Category: Legislation

Steering Wheels Become Increasingly Optional

Florida is the latest state to allow vehicles to operate on the road without a steering wheel.  In doing so, Florida became the third state after Michigan and Texas to allow vehicles on its roads without a human even having the ability to drive them.  The legislation signed into law includes:

The bill authorizes operation of a fully autonomous vehicle on Florida roads regardless of whether a human operator is physically present in the vehicle. Under the bill, a licensed human operator is not required to operate a fully autonomous vehicle. The bill authorizes an autonomous vehicle or a fully autonomous vehicle equipped with a teleoperation system to operate without a human operator physically present in the vehicle when the teleoperation system is engaged. A remote human operator must be physically present in the United States and be licensed to operate a motor vehicle by a United States jurisdiction.

Florida is sure to become a hotbed of autonomous vehicle testing with this new law.  Starsky Robotics is one of the companies expected to take advantage by putting driverless vehicles on the road in 2020.  These would not be just any vehicles, but big rig trucks.  These trucks have already hit 55 mph, without a driver or crew.  Most predict that this is just the beginning with as many as eight million autonomous vehicles expected on the road by 2025 and 30 million by 2030. Of course, the devil is in some of the details. There are six levels of autonomous vehicles, with level 5, Full Automation, being the highest.

Not everyone agrees that this is all happening so quickly.  As the New York Times noted, “A growing consensus holds that driver-free transport will begin with a trickle, not a flood.” Of course, this makes sense.  Outside of people with a vested interest (we are looking at you Mr. Musk), few seem to truly believe that millions of level 5, completely driverless vehicles will be on the road.

But this does not mean that they will not make an impact. While vehicles may not be navigating complex systems in dense areas next year, they are likely to find plenty of uses.  Gated communities with known road structures and limited traffic might be a good location for the first generation of fully autonomous vehicles. And think of the myriad of shuttles at various locations that run the same route, over and over, day after day. That seems like a good use of a fully autonomous vehicle run by something other than gasoline. How about college campuses, with autonomous vehicles running all day and all night providing safe routes and passage for vulnerable students at all hours. Suffice to say, the day when people can wake up, get into a fully autonomous vehicle, and go to sleep while it takes them to work is perhaps not something the current work force will enjoy (except apparently for the occasional Tesla rider taped sleeping behind the wheel).

But whatever generation comes after Generation Z is unlikely to know a driving experience like what exists today, if there is any driving at all. Will they even drive at all, or will they fly in their autonomous flying cars? Project Vahana aims to offer just that. In their own words: “Project Vahana intends to open up urban airways by developing the first certified electric, self-piloted vertical take-off and landing (VTOL) passenger aircraft.” Getting to work will never be easier.  Unless of course, all this transportation runs into the fact that everyone works remotely.

 

© 2019 Foley & Lardner LLP
For more on Vehicle Legislation see the National Law Review page on Utilities & Transport.

Connecticut Enacts Law to Increase Access to Epinephrine Auto Injectors

On June 13, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-19 “An Act Concerning Epinephrine Auto Injectors” (PA 19-19). PA 19-19 went into effect on the same date.

This legislation expands access to epinephrine, which can be lifesaving when treating anaphylactic allergic reactions. PA 19-19 permits “authorized entities” to acquire and maintain a supply of epinephrine cartridge injectors, subject to certain conditions. With a few exceptions, authorized entities are for-profit or nonprofit entities or organizations that employ at least one “person with training.” The new legislation defines a person with training as a person who either:

  • Has completed and received a certification in a first aid course that has been approved by a “prescribing practitioner” pursuant to a medical protocol (as described below); or
  • Has received training in the recognition of the signs and symptoms of anaphylaxis, the use of an epinephrine cartridge injector and emergency protocol by a licensed physician, physician assistant, advanced practice registered nurse or emergency medical services personnel.

Prior to PA 19-19, drug wholesalers and manufacturers were permitted to sell epinephrine cartridge injectors to select categories of purchasers, including hospitals, physicians, nursing homes with a full-time pharmacist, pharmacies and certain other institutions with a full-time pharmacist.

PA 19-19 requires authorized entities who desire to acquire or maintain epinephrine cartridge injectors, together with a “prescribing practitioner,” to establish a medical protocol on the administration of epinephrine cartridge injectors by a person with training. Under PA 19-19, a prescribing practitioner is a Connecticut-licensed physician, dentist, podiatrist, optometrist, physician assistant, advanced practice registered nurse, nurse-midwife or veterinarian, authorized to prescribe medication within his or her scope of practice. The medical protocol must address, among other things, proper storage, maintenance and documentation of epinephrine cartridge injectors, and procedures for emergency medical situations involving anaphylactic allergic reactions at the authorized entity’s place of business. The authorized entity must maintain a copy of the medical protocol at the place of business to which it applies, and must annually review the medical protocol with a person with training and a prescribing practitioner.

In the event of an anaphylactic reaction, a person with training may, in accordance with the medical protocol, provide an epinephrine cartridge injector to the individual or to the individual’s parent, guardian or caregiver, or administer the epinephrine cartridge injector, regardless of whether the individual has a prescription or a prior medical diagnosis of an allergic condition. After any such administration of epinephrine, the authorized entity must notify a local emergency medical services organization as well as the prescribing practitioner.

Notably, PA 19-19 holds prescribing practitioners free from civil and criminal liability for establishing the medical protocol or for use of the epinephrine cartridge injector in accordance with PA 19-19. This legislation also holds persons with training and authorized entities free from civil or criminal liability to the individual who experienced anaphylaxis for the provision or administration, in accordance with PA 19-19, of the epinephrine cartridge injector when the person with training has a good faith belief that the individual is experiencing anaphylaxis.  However, the immunity does not apply to willful or wanton misconduct or acts or omissions constituting gross negligence.

 

Copyright © 2019 Robinson & Cole LLP. All rights reserved.
Read more about healthcare legislation on the National Law Review Health Law and Managed Care page.

New Washington State Privacy Bill Incorporates Some GDPR Concepts

A new bill, titled the “Washington Privacy Act,” was introduced in the Washington State Senate on January 18, 2019. If enacted, Washington would follow California to become the second state to adopt a comprehensive privacy law.

Similar to the California Consumer Privacy Act (CCPA), the Washington bill applies to entities that conduct business in the state or produce products or services that are intentionally targeted to residents of Washington and includes similar, though not identical size triggers. For example, it would apply to businesses that 1) control or process data of 100,000 or more consumers; or 2) derive 50 percent or more of gross revenue from the sale of personal information, and process or control personal information of 25,000 or more consumers. The bill would not apply to certain data sets regulated by some federal laws, or employment records and would not apply to state or local governments.

