Holland & Knight - Israel Practice Newsletter: Spring 2019

ISRAEL PRACTICE NEWSLETTER TABLE OF CONTENTS

SPRING 2019

Introduction.................................................................................................................................................... 2 Financial Companies Should Review SCRA and MLA Requirements to Avoid Costly Issues........................... 2 FDA’s New Pharma Shame Game.................................................................................................................. 3 Legal Issues and Challenges in the Cosmetics Industry.................................................................................. 3 Prospering with Pop-Ups: Legal Considerations for Landlords and Tenants.................................................... 4 E-2 Treaty Investor Visas Available to Israeli Nationals as of May 1, 2019........................................................ 4 CleanTech: Billions of Dollars Are Available Through U.S. Federal Funding Programs...................................... 5 FDA Considering Changes to Regulation of CBD Products............................................................................. 5

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ISRAEL PRACTICE

NEWSLETTER Holland & Knight is a U.S.-based global law firm with a strong commitment to the state of Israel. We focus on providing guidance to Israeli investors and companies interested in doing business in the United States and Latin America. With more than 1,300 professionals in 28 offices, our lawyers and professionals are highly experienced in all the interdisciplinary areas necessary to guide entrepreneurs, investors, and startup or established companies through the opportunities and challenges that arise throughout the business or investment life cycles.

Areas of legal guidance that are typically provided to our Israel Practice clients include real estate, mergers and acquisitions, private equity, international tax, cross border and customs, Internet privacy and cybersecurity, intellectual property, government lobbying, regulations and compliance, U.S. Foreign Corrupt Practices Act (FCPA), U.S. Foreign Account Tax Compliance Act (FATCA), and litigation and dispute resolution.

We invite you to read our Israel Practice newsletter, in which our authors discuss pertinent American-Israeli topics. As Israel has been a crossroads and a prolific source of new ideas for more than 3,000 years, a natural tradition of inventiveness finds its most recent expression in the creation of a technology startup ecosystem with global impact. This newsletter addresses, among other relevant topics, how the innovative technologies and ideas generated in Israel can be deployed in the United States and globally. We invite you to discuss your thoughts on this issue with our authors listed within the document.

Financial Companies Should Review SCRA and MLA Requirements to Avoid Costly Issues

By Leonard A. Bernstein and Daniel T. Sylvester Israeli companies that want to do business in the U.S. and have business models that are based on, or include, lending money or other financial transactions, or leasing real or personal property, need to be aware of the Servicemembers Civil Relief Act (SCRA) and the Military Lending Act (MLA).

The SCRA and MLA were enacted by the U.S. Congress to protect service members and their families from financial, and other civil, risks associated with or exacerbated by their military service.

The U.S. Department of Justice (DOJ) enforces the SCRA. Over the last seven years, the DOJ has returned $471 million of compensation to more than 119,000 service members whose rights were violated under the SCRA. Those rights include, a 6 percent rate cap on any financial obligations that were incurred prior to a service member entering active duty.

This would include, among other things, student loans, car loans, mortgages and credit card debt. Additionally, if a service member has a lease on a vehicle, there are certain rules that apply when he/she receives orders and wants to return the vehicle prior to the lease expiration date. Finally, a lender cannot foreclose on a service member’s preservice mortgage without a court order, even in a U.S. state that has a nonjudicial foreclosure procedure.

Read full article >> 2

FDA’s New Pharma Shame Game

By Eric H. Yecies On May 17, 2018, the U.S. Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used “certain ‘gaming’ tactics to delay generic competition.” The list is intended to “improv[e] transparency about this and other gaming tactics that delay the generic competition Congress intended.”

In particular, the FDA seeks to discourage branded pharmaceutical companies from preventing potential generic applicants from obtaining samples of certain brand products necessary to support approval of a generic drug. Typically, generic applicants need between 1,500 and 5,000 units of the branded product to conduct studies seeking to demonstrate the necessary bioequivalence of its proposed generic product to the branded product.

This information provides Israeli generic-focused pharmaceutical and biotechnology companies with another avenue to facilitate overcoming problems in accessing certain branded pharmaceutical products for generic development work or a new tool should they encounter such problems moving forward.

Read full article >>

Legal Issues and Challenges in the Cosmetics Industry

By Charles A. Weiss Israeli companies manufacturing, importing, distributing or selling cosmetics face a number of legal challenges that are unique to that industry. Persons investing in cosmetics companies, or considering entering the U.S. market, should also be aware of these particular challenges. If not completely understood and planned for, these issues can derail what would otherwise be a successful venture.

