The World in Brief ( May 1st Edition)
The World in Brief This e-newsletter is provided by courtesy of Reed CNY Business Law, P.C.
Securities - Insider Trading; In re SillaJen
Moon, Eun Sang, chief executive officer of SillaJen, was investigated under the Financial Service and Capital Market Act in Korea. The Korean prosecution office had arrested the ex-CEO and several board members. Moon and the other arrestees allegedly learned that the Phase 3 clinical trial of Pexa-Vec, an oncolytic virus therapy, had failed, and then sold massive numbers of shares before the information became publicly known and the stockโs value fell on the open market.
Such insider trading is clearly a crime in the U.S. In SEC vs Texas Gulf Sulphur, the Second Circuit ruled if insiders obtain undisclosed material information, they must i) disclose the information to the public, or ii) abstain from any transaction regarding that information. And, in U.S. vs. OโHagen, the Supreme Court stated โa person could be liable for insider trading simply by possessing inside information regarding a given security, breaching a fiduciary duty to the source of the information, and then trading [shares] with a self-serving intent, even if he or she would have made the trade anyway.โ However, in Korea the courts have not always been as clear on what constitutes โinsider tradingโ and when it is a crime. This is a case worth watching and we will continue to report it.
์ ๋ผ์ ๋ํ, ๋ฌธ์์์จ๊ฐ ๋ฏธ๊ณต๊ฐ ์ ๋ณด๋ฅผ ์ด์ฉํด ์ฃผ์์ ๊ฑฐ๋ํ๋ค๋ ์ํน์ผ๋ก ๊ฒ์ฐฐ์ ์กฐ์ฌ๋ฅผ ๋ฐ๊ณ ์์ต๋๋ค. ์ ๋ผ์ ์ ํญ์๋ฐ์ด๋ฌ์ค ์น๋ฃ์ ์ธ ํ์ฌ๋ฒก์ ๊ธ๋ก๋ฒ ์์ ์คํ 3 ์ฐจ๊ฐ ์คํจํ๋ค๋ ๋ฐํ๊ฐ ์๊ธฐ์ ์, ๋๋์ ์ฃผ์์ ๋งค๋ํ๋ค๋ ์ํน์ ๋๋ค. ๋ฏธ๊ตญ SEC ๋ ๋ฏธ๊ณต๊ฐ ์ค์์ ๋ณด๋ฅผ ์ด์ฉํ ๋ด๋ถ์ ์ฃผ์๊ฑฐ๋์ ๋ํด ์ฌ๊ฐํ ์ธ์งํ๊ณ , ๊ด๋ จ์๋ค์ ๋ํ ๋ฏผ, ํ์ฌ์ฒ๋ฒ์ ํ๊ณ ์์ต๋๋ค. Texas Gulf Sulphur ์ฌ๊ฑด์์ ์ 2 ์ฐ๋ฐฉ์ํํญ์๋ฒ์์ ๋ด๋ถ์๊ฐ ๋ฏธ๊ณต๊ฐ ์ค์์ ๋ณด๋ฅผ ์ทจ๋ํ์๋ค๋ฉด, ๊ด๋ จ ์ฃผ์๊ฑฐ๋๋ฅผ ์ผ๊ฐํ๊ฑฐ๋ ๋๋ํด๋น ์ ๋ณด๋ฅผ ๋์ค์ ๊ณต๊ฐํด์ผ ํ๋ค๋ ํ๊ฒฐ์ ๋ด๋ ธ์ต๋๋ค. ๋ํ OโHagen ์ฌ๊ฑด์์ ๋ฏธ๊ตญ๋๋ฒ์์ ๋ด๋ถ์ ๋ณด์ ๊ณต์ ๋ฟ๋ง ์๋๋ผ ์ ๋ณด์๋ น์๋ ์ฑ ์์ด ์๋ค๋ ํ๊ฒฐ์ ๋ด๋ ธ์ต๋๋ค. ์ ํฌ ๋กํ์ ์ ๋ผ์ ์ ๋ฏธ๊ณต๊ฐ ์ ๋ณด ์ฃผ์๊ฑฐ๋์ ๋ํ ์ฌ๊ฑด์ ์ถ์ด๋ฅผ ์ฃผ์๊น๊ณ ์ดํด๋ณด๊ณ ๊ณ ๊ฐ๋ค์๊ฒ ์ ํํ ์ ๋ณด๋ฅผ ์ ๋ฌํด์ฃผ๊ณ ์์ต๋๋ค.
