Key Assumptions. Number of patients to be screened 300 400 Number of patients to be randomised 150 150 Number of patients randomised during interim analysis 30 Sites 5 sites 8 Sites Number of monitoring visits (180 patients) Estimated pool of 56 monitoring site visits Total CRF pages per patient TBC Change order no 1 Kitov/ Java MSA ACTIVITY RATE UNIT EST. REQ. ESTIMATED CHARGE Comments € Range Range € Project Preparation PM project training 110.00 hour 16 1,760.00 To include protocol, CRF and SOP training CRA project training 85.00 hour 16 1,360.00 To include protocol, CRF and SOP training PM project preparation time 1,760.00 week 22 38,720.00 Includes site contacts/feasibility assessments to ensure all required systems are in place for study initiation, assistance with eCRF development to include advice on required CRF data fields, communication with Kitov Ltd on project related progress/issue PM Feasibility & Preparation UK sites 880.00 day 12 10,560.00 Site & laboratory feasibility and selection activities including budget and contract negotiations CRA project preparation time 1,360.00 week 14 19,040.00 Includes site contacts/feasibility, communication with Kitov Ltd, collating all study related materials required for initiation, addressing site queries and issues, preparation/customisation of Investigator Study Files and Forms, collection of essential d CRA project preparation time 2,040.00 site 3 6,120.00 additional 3 sites CTA project preparation time 400.00 week 18 7,200.00 Preparation total 84,760.00 Regulatory and Ethics Review and submission of CTA to IMB (including submission of responses to any queries raised during review period) 3,840.00 submission 1 3,840.00 Review and submission of CTA to MHRA (including submission of responses to any queries raised during review period) 3,840.00 submission 1 3,840.00 Submission of Substantial Amendment to MHRA 120.00 hour 38 4,560.00 12 hours Amen1: 8 hours Axxxx 2 ; 16 hours Amen 3 :12 hours amendment 4 Submission to National Ethics Committee in Northern Ireland (including submission of responses to any queries raised during review period) 2,040.00 submission 1 2,040.00 Submission to National Ethics Committee in Northern Ireland (including submission of responses to any queries 2,720.00 submission 1 2,720.00 Preparation and submission of substantial amendments to National Ethics Committee in Northern Ireland 880.00 submission 12 10,560.00 Preparation and submission of non substantial amendments to National Ethics Committ...
Key Assumptions. The