Sentences with phrase «approvals for development»

Although the withdrawal can't be tied directly to NAR's high - profile opposition to earlier OCC approvals for development and other projects that NAR says breach the separation of banking and commerce, news reports attribute the pullout to NAR's campaign.

If a real estate developer retains a civil engineering firm to prepare a set of construction documents or to acquire the necessary permits and approvals for development, what the client wants is neither the construction documents nor the permit.

The Borrower plans to obtain approval for the development of ap...

The planning commission upheld the approval for development issued by Banff, and it is this decision which Arctos & Bird Management sought leave to appeal.

This is a decision by Justice Barbara Veldhuis to deny the applicant leave to appeal an approval for development of lands in the Town of Banff.

Not exact matches

Important factors that could cause actual results to differ materially from those reflected in such forward - looking statements and that should be considered in evaluating our outlook include, but are not limited to, the following: 1) our ability to continue to grow our business and execute our growth strategy, including the timing, execution, and profitability of new and maturing programs; 2) our ability to perform our obligations under our new and maturing commercial, business aircraft, and military development programs, and the related recurring production; 3) our ability to accurately estimate and manage performance, cost, and revenue under our contracts, including our ability to achieve certain cost reductions with respect to the B787 program; 4) margin pressures and the potential for additional forward losses on new and maturing programs; 5) our ability to accommodate, and the cost of accommodating, announced increases in the build rates of certain aircraft; 6) the effect on aircraft demand and build rates of changing customer preferences for business aircraft, including the effect of global economic conditions on the business aircraft market and expanding conflicts or political unrest in the Middle East or Asia; 7) customer cancellations or deferrals as a result of global economic uncertainty or otherwise; 8) the effect of economic conditions in the industries and markets in which we operate in the U.S. and globally and any changes therein, including fluctuations in foreign currency exchange rates; 9) the success and timely execution of key milestones such as the receipt of necessary regulatory approvals, including our ability to obtain in a timely fashion any required regulatory or other third party approvals for the consummation of our announced acquisition of Asco, and customer adherence to their announced schedules; 10) our ability to successfully negotiate, or re-negotiate, future pricing under our supply agreements with Boeing and our other customers; 11) our ability to enter into profitable supply arrangements with additional customers; 12) the ability of all parties to satisfy their performance requirements under existing supply contracts with our two major customers, Boeing and Airbus, and other customers, and the risk of nonpayment by such customers; 13) any adverse impact on Boeing's and Airbus» production of aircraft resulting from cancellations, deferrals, or reduced orders by their customers or from labor disputes, domestic or international hostilities, or acts of terrorism; 14) any adverse impact on the demand for air travel or our operations from the outbreak of diseases or epidemic or pandemic outbreaks; 15) our ability to avoid or recover from cyber-based or other security attacks, information technology failures, or other disruptions; 16) returns on pension plan assets and the impact of future discount rate changes on pension obligations; 17) our ability to borrow additional funds or refinance debt, including our ability to obtain the debt to finance the purchase price for our announced acquisition of Asco on favorable terms or at all; 18) competition from commercial aerospace original equipment manufacturers and other aerostructures suppliers; 19) the effect of governmental laws, such as U.S. export control laws and U.S. and foreign anti-bribery laws such as the Foreign Corrupt Practices Act and the United Kingdom Bribery Act, and environmental laws and agency regulations, both in the U.S. and abroad; 20) the effect of changes in tax law, such as the effect of The Tax Cuts and Jobs Act (the «TCJA») that was enacted on December 22, 2017, and changes to the interpretations of or guidance related thereto, and the Company's ability to accurately calculate and estimate the effect of such changes; 21) any reduction in our credit ratings; 22) our dependence on our suppliers, as well as the cost and availability of raw materials and purchased components; 23) our ability to recruit and retain a critical mass of highly - skilled employees and our relationships with the unions representing many of our employees; 24) spending by the U.S. and other governments on defense; 25) the possibility that our cash flows and our credit facility may not be adequate for our additional capital needs or for payment of interest on, and principal of, our indebtedness; 26) our exposure under our revolving credit facility to higher interest payments should interest rates increase substantially; 27) the effectiveness of any interest rate hedging programs; 28) the effectiveness of our internal control over financial reporting; 29) the outcome or impact of ongoing or future litigation, claims, and regulatory actions; 30) exposure to potential product liability and warranty claims; 31) our ability to effectively assess, manage and integrate acquisitions that we pursue, including our ability to successfully integrate the Asco business and generate synergies and other cost savings; 32) our ability to consummate our announced acquisition of Asco in a timely matter while avoiding any unexpected costs, charges, expenses, adverse changes to business relationships and other business disruptions for ourselves and Asco as a result of the acquisition; 33) our ability to continue selling certain receivables through our supplier financing program; 34) the risks of doing business internationally, including fluctuations in foreign current exchange rates, impositions of tariffs or embargoes, compliance with foreign laws, and domestic and foreign government policies; and 35) our ability to complete the proposed accelerated stock repurchase plan, among other things.

