License terms for medical use licenses--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations pertaining to the medical use of byproduct material to eliminate the 5-year term limit for medical use licenses. License terms for licenses issued under these regulations will be set by policy. Other materials licenses are issued for up to 10 years. The NRC will issue some licenses for shorter terms if warranted by the individual circumstances of license applicants. The amendment reduces the administrative burden of license renewals on a 5-year cycle for both NRC and licensees and supports NRC's goal of streamlining the licensing process.     

Objectives, Characteristics and Outcomes of University Licensing: A Survey of Major U.S. Universities

This paper describes results of our survey of licensing at 62 research universities. We consider ownership, income splits, stage of development, marketing, license policies and characteristics, goals of licensing and the role of the inventor in licensing. Based on these results we analyze the relationship between licensing outcomes and both the objectives of the TTO and the characteristics of the technologies. Patent applications grow one-to-one with disclosures, while sponsored research grows similarly with licenses executed. Royalties are typically larger the higher the quality of the faculty and the higher the fraction of licenses that are executed at latter stages of development. Sponsored research is more likely to be included in a license if the new technology is at an early stage of development or if the TTO evaluates it as important. We find that additional disclosures generate smaller percentage increases in licenses, and those increases in licenses generate smaller percentage increases in royalties.     

撤销许可的法律性质及效力研究——以撤销司法鉴定许可为例

基于撤销的理由、目的和法律效果,撤销许可分为两类:一类是已经生效但在成立时即存在瑕疵的行政许可事后被撤销;另一类是合法的行政许可因被许可人在获得许可后从事违法行为而被撤销。撤销许可很有可能构成一种行政处罚,但并非所有的撤销许可都是行政处罚。司法行政机关以申请人提供虚假信息或隐瞒真实信息而骗取许可登记为由撤销许可,在本质上属于行政处罚。该撤销许可不具有溯及力,也不影响司法鉴定机构在撤销许可前出具的、被司法机关采信的司法鉴定文书的效力。     

License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions

Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or from living organisms and are the most complex of all commercial medicines to develop, manufacture and qualify for regulatory approval. In recent years biopharmaceuticals have rapidly increased in number and importance with over 400() already marketed in the U.S. and European markets alone. Many companies throughout the world are now ramping up investments in biopharmaceutical R&D and expanding their portfolios through licensing of early-stage biotechnologies from universities and other non-profit research institutions, and there is an increasing number of license agreements for biopharmaceutical product development relative to traditional small molecule drug compounds. This trend will only continue as large numbers of biosimilars and biogenerics enter the market.A primary goal of technology transfer offices associated with publicly-funded, non-profit research institutions is to establish patent protection for inventions deemed to have commercial potential and license them for product development. Such licenses help stimulate economic development and job creation, bring a stream of royalty revenue to the institution and, hopefully, advance the public good or public health by bringing new and useful products to market. In the course of applying for such licenses, a commercial development plan is usually put forth by the license applicant. This plan indicates the path the applicant expects to follow to bring the licensed invention to market. In the case of small molecule drug compounds, there exists a widely-recognized series of clinical development steps, dictated by regulatory requirements, that must be met to bring a new drug to market, such as completion of preclinical toxicology, Phase 1, 2 and 3 testing and product approvals. These steps often become the milestone/benchmark schedule incorporated into license agreements which technology transfer offices use to monitor the licensee's diligence and progress; most exclusive licenses include a commercial development plan, with penalties, financial or even revocation of the license, if the plan is not followed, e.g., the license falls too far behind.This study examines whether developmental milestone schedules based on a small molecule drug development model are useful and realistic in setting expectations for biopharmaceutical product development. We reviewed the monitoring records of all exclusive Public Health Service (PHS) commercial development license agreements for small molecule drugs or therapeutics based on biotechnology (biopharmaceuticals) executed by the National Institutes of Health (NIH) Office of Technology Transfer (OTT) between 2003 and 2009. We found that most biopharmaceutical development license agreements required amending because developmental milestones in the negotiated schedule could not be met by the licensee. This was in stark contrast with license agreements for small molecule chemical compounds which rarely needed changes to their developmental milestone schedules. As commercial development licenses for biopharmaceuticals make up the vast majority of NIH's exclusive license agreements, there is clearly a need to: 1) more closely examine how these benchmark schedules are formed, 2) try to understand the particular risk factors contributing to benchmark schedule non-compliance, and 3) devise alternatives to the current license benchmark schedule structural model. Schedules that properly weigh the most relevant risk factors such as technology classification (e.g., vaccine vs recombinant antibody vs gene therapy), likelihood of unforeseen regulatory issues, and company size/structure may help assure compliance with original license benchmark schedules. This understanding, coupled with a modified approach to the license negotiation process that makes use of a clear and comprehensive term sheet to minimize ambiguities should result in a more realistic benchmark schedule.     

