License Fees Research Articles

Developing a cost-effective and efficient safety case management solution for data coordinating center projects.

A centralized safety function can support multiple clinical trials and provide efficient, standardized processes for the management of serious adverse events. From 2017 to 2022, the centralized safety desk used pharmacovigilance software compliant with FDA regulations, including 21 CFR Part 11. This software assisted with processing safety cases for regulated clinical trials, including allowing capture of event data, and provided process flow management, documentation storage, and transmission of safety reports to FDA. During the software's tenure, we experienced incompatibilities with other clinical research software resulting in unanticipated inefficiencies. Furthermore, the small number of periodic and suspected unexpected serious adverse reaction (SUSAR) cases rendered the annual license fee not cost-effective. An internal analysis of our workflow, systems, and processes revealed that developing a cost-effective and efficient customized solution for our existing data coordinating center (DCC) projects was feasible. The customized solution mimics the key functionality and workflow of the prior software. It utilizes existing electronic data capture systems and document management solutions, ensuring 21 CFR Part 11 compliance without incurring additional expenses. The proposed process received internal approval and launched in December 2022. The process outlined in this paper is particularly advantageous for DCCs or academic clinical research sites that must meet regulatory reporting requirements without depending on specialized pharmacovigilance software. Additionally, it is a cost-effective option for organizations with a low volume of SUSAR events. In this paper, we present the process of developing and implementing a customized safety case management solution and the lessons learned pre and post implementation.

Impact of Seed Regulation Reform on Licensing Fees of Varieties in China

ABSTRACTCrop breeding research and seed industry development are critical to promoting sustainable growth in agricultural production and ensuring food security. The Chinese government introduced a significant reform to the original seed regulation system, which was overly focused on market access management. This revision can profoundly impact the licensing market of seed varieties in China. However, the licensing issue in the seed industry has barely been tapped owing to the limited availability of real licensing data. This study aims to analyze the impacts of the seed regulation reform on the licensing fees of varieties in China based on some unique actual transaction data of variety licensing. We employed a nationwide in‐person survey of seed companies and used a multivariate analysis. The results indicate that most seed companies in China were obliged to buy licenses for new varieties bred by others. An upfront lump‐sum fixed‐fee payment had also been the most used strategy for variety licensing. The estimation results of the multivariate analysis indicate that seed regulation reform in China led to an average decline of nearly half of the licensing fee of a variety. After the reform, the licensing prices of conventional rice varieties decreased the most, followed by maize varieties. By contrast, the reform did not significantly affect the licensing fees of hybrid rice varieties. The reform resulted in a 63% drop in licensing fee of a public‐bred variety, while having no significant impact on that of private‐bred varieties. Post reform, the licensee fee of a variety paid by smaller seed companies and non‐state‐owned enterprises (SOEs) decreased by 62% and 65%, respectively, while the fees paid by bigger seed companies and SOEs were not significantly affected. Moreover, the results confirm that newer varieties and the varieties with higher yield and exclusive contracts have significantly higher licensing fees, and large seed companies paid significantly more on a variety license. These results have important implications for market participants and policymakers in China's seed industry as well as other industries.

Closed-loop supply chain decision making considering product design strategy under patent protection

This paper combines product design and patent protection and construct a dynamic decision-making model consisting of a single original manufacturer and a single remanufacturer based on Stackelberg game. We study the impact of different product design strategies on remanufacturing decisions in the presence of patent protection and explore the influencing factors of the original manufacturer's product design level. The results show that: (1) the original manufacturer’s product design level is negatively correlated with the coefficient of R&D cost impact and the coefficient of remanufacturing cost, and positively correlated with the coefficient of consumer utility impact; (2) the unit patent licensing fee is positively correlated with the coefficient of R&D cost impact and negatively correlated with the coefficient of remanufacturing cost and the coefficient of consumer utility impact; (3) under different product design strategies, product design strategies that consider both eco-orientation and remanufacturing-orientation are most conducive to the stable development of the closed-loop supply chain.