Related news: https://www.sec.gov/fast-answers/answersinsiderhtm.html http://www.koreabiomed.com/news/articleView.html?idxno=7616
FDA โ Lifting Requirements for COVID-19 Products
The US FDA week issued guidance detailing exclusions and exemptions to certain Drug Supply Chain Security Act (DSCSA) requirements, due to the COVID-19 public health emergency. The guidance โensure[s] adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19.โ The DSCSA was signed into law in 2013 and, despite delays in enforcement of some provisions, has been credited with improving drug traceability throughout the supply chain. During this public health emergency, certain DSCSA wholesaling and distribution requirements for drugs and products that treat COVID-19 do not apply. The FDA stresses, however, that distribution of products unrelated to COVID-19 โmust comply with all applicable DSCSA requirements.โ FDA cautions that trading partners must still take appropriate steps when suspect or illegitimate products are found. Our firm is able to assist clients in navigating the ever-changing rules and regulations.
๋ฏธ FDA ๋ COVID-19 ์ ์ํฅ์ผ๋ก ์ฝํ๊ณต๊ธ๋ณดํธ๋ฒ์ ์์ธ์กฐํญ์ ๋ํ ๊ฐ์ด๋๋ผ์ธ์ ๋ฐํํ์ต๋๋ค. ํด๋น๊ฐ์ด๋๋ผ์ธ์ ์ฝ๋ก๋๋ฐ์ด๋ฌ์ค์ ์น๋ฃ๋ฅผ ์ํ ์ฒ๋ฐฉ์ฝ์ ์ ์ ํ ๋ฐฐ๋ถ์ ๋ชฉ์ ์ผ๋ก ์ฐ์ฌ์ก์ต๋๋ค. ๊ทธ๋ฌ๋, FDA ๋ ์ฝ๋ก๋๋ฐ์ด๋ฌ์ค์ ์น๋ฃ์ ๊ด๊ณ์๋ ์ฝํ๋ค์ ๋ํด์๋ ์์ธ์กฐํญ์ ์ ์ฉํ์ง ์๋๋ค๊ณ ๊ฐ์กฐํ์ต๋๋ค. ์ ํฌ ๋กํ์ ํด๋น ๊ฐ์ด๋๋ผ์ธ์ ์์ธํ ์ค๋ช ์ด ํ์ํ ๊ณ ๊ฐ๋ค์๊ฒ ์ปจ์คํ ํด๋๋ฆฌ๊ณ ์์ต๋๋ค.
Related news: https://www.fda.gov/media/137478/download
BIO-PHARMA โ Drug Shortage; DA Eases Guidance on Compounders
Stockpiles of many drugs are running low in the US - Pfizer and Teva announced they are running out of azithromycin, and the FDA said it will allow (a) importation of many drugs from unapproved foreign facilities and (b) compounders to repackage or combine propofol to meet hospital needs. The full extent of US shortages may never be learned, but this is clearly an unprecedented opportunity for international drug manufacturers to sell their products in the U.S. Our firm can interpret FDA guidances, making drug exporting to the U.S. faster and more profitable than ever before.
