Follow-up Reports. Two business days after particular securities are fair-valued in accordance with these procedures, PNC will provide to VP Distributors by 12:00 p.m. (Eastern Time) an Excel file containing the following information, to the extent available: Cusip/Sedol Portfolio ID Security Long Name Country Closing Price Fair Value Price Opening Price in Local Market FV Price/Closing Price (expressed as percentage) Opening Price/FV Price (expressed as a percentage) Opening Price/Closing Price (expressed as a percentage)
Follow-up Reports. By no later than January 31st of the year immediately following the year on which the ten (10) year anniversary of the Completion Date falls, Grantee shall provide DEO with a written certification of the actual number of New Jobs created by each business as a result of the Project (including the name of each business), Retained Jobs retained by each business as a result of the Project (including the name of each business) (if applicable), and the amount of private capital investment made and paid for by private businesses at the location of the Project or in connection with the Project after the Effective Date (including the name of each business). This paragraph will survive termination of this Agreement.
Follow-up Reports. Aptalis shall be responsible for obtaining further information on AE reports occurring in the Territory and Strakan shall be responsible for obtaining further information on AE reports occurring outside the Territory. Specifically, the Parties’ respective responsibilities shall be for critical data elements that ensure a comprehensive AE description and a true clinical understanding of the case or to ensure sufficient data to secure a “valid” case (a patient with at least one patient identifier, a reporter, an event, where the product is identified as the Product or glyceryl trinitrate unknown). Additional information may include laboratory data, biopsy results, hospital discharge summaries, etc. Each Party will transmit follow-up information received within the timeframe and by the methods described above for serious and non-serious cases.
Follow-up Reports. Follow-up reports concerning the performance of any employee who has received an “Unacceptable” or “Needs Improvement” rating shall be prepared at three- month intervals. If, in the opinion of the appointing authority, the employee improves to the extent that the restoration of any merit step advancement previously withheld under provisions of Section 8.1 is justified, the appointing authority shall so recommend to the City Manager. Upon approval of the City Manager, such restoration shall be made and shall be effective on beginning date of a subsequent pay period as specified in the recommendation of the appointing authority.
Follow-up Reports. Forwarding of an AE report should not be delayed while further information is awaited. If all the necessary details are not available at the time that the initial report is forwarded, the Nominated Contact will make further contact by telephone, correspondence or personal visit to the reporter to obtain the missing information. When serious reports originate from pharmacists, nurses or consumers, efforts should be made to obtain further information about the case from the physician responsible for the patient. Any additional information, including final outcome, will be forwarded to Skye as an addendum or ‘follow-up’ to the original report. This follow-up information should be identified with Skye’s reference number. Submission of reports to Regulatory Authorities Reports originating in the Territory Skye is responsible for submitting AE reports to the EMEA and in other countries where it holds the Regulatory Approval. Mundipharma shall be responsible for submitting AE reports in countries where it holds the Regulatory Approval. A copy of all correspondence with the Regulatory Authority will be submitted to the other party. Reports originating in territories other than the Territory Skye will notify Mundipharma of any serious unexpected foreign reports for information. Where Mundipharma is holder of the Regulatory Approval Mundipharma will submit the report to the local Regulatory Authority if appropriate. Where Skye is the holder of the Regulatory Approval, notification will be by copy of the report submitted to the Regulatory Authority. The activities of both parties summarised below.
Follow-up Reports. Any observation/evaluation report which notes an area in need of correction shall be handled in the following manner: within five (5) days of the signing of the observation report, the Administration shall identify specific ways/means/steps that the teacher may use to correct the noted problem. The method by which the correction process will be monitored and a realistic time frame for doing so will also be noted. Two (2) copies of the above will be given to the teacher with one (1) to be signed by the teacher within five (5) days and returned to the Administration, the other to be retained by the teacher. The teacher’s signature does not necessarily indicate agreement with the report but only acknowledges receipt of the report.
Follow-up Reports. For each of the two years following the Grant Period, Grantee shall file an annual report with Impact detailing the progress and sustainability of the Grant Project.
Follow-up Reports. The investigator must continue to follow the subject until the SAE has subsided or until the condition becomes chronic in nature, stabilizes (in the case of persistent impairment, or the subject dies. Within 24 hours of receipt of new information, the SAE form should be updated within the clinical database and submitted along with any supporting documentation (e.g., subject discharge summary or autopsy reports) (refer to Table 6). If the clinical database is down for any reason, the manual SAE forms should be used; however, sites are responsible for ensuring the updated information on the manual SAE forms is entered into the clinical database once available. The Sponsor or designee will notify regulatory agencies of any fatal or life-threatening unexpected events associated with the use of the study drug as soon as possible but no later than 7 calendar days after the initial receipt of the information. Initial notification will be followed by a written report within the timeframe established by the appropriate regulatory agency. For other SAEs that do not meet the fatal or life-threatening unexpected criteria, but are reported to be associated with the use of the study drug, Reata or designee will notify the appropriate regulatory agencies in writing within the timeframe established by those regulatory agencies. Reata or designee will provide copies of any reports to regulatory agencies regarding serious and unexpected SAEs to the investigators for review and submission to their institutional review board (IRB or Ethics Committee (EC, as appropriate. Principal investigators are responsible for informing their IRB/EC of any SAEs at their site. SAE correspondence with regulatory authorities or IRBs/ECs must be submitted to the Sponsor or designee for recording in the study file. Note that the following adverse events which are commonly observed in this patient population will not be reported to regulatory authorities as individual expedited reports, except in unusual circumstances. • Shortness of breath • Lightheaded/dizzy • Syncope • Chest pain • Palpitations • Fatigue • Edema/fluid retention • Exertional dyspnea • Hypoxemia These events will be reviewed on a regular basis in aggregate and will be reported in an expedited manner if a safety signal is detected. Regular safety study updates will be reported to regulatory authorities according to local guidelines. 12. STATISTICS 12.1. Sample Size
Follow-up Reports. 9.1. Subject to what is stated in paragraph 9.2 below, the Firm will, following the provision of the Initial Assessment Report, furnish written reports to the Fund on a regular basis, or as and when requested.
Follow-up Reports. DUSA shall request specific follow-up information as it may need to fulfill its regulatory obligations. XXXXXXX shall be responsible for acting on this request and for obtaining follow-up information on all ICSRs and pregnancy reports for Levulan(R) Kerastick(R) in the Territory according to its internal practices and procedures. XXXXXXX shall be responsible for collecting good quality data from the reporter in the Territory.
