Risk Summary Sample Clauses

Risk Summary. 7.7 The Civil Interstate Transfer Notice is to be in the form as Schedule 2 and is to include all the relevant information specified therein.
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Risk Summary. There are no studies conducted with EXPAREL in pregnant women. In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. Subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the MRHD [see Data]. Based on animal data, advise pregnant women of the potential risks to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Clinical Considerations Labor or Delivery Bupivacaine is contraindicated for obstetrical paracervical block anesthesia. While EXPAREL has not been studied with this technique, the use of bupivacaine for obstetrical paracervical block anesthesia has resulted in fetal bradycardia and death.
Risk Summary. Limited published literature reports that bupivacaine and its’ metabolite, pipecolylxylidide, are present in human milk at low levels. There is no available information on effects of the drug in the breastfed infant or effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EXPAREL and any potential adverse effects on the breastfed infant from EXPAREL or from the underlying maternal condition.
Risk Summary. Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.3)]. There are no available human data on hydrocodone or APADAZ use during pregnancy to inform any drug associated risks. However, neonatal opioid withdrawal and other adverse reactions during pregnancy and labor can occur with use of APADAZ [see Clinical Considerations]. Published studies with oral acetaminophen use during pregnancy have not reported an association with major congenital malformations. No reproductive or developmental toxicology studies in animals have been conducted with benzhydrocodone or the combination of benzhydrocodone and acetaminophen. Reproductive and developmental studies in rats and mice from the published literature identified adverse events at clinically relevant doses with acetaminophen. Treatment of pregnant rats with doses of acetaminophen approximately equal to the maximum human daily dose (MHDD) showed evidence of fetotoxicity and increases in bone variations in the fetuses. In another study, necrosis was observed in the liver and kidney of both pregnant rats and fetuses at doses approximately equal to the MHDD. In mice and rats treated with acetaminophen at doses within the clinical dosing range, cumulative adverse effects on reproductive capacity were reported. In mice, a reduction in number of litters of the parental mating pair was observed as well as retarded growth, abnormal sperm in their offspring, and reduced birth weight in the next generation. In rats, female fertility was decreased following in utero exposure to acetaminophen [see DATA]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations
Risk Summary. Hydrocodone is present in human milk. A published lactation study reports variable concentrations of hydrocodone and hydromorphone (an active metabolite) in breast milk with administration of hydrocodone to nursing mothers in the early post-partum period. This lactation study did not assess breastfed infants for potential adverse drug reactions. There is potential for sedation and respiratory depression resulting from infant exposure to hydrocodone and its metabolites in breast milk. Acetaminophen is present in human milk in small quantities after oral administration. Based on data from more than 15 nursing mothers, the calculated infant daily dose of acetaminophen is approximately 1 to 2% of the maternal dose. There is one well-documented report of a rash in a breast-fed infant that resolved when the mother stopped acetaminophen use and recurred when she resumed acetaminophen use. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for APADAZ and any potential adverse effects on the breastfed child from APADAZ or from the underlying maternal condition. Clinical Considerations Infants exposed to APADAZ through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.

Related to Risk Summary

  • Risk Analysis The Custodian will provide the Fund with a Risk Analysis with respect to Securities Depositories operating in the countries listed in Appendix B. If the Custodian is unable to provide a Risk Analysis with respect to a particular Securities Depository, it will notify the Fund. If a new Securities Depository commences operation in one of the Appendix B countries, the Custodian will provide the Fund with a Risk Analysis in a reasonably practicable time after such Securities Depository becomes operational. If a new country is added to Appendix B, the Custodian will provide the Fund with a Risk Analysis with respect to each Securities Depository in that country within a reasonably practicable time after the addition of the country to Appendix B.

