Terms Of License Research Articles

Legal regulation of the economic activities of pharmacies in Ukraine

The scientific article is devoted to the peculiarities of the legal regulation of the economic activity of pharmacies in Ukraine. The legislative and by-laws regulating the circulation of medicinal products have been studied. Scientific works devoted to the legal regulation of pharmaceutical activity have been studied. The peculiarities of the economic activity of pharmacies have been determined. A doctrinal definition of a pharmacy has been proposed as a business entity that carries out the wholesale purchase of medicinal products for retail sale to citizens as end consumers.
 It is claimed that the retail sale of medicinal products should occur based on a license if the pharmacy complies with the license terms of such activity. Licensing conditions are established for the pharmacy staff and the equipment on the premises for the storage of medicinal products. Requirements are set for the total area of the pharmacy and the size of the sales hall, staff room, and warehouse space. Attention is drawn to the fact that pharmacy employees must comply with the requirements of legislation on the protection of consumer rights. The subject of trade is specific products, that are medicinal products registered in Ukraine. Medicines must have the necessary manufacturer’s documentation. It is essential to prevent trade in falsified medicines. It has been concluded that several conditions characterize the contract for the supply of medicinal products. In particular, regarding the assortment and quantity of medicinal products, that are transferred to the property and the conditions of storage of medicine during transportation.
 It has been proposed to introduce a number of amendments to the Law of Ukraine “On Medicinal Products”. At the legislative level, it is necessary to regulate the legal status of pharmacies and the peculiarities of the retail trade of medicinal products. It has been claimed that a separate section should be established in the Law of Ukraine On Medicinal Products that would regulate the economic activity of pharmacies. In this section, it is necessary to provide norms that would regulate the conditions for the pharmacy establishment. It is necessary to establish requirements for the pharmacy staff, separate premises, and conditions for the storage of medicinal products. Features of the protection of the consumer’s rights of medicinal products should be established in the legislation by separate norms. Special terms of contracts for the supply of medicinal products should be enshrined in the branch legislation on the circulation of medicinal products.

CHOIRBM: An R package for exploratory data analysis and interactive visualization of pain patient body map data.

Body maps are commonly used to capture the location of a patient’s pain and thus reflect the extent of pain throughout the body. With increasing electronic capture body map information, there is an emerging need for clinic- and research-ready tools capable of visualizing this data on individual and mass scales. Here we propose CHOIRBM, an extensible and modular R package and companion web application built on the grammar of graphics system. CHOIRBM provides functions that simplify the process of analyzing and plotting patient body map data integrated from the CHOIR Body Map (CBM) at both individual patient and large-dataset levels. CHOIRBM is built on the popular R graphics package, ggplot2, which facilitates further development and addition of functionality by the open-source development community as future requirements arise. The CHOIRBM package is distributed under the terms of the MIT license and is available on CRAN. The development version of the package with the latest functions may be installed from GitHub. Example analysis using CHOIRBM demonstrates the functionality of the modular R package and highlights both the clinical and research utility of efficiently producing CBM visualizations.

EXTENT AND PATTERN OF OFF-LABEL AND UNLICENSED DRUG UTILIZATION IN NEONATAL INTENSIVE CARE UNIT IN THE TERTIARY CARE TEACHING HOSPITAL

Background & Objectives: Many drugs that are used to treat children have not undergone evaluation to assure acceptable standards for optimal dose, safety and efcacy. As a result, drugs that are used to treat children are either not licensed for use in pediatric patients (unlicensed) or prescribed outside the terms of the product license (off-label).The extent of off-label and unlicensed drug use in neonates is unknown. Hence the purpose of the study is to determine the extent and pattern of off-label and unlicensed use of drugs amongst neonates in neonatal intensive care unit of a tertiary care hospital. A prospective study was carried Materials and Methods: out on 69 patients admitted in a tertiary care hospital for the period of ve months. Demographic data and complete prescriptions were noted in predesigned case record form. The off-label drugs were categorized by using National Formulary of India. Off-label drugs were classied in regards to their indications by using Anatomical Therapeutic Chemical Classication. The frequency was measured in terms of percentage and multiple binary logistic regressions were used for selecting confounding factors. A Results: total of 329 drugs were prescribed out of which 183(55.6%) were off-label and 65(19.8%) were unlicensed remaining 81(24.6%) labelled drugs. Most off-label drugs were prescribed for indication of alimentary tract (93.6%) and anti-infective (38.6%). Signicant confounding factors for prescription of unlicensed drugs were single diagnosis (OR 0.20, P<0.05) and hospital stay (OR 1.30, P<0.05) Common reasons for off-label prescribing were dosage 52.4% and age 23.2%. There was a high extent of utilization of off-label and unlicensed drugs. Hence Conclusion: , national drug regulatory authorities need to review and revise existing guidelines for safe administration of such drugs.

