• Title/Summary/Keyword: LICENSING

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Determine Optimal Timing for Out-Licensing of New Drugs in the Aspect of Biotech (신약의 기술이전 최적시기 결정 문제 - 바이오텍의 측면에서)

  • Na, Byungsoo;Kim, Jaeyoung
    • Knowledge Management Research
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    • v.21 no.3
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    • pp.105-121
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    • 2020
  • With regard to the development of new drugs, what is most important for a Korean Biotech, where no global sales network has been established, is decision-making related to out-licensing of new drugs. The probability of success for each clinical phase is different, and the licensing amount and its royalty vary depending on which clinical phase the licensing contract is made. Due to the nature of such a licensing contract and Biotech's weak financial status, it is a very important decision-making issue for a Biotech to determine when to license out to a Big Pharma. This study defined a model called 'optimal timing for out-licensing of new drugs' and the results were derived from the decision tree analysis. As a case study, we applied to a Biotech in Korea, which is conducting FDA global clinical trials for a first-in-class new drug. Assuming that the market size and expected market penetration rate of the target disease are known, it has been shown that out-licensing after phase 1 or phase 2 of clinical trials is a best alternative that maximizes Biotech's profits. This study can provide a conceptual framework for the use of management science methodologies in pharmaceutical fields, thus laying the foundation for knowledge and research on out-licensing of new drugs.

SCALING ANALYSIS IN BEPU LICENSING OF LWR

  • D'auria, Francesco;Lanfredini, Marco;Muellner, Nikolaus
    • Nuclear Engineering and Technology
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    • v.44 no.6
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    • pp.611-622
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    • 2012
  • "Scaling" plays an important role for safety analyses in the licensing of water cooled nuclear power reactors. Accident analyses, a sub set of safety analyses, is mostly based on nuclear reactor system thermal hydraulics, and therefore based on an adequate experimental data base, and in recent licensing applications, on best estimate computer code calculations. In the field of nuclear reactor technology, only a small set of the needed experiments can be executed at a nuclear power plant; the major part of experiments, either because of economics or because of safety concerns, has to be executed at reduced scale facilities. How to address the scaling issue has been the subject of numerous investigations in the past few decades (a lot of work has been performed in the 80thies and 90thies of the last century), and is still the focus of many scientific studies. The present paper proposes a "roadmap" to scaling. Key elements are the "scaling-pyramid", related "scaling bridges" and a logical path across scaling achievements (which constitute the "scaling puzzle"). The objective is addressing the scaling issue when demonstrating the applicability of the system codes, the "key-to-scaling", in the licensing process of a nuclear power plant. The proposed "road map to scaling" aims at solving the "scaling puzzle", by introducing a unified approach to the problem.

A Study on Analysis of Information on Technology Valuation for Technology Licensing (기술 라이센싱과 기술가치 평가정보 분석기법 연구)

  • Park, Hyun-Woo
    • Journal of Information Management
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    • v.32 no.2
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    • pp.54-71
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    • 2001
  • This paper analyzes the role of technology valuation in licensing, a commonly used type of transaction of technology, and reviews methods to analyze information on technology valuation for technology licensing. It contemplates the concepts, types and practical application of cost-based valuation, market-based valuation, discounted cash flow, and economic analysis. It shows that each method considers how to share profits associated with technology between licensor and licensee in a fair and reasonable manner when we apply any method to technology licensing.

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Policies on Complementary and Alternative Medicine in the United States - Focusing on Licensing and Insurance - (미국의 보완대체의학 제도와 정책 - 면허제도와 의료보험급여를 중심으로 -)

  • Lim, Byung-Mook
    • Journal of Society of Preventive Korean Medicine
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    • v.14 no.1
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    • pp.137-149
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    • 2010
  • In recent decades, as the utilization of complementary and alternative medicine in the United State have been growing rapidly, regulatory controls surrounding complementary and alternative medicine(CAM) aims to ensure patient protection against unproven practices and to provide safe and effective treatments. Regulation and policy method on licensing CAM practitioners varies across the states. Over 85% of the states have the licensing system for acupuncturists, chiropractors, and naturopaths. For acupuncture, although the requirements for formal education are various across the states, a unified written examination has been adopted by almost entire states which have acupuncturist licensing law. Medicare, the public medical insurance, does not cover CAM practices except chiropractic and biofeedback. In some states, however, Medicaid programs cover some CAM therapies including acupuncture, naturopathy, and massage therapy. 67% of Health Maintenance Organizations, the private health plans, provide at least one modality of CAM services. In conclusion, government policies have been strengthened to ensure patient protection, and will continue to integrate CAM practices that are proven to be safe and effective into mainstream health care system.

A Strategic Effect of Bundling on Product Distribution

  • Gwon, Jae-Hyun
    • Journal of Distribution Science
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    • v.13 no.10
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    • pp.15-21
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    • 2015
  • Purpose - This study examines a bundling effect on production and distribution in a patent-protected industry. Despite the heavy use of bundling strategies in the information and technology industry, literature has paid scant attention to bundling of intellectual property rights. This study examines a theoretical exploration of the bundling effect on licensing behavior. Research design, data, and methodology - To address this behavior, we build a simplified model consisting of three stages: 1) bundling decision, 2) licensing agreement, and 3) competition. The subgame perfect Nash equilibrium is applied to the model. Results - A single-patent holder with superior technology grants its own license to the multiple-patent firm, thereby leaving the market. Anticipating the single right holder's licensing strategy, the multiple-patent firm offers a bundle, making the single-right holder's bargaining position weaker. Conclusions - Bundling is an effective business strategy, resulting in multiple products for a firm as it faces other firms with single-product lines in each market. Taking advantage of the multi-patent or multi-product lines, the firm utilizes the bundling strategy obtaining better technology from the standalone single-patent firms.

