Long-Term Follow-up of Subjects Withdrawn from Study Treatment Sample Clauses

Long-Term Follow-up of Subjects Withdrawn from Study Treatment. On entry to the study, subjects will be requested to give consent for the investigator to follow-up their health following withdrawal from the study treatment, for whatever reason, at 12-weekly time points for a period of 156 weeks (3 years) from randomisation. The investigator must record the following information: • Subject survival status (as described in Section 5.4.1) • Number of moderate and severe exacerbations in the previous 12 weeks (see Section 3.3.4.1 for COPD exacerbation definitions) • COPD concomitant medications • Whether the subject discontinued from long-term follow up by withdrawing consent, lost to follow-up, death or for other reasons will be recorded in the CRF. • Subjects will be provided with a medication diary card in order to facilitate capture of the above information. Subjects will be asked to complete the medication diary card throughout the long-term follow up period (3 years post randomisation). Following withdrawal from study treatment this information should continue to be captured and provided to the investigator or subject’s general practitioner as appropriate. • The long-term follow-up should commence from the last scheduled visit prior to withdrawal from the study treatment. • Please note that during this period all deaths in addition to all SAEs that the investigator considers to be related to the discontinued study drug must be reported as per Section 7 of the protocol.
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Related to Long-Term Follow-up of Subjects Withdrawn from Study Treatment

  • How Are Distributions From a Traditional IRA Taxed for Federal Income Tax Purposes Amounts distributed to you are generally includable in your gross income in the taxable year you receive them and are taxable as ordinary income. To the extent, however, that any part of a distribution constitutes a return of your nondeductible contributions, it will not be included in your income. The amount of any distribution excludable from income is the portion that bears the same ratio as your aggregate non-deductible contributions bear to the balance of your Traditional IRA at the end of the year (calculated after adding back distributions during the year). For this purpose, all of your Traditional IRAs are treated as a single Traditional IRA. Furthermore, all distributions from a Traditional IRA during a taxable year are to be treated as one distribution. The aggregate amount of distributions excludable from income for all years cannot exceed the aggregate non-deductible contributions for all calendar years. You must elect the withholding treatment of your distribution, as described in paragraph 22 below. No distribution to you or anyone else from a Traditional IRA can qualify for capital gains treatment under the federal income tax laws. Similarly, you are not entitled to the special five- or ten-year averaging rule for lump-sum distributions that may be available to persons receiving distributions from certain other types of retirement plans. Historically, so-called “excess distributions” to you as well as “excess accumulations” remaining in your account as of your date of death were subject to additional taxes. These additional taxes no longer apply. Any distribution that is properly rolled over will not be includable in your gross income.

  • Certification of Funds; Budget and Fiscal Provisions; Termination in the Event of Non-Appropriation This Agreement is subject to the budget and fiscal provisions of the City’s Charter. Charges will accrue only after prior written authorization certified by the Controller, and the amount of City’s obligation hereunder shall not at any time exceed the amount certified for the purpose and period stated in such advance authorization. This Agreement will terminate without penalty, liability or expense of any kind to City at the end of any fiscal year if funds are not appropriated for the next succeeding fiscal year. If funds are appropriated for a portion of the fiscal year, this Agreement will terminate, without penalty, liability or expense of any kind at the end of the term for which funds are appropriated. City has no obligation to make appropriations for this Agreement in lieu of appropriations for new or other agreements. City budget decisions are subject to the discretion of the Mayor and the Board of Supervisors. Contractor’s assumption of risk of possible non-appropriation is part of the consideration for this Agreement. THIS SECTION CONTROLS AGAINST ANY AND ALL OTHER PROVISIONS OF THIS AGREEMENT.

  • How Are Contributions to a Xxxx XXX Reported for Federal Tax Purposes You must file Form 5329 with the IRS to report and remit any penalties or excise taxes. In addition, certain contribution and distribution information must be reported to the IRS on Form 8606 (as an attachment to your federal income tax return.)