  • General Summary The Contractor shall be required to maintain all equipment in the Facility including, but not limited to the ventilating system, fire suppression, fire extinguishers, guard radio system, Traffic and Revenue Equipment, intercom system, Closed Circuit Television (CCTV), computers, guard tour verification hand held sensors and guard tour verification hand held stations, heat rise indicators, passenger elevators, roll down gates and all mechanical machinery, including replacement valve seats, valve bodies, door operating mechanism, car door hanger rollers, door saddle, pumps, and other required hydraulic elevator equipment, including cables, pulleys, tracks and other equipment for the cable elevator, ticket issuing machines, cash registers, fee indicators, toll equipment, and traffic counting apparatus. The Contractor shall maintain the 3M/Federal APD Auto Read-Fully Automated Traffic and Revenue System with Bar Code currently installed in the Facility. Contractor shall continue to maintain existing equipment and systems even if they are scheduled to be replaced. Failure to provide maintenance to any equipment or systems will result in the assessment of liquidated damages of $100.00/per day. All existing equipment and systems should be verified by each Bidder. At the commencement of this Contract, the Contractor shall re-key all appropriate locks in the Facility and provide NYCDOT with 2 sets of copies adequately identified for each lock that has been changed. Furthermore, the Contractor shall be required to maintain, at its own expense, all other equipment in the Facility, excluding equipment or systems designated for rehabilitation until such systems and equipment’s have been rehabilitated. Such maintenance shall include periodic testing, cleaning, lubrication, and preventive maintenance. Contractor shall maintain a record in the Facility of all such work. In addition, a written inventory of all furniture and all portable equipment owned by NYCDOT shall be taken on the effective date of this Contract, and signed by both parties. A similar inventory shall be taken at the expiration or termination of the Contract and signed by both parties. The Contractor is responsible for all structure, equipment and/or systems which may exist in spaces occupied or utilized in the performance of this Contract, including storage areas. The Contractor shall be responsible for the maintenance, care and custody of the Facility and all fixed and portable equipment and furniture and shall return same to NYCDOT in satisfactory condition when the contract expires or terminates. The Contractor agrees to maintain in good and safe condition required, electronic equipment, heating, and air conditioning equipment in the booths and in the manager office. The Contractor shall be responsible for the routine maintenance and cleaning of the Facility and shall inspect the Facility for dangerous conditions or defects, including but not limited to accumulations of grease or oil, broken glass, protruding objects, leaking gas tanks, broken or burned out lighting fixtures, litter, trip spots and hazards to tires. The Contractor shall immediately perform all necessary routine maintenance to remedy any such condition, defect, hazardous or public safety issue. Failure to provide immediate action to make condition safe can result in the assessment of $100.00/per day liquidated damages. When the Contractor does not provide satisfactory maintenance or service, the Contractor must pay to the City the value of such maintenance or service, when the value of such maintenance or service can be accurately determined. In the event that the value of said maintenance or service cannot be accurately determined, the Contractor shall be subject to the assessment of liquidated damages as noted below. The Contractor shall submit certified payrolls, sign in/out sheets, and proof of wage rate and/or supplemental benefits rate for any Work related to construction, reconstruction or maintenance of the Facility, including but not limited to, painting, concrete, brick, and plumbing. Subcontractor must submit Prevailing Wages Statement with Subcontractor Profile Form. Such documentation shall be submitted with the respective monthly invoices for the period of time the Work is carried out. Prevailing wages shall apply for this type of Work. The Contractor must obtain prior written approval from NYCDOT for any of its subcontractors to perform the Work. For further information, please refer to the Comptroller’s website, Labor Law, prevailing wage schedules, xxx.xxxxxxxxxxx.xxx.xxx.