JURIDICAL ANALYSIS OF BUSINESS CONVENIENCE FOR MICRO, SMALL AND MEDIUM ENTERPRISES (MSMEs) IN MEDAN CITY

The problems faced by MSME business actors are licensing and capital issues to continue their business in the midst of the COVID-19 pandemic. So special attention is needed for MSME actors from the Government during a pandemic. This research uses normative legal research and empirical legal research. Therefore, the data used include primary data and secondary data. Data were collected using library research and field research using interview methods. The results of the study indicate that the ease of doing business permits for MSME business actors according to the job creation law will be freed from business licensing fees and will provide cost relief for small businesses. The Government's policy is to provide social assistance to MSMEs affected by COVID-19 in the amount of 2.4 million Rupiah. Obstacles Faced First, there are obstacles in terms of licensing, the second is obstacles in distributing BPUM, and the third is the obstacles to providing capital credit for Micro, Small and Medium Enterprises (MSMEs).

Aligning restricted access data with FAIR: a systematic review.

Understanding the complexity of restricted research data is vitally important in the current new era of Open Science. While the FAIR Guiding Principles have been introduced to help researchers to make data Findable, Accessible, Interoperable and Reusable, it is still unclear how the notions of FAIR and Openness can be applied in the context of restricted data. Many methods have been proposed in support of the implementation of the principles, but there is yet no consensus among the scientific community as to the suitable mechanisms of making restricted data FAIR. We present here a systematic literature review to identify the methods applied by scientists when researching restricted data in a FAIR-compliant manner in the context of the FAIR principles. Through the employment of a descriptive and iterative study design, we aim to answer the following three questions: (1) What methods have been proposed to apply the FAIR principles to restricted data?, (2) How can the relevant aspects of the methods proposed be categorized?, (3) What is the maturity of the methods proposed in applying the FAIR principles to restricted data?. After analysis of the 40 included publications, we noticed that the methods found, reflect the stages of the Data Life Cycle, and can be divided into the following Classes: Data Collection, Metadata Representation, Data Processing, Anonymization, Data Publication, Data Usage and Post Data Usage. We observed that a large number of publications used ‘Access Control‘ and ‘Usage and License Terms’ methods, while others such as ‘Embargo on Data Release’ and the use of ‘Synthetic Data’ were used in fewer instances. In conclusion, we are presenting the first extensive literature review on the methods applied to confidential data in the context of FAIR, providing a comprehensive conceptual framework for future research on restricted access data.

The HAPPE plus Event-Related (HAPPE+ER) software: A standardized preprocessing pipeline for event-related potential analyses

Event-Related Potential (ERP) designs are a common method for interrogating neurocognitive function with electroencephalography (EEG). However, the traditional method of preprocessing ERP data is manual-editing – a subjective, time-consuming processes. A number of automated pipelines have recently been created to address the need for standardization, automation, and quantification of EEG data pre-processing; however, few are optimized for ERP analyses (especially in developmental or clinical populations). We propose and validate the HAPPE plus Event-Related (HAPPE+ER) software, a standardized and automated pre-processing pipeline optimized for ERP analyses across the lifespan. HAPPE+ER processes event-related potential data from raw files through preprocessing and generation of event-related potentials for statistical analyses. HAPPE+ER also includes post-processing reports of both data quality and pipeline quality metrics to facilitate the evaluation and reporting of data processing in a standardized manner. Finally, HAPPE+ER includes post-processing scripts to facilitate validating HAPPE+ER performance and/or comparing to performance of other preprocessing pipelines in users’ own data via simulated ERPs. We describe multiple approaches with simulated and real ERP data to optimize pipeline performance and compare to other methods and pipelines. HAPPE+ER software is freely available under the terms of GNU General Public License at https://www.gnu.org/licenses/#GPL

