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.
Taking a page from laws creating sanctuary cities for illegal immigrants, a group of lawmakers have
submitted a bill that bans California law enforcement from working with federal
authorities if they attempt
to take action against marijuana grow facilities or dispensaries that operate legally
under state law.
``... Internal checks revealed unauthorized transactions which led
to a 17 million Nano shortfall, an amount forming part of the wallet managed by BitGrail... Today a charge about those fraudulent activities has been
submitted to the competent
authorities and now is
under police investigation.»
Rather, those who have been entrusted with the truth of the gospel
submit together as equals
under the
authority of the one who entrusted it
to them (2.7) and gave Paul grace (2.9).
If any of you are
under the mistaken notion that Mormonism is a christian denomination I
submit the following from the 1984 Melchizedek Priesthood Manual «If we get our salvation, we shall have
to pass by him (Joseph Smith) if we enter into our glory, it will be through the
authority he has received.
The California Avocado Inspection Committee (AIC), which operates
under authority of the California Department of Food and Agriculture (CDFA), has
submitted a petition
to the Department seeking
to modernize regulations governing the packing of California avocados.
We will be
submitting cases
to the
authorities calling for action
to be taken
under the new Improvement Notice regime.
The contract was for an upgrade
to the Transit
Authority's VHF radio system in Brooklyn, Manhattan, Queens and the Bronx was the first contract
submitted to DiNapoli's office
under the Public
Authority Reform Act passed earlier this year.
-- The President shall direct relevant Federal agencies
to use existing statutory
authority to take appropriate actions identified in the reports
submitted under sections 705 and 706, and
to address any shortfalls identified in such reports, not later than July 1, 2015, and every 4 years thereafter.
Therefore, the right of family reunification
under Article 10 (3)(a) of the Family Reunification Directive can not depend upon the moment where the national competent
authorities formally adopt their decision recognizing the status as refugee, as this would mean
submitting it
to the functioning of the national administration.
Under British Columbia law, the Motor Vehicles Act gives ICBC the
authority to deny claims if this information is not
submitted properly.
She
submitted that the
authority's action in providing her with temporary accommodation
under HA 1996 was unlawful, and that as a consequence she had been deprived of the services which would have been available
to her at the age of 18, had the provisions of the Children (Leaving Care)(England) Regulations 2001 (SI 2001 / 2874) been applied
to her, and had she, in particular, been treated as «a former relevant child» pursuant
to ChA 1989, s 23C.
Under Section 6.4 of the Regulations, custodians will have
to submit an annual report as early as March 1, 2019 that sets out the number of times PHI in the custodian's custody or control was stolen, lost, used or disclosed without
authority.
The respondent also
submitted that in the absence of a specific statutory provision allowing for the payment of interest, the Minister has no
authority to award interest no matter how broadly remedial powers are drafted
under ss.
In its application for judicial review, Access Copyright
submitted that the deletion provision is «a condition of the grant of rights» and that the Board has no
authority under the Copyright Act
to vary the terms and conditions.
«Today a charge about those fraudulent activities has been
submitted to the competent
authorities and now is
under police investigation.»
Research undertaken as part of the Inquiry including a freedom of information request
submitted to all English local
authorities found that 163 children in care
under a voluntary arrangement have been placed with foster carers who are already approved as suitable adopters since foster for adoption legislation came into force three years ago.
When a written application for benefits, an appeal or any other declaration
under the legislation of a Contracting State is
submitted to a competent
authority or competent institution of the other Contracting State which is competent
to receive similar applications, appeals or declarations
under the legislation of that other Contracting State, that application for benefits, appeal or declaration shall be deemed
to be
submitted on the same date
to the competent
authority or competent institution of the first Contracting State and shall be dealt with according
to the procedure and legislation of the first Contracting State.