrimination based on age?1294
  • Q 34.6 : How is a disability protected in the workplace?1294
    • Q 34.6.1 : What is the ADA’s definition of “disability”?1294
    • Q 34.6.2 : What qualifies a person to be protected under the ADA?1295
    • Q 34.6.3 : How does ADA protection extend to an employee’s family?1295
    • Q 34.6.4 : How must an employer assist a disabled individual?1295
    • Q 34.6.5 : What kind of standards can employers maintain for disabled employees?1296
    • Q 34.6.6 : What compliance issues arise during the hiring process when disabled applicants are involved?1296
    • Q 34.6.7 : What are the ADA’s confidentiality requirements?1297
  • Q 34.7 : What are the rules governing pay differences between men and women?1297
    • Q 34.7.1 : What kinds of pay differences are allowed?1297
  • Q 34.8 : What types of employment-related actions are subject to the discrimination prohibitions?1298
  • Q 34.9 : What affirmative accommodation obligations are imposed by employment discrimination laws?1298
  • Q 34.10 : What written statements and policies should be adopted to help assure nondiscrimination compliance?1299
  • Q 34.11 : What notice requirements are imposed by employment discrimination laws?1299
  • Q 34.12 : What compliance issues are triggered by discrimination claims or other assertions of employee rights?1300
  • Q 34.13 : What types of harassment are prohibited?1300
    • Q 34.13.1 : What kinds of conduct constitute harassment?1301
    • Q 34.13.2 : What policies should be adopted to address harassment concerns?1302
    • Q 34.13.3 : Are there particular notice requirements that must be met to address harassment concerns?1302
    • Q 34.13.4 : What compliance concerns does the threat of retaliation raise?1303
  • Q 34.14 : What minimum wage and overtime requirements apply generally to employees?1303
    • Q 34.14.1 : Which employees and employers are subject to the minimum wage and overtime requirements?1304
    • Q 34.14.2 : Who is exempt from the minimum wage and overtime requirements?1305
    • Q 34.14.3 : What are the rules for application of the “white-collar” exemptions?1305
    • Q 34.14.4 : How must exempt employees be paid to ensure that they are paid on a “salary basis,” as required for their exempt status?1306
    • Q 34.14.5 : Who qualifies for the “computer-related professionals” exemption?1307
    • Q 34.14.6 : Can “compensatory time” be provided in lieu of overtime pay?1308
    • Q 34.14.7 : What are compensable hours of work?1308
    • Q 34.14.8 : What policies should be adopted to assure compliance with wage/hour laws?1309
    • Q 34.14.9 : What notice requirements are imposed by wage/hour laws?1309
    • Q 34.14.10 : What other requirements should be considered?1309
  • Q 34.15 : What types of benefit programs are subject to federal regulation?1310
    • Q 34.15.1 : What does ERISA generally require?1310
    • Q 34.15.2 : What are the reporting requirements associated with employee benefit plans?1311
  • Q 34.16 : What are the HIPAA requirements?1311
  • Q 34.17 : What are an employer’s obligations regarding family and medical leave?1311
    • Q 34.17.1 : Who qualifies for FMLA leave?1312
    • Q 34.17.2 : When is FMLA leave available?1312
    • Q 34.17.3 : What qualifies as a “serious medical condition” under the FMLA?1313
    • Q 34.17.4 : Must a “serious medical condition” also qualify as a “disability” under the ADA?1313
    • Q 34.17.5 : Is a leave for the birth or adoption of a child only permitted for the mother?1313
    • Q 34.17.6 : How does an employee request FMLA leave?1314
    • Q 34.17.7 : Are there restrictions on how FMLA leave time may be taken?1314
    • Q 34.17.8 : What notice and medical documentation are required for FMLA leave?1314
    • Q 34.17.9 : What are the requirements pertaining to pay during FMLA leave?1315
    • Q 34.17.10 : What are the requirements pertaining to benefits during FMLA leave?1315
    • Q 34.17.11 : What are an employer’s obligations to an employee returning from FMLA leave?1315
    • Q 34.17.12 : What leave rights does an employee caring for a sick or injured service member have?1316
  • Q 34.18 : What FMLA policies should employers adopt?1316
  • Q 34.19 : What statute governs military leave?1317
    • Q 34.19.1 : What notice requirements does the USERRA impose?1317
    • Q 34.19.2 : How must pay and benefits be handled for employees on military leave?1317
    • Q 34.19.3 : What requirements apply to reinstatement of employees returning from military leave?1318
  • Q 34.20 : What statute governs employees’ medical insurance?1318
    • Q 34.20.1 : What are “qualifying events” under COBRA?1319
    • Q 34.20.2 : What are the notice requirements under COBRA?1319
  • Q 34.21 : What are the notice requirements for plant closings and layoffs?1319
    • Q 34.21.1 : What events trigger WARN requirements?1319
