End of Study Visit Sample Clauses

End of Study Visit. The EOS Visit will take place between 104 and 116 weeks after the first IMP administration (Day 1). Subjects may receive study retreatment up to and including Week 104 and a minimum of 12 weeks of follow-up is required after each IMP administration. For those subjects completing the study, the EOS Visit will occur: • 104 weeks after the first IMP administration; if it has been more than 12 weeks since the previous IMP administration • At the Week 12 Retreatment Follow-up Visit, if the subject received their most recent IMP administration between Week 92 and Week 104 following their first IMP administration. Early discontinuation A subject who discontinues early should, if at all possible, be followed-up for at least 12 weeks following their most recent IMP administration and should attend the EOS Visit. Diagnosis and criteria for inclusion: Inclusion criteria The following inclusion criteria will be assessed at the beginning of the Screening process: 1) Written informed consent prior to any study-related procedure. 2) Male or female, aged 18 to 80 years inclusive. 3) UI for at least 3 months prior to Screening as a result of NDO due to SCI or MS. 4) Subjects with SCI must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening. OR Subjects with MS must be clinically stable iu the iuvestigator's opiuiou, with no exacerbation (relapse) of MS for at least 3 months prior to Screening. 5) Subjects in the non-urodynamic subset only, must have NDO (defined as the presence of involuntary detrusor contractions during the storage phase of urodynamic filling cystometry) on a historic urodynamic assessment performed in the 12 months prior to Screening • If urodynamics are not performed in the 12 months prior to Screening or if results are not available, then a urodynamic filling cystometry assessment must be performed during Screening, per local practice (see inclusion criterion # 16).
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End of Study Visit. The EOS Visit will take place between 104 and 116 weeks after the first IMP administration (Day 1). Subjects may receive study retreatment up to and including Week 104 and a minimum of 12 weeks of follow-up is required after each IMP administration. For those subjects completing the study, the EOS Visit will occur: • 104 weeks after the first IMP administration; if it has been more than 12 weeks since the previous IMP administration • At the Week 12 Retreatment Follow-up Visit, if the subject received their most recent IMP administration between Week 92 and Week 104 following their first IMP administration. CCI
End of Study Visit or Early Withdrawal Visit 63 6.1.1 Dysport® 65 6.1.2 Placebo 65
End of Study Visit. You will be asked to complete a second Quality of Life survey and your records will be reviewed. You will be required to relinquish both the activity monitor and the video monitoring system at this visit. Your dog will be humanely treated at all times and all investigative procedures will be performed using the customary methods applied to all other client-owned patients at NC State University Veterinary Hospital. There are no known risks and side effects associated with use of a collar mounted activity monitor.

