Sentences with phrase «regulatory approval of»

Abu Dhabi's financial watchdog has granted regulatory approval of initial coin offerings (ICOs), but has warned of «many risks» involved in the new crowdfunding model.

The completion of the arrangement and the listing of Global Blockchain Mining will be subject to regulatory approval of this transaction and the approval of shareholders, the Supreme Court of British Columbia, and the CSE, which is not guaranteed.

This price is 145 % higher than when CME Group announced on October 31 that it would launch bitcoin futures trading by the end of the year, and 53 % higher than when news broke of the CFTC's regulatory approval of these markets on December 1.

The completion of the arrangement and the listing of Global Blockchain Mining will be subject to regulatory approval of this transaction, the approval of shareholders, the Supreme Court of British Columbia and the Canadian Securities Exchange, which is not guaranteed.

Policy Drafting & Interpretation Attorneys in the Insurance Group provide advice and assistance in drafting and interpreting policy wording and in obtaining regulatory approval of policy forms.

By 2030, within 10 years of regulatory approval of autonomous vehicles (AVs), 95 % of U.S. passenger miles traveled will be served by on - demand autonomous electric vehicles owned by fleets, not individuals, in a new business model we call «transport - as - a-service» (TaaS).

The next wave, pending regulatory approval of infrequent reporting of fund holdings, will be about active management.

University of California - San Francisco Advancing new methodologies to measure patient preference for regulatory approval of devices

Mike currently serves as Chief Development Officer for Silvergate, and was previously instrumental in the worldwide development and regulatory approval of products spanning a broad range of therapeutic categories at Beckloff Associates.

It is hoped that these studies and previous European published experience will ultimately lead to regulatory approval of these agents within the next one to two years.»

Among the measures that the HELP panel approved yesterday were a bill broadly authorizing President Obama's Precision Medicine Initiative, another that cuts down on administrative requirements for NIH employees, and a long - discussed proposal to speed the regulatory approval of antibiotics for serious infections in limited populations.

Some require regulatory approval of increases.»

DuPont Nutrition & Health and Inbiose have received regulatory approval of their first human milk oligosaccharide (HMO) ingredient for infant formula in the European market.

DuPont Nutrition & Health and Inbiose Meet Regulatory Requirements to Bring 2» - Fucosyllactose to the European Market COPENHAGEN, Denmark, 27 March 2018 — Today, DuPont Nutrition & Health and Inbiose NV celebrated regulatory approval of their first human milk oligosaccharide (HMO) ingredient for infant formula in the European...

Dynavax's stock has gained a jaw - dropping 387 % this year, thanks to the unexpected regulatory approval of its hepatitis B vaccine, Heplisav - B.

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.

Synthetic lethality has become a therapeutic reality with the regulatory approval of PARP inhibitors in BRCA - deficient cancers.

But it's still him, not SoftBank's Masa Son, leading the push for regulatory approval of the T - Mobile deal.

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

Musk blamed the negative media coverage for slowing down regulatory approval of self - driving cars.

Dennis Patrick, former FCC chair and former Time Warner Telecommunication CEO, discusses the likelihood of regulatory approval of the potential deal for Disney to acquire most of 21st Century Fox.

The PGS platform promised genetic risk reports for more than 250 disease at the time — but, after the FDA smackdown, 23andMe was forced to stop marketing the service and pursue a piecemeal strategy of winning regulatory approval of individual tests.

For example, the expected timing and likelihood of completion of the proposed merger, including the timing, receipt and terms and conditions of any required governmental and regulatory approvals of the proposed merger that could reduce anticipated benefits or cause the parties to abandon the transaction, the ability to successfully integrate the businesses, the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement, the possibility that Kraft shareholders may not approve the merger agreement, the risk that the parties may not be able to satisfy the conditions to the proposed transaction in a timely manner or at all, risks related to disruption of management time from ongoing business operations due to the proposed transaction, the risk that any announcements relating to the proposed transaction could have adverse effects on the market price of Kraft's common stock, and the risk that the proposed transaction and its announcement could have an adverse effect on the ability of Kraft and Heinz to retain customers and retain and hire key personnel and maintain relationships with their suppliers and customers and on their operating results and businesses generally, problems may arise in successfully integrating the businesses of the companies, which may result in the combined company not operating as effectively and efficiently as expected, the combined company may be unable to achieve cost - cutting synergies or it may take longer than expected to achieve those synergies, and other factors.

He wants Ontario's Divisional Court to overturn the regulatory approvals of three projects, the St. Columban Wind and K2 Wind Energy project in Huron County, and the SP Armow Wind project near Kincardine, Ont.

