Sentences with phrase «for subsequent approvals»

Leveraged knowledge of loan products to help restructure turned - down loans for subsequent approvals.

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Such risks and uncertainties include, but are not limited to: our ability to achieve our financial, strategic and operational plans or initiatives; our ability to predict and manage medical costs and price effectively and develop and maintain good relationships with physicians, hospitals and other health care providers; the impact of modifications to our operations and processes; our ability to identify potential strategic acquisitions or transactions and realize the expected benefits of such transactions, including with respect to the Merger; the substantial level of government regulation over our business and the potential effects of new laws or regulations or changes in existing laws or regulations; the outcome of litigation, regulatory audits, investigations, actions and / or guaranty fund assessments; uncertainties surrounding participation in government - sponsored programs such as Medicare; the effectiveness and security of our information technology and other business systems; unfavorable industry, economic or political conditions, including foreign currency movements; acts of war, terrorism, natural disasters or pandemics; our ability to obtain shareholder or regulatory approvals required for the Merger or the requirement to accept conditions that could reduce the anticipated benefits of the Merger as a condition to obtaining regulatory approvals; a longer time than anticipated to consummate the proposed Merger; problems regarding the successful integration of the businesses of Express Scripts and Cigna; unexpected costs regarding the proposed Merger; diversion of management's attention from ongoing business operations and opportunities during the pendency of the Merger; potential litigation associated with the proposed Merger; the ability to retain key personnel; the availability of financing, including relating to the proposed Merger; effects on the businesses as a result of uncertainty surrounding the proposed Merger; as well as more specific risks and uncertainties discussed in our most recent report on Form 10 - K and subsequent reports on Forms 10 - Q and 8 - K available on the Investor Relations section of www.cigna.com as well as on Express Scripts» most recent report on Form 10 - K and subsequent reports on Forms 10 - Q and 8 - K available on the Investor Relations section of www.express-scripts.com.

Actual results may vary materially from those expressed or implied by forward - looking statements based on a number of factors, including, without limitation: (1) risks related to the consummation of the Merger, including the risks that (a) the Merger may not be consummated within the anticipated time period, or at all, (b) the parties may fail to obtain shareholder approval of the Merger Agreement, (c) the parties may fail to secure the termination or expiration of any waiting period applicable under the HSR Act, (d) other conditions to the consummation of the Merger under the Merger Agreement may not be satisfied, (e) all or part of Arby's financing may not become available, and (f) the significant limitations on remedies contained in the Merger Agreement may limit or entirely prevent BWW from specifically enforcing Arby's obligations under the Merger Agreement or recovering damages for any breach by Arby's; (2) the effects that any termination of the Merger Agreement may have on BWW or its business, including the risks that (a) BWW's stock price may decline significantly if the Merger is not completed, (b) the Merger Agreement may be terminated in circumstances requiring BWW to pay Arby's a termination fee of $ 74 million, or (c) the circumstances of the termination, including the possible imposition of a 12 - month tail period during which the termination fee could be payable upon certain subsequent transactions, may have a chilling effect on alternatives to the Merger; (3) the effects that the announcement or pendency of the Merger may have on BWW and its business, including the risks that as a result (a) BWW's business, operating results or stock price may suffer, (b) BWW's current plans and operations may be disrupted, (c) BWW's ability to retain or recruit key employees may be adversely affected, (d) BWW's business relationships (including, customers, franchisees and suppliers) may be adversely affected, or (e) BWW's management's or employees» attention may be diverted from other important matters; (4) the effect of limitations that the Merger Agreement places on BWW's ability to operate its business, return capital to shareholders or engage in alternative transactions; (5) the nature, cost and outcome of pending and future litigation and other legal proceedings, including any such proceedings related to the Merger and instituted against BWW and others; (6) the risk that the Merger and related transactions may involve unexpected costs, liabilities or delays; (7) other economic, business, competitive, legal, regulatory, and / or tax factors; and (8) other factors described under the heading «Risk Factors» in Part I, Item 1A of BWW's Annual Report on Form 10 - K for the fiscal year ended December 25, 2016, as updated or supplemented by subsequent reports that BWW has filed or files with the SEC.