HAPPILEE: HAPPE In Low Electrode Electroencephalography, a standardized pre-processing software for lower density recordings

Lower-density Electroencephalography (EEG) recordings (from 1 to approximately 32 electrodes) are widely-used in research and clinical practice and enable scalable brain function measurement across a variety of settings and populations. Though a number of automated pipelines have recently been proposed to standardize and optimize EEG pre-processing for high-density systems with state-of-the-art methods, few solutions have emerged that are compatible with lower-density systems. However, lower-density data often include long recording times and/or large sample sizes that would benefit from similar standardization and automation with contemporary methods. To address this need, we propose the HAPPE In Low Electrode Electroencephalography (HAPPILEE) pipeline as a standardized, automated pipeline optimized for EEG recordings with lower density channel layouts of any size. HAPPILEE processes task-free (e.g., resting-state) and task-related EEG (including event-related potential data by interfacing with the HAPPE+ER pipeline), from raw files through a series of processing steps including filtering, line noise reduction, bad channel detection, artifact correction from continuous data, segmentation, and bad segment rejection that have all been optimized for lower density data. HAPPILEE also includes post-processing reports of data and pipeline quality metrics to facilitate the evaluation and reporting of data quality and processing-related changes to the data in a standardized manner. Here the HAPPILEE steps and their optimization with both recorded and simulated EEG data are described. HAPPILEE's performance is then compared relative to other artifact correction and rejection strategies. The HAPPILEE pipeline is freely available as part of HAPPE 2.0 software under the terms of the GNU General Public License at: https://github.com/PINE-Lab/HAPPE.

Distributed 3D Printing of Spare Parts via IP Licensing

Problem definition: We consider an OEM supplying a single part to multiple buyers over an infinite horizon. We study how the OEM can digitize the spare parts supply chain by leveraging 3D printing via intellectual property (IP) licensing. Academic/practical relevance: Additive manufacturing, also known as 3D printing, has the potential to shift supply chains from global networks that rely on centralized production with traditional manufacturing technologies to mainly digital networks with distributed, local printing. Particularly well positioned to drive this transition are original equipment manufacturers (OEMs) who design and produce capital goods. Methodology: We first set up a benchmark model of the traditional physical supply chain with centralized production by the OEM. We then propose the OEM to act as an IP licensor by selling spare parts designs, rather than physical parts. With the license agreement, a buyer can print parts locally through a third-party printing service provider, enjoying a shorter lead time and lower setup cost. Given a license, each buyer chooses whether to switch to the IP licensing channel or stay in the traditional channel. The OEM selects the license terms to maximize the total profit across both channels. Results: We characterize the OEM’s optimal license and the resulting supply chain configuration. We show that 3D printing’s competency in price plays a dominant role in production decentral- ization. The conventional wisdom that 3D printing is suitable for slow moving parts holds only when it is competent along several dimensions. In a numerical experiment with realistic parameter settings, decentralized production occurs in a surprisingly large number of cases, and the proposed new business model can significantly increase the OEM’s profit. Managerial implications: Our results indicate that IP licensing by OEMs can become a major enabler in the transition to digital supply networks with distributed 3D printing, benefiting all parties involved.

The Use and Abuse of Anti-Suit Injunctions in SEP Litigation: Is There a Way Forward?

Abstract Cross-border litigation over standard essential patents (SEPs) entered a new phase when the English courts decided in Unwired Planet v Huawei that they have the power to set the terms of a global license within the context of national patent infringement proceedings. Unwired Planet appears to have unleashed a global race to the bottom and a race to the courthouse, with litigants racing to seize their preferred forum to set global rates while trying to prevent their opponents from bringing proceedings elsewhere through ‘anti-suit injunctions’, a type of relief traditionally granted by common law jurisdictions but now increasingly by civil law jurisdictions such as China. Yet this is rarely the end of the matter, with litigants applying for anti-anti-suit injunctions or even anti-anti-anti-suit injunctions. The purpose of this paper is to explore the new realities in SEP litigation post-Unwired Planet, with a focus on the use of anti-suit injunctions and the corresponding turf war between national courts. After discussing the legal test for granting such relief in various legal systems, the paper discusses the worrying proliferation of anti-suit injunctions across major jurisdictions, noting how this trend wastes judicial resources and may undermine international comity. It considers that in the absence of some form of international coordination, a satisfactory solution is unlikely to emerge in the short term. As a first step, it proposes that governments consider establishing ‘best practices’ for SEP licensing dispute resolution, including for jurisdictional issues such as the scope of licenses fashioned by national courts.