License term for medical use licenses--NRC. Proposed rule

The U.S. Nuclear Regulatory Commission is proposing to amend 10 CFR part 35 to eliminate the five-year term limit for medical use licenses in 10 CFR 35.18. License terms for licenses issued pursuant to part 35 would be set, by policy up to ten years, as are the license terms for other materials licenses. The NRC would issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants. The amendment would reduce the administrative burden of license renewals for both NRC and licensees, and would support NRC's goal of streamlining the licensing process.     

Stature- and age-related bias in self-reported stature.

The use of reported stature, especially self-reported stature such as on a driver's license, as a proxy for measured stature is necessary when measured stature is unavailable, for example, in matching data calculated from skeletal remains with data for missing persons. The accuracy of self-reported stature for older persons and especially for tall and short people is not well ascertained. Examination of published reports provides evidence that beginning at age 45, people compound their stature overestimation by an additional amount related to age (women by twice the amount of men). Analysis of anthropometric data from 8000 U.S. Army personnel indicates that the amount of general overestimation of stature by men is 2 1/2 times greater than that by women. Neither tall men nor tall women underestimate their stature, but men in the upper third of the stature range, and women in the upper 10%, self-report their stature with greater accuracy. No trends in accuracy are apparent in the remainder of the stature spectrum for men or women.     

复议《道路交通安全法》第110条

《道路交通安全法》第110条中的吊销驾驶证,从行政法角度而言,是行政的强制执行。用吊销驾驶证之＂手段＂去追求处罚当事人放弃合法听审权利之＂目的＂,手段与目的间并不存在实质之内在联系或合理正当之连结关系,属于立法上违反＂不当连结禁止原则＂。从宪法角度看,是对人民工作基本权的侵害,且这种侵害已达侵害最强烈之职业禁止的程度,...     

应急状态下行政许可的实施

《行政许可法》和《突发事件应对法》未涉及行政许可的效力基于应急状态的变动问题。行政许可的实施在应急状态下面临合法性困境,其纾解应从形式与实质两个层面着手。应急状态下,行政机关原则上具有概括的许可实施职权,在缺乏可预见性的规范时,可在满足基本的形式合法性前提下,通过情事变更原则满足实质合法性。此时,行政许可的条件、审查标准与程序等应与常态有所差异。许可中止制度在应急状态下具有适用空间,其核心在于有效期的中止,适用于被许可人无过错的情况,有必要在《行政许可法》中加以规定。应急状态作为不可抗力,可能但不一定完全导致行政许可废止的结果。此时,行政许可的废止仍需以许可目标完全不可实现或者许可的继续实施极可能导致个人或公共利益的严重损害为前提。现行行政许可有效期延续制度在审查强度和程序等方面规则不明。应急状态下,应当放宽许可延续的申请期,对延续申请可以采用形式和书面审查,并建立依职权延续和临时延续制度。为更好应对应急状态,应当根据应急状态各处置阶段的需要,创设新的许可类型。     

临时性许可上升的法律问题——透视地方人大及其常委会的立法和监督职权

地方人大及其常委会在做好涉及临时性许可的政府规章上升为地方性法规工作时,首先要正确理解行政许可法的立法原意,“一年”的期限是地方政府就临时性许可提请地方人大及其常委会启动立法程序的期限;同时还要主动把握立法权限和时机,对临时性许可的合法性和合理性进行“再审查”,切实履行人大的立法和监督职责。     

