Sentences with phrase «under development right»

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.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

Big losers will include our cultural institutions, including the CBC and the Canada Council who will likely face further devastating cuts, as well as human rights, international development and arts organizations who were funded historically by the Canadian government (some of whom had already lost funding under the minority Conservative government).

Human rights holism must be read in the light of environmental and ecological justice because man can survive only under appropriate environment and ecological milieu whereunder sustainable development and growth with justice may be possible.

Shall the Missouri Constiitution be amended to define the term «person» to be from the beginning of biological development and grant such person constiitutional rights and access to courts under the equal protection, due process, and open courts provisions of the Missouri Constiitution?

All these developments, and in particular the drive under the WTO regime to make access to food mainly dependent upon market mechanisms, are a threat to food security - the most fundamental of all human rights.

Just then the nice people at The American Interest came with a very different suggestion — that I should write a blog under their auspices (if that is the right term in cyberspace language), dealing mainly with current developments in religion, but allowing for occasional excursions into other areas.

I turn to the Bible, not for scientific instruction, but for spiritual illumination, to share in the most influential development of religious ideas in man's history, to watch divine deeds that have changed human destiny, to sit at the feet of great prophets, to learn from the insights of the seers, to find guidance in distinguishing right from wrong, and above all to come under the saving influence of Jesus Christ.

Finding and nurturing the right person has led to tremendous growth for Hay Creek — with this summer's openings, the group is now up to 18 different properties under management and several more in the development stage.

The court also found the purpose of Woolworths having the first right of refusal was not to exclude Woolworths» competitors from the Double Bay site, but to give Woolworths the opportunity to re-acquire its interest in the Double Bay lease it had under the development deal it had with the Woollahra Council.

The New Patriotic Party (NPP) in Ghana believes in the principles that democratic societies provide individuals with the best conditions for political liberty, personal freedom, equality of opportunity and economic development under the rule of law; and therefore being committed to advancing the social and political values on which democratic societies are founded, including the basic personal freedoms and human rights, as defined in the Universal Declaration of Human Rights; in particular, the right of free speech, organization, assembly and non-violent dissent; the right to free elections and the freedom to organize effective parliamentary opposition to government; the right to a free and independent media; the right to religious belief; equality before the law; and individual opportunity and prosprights, as defined in the Universal Declaration of Human Rights; in particular, the right of free speech, organization, assembly and non-violent dissent; the right to free elections and the freedom to organize effective parliamentary opposition to government; the right to a free and independent media; the right to religious belief; equality before the law; and individual opportunity and prospRights; in particular, the right of free speech, organization, assembly and non-violent dissent; the right to free elections and the freedom to organize effective parliamentary opposition to government; the right to a free and independent media; the right to religious belief; equality before the law; and individual opportunity and prosperity.

The IWD otherwise known as the United Nations (UN) Day for Women's Rights and International Peace has since gained international recognition and celebrated world wide in different forms and even gained the status of a holiday in some countries such as Ukraine The day has also been marked under various themes encompassing peace and security, human rights, gender based violence, conflicts and hunger, education, gender equality, empowerment and affirmative actions, inclusion of woman in decision making, the Millenium Development Goals (MDGs) and manyRights and International Peace has since gained international recognition and celebrated world wide in different forms and even gained the status of a holiday in some countries such as Ukraine The day has also been marked under various themes encompassing peace and security, human rights, gender based violence, conflicts and hunger, education, gender equality, empowerment and affirmative actions, inclusion of woman in decision making, the Millenium Development Goals (MDGs) and manyrights, gender based violence, conflicts and hunger, education, gender equality, empowerment and affirmative actions, inclusion of woman in decision making, the Millenium Development Goals (MDGs) and many more.

We've seen tremendous improvement in the economy and at the social level since 1992, the Rawlings regime and that of Kufour all contributed immensely to the growth we seeing, the Mahama administration has added value to what he inherited.The infrastructure development recorded under this government is the highest after Nkrumah, the improvement in the health and education sector can not be downplayed.Policies rolled out by the regime to close the yawning gap between the toiling but highly productive rural folks and city officials is commendable.The IMF director Christie Lagarde was right when she described what we called economic success between 2005 - 2008 as mediocre growth.The base of the economy was still shattered and now being built to restore the confidence of the people.