Technology licensing for quality improvement under oligopoly competition

In this paper, we investigate the optimal technology licensing strategy in an oligopolistic market where customers consider both the selling price and quality of each firm’s product when making purchasing decisions. A firm that invests in improving product quality may choose to license its proprietary quality-enhancing technology to either one or multiple competitors (referred to as exclusive and non-exclusive licensing, respectively). We develop models for each of these two licensing strategies, as well as the benchmark model with no licensing. Analysis of the equilibrium outcomes shows that licensing becomes the equilibrium only if the royalty rate is moderate; both high and low royalty rates result in the equilibrium being no licensing. When licensing occurs, there exist thresholds in relation to the royalty rate (above) below which the equilibrium is (non-)exclusive licensing. Crucially, licensing has the potential to yield a Pareto improvement, and we explicitly identify the conditions for this outcome. Moreover, our key findings remain robust when the model is extended to scenarios with varying degrees of product substitutability or a generalized oligopolistic market with n ( > 3 ) firms. Finally, we clarify how the licensee’s absorptive capacity and product substitutability affect the licensing equilibrium and the Pareto improvement under both exogenous and endogenous licensing fees. Overall, our findings offer insights for firms investing in quality improvement and seeking to license their proprietary technologies to competitors to enhance profitability.

The State of the Art in mobile Augmentative and Alternative Communication Devised for People with Dementia: Evaluation of Features and Functions

AbstractPatients with dementia (PWD) often face challenges with daily activities due to communication challenges, which may lead to negative outcomes for those with dementia and their family caregivers alike. Augmentative and alternative communication (AAC) devices have demonstrated to be feasible in supporting communication among PWD (May et al., 2019) through text, graphics, and/or sound. Traditional AAC devices have been non‐electronic memory and communication aids (May et al., 2019). However, in recent years many primary caregivers of PWD are seeking out mobile applications to address this challenge using their smartphone or tablet. However, mobile applications addressing communication skills specifically for dementia care are scarce despite their potential to improve quality of life (Ambegaonkare et al., 2021; Brown et al., 2023). To better understand the current landscape of AAC mobile applications, this systematic review identified and evaluated the features and design of commercially‐available mobile applications. A total of 27 AAC apps were identified through searches on the Apple IOS store and Google Play, after excluding duplicates and apps that targeted primarily children. Four research team members were involved in cataloging features and evaluating the apps using a modified version of the Mobile App Rating Scale (Stoyanov et al., 2015). The price of apps varied, though many listed as being free or low‐cost often required higher‐priced subscriptions or licensing fees. All apps were compatible for English speakers, though several were available in multiple languages. It was found that the apps varied in their potential for engagement, functionality, aesthetics, and information. It was also found that many apps are limited in their potential to support caregiving activities (e.g., mealtime, dressing) for those with communication barriers related to cognitive impairment. Apps that are limited in their ability to customize the interface to the user’s preferences for daily care may impede person‐centered care practices for PWD. Implications for practice, policy, and research are discussed.

Standard Essential Patents and Abuse of Dominance: Implications for India's Telecom Sector

The rapid advancement of technology has positioned Standard Essential Patents (SEPs) as a critical component of innovation in the telecommunications sector, particularly in India. SEPs are patents that cover inventions essential to industry standards, facilitating interoperability and ensuring effective communication between devices. However, the significant market power held by SEP holders raises important concerns regarding the potential abuse of dominance, especially when these entities impose excessive licensing fees or engage in discriminatory practices. This paper examines the intersection of SEPs and competition law in India, focusing on the legal challenges faced by the Competition Commission of India (CCI) in regulating SEP holders under the Competition Act, 2002. By analyzing the regulatory framework and its implications for market dynamics, this study highlights the necessity for a balanced approach that protects both intellectual property rights and competitive practices. The findings suggest that while existing legal mechanisms aim to address abuses of dominance, there is a pressing need for clearer guidelines and stronger enforcement to ensure that SEPs foster innovation without stifling competition in India's rapidly evolving telecom landscape.

Exploring small retailers’ perspectives on selling tobacco after the tripling of Tasmania’s tobacco licence fee

BackgroundLicensing of tobacco retailers, including high retail licence fees, is one tobacco control measure that may reduce tobacco retail availability. Between 2015 and 2018, the tobacco licence fee in Tasmania,...