Pengaruh Penetapan Harga Pokok Produksi Dan Strategi Pemasaran Terhadap Tingkat Pendapatan Usaha Mikro Kecil Menengah (UMKM)

Micro, Small and Medium Enterprises or known as MSMEs have many roles in eradicating poverty, reducing unemployment, and increasing people's income so that they can be independent in supporting their economy. Therefore, the government continues to strive so that MSMEs in various regions can develop so as to support the economy of small communities by providing various facilities both in terms of funding, marketing, licensing and other supporting facilities. The presence of the industrial revolution 4.0 has the impact of intense competition, MSMEs must be able to overcome this challenge creatively, product innovation, marketing, product packaging, human resource development and technology. The MSME empowerment strategy can be pursued through the role of the Government in issuing fiscal and non-fiscal policies, the role of universities in carrying out services to educate and prosper the community and the role of stakeholders in encouraging MSMEs to be more independent and innovative. Research by Beginner Lecturers using university grant funds is focused on SMEs located in Ciawi Village, Bogor Regency, who are able to calculate the cost of production and are able to make plans in the budget for running a business.

Digital use of standardised assessment tools for children and adolescents: can available paper-based questionnaires be used free of charge in electronic format?

QuestionMost adolescents live in low- and middle-income countries (LMIC), and about 10% of them face mental problems. The mental health provision gap in low- and middle-income countries could be addressed by evidence-based practices, however costs are implementational barriers. Digitalization can improve the accessibility of these tools and constitutes a chance for LMIC to use them more easily at a low cost. We reviewed free and brief evidence-based mental health assessment tools available for digital use to assess psychopathology across different domains in youth.MethodsFor the current study, instruments from a recent review on paper-based instruments were re-used. Additionally, a systematic search was conducted to add instruments for the personality disorder domain. We searched and classified the copyright and license terms available from the internet in terms of free usage and deliverability in a digital format. In the case that this information was insufficient, we contacted the authors.ResultsIn total, we evaluated 109 instruments. Of these instruments, 53 were free and digitally usable covering 11 mental health domains. However, retrieving information on copyright and license terms was very difficult.ConclusionsFree and digitally adaptable instruments are available, supporting the strategy of using instruments digitally to increase access. The instrument’s authors support this initiative, however, the lack of copyright information and the difficulties in contacting the authors and licence holders are barriers to using this strategy in LMIC. A comprehensive, online instrument repository for clinical practice would be an appropriate next step to make the instruments more accessible and reduce implementation barriers.

Cardio PyMEA: A user-friendly, open-source Python application for cardiomyocyte microelectrode array analysis.

Open source analytical software for the analysis of electrophysiological cardiomyocyte data offers a variety of new functionalities to complement closed-source, proprietary tools. Here, we present the Cardio PyMEA application, a free, modifiable, and open source program for the analysis of microelectrode array (MEA) data obtained from cardiomyocyte cultures. Major software capabilities include: beat detection; pacemaker origin estimation; beat amplitude and interval; local activation time, upstroke velocity, and conduction velocity; analysis of cardiomyocyte property-distance relationships; and robust power law analysis of pacemaker spatiotemporal instability. Cardio PyMEA was written entirely in Python 3 to provide an accessible, integrated workflow that possesses a user-friendly graphical user interface (GUI) written in PyQt5 to allow for performant, cross-platform utilization. This application makes use of object-oriented programming (OOP) principles to facilitate the relatively straightforward incorporation of custom functionalities, e.g. power law analysis, that suit the needs of the user. Cardio PyMEA is available as an open source application under the terms of the GNU General Public License (GPL). The source code for Cardio PyMEA can be downloaded from Github at the following repository: https://github.com/csdunhamUC/cardio_pymea.

Orthopaedic Surgeons Have a High Prevalence of Burnout, Depression, and Suicide: Review of Factors Which Contribute or Reduce Further Harm.