The bill incorporates aspects of the EU’s General Data Protection Regulation (GDPR) and borrows the “controller”/“processor” lexicon in identifying obligations for each role from the GDPR. It defines personal data as any information relating to an identified or identifiable natural person, but does not include de-identified data. Similar to the GDPR, it treats certain types of sensitive information differently. Unlike the CCPA, the bill excludes from the definition of “consumer” employees and contractors acting in the scope of their employment. Additionally, the definition of “sale” is narrower and limited to the exchange of personal data to a third party, “for purposes of licensing or selling personal data at the third party’s discretion to additional third parties,” while excluding any exchange that is “consistent with a consumer’s reasonable expectations considering the context in which the consumer provided the personal data to the controller.”

Another element similar to the GDPR in the bill, requires businesses to conduct and document comprehensive risk assessments when their data processing procedures materially change and on an annual basis. In addition, it would impose notice requirements when engaging in profiling and a prohibition against decision-making solely based on profiling.

Consumer rights 

Similar to both the GDPR and the CCPA, the bill outlines specific consumer rights.  Specifically, upon request from the consumer, a controller must:

  • Confirm if a consumer’s personal data is being processed and provide access to such data.
  • Correct inaccurate consumer data.
  • Delete the consumer’s personal data if certain grounds apply, such as in cases where the data is no longer necessary for the purpose for which it was collected.
  • Restrict the processing of such information if certain grounds apply, including the right to object to the processing of personal data related to direct marketing. If the consumer objects to processing for any purpose other than direct marketing, the controller may continue processing the personal data if the controller can demonstrate a compelling legitimate ground to process such data.

If a controller sells personal data to data brokers or processes personal data for direct marketing purposes, it must disclose such processing as well as how a consumer may exercise the right to object to such processing.

The bill specifically addresses the use of facial recognition technologies. It requires controllers that use facial recognition for profiling purposes to employ meaningful human review prior to making final decisions and obtain consumer consent prior to deploying facial recognition services. State and local government agencies are prohibited from using facial recognition technology to engage in ongoing surveillance of specified individuals in public spaces, absent a court order or in the case of an emergency.

The Washington State Attorney General would enforce the act and would have the authority to obtain not more than $2,500 for each violation or $7,500 for each intentional violation. There is no private right of action.

The Washington Senate Committee on Environment, Energy & Technology held a public hearing on January 22, 2019 to solicit public opinions on this proposed legislation. At the beginning of the public hearing, the Chief Privacy Officer of Washington, Alex Alben, commented that the proposed legislation would be just in time to address a “point of crisis [when] our economy has shifted into a data-driven economy” in the absence of federal legislation regarding data security and privacy protection.

Industry reaction to the bill

Companies and industry groups with an interest in this process applauded this proposed legislation as good news for entities that have become, or are on their way, to becoming compliant with the GDPR. Many also shared suggestions or criticisms. Among others, some speakers cautioned that by setting a high standard closely resembling the GDPR, the bill might drive small- or medium-sized companies to block Washington customers, just as they have done in the past to avoid compliance with the GDPR.

Some representatives, including the Chief of the Consumer Protection Division of the Washington Attorney General’s Office, call for a private cause of action so that this law would mean more to a private citizen than simply “a click on the banner.” The retail industry, the land title association, and other small business representatives expressed their preference for legislation on a federal level and a higher threshold for applicable businesses. Specifically, Stuart Halsan from the Washington Land Title Association recommended that the Washington Senate consider this bill’s impact on industries, such as the land title insurance industry, where the number of customers is significantly lower than the amount of data it processes in their ordinary course of business.

In response to these industry concerns, the committee acknowledged that this new legislation would need to be very sensitive to apply proportionately to businesses of different sizes and technology capabilities. The committee also recognized the need to make this legislation more administratively feasible for certain industries or entities that face difficulty in compliance (such as the secondary ticketing market) or subject to complicated regulatory frameworks (such as the bank industry). The Washington Senate continues to invite individuals, companies, or industry groups to submit brief written comments here.

 

©2019 Drinker Biddle & Reath LLP. All Rights Reserved

CFIUS Broadens Coverage of Cross-Border Biotech Transactions

Summary

The Committee on Foreign Investment in the United States recently broadened its coverage of biotechnology transactions via new regulations that became effective on November 10, 2018. This article provides perspectives about how broadly these new rules will affect the biotech industry. All parties to cross-border transactions involving US biotech businesses, whether mere licensing arrangements or full M&A, should carefully consider all US regulatory implications, including application of the new CFIUS rules, US export controls and related requirements. Parties to pending biotech transactions or contemplating future biotech transactions are well advised to take actions.

In Depth

INTRODUCTION

Recent statutory and regulatory enactments have broadened the scope and jurisdiction of the Committee on Foreign Investment in the United States (CFIUS), including its jurisdiction over transactions in the biotechnology industry. This article provides perspectives about how broadly the new CFIUS regulations, which became effective November 10, 2018, will affect cross-border biotech transactions.

The development and growth of the biotechnology industry has spurred a growing volume of cross-border transactions with US life sciences businesses in recent years, involving early stage research companies as well as large pharmaceutical conglomerates. Foreign parties to cross-border biotech transactions have been active and diverse, involving financial and strategic investors and collaborators from Asia, Europe and other regions. Such transactions take a variety of forms, and can be grouped primarily in the following categories:

  • Controlling investments by foreign entities, such as acquisitions of a majority or more of equity or assets of US biotech companies;
  • Joint ventures between US and foreign entities to which US biotech companies contribute assets and/or intellectual property;
  • Non-controlling investments by foreign entities in US biotech companies with or without outbound licenses and/or options to acquire future equity interests or assets; and
  • Straightforward technology licenses granted by US biotech companies to foreign entities without corresponding equity interests issued in US companies.

How many of the foregoing types of transactions are now subject to the broadened jurisdiction of CFIUS? This On the Subject addresses the effect of recent CFIUS regulations on different types of cross-border biotech transactions.

FIRRMA AND BROADENED JURISDICTION OF CFIUS

CFIUS is a federal interagency committee chaired by the US Treasury Department (Treasury) that is charged with reviewing and addressing any adverse implications for US national security posed by foreign investments in US businesses. For background on the fundamentals of the CFIUS process and recent developments, see here, here and here.