Manhattan federal Judge Valerie Caproni dismissed a charge of «extortion under color of official right» based on allegations that the former Cuomo confidante used his government post to shake down $ 35,000 in bribes from two execs at the Syracuse - based development company.

«Our support for freedom of expression, development of independent civil society and our conviction that the transparent and consistent application of human rights under the rule of law, are essential prerequisites for China's long term prosperity and stability,» No 10 said before the summit.

In Skaneateles, where the governor was making another economic development announcement, a reporter asked him how he could not have known what was going on «right under his nose.»

During the past 20 years, under Governments of different political stripes, significant developments have included the removal of most hereditary peers from the House of Lords, freedom on information legislation, the establishment of the Supreme Court, the introduction of fixed - term Parliaments, and the domestic legal entrenchment of human rights.

Since independence in 1957, Ghanaians experienced rule of Law, Good governance, respect for human rights, freedom of speech and real economic development from 2001 to 2008 when the destiny of country was in the hands of the New Patriotic Party under the leadership of Ex-Former President, His Excellency John Agyekum Kuffour.

The sale is subject to agreement with Rio Tinto's joint venture partners, Mitsubishi Development Pty Ltd, J - Power Australia Pty Ltd and J.C.D. Australia Pty Ltd on certain matters under the Clermont Joint Venture Agreement such as pre-emption rights.

Disclosing that efforts are being made to enhance the operational capacity of officers of the Nigeria Police force through tailor made training programme that will give them the right civil orientation in their roles as guardians of the constitution, the President said his administration will encourage the development of state - level community policing under a model that will integrate members of the community to policing functions at the grassroots level.

Cuomo likened New York to a hardy ship sailing choppy waters, where economic development has been swift but the middle class feels left behind, where social progress has been significant but people's rights now feel under attack.

Under new permitted development rights, from October 1st, up to two flats will be allowed to be created in office or storage space.

The consultant's report confirmed that we were on the right track, and the development of Graduate Student Employment Services (GSES) at Dalhousie University was officially under way.

Mature embryonic stem cells cultivated in the laboratory can, under the right conditions, be backed up in their development to the more immature stem cell type.

Techniques to make the right quality of graphene on an industrial scale are still under development.

But they also said the policy, which has been rescinded by Secretary of Education Lamar Alexander, was under development before they arrived at the agency and was not initiated by the assistant secretary for civil rights, Michael L. Williams, who has been sharply criticized for it.

First and foremost, the provider will need to consider whether any works it wants to do can be done under permitted development rights; whether planning permission is required and whether redevelopment should include other uses in addition to education facilities.

Along with other young men from The Man Project, and Bloom, which are programs under the Brotherhood Crusade youth development model, we helped the Brother, Sons, Selves Coalition (Every Student Matters Campaign) pass the School Climate Bill of Rights in Los Angeles Unified School District (LAUSD), in May of 2013.

• School Expansion, Growth & Strategic Planning • State and Federal Employment Law • School Board and Nonprofit Governance • Administrative Law & Appeals of State and Federal Agency Decisions and Actions • Special Investigations & Legal / Compliance Audits • Policy Guidance and Development • Constitutional Challenges and Claims • School Employee and School Board Training • Litigation in Federal and State Courts • Administrative Hearings and Appeals Before State and Federal Agencies • Public Entity Purchasing and Procurement; Business Transactions; & Contract Negotiation, Review and Drafting • Construction Law, AIA Construction Contracts, Review and Drafting • Real Estate Transactions and Condemnation • Special Education under IDEA and Section 504 • Student Rights & Discipline Issues and Hearings • State and Federal Claims of Discrimination • State and Federal Civil Rights • Administrative Grievances and Hearings • False Claims Act / Qui Tam Defense for Local Government Entities

The FEAs have taken many forms, including: sheltered instruction observation protocol (SIOP) implementation in Texas; community - based equity assessment in Texas; IDRA's Focusing on Language and Academic Instructional Renewal (FLAIR) program implementation in reading in Louisiana; gender equity also in Louisiana; implementation of a multicultural framework in staff development to support student success in New Mexico; parent leadership in New Mexico; unitary status planning in Arkansas; English as a second language (ESL) classroom strategies in Arkansas; service learning in Oklahoma; and meeting civil rights requirements under the law in Oklahoma.

