Schedule of Study Procedures Sample Clauses

Schedule of Study Procedures. 9.1.1. Screening • The following data can be obtained from the RP103-03 Screening visit: o Demographics. o Medical history. o Medication history. o Menstrual history for females of childbearing potential. • The following data can be obtained from the RP103-03 Termination visit: o Clinical laboratory o Physical examination o 12-lead ECG o Xxxxx xxxxx • Dispense RP103 study medication. • Schedule return clinic visit for Monthly Visit 1. • Review inclusion/exclusion criteria. • Record demographics. • Record medical history. • Record medication history. • Record menstrual history for females of childbearing potential. • Perform a physical examination (see Section 9.10). • Obtain clinical laboratory samples (serum chemistry, hematology, and urinalysis, see Section 9.7). • Collect a cysteamine PK sample pre-dose RP103 administration. Actual collection time will be recorded. • Collect a WBC cystine PD sample pre-dose RP103 administration (which should be 5-6 hours post last Cystagon® administration). Actual collection time will be recorded. • Measure xxxxx xxxxx (blood pressure, heart rate, respiratory rate, and oral body temperature, see Section 9.11). • Obtain a 12-lead ECG (see Section 9.9). • Provide training for Daily Diary log of cysteamine and gastric acid reduction medications. Provide copy of daily medication diary. • Schedule return clinic visits for Days 1, 4 and 5. • Obtain serum pregnancy test from females of childbearing potential. • Measure height and weight. • Calculate BMI and BSA (see Appendix 14.5). • • • Prepare subjects for study participation by informing them of study restrictions and procedures. • Provide copy of daily medications diary. • Record concomitant medications. • Monitor AEs. For patients whose Screening visit was > 7 days prior to Day 1, complete the following prior to RP103 dosing: • Re-assess inclusion/exclusion criteria. • Record any changes since Screening to medical history, medication history, menstrual history for females of childbearing potential. • Obtain serum pregnancy test from females of childbearing potential. • Measure height and weight. • Calculate BMI and BSA (see Appendix 14.5). • Perform a physical examination (see Section 9.10). • Collect a cysteamine PK sample pre-dose RP103 administration. Actual collection time will be recorded. • Collect a WBC cystine PD sample pre-dose RP103 administration. Actual collection time will be recorded. • Obtain clinical laboratory tests (serum chemistry, hematology, and urina...
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Related to Schedule of Study Procedures

  • New Procedures New procedures as to who shall provide certain of these services in Section 1 may be established in writing from time to time by agreement between the Fund and the Transfer Agent. The Transfer Agent may at times perform only a portion of these services and the Fund or its agent may perform these services on the Fund's behalf;

  • Filing Procedures The Company shall (A) permit counsel to the Investor an opportunity to review and comment upon (i) each Registration Statement at least three (3) Trading Days prior to its filing with the SEC and (ii) all amendments and supplements to each Registration Statement (including, without limitation, the Prospectus contained therein) (except for Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any similar or successor reports or Prospectus Supplements the contents of which is limited to that set forth in such reports) within a reasonable number of days prior to their filing with the SEC, and (B) shall reasonably consider any comments of the Investor and its counsel on any such Registration Statement or amendment or supplement thereto or to any Prospectus contained therein. The Company shall promptly furnish to the Investor, without charge, (i) electronic copies of any correspondence from the SEC or the Staff to the Company or its representatives relating to each Registration Statement (which correspondence shall be redacted to exclude any material, non-public information regarding the Company or any of its Subsidiaries), (ii) after the same is prepared and filed with the SEC, one (1) electronic copy of each Registration Statement and any amendment(s) and supplement(s) thereto, including, without limitation, financial statements and schedules, all documents incorporated therein by reference, if requested by the Investor, and all exhibits and (iii) upon the effectiveness of each Registration Statement, one (1) electronic copy of the Prospectus included in such Registration Statement and all amendments and supplements thereto; provided, however, the Company shall not be required to furnish any document to the extent such document is available on XXXXX).

  • Claim Procedures Claim forms or claim information as to the subject policy can be obtained by contacting Benmark, Inc. (800-544-6079). When the Named Fiduciary has a claim which may be covered under the provisions described in the insurance policy, they should contact the office named above, and they will either complete a claim form and forward it to an authorized representative of the Insurer or advise the named Fiduciary what further requirements are necessary. The Insurer will evaluate and make a decision as to payment. If the claim is payable, a benefit check will be issued in accordance with the terms of this Agreement. In the event that a claim is not eligible under the policy, the Insurer will notify the Named Fiduciary of the denial pursuant to the requirements under the terms of the policy. If the Named Fiduciary is dissatisfied with the denial of the claim and wishes to contest such claim denial, they should contact the office named above and they will assist in making an inquiry to the Insurer. All objections to the Insurer's actions should be in writing and submitted to the office named above for transmittal to the Insurer.

  • Purpose; Incorporation by Reference of Auction Procedures and Settlement Procedures (a) The Statement for each series of MuniPreferred will provide that the Applicable Rate for such series for each Subsequent Rate Period thereof shall, except under certain conditions, be the rate per annum that a bank or trust company appointed by the Fund advises results from implementation of the Auction Procedures for such series. The Board of Directors or Board of Trustees, as the case may be, of the Fund has adopted a resolution appointing the Auction Agent as auction agent for purposes of the Auction Procedures for each series of MuniPreferred. The Auction Agent accepts such appointment and agrees to follow the procedures set forth in this Section 2 and the Auction Procedures for the purpose of determining the Applicable Rate for each series of MuniPreferred for each Subsequent Rate Period thereof for which the Applicable Rate is to be determined by an Auction. Each periodic implementation of such procedures is hereinafter referred to as an "Auction." (b) All of the provisions contained in the Auction Procedures and the Settlement Procedures are incorporated herein by reference in their entirety and shall be deemed to be a part hereof to the same extent as if such provisions were fully set forth herein.