As biotechnology entities generally focus on researching and finding therapeutics and diagnostics for diseases and saving patients’ lives, this industry has spurred very little concern for US national security outside of limited areas of bioterrorism and toxins. CFIUS review procedures were largely irrelevant for parties to cross-border biotech transactions. Under the voluntary CFIUS notification rules, parties to very few biotech transactions involving foreign acquirers notified CFIUS and sought CFIUS’s review and clearance of their deals. This may significantly change with the recent enactment of the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA) in August 2018.

Prior to the enactment of FIRRMA, CFIUS was authorized to review the national security implications of only transactions that could result in control of a US business by a foreign person. FIRRMA expanded the scope of transactions subject to CFIUS’s review to include certain foreign investments in US businesses even in cases where the investment does not result in a controlling interest and imposedmandatory reporting requirements for certain transactions.

On October 10, 2018, Treasury issued new interim rules to implement FIRRMA, establishing a temporary “Pilot Program” that includes a mandatory declaration process. The Pilot Program went into effect on November 10, 2018, and will end no later than March 5, 2020. The interim rules specify 27 industries for focused attention under the Pilot Program, including Nanotechnology (NAICS Code: 541713) and Biotechnology (NAICS Code: 541714), as follows:

Research and Development in Nanotechnology
NAICS Code: 541713

“This U.S. industry comprises establishments primarily engaged in conducting nanotechnology research and experimental development. Nanotechnology research and experimental development involves the study of matter at the nanoscale (i.e., a scale of about 1 to 100 nanometers). This research and development in nanotechnology may result in development of new nanotechnology processes or in prototypes of new or altered materials and/or products that may be reproduced, utilized, or implemented by various industries.”

Such establishments include “Nanobiotechnologies research and experimental development laboratories.”

Research and Development in Biotechnology (except Nanobiotechnology)
NAICS Code: 541714

“This US industry comprises establishments primarily engaged in conducting biotechnology (except nanobiotechnology) research and experimental development. Biotechnology (except nanobiotechnology) research and experimental development involves the study of the use of microorganisms and cellular and biomolecular processes to develop or alter living or non-living materials. This research and development in biotechnology (except nanobiotechnology) may result in development of new biotechnology (except nanobiotechnology) processes or in prototypes of new or genetically-altered products that may be reproduced, utilized, or implemented by various industries.”

The new Pilot Program rules could directly affect parties to multiple cross-border biotech industry transactions, whether they are potential target companies, investors or acquirers. Mandatory, not voluntary, filings with CFIUS will be required for controlling and non-controlling investments that fall within the definition of “Pilot Program Covered Transactions,” and violations of the new rules could result in substantial penalties.

EFFECT ON CROSS-BORDER TRANSACTIONS IN BIOTECH SECTOR

PILOT PROGRAM COVERED TRANSACTIONS

The Pilot Program requires that parties to a “pilot program covered transaction” notify CFIUS of the transaction by either submitting an abbreviated declaration or filing a full written notice.

A “pilot program covered transaction” means either of the following:

1. Any non-controlling investment, direct or indirect, by a foreign person in an unaffiliated “pilot program US business” that affords the foreign person the following (a “pilot program covered investment”):

  • Access to any material nonpublic technical information in the possession of the target US business;
  • Membership or observer rights on the board of directors or equivalent governing body of the US business, or the right to nominate an individual to a position on the board of directors or equivalent governing body of the US business; or
  • Any involvement, other than through voting of shares, in substantive decision-making of the US business regarding the use, development, acquisition or release of critical technology.

As it relates to the biotech sector, the term “pilot program US business” means any US business that produces, designs, tests, manufactures, fabricates or develops one or more “critical technologies” either used in connection with, or designed specifically for use in, the biotechnology industry and/or nanobiotechnology industry. The determining factor is “critical technologies.”

An “unaffiliated” pilot program US business is defined as a “pilot program US business” in which the foreign investor does not directly hold more than 50 percent of outstanding voting interest or have the right to appoint more than half of the members of the board or equivalent governing body.

2. Any transaction by or with any foreign person that could result in foreign control of a “pilot program US business,” including such a transaction carried out through a joint venture.

By contrast, an investment by a foreign person in a US biotech company that does not produce, design, test, manufacture, fabricate or develop one or more “critical technologies” is not a “pilot program covered transaction.”

As it relates to the biotech industry, the term “critical technologies” under the Pilot Program may include:

  • Civilian/military dual-use technologies subject to Export Administration Regulations (EAR) that are relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation or missile technology, excluding, for instance, “EAR99” items (i.e., those not covered by a specific Export Classification Control Number in the EAR);
  • Select agents and toxins; and
  • “Emerging and foundational technologies” controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (the definition of which is forthcoming from the Department of Commerce).

Because most biotech products and technologies are classified as EAR 99 or are not otherwise subject to existing US export license requirements, a US biotech company (not involved with select agents and toxins) would fall under the “pilot program US business” category when one or more technologies such US biotech company produces, designs, tests, manufactures, fabricates or develops are covered in the to-be-released definition of “emerging and foundational technologies,” which are sensitive and innovation technologies not currently subject to export controls but deemed important for US economic security and technological leadership.  Industry observers predict that such definition will likely encompass certain biopharmaceuticals, biomaterials, advanced medical devices, and new vaccines and drugs, because some of these have been the subject of recent economic espionage efforts from groups in select countries such as China and Russia.

The US Commerce Department’s Bureau of Industry and Security (BIS) is expected soon to announce an advance notice of proposed rulemaking, inviting public comments on the development of the scope of such “emerging and foundational technologies.” Interested members of the US biotech industry should monitor and/or participate in this rulemaking procedure, which will define the scope of these new controls. Until new rules defining “emerging and foundational technologies” are issued, many in the biotech industry are expected to take a conservative approach in treating a broad range of biotechnology as potentially within the scope of “emerging and foundational technologies” for CFIUS purposes.

PRACTICAL IMPLICATIONS FOR DIFFERENT TYPES OF TRANSACTIONS

Controlling Investments by Foreign Persons

As discussed above, the Pilot Program applies to “any transaction by and with any foreign person that could result in foreign control of any pilot program US business, including such a transaction carried out through a joint venture.” Thus, parties to a controlling investment by a foreign entity in a US biotech company which is a “pilot program US business” are required to submit a declaration to CFIUS.

It is important to note that the CFIUS regulations define “US business,” “control” and “foreign person” very broadly. Such broad definitions could subject even transactions between two non-US entities to the jurisdiction of CFIUS, at least to the extent their venture involves any US business.