U.K. February mortgage data also showed an annual decline of 5.6 percent for approvals with analysts at Jefferies saying they anticipate a further fall in March given difficult to match comparable figures from last year before an improvement in trends returns in subsequent quarters.

These don't require approval of two - thirds of the Senate, instead setting up a framework law that gave some level of oversight to Congress and requires fewer votes for subsequent treaties to pass.

The Portland, Oregon - based company said that, once approved, global demand for its plants will create thousands of jobs during manufacturing, construction and operation, and «re-establish US global leadership in nuclear technology», paving the way for NRC approval and subsequent deployment of other advanced nuclear technologies.

While experiments have raced ahead at a breathtaking pace, the likelihood of global spread once released into the wild may prove a formidable barrier to deployment due to the need for international public support, field trials, and subsequent regulatory approval.

Written approval for all somatic derivations and subsequent iPSC generation performed in this study was obtained from the Stanford University Institutional Review Board (IRB protocol 10368) and the Stanford University Stem Cell Research Oversight Committee (SCRO protocol 40), and written informed consent was obtained from each individual participant.

Del Toro briefly mentioned he was still waiting for approval from DC's parent company, and subsequent interviews in July and October cemented his continued work in it.

The commissioner may require that any plan, or subsequent modification of a plan, be submitted for prior approval.

You can get funds within 24 hours for either product, but there can be another 24 - hour delay to assess new customers» creditworthiness for invoice factoring; subsequent customer approvals can take as little as one hour once you've successfully completed an invoice factoring agreement.

These were subsequently incorporated these into the Proxy statement provided to shareholders for their approval at the Annual Meeting: an initial distribution of $ 3.23 per share shortly after filing the dissolution certificate with subsequent distributions of between $ 6.47 and $ 11.32 per share.

(c) As to transactions entered into after May 20, 1996, a creditor shall have no liability under this chapter for any act or practice done or omitted in conformity with any (i) regulation of the administrator, or (ii) any rule, regulation, interpretation, or approval of any applicable Alabama or federal agency or any opinion of the Attorney General, notwithstanding that after such act or omission has occurred, the regulation, rule, interpretation, opinion, or approval is amended, rescinded, or determined by judicial or other authority to be invalid for any reason; provided, however, that any interpretation or opinion issued after May 20, 1996, shall not have any effect on any litigation pending on May 20, 1996, nor shall any interpretation or opinion issued after May 20, 1996, have any effect on litigation if issued subsequent to filing of the litigation.

Section 4: Retired Membership Category Retired Membership status may be approved for a member upon written application to the Society's Executive Director and subsequent Board of Directors approval.

What does happen is that in some instances parties are able to negotiate settlements and ask for subsequent regulatory approvals thereof and avoid litigation in this manner.

The application for and subsequent approval of a LTCSO will be considered irrevocable except that an owner may elect to discontinue the option and reinstate insurance benefits as a Reduced Paid Up benefit plan if, and ONLY if, the annual recertification fails to comply with IRS code.

Well, 9to5Mac has found out with the iOS 11.3 developer beta that after requiring password entry for an initial purchase, the system will prompt the user to set up Face ID for subsequent family purchase approvals.

Antpool, the biggest mining pool in the Bitcoin ecosystem with over 14 % of the global hashrate, has mined its first SegWit2x block today, signaling approval for the ambitious scaling agreement that seeks to implement the SegWit soft fork and a subsequent hard fork to increase block size capacity to 2 MB.

Members who have met upper - tier sales performance standards and submitted an application for the designation with all required supporting documentation can earn the CLHMS designation upon review and subsequent approval of their applications.