  • How Are Distributions from a Xxxx XXX Taxed for Federal Income Tax Purposes Amounts distributed to you are generally excludable from your gross income if they (i) are paid after you attain age 59½, (ii) are made to your beneficiary after your death, (iii) are attributable to your becoming disabled, (iv) subject to various limits, the distribution is used to purchase a first home or, in limited cases, a second or subsequent home for you, your spouse, or you or your spouse’s grandchild or ancestor, or (v) are rolled over to another Xxxx XXX. Regardless of the foregoing, if you or your beneficiary receives a distribution within the five-taxable-year period starting with the beginning of the year to which your initial contribution to your Xxxx XXX applies, the earnings on your account are includable in taxable income. In addition, if you roll over (convert) funds to your Xxxx XXX from another individual retirement plan (such as a Traditional IRA or another Xxxx XXX into which amounts were rolled from a Traditional IRA), the portion of a distribution attributable to rolled-over amounts which exceeds the amounts taxed in connection with the conversion to a Xxxx XXX is includable in income (and subject to penalty tax) if it is distributed prior to the end of the five-tax-year period beginning with the start of the tax year during which the rollover occurred. An amount taxed in connection with a rollover is subject to a 10% penalty tax if it is distributed before the end of the five-tax-year period. As noted above, the five-year holding period requirement is measured from the beginning of the five-taxable-year period beginning with the first taxable year for which you (or your spouse) made a contribution to a Xxxx XXX on your behalf. Previously, the law required that a separate five-year holding period apply to regular Xxxx XXX contributions and to amounts contributed to a Xxxx XXX as a result of the rollover or conversion of a Traditional IRA. Even though the holding period requirement has been simplified, it may still be advisable to keep regular Xxxx XXX contributions and rollover/ conversion Xxxx XXX contributions in separate accounts. This is because amounts withdrawn from a rollover/conversion Xxxx XXX within five years of the rollover/conversion may be subject to a 10% penalty tax. As noted above, a distribution from a Xxxx XXX that complies with all of the distribution and holding period requirements is excludable from your gross income. If you receive a distribution from a Xxxx XXX that does not comply with these rules, the part of the distribution that constitutes a return of your contributions will not be included in your taxable income, and the portion that represents earnings will be includable in your income. For this purpose, certain ordering rules apply. Amounts distributed to you are treated as coming first from your non-deductible contributions. The next portion of a distribution is treated as coming from amounts which have been rolled over (converted) from any non-Xxxx IRAs in the order such amounts were rolled over. Any remaining amounts (including all earnings) are distributed last. Any portion of your distribution which does not meet the criteria for exclusion from gross income may also be subject to a 10% penalty tax. Note that to the extent a distribution would be taxable to you, neither you nor anyone else can qualify for capital gains treatment for amounts distributed from your account. Similarly, you are not entitled to the special five- or ten- year averaging rule for lump-sum distributions that may be available to persons receiving distributions from certain other types of retirement plans. Rather, the taxable portion of any distribution is taxed to you as ordinary income. Your Xxxx XXX is not subject to taxes on excess distributions or on excess amounts remaining in your account as of your date of death. You must indicate on your distribution request whether federal income taxes should be withheld on a distribution from a Xxxx XXX. If you do not make a withholding election, we will not withhold federal or state income tax. Note that, for federal tax purposes (for example, for purposes of applying the ordering rules described above), Xxxx IRAs are considered separately from Traditional IRAs.