She said she is particularly concerned that newer developments — such as rules protecting the right of transgender students to use the bathroom, gym, or athletic team of their gender — would be neglected or rescinded under a Trump administration.

Programs that fully inform parents of their rights under ESSA, and also address the specific needs of diverse communities for relevant information, skill - building, and leadership development.

The principal mission of the Lawyers» Committee for Civil Rights Under Law is to secure, through the rule of law, equal justice for all, particularly in the areas of criminal justice, fair housing and community development, economic justice, educational opportunities, and voting rRights Under Law is to secure, through the rule of law, equal justice for all, particularly in the areas of criminal justice, fair housing and community development, economic justice, educational opportunities, and voting rightsrights.

Aston Martin's V8 Vantage and DB9 have become familiar sights on the racing scene over the past decade, but constant development under the skin has kept the name right at the top of the time sheets.

BMW has both under intensive development right now.

«We are devoted fans of Fleming's Bond novels here at Amazon Publishing, and we're thrilled these books — already known across the world and across generations — will continue to flourish under our Thomas & Mercer imprint,» says Philip Patrick, Director, Business Development, Rights and Licensing.

The Photoshop app right now is under development, but should be ready for downloading by next month.

Additional laws such as the Department of Transportation's Air Carrier Access Act, the Housing and Urban Development's Fair Housing Act, and the Federal Rehabilitation Act protect the rights of people with disabilities to be accompanied by their service animals in a wide variety of circumstances under which the ADA may not be applicable.

- still in development - plays actual Game Boy carts, and may play Game Boy Color carts - aluminum housing - retains the same volume and contrast dials - includes a third dial allowing you to adjust a backlit LCD through the entire RGB spectrum - backlight can also be turned off - built - in six - hour battery - USB - C port for charging - pair of stereo speakers, and left and right audio - out connections - aiming for a late Summer 2018 release - aiming for a price under $ 100

Dear Tom # 1: JD # 6 is right, but in my view (as one who works with tree rings and publishes) the use of ring width as a rigorous temperature proxy is still under development.

Emphasizing the importance of promoting, protecting and respecting all human rights, the right to development, the right to health, and the rights of indigenous peoples, migrants, children, persons with disabilities and people in vulnerable climate situations -LSB-, and under occupation,] as well as promoting gender equality and the empowerment of women, while taking into account the needs of local communities, intergenerational equity concerns, and the integrity of ecosystems and of Mother Earth, when taking action to address climate change,...

as calculated by the Greenhouse Development Rights framework under a 2ºC emergency stabilization pathway (shown in red).

Figure 5: The EU's mitigation obligations, as calculated by the Greenhouse Development Rights framework, under a 2ºC emergency stabilization pathway, compared to the current European Commission reduction proposal.

Canada's Fair Share in a Climate Constrained World: An Analysis of Canada's Obligations under the Greenhouse Development Rights Framework.

This is illustrated in Figure 8, below, which compares national allocations under the EU's «30 % below» scenario with Greenhouse Development Rights allocations under the 2ºC emergency pathway.

3.2 The Licensee owns no right to use the data or products provided under this agreement for commercial purposes and not for development or production of meteorological, hydrological and oceanographic value added - value services.

It is therefore the least controversial of all of the equity frameworks under serious consideration by the international community although there are other equity frameworks that have some supporters including the Greenhouse Development Rights Framework (GDR).

(Sec. 388) Amends the Outer Continental Shelf Lands Act to authorize the Secretary of the Interior to grant, on either a competitive or noncompetitive basis, a lease, easement, or right - of - way on the outer Continental Shelf for activities not otherwise authorized under specified laws, if those activities: (1) support exploration, development, production, transportation, or storage of oil, natural gas; (2) produce or support production, transportation, or transmission of energy from sources other than oil and gas; or (3) use, for energy - related or marine - related purposes, facilities currently or previously used for activities authorized under this Act, unless prohibited by moratorium.

Under the agreement's clean development mechanism, Canada can keep right on polluting with a clean conscience if we simply invest in green initiatives in other countries.

Under the action alternatives, the BLM would implement new policies and design features (i.e., mitigation requirements) for utility - scale solar energy development on BLM - administered lands and identify lands available for right - of - way application.