Our lawyers have expertise in biotechnology patents, licensing biotechnology innovation, biological material transfer contracts, confidentiality agreements and sponsored research agreements, litigation and dispute resolution, designing around patents and regulatory approvals of new drugs (including biologics) and foods.

Heelan Realty and Development Corp. v. Ocskasy (27 A.D. 3d 620)- broker's claim dismissed; although testimony supported conclusion that the contractional relationship of the parties continued beyond the expiration date of the written listing agreement, the broker failed to present legally sufficient evidence of its entitlement to payment of a brokerage commission; prospective buyer's principal testified that buyer was not advised regarding the environmental contamination and subsequent remediation of the property, that regulatory approvals of the clean up work had not been obtained and was unable to state that the prospective buyer would have consummated the purchase had it been aware of the contamination issues; broker failed to establish that buyer was ready, willing and able to purchase the property and that there was a meeting of the minds between the buyer and the seller

Not exact matches

The transaction, which is expected to close in the second half of 2018, is subject to regulatory approvals and customary closing conditions.

AT&T was confident it would win regulatory approval for its $ 85.4 billion acquisition of Time Warner before year's end as the Justice Department continues its review, but was still awaiting details about any final requirements for the deal, a senior executive said.

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.

The acquisition is meant to build on Takeda's forays into drugs for gastrointestinal disorders; TiGenix is on the cusp of securing a European regulatory approval for a treatment for Crohn's disease.

So, at the end of the day, are companies simply flocking to disease areas like oncology, and rare diseases — which have low chances of approval from phase one trials due to their complexities but carry high margins and high rewards if they do cross the regulatory finish line — at the expense of other conditions?

CVS Health Corp. said it's making progress on the regulatory review of its $ 68 billion deal to buy health insurer Aetna Inc., and has suspended its share buyback plan while waiting for the approval.

At a Wells Fargo media and telecom conference on Wednesday morning, AT&T chief financial officer John Stephens said that closing the mega-deal for Time Warner «is now uncertain» even as he declined to elaborate on the company's ongoing discussions with the U.S. Department of Justice about securing regulatory approval for the transaction.

But the initiative comes with another huge financial prize for firms that successfully win FDA approval for these niche therapies: a priority review voucher that can be used to slash the regulatory period for a different experimental specialty treatment being developed by a drug maker or, more often, sold for potentially hundreds of millions of dollars to another pharma company.

Under the proposed demerger, which is subject to regulatory approval and a shareholder vote in the first half of 2015, he said there would be benefits for both companies and all shareholders.

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.

«Tax reform does not change our capital return goals as we remain committed to returning at least $ 60 billion of capital in the current and next two CCAR cycles, subject to regulatory approval,» CEO Michael Corbat said in a press release on Tuesday.

After two years of wrangling, Walgreens received regulatory approval Tuesday to buy stores from Rite Aid, but the agreement is for fewer stores than had previously been proposed.

For one, Emflaza's approval to bolster muscle strength in DMD patients won the firm a coveted «priority review voucher» which it can sell for hundreds of millions of dollars to a pharma giant or use itself to shave four months off of the regulatory review period for another therapy.

21st Century Fox is currently trying to gain regulatory approval in the UK for a merger with Sky, both of which are owned by billionaire Rupert Murdoch.

But a less publicized move to replace the head of a federal regulatory agency will almost certainly slow federal approval for new natural gas pipelines.

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.

One of the concessions for winning state regulatory approval to convert Fidelis to a for - profit unit includes a $ 340 million contribution to New York state, payable over a five - year period, which will be treated as increased administrative costs.

The company has pushed back the close of its $ 3.75 billion acquisition of nonprofit insurer Fidelis to the end of the current quarter due to regulatory conditions for approval.

The company built its Aurora manufacturing facility specifically with the U.S. regulatory approval process in mind; the FDA, as part of its sign - off, insists on a detailed facility audit.

U.S. regulatory concerns about the manufacturing process could push approval of fremanezumab back to 2019.

U.S. officials blocked a $ 2.9 - billion bid by Chinese investors to buy a controlling stake in a California - based unit of Dutch electronics firm Phillips last year, while another U.S. semiconductor firm rejected a lucrative offer from Chinese investors in favour of a lower bid from an American company because of concerns the deal would not win regulatory approval.

McInerney said the capital commitment from China Oceanwide would strengthen Genworth's business, increasing the likelihood of obtaining regulatory approval.

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.