CFIUS regulations define a “US business” to include any entity engaged in interstate commerce in the United States, regardless of who owns it or where it is formed or headquartered. This broad definition authorizes CFIUS to review investments by a foreign business (e.g., a Chinese company) in another foreign business (e.g., a German target company) to the extent the deal involves elements of the foreign target company which is engaged in US interstate commerce, such as a US subsidiary or sales office. In other words, an investment or M&A transaction between two non-US biotech companies could be subject to CFIUS review if there are US business activities that will be controlled by the foreign company post-closing.

The CFIUS rules define “control” to mean the power to determine, direct, take, reach or cause decisions regarding important matters of a US business through the ownership of a majority or a “dominant minority” of the voting shares, board representation, proxy voting or contractual arrangements.

Under the CFIUS regulations, the term “foreign person” includes any entity over which a foreign national, foreign government or foreign entity exercises, or has the power to exercise control, (including a foreign-owned US subsidiary or investment fund). In contrast to a US citizen, a US permanent resident visa holder (i.e., green card holder) is a foreign national under the CFIUS regulations. Hence, a company formed as a Delaware corporation or Delaware limited liability company, which is controlled by green card holders, is also a foreign person for CFIUS purposes. An investment by such a Delaware company into a US biotech company will need to be analyzed under the new CFIUS regulations.

The Pilot Program applies to investments by any foreign investor, regardless of the investor’s country, and there are currently no exemptions. FIRRMA provides that CFIUS “may consider” whether a covered transaction involves a country of “special concern” for US national security, and practitioners generally expect CFIUS will consider the countries of foreign investors and will place heightened scrutiny on select countries, particularly if there is government involvement. However, the new regulations themselves do not establish different treatment for different countries, e.g., China, Canada, France or Germany.

Non-Controlling Direct Investments by Foreign Strategic Investors or Foreign Investment Funds

A large number of recent biotech deals take the form of a non-controlling investment, for example, a 5 – 15 percent investment, directly by a foreign strategic investor (e.g., foreign pharmaceutical companies) or by a foreign venture capital or private equity fund in a US biotech business. In some cases, the investment is coupled with, or conditioned upon, a grant by the US biotech business to such foreign strategic investor or its affiliate of an exclusive license of the former’s intellectual property for a particular geographic territory. A typical provision in such investment transactions entitles the investor to serve as, or nominate, a director or observer on the board. Assuming other features of the deal satisfy the new CFIUS regulations, this common transaction term would now trigger a mandatory CFIUS declaration filing whenever such rights are granted to a foreign investor.

Even non-controlling investments with no rights to a board seat or board observer status could be a “pilot program covered investment” subject to the mandatory filing requirement if the investment involves access for the foreign investors to material non-public technological data and scientific findings.  The term “material nonpublic technical information” means “information that is not available in the public domain, and is necessary to design, fabricate, develop, test, produce, or manufacture critical technologies, including process, techniques, or methods,” and does not include “financial information regarding the performance of an entity.” Access to such information is common for biotech investors, precisely because of the need for parties to any biotech deal to focus on the business’s underlying science. For both controlling and non-controlling investments, the ability to undertake careful diligence inquiries into underlying key technologies and scientific findings of biotechnology company targets is critical, especially with respect to the targets that are pre-revenue businesses. When such data and information are not yet patented or published in patent applications or other published scientific literatures, the access by a foreign investor to them in a non-controlling investment would make the transaction fall within the definition of a “pilot program covered investment.”

The CFIUS regulations define the term “investment” to mean the acquisition of equity interests, including not only voting securities, but also contingent equity interests, which are financial instruments or rights that currently do not entitle their holders to voting rights, but are convertible into equity interests with voting rights. For example, if a foreign investor is granted a warrant, option or right of first refusal to obtain additional equity interest in a “pilot program US business,” future exercise of the warrant, option or the right of first refusal should be analyzed to assess whether a declaration must be filed with CFIUS and whether CFIUS might find any US national security implications.

Indirect Investments by Foreign Persons via US Investment Funds

The Pilot Program rules establish an exemption from the mandatory declaration requirement for certain passive investments in US businesses made through investment funds. If a foreign investor makes an investment indirectly through a US-managed investment fund in a “pilot program US business,” such an indirect investment will not constitute a covered transaction under the Pilot Program and will not be subject to CFIUS review, even if it affords the foreign person membership as a limited partner or a seat on an advisory board or investment committee of the fund, provided that the following conditions are satisfied:

  • The fund is managed exclusively by a general partner, managing partner or equivalent who is not the foreign person;
  • The advisory board or investment committee does not have the ability to approve, disapprove or otherwise control (i) investment decisions or (ii) decisions by the general partner (or equivalent) related to entities in which the fund is invested;
  • The foreign person does not otherwise have the ability to control the fund, including authority to (i) approve or control investment decisions; (ii) unilaterally approve or control decisions by the general partner (or equivalent) related to entities in which the fund is invested; or (iii) unilaterally dismiss, select or determine the compensation of the general partner (or equivalent); and
  • The foreign person does not have access to material nonpublic technical information as a result of participation on the advisory board or investment committee.

Private equity funds that have foreign investors, especially foreign sovereign funds, as their limited partners, should carefully review their existing contractual arrangements with their foreign investors, as well as the ownership and control of general partners of such funds, to determine whether this “safe harbor” exemption applies to them.

Follow-On Investments

For any transaction that is not subject to the Pilot Program because it was completed before the effective date of the new rules (November 10, 2018), it is important to note that future investments by the same foreign investor may trigger the Pilot Program’s mandatory declaration requirement and should be reviewed for CFIUS implications earlier than 45 days in advance of such new investment.

CFIUS’s prior approval of a “pilot program covered investment” does not automatically endorse any subsequent “pilot program covered investment” by the same foreign person in the same US business. For example, if a foreign person acquired a 4 percent, non-controlling interest in a US biotech company that is a “pilot program US business” which was cleared by CFIUS, and then subsequently acquires an additional 6 percent non-controlling interest in the same US biotech company and obtains access to material nonpublic technical information, the parties to such follow-on investment would be required to file with CFIUS again.

Outbound License of US Technologies

Under new CFIUS regulations, outbound licensing of only intellectual property or technology by a US business to a foreign person does not fall within CFIUS’s jurisdiction, unless it also involves the acquisition of, or investments in, a US business or unless such license is a disguised acquisition of a US business or all or substantially all of its assets. Note, however, that if such technology is controlled under the EAR, access to such technology by a foreign person may require a US export license under the EAR.

Any contribution by a US critical technology company of both intellectual property and associated support to a foreign person through any type of arrangement (e.g., outbound licensing agreements) are now regulated under enhanced US export controls. Under US export control regulations, an export license is required to be obtained before a “controlled technology” classified in certain export classifications under the EAR is transferred or released to a foreign person. US businesses must carefully determine the export classification of any technology before transferring or releasing (e.g., pursuant to a licensing agreement) such technology to any foreign person.