LAGUNA NIGUEL, Calif. — The cost to develop and gain FDA approval for a new drug today is more than $ 2.5 billion, according to the Tufts Center for the Study of Drug Development.

Such factors include, among others, general business, economic, competitive, political and social uncertainties; the actual results of current and future exploration activities; the actual results of reclamation activities; conclusions of economic evaluations; meeting various expected cost estimates; changes in project parameters and / or economic assessments as plans continue to be refined; future prices of metals; possible variations of mineral grade or recovery rates; the risk that actual costs may exceed estimated costs; failure of plant, equipment or processes to operate as anticipated; accidents, labour disputes and other risks of the mining industry; political instability; delays in obtaining governmental approvals or financing or in the completion of development or construction activities, as well as those factors discussed in the section entitled «Risk Factors» in the Company's Annual Information Form for the year ended December 31, 2017 dated March 15, 2018.

The model has produced some modest success so far: ZenHub has that impressive list of clients; Timeline, an external startup the company did design and development work for, landed on Apple's list of the top apps of 2015; Routific has TechStars» seal of approval.

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.

Factors which could cause actual results to differ materially from these forward - looking statements include such factors as the Company's ability to accomplish its business initiatives, obtain regulatory approval and protect its intellectual property; significant fluctuations in marketing expenses and ability to achieve or grow revenue, or recognize net income, from the sale of its products and services, as well as the introduction of competing products, or management's ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in the Company's filings with the United States Securities and Exchange Commission.

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.

Such risks, uncertainties and other factors include, without limitation: (1) the effect of economic conditions in the industries and markets in which United Technologies and Rockwell Collins operate in the U.S. and globally and any changes therein, including financial market conditions, fluctuations in commodity prices, interest rates and foreign currency exchange rates, levels of end market demand in construction and in both the commercial and defense segments of the aerospace industry, levels of air travel, financial condition of commercial airlines, the impact of weather conditions and natural disasters and the financial condition of our customers and suppliers; (2) challenges in the development, production, delivery, support, performance and realization of the anticipated benefits of advanced technologies and new products and services; (3) the scope, nature, impact or timing of acquisition and divestiture or restructuring activity, including the pending acquisition of Rockwell Collins, including among other things integration of acquired businesses into United Technologies» existing businesses and realization of synergies and opportunities for growth and innovation; (4) future timing and levels of indebtedness, including indebtedness expected to be incurred by United Technologies in connection with the pending Rockwell Collins acquisition, and capital spending and research and development spending, including in connection with the pending Rockwell Collins acquisition; (5) future availability of credit and factors that may affect such availability, including credit market conditions and our capital structure; (6) the timing and scope of future repurchases of United Technologies» common stock, which may be suspended at any time due to various factors, including market conditions and the level of other investing activities and uses of cash, including in connection with the proposed acquisition of Rockwell; (7) delays and disruption in delivery of materials and services from suppliers; (8) company and customer - directed cost reduction efforts and restructuring costs and savings and other consequences thereof; (9) new business and investment opportunities; (10) our ability to realize the intended benefits of organizational changes; (11) the anticipated benefits of diversification and balance of operations across product lines, regions and industries; (12) the outcome of legal proceedings, investigations and other contingencies; (13) pension plan assumptions and future contributions; (14) the impact of the negotiation of collective bargaining agreements and labor disputes; (15) the effect of changes in political conditions in the U.S. and other countries in which United Technologies and Rockwell Collins operate, including the effect of changes in U.S. trade policies or the U.K.'s pending withdrawal from the EU, on general market conditions, global trade policies and currency exchange rates in the near term and beyond; (16) the effect of changes in tax (including U.S. tax reform enacted on December 22, 2017, which is commonly referred to as the Tax Cuts and Jobs Act of 2017), environmental, regulatory (including among other things import / export) and other laws and regulations in the U.S. and other countries in which United Technologies and Rockwell Collins operate; (17) the ability of United Technologies and Rockwell Collins to receive the required regulatory approvals (and the risk that such approvals may result in the imposition of conditions that could adversely affect the combined company or the expected benefits of the merger) and to satisfy the other conditions to the closing of the pending acquisition on a timely basis or at all; (18) the occurrence of events that may give rise to a right of one or both of United Technologies or Rockwell Collins to terminate the merger agreement, including in circumstances that might require Rockwell Collins to pay a termination fee of $ 695 million to United Technologies or $ 50 million of expense reimbursement; (19) negative effects of the announcement or the completion of the merger on the market price of United Technologies» and / or Rockwell Collins» common stock and / or on their respective financial performance; (20) risks related to Rockwell Collins and United Technologies being restricted in their operation of their businesses while the merger agreement is in effect; (21) risks relating to the value of the United Technologies» shares to be issued in connection with the pending Rockwell acquisition, significant merger costs and / or unknown liabilities; (22) risks associated with third party contracts containing consent and / or other provisions that may be triggered by the Rockwell merger agreement; (23) risks associated with merger - related litigation or appraisal proceedings; and (24) the ability of United Technologies and Rockwell Collins, or the combined company, to retain and hire key personnel.