  • Billing Procedures The Supporting Party will xxxx the Protecting Party for actual costs incurred for Assistance by Hire. Reimbursements will be limited to the provisions of the Agreement and the applicable OP, regardless of whether or not it is authorized on the Resource Order or other documentation produced by the incident. Reimbursable costs may include transportation, salary, overtime, per diem and other approved expenses of Supporting agency personnel. Rates and conditions of use for the equipment and personnel are documented in the OP. Parties shall submit a xxxx within 90 days of the incident. Parties must use their own invoice form for billing under this Agreement to avoid any confusion with other services that may have been ordered under other agreements. Invoices must identify Supporting Party’s name, address, and Taxpayer Identification Number (Department only), fire name, order and request number, and xxxx number and amount. Invoice supporting documentation must include description of services performed, period of services performed, and any applicable cost share agreements. Supporting documentation will itemize details of billing, listing personnel, equipment, travel and per diem, aircraft, supplies and purchases as approved in the attached AOP. It will also include itemized deductions for maintenance and repair of equipment. Department invoices will include “Record of Activities” (FSLA-5) and U.S. Forest Service invoices will include transaction register. Invoices for services under this agreement must be sent to: Name: Xxxx Xxxxxx-Xxxxx, ECC Manager Address: 0000 Xxxxxxxxx Xxxxx Xxxx, Xxxxx, Xxx: Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 FAX: (000) 000-0000 Email: xxxxxxxxxxxx@xx.xxx.xx Name: Spalding Community Service District Address: 000-000 Xxxxxxxx Xxx Xxxx, Xxxxx, Xxx: Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 FAX: (000) 000-0000 Email: xxxxxxxxxxxxx@xxxxxxx.xxx All bills will have a payment due date 30 days upon receipt. Contested Xxxxxxxx: Written notice that a xxxx is contested will be mailed to the Party within 30 days of receipt of the invoice and will fully explain the contested items. Contested items should be resolved no later than 60 days following receipt of the written notice. Parties are responsible for facilitating resolution of contested xxxxxxxx. Billing requirements and rates are documented in the attached OP.

  • Safety Procedures The Contractor shall: (a) comply with all applicable safety regulations according to Attachment H; (b) take care for the safety of all persons entitled to be on the Site; (c) use reasonable efforts to keep the Site and Works clear of unnecessary obstruction so as to avoid danger to these persons; (d) provide fencing, lighting, guarding and watching of the Works until completion and taking over under clause 10 [Employer's Taking Over]; and (e) provide any Temporary Works (including roadways, footways, guards and fences) which may be necessary, because of the execution of the Works, for the use and protection of the public and of owners and occupiers of adjacent land.

  • Reply Procedures In connection with any Auction, each Lender holding the relevant Term Loans subject to such Auction may, in its sole discretion, participate in such Auction and may provide the Auction Agent with a notice of participation (the “Return Bid”) which shall be in a form reasonably acceptable to the Auction Agent, and shall specify (i) a discount to par (that must be expressed as a price at which it is willing to sell all or any portion of such Term Loans) (the “Reply Price”), which (when expressed as a percentage of the par principal amount of such Term Loans) must be within the Discount Range and (ii) a principal amount of such Term Loans, which must be in whole increments of $1,000,000 (or, in any case, such lesser amount of such Term Loans of such Lender then outstanding or which is otherwise reasonably acceptable to the Auction Agent) (the “Reply Amount”). Lenders may only submit one Return Bid per Auction, but each Return Bid may contain up to three bids only one of which may result in a Qualifying Bid. In addition to the Return Bid, the participating Lender must execute and deliver, to be held in escrow by the Auction Agent, an Assignment and Assumption with the dollar amount of the Term Loans to be assigned to be left in blank, which amount shall be completed by the Auction Agent in accordance with the final determination of such Lender’s Qualifying Bid pursuant to clause (c) below. Any Lender whose Return Bid is not received by the Auction Agent by the Auction Response Date shall be deemed to have declined to participate in the relevant Auction with respect to all of its Term Loans.

  • Funding Procedures Not later than 11:00 a.m. (Boston time) on the proposed Drawdown Date of any Loans, each of the Banks will make available to the Agent, at its Head Office, in immediately available funds, the amount of such Bank's Commitment Percentage of the amount of the requested Loans. Upon receipt from each Bank of such amount, and upon receipt of the documents required by ss.ss.11 and 12 and the satisfactIon of the other conditions set forth therein, to the extent applicable, the Agent will make available to the Borrower the aggregate amount of such Loans made available to the Agent by the Banks. The failure or refusal of any Bank to make available to the Agent at the aforesaid time and place on any Drawdown Date the amount of its Commitment Percentage of the requested Loans shall not relieve any other Bank from its several obligation hereunder to make available to the Agent the amount of such other Bank's Commitment Percentage of any requested Loans.

  • Important Information About Procedures for Opening a New Account To help the government fight the funding of terrorism and money laundering activities, Federal law requires all financial organizations to obtain, verify, and record information that identifies each person who opens an account. What this means for you: When you open an account, you are required to provide your name, residential address, date of birth, and identification number. We may require other information that will allow us to identify you.

  • RECOVERY PROCEDURES The nature and severity of any disaster will influence the recovery procedures. One crucial factor in determining how BellSouth will proceed with restoration is whether or not BellSouth's equipment is incapacitated. Regardless of who's equipment is out of service, BellSouth will move as quickly as possible to aid with service recovery; however, the approach that will be taken may differ depending upon the location of the problem.

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