With appropriate legal and regulatory guidance, however, the challenges can be addressed in advance to minimize potential disruption and reduce the risk of incurring costs to address problems after they manifest.

This article presents a brief overview of several areas of law that are either unique to the cosmetics industry, or present risks that are different from other types of consumer products categories. Its purpose is to surface these issues in a way that can help provide guidance as to when to engage specialty counsel and what questions to ask.

Read full article >>

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Prospering with Pop-Ups: Legal Considerations for Landlords and Tenants What Is the Proper Way to Draft a Pop-Up Store Agreement to Avoid Issues Later On?

By Herman R. Lipkis Short term or “pop-up” retail has grown from a limited seasonal business to a multibillion-dollar industry. Pop-up shops provide an excellent opportunity for new or established Israeli companies to test out their products in the U.S. market without taking on the risk and significant costs associated with a long-term lease. For real estate owners and operators, pop-ups can help fill an otherwise vacant space and drive additional traffic to your mall or shopping center without the need to expend significant sums on tenant improvements and buildouts. Many agreements for pop-ups or short-term tenants are structured as license agreements instead of leases. License agreements for pop-up operations may contain significantly different terms than conventional retail lease and should thus be negotiated and drafted carefully. This article highlights some considerations that any Israeli landlord, tenant or operator should consider before entering into an agreement for a pop-up arrangement in the United States.

While temporary “pop-up” stores are not a new concept, their prevalence has grown exponentially in recent years. Anyone who has ever purchased a Halloween costume or a Christmas tree has likely visited a pop-up store; however this type of retail is no longer limited to focusing on holiday decorations or special events. Today, one can find pop-ups selling everything from the newest electronics to the hottest fashion accessories.

Read full article >> Reprinted with permission from National Real Estate Investor

E-2 Treaty Investor Visas Available to Israeli Nationals as of May 1, 2019

By Tara L. Vance The U.S. Embassy in Israel has finally made the long-awaited announcement that the required treaty agreement has been signed pursuant to which nationals of Israel will be able to apply for an E-2 visa as of May 1, 2019.

What Is an E-2 Visa?

An E-2 visa is a nonimmigrant work visa that permits a national of a qualifying country, such as Israel beginning May 1, 2019, to come to the U.S. temporarily if a number of prerequisites are satisfactorily met.

Read full article >>

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CleanTech: Billions of Dollars Are Available Through U.S. Federal Funding Programs

By Meital Stavinsky While it may appear as though the U.S. federal government’s support of CleanTech and related innovative technologies has been diminished, the reality is far from it. U.S. Congressional support for CleanTech research and development remains strong.

The budgets of applicable programs at U.S. federal agencies has even been increased from previous years in some cases.

Among the relevant agencies are the U.S. Department of Energy (DOE) and U.S. Department of Defense (DOD). Grant funding at most agencies is now flowing at a rate in line with historical norms. Billions of dollars are available through grants, cooperative agreements, procurements and other transactions.

If the U.S. is a significant target market for your company, U.S. grant funding comes with potentially significant benefits, including prestige, non-dilutive capital and technical validation, and can be regarded as a purported “stamp of approval” with great value, particularly for foreign companies. Although U.S. federal funding is primarily designated to U.S. awardees, there are ways in which Israeli companies can also qualify. However, it is important to note that such funding has several potential pitfalls, including complicated application procedures, long planning horizons, and significant post-award accounting and reporting requirements.

Read more about the CleanTech U.S. federal funding programs and opportunities >>

FDA Considering Changes to Regulation of CBD Products Agency Holds Public Hearing on Cannabis to Gather Input from Stakeholders, Consumers

By Michael J. Werner and Sara M. Klock The U.S. Food & Drug Administration’s (FDA) actions to modify its existing regulations of CBD food and dietary supplement products could dramatically change the U.S. market. Under current law, FDA prohibits the sale of such products though it has so far focused its regulatory enforcement on companies, including Israel-based companies, that make egregious medical claims about CBD. FDA is likely to announce proposed regulatory changes later this summer or in the early fall.

The U.S. Food and Drug Administration (FDA) held a nine-hour public hearing on May 31, 2019, to gather scientific data and information from approximately 140 stakeholders representing various industries as well as consumers about the safety, manufacturing, quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds. FDA has signaled it is considering modifications to its regulation of these products.