  • SUMMARY As provided in the Fifth Amended and Restated Declaration of Trust and Trust Agreement of the Trust, as amended from time to time (the “Trust Agreement”) as currently in effect and described in the applicable Prospectus (defined below), units of fractional undivided beneficial interest in and ownership of each Fund (individually and collectively, the “Shares”) may be created or redeemed by the Managing Owner for an Authorized Participant in aggregations of two hundred thousand (200,000) Shares (each aggregation, a “Basket”). Baskets are offered only pursuant to the applicable registration statement of the Trust, with respect to all the Funds, excluding the DBA Fund and the DBS Fund, on Form S-3, with respect to the DBA Fund on Form S-3ASR, and with respect to the DBS Fund on Form S-1, as amended (Registration Nos.: 333-203008 et seq. with respect to all the Funds, excluding the DBA Fund and the DBS Fund; Registration Nos.: 333-185865 et seq. with respect to the DBA Fund only; Registration Nos.: 333-193222 et seq. with respect to the DBS Fund only), as currently effective and on file with the Securities and Exchange Commission (“SEC”) and as the same may be amended from time to time thereafter or any successor registration statement in respect of Shares of each Fund (each, a “Registration Statement,” collectively, the “Registration Statements”) together with the prospectuses of the Trust in the form filed with the SEC under Rule 424(b) under the Securities Act of 1933, as amended (the “1933 Act”), after the effectiveness of the Registration Statements (each, a “Prospectus,” collectively, the “Prospectuses”). Under the Trust Agreement, the Managing Owner is authorized to issue Baskets to, and redeem Baskets from, Authorized Participants, (i) through the Continuous Net Settlement (“CNS”) clearing processes of the National Securities Clearing Corporation (the “NSCC”) as such processes have been enhanced to effect purchases and redemptions of Creation Baskets and Redemption Baskets (the “CNS Clearing Process”), or (ii) if outside the CNS Clearing Process, only through the facilities of The Depository Trust Company (“DTC” or the “Depository”) (the “DTC Process”), or a successor depository, and only in exchange for cash. This Agreement sets forth the specific procedures by which an Authorized Participant may create or redeem Baskets. For the avoidance of doubt, the term “Prospectus” shall mean the Prospectus for the DBA Fund, the Prospectus for the DBS Fund or the Prospectus for all of the Funds, excluding the DBA Fund and the DBS Fund, as the context requires. Because new Shares for each Fund can be created and issued by the Trust on an ongoing basis, at any point during the life of each respective Fund, a “distribution,” as such term is used in the 1933 Act, may be occurring. The Authorized Participant is cautioned that some of its activities may result in its being deemed a participant in a distribution in a manner that would render it a statutory underwriter and subject it to the prospectus delivery and liability provisions of the 1933 Act. The Authorized Participant should review the “Plan of Distribution” section of the applicable Prospectus and consult with its own counsel in connection with entering into this Agreement and submitting a Purchase Order Subscription Agreement (defined below). Capitalized terms used but not defined in this Agreement shall have the meanings assigned to such terms in the Trust Agreement. To the extent there is a conflict between any provision of this Agreement and the provisions of the Trust Agreement, the provisions of the Trust Agreement shall control. To the extent there is a conflict between any provision of this Agreement and the provisions of the applicable Prospectus, the applicable Prospectus shall control. For the avoidance of doubt, any action which is an action being taken by the Managing Owner may be taken by a party whom the Managing Owner has duly authorized to take such action. To give effect to the foregoing premises and in consideration of the mutual covenants and agreements set forth below, the parties hereto agree as follows:

  • Descriptions and Summaries The statements included in the Registration Statement under the captions “Cash Distribution Policy,” “The Partnership Agreement” and “Investment in Targa Resources Partners LP by Employee Benefit Plans” and under the caption “Certain Relationships and Related Transactions, and Director Independence,” in the Partnership’s Annual Report on Form 10-K for the year ended December 31, 2012 (“2012 Annual Report”) insofar as they purport to constitute summaries of the terms of federal or Texas statutes, rules or regulations or the Delaware LP Act or the Delaware LLC Act, any legal and governmental proceedings or any contracts, constitute accurate summaries of the terms of such statutes, rules and regulations, legal and governmental proceedings and contracts in all material respects. The description of the federal statutes, rules and regulations set forth in the 2012 Annual Report under “Business—Regulation of Operations” and “Business—Environmental, Health and Safety Matters” constitute accurate summaries of the terms of such statutes, rules and regulations in all material respects.

