The SEC's enforcement programme on biotechnology's communications with the investment community

2006 ◽  
Vol 12 (3) ◽  
Author(s):  
Arthur S Gabinet
Keyword(s):  
Basic Structure ◽  
The United States ◽  
Securities And Exchange Commission ◽  
Regulatory Agencies ◽  
Securities Markets ◽  
Start Up ◽  
Enforcement Programme ◽  
Biotechnology Companies ◽  
Securities Laws ◽  
The U.S

The proliferation of biotechnology start-up companies has led to increased scrutiny by the regulators of the securities markets. The author, a former head of a field office of the United States Securities and Exchange Commission, examines the growing cooperation among regulatory agencies in the U.S. and the basic structure of the disclosure and anti-fraud provisions of the U.S. securities laws. The author articulates the approaches that the SEC division of enforcement has taken to investigating and prosecuting violations of the securities laws by biotechnology companies and provides useful guidance for dealing with news that may impact the securities markets.

Significant Differences in Proved Reserves Estimates Using SPE/WPC Definitions Compared to United States Securities and Exchange Commission (SEC) Definitions

2005 ◽  
Vol 8 (06) ◽  
pp. 520-527 ◽  
Author(s):  
D.R. Harrell ◽  
Thomas L. Gardner
Keyword(s):  
United States ◽  
Oil And Gas ◽  
The United States ◽  
Securities And Exchange Commission ◽  
Classification Systems ◽  
Direct Function ◽  
Oil Companies ◽  
Publicly Owned ◽  
Hydrocarbon Reserves ◽  
The U.S

Summary A casual reading of the SPE/WPC (World Petroleum Congresses) Petroleum Reserves Definitions (1997) and the U.S. Securities and Exchange Commission(SEC) definitions (1978) would suggest very little, if any, difference in the quantities of proved hydrocarbon reserves estimated under those two classification systems. The differences in many circumstances for both volumetric and performance-based estimates may be small. In 1999, the SEC began to increase its review process, seeking greater understanding and compliance with its oil and gas reserves reporting requirements. The agency's definitions had been promulgated in 1978 in connection with the Energy Policy and Conservation Act of 1975 and at a time when most publicly owned oil and gas companies and their reserves were located in the United States. Oil and gas prices were relatively stable, and virtually all natural gas was marketed through long-term contracts at fixed or determinable prices. Development drilling was subject to well-spacing regulations as established through field rules set by state agencies. Reservoir-evaluation technology has advanced far beyond that used in 1978;production-sharing contracts were uncommon then, and probabilistic reserves assessment was not widely recognized or appreciated in the U.S. These changes in industry practice plus many other considerations have created problems in adapting the 1978 vintage definitions to the technical and commercial realities of the 21st century. This paper presents several real-world examples of how the SEC engineering staff has updated its approach to reserves assessment as well as numerous remaining unresolved areas of concern. These remaining issues are important, can lead to significant differences in reported quantities and values, and may result in questions about the "full disclosure" obligations to the SEC. Introduction For virtually all oil and gas producers, their company assets are the hydrocarbon reserves that they own through various forms of mineral interests, licensing agreements, or other contracts and that produce revenues from production and sale. Reserves are almost always reported as static quantities as of a specific date and classified into one or more categories to describe the uncertainty and production status associated with each category. The economic value of these reserves is a direct function of how the quantities are to be produced and sold over the physical or contract lives of the properties. Reserves owned by private and publicly owned companies are always assumed to be those quantities of oil and gas that can be produced and sold at a profit under assumed future prices and costs. Reserves under the control of state-owned or national oil companies may reflect quantities that exceed those deemed profitable under the commercial terms typically imposed on private or publicly owned companies.

Sold—to the Highest Bidder in Japan: Operational Challenges and Culture

2015 ◽  
pp. 1-5
Author(s):  
Gerry Yemen ◽  
Kristin J. Behfar ◽  
Allison Elias
Keyword(s):  
United States ◽  
The United States ◽  
Japanese Firm ◽  
Cultural Norms ◽  
Exit Strategy ◽  
Cross Border ◽  
Start Up ◽  
Financial Benefits ◽  
Operational Issues ◽  
The U.S

Most talented executives can recognize when an acquisition has strategic or financial benefits, and in this case, the decision to be acquired was an appropriate exit strategy for a successful start-up. Peter Street’s start-up had been growing quickly and was building a reputation for reliability in a booming industry when a Japanese firm offered to pay a premium for the U.S. firm. Having done business in Japan (and extensively with the acquiring company) before the sale of his company, Street entered the acquisition with enthusiasm. As part of the deal, Street’s former company would continue to operate in the United States as a division of its parent company and Street would remain as CEO. A few months into the transition, however, Street discovered a huge difference between working with and working for the Japanese firm. Cultural norms for confronting seemingly small problems quickly became bigger operational issues, and Street experienced a growing dichotomy between corporate (in Japan) and his division (in the United States). This case focuses on the challenges of implementing a cross-border acquisition.