Investment in the Ukrainian gambling market in wartime

This study is the first scientific study in Ukraine on the issue of investment attractiveness of the gambling market in conditions of full-scale war, in which the authors attempted to calculate and assess the costs and benefits that an investor can receive from investing in this type of activity. This study used the method of comparative analysis, the method of system analysis, the hermeneutic method, formal-logical (synthesis, analysis, deduction, analogy), economic analysis, absolute and comparative advantages and statistical methods. The authors analyzed the economic indicators of the market and concluded that despite the hostilities, the market shows a large and stable growth due to the online segment. At the same time, although more than 20 different licenses were issued, the market was divided among only five major players, which indicates the potential for new organizers to enter the market. The assessment of losses and benefits for the investor was carried out according to the following indicators: calculations of official costs for starting a business in Ukraine (license fees); assessment of the tax system of Ukraine regarding the gambling business from the point of view of the benefits of running such a business; assessment of the war risks of running a gambling business in Ukraine. The calculations showed that the high cost of licenses can be the main obstacle to entering the market for new investors, since in neighboring countries the entry price is much lower. The research conducted allowed us to conclude that today the only promising direction of investment can be the gambling business on the Internet. After the end of hostilities, we expect that the implementation of investment projects and obtaining free investment licenses will become attractive for investment, because today the potential of free investment licenses in Ukraine has not been used, not a single license has been issued, but there are no similar offers in other European markets. Promising areas of research remain the issues of the impact of gambling market taxation rates on market development, as well as on the fight against illegal gambling. A promising direction is the issue of researching the investment attractiveness of the Ukrainian lottery market and the possibilities of holding interstate lotteries in Ukraine.

Open-Source Solutions in Archival Institutions

Open-source solutions offer a cost-effective alternative for archival institutions facing budget constraints. The absence of licensing fees and the ability to modify and customize the software without vendor lock-in make open source particularly appealing. This financial flexibility allows institutions to allocate resources to other critical aspects of preservation and access. In the article the author presents various advantages and disadvantages of using open-source software.

Usury enforcement as an alternative to capital taxation in pre-modern states

AbstractAll governments have an obligation to protect their territory and the wealth within that territory from external predation. In fact, since war has historically resulted in the plunder and destruction of wealth, it seems straightforward to suggest that the cost of providing adequate defense of one’s territory is a function of the accumulated wealth within the territory. Suppose that all wealth in society is capital. The accumulation of capital conveys a private benefit to its owner, but imposes an external cost on society. As with any externality, the optimal tax policy would be to tax capital. The revenue from capital taxation could then be used to finance defense. Such a taxation scheme, however, requires the state has an appropriate level of bureaucratic capacity. During the Middle Ages and the early Renaissance, this sort of state infrastructure did not exist. Yet the rulers of those states faced the same constraint. In this paper, I argue that the enforcement of usury laws during this period replicate the outcome of the optimal capital tax. Lending at interest was prohibited. However, rulers often allowed certain groups to lend in society in exchange for a license fee. This granted monopoly status to lenders. At the same time, rulers imposed binding price ceilings on interest rates. The combination of these three characteristics of enforcement replicate the long-run restriction on capital accumulation of the optimal capital tax and generate revenue that is possibly equivalent to the tax as well. I then model ruler behavior given these incentives. Finally, I use historical evidence from England, Italy, and France to support my argument.