THE NEW MANDATORY DECLARATION PROCEDURE

Parties to a “pilot program covered transaction” (i.e., the foreign investor and the US business) must submit to CFIUS an abbreviated declaration or, if preferred, file a full written notice (as provided under previous CFIUS rules and procedures). The filing must be made at least 45 days prior to the expected completion date of the transaction, so that CFIUS has an opportunity to review the transaction. The penalty for failing to file can be up to the entire amount of the investment.

A declaration, at around five pages in anticipated length, is expected to be easier to prepare than the typically much longer joint voluntary notice. CFIUS is preparing to release a declaration form for parties to use. The Pilot Program rules require fairly substantial information in a declaration, including but not limited to the following:

  • Brief description of the nature of the transaction and its structure (e.g., share purchase, merger, asset purchase)
  • The percentage of voting interest acquired;
  • The percentage of economic interest acquired;
  • Whether the “pilot program US business” has multiple classes of ownership;
  • The total transaction value;
  • The expected closing date;
  • All sources of financing for the transactions;
  • A list of the addresses or geographic coordinates of all “locations” of the“pilot program US business,” including “headquarters, facilities, and operating locations”; and
  • A complete organization chart, including information that identifies the name, principal place of business and place of incorporation of the immediate parent, the ultimate parent and each intermediate parent (if any) of each foreign person that is a party to the transaction.

After CFIUS receives a declaration, the CFIUS staff chair will initially assess its completeness and decide whether to accept it as complete. After such acceptance, CFIUS must take action within 30 days. CFIUS may either

  • Request that the parties file a full written notice;
  • Inform the parties that CFIUS cannot complete action on the basis of the declaration (and that the parties may file a full written notice);
  • Initiate a unilateral review of the transaction through an agency notice; or
  • Notify the parties that CFIUS has approved the transaction.

TAKEAWAYS

All parties to cross-border transactions involving US biotech businesses, whether mere licensing arrangements or full M&A, should carefully consider all US regulatory implications, including application of the new CFIUS rules, US export controls and related requirements. Parties to pending biotech transactions or contemplating future biotech transactions are well advised to:

  • Analyze at the outset whether the US businesses’ products and technologies are controlled under the US export control regimes and/or fall within the scope of “critical technologies”;
  • Monitor and participate in the BIS rulemaking procedure for establishing export controls on “emerging” and “foundational” technologies;
  • Determine well in advance of their transactions if the new Pilot Program rules apply, requiring a mandatory declaration filing and review by CFIUS;
  • Establish deal terms and conditions with a full understanding of how the various US requirements apply; and
  • Monitor continuing regulatory developments, as the new CFIUS Pilot Program will be supplanted by final CFIUS regulations to be issued by February 2020.
© 2018 McDermott Will & Emery

Celebrating the Promise of Mental Health Parity and the Path Forward

This October 3rd marked the 10-year anniversary of the passage of the Mental Health Parity and Addiction Equity Act (MHPAEA). Thinking back to 2008, there had already been several failed attempts to pass a more substantive parity bill. New rounds of negotiations began and were difficult. Substance use disorders (SUD) were still considered a step-child to mental health and labeled a human failing rather than a treatable disease with disabling consequences. If these conditions were not recognized and addressed, it would become a national crisis. However, value change is hard to legislate.

MHPAEA was intended to be more than insurance reform, it was intended to be civil rights legislation that brought mental health (and, for the first time SUD) to a level playing field with physical health. It was a long road to passage because it required a change in health care philosophy and value related to mental health and SUD— not just a change in coverage and payment protocols.

Now, 10 years later, the question is whether the law has changed the playing field to ensure greater access to care and more equitable financial parameters. Close to 100 million people now have parity protections and lives have been saved. Through enforcement of the law more restrictive financial requirements have been removed for patients, additional coverage has been added to insurance plans for mental health/SUD, and overly stringent precertification requirements have been eliminated.

Although the passage of this legislation created a pathway for change, there are still challenges to address.  Discrimination related to SUD remains a challenge, as evidenced by the exclusion of ADA protections for those with SUD.  Advocates continue to call for more transparency, established certifications, expanded provider network capacity, and more guidance on non-quantitative treatment limitations.  The ongoing silos in which mental health/SUD and physical health conditions are treated as separate benefits with their own eligibility, fee schedules for services, credentialing, and poor provider network adequacy continue as areas to be addressed.

A couple of examples in which mental health/SUD services are treated differently: Providers have not been eligible for incentive payments to move to electronic medical records; payers have struggled in designing alternative payment models and value-based payments for providers that move beyond simple process measures;  payment restriction on same-day care are problematic in integrated settings where a person may be seen by both a mental health professional and a non-psychiatric physician; and physicians (non-psychiatrists) providing services in a specialty clinic creates credentialing and payment challenges.

New bipartisan legislation enacted to address the opioid crisis will be an important step to improving access to and the quality of substance use treatment, particularly in the Medicaid and Medicare programs — but doesn’t address the health system transformation that is needed to promote sustainable recovery. That is the challenge we face.

Hopefully our path forward will continue address these issues of implementation, so we approach the day when those living with mental health and substance use disorders will be seen as having a condition or disease that deserves prevention strategies, supports and treatment services, and civil rights protections similar to all other medical conditions.

 

©1994-2018 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.
ARTICLE BY: Health Law Practice

Compliance With Florida’s “Generator” Laws

Earlier this year, Florida Governor Rick Scott signed into law HB7099and SPB7028 (collectively referred to as the “Bills”), ratifying emergency rules that require nursing homes and assisted living facilities to acquire alternative power sources– such as generators- and fuel in preparation of the upcoming hurricane season. See Rule 59A-4.1265 and Rule 58A-5.036. These rules were enacted after 14 residents died from heat-related illnesses and complications during Hurricane Irma last year when a Florida nursing home lost power to its air conditioning units for three days.

The Bills went into effect on March 28, 2018, and required qualifying facilities to come into compliance by June 1, 2018, unless granted an extension by the Governor whereby compliance is expected by January 2019. Facilities that can show delays caused by necessary construction, delivery of ordered equipment, zoning, or other regulatory approval processes are eligible for an extension if the facility can provide residents an area that meets the ambient temperature requirements for 96 hours. Extensions are granted on a case-by-case basis, although so far a majority of Florida facilities have been granted an extension. Indeed, it appears that over 77% of nursing homes received an extension in the first week of June. Additionally, facilities located in an evacuation zone pursuant to Chapter 252, F.S., must either evacuate its residents prior to the arrival of any emergency event, or have an alternative power source and no less than 96 hours of fuel stored onsite at least within 24 hours of the issuance of a state of emergency. Failure to comply with any provision may result in the revocation or suspension of a facility’s license and/or the imposition of administrative fines.