Orthopaedic surgeons have the highest prevalence of death by suicide among all surgical subspecialties, comprising 28.2% of surgeon suicides from 2003 to 2017. There is a continuum of burnout, depression, and other mental health illnesses likely contributing to these numbers in our profession. Stigmatization in terms of medical licensing and professional development are currently barriers to seeking mental health treatment. Education on the risk and treatment of burnout, depression, and suicidal ideations should begin early in a surgeon's career. This review documents the issue of physician burnout and depression and makes recommendations regarding necessary changes to counteract mental illness in orthopaedic surgeons.

Development Strategy of Msme Through Zakat, Infak, Sedakah to Realize Economic Empowerment

This study aims to determine the potential of ZIS funds in developing MSMEs and the mechanisms carried out in empowering MSMEs through ZIS funds so that they can realize a better economy. Micro, Small and Medium Enterprises (MSMEs) are business actors who have a strategic role in economic development efforts. national. However, the potential possessed by micro-enterprises still has various obstacles both in increasing market share and in terms of capital. These obstacles can be minimized by utilizing Zakat, Infak, Alms (ZIS) funds in the form of financing assistance along with productive empowerment so that they can have an impact on the development of micro-enterprises. The method in this research is conceptual research using secondary data through a qualitative descriptive approach. The results showed that the mechanism for developing MSMEs through ZIS funds, apart from providing capital or financing, was followed by a sustainable empowerment model in the form of monitoring, coaching, and training. Another impact obtained from optimizing ZIS funds is creating economic independence and increasing the selling value of business products both in terms of licensing and halal certification.

RESENTRALISASI PERIZINAN BERUSAHA PERTAMBANGAN MINERAL DALAM UNDANG-UNDANG NOMOR 11 TAHUN 2020 TENTANG CIPTA KERJA

The division of concurrent government affairs in terms of licensing of mineral and coal mining businesses in their development has been degraded as a result of the establishment of Law No. 11 of 2020 concerning Job Creation. The reduced concurrent government affairs illustrate the desire of the central government to decentralize government affairs, even though ideally the authority to distribute concurrent government affairs is an authority that should be the jurisdiction of local governments. This research is legal research. The problem approach used to answer the legal issues of this research is the statutory approach, which is an approach that uses statutory regulations. Next is the conceptual approach used to examine and analyze the framework of thought, conceptual framework, or juridical basis. From the approach used, the researcher can use an analytical knife in finding answers to the legal issues of writing this thesis. Based on the analysis of legal materials, it can be concluded that the recentralization of licensing arrangements conflicts with the principle of Regional Autonomy because First, there is a conflict of norms against the provisions in Article 18 paragraph (2) of the 1945 Constitution of the Republic of Indonesia. Second, it is not under the principle of division of affairs. Governance, namely accountability, externalities, efficiency, and national strategic interests. The suggestion that can be given is that the DPR together with the President revise Article 402 A of Law No. 11 of 2020 concerning Job Creation which in this provision is contrary to the principle of regional autonomy.

CropPol: A dynamic, open and global database on crop pollination.

Seventy five percent of the world's food crops benefit from insect pollination. Hence, there has been increased interest in how global change drivers impact this critical ecosystem service. Because standardized data on crop pollination are rarely available, we are limited in our capacity to understand the variation in pollination benefits to crop yield, as well as to anticipate changes in this service, develop predictions, and inform management actions. Here, we present CropPol, a dynamic, open, and global database on crop pollination. It contains measurements recorded from 202 crop studies, covering 3,394 field observations, 2,552 yield measurements (i.e., berry mass, number of fruits, and fruit density [kg/ha], among others), and 47,752 insect records from 48 commercial crops distributed around the globe. CropPol comprises 32 of the 87 leading global crops and commodities that are pollinator dependent. Malus domestica is the most represented crop (32 studies), followed by Brassica napus (22 studies), Vaccinium corymbosum (13 studies), and Citrullus lanatus (12 studies). The most abundant pollinator guilds recorded are honey bees (34.22% counts), bumblebees (19.19%), flies other than Syrphidae and Bombyliidae (13.18%), other wild bees (13.13%), beetles (10.97%), Syrphidae (4.87%), and Bombyliidae (0.05%). Locations comprise 34 countries distributed among Europe (76 studies), North America (60), Latin America and the Caribbean (29), Asia (20), Oceania (10), and Africa (7). Sampling spans three decades and is concentrated on 2001-2005 (21 studies), 2006-2010 (40), 2011-2015 (88), and 2016-2020 (50). This is the most comprehensive open global data set on measurements of crop flower visitors, crop pollinators and pollination to date, and we encourage researchers to add more datasets to this database in the future. This data set is released for non-commercial use only. Credits should be given to this paper (i.e., proper citation), and the products generated with this database should be shared under the same license terms (CC BY-NC-SA).