However, if it gets final approval it won't be built for at least a decade and faces opposition from local residents who could see their homes compulsorily acquired for the development against their wishes.

Developer Luke Saraceni is preparing to lodge a development approval for Raine Square, the latest addition in the race to get a new office building out of the ground in the CBD.

And there have been developments in cellular therapies to treat cancer, with two treatments aiming for approval by the end of 2017.

International development: Announced the first international approval for Vascepa with the regulatory approval of Vascepa in Lebanon.

Besides Xyrem, Jazz has a handful of sleep drugs in late - stage development, including one that has been submitted to the Food and Drug Administration for approval to treat narcolepsy and obstructed sleep apnea.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

«There's a question of whether going along with the approval of the Northern Gateway pipeline will make LNG development in B.C. more challenging by angering First Nations so adamantly opposed to the oil sands pipeline,» said George Hoberg, a professor at the University of British Columbia's school of forestry and founder of UBCC350, a group pressing for action on greenhouse gas emissions.

In March the budget featured, for the first time, a chapter on natural - resource development and included language about reducing environmental protection, penalizing environmental groups that tried to meddle in resource extraction, and speeding the approval of big resource projects.

The new center — GSK's first dedicated vaccine R&D facility in the U.S. — will house 12 vaccine development programs, including projects supporting its candidate shingles vaccine, for which GSK applied for FDA approval in October.

China's regulatory authorities have also recognised these demographics, and are keen on overhauling the drug approval mechanism and accelerating the research and development process for innovative drugs.

Under Armour CEO Kevin Plank's Sagamore Development has already amassed the land, secured the public approvals and started work on a development planned to include not just a new corporate campus for the athletic apparel company but also millions of square feet of additional office, residential and recreatiDevelopment has already amassed the land, secured the public approvals and started work on a development planned to include not just a new corporate campus for the athletic apparel company but also millions of square feet of additional office, residential and recreatidevelopment planned to include not just a new corporate campus for the athletic apparel company but also millions of square feet of additional office, residential and recreational space.

The Barangaroo project has been a drawn - out planning and approval process for Crown, which has contributed to a delay of about 18 months to the development Mr Packer has called his biggest priority and one he hopes will improve the performance of its Australian business as part of a unique three - way split of Crown designed to drive stronger shareholder returns.

Our maiden Mission Approval establishes an important precedent for the private sector to engage in peaceful space exploration, bringing with it monumental implications for the advancement of technology, science, research, and development, as well as commercial ventures that expand Earth's economic sphere.