Nursing Homes and Assisted Living Facilities Must Develop Emergency Plans that Provide for Alternative Power Sources and Fuel Capable of Maintaining an Ambient Temperature of No Greater Than 81 Degrees Fahrenheit for At Least 96 Hours.

Nursing Homes and Assisted Living Facilities must prepare a detailed plan (“Plan”) that provides for the acquisition and maintenance of alternative power sources- such as generators- and fuel. The Plan will supplement a facility’s Comprehensive Emergency Management Plan and must be submitted to and approved by the requisite agency. While the Bills do not require facilities to maintain a specific type of power system or equipment; the alternative power sources utilized by a facility must be capable of maintaining an ambient temperature of no greater than 81 degrees Fahrenheit for at least 96 hours after the loss of primary electrical power. This temperature must be maintained in areas of sufficient size to shelter residents safely. Alternative power sources and fuel should be maintained in accordance with local zoning restrictions and the Florida Building Code.

Moreover, the Bills set forth additional requirements for nursing homes and assisted living facilities in evacuation zones, as well as for single campus and multistory facilities.

  • Facilities in Evacuation Zones – A facility in an evacuation zone pursuant to Chapter 252, F.S. must provide in their Plan for the maintenance of an alternative power source and fuel at all times when the facility is occupied but may utilize mobile generators to facilitate evacuation.
  • Single Campus – Single campus facilities under common ownership may share alternative power sources and fuel space if such resources are sufficient to maintain the ambient temperature required under the rules.
  •  Multistory Facilities – Multistory facilities, whose Comprehensive Emergency Management Plan comprises of moving residents to a higher floor during flood or surge events, must place their alternative power source and all additional equipment in a location protected from flooding or storm surge damage.

Fuel Storage Requirements Vary by Facility Size and Location.

The Bills require facilities to provide for storage of a certain amount of fuel based on their size and location. Assisted living facilities with 16 beds or less must store a minimum of 48 hours of fuel, while assisted living facilities with 17 beds or more a required to store a minimum of 72 hours of fuel. All nursing homes must store a minimum of 72 hours of fuel. Nursing homes and assisted living facilities located in a declared state of emergency area pursuant to Section 252.36, F.S., that may impact primary power delivery, must secure 96 hours of fuel; these facilities may utilize portable fuel storage containers for the remaining fuel necessary for 96 hours during the period of a declared state of emergency.

Emily Budicin, a 2018 Summer Associate in the firm’s Washington, DC office, contributed significantly to the preparation of this post.

 

©2018 Epstein Becker & Green, P.C. All rights reserved.

Proposed House Bill Would Set National Data Security Standards for Financial Services Industry

A new bill introduced by House Financial Services subcommittee Chairman Rep. Blaine Luetkemeyer would significantly change data security and breach notification standards for the financial services and insurance industries. Most notably, the proposed legislation would create a national standard for data security and breach notification and preempt all current state law on the matter.

Breach Notification Standard

The Gramm-Leach-Bliley Act (GLBA) currently requires covered entities to establish appropriate safeguards to ensure the security and confidentiality of customer records and information and to protect those records against unauthorized access to or use. The proposed House bill would amend and expand  GLBA to mandate notification to customers “in the event of unauthorized access that is reasonably likely to result in identify theft, fraud, or economic loss.”

To codify breach notification at the national level, the proposed legislation requires all GLBA covered entities to adopt and implement the breach notification standards promulgated by the Comptroller of the Currency, the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation, and the Office of Thrift Supervisor in its  Interagency Guidance on Response Programs for Unauthorized Access to Customer Information and Customer Notice. This guidance details the requirements for notification to individuals in the event of unauthorized access to sensitive information that has or is reasonably likely to result in misuse of that information, including timing and content of the notification.

While the Interagency Guidance was drafted specifically for the banking sector, the proposed legislation also covers insurance providers, investment companies, securities brokers and dealers, and all businesses “significantly engaged” in providing financial products or services.

If enacted, this legislation will preempt all laws, rules, and regulations in the financial services and insurance industries with respect to data security and breach notification.

Cohesiveness in the Insurance Industry

The proposed legislation provides uniform reporting obligations for covered entities – a benefit particularly for insurance companies who currently must navigate a maze of something conflicting state law breach notification standards. Under the proposed legislation, an assuming insurer need only notify the state insurance authority in the state in which it is domiciled. The proposed legislation also requires the insurance industry to adopt new codified standards for data security.

To ensure consistency throughout the insurance industry, the proposed legislation also prohibits states from imposing any data security requirement in addition to or different from the standards GLBA or the Interagency Guidance.

If enacted, this proposed legislation will substantially change the data security and breach notification landscape for the financial services and insurance industries. Entities within these industries should keep a careful eye on this legislation and proactively consider how these proposed revisions may impact their current policies and procedures.

 

Copyright © by Ballard Spahr LLP

Mississippi Has a Passed a Lottery Bill: Now What?

On August 31, 2018, Governor Phil Bryant signed legislation authorizing a lottery, removing Mississippi from the list of states without a lottery (now down to five jurisdictions).

So, when will Mississippians be able to buy a lottery ticket? Through close analysis of the statute and anticipated procedure, it is possible to get some sense of the potential timeline.

The bill establishes the Mississippi Lottery Corporation, run by a five-member Board of Directors. The Board members are appointed by the Governor with the advice and consent of the Mississippi Senate. Once confirmed, the Board members will have five-year rotating terms, with no member able to serve more than two terms.

The Board is authorized to hire a full-time President of the Corporation to oversee the day-to-day affairs of the lottery, subject to the approval of the Governor. Once constituted, the Board will determine the process for solicitation of applicants for President and make a selection subject to the Governor’s approval. This process should take several months, even under the best of circumstances.

The appointment and hiring process will be closely monitored by both the press and the public. All meetings of the Board are subject to the Mississippi Open Meetings Act. All records of the Corporation are deemed public records and thus open to public inspection, subject to certain statutory exceptions.

Once the President is selected, he or she will begin to staff the Corporation. All employees of the lottery will be subject to background investigations prior to hiring, and certain senior level administrative personnel must be investigated by the Mississippi Department of Public Safety. No person who has been convicted of a felony, bookmaking or other forms of illegal gambling, or a crime involving moral turpitude may be employed by the corporation. This investigation and vetting process will be time consuming and lengthy, and will delay all hiring several months.