Social License and Environmental Protection: Why Businesses Go Beyond Compliance

This article examines the concept of the corporate "social license," which governs the extent to which a corporation is constrained to meet societal expectations and avoid activities that societies (or influential elements within them) deem unacceptable, whether or not those expectations are embodied in law. It examines the social license empirically, as it relates to one social problem–environmental protection–and as it relates to one particular industry: pulp and paper manufacturing. It shows try the social license is important, the circumstances in which it may encourage companies to go "beyond compliance" with regulation, how its terms are monitored and enforced, and how it interacts with what we term the regulatory and economic licenses. Overall, this research demonstrates that corporate environmental behavior cannot be explained purely in terms of instrumental threats and moral obligations to comply with the law, and that the increasing incidence of "beyond compliance" corporate behavior can be better explained in terms of the interplay between social pressures and economic constraints.     

《著作权法》修改:关键条款的解读与分析(下)

修改后的《著作权法》将视听作品分为"电影作品、电视剧作品及其他视听作品",并分别规定了不同的著作权归属规则,但两类视听作品分类标准不明,且对其他视听作品采用约定优先的著作权归属规则,不利于此类视听作品的许可与传播。当一名合作作者无正当理由反对对合作作品的特定利用时,其他合作作者不能发放专有许可,这可能给合作创作的学术论文和专著的出版带来负面影响。修改后的著作权法将电台、电视台和报刊通讯社员工的职务作品定为特殊职务作品,可能产生其员工离职后无法获得出版其职务作品文集所须授权的问题。新增的有关职务表演的规定合理地解决了长期以来将"演出单位"作为"表演者"的问题。对传播录音制品获酬权的规定并不是法定许可,因为《著作权法》并没有为录音制作者规定除信息网络传播权之外的传播权专有权利。修改后的《著作权法》的一大亮点是将广播组织的转播权以技术中立的方式拓展至网络环境。有关用作者的署名推定权利存在的规定,被诉侵权人应证明其使用涉案作品已获许可的规定,以及法院有权没收和销毁侵权复制品的规定,均直接来源于《中美经济贸易协定》,其中有些仅具有形式意义。修改后的《著作权法》为摄影作品享受新的保护期(作者有生之年加50年)所设定的条件与《世界知识产权组织版权条约》不一致,可能需要再次修改。     

我国行政审批与行政许可关系的重新梳理与规范

在我国,行政审批、行政许可的涵义及其两者之间的关系极为复杂且极具争议,《行政许可法》最终采纳了同一概念说,从立法上将两者统一起来。但在实际执行中,行政审批与行政许可又出现了分离,大量的行政审批被以非许可类审批的名义从行政许可中分离出去,导致《行政许可法》的调整范围不断被限缩,重新梳理行政审批与行政许可的关系以明确《行政许可法》的调整范围已经成为《行政许可法》实施中迫切需要解决的问题。本文分析了两者之间出现分离的原因,讨论了行政许可行为的识别标准,并对立法上如何规范和约束行政审批行为提出了构想。     

On the joint use of licensing and liability

Licensing is a widely used technique applied to impose regulations. Firms inducing harm must hold a license issued by a regulatory agency on a case-by-case basis. A firm may also be subject to liability. This paper studies the implications on social welfare of combining licensing with strict liability. Contributions include the study of a joint use and related administrative costs. The latter include costs pertaining to litigation and the issuing and enforcing of licenses. It is established when a joint use is motivated. Regulatory compliance should protect from liability in order to decrease litigation and enforcement costs and associated distortions.     

