Litigation and
regulatory time and expenses continue to rise, but internal legal budgets and staff do not.
Not exact matches
Weinberg says he advises entrepreneurs participating in Blueprint Health to start a dialogue with the FDA
and their legal advisors early in the startup process so they can clarify
regulatory requirements
and be prepared for any resulting
time and expense.
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.
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.
These risks
and uncertainties include competition
and other economic conditions including fragmentation of the media landscape
and competition from other media alternatives; changes in advertising demand, circulation levels
and audience shares; the Company's ability to develop
and grow its online businesses; the Company's reliance on revenue from printing
and distributing third - party publications; changes in newsprint prices; macroeconomic trends
and conditions; the Company's ability to adapt to technological changes; the Company's ability to realize benefits or synergies from acquisitions or divestitures or to operate its businesses effectively following acquisitions or divestitures; the Company's success in implementing
expense mitigation efforts; the Company's reliance on third - party vendors for various services; adverse results from litigation, governmental investigations or tax - related proceedings or audits; the Company's ability to attract
and retain employees; the Company's ability to satisfy pension
and other postretirement employee benefit obligations; changes in accounting standards; the effect of labor strikes, lockouts
and labor negotiations;
regulatory and judicial rulings; the Company's indebtedness
and ability to comply with debt covenants applicable to its debt facilities; the Company's ability to satisfy future capital
and liquidity requirements; the Company's ability to access the credit
and capital markets at the
times and in the amounts needed
and on acceptable terms;
and other events beyond the Company's control that may result in unexpected adverse operating results.
Important factors that may affect the Company's business
and operations
and that may cause actual results to differ materially from those in the forward - looking statements include, but are not limited to, increased competition; the Company's ability to maintain, extend
and expand its reputation
and brand image; the Company's ability to differentiate its products from other brands; the consolidation of retail customers; the Company's ability to predict, identify
and interpret changes in consumer preferences
and demand; the Company's ability to drive revenue growth in its key product categories, increase its market share or add products; an impairment of the carrying value of goodwill or other indefinite - lived intangible assets; volatility in commodity, energy
and other input costs; changes in the Company's management team or other key personnel; the Company's inability to realize the anticipated benefits from the Company's cost savings initiatives; changes in relationships with significant customers
and suppliers; execution of the Company's international expansion strategy; changes in laws
and regulations; legal claims or other
regulatory enforcement actions; product recalls or product liability claims; unanticipated business disruptions; failure to successfully integrate the business
and operations of the Company in the expected
time frame; the Company's ability to complete or realize the benefits from potential
and completed acquisitions, alliances, divestitures or joint ventures; economic
and political conditions in the nations in which the Company operates; the volatility of capital markets; increased pension, labor
and people - related
expenses; volatility in the market value of all or a portion of the derivatives that the Company uses; exchange rate fluctuations; risks associated with information technology
and systems, including service interruptions, misappropriation of data or breaches of security; the Company's inability to protect intellectual property rights; impacts of natural events in the locations in which the Company or its customers, suppliers or regulators operate; the Company's indebtedness
and ability to pay such indebtedness; tax law changes or interpretations;
and other factors.
«At a
time when New York still faces steep fiscal challenges, we can not afford to introduce measures that eliminate jobs, increase
regulatory hurdles
and drive
expenses up for taxpayers.
«Instead, the Woodstock Town Board should be supporting developers like us, who are spending substantial amounts of
time and effort to follow the rules through the
regulatory wringer at great
expense while Airbnb gets a free ride.»
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and that neither we nor any third party lender will retain
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time beyond the
regulatory requirements.