Follow-up Period. For the six (6) month period following LICENSEE’s receipt of the PFIZER Transfer Notice (the “Transition Period”), if LICENSEE learns of any incomplete Transfer Activities, LICENSEE shall provide written notice to PFIZER and reasonably following receipt thereof, PFIZER shall use reasonable efforts to perform such Transfer Activities; provided that PFIZER’s obligation to perform the Transfer Activities pursuant to this Section 3.2 and Section 3.1 shall not exceed a total of ***** hours in the aggregate.
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
5.2.4.1 Week 1 and Week 4 Telephone Visits 56
5.2.4.2 Week 2 Clinic Visit 56
Follow-up Period. (after First Treatment and Retreatments) 58
5.2.4.1 Week 1 and Week 4 Telephone Visits 58
5.2.4.2 Week 2 Clinic Visit 58
5.2.4.3 Week 6 Clinic Visit after First Treatment 60
5.2.4.4 Week 6 Clinic Visit after Retreatments 61
5.2.4.5 Week 12 Clinic Visit 62
5.2.4.6 Routine Telephone Visits Every 12 weeks 62
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.
3.2.2 Sellas may request that GenFleet provide additional document(s) directly related to the Compounds, including their Development, Manufacture and Commercialization, or the Licensed Patent Rights or Licensed Know-How. Sellas’ request to receive such additional document(s) shall be in writing, shall identify with specificity the document(s) that Sellas would like GenFleet to provide, and shall be delivered to the GenFleet’s Transfer Liaison. Following receipt of Sellas’ written request for the additional document(s), GenFleet will provide such additional document(s).
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. 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 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 will be performed prior to the 2 hr. PK draw. ECGs performed on non-dosing Days should be completed within the same time window as the ECGs that were done 1½ to 3 hours after the time the morning doses were administered. The timing of the ECG may be ...
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).
Follow-up Period. Follow-up Visit
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. 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.
