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:  

“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.”

“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.