  • Sector Sub-Sector Industry Classification Level of Government Type of Obligation Description of Measure Source of Measure All sectors : : - : Central : National Treatment Senior Management and Board of Directors : National Treatment and the Senior Management and Board of Directors obligations shall not apply to any measure relating to small and medium sized domestic market enterprise2. Foreign equity is restricted to a maximum of 40% for domestic market enterprises with paid-in equity capital of less than the equivalent of USD 200,000 Note: Members of the Board of Directors or governing body of corporation or associations shall be allowed in proportion to their allowable participation or share in the capital of such enterprises. : -1987 Constitution of the Republic of the Philippines. - Foreign Investments Act of 1991 (R.A. No. 7042, as amended by R.A. No. 8179). -Presidential and Administrative Issuances. ∞ 2 The concept of a small and medium sized domestic market enterprise is an enterprise with paid in equity capital of less than the equivalent of USD 200,000.00.

  • CHILD AND DEPENDENT ADULT/ELDER ABUSE REPORTING CONTRACTOR shall establish a procedure acceptable to ADMINISTRATOR to ensure that all employees, agents, subcontractors, and all other individuals performing services under this Agreement report child abuse or neglect to one of the agencies specified in Penal Code Section 11165.9 and dependent adult or elder abuse as defined in Section 15610.07 of the WIC to one of the agencies specified in WIC Section 15630. CONTRACTOR shall require such employees, agents, subcontractors, and all other individuals performing services under this Agreement to sign a statement acknowledging the child abuse reporting requirements set forth in Sections 11166 and 11166.05 of the Penal Code and the dependent adult and elder abuse reporting requirements, as set forth in Section 15630 of the WIC, and shall comply with the provisions of these code sections, as they now exist or as they may hereafter be amended.

  • HHS Single Audit Unit will notify Grantee to complete the Single Audit Determination Form If Grantee fails to complete the form within thirty (30) calendar days after receipt of notice, Grantee maybe subject to sanctions and remedies for non-compliance.

  • Staffing Levels to deal with Potential Violence The Employer agrees that, where there is a risk of violence, an adequate level of trained employees should be present. The Employer recognizes that workloads can lead to fatigue and a diminished ability both to identify and to subsequently deal with potentially violent situations.

  • When Must Distributions from a Traditional IRA Begin You must begin receiving the assets in your account no later than April 1 following the calendar year in which you reach RMD age.

  • Long Term Cost Evaluation Criterion 4. READ CAREFULLY and see in the RFP document under "Proposal Scoring and Evaluation". Points will be assigned to this criterion based on your answer to this Attribute. Points are awarded if you agree not increase your catalog prices (as defined herein) more than X% annually over the previous year for the life of the contract, unless an exigent circumstance exists in the marketplace and the excess price increase which exceeds X% annually is supported by documentation provided by you and your suppliers and shared with TIPS, if requested. If you agree NOT to increase prices more than 5%, except when justified by supporting documentation, you are awarded 10 points; if 6% to 14%, except when justified by supporting documentation, you receive 1 to 9 points incrementally. Price increases 14% or greater, except when justified by supporting documentation, receive 0 points. increases will be 5% or less annually per question Required Confidentiality Claim Form Required Confidentiality Claim Form This completed form is required by TIPS. By submitting a response to this solicitation you agree to download from the “Attachments” section, complete according to the instructions on the form, then uploading the completed form, with any confidential attachments, if applicable, to the “Response Attachments” section titled “Confidentiality Form” in order to provide to TIPS the completed form titled, “CONFIDENTIALITY CLAIM FORM”. By completing this process, you provide us with the information we require to comply with the open record laws of the State of Texas as they may apply to your proposal submission. If you do not provide the form with your proposal, an award will not be made if your proposal is qualified for an award, until TIPS has an accurate, completed form from you. Read the form carefully before completing and if you have any questions, email Xxxx Xxxxxx at TIPS at xxxx.xxxxxx@xxxx-xxx.xxx 8 Choice of Law clauses with TIPS Members If the vendor is awarded a contract with TIPS under this solicitation, the vendor agrees to make any Choice of Law clauses in any contract or agreement entered into between the awarded vendor and with a TIPS member entity to read as follows: "Choice of law shall be the laws of the state where the customer resides" or words to that effect. 9

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