Related to End of Study Visit

  • Feasibility Study A feasibility study will identify the potential costs, service quality and other benefits which would result from contracting out the work in question. The cost analysis for the feasibility study shall not include the Employer’s indirect overhead costs for existing salaries or wages and benefits for administrative staff or for rent, equipment, utilities, and materials, except to the extent that such costs are attributable solely to performing the services to be contracted out. Upon completion of the feasibility study, the Employer agrees to furnish the Union with a copy if the feasibility study, the bid from the Apparent Successful Bidder and all pertinent information upon which the Employer based its decision to contract out the work including, but not limited to, the total cost savings the Employer anticipates. The Employer shall not go forward with contracting out the work in question if more than sixty percent (60%) of any projected savings resulting from the contracting out are attributable to lower employee wage and benefit costs.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Technical Feasibility of String While ICANN has encouraged and will continue to encourage universal acceptance of all top-­‐level domain strings across the Internet, certain top-­‐level domain strings may encounter difficulty in acceptance by ISPs and webhosters and/or validation by web applications. Registry Operator shall be responsible for ensuring to its satisfaction the technical feasibility of the TLD string prior to entering into this Agreement.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Development of the Project 4.1 TSP's obligations in development of the Project: a. for procuring and maintaining in full force and effect all Consents, Clearances and Permits, required in accordance with Law for development of the Project; b. for financing, constructing, owning and commissioning each of the Element of the Project for the scope of work set out in Schedule 1 of this Agreement in accordance with: i. the Electricity Act and the Rules made thereof; ii. the Grid Code; iii. the CEA Regulations applicable, and as amended from time to time, for Transmission Lines and sub-stations: • the Central Electricity Authority (Technical Standards for Connectivity to the Grid) Regulations, 2007; • Central Electricity Authority (Technical Standards for construction of Electrical Plants and Electric Lines) Regulation, 2010; • Central Electricity Authority (Grid Standard) Regulations, 2010; • Central Electricity Authority (Safety requirements for construction, operation and maintenance of Electrical Plants and Electrical Lines) Regulation, 2011; • Central Electricity Authority (Measures relating to Safety and Electricity Supply) Regulation, 2010; • Central Electricity Authority (Technical Standards for Communication System in Power System Operation) Regulations, 2020. iv. Safety/ security Guidelines laid down by the Government; v. Prudent Utility Practices, relevant Indian Standards and the Law; not later than the Scheduled COD as per Schedule 2 of this Agreement; c. for entering into a Connection Agreement with the concerned parties in accordance with the Grid Code. d. for owning the Project throughout the term of this Agreement free and clear of any encumbrances except those expressly permitted under Article 15 of this Agreement; e. to co-ordinate and liaise with concerned agencies and provide on a timely basis relevant information with regard to the specifications of the Project that may be required for interconnecting the Project with the Interconnection Facilities; f. for providing all assistance to the Arbitrators as they may require for the performance of their duties and responsibilities; g. to provide to the Nodal Agency and CEA, on a monthly basis, progress reports with regard to the Project and its execution (in accordance with prescribed form) to enable the CEA to monitor and co-ordinate the development of the Project matching with the Interconnection Facilities; h. to comply with Ministry of Power order no. 25-11/6/2018 – PG dated 02.07.2020 as well as other Guidelines issued by Govt. of India pertaining to this; i. to procure the products associated with the Transmission System as per provisions of Public Procurement (Preference to Make in India) orders issued by Ministry of Power vide orders No. 11/5/2018 - Coord. dated 28.07.2020 for transmission sector, as amended from time to time read with Department for Promotion of Industry and Internal Trade (DPIIT) orders in this regard (Procuring Entity as defined in above orders shall deemed to have included Selected Bidder and/ or TSP). Also, to comply with Department of Expenditure, Ministry of Finance vide Order (Public Procurement No 1) bearing File No. 6/18/2019- PPD dated 23.07.2020, Order (Public Procurement No 2) bearing File No. 6/18/2019-PPD dated 23.07.2020 and Order (Public Procurement No. 3) bearing File No. 6/18/2019-PPD, dated 24.07.2020, as amended from time to time, regarding public procurement from a bidder of a country, which shares land border with India; j. to submit to Nodal Agency information in the prescribed format [To be devised by Nodal Agency] for ensuring compliance to Article 4.1 i) above. k. to comply with all its obligations undertaken in this Agreement. 4.2 Roles of the Nodal Agency in implementation of the Project: 4.2.1 Subject to the terms and conditions of this Agreement, the Nodal Agency shall be the holder and administrator of this Agreement and shall inter alia: a. appoint an Independent Engineer within 90 days of the Effective Date b. provide letters of recommendation to the concerned Indian Governmental Instrumentality, as may be requested by the TSP from time to time, for obtaining the Consents, Clearances and Permits required for the Project; c. coordinate among TSP and upstream/downstream entities in respect of Interconnection Facilities; and d. monitor the implementation of the Agreement and take appropriate action for breach thereof including revocation of guarantees, cancellation of Agreement, blacklisting etc e. provide all assistance to the Arbitrators as required for the performance of their duties and responsibilities; and f. perform any other responsibility (ies) as specified in this Agreement.

  • Evaluation of Students Acknowledging the District’s adopted grading system, the teacher shall maintain the right and responsibility to determine grades and other evaluation of a student. No grade or evaluation shall be changed except by the teacher with the approval of the building administrator.

  • Completion of Concrete Pours and Emergency Work (a) Except as provided in this sub-clause an Employee shall nor work or be required to work in the rain. (b) Employees shall not be required to start a concrete pour in Inclement Weather. (c) Where a concrete pour has been commenced prior to the commencement of a period of Inclement Weather Employees may be required to complete such concrete pour to a practical stage and for such work shall be paid at the rate of double time calculated to the next hour, and in the case of wet weather shall be provided with adequate wet weather gear. (d) If an Employee’s clothes become wet as a result of working in the rain during a concrete pour the Employee shall, unless the Employee has a change of dry working clothes available, be allowed to go home without loss of pay. (e) The provisions of clauses 32.7(c) and 32.7(d) hereof shall also apply in the case of emergency work where the Employees concerned and their delegates agree that the work is of an emergency nature and can start and/or proceed.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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