Prior to any operations or procurements, the Board must adopt rules and regulations governing lottery operations in Mississippi. Once retained, staff will draft and revise proposed lottery regulations – another process that could take several months.

By law, the corporation has the option to purchase, lease or lease-purchase necessary goods or services. While the corporation is not able to contract out the total operation and administration of the lottery, it may make procurements for lottery game design, lottery ticket distribution to retailers, supply of goods and services, advertising and the like.

The Board must approve “major procurements”, which are for items, products or services of $1,000,000 or more, including major advertising contracts, annuity contracts, prizes, products and services unique to the lottery, and may enter into such contracts only after a formal bidding process. In bidding, the corporation may do its own procurement or may utilize the services of the Department of Finance and Administration, the Department of Information Technology Services, or other state agencies. Bidding and service procurement will be another time-consuming process; unsuccessful bidders may litigate over not being selected, resulting in even further delays.

Finally, the corporation must investigate, select and enter into agreements with hundreds of lottery retailers. The legislation sets minimum standards for such retailers, and it specifically authorizes Mississippi casinos to act as lottery retailers. This retailer investigation and retention process could also take months.

So, even with a lot of luck, the first Mississippi lottery ticket will likely not be sold until the last quarter of 2019 or first quarter of 2020.

 

© 2018 Jones Walker LLP
This post was written by Thomas B. Shepherd and Zachary W. Branson of Jones Walker LLP.
Read more about Mississippi legislation on our Mississippi Jurisdiction page.

The Blame Game: Senators Clash with the Trump Administration

Why are prescription drug prices so high in the U.S.? While this question can hardly be considered a new topic in American healthcare, the recent clash of words between the Trump Administration and Democratic Senators has once again brought focus to the issue of prescription drug prices. According to the Administration, pharmacy benefit managers (“PBMs”) and drug distributors – who President Trump has dubbed as “middlemen” – are largely to blame for higher drug prices. However, Democratic Senators, PBMs, and drug distributors have recently pushed back against the Administration’s claims, arguing that the Administration’s claims are not supported by any evidence, and, in some cases, are contrary to the core functions of PBMs and drug distributors.

Background

PBMs and drug distributors have been in the crosshairs of the Administration for several months. In a speech on May 11, 2018, President Trump outlined the American Patients First blueprint (the “Blueprint”), which outlined the approach that the Administration would pursue to lower drug prices. Among several targets for change were PBMs and drug distributors, noting that among the Administration’s top goals was “eliminating the middlemen.”[1]

The Blueprint specifically sets forth the Administration’s belief that “[b]ecause health plans, pharmacy benefit managers [], and wholesalers receive higher rebates and fees when list prices increase, there is little incentive to control list prices.”[2] The Blueprint did not, however, provide any evidence or rationale for these claims. Nevertheless, the Blueprint proposes several changes to the way that PBMs operate, including creating a fiduciary duty for PBMs, and restricting the ability of PBMs to retain a percentage of the rebate collected on behalf of health plans. The Blueprint does not, however, elaborate on the Administration’s plans for drug distributors.

United States Department of Health and Human Services (“HHS”) Secretary Alex Azar elaborated on the Blueprint’s claims during a June 12, 2018 hearing before the Senate Committee on Health, Education, Labor and Pensions, where he claimed that PBMs threatened to remove drugs from their formularies if the drug manufacturers decreased list prices.[3] Secretary Azar repeated these claims on June 26, 2018, before the Senate Committee on Finance, where he claimed that drug manufacturers who voluntarily reduced list prices would be harmed by PBMs that would prioritize competing drugs with higher prices when setting their drug formularies.[4]

Senators and Stakeholders Push Back

In a letter to Secretary Azar , Senators Elizabeth Warren (D-MA) and Tina Smith (D-MN) criticize Secretary Azar’s allegations regarding the role of PBMs in drug pricing, calling them “disturbing and serious.” [5] The Senators argue that PBMs and drug distributors hold themselves out as “key players in negotiating lower drug prices and making the market for drugs more efficient” – directly contrary to Secretary Azar’s claims.[6]

The Senators investigated Secretary Azar’s claims by reaching out to the six largest PBMs and three largest drug distributors in the United States. The PBMs unanimously indicated that they never pushed back or otherwise disadvantaged any drug manufacturer for lowering list prices. Express Scripts noted that lower list prices receive favorable formulary consideration, exactly the opposite of Secretary Azar’s claims.[7] The drug distributors gave similar answers, indicating that they did not influence or have any ability to influence the list prices for drugs. Instead, one drug distributor indicated that it negotiated fees for distribution services “agnostic of [the manufacturer’s] product pricing.”[8]

Moving Forward

The Administration appears unfazed by the questions and concerns of PBMs, drug distributors, and Democratic Senators, and has focused its attention on changes to the way PBMs operate. One manner in which PBMs aim to reduce drug prices is by negotiating rebates with drug manufacturers who want to list their products on PBM formularies. On August 17, 2018, Secretary Azar claimed that HHS has the power to eliminate rebates on prescription drug purchases. While the PBM industry contends that only Congress has the ability to change the rebate system, Secretary Azar stated that rebates were created by HHS regulations, and “[w]hat one has created by regulation, one could address by regulation.” [9]

The Secretary’s claims are likely related to a proposed rule that HHS submitted to the Office of Management and Budget (“OMB”) titled “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection” on July 18, 2018.[10] The OMB is still reviewing the proposed rule, and nothing is currently known about the rule beyond its title; however, Secretary Azar’s comments indicate that the rule may be aiming to adjust or eliminate the ability of PBMs to negotiate with drug manufacturers for rebates. While it is unclear exactly what will be presented in such proposed rule, it appears likely that the Administration will continue pursuing aggressive changes to the way that PBMs operate.

[1] Kerry Dooley Young, Trump Lays Out Drug Plan, Calling for More Competition, Less ‘Global Freeloading’, Medscape (May 11, 2018)

[2] United States Department of Health & Human Services, American Patients First, The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, (May 2018)

[3] Prescription Drug Pricing, C-SPAN, (June 12, 2018)

[4] Prescription Drug Supply and Cost, C-SPAN, (June 26, 2018)

[5] Senator Elizabeth Warren & Senator Tina Smith, Letter to U.S. Department of Health and Human Services Secretary Alex Azar, August 17, 2018, at 3, Senator Elizabeth Warren & Senator Tina Smith, Letter to U.S. Department of Health and Human Services Secretary Alex Azar, August 17, 2018, at 3

[6] Id. The Pharmaceutical Care Management Association, which promotes PBMs nationwide, claims PBMs will save employers, unions, government programs, and consumers $654 on drug costs over the next decade. Pharmaceutical Care Management Association, Our Industry

[7] Senators Warren and Smith, at 4

[8] Id. at 6.