Linkja: Open Source Privacy-Preserving Record Linkage Tool

ObjectiveTo introduce Linkja, an open-source, certified, Privacy-Preserving Record Linkage (PPRL) tool with the primary objective of facilitating secure and efficient record linkage across diverse datasets, while preserving individual privacy, providing a comprehensive and privacy-centric approach to program assessments. ApproachLinkja has been used to evaluate Chicago’s Flexible Housing Pool program by securely linking various datasets, including Homeless Management Information Systems (HMIS), Electronic Health Records, Jail records, Medical Examiner reports, and Public Health data. Data contributors used separate honest brokers for record linkage, and generation of salt and cryptography keys. ResultsLinkja enabled this multi-sector linkage by facilitating legal and data sharing agreements, avoided licensing fees and procurement processes for all parties, and provided a de-identified for analysis. The insights gleaned from the analysis motivated the FHP program to plan a follow-up evaluation that will add emergency serviced records from a separate City of Chicago department. The successful linkage provided a nuanced understanding of the association between stable housing and reduced healthcare utilization. ConclusionsLinkja's cryptographic certification ensures the highest standards of security during data linkage, safeguarding sensitive information. The matching rules, validated on hard-to-match populations, prove essential in maintaining accuracy and reliability in the linkage process. ImplicationsThe open-source nature of Linkja promotes transparency and collaboration in the development and enhancement of privacy-preserving record linkage techniques. This tool has broad implications for sectors dealing with sensitive data, fostering responsible data-sharing practices, and enabling secure collaborative research initiatives without compromising individual privacy.

Cas-CLOVER-mediated knockout of STAT1: A novel approach to engineer packaging HEK-293 cell lines used for rAAV production.

In addressing the limitations of CRISPR-Cas9, including off-target effects and high licensing fees for commercial use, Cas-CLOVER, a dimeric gene editing tool activated by two guide RNAs, was recently developed. This study focused on implementing and evaluating Cas-CLOVER in HEK-293 cells used for recombinant adeno-associated virus (rAAV) production by targeting the signal transducer and activator of transcription 1 (STAT1) locus, which is crucial for cell growth regulation and might influence rAAV production yields. Cas-CLOVER demonstrated impressive efficiency in gene editing, achieving over 90% knockout (KO) success. Thirteen selected HEK-293 STAT1 KO sub-clones were subjected to extensive analytical characterization to assess their genomic stability, crucial for maintaining cell integrity and functionality. Additionally, rAAV9 productivity, Rep protein pattern profile, and potency, among others, were assessed. Clones showed significant variation in capsid and vector genome titers, with capsid titer reductions ranging from 15% to 98% and vector genome titers from 16% to 55%. Interestingly, the Cas-CLOVER-mediated STAT1 KO bulk cell population showed a better ratio of full to empty capsids. Our study also established a comprehensive analytical workflow to detect and evaluate the gene KOs generated by this innovative tool, providing a solid groundwork for future research in precise gene editing technologies.

Gravity for cross‐border licensing and the impact of deep trade agreements: Theory and evidence

AbstractWe examine whether deep regional trade agreements facilitate cross‐border licensing. A micro‐founded gravity equation for each supply mode is derived from a model in which heterogeneous firms choose to supply their goods to foreign markets through export, foreign direct investment or licensing. We present several comparative statics results regarding the effects of changes in the fixed costs of serving the destination country, the freeness of trade, and the strength of intellectual property rights protection on bilateral flows of licensing revenues. We then empirically test our theoretical predictions using data on the cross‐border flows of royalties and licence fees for 49 countries in the period 1995–2012. In addition to variables that capture the impact of shallow and deep regional trade agreements, we construct dummy variables that represent subcategories of IP rights‐related provisions. Consistent with our theoretical predictions, we find that improved access to the destination market through a deep regional trade agreement and stronger IP rights protection through a regional trade agreement with legally enforceable IP rights and technology‐related provisions increase bilateral flows of licensing revenues. Among IP rights‐related provisions, the accession to or ratification of existing international IP agreements and the protection of trademarks, patents, or industrial designs are important for facilitating cross‐border licensing.

Global policy scan of commercial combustible tobacco product retailing regulations by WHO region

Background/aimsRegulatory schemes for tobacco retailing help restrict the supply and availability of smoked tobacco products. Tobacco retailer density and the proximity of tobacco outlets to youth spaces, such as schools,...

