Sentences with phrase «other regulatory side»

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Qualcomm said the two sides had made progress on regulatory and other issues at a meeting last week.

On April 12, on the other side of the body of water known alternatively as the East Sea and the Sea of Japan, 16 cryptocurrency exchanges announced plans for a self - regulatory body called the Japan Virtual Currency Exchange Association.

The regulatory approaches to marijuana and tobacco in the United States are on decidedly different paths and, according to researchers from the U.S. and Australia, neither side appears interested in learning from the other.

Other bills that the committee approved on Wednesday are similar to provisions already included in the Senate package, and members on both sides of the aisle expressed their desire to advance a regulatory relief deal.

[The perceived «other side» is from] well - funded campaigns by interests who are worried about what the reality of climate change might imply on the regulatory front.

Proposing regulatory solutions rather than technological ones similarly motivated one side of the population to take it as a new justification for their political beliefs, and the other side to see it as an assault on their freedom and motivated them to find flaws in it.

Well, most problems are connected to the discrepancy between the understanding of ICOs and the related technology on the side of the team working on the project and on the other side the low understanding on part of regulatory bodies, banks, etc..

Depending on the type of legal or regulatory matter, and the issues involved, certain information may need to be redacted (deleted or removed) before a document is produced to the other side.

Under English law «legal professional privilege» entitles a party to withhold evidence (electronic, written, or oral) and not disclose it to either the other side, the court, or regulatory bodies (subject to certain exceptions).

Their collective experience bolsters Akerman's national capabilities for employers in the healthcare, hospitality and restaurant sectors, among others, adding new depth in management - side litigation, regulatory compliance, as well as corporate and investment - based immigration.

Other than that, I think the Consumer Products Safety Improvements Act implementation is significant if only because the changes made in 2008 by the statute reflect a substantial re-focus on regulating product safety from the federal regulatory side.

Prior to the debacle, cryptocurrency investors had reacted warmly to positive regulatory events on the other side of the world at the G20 Summit in Argentina.