Healthcare in the United States

2018 ◽  
pp. 73-85
Author(s):  
Hillary Knepper
Keyword(s):  
United States ◽  
Healthcare Delivery ◽  
Basic Structure ◽  
The United States ◽  
Healthcare Industry ◽  
Healthcare Delivery System ◽  
Patient Protection ◽  
Public Revenue ◽  
The Impact ◽  
The U.S

Healthcare in the United States is a dynamic mix of public and marketplace solutions to the challenge of achieving the maximum public good for the greatest number of people. Indeed, in the U.S. the healthcare industry generates over $3 trillion in the economy. This creates a uniquely American paradox that is examined here. The basic structure of the U.S. public-private healthcare delivery system is explored. The dynamics of public sector involvement in healthcare delivery is reviewed, with particular emphasis on the impact of the Patient Protection and Affordable Care Act. Economic impact, employment indicators, and recent cost estimates of public revenue investment will be considered. Finally, a discussion about the future implications of healthcare for public administration in the 21st century is presented. Eight tables and figures present a visual and detailed explanation to accompany the narrative.

Healthcare in the United States

2021 ◽  
pp. 480-491
Author(s):  
Hillary Knepper
Keyword(s):  
United States ◽  
Healthcare Delivery ◽  
Basic Structure ◽  
The United States ◽  
Healthcare Industry ◽  
Healthcare Delivery System ◽  
Patient Protection ◽  
Public Revenue ◽  
The Impact ◽  
The U.S

Healthcare in the United States is a dynamic mix of public and marketplace solutions to the challenge of achieving the maximum public good for the greatest number of people. Indeed, in the U.S. the healthcare industry generates over $3 trillion in the economy. This creates a uniquely American paradox that is examined here. The basic structure of the U.S. public-private healthcare delivery system is explored. The dynamics of public sector involvement in healthcare delivery is reviewed, with particular emphasis on the impact of the Patient Protection and Affordable Care Act. Economic impact, employment indicators, and recent cost estimates of public revenue investment will be considered. Finally, a discussion about the future implications of healthcare for public administration in the 21st century is presented. Eight tables and figures present a visual and detailed explanation to accompany the narrative.

Private Securities Litigation

2021 ◽  
pp. 163-210
Author(s):  
Marc I. Steinberg
Keyword(s):  
United States ◽  
The United States ◽  
Federal Courts ◽  
Federal Legislation ◽  
Securities Markets ◽  
Securities Litigation ◽  
Disparate Treatment ◽  
Degree Of Certainty ◽  
Judicial Actions ◽  
Securities Laws

This chapter focuses on the erratic and unacceptable private securities litigation framework that prevails in the United States. The litigation structure contained in the federal securities acts was based on a different era and is not suitable for today’s securities markets. Although federal legislation has been enacted to address perceived shortcomings on an episodic basis, significant gaps and inconsistencies exist. Likewise, the federal courts, faced with a fractured statutory regimen, frequently have construed the remedial provisions in a wooden and unduly restrictive manner. The consequence of these congressional and judicial actions is a disparate liability framework that lacks sound logic, consistency, and even-handed treatment for plaintiffs and defendants alike. This chapter provides several examples of the inconsistencies and disparate treatment that prevail under the federal securities laws. Thereafter, recommendations for corrective measures are proffered. These proposals, if adopted and effectively implemented, should instill a substantially greater degree of certainty, uniformity, and equity than currently exists.