[9] Yasmeen Abutaleb, U.S. Health Secretary Says Agency Can Eliminate Drug Rebates, U.S. News, (Aug. 20, 2018)

[10] Office of Management and Budget, RIN 0936-AA08, (July 18, 2018)

 

Copyright © 2018, Sheppard Mullin Richter & Hampton LLP.

Congress Enacts New Law to Control Foreign Investments in the U.S.

President Trump signed into law the Foreign Investment Risk Review Modernization Act (FIRRMA) to modernize the CFIUS review process to address 21st century national security concerns today. Congress enacted FIRRMA as Title XVII of the Fiscal Year 2019 National Defense Authorization Act, HR 5515.

Background and Rationale for the New Law

The Committee on Foreign Investment in the United States (CFIUS) is an inter-agency committee led by the Treasury Department to review transactions that could result in control of a U.S. business by a foreign person (referred to as “covered transactions”) in order to determine the effect of such transactions on the national security of the United States. CFIUS operates pursuant to section 721 of the Defense Production Act of 1950 (the “Exon-Florio” amendment), as later amended by Congress and as implemented by Executive Order.

For many years, CFIUS has worked to police national security concerns arising from investment in the U.S. by foreign companies and entities. Two transactions in the last few years have made the issue of foreign investment in the U.S. (and the role of CFIUS) notorious: first, the Dubai Ports World controversy in 2006 involving the sale of port management businesses in six major U.S. seaports to a company based in the United Arab Emirates and, second, the 2012 effort by a Chinese-owned company to purchase land for a windfarm next to a U.S. military weapons testing facility in Oregon. Current law governing CFIUS was last updated more than a decade ago, and its jurisdiction has been increasingly perceived as too limited.

Many government and private industry observers have come to believe that the CFIUS review process is neither designed to, nor sufficient to, address modern threats to national security. Their perception was that China and others have cheated the system, exploited the gaps in its authorities, and have structured their investments in U.S. businesses to evade scrutiny. In short, their view was that many transactions that could pose national security concerns often escaped review altogether.

For example, in introducing the bipartisan FIRRMA in late 2017, Sens. Dianne Feinstein (D-CA) and John Cornyn (R-TX) asserted that:

To circumvent CFIUS review, China will often pressure U.S. companies into arrangements such as joint ventures, coercing them into sharing their technology and know-how. This enables Chinese companies to acquire and then replicate U.S.-bred capabilities on their own soil. China has also been able to exploit minority-position investments in early-stage technology companies to gain access to cutting-edge IP, trade secrets, and key personnel. It has figured out which dual-use emerging technologies are in development and not yet subject to export controls.

Substantive Changes in CFIUS Law

To counteract these new threats, FIRRMA is intended to strike a balance between giving CFIUS additional authority that it needs to address modern national security issues without unduly chilling foreign investment in the American economy and slowing American economic growth in the process. The new law refashions the authority of CFIUS to allow it to reach additional types of investments like minority-position investments and overseas joint ventures. Plus, it creates a new streamlined filing process to encourage notification of potentially problematic transactions. The provisions of FIRRMA make the following changes:

  • FIRRMA expands CFIUS jurisdiction to cover minority investments, any change in a foreign investor’s rights regarding a U.S. business, and any device or scheme designed to evade CFIUS, as well as the purchase, lease, or concession of certain real-estate by or to a foreign person.

  • FIRRMA recognizes the authority of CFIUS to review non-controlling, non-passive investments, especially those involving critical technology and critical infrastructure

  • FIRRMA for the first time recognizes the authority and responsibility of CFIUS to protect against the exposure of sensitive personal data as part of its national security jurisdiction.

  • FIRRMA allows CFIUS to include in the review process any emerging and critical technologies and sets reporting requirements for them.

  • FIRRMA expands CFIUS’s ability to unilaterally choose to initiate a review in the case of a breach of a prior agreement with CFIUS and with respect to covered transactions that have not been submitted to CFIUS for review.

FIRRMA modifies the definition for covered transaction to include “other investments” by a foreign person in a U.S. business that owns, operates, manufactures, supplies, or services to critical infrastructure, produces critical technologies, or maintains or collects sensitive personal data of U.S. citizens. The “other investments” provisions is designed to capture small investments that might not otherwise fall within CFIUS jurisdiction because they lack the previously-required threshold of “control.”

Procedural Changes

Among the procedural changes is that FIRRMA establishes a new expedited process for securing CFIUS clearance by filing a five-page “declaration” (instead of a lengthier written notice). After reviewing such a declaration, CFIUS may direct the parties to submit a full notice.

Any party to a covered transaction may choose to follow the declaration approach, but a declaration is mandatory for any “foreign person in which a foreign government has, directly or indirectly, a substantial interest.” This requirement may be waived by CFIUS if the foreign government does not direct the foreign business and the foreign business has previously cooperated with the Committee. CFIUS may also choose to require a mandatory declaration where a U.S. business that controls critical infrastructure, technology, or sensitive personal data is a party to the transaction.

The new legislation also is intended to improve information-sharing with U.S. allies and partners and provides needed additional resources to the panel while maintaining safeguards to ensure that CFIUS would review transactions only when necessary.

Effective Date

Effective immediately, FIRRMA increases the filing and review schedule to 45 days and the investigatory phase to a second 45 day period. The act permits CFIUS to extend the investigation period by another 15 days in “extraordinary circumstances.” The legislation also adds an additional 15 days to the President’s current 15-day review period in extraordinary cases. Thus, relatively complex CFIUS cases may routinely begin to take 105 days (45+45+15) following initiation, instead of the previous 75 days (assuming that the parties do not withdraw and refile their notice).

Certain other provisions of FIRRMA have a delayed effective date (which is the earlier of 18 months following enactment or 30 days after CFIUS determines that it has sufficient resources). For example, the delayed date applies to the expansion of “covered transactions” to include real estate located in important ports or near sensitive US government facilities such as military installations. The delayed date also applies to CFIUS’s expanded jurisdiction with respect to “other investments” in U.S. business that own critical infrastructures or technologies or that maintain sensitive personal data of U.S. citizens.

 

© 2018 Schiff Hardin LLP
This post was written by William M. Hannay of Schiff Hardin LLP.