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 stock’s 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. O’Hagen, the Supreme Court stated “a 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.” However, in Korea the courts have not always been as clear on what constitutes ‘insider trading’ and when it is a crime. This is a case worth watching and we will continue to report it.

신라젠 대표, 문은상씨가 미공개 정보를 이용해 주식을 거래했다는 의혹으로 검찰에 조사를 받고있습니다. 신라젠의 항암바이러스 치료제인 펙사벡의 글로벌 임상 실험 3 차가 실패했다는 발표가 있기전에, 대량의 주식을 매도했다는 의혹입니다. 미국 SEC 는 미공개 중요정보를 이용한 내부자 주식거래에 대해 심각히 인지하고, 관련자들에 대한 민, 형사처벌을 하고있습니다. Texas Gulf Sulphur 사건에서 제 2 연방순회항소법원은 내부자가 미공개 중요정보를 취득하였다면, 관련 주식거래를 삼가하거나 또는해당 정보를 대중에 공개해야 한다는 판결을 내렸습니다. 또한 O’Hagen 사건에서 미국대법원은 내부정보제공자 뿐만 아니라 정보수령자도 책임이 있다는 판결을 내렸습니다. 저희 로펌은 신라젠의 미공개 정보 주식거래에 대한 사건의 추이를 주의깊고 살펴보고 고객들에게 정확한 정보를 전달해주고 있습니다.

Related news: https://www.sec.gov/fast-answers/answersinsiderhtm.html http://www.koreabiomed.com/news/articleView.html?idxno=7616

FDA – 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 “ensure[s] adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19.” 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 “must comply with all applicable DSCSA requirements.” 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.

미 FDA 는 COVID-19 의 영향으로 약품공급보호법의 예외조항에 대한 가이드라인을 발표했습니다. 해당가이드라인은 코로나바이러스의 치료를 위한 처방약의 적절한 배분의 목적으로 쓰여졌습니다. 그러나, FDA 는 코로나바이러스의 치료에 관계없는 약품들에 대해서는 예외조항을 적용하지 않는다고 강조했습니다. 저희 로펌은 해당 가이드라인의 자세한 설명이 필요한 고객들에게 컨설팅 해드리고 있습니다.

Related news: https://www.fda.gov/media/137478/download

BIO-PHARMA – 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.

파이자제약과 테바제약회사는 항생제인 아지트로마이신의 보유고가 줄고있다고 발표했습니다. 약품공급의 차질을 우려한 미 FDA 는 1. 인가되지않은 미국 외의 공장에서 제조한 약품수입을 허용하고 2. 병원들의 수요를 충족시키기 위해 프로포폴의 재포장을 허용했습니다. 전체 약품수요의 미달에 대한 분석은 현재로썬 어렵지만, 글로법 제약제조회사에겐 전례없는 기회인 것은 분명합니다. 저희 로펌은 FDA 의 정책발표에 대한 분석 및 컨설팅을 고객들에게 해드리고 있습니다.

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 – 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 – 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.

봄은 이사의 계절입니다. 그러나 코로나바이러스의 영향으로 올해봄의 부동산시장은 예년과 현저히 다릅니다. 주식시장의 불확실성이 높을시 부동산은 매력적인 투자이나, 현재 판매자, 구매자, 변호사, 은행 등, 부동산 거래주체들은 선뜻 거래에 나서지 않으려고 합니다. 뉴욕주에서는 행정명령 202.6 에 의거해 부동산거래가 간접적으로 이루어질수 있게 했습니다. 당사자들이 직접 계약에 임하지 않더라도 간접 공증이 된 위임장이 있으면, 거래를 인정하고 있습니다. 저희 로펌은 상업용, 주거용 부동산의 매매, 취득에 대해 최선의 상담을 해드리고 있습니다.

Related news: https://esd.ny.gov/guidance-executive-order-2026