Sentences with phrase «among other approvals»

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.

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.

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.

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.

The FDA's most controversial drug approval of the year, for Sarepta's Exondys 51, continues to face major headwinds among insurers, benefits managers, and other health care payers, according to a new Jeffries survey.

The acquisition is not conditional on getting antitrust approvals or a green light from the Committee on Foreign Investment in the United States (CFIUS), among others.

Among other things, that change would have required President Obama to get approval from Congress.

Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward - looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the willingness of health insurance companies and other payers to cover Cologuard and adequately reimburse us for our performance of the Cologuard test; the amount and nature of competition from other cancer screening and diagnostic products and services; the effects of the adoption, modification or repeal of any healthcare reform law, rule, order, interpretation or policy; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10 - K and our subsequently filed Quarterly Reports on Form 10 - Q.

In addition to factors previously disclosed in Tesla's and SolarCity's reports filed with the U.S. Securities and Exchange Commission (the «SEC») and those identified elsewhere in this document, the following factors, among others, could cause actual results to differ materially from forward - looking statements and historical performance: the ability to obtain regulatory approvals and meet other closing conditions to the transaction, including requisite approval by Tesla and SolarCity stockholders, on a timely basis or at all; delay in closing the transaction; the ultimate outcome and results of integrating the operations of Tesla and SolarCity and the ultimate ability to realize synergies and other benefits; business disruption following the transaction; the availability and access, in general, of funds to meet debt obligations and to fund ongoing operations and necessary capital expenditures; and the ability to comply with all covenants in the indentures and credit facilities of Tesla and SolarCity, any violation of which, if not cured in a timely manner, could trigger a default of other obligations under cross-default provisions.

The separation is subject to certain conditions, including, among others, obtaining final approval from HP Co.'s board of directors, receipt of a private letter ruling from the IRS and one or more opinions with respect to certain U.S. federal income tax matters relating to the separation and the SEC declaring the effectiveness of the registration statement of which this information statement forms a part.

The separation is subject to certain conditions, including, among others, obtaining final approval from Parent's board of directors, receipt of a private letter ruling from the IRS and one or more opinions with respect to certain U.S. federal income tax matters relating to the separation and the SEC declaring the effectiveness of the registration statement of which this information statement forms a part.

The GNC reviews the individual components and total amount of director compensation at least annually and may recommend changes in director compensation to the Board for its approval more or less frequently based on, among other factors, competitive pay data for non-employee directors of the financial services companies in the Company's Labor Market Peer Group.

Statements regarding future events are based on the parties» current expectations and are necessarily subject to associated risks related to, among other things, regulatory approval of the proposed acquisition or that other conditions to the closing of the deal may not be satisfied, the potential impact on the business of WhatsApp due to the announcement of the acquisition, the occurrence of any event, change or other circumstances that could give rise to the termination of the definitive agreement, and general economic conditions.

Payment of a dividend is subject to the approval of the Board of Directors in its sole discretion and is dependent upon, among other things, the financial condition of and outlook for the Company, general business conditions, legal restrictions and the Company's cash flow and financing needs.

However, this amount can be quite volatile from year - to - year depending upon the amount of new funding allocated during the year (delays in signing agreements, etc. could result in delays in getting the funds out the door), timing of elections (delays in approvals), weather, among others.

According to the poll, the president's approval rating among Protestants and other Christians was 43 percent, it stood at 50 percent for Catholics, 61 percent among Jews, 63 percent for Atheists, Agnostics and those with no religion, and 64 percent for those from other non-Christian religions.

Recipes that got the group's approval include my Oatmeal Chocolate Chip Cream Cheese Cookies, Banana Pudding Cookies, and Maple Creme Sandwich Cookies, among others in the archives.

In Australia, companies are required to gain approval from the TGA to manufacture and sell pharmaceutical agents and must adhere to Good Manufacturing Practice among other quality assurance frameworks.

Netsch also sought board approval of a policy that would require lakefront park projects to conform with the Lake Michigan and Chicago Lakefront Protection Ordinance, which, among other things, requires that lakefront projects get city approval.

Other experts say food dyes, which require pre-market approval, are among the most tightly regulated additives on the market and there's little evidence for the long - suspected link between food colors and hyperactivity.

He cited among other things that the Presbyterian Church USA approval to ordain gay pastors, elders and deacons is unbiblical and described it as «demonic».

He says he's working to get approval for the commission that Riverhead Town has advocated as a way of fast - tracking projects at EPCAL and, among other things, has been instrumental in establishing the Stony Brook Business Incubator in Calverton; has secured grant money for the J. Kings food processing facility in Baiting Hollow; and has helped to create a synergy among the three East End hospitals.

Among others, this requires unanimous approval by all present members — which might get blocked by Spain as well as by a few other member states who are afraid of secession movements within their own borders.

It has now been agreed that when the European Banking Authority votes on banking union matters a double vote will take place: one for eurozone countries and a separate vote, requiring a simple majority for approval, among the EU's ten other member states.