The Determinants of Social Policy a Case Study: Regulating Health and Safety at the Workplace in Sweden

1983 ◽  
Vol 13 (4) ◽  
pp. 517-561 ◽  
Author(s):  
Vicente Navarro
Keyword(s):  
Occupational Health ◽  
Political Parties ◽  
Important Determinant ◽  
Health And Safety ◽  
Occupational Health And Safety ◽  
The United States ◽  
Regulatory Agencies ◽  
Historical Evolution ◽  
The U.S

This article presents an analysis and critique of the “technocratic” view of occupational health and safety policies, which sees the values of the personnel of the “postindustrial” regulatory agencies as the most important determinant of those policies. An alternate position is put forth which explains those occupational health and safety policies as primarily the result of different degrees of political power of the two major classes (capital and labor) and the set of influences exerted on the regulatory agencies by the instruments (e.g., political parties, unions, trade organizations) of those classes. It is shown how an analysis of the historical evolution of those classes in Sweden and their conflict in both civil and political societies better explains the Swedish occupational health and safety policies than the mere analysis of the regulators' views. It is concluded that the occupational health and safety policies in Sweden are not identical to the U.S. policies–as the “technocratic” theorists assume–but rather they offer more protection to the workers than the U.S. ones. This situation is a result of labor's greater power in Sweden than in the United States. The different class formations and class behavior in both societies are compared, and the implications of this comparison for occupational health and safety policies are discussed.

Rethinking Securities Law—Laying the Groundwork

2021 ◽  
pp. 1-12
Author(s):  
Marc I. Steinberg
Keyword(s):  
United States ◽  
Public Policy ◽  
The United States ◽  
Securities Regulation ◽  
Securities Law ◽  
Judicial Decisions ◽  
Securities Laws ◽  
Regulatory Organization ◽  
Policy Setting ◽  
The U.S

This chapter explains the need for the “rethinking” of the federal securities laws, with particular emphasis on the Securities Act of 1933 and the Securities Exchange Act of 1934. Recognizing the historical preeminence of the U.S. securities law framework, the chapter first highlights key attributes that facilitate the effectuation of this achievement. Thereafter, the chapter addresses problematic characteristics of U.S. securities regulation. As set forth therein, the framework of securities regulation that exists today in the United States is comprised of piecemeal federal legislation, judicial decisions, SEC action, state securities (blue sky) activity, and self-regulatory organization oversight. As a consequence, the presence of consistent and logical regulation all too often is absent. With frequency, in both transactional and litigation settings, mandates apply that are erratic and antithetical to sound public policy. Setting the stage, in a preliminary manner, the chapter identifies several of the key problematic areas, succinctly explains their deficiencies, and suggests corrective measures that should be implemented.

scholarly journals Why the CHIPS Are Down: Stock Buybacks and Subsidies in the U.S. Semiconductor Industry

2021 ◽  
Author(s):  
William Lazonick ◽  
◽  
Matt Hopkins ◽  
Keyword(s):  
United States ◽  
Stock Prices ◽  
Semiconductor Industry ◽  
The United States ◽  
Securities And Exchange Commission ◽  
Open Market ◽  
Chip Technology ◽  
The Government ◽  
Stock Buybacks ◽  
The U.S

The Semiconductor Industry Association (SIA) is promoting the Creating Helpful Incentives to Produce Semiconductors (CHIPS) for America Act, introduced in Congress in June 2020. An SIA press release describes the bill as “bipartisan legislation that would invest tens of billions of dollars in semiconductor manufacturing incentives and research initiatives over the next 5-10 years to strengthen and sustain American leadership in chip technology, which is essential to our country’s economy and national security.” On June 8, 2021, the Senate approved $52 billion for the CHIPS for America Act, dedicated to supporting the U.S. semiconductor industry over the next decade. As of this writing, the Act awaits approval in the House of Representatives. This paper highlights a curious paradox: Most of the SIA corporate members now lobbying for the CHIPS for America Act have squandered past support that the U.S. semiconductor industry has received from the U.S. government for decades by using their corporate cash to do buybacks to boost their own companies’ stock prices. Among the SIA corporate signatories of the letter to President Biden, the five largest stock repurchasers—Intel, IBM, Qualcomm, Texas Instruments, and Broadcom—did a combined $249 billion in buybacks over the decade 2011-2020, equal to 71 percent of their profits and almost five times the subsidies over the next decade for which the SIA is lobbying. In addition, among the members of the Semiconductors in America Coalition (SIAC), formed specifically in May 2021 to lobby Congress for the passage of the CHIPS for America Act, are Apple, Microsoft, Cisco, and Google. These firms spent a combined $633 billion on buybacks during 2011-2020. That is about 12 times the government subsidies provided under the CHIPS for America Act to support semiconductor fabrication in the United States in the upcoming decade. If the Congress wants to achieve the legislation’s stated purpose of promoting major new investments in semiconductors, it needs to deal with this paradox. It could, for example, require the SIA and SIAC to extract pledges from its member corporations that they will cease doing stock buybacks as open-market repurchases over the next ten years. Such regulation could be a first step in rescinding Securities and Exchange Commission Rule 10b-18, which has since 1982 been a major cause of extreme income inequality and loss of global industrial competitiveness in the United States.