    • Q 34.21.2 : What notices must be given if a WARN trigger event occurs?1320
    • Q 34.21.3 : When must the notices be given?1320
  • Q 34.22 : When may polygraphs be used for employment-related purposes?1320
    • Q 34.22.1 : What limitations apply to the use of polygraphs?1321
  • Q 34.23 : What employee activity is protected under unionization?1321
    • Q 34.23.1 : What legal obligations apply when employees try to join or form a union?1322
    • Q 34.23.2 : What are the compliance implications of employees unionizing?1322
    • Q 34.23.3 : What are the compliance implications of a collective bargaining agreement?1322
  • Q 34.24 : What laws govern employment issues with government contractors?1323
    • Q 34.24.1 : How must employers comply with requirements regarding identifying under-utilization of women or minorities?1323
    • Q 34.24.2 : What types of prevailing wage requirements might apply?1324
Chapter 35: Consumer Product Safety Act Charles E Joern, Jr. ~ Holland & Knight LLC
  • Q 35.1 : How are consumer products regulated in the United States?1329
  • Q 35.2 : What is a “consumer product” for regulatory purposes?1329
  • Q 35.3 : What businesses are covered by consumer product safety laws?1330
  • Q 35.4 : What consumer product safety laws does the Commission enforce?1330
  • Q 35.5 : How important is consumer product safety law compliance?1330
  • Q 35.6 : What constitutes a violation under the CPSA?1331
  • Q 35.7 : What requirements must a business meet to comply with the CPSA?1332
    • Q 35.7.1 : What does it mean for a business to “comply”?1332
    • Q 35.7.2 : What are a business’s specific testing and certification obligations?1332
    • Q 35.7.3 : What are a business’s reporting obligations?1332
  • Q 35.8 : Does the Commission certify that products comply with applicable product safety standards?1333
  • Q 35.9 : How does a business know what product safety standards apply to its product?1333
    • Q 35.9.1 : How do we determine if our product is a “consumer product” under the jurisdiction of the Commission?1333
    • Q 35.9.2 : Once we determine that our product is a consumer product, how do we decide what specific standards apply?1334
    • Q 35.9.3 : What sources of information can we use to determine what regulations apply to our product?1334
  • Q 35.10 : What is an “unregulated” product?1335
  • Q 35.11 : What are voluntary standards?1335
  • Q 35.12 : Is the Commission’s treatment of children’s products different from its treatment of non-children’s products?1336
  • Q 35.13 : What testing and certification requirements apply to our product?1337
    • Q 35.13.1 : Are all businesses required to issue certifications?1337
    • Q 35.13.2 : What is a “reasonable testing program” as required for a General Certificate of Conformity?1338
  • Q 35.14 : What testing program is required for children’s products?1338
    • Q 35.14.1 : What are the new general certification testing requirements for children’s products?1338
    • Q 35.14.2 : What “periodic testing” is required for certification of children’s products?1339
    • Q 35.14.3 : What are the “undue influence” requirements that a manufacturer of children’s product must meet?1339
    • Q 35.14.4 : What are the record-keeping obligations required for a manufacturer/importer of a children’s product?1340
  • Q 35.15 : May a company rely on testing of component parts in order to fulfill compliance requirements?1340
  • Q 35.16 : What reporting requirements should a business be aware of?1341
    • Q 35.16.1 : What type of information can trigger a report?1341
  • Q 35.17 : What is a “substantial product hazard”?1341
  • Q 35.18 : What should we do if we are uncertain if there is an actual product safety problem with a product?1342
  • Q 35.19 : How soon must a company report a problem?1343
  • Q 35.20 : What should a firm do to ensure compliance with CPSA reporting obligations?1343
    • Q 35.20.1 : If a lawsuit is filed against my company, do I have to file a report with the Commission?1343
    • Q 35.20.2 : If I report a suspected problem, will my business have to recall the product?1343
  • Q 35.21 : When does a company have to recall a product?1344
    • Q 35.21.1 : Under what circumstances does the Commission decide that a recall is not necessary at all?1344
  • Q 35.22 : What is a fast-track recall?1344
  • Q 35.23 : What information must be included in recall notices?1344
  • Q 35.24 : Is there a database of consumer product safety complaints?1345
    • Q 35.24.1 : Does the database affect businesses?1345
    • Q 35.24.2 : Is a company notified of reports concerning its products?1346
    • Q 35.24.3 : Can a company submit anything to the database?1346
  • Q 35.25 : What aspects of the CPSA have been amended?1346
Chapter 36: Index to Corporate Compliance Answer Book 2012-13

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