Read full article >>

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A Strong Commitment to the State of Israel Holland & Knight is a U.S.-based global law firm with a strong commitment to the state of Israel. We focus on providing guidance to Israeli investors and companies interested in doing business in the United States and Latin America. With more than 1,300 professionals in 28 offices, the lawyers and professionals in our Israel Practice are highly experienced in all of the interdisciplinary areas necessary to guide an entrepreneurial or an established company through the opportunities and challenges that arise throughout the company’s life cycle.

Areas of legal guidance that are typically provided to our Israel Practice clients include real estate, mergers and acquisitions, private equity, international tax, cross border and customs, internet privacy and cybersecurity, intellectual property, government lobbying, regulations and compliance, reimbursement, U.S. Foreign Corrupt Practices Act (FCPA), U.S. Foreign Account Tax Compliance Act (FATCA), and litigation and dispute resolution.

Among our Israeli clients are leading innovative technology companies in a wide range of industries, including information technology, advanced transportation, agtech, cleantech, healthcare and life sciences, medical devices and cybersecurity.

Our Israeli real estate clients are leading commercial and residential developers and investors, and Holland & Knight’s venture capital and private equity attorneys advise both Israeli funds and U.S. funds investing in Israeli companies.

A core value of Holland & Knight is our dedication to delivering the highest quality of legal services and providing responsive and cost-effective counsel to every client. This core value of the firm – coupled with our business acumen, legal experience and solid commitment to the Israeli marketplace – enables us to successfully assist our Israeli clients operating in the United States, as well as companies and investors doing business in Israel. The members of our team have client and business meetings in Israel on a regular basis and would be delighted to arrange for a meeting in person. Please do not hesitate to reach out to us with any questions, as we look forward to helping you excel and achieve your business goals in the U.S. and Latin America.

‫מחויבות עמוקה למדינת ישראל‬ ‫ אנו מתמקדים במתן שירותי יעוץ למשקיעים וחברות ישראליות‬.‫ הינה פירמת עורכי דין אמריקאית גלובלית בעלת מחויבות עמוקה לשוק הישראלי‬Holland & Knight ‫ עורכי דין ואנשי מקצוע‬1,250-‫ מעסיקה למעלה מ‬Holland & Knight ‫ פירמת עורכי הדין‬.‫המעוניינים להרחיב פעילות או להשקיע בארצות הברית ובאמריקה הלטינית‬ ‫ ומספקים מגוון‬,‫ הפוליטיקה והסביבה החברתית בישראל‬,‫ הינם בעלי הבנה עמוקה של הכלכלה‬Holland & Knight ‫ חברי הפרקטיקה הישראלית של‬.‫ משרדים‬27-‫ב‬ ‫ לחברי הפרקטיקה הישראלית שלנו ניסיון רב בכל תחומי המשפט‬.‫רחב של שירותים משפטיים ללקוחות ישראלים שפועלים בחו"ל ולחברות ומשקיעים הפועלים בישראל‬ .‫ חברות הזנק וחברות מבוססות בכל שלבי ותהליכי הצמיחה וההתפתחות של החברה‬,‫ משקיעים‬,‫הנחוצים כדי להנחות יזמים‬ ‫ פרטיות ואבטחת‬,‫ מסחר בינלאומי ומכסים‬,‫ מיסוי בינלאומי‬,‫ קרנות השקעה‬,‫ מיזוגים ורכישות‬,‫ נדל"ן‬,‫התחומים בהם אנו מייעצים ללקוחותינו הישראלים כוללים בין היתר‬ .‫ סיוע ביישוב סכסוכים עסקיים וליטיגציה‬,FATCA -‫ ו‬FCPA ‫ לרבות‬,‫ ייעוץ לוביסטי ורגולטורי‬,‫ קניין רוחני‬,‫מידע‬ ,‫ מים‬,‫ סביבה‬,‫ חקלאות‬,‫ תחבורה חכמה‬,‫ לרבות בתחומי טכנולוגיות מידע ותקשורות‬,‫בין לקוחותינו הישראלים נמנות חברות מובילות בתחומי החדשנות הטכנולוגית‬ .‫ עם לקוחות הנדל"ן שלנו נמנים משקיעים וחברות מובילות העוסקים הן בנכסים לשימוש מסחרי והן בנכסי נדל"ן למגורים‬.‫ ציוד רפואי ואבטחת מידע‬,‫ מדעי החיים‬,‫אנרגייה‬ .‫עם לקוחותינו בתחומי ההון סיכון וקרנות השקעה נמנות קרנות ישראליות וקרנות זרות המשקיעות בישראל‬ ‫ ערך‬.‫ הוא מחויבותנו להעניק שירותים משפטיים באיכות הגבוהה ביותר ולספק יעוץ אישי המותאם לצרכיו של כל לקוח ולקוח‬Holland & Knight ‫ערך מרכזי של‬ ‫ מאפשרים לנו לסייע בהצלחה ללקוחותינו הישראלים הפועלים בארצות‬- ‫ הניסיון המשפטי ומחויבותנו האיתנה לשוק הישראלי‬,‫מרכזי זה בשילוב האינטיליגציה העסקית‬ ‫ נפגשים עם לקוחות בישראל באופן קבוע‬,‫ שחלקם דוברי עברית‬,‫ חברי הפרקטיקה הישראלית שלנו‬.‫ ולחברות ומשקיעים הפועלים בישראל‬,‫הברית ובאמריקה הלטינית‬ .‫וישמחו לתאם פגישות עם חברות ויזמים המעוניינות ללמוד על הדרכים בהן נוכל לסייע להצלחת מיזמים עסקיים בארצות הברית ובאמריקה הלטינית‬