Evaluating the demand for and price elasticity of state hunting licenses in the United States using panel data

ABSTRACT As wildlife management agencies have been struggling financially, there continues to be a greater need for revenue to sustain wildlife and cover their costs. With the sales of hunting licenses playing an important role in a state wildlife agency’s revenue, there has been a debate regarding whether to raise the license fee since a loss of revenue will result if the price elasticity of the hunting license is elastic. This study first used a panel dataset containing national surveys from 1996 to 2011 across the United States to explore this issue. A General Two-Stage Least Squares (G2SLS) model was employed to estimate the demand for residents’ hunting licenses, while an Ordinary Least Squares ;(OLS) model was applied to determine the demand for nonresidents’ hunting licenses. Price elasticities of −0.176 and −0.066 for resident and nonresident hunting licenses were obtained, respectively. The results supported the view that raising the hunting license fee would bring in more license sales revenue.

Revisiting the Scope of Section 35ABB of the Income Tax Act

The Supreme Court (SC), on 16 October 2023, observed that licence fees paid by telecom companies under the New Telecom Policy 1999 would be a capital expenditure under section 35ABB of the Income Tax Act, 1961. Quashing the judgments of high courts of Delhi, Bombay and Karnataka, the SC ruled that the nomenclature and mode of payment have no relevance as such payment relates to the licence fee, an integral part of the licence agreement to remain in the business. It ruled under the New Telecom Policy 1999 that there is no basis to reclassify the variable portion of the licence fee as revenue expenditure; instead, both fixed and variable fees are homogeneous and are capital expenditures. Moreover, a single transaction cannot be artificially bifurcated into capital and revenue components by mere consideration of payment mode, posing a challenge for the sector already confronting significant financial stress. However, the Telecommunication Act enacted in December 2023 attempts to address multiple challenges of the sector, but grey areas still need to be addressed, which could lead to future litigation. Against those backdrops, the study attempts to assess the impact of the ruling connecting with the New Act on the sector.

Initial Payment and Refunding Scheme for Climate Change Mitigation and Technological Development Among Heterogeneous Countries

Abstract We examine international environmental agreements (IEAs) in which heterogeneous countries work together to not only participate in the abatement of greenhouse gas emissions but also develop breakthrough technologies. In this paper, the country with the most advanced technology (i.e. the technological leader) develops a new abatement technology and distributes it to other countries (i.e. technological laggards) through licensing. We design a new mechanism to achieve cooperation among heterogeneous countries through an initial payment and refunding (IPR) scheme and licensing involving third-party organizations (TPOs). Under our new IPR scheme with licensing, the cost incurred by a technology leader in developing new technology is covered by licensing fees using a portion of the initial payments collected from technological laggards by a TPO. As a result, TPOs sustain IEAs by flexibly adjusting technological laggards’ share of costs for licensing, comprising initial payments and refunds, and the amount of the licensing payment made to the technological leader.

Strategic Agility and Performance of Pay Television Industry in Kenya.

The Pay TV market in Kenya operates in a highly competitive business environment, which in turn calls for aggressiveness and more efficient ways of keeping the business afloat. Advancement in technology also comes with several options for Pay TV customers such as online streaming which poses more threat to the market. This research seeks to assess the influence of strategic agility on the performance of the Kenyan Pay TV industry using Multichoice Kenya Limited as the case study. The objectives of this study were to establish the influence of leadership agility, determine the influence cultural agility, assess the influence of business agility, and to determine the influence of career agility on organizational performance in the Kenyan Pay TV industry. The study is of great significance to the government of Kenya since the improved performance of the Pay TV companies can generate more revenue for the government in form of taxes and license fees. New and existing Pay TV companies may also benefit from this study by employing agile strategies for competitive advantage as well as getting more information on how to handle uncertain situations in the business environment. Additionally, academicians who may want to research more on strategic agility may benefit by accessing more information from this study. The concept of strategic agility has not been sufficiently researched especially on the variables such as leadership agility, cultural agility, business agility, career agility and how they influence organizational performance. This research was anchored on four theories namely; The Great Man Theory, Theory of Change, Theory of Constraints, and the Broaden and Build Theory. The reviewed literature on these theories indicates that there is a positive influence of strategic agility on organizational performance. This is a cross-sectional study which involves 60 employees with managerial roles. Descriptive design was used in this study adopting qualitative and quantitative methods. Data collection was done through closed and open-ended questionnaires, keeping a register of questionnaire distribution and feedback collection. A pilot study was carried out to determine the accuracy, clarity and relevance of the study questionnaire. Data analysis was carried using SPSS (V29) and multiple regression analysis. The study found that leadership agility, cultural agility business agility and career agility all have a significant effect on the performance of Pay TV firms in Kenya. The top leadership of firms in Pay TV industry should establish cross-cultural collaboration initiatives to encourage knowledge-sharing and teamwork among employees from different cultural backgrounds, foster a culture that encourages and rewards agile leadership behaviors, such as risk-taking and experimentation and encourage leaders to seek mentorship and coaching to enhance their agility capabilities, should invest in technology and infrastructure that support flexibility and adaptability in responding to market changes and also develop cross-functional teams that can quickly adapt to changing business requirements and address emerging challenges, implement career development plans and pathways that align with the organization's strategic objectives and employees' career aspiration and encourage a growth mindset among employees.