  • Risk Factors You should carefully consider the risks and uncertainties described below and in our reports filed with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, before exchanging Outstanding Notes for the New Notes. In particular, we refer you to the disclosure regarding certain risk factors applicable to us and our business in our Annual Report on Form 10-K for the year ended December 31, 2011 and our Quarterly Reports on Form 10-Q filed after that date. Risks related to the Exchange If an active trading market for the New Notes does not develop, then the market price of the New Notes may decline or you may not be able to sell your New Notes. We do not intend to list the New Notes on any securities exchange. If the New Notes are traded, they may trade at a discount, depending on prevailing interest rates, the market for similar securities, the price of our common stock, the performance of our business and other factors. We do not know whether an active trading market will develop for the New Notes. To the extent that an active trading market does not develop, you may not be able to resell the New Notes or may only be able to sell them at a substantial discount. The consummation of the Exchange may be delayed or may not occur. Consummation of the Exchange will be subject to the satisfaction of certain conditions, including, among others, that the Indenture is qualified under the Trust Indenture Act and that the New Notes will be fungible with the December 2011 Series B Notes for U.S. federal income tax purposes as of the closing date of the Exchange. Even if an exchange agreement is executed, the closing of the Exchange may be delayed for a significant period of time. Accordingly, you may have to wait longer than expected to receive New Notes in the Exchange, during which time you will not be able to effect transfers of your Outstanding Notes subject to the exchange agreement. In addition, if the Company concludes that any of the conditions to consummation of the Exchange will not be satisfied, it may terminate the exchange agreement by giving notice to you of such termination. Upon termination of the exchange agreement, any Old Notes that you have previously delivered for exchange will be returned to you and we will not be required to make any payment of any amount under the exchange agreement. The consideration to be received in the Exchange Offer does not reflect any fairness valuation. Our board of directors has made no determination that the consideration to be received in the Exchange represents a fair valuation of either the Outstanding Notes or the New Notes. We have not obtained a fairness opinion from any financial advisor about the fairness to us or to you of the consideration to be received by holders of Outstanding Notes. Any obligations we have that mature prior to December 15, 2016 will be paid before the optional redemption date of the New Notes. We have outstanding indebtedness, and may incur additional indebtedness from time to time, that is or may become due prior to the optional redemption date of the New Notes. In particular, the holders of the Outstanding Notes can require us to repurchase their notes on December 15, 2013, and the holders of other series of our convertible senior subordinated notes can require us to repurchase their notes on multiple dates prior to the optional redemption date of the New Notes. The Outstanding Notes and other series of our convertible senior subordinated notes will be convertible at the option of the holder prior to the time the New Notes become convertible. Except in limited cases, the New Notes are not convertible prior to June 15, 2016. The Outstanding Notes and other series of our convertible senior subordinated notes (other than the December 2011 Series B Notes) have or will become convertible prior to that date. The adjustment to the conversion rate for notes converted in connection with certain fundamental changes may not adequately compensate you for any lost value of your notes as a result of such transaction. If certain fundamental changes occur prior to December 15, 2016, we will increase the conversion rate by a number of additional shares of our common stock for notes converted in connection with such fundamental change. The increase in the conversion rate will be determined based on the date on which the fundamental change becomes effective and the price paid per share of our common stock in such transaction. The adjustment to the conversion rate for notes converted in connection with a fundamental change may not adequately compensate you for any lost value of your notes as a result of such transaction. In addition, if the price of our common stock in the transaction is greater than $50.00 per share or less than $8.04 per share (in each case, subject to adjustment), no adjustment will be made to the conversion rate. Moreover, in no event will the total number of shares of common stock issuable upon conversion exceed 124.3781 per $1,000 principal amount of notes, subject to adjustment. The enforceability of our obligation to deliver the additional shares upon a fundamental change could be subject to general principles of reasonableness of economic remedies. CERTAIN U.S. FEDERAL INCOME TAX CONSIDERATIONS This summary does not address all of the U.S. federal income tax consequences that may be relevant to holders, nor does it address specific tax consequences that may be relevant to particular holders that are subject to special tax rules (including, for example, banks or financial institutions, broker-dealers, insurance companies, regulated investment companies, tax-exempt entities, common trust funds, dealers in securities or currencies, traders who elect to xxxx to market their securities, pass-through entities (and investors in such entities), “controlled foreign corporations,” “passive foreign investment companies,” U.S. expatriates, U.S. holders that have a functional currency other than the U.S. dollar, individuals who are present in the United States for more than 183 days in the taxable year of the Exchange, persons subject to the alternative minimum tax and persons in special situations, such as those who hold Outstanding Notes or New Notes as part of a straddle, hedge, conversion transaction or other integrated investment).

  • Executive Summary Based on the requirements and qualifications set forth in the Pooling and Servicing Agreement, as well as the items listed below, the Trust Advisor has undertaken a limited review of the Special Servicer’s operational activities to service the Specially Serviced Mortgage Loans in accordance with the Servicing Standard. Based on such review, the Trust Advisor [does, does not] believe there are material violations of the Special Servicer’s compliance with its obligations under the Pooling and Servicing Agreement. In addition, the Trust Advisor notes the following: [PROVIDE SUMMARY OF INFORMATION]. In connection with the assessment set forth in this report:

  • Risk Assessments a. Risk Assessment - Transfer Agent shall, at least annually, perform risk assessments that are designed to identify material threats (both internal and external) against Fund Data, the likelihood of those threats occurring and the impact of those threats upon the Transfer Agent organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”).

  • Status Reports DSI will issue to Depositor and Preferred Beneficiary a report profiling the account history at least semi-annually. DSI may provide copies of the account history pertaining to this Agreement upon the request of any party to this Agreement.

  • Aircraft Description The Option Aircraft are described by Boeing Detail Specification D6-38808, Revision E, dated September 15, 1995, as amended and revised pursuant to the Agreement.

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