UNWIRED PLANET INTERNATIONAL LTD v HUAWEI TECHNOLOGIES CO LTD

Abstract H1 Patents — European patents — Standards essential patents — Infringement proceedings — Nature of the FRAND undertaking — FRAND terms — Global licences — Jurisdiction — Forum conveniens — Justiciability — Non-discrimination — Assessment of comparability — Interplay between FRAND terms and competition law — No offer of licence terms before action — Injunctive relief — Appeal to Supreme Court

Chinese court rules for the first time that it has jurisdiction over SEP global licensing disputes

Abstract OPPO v Sharp Corporation: Jurisdictional Objection in Global Rate Setting of Standard Essential Patent ((2020) Zui Gao Fa Zhi Min Xia Zhong No. 517), 19 August 2021 The Intellectual Property Court of the Supreme People’s Court (SPC) of China ruled that Chinese courts have jurisdiction over global licensing terms disputes for standard essential patent (SEP) in the communications sector.

Implementation of a practical Markov chain Monte Carlo sampling algorithm in PyBioNetFit.

Bayesian inference in biological modeling commonly relies on Markov chain Monte Carlo (MCMC) sampling of a multidimensional and non-Gaussian posterior distribution that is not analytically tractable. Here, we present the implementation of a practical MCMC method in the open-source software package PyBioNetFit (PyBNF), which is designed to support parameterization of mathematical models for biological systems. The new MCMC method, am, incorporates an adaptive move proposal distribution. For warm starts, sampling can be initiated at a specified location in parameter space and with a multivariate Gaussian proposal distribution defined initially by a specified covariance matrix. Multiple chains can be generated in parallel using a computer cluster. We demonstrate that am can be used to successfully solve real-world Bayesian inference problems, including forecasting of new Coronavirus Disease 2019 case detection with Bayesian quantification of forecast uncertainty. PyBNF version 1.1.9, the first stable release with am, is available at PyPI and can be installed using the pip package-management system on platforms that have a working installation of Python 3. PyBNF relies on libRoadRunner and BioNetGen for simulations (e.g. numerical integration of ordinary differential equations defined in SBML or BNGL files) and Dask.Distributed for task scheduling on Linux computer clusters. The Python source code can be freely downloaded/cloned from GitHub and used and modified under terms of the BSD-3 license (https://github.com/lanl/pybnf). Online documentation covering installation/usage is available (https://pybnf.readthedocs.io/en/latest/). A tutorial video is available on YouTube (https://www.youtube.com/watch?v=2aRqpqFOiS4&t=63s). Supplementary data are available at Bioinformatics online.

Historical analysis of coffee production and associated challenges in Kenya from 1893 to 2018

Coffee is one of the most important export crops in Kenya, contributing about 22 per cent of the national income and is a source of livelihood for more than 700 000 households. However, despite its immense importance to the Kenyan economy, coffee exports have continued to shrink. This paper explores the introduction and upscaling production of coffee in Kenya from 1893 to 2018 and associated challenges. It assesses the role of white settlers and Kenyans in coffee production during the colonial period (1893-1962) and the post-independence period (1963-2018). This research showcases how a mismatch in policy direction at a local level and insufficient support to coffee farmers in Kenya have led to a downward trajectory of coffee production. The data was collected from secondary sources and was analysed chronologically to historicise coffee production and its associated challenges. The study concludes that the dismal performance of coffee production is partly attributable to coffee prices, marketing channels, coffee financing, coffee regulations, cost of production, management of cooperatives and processing of exported coffee. Thus, it is recommended that the Kenyan government harmonise existing policies regulating the coffee industry in terms of licensing, marketing, and making credit available to farmers.