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (PHS Act). In lieu of filing an establishment license application (ELA) and product license application (PLA) in order to market a biological product in interstate commerce, a manufacturer would file a single biologics license application (BLA) with the agency. Upon approval of the BLA, a manufacturer would receive a biologics license to market the product in interstate commerce. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and is intended to reduce unnecessary burdens for industry without diminishing public health protection. This action also proposes regulations to implement certain sections of the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Half the Spectrum: A Title IX Approach to Broadcast Ownership Regulation

In theory, the electromagnetic spectrum belongs to everyone. In practice, stations owned by men hold approximately 90% of the licenses to broadcast on the public spectrum in the United States. In order to address this problem, federal legislation should be adopted that mimics the framework of Title IX of the Education Amendments of 1972 by prohibiting broadcast media companies from discriminating based on gender. Instead of the federal funds received by colleges and universities, the federal benefits here are the potentially lucrative broadcast licenses select radio and television stations receive. Under the proposed legislation, broadcasters would be required to establish gender parity within their organizations or risk losing their license to operate on the public spectrum.     

Corruption and hold-up: the role of intermediaries

Corrupt contracts are illegal and, therefore, vulnerable to hold-up. That is, a bureaucrat who has accepted a bribe from a firm in exchange for a license may still choose not to grant the firm that license (hold-up). This paper develops a model to study the role that intermediaries play in preventing hold-up. There are two types of firms, good firms that are legally entitled to receive a license, and harmful firms that are not. Without intermediaries only good firms enter the market, and harmful firms do not enter because of hold-up. Intermediaries are legally permitted to help firms reduce their navigation costs of obtaining licenses. Thus, intermediaries increase entry of good firms. However, by utilizing the legal aspects of their transaction with good firms as leverage against the bureaucrat, intermediaries can prevent hold-up among harmful firms. Thus, intermediaries increase participation by both good and harmful firms and their welfare costs are ambiguous. Data obtained from occurrences of violations of the Foreign Corrupt Practices Act are broadly consistent with our model.     

Assessing the risk of recidivism in physicians with histories of sexual misconduct

Physicians who engage in sexual conduct with patients usually cause serious harm and have a high rate of recidivism. Although offending physicians may lose their privilege to practice, they have the right to appeal for restoration of the license. Yet medical licensing board members do not currently have any clear standards by which to predict whether a given physician is likely to abuse again. Using New York as a paradigm, this paper offers practical, clinically based guidelines for assessing the risk of restoring an offending physician's license. These guidelines are derived from psychoanalytic theories of character, the insights of therapists who have worked with abusive physicians, and the psychiatric model of assessing dangerousness. Recognizing character patterns and psychological vulnerabilities of physicians with histories of sexual misconduct will help board members identify those who are at high risk of abusing again if their licenses are restored.     

Stature estimation based on dimensions of the bony pelvis and proximal femur

Pelin et al. recently showed that sacral height measured on lateral magnetic resonance images can be used with moderate accuracy to reconstruct stature in males. In most forensic anthropological cases, however, sacral dimensions must be obtained from dry bones. In this study, the relationship between stature and sacral height, hip height, and femur head diameter measured on dry bone was evaluated for American Blacks and Whites of both sexes (n = 247). There are significant correlation between stature and these three dimensions, but the results suggest that none of the dimensions predict stature with the accuracy needed to be useful in forensic anthropological investigations.     

Suspect Height Estimation Using the Faro Focus3D Laser Scanner

At present, very little research has been devoted to investigating the ability of laser scanning technology to accurately measure height from surveillance video. The goal of this study was to test the accuracy of one particular laser scanner to estimate suspect height from video footage. The known heights of 10 individuals were measured using an anthropometer. The individuals were then recorded on video walking along a predetermined path in a simulated crime scene environment both with and without headwear. The difference between the known heights and the estimated heights obtained from the laser scanner software were compared using a one-way t-test. The height estimates obtained from the software were not significantly different from the known heights whether individuals were wearing headwear (p = 0.186) or not (p = 0.707). Thus, laser scanning is one technique that could potentially be used by investigators to determine suspect height from video footage.     

Fatal accident with a special automobile

The authors report on a traffic accident in which the passenger of a Light Four-wheeled Vehicle (Microcar) approved for use by a disabled person was killed after a rear collision with a compact car. The severity of the accident trauma was critically determined by the vehicle's light construction. Consideration is also given to the legal situation regarding registration and driver's license issues.