Among Manhattan voters, the mayor's overall approval rating stands at 62 percent, while 49 percent approval of his handling of the budget — higher than any other borough.

Charlotte Osei among other claims, accused deputy Chairperson of the Commission of illegally signing contracts worth over GHC 40 million without her approval.

Zimpher met last week in the Red Room with members of the state Black, Puerto Rican and Asian legislative caucus, who have been among the most outspoken critics of the plan that would, among other things, allow SUNY and CUNY schools to raise their own tuitions without legislative approval.

The meeting was among other things to consider the 2017 Composite Budget and Fee Fixing Resolution for approval.

The main difference is that Mr Trump's approval ratings among non-Republicans are much lower than other presidents.

That is likely to depend on President Barack Obama's job approval rating and the appeal (or lack thereof) of the GOP presidential nominee, among other reasons.

Among other officials, current Mayor Bloomberg posted his strongest approval ratings in two years, the New York Times reported.

Other achievements, according to the Organized Labour include, «payment of 13th Month salary as Christmas bonus to the state workers; elaborate infrastructural developments of both urban and rural areas of the state through unique fiscal management of the state's meager resources; transformation of the education, agriculture and health sectors, other areas of governance which have improved the quality of lives of the people of Enugu State; approval of payment of arrears of salaries of 731 former staff of some state parastatals and also, the regularization of 42 casual staff of the Enugu State University Teaching Hospital, Parklane Enugu, as permanent staff of the institution», among otOther achievements, according to the Organized Labour include, «payment of 13th Month salary as Christmas bonus to the state workers; elaborate infrastructural developments of both urban and rural areas of the state through unique fiscal management of the state's meager resources; transformation of the education, agriculture and health sectors, other areas of governance which have improved the quality of lives of the people of Enugu State; approval of payment of arrears of salaries of 731 former staff of some state parastatals and also, the regularization of 42 casual staff of the Enugu State University Teaching Hospital, Parklane Enugu, as permanent staff of the institution», among otother areas of governance which have improved the quality of lives of the people of Enugu State; approval of payment of arrears of salaries of 731 former staff of some state parastatals and also, the regularization of 42 casual staff of the Enugu State University Teaching Hospital, Parklane Enugu, as permanent staff of the institution», among others.

Ms Richards may only bring court cases in future with the prior approval of a judge after failed actions against MI5, MI6, the Metropolitan police and the Army among others.

Among other things, the law requires facilities to win approval for animal experiments from the Committee for the Purpose of Control and Supervision of Experiments on Animals.

The company had already received city approval to construct a new hydrogen plant and upgrade equipment that would increase production and capacity to remove sulfur from crude oil, among other things.

ICMJE notes that» [a] uthorship credit should be based on... final approval of the version to be published,» among other things.

A report of the findings, published Oct. 16 in the Journal of Investigative Dermatology, marks efforts to seek approval from the U.S. Food and Drug Administration (FDA) to use the gel application in treatment - resistant skin wounds among diabetics and others, particularly older adults.

These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, uncertainty regarding potential future deterioration in the market for auction rate securities which could result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, our ability to form collaborative relationships, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

These risks and uncertainties include, among others, those relating to technology and product development, integration of acquired businesses, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission.

These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, the outcome of the review of the continued listing of our common stock on The Nasdaq Stock Market, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, our ability to form collaborative relationships, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

University research administrators have many responsibilities, among which invoicing financial reporting, proposal submission, approval and review, proposal preparation, and accounts receivable management, among others.

It's repainted itself as a tribute to the outsiders, to the dreamers, to those who've always felt like they're on the outside and finally find a home among one another, rather than in seeking the approval of others.

Instead of choosing among four contentious turnaround models (turnaround, restart, school closure, and transformation), schools have two new additional options: One option allows state agencies to establish any whole school improvement strategy for use by local education agencies with approval from the U.S. Secretary of Education, and the other option permits schools to partner with outside organizations who have successful records in school turnarounds.

Your book will be featured among the other books of the day, guaranteed (subject to approval, before payment is rendered).

Having to seek story approval and take endless notes from fickle, risk - averse creative execs (among others) who know nothing about the art of storytelling has left me creatively frustrated, and I find the freedom offered by the burgeoning frontier of self - publishing — the opportunity to shift the balance of power back in the writer's favor — fairly irresistible for all the reasons Mr. Howey propounds above.

Your credit record can also be reviewed by prospective employers, utilities and apartment rental companies among others as part of their approval process.

They'll need to get approval from their bankruptcy trustee among other requirements.

Closing of the transaction, which is expected to take place on or before July 31, 2010, is subject to completion of a fairness opinion, completion of due diligence and final approval of the merger by Aspen's board of directors, among other conditions.

There are other lenders in the SME space (including Amazon and PayPal), but Kabbage was among the first to use data and analytics to accelerate the credit approval process.