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The World in Brief (June 1st Edition)

The World in Brief This e-newsletter is provided courtesy of Reed CNY Business Law, P.C.


Businesses routinely purchase insurance to provide protection against many risks – Errors and Omissions, General Liability, Automobile, Health, Life, etc. “Business Interruption Insurance” is a lesser- known policy, providing money to a business when it can’t operate due to damages to its physical spaces, such as a fire that burns through a warehouse, a flood that inundates an office, or a tornado that tears the roof off a distribution center. As with all policies, however, the significant language is not the type of coverage – ‘business interruption insurance’ – but the types of exclusions. For example, interruptions due to tornados and hurricanes may be excluded in some geographic areas, while shut downs due to floods may not be covered in others. And many policies will not cover losses a business suffers if it is shut down as a result of governmental orders. So, it is likely that claims put in by companies closed down due to government orders related to corona virus may be denied by the insurance company. The likelihood of denial increases the longer business remain closed and the more companies that place claims under their policies. Proper interpretation of the language in the insurance policy (which is a contract), proper documentation of the amounts of losses and cause of losses, and accurate communication of the claim will minimize the chance of denial. If your company has been forced to shut down completely, or has had to reduce its operations, Reed Business Law can review your policies and improve your chances of receiving the coverage benefits you paid for.

비지니스를 경영하는데는 리스크가 항상 따르게 되므로, 보험에 가입하는 것은 매우 중요한 사업의 일부분입니다. “휴업보험”은 천재지변등의 이유로 사업진행이 불가하게되었을때 보험회사에서 가입자에게 지급되는 보험입니다. 휴업보험가입자는 어떤상황에서 보헙지급이 거부되는지를 잘 알고 있어야 합니다. 허리케인 등의 이유로 휴업을 결정하였다하더라도 그러한 재난이 빈번히 일어나는 지역에서 사업을 하는 가입자는 휴업보험의 지급이 거부될수도 있습니다. 무엇보다 보험가입계약서의 원문을 잘이해하고 적시에 보험금 지급청구를 신청하는 것이 중요합니다. 저희 로펌은 이러한 휴업보험의 가입과 계약서 컨설팅들의 업무를 클라이언트들에게 제공해드리고 있습니다.

Bio-Pharma – FDA Provides New Tool of Diagnostic Tests Kits for COVID-19 U.S. FDA announced that it began to provide a SARS-CoV-2 reference panel to support industry’s effort for manufacturing diagnostic test kits for COVID-19. According to FDA, the reference panel is additional help to ensure the quality of the tests, validation of new assay, test calibration, and monitoring assay performance. FDA developed the similar measure to respond the needs of proper reference panel, when ZIKA outbreak was in 2015. Important issue is, since the reference panel for COVID-19 is brand-new, it can be confused to not only Americans, but international manufacturers. Reed Business Law assures our clients that we provide the excellent consulting about any issues with diagnostic test kits.

미국 FDA 는 코비드 19 의 진단키트제조사들의 FDA 신청을 좀더 용이하게 도모하기 위해, 관련 패널을 개발하여 지급했습니다. 지난 2015 년 지카바이러스 창궐시에도 FDA 는 관련 패널을 지급하여 지카바이러스 진단키트 제조사들이 쉽게 FDA 신청을 하여 공중보건에 이바지할수있도록 노력한바있습니다. 코비드 19 진단키트 패널은 간단하지만, 시장에 처음 발표되었기 때문에, 제조사들에게 혼동을 줄수있습니다. 저희로펌은 진단키트제조사들의 어려움을 충분히 이해하고 그에맞는 컨설팅을 해드리고 있습니다.

Bio-Pharma – FDA Updates the Guidance, “Conduct of Clinical Trials of Medical Products”

U.S. FDA updated the guidance, “Conduct of Clinical Trials of Medical Products during COVID- 19 Public Health Emergency” by adding Q & A sections. The updated guideline has electronic systems that are used to generate electronic signatures on clinical trial records. In addition, the guidance expands on an existing Q & A about remote clinical outcomes assessments (COAs) to include four types of COAs: performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes, and observer-reported outcomes. Reed Business Law interprets the most updated FDA’s guidelines for clients so that clients would communicate with FDA effectively.

미국 FDA 는 최근 코비드 19 관련 의료기기를 위한 임상실험에 대한 가이드라인을 업데이트했습니다. 업데이트된 가이드라인에는 임상기록의 전자서명 기능뿐만 아니라, 간접 임상실험결과에 대한 질의응답에 관한 부분을 심화했습니다. 저희로펌은 업데이트된 FDA 가이드라인에 대해 상세하고 전문적인 컨설팅을 클라이언트들에게 제공해드리고 있습니다.

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