ํ์ด์์ ์ฝ๊ณผ ํ ๋ฐ์ ์ฝํ์ฌ๋ ํญ์์ ์ธ ์์งํธ๋ก๋ง์ด์ ์ ๋ณด์ ๊ณ ๊ฐ ์ค๊ณ ์๋ค๊ณ ๋ฐํํ์ต๋๋ค. ์ฝํ๊ณต๊ธ์ ์ฐจ์ง์ ์ฐ๋ คํ ๋ฏธ FDA ๋ 1. ์ธ๊ฐ๋์ง์์ ๋ฏธ๊ตญ ์ธ์ ๊ณต์ฅ์์ ์ ์กฐํ ์ฝํ์์ ์ ํ์ฉํ๊ณ 2. ๋ณ์๋ค์ ์์๋ฅผ ์ถฉ์กฑ์ํค๊ธฐ ์ํด ํ๋กํฌํด์ ์ฌํฌ์ฅ์ ํ์ฉํ์ต๋๋ค. ์ ์ฒด ์ฝํ์์์ ๋ฏธ๋ฌ์ ๋ํ ๋ถ์์ ํ์ฌ๋ก์ฌ ์ด๋ ต์ง๋ง, ๊ธ๋ก๋ฒ ์ ์ฝ์ ์กฐํ์ฌ์๊ฒ ์ ๋ก์๋ ๊ธฐํ์ธ ๊ฒ์ ๋ถ๋ช ํฉ๋๋ค. ์ ํฌ ๋กํ์ FDA ์ ์ ์ฑ ๋ฐํ์ ๋ํ ๋ถ์ ๋ฐ ์ปจ์คํ ์ ๊ณ ๊ฐ๋ค์๊ฒ ํด๋๋ฆฌ๊ณ ์์ต๋๋ค.
Related news: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Mida zolam+Injection%2C+USP&st=c&tab=tabs-4&panels=0
Real Estate โ Remote Real Estate Closing
Spring is usually the busiest time of the year for real estate sales. The industry is drastically changed, however, because of COVID-19. Even though real estate can be a wonderful investment when the stock market is uncertain, sellers, buyers, realtors, lawyers and banks are unsure how to do deals. In New York, however, Executive Order 202.6 allows real estate transaction to be conducted remotely โ everything from virtual showings of the property, to virtual notarizations, to using virtually notarized Powers of Attorney (POA) at closing. Reed Business Law has already consulted on closings under the new guidelines and can report that deals are being closed. If you are looking for real estate bargains during this pandemic, our firm can help.
๋ด์ ์ด์ฌ์ ๊ณ์ ์ ๋๋ค. ๊ทธ๋ฌ๋ ์ฝ๋ก๋๋ฐ์ด๋ฌ์ค์ ์ํฅ์ผ๋ก ์ฌํด๋ด์ ๋ถ๋์ฐ์์ฅ์ ์๋ ๊ณผ ํ์ ํ ๋ค๋ฆ ๋๋ค. ์ฃผ์์์ฅ์ ๋ถํ์ค์ฑ์ด ๋์์ ๋ถ๋์ฐ์ ๋งค๋ ฅ์ ์ธ ํฌ์์ด๋, ํ์ฌ ํ๋งค์, ๊ตฌ๋งค์, ๋ณํธ์ฌ, ์ํ ๋ฑ, ๋ถ๋์ฐ ๊ฑฐ๋์ฃผ์ฒด๋ค์ ์ ๋ป ๊ฑฐ๋์ ๋์์ง ์์ผ๋ ค๊ณ ํฉ๋๋ค. ๋ด์์ฃผ์์๋ ํ์ ๋ช ๋ น 202.6 ์ ์๊ฑฐํด ๋ถ๋์ฐ๊ฑฐ๋๊ฐ ๊ฐ์ ์ ์ผ๋ก ์ด๋ฃจ์ด์ง์ ์๊ฒ ํ์ต๋๋ค. ๋น์ฌ์๋ค์ด ์ง์ ๊ณ์ฝ์ ์ํ์ง ์๋๋ผ๋ ๊ฐ์ ๊ณต์ฆ์ด ๋ ์์์ฅ์ด ์์ผ๋ฉด, ๊ฑฐ๋๋ฅผ ์ธ์ ํ๊ณ ์์ต๋๋ค. ์ ํฌ ๋กํ์ ์์ ์ฉ, ์ฃผ๊ฑฐ์ฉ ๋ถ๋์ฐ์ ๋งค๋งค, ์ทจ๋์ ๋ํด ์ต์ ์ ์๋ด์ ํด๋๋ฆฌ๊ณ ์์ต๋๋ค.
Related news: https://esd.ny.gov/guidance-executive-order-2026