scholarly journals Comparison of risk management regulation from a corporate governance perspective within the German and united states legal areas

2014 ◽  
Vol 3 (4) ◽  
pp. 138-148
Author(s):  
Remmer Sassen
Keyword(s):  
United States ◽  
Risk Management ◽  
Corporate Governance ◽  
The United States ◽  
Securities And Exchange Commission ◽  
Future Research ◽  
Governance System ◽  
National Interests ◽  
Legal Norms ◽  
The U.S

Risk management is one of the main corporate governance components or management tasks. This paper details a comparison of risk management regulation from a corporate governance perspective of listed stock corporations in Germany and the United States (U.S.). Obviously, there are differences and commonalities between the national legal norms and the regulatory levels of risk management in both countries. The comparison helps to understand different traditions and practices in terms of how significant corporate governance rules are for risk management. Therefore, this article intends to inspire future research on the regulation of risk management across different regions and explore the relevance of national interests in the regulation of risk management. A principal finding of the comparison is that the U.S. corporate governance system seems to be more strongly regulated than the German system. This results from the powerful and coordinating role of the U.S. Securities and Exchange Commission (SEC). Thus, the seemingly more liberal system of non-binding standards in the U.S. has a higher impact on the regulation of risk management than in Germany.

Erythropoietin Stimulating Agents (ESAs): Reassessment of Use in Cancer and Chronic Kidney Disease (CKD) Settings in the United States, Canada, and Europe.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4538-4538
Author(s):  
Charles L Bennett ◽  
Athena T Samaras ◽  
June M McKoy ◽  
Beatrice J Edwards ◽  
Mi Zheng ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Cancer Patients ◽  
Conflicts Of Interest ◽  
The United States ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Cancer Setting ◽  
The U.S

Abstract Abstract 4538 Introduction International reassessments of erythropoiesis stimulating agents (ESAs) for anemia have recently occurred. While ESAs prevent blood transfusions and, improve select quality of life domains among chronic kidney disease (CKD) patients, 8 trials individually identified increased mortality and/or tumor progression among cancer patients treated with ESAs. For CKD, one study of non-dialysis CKD patients targeted to higher versus lower hemoglobin (Hb) levels identified 34% increased relative risk (17.5% vs. 13.5%) for death, acute myocardial infarction, congestive heart failure hospitalization, or stroke with a higher Hb target. Methods Guidelines, notifications from regulatory agencies and manufacturers, reimbursement policies, and utilization for ESAs in the cancer and CKD settings within the U.S., Europe, and Canada were reviewed. Results: Cancer Setting In 2008, the Food and Drug Administration (FDA) restricted ESAs from cancer patients seeking cure. Reimbursement is limited to Hb levels < 10 g/dL. In the U.S., ESA usage increased 340% between 2001 and 2006, and decreased 60% since 2007. The European Medicines Agency (EMEA) reports that ESA benefits do not outweigh risks. In Europe, ESA reimbursement is included in global provider payments. Between 2001 and 2006, ESA use increased 51%; since 2006, use has decreased 10%. Canadian manufacturers recommend ESA usage based on patient preference. In Canada, reimbursement for myelosuppressive chemotherapy with ESAs is restricted to Hb levels of 10-11 g/dL in Alberta and 11-12.5 g/dL in British Columbia. Usage increased 20% between 2004 and 2007. CKD Setting The FDA recommends Hb levels < 12 g/dL and Medicare reimbursement is restricted to Hb levels ≥ 13 g/dL. Between 2001 and 2006, usage increased 480% (non-dialysis) and 40% (dialysis) in the U.S. Since 2007, ESA use has decreased 30% (non-dialysis) and 17% (dialysis). The EMEA recommends target Hb levels of 10-12 g/dL. In Europe, ESA usage has increased 10% since 2001. The 2009 Canadian label recommends Hb levels < 12 g/dL. Within Canada, ESA usage increased 30% since 2004. Conclusions While reassessments of ESA safety have occurred internationally, safety concerns in the U.S. have resulted in marked decrements in ESA use among cancer and CKD patients, whereas in Europe and Canada ESA use has increased over time. Disclosures: No relevant conflicts of interest to declare.

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