A multifamily residential development is nearing town approval for the now - demolished Nassau - Suffolk Lumber and Supply Corp. on Main Street.

Third time's a charm: Chicago approves revised Uptown development The Chicago Plan Commission gave approval for a 12 - story development in Uptown after changes to the design.

These include: scientific advice; compassionate use; the conditional approval mechanism (for medicines addressing life - threatening conditions); patient registries and other pharmacovigilance tools that allow collection of real - life data and development of a risk - management plan for each medicine.

Xu Lin, head of the planning department at the National Development and Reform Commission, told reporters in Beijing yesterday that recently published approvals for projects only represent part of what's in the pipeline.

«The reason that Facebook has just two development centers is that it's not an organization in which you work on some sub-region, and wait for approval from head office to decide on cooperation with someone from a different country.

Mountain Province Diamonds (MPV: TSX; MDM: NYSE) receives development approval for the world's largest and richest new diamond mine.

Investments in fast - growing industries like the technology and healthcare sectors (which have historically been volatile) could result in increased price fluctuation, especially over the short term, due to the rapid pace of product change and development and changes in government regulation of companies emphasizing scientific or technological advancement or regulatory approval for new drugs and medical instruments.

Risk Versus Reward: The Value of Cell Therapy for Patients and Investors Source: Streetwise Reports (4/25/18) The cell therapy space, encompassing disruptive new treatment including stem cell therapy, immunotherapy and gene editing, has begun to mature, with a handful of product approvals and others in late - stage development.

As federal agencies like FEMA and the US Department of Housing and Urban Development were waiting for final approval, Trump nixed the standards.

Investments in fast - growing industries like the technology and health care sectors (which have historically been volatile) could result in increased price fluctuation, especially over the short term, due to the rapid pace of product change and development and changes in government regulation of companies emphasizing scientific or technological advancement or regulatory approval for new drugs and medical instruments.

The same week Andrew Cuomo announced the ban on fracking, a New York State board recommended the approval of three sites for the development of resort casinos.

Be it trademarking brand design, flavor profile development, regulatory approvals or packaging, Terressentia provides end to end solutions for your bulk and private label spirits needs.

With final approval from Del Taco's Franchise Review Committee, a Multi-Unit Development Agreement will be forwarded to you for your signature.

The County Board's Development Committee recommended full board approval of the plan for a 6,000 - square - foot fieldhouse in Glenbriar Park, on Butterfield Road east of Illinois Highway 53, near Lombard.

Although a call for a referendum to decide the path of Yunker farm development has become a campaign issue for the April 1 election, trustees said they would not make their approval contingent on a referendum.

To fund the project, the park district has received approval from the Rolling Meadows City Council to include their $ 450,000 grant request with the city's application for Cook County Community Development Block Grants.

Ron Drake, the former mayor of Avondale, Ariz., said he'll push to streamline the development process in Arlington Heights by combining some of the required reviews and approvals to make it easier for businesses to move into the village.

According to an agenda posted on the village website, trustees will vote on approval of a letter of intent for a proposed development in Orland Park's Main Street Triangle at a special board meeting Thursday evening.

But in his response to the Chairman's lamentation, Kwaku Agyemang - Manu indicated that the approval of loan facility with African Development Bank has been procured and all that's left is the value for money report.

«Both cabinet and parliamentary approvals have been received to contract the loan for the construction there is a loan that have been found with African Development Bank we got all approvals we are only waiting for the value for money report to proceed to parliament of the approval of the supply contract.

«There are a lot of irregularities and I have spoken to Birth and Death [registry] and I have written to the minister of local government that without approval from the department of social development and the minister, no birth certificate for adoption should be processed.

Feasibility Studies for the development of Boankra Inland Port and Eastern Railway Line using PPP was completed and approval granted.

Cleanup and construction work will begin by midsummer on the initial phase of the planned Elmwood Crossing redevelopment of the former Women & Children's Hospital site in Elmwood Village, now that the development team has received final city approval for the first building.

Rosengarten already has received town approval to develop just over 40 acres of the Mastic property in a phased development that would leave another 20 acres for future development, along with a structure.