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.
(2) There are a dozen or so
different technologies being used
in a typical business today, meaning there is a growing
risk to mission critical parts of their business operations that most owners are simply unprepared to respond to
in any timely
manner.
Perhaps it would be impossible to get Daniel to stop collecting, but getting him to organize or store his hoard
in a
different manner might reduce the
risk to Edith and the rest of his family.
Such contracts normally have a high degree of
risk associated with them, could be substantial
in value and have a range of
different insurances, warranties and the like which also have to be taken account of and balanced
in an appropriate
manner.
Mobile homes are constructed
in a
different manner, allowing for individual
risks that you might not have with a traditional stick built home.