Stakeholders' perception and willingness-to-pay for an aquaculture-based fisheries enhancement program for coastal cod in Southern Norway

The coastal cod fishery in Southern Norway has experienced a significant decline over the last decades. Recreational fishing for cod in the eastern part of the country is currently banned. Fisheries managers have adopted a variety of strategies to sustain the populations for resource users. Aquaculture-based fisheries enhancement has been considered as an alternative intervention to rebuild overexploited cod stock or to improve the opportunity for marine fishing. However, there has been a debate regarding its ecological and social effectiveness among stakeholders. In this paper, we conducted an online contingent valuation survey aiming to understand stakeholders' perceptions and attitude towards restocking of hatchery-produced juveniles as a potential restoration approach to rebuild depleted coastal cod populations and their willingness to pay for the implementation of such an enhancement program in southern Norway. Results indicate that the public has a positive perception to the potential restocking program. The average Willingness-To-Pay (WTP), e.g. fishing license fee, is approximately 175 NOK and 693 NOK if all of the respondents, and only counting those who are willing to, contribute. The introduction of a minimum fishing license fee of 175 NOK (approximately 17€) would cover the cost of production of over 20 million juvenile cod of appropriate size for release. Age of the respondents, the frequency of their fishing trips, and their perception of the decline of coastal cod were the main drivers for the WTP contribution while the amount of the WTP was strongly correlated to targeting particular species, educational level, and place of residence. Considering the critical situation of the coastal cod populations in southern Norway, together with the significant advances in cod rearing techniques, in fish tagging technology and the maturation of fisheries enhancement as science, and the positive stakeholders' perceptions and attitudes towards such an aquaculture-based enhancement program revealed from this study, it may be the time to re-evaluate the potential integration of a holistic cod restocking program within Norwegian coastal zone management.

Standard-essential patent legal protection in China’s telecommunication industry: an international trade and economy perspective

ABSTRACT Standard-essential patents (SEPs) are specific types of patents that protect the technology incorporated in a standard. China has one of the world’s largest telecommunication markets, and its legal policies and practices regarding SEP protection profoundly influence the competitive environment of the Chinese telecommunication market, international economic and trade cooperation, and global telecommunication technology innovation. Recently, frequent disputes in the communication sector surrounding SEPs in China’s judicial practice revolved around the fair, reasonable, and non-discriminatory (FRAND) principles, embodying three key issues: patent hold-up, licence fee rates, and anti-suit injunction. Regarding the patent hold-up and hold-out of SEPs in the telecommunication industry, a balance of interests between SEP holders and implementers in licence negotiations should be achieved under the guidance of the principles of FRAND from the perspective of legislation, administrative management, and the judiciary. Concerning licence fee rates, billing benchmarks should be judged based on individual cases, utilizing a comprehensive approach combining comparable licence agreement methods and top-down methods to determine a fair and reasonable licencing fee acceptable to all parties. In the conflict between anti-suit and anti–anti-suit injunctions, improving the anti-suit injunction rules and international cooperation mechanisms is necessary to achieve fair and non-discriminatory judicial processes and judgment results.