For inquiries regarding this newsletter, you may contact: Ronald J. Klein Co-Chair, Israel Practice Fort Lauderdale +1.954.468.7874

Meital Stavinsky Co-Chair, Israel Practice Miami +1.305.789.7710

Washington, D.C. +1.202.469.5152 ron.klein@hklaw.com

Washington, D.C. +1.202.828.5004 meital.stavinsky@hklaw.com 6

Media Mentions FDA scruples on CBD hit cannabis sector, Globes, Meital Stavinsky, June 2, 2019 Four Days, 20 Trade Pacts between Florida-Israeli Business, Tech, Academic Groups, Sunshine State News, Ron Klein, May 30, 2019 Funding Sources for Israel’s High-Tech Industry, Globes, Meital Stavinsky, May 28, 2019 Data Protection in the U.S.: What Israeli Companies Need to Know, The Times of Israel, Meital Stavinsky, May 26, 2019 Cannabis-Tech Transforms Israel from a Start-Up Nation into an AgTech Nation, The Times of Israel, Meital Stavinsky, May 12, 2019 Israel Taps Holland & Knight for U.S. Diplomatic Representation, Daily Business Review, Meital Stavinsky, April 29, 2019 What Israeli Entrepreneurs Need to Know About the New E-2 Visa, The Times of Israel, Meital Stavinsky, April 28, 2019 South Floridians React to Close Israeli Election, South Florida Sun-Sentinel, Meital Stavinsky, April 10, 2019 Five Things Entrepreneurs Should Consider Before Moving to the U.S., GeekTime, Meital Stavinsky, April 10, 2019 Women Discover the Benefits of Cannabis, TheMarker Women, Meital Stavinsky, April 3, 2019 From “Cannabis Nation” to “AgTech Nation”, Globes, Meital Stavinsky, April 1, 2019 How Startup Nation Could Make Medical Marijuana ‘The Next Coca Cola’, Haaretz, Meital Stavinsky, March 7, 2019 Daily Chip, People and Computers, Meital Stavinsky, February 21, 2019 What a Company Needs to Know Before Expanding Operations to the U.S., Calcalist, Meital Stavinsky, February 20, 2019 Harvest the Billions: Israeli HighTech Stops Being Afraid of Cannabis, The Marker, Meital Stavinsky, February 17, 2019 Watch: Women Entrepreneurs - How to Plant Change, The Marker, Meital Stavinsky, February 17, 2019

Speaking Engagements Expand Your Business to the U.S. – Do’s and Don’ts, Israel-USA Business Summit, Meital Stavinsky, Ron Klein, May 29, 2019 Security, Sustainability, Prosperity: The Story Behind U.S. – Israel Food and Water Cooperation in a Changing Climate and a Resource-Starved World, American Israel Public Affairs Committee (AIPAC) Policy Conference, Meital Stavinsky, March 24, 2019 How Women in Tech Can Enhance the Business Landscape, Women in Technology International (WITI) Summit, Meital Stavinsky, January 30, 2019 Sowing Seeds of Change – Women Agtech & Foodtech Entrepreneurship, Israeli Women Business Builders: The Untapped Resource of the Economy, Start-Up Nation Central, Meital Stavinsky, January 16, 2019

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