The Analysis on the Roles of Patents, Standards, and Licensing as Technology Diffusion Media for Technology Innovation (기술혁신을 위한 기술확산매체로서의 특허와 표준, 그리고 라이센싱의 역할 분석)

  • 이상무
    • Proceedings of the Technology Innovation Conference
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    • 1999.06a
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    • pp.226-244
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    • 1999
  • Very closely related to technologies, patents, standards, and licensing interact with them, cores of technology innovation, as the technology diffusion media for technology innovation. Todays it is usually impressed that no one can face to international technology competetion environment without the strategy of patent, standardization, and licensing. In this paper, the whole configuration of technology innovation is represented including the patent, standard, licensing as these media, their basic characteristics and how they roles as technology diffusion media interacting with the technology, core of the technology innovation configuration are analyzed, and some related practical cases to be understood as the applications of these three media for technology innovation are also explained : such as IMT-2000 and CDMA technology which have been international issues currently involved in patents and standardization together, the advent of Linux operating system being the new event in the field of computer technology. Finally this paper intends to have the implicated meanings needed for national policy improvement, through appreciating the importance and the mechanism of roles of three media factors for technology innovation.

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DESIGN SCOPE AND LEVEL FOR STANDARD DESIGN CERTIFICATION UNDER A TWO STEP LICENSING PROCESS

  • Suh, Nam-Duk;Huh, Chang-Wook
    • Nuclear Engineering and Technology
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    • v.44 no.6
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    • pp.689-696
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    • 2012
  • A small integral reactor SMART (System Integrated Modular Advanced ReacTor), being developed in Korea since late 1990s and targeted to obtaining a standard design approval by the end of 2011, is introduced. The design scope and level for design certification (DC) is well described in the U.S. NRC SECY documents published the early 1990s. However, the documents are valid for a one-step licensing process called a combined operating license (COL) by the U.S. NRC, while Korea still uses a two-step licensing process. Thus, referencing the concept of the SECY documents, we have established the design scope and level for the SMART DC using the contexts of the standard review plan (SRP). Some examples of the results and issues raised during our review are briefly presented in this paper. The same methodology will be applied to other types of reactor under development in Korea, such as future VHTR reactors.

I-Umlaut in Old English: A Weak Trigger Effect

  • Moon, An-Nah
    • Journal of English Language & Literature
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    • v.57 no.6
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    • pp.1043-1065
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    • 2011
  • This study investigates i-umlaut which occurred in the period of pre Old English (OE) in two aspects: what motivates i-umlaut in OE and how the phenomenon can be analyzed within the framework of OT. Unlike root-controlled vowel harmony, i-umlaut in OE is triggered by the suffixal i or j in the unstressed syllable whereby a stressed root vowel becomes fronted or raised. In this study, it is proposed that i-umlaut in OE is driven by the weak trigger i or j to improve its poor perception: I-umlaut improves the poor perceptibility of the weak trigger by extending its feature-either [-back] or [-low]-onto the vowel in the stressed syllable. This study provides an OT-theoretic analysis utilizing the licensing account to vowel harmony proposed by Walker (2004, 2005). The licensing constraints, IDENT-IO(F) and the locally conjoined constraints are proposed and their interaction correctly captures the pattern of i-umlaut in OE. Also, it is shown that the licensing account proposed in this paper is superior to the previous analyses as well as the nonlicensing approaches in that it can provide a perceptual motivation couched in i-umlaut in OE.

A Study on Appropriate Licensing of Convergence Products through Comparative Analysis of Domestic Radio Station and Other Industrial Licensing (국내 무선국 및 타 산업 인·허가제도 비교분석을 통한 융합상품의 적정 인·허가제도 조성방안에 관한 고찰)

  • Yeon, In-Won;Choi, Joo-Pyoung;Lee, Won-Cheol
    • The Journal of Korean Institute of Electromagnetic Engineering and Science
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    • v.28 no.12
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    • pp.974-981
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    • 2017
  • Globally, owing to the rapid expansion of radio stations overseas, the frequency coordination system is managed as a preconditioning system. As a result, it is predicted that many types of radio stations will be established for domestic purposes, such as 5G, low-power IoT devices with long distance, based on licenses and non-license in the future. Many problems such as unnecessary launching of radio resources and spectrum-sharing technology exist, and it is necessary to consider the introduction of the abovementioned system and other plan system. In this paper, we explore the outline of radio station licensing and introduce the contents of the survey on another industry licensing. The plans were studied by discussing problems that may occur in future, through comparative analysis of radio stations and other industry licensing. Moreover, the differences were compared and analyzed using graphs. Finally, we discussed the problems convergence products such as drone may offer in the future.

A study on the Effects and Improvements of a Train Drivers' Licensing System (철도기관사 면허제 시행효과 및 개선방안에 관한 연구)

  • Lee, Chan-Bong;Park, Jin-Pyo
    • Journal of the Korean Society for Railway
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    • v.18 no.1
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    • pp.71-80
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    • 2015
  • During normal subway rush hours, a train-driver is in charge of more than 3,000 people on a daily basis. When an emergency event occurs, millions of people and their property come to depend only on the train-driver's ability. After the Daegu subway fire disaster in February 2003, the Railway Safety Act was enacted in October 2004 and the 'Train Drivers' Licensing System' was introduced by the National Railroad Administration in July 2006 to secure and improve protection. This study was conducted to investigate and evaluate the effects of the Train Drivers' Licensing System since the Licensing System was first introduced eight years ago. In addition, the analysis will suggest better policies for the effectiveness of the 'Train Drivers' Licensing System'.