Follow-up Period. For a period of six (6) months following LICENSEE’s receipt of the PFIZER Transfer Notice, if LICENSEE discovers or learns of any incomplete Transfer Activities, LICENSEE shall provide written notice to PFIZER, and PFIZER shall use reasonable efforts to perform such Transfer Activities provided that PFIZER’s efforts to engage in the Transfer Activities under this Section 3 shall not exceed a total of forty (40) hours.
Follow-up Period. The period of time following a family’s exit from a program where service providers continue to monitor a family’s stability but are not actively providing services unless the family requests additional assistance.
Follow-up Period. (after First Treatment and Retreatments) 56
Follow-up Period. 30-day Follow-up Visit The mandatory Safety Follow- up visit should be conducted approximately 30 (± 5 days) after the last dose of trial treatment and before initiation of a new anti-cancer treatment, whichever comes first. The following assessments will be performed: • Serum β-HCG pregnancy test (for WOCBP) • AEs using the NCI CTCAE Version 4.0 (see Appendix 3) • Review contraception use as required by protocol Section 4.7.2 (where applicable) • Confirm contact information for patient and a designated family member and remind patient of FU telephone contact that will be conducted every 90 days for survival status. All AEs that occur prior to the Safety Follow-Up Visit should be recorded. Patients with an AE of Grade > 1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-cancer therapy, whichever occurs first. SAEs that occur within 90 days of the end of trial treatment or before initiation of a new anti- cancer treatment should also be followed and recorded.
Follow-up Period. Following the End of Treatment visit, subjects will be followed for survival. During the follow-up period, subjects will be contacted every 8 weeks to assess vital status and disease state, including the initiation of any new anticancer interventions. Remainder of page intentionally left blank.
Follow-up Period. After completion of the treatment period, the subjects will be monitored for additional 14 days. A visit window of ±2 days will be allowed for the Day42/EOS visit. Subjects who do not complete the study may be replaced within a dosing cohort, unless a stopping rule precludes replacement. Safety criteria for dose adjustments or stopping rules are provided in Section 7.5. The overall study design of all scheduled procedures is shown in Table 3. Table 3: Schedule of Events Procedure Screening (Day -30 to -2) Day -1 Day 1 Day 2 Day 7 (±1) Day 14 (±1) Day 28 (+2) EOS/ Day 42 (±2) ETa Informed Consentb X Demographics X Weight and height X HIV, HBV, HCV tests X Physical exam X Medical history X Inclusion/exclusion X X Randomization X Pregnancy testc X X X X FSH X Drugs of abuse and alcohol screen X X X Vital signsd X X X X X X X X X ECGe X X X X X X X X X Blood chemistryf X X X X X X X X X Hematology and Coagulation X X X X X X X X X Urinalysis X X X X X X X X X PKg X X X Xh Fraction Unboundg X X ELF Score X X Procedure Screening (Day -30 to -2) Day -1 Day 1 Day 2 Day 7 (±1) Day 14 (±1) Day 28 (+2) EOS/ Day 42 (±2) ETa Xi X X X X X X X X X X X X X X X Study Drug Administrationk Adverse events X Concomitant medications X Abbreviations: ECG, electrocardiogram; EOS, End of Study; ET, Early Termination; FSH, follicle stimulating hormone; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; PK, pharmacokinetic(s). a If an Early Termination visit and a scheduled visit coincide, procedures for both visits should be completed without duplication. b Subjects must provide written informed consent prior to initiating any study procedures. To participate in this study, subjects must consent to all procedures outlined in Table 3, c All females of childbearing potential will have a serum beta human chorionic gonadotropin pregnancy test or urine dipstick pregnancy test at Screening, and urine dipstick pregnancy tests at all other indicated visits. d Blood pressure will be measured with a standard mercury sphygmomanometer or an automated oscillometric blood pressure monitor after the subject has been resting in a supine position for at least 5 minutes. Heart rate will be measured by an automated xxxxx xxxxx machine. Respiratory rate will be measured only if medically indicated. e Twelve-lead ECGs should be performed after the subject has been supine for 5 minutes and should be scheduled 1½ to 3 hours after the morning dose. On Day 1 and Day 28, ECGs...
Follow-up Period. If no later than [***] after the Termination Effective Date, either Party discovers or learns of any material, non-duplicative documents or other materials that should have been included in the Winddown Plan, such Party shall provide written notice to the other Party, and Roche shall use commercially reasonable efforts to provide BPM with such documents or other materials in accordance with the manner specified in the Winddown Plan within [***] after receipt of the aforementioned notice.
Follow-up Period. 3.2.1 Following the Effective Date (i) if Sellas learns of any documents or materials that fall within the scope of Exhibit A but were inadvertently omitted from Exhibit A, or were not transferred to Sellas by GenFleet, then upon Sellas’ request to the GenFleet’s Transfer Liaison, GenFleet shall use reasonable efforts to promptly provide such documents or materials to Sellas, and (ii) to the extent that GenFleet learns of any documents or materials that fall within the scope of Exhibit A but were inadvertently omitted from Exhibit A or not transferred to Sellas by GenFleet, then GenFleet shall promptly provide such documents or materials to Sellas.
Follow-up Period. If no later than [***], either Party discovers or learns of any material, non-duplicative documents or materials that should have been included in the Documents and Filings or any Know-How that should have been included in the Licensed Technology, such Party shall provide written notice to the other Party, and Blueprint shall [***] provide Clementia with such Documents and Filings or such Licensed Know-How in accordance with the manner specified on Schedule 2 to the Transition Plan.
Follow-up Period. All patients who have received at least one dose of NI-0501 will be monitored for 4 weeks after the last administration of NI-0501 within the context of the NI-0501-04 protocol, independently of the duration of treatment with NI-0501. In the event that the NI-0501 concentration is still measurable after the 4 week follow-up period (i.e. short-term follow-up), NI-0501 monitoring will continue until a measurable concentration of NI-0501 is no longer detectable. This monitoring should occur, whenever possible, in the context of the long-term follow-up study, NI-0501-05. Patients for whom an Investigator has requested a prolongation of NI-0501 treatment beyond Week 8 will directly enter the long-term follow-up study NI-0501-05, without having to complete the 4 week short- term follow-up. All patients having completed the follow-up period will also be asked to enter the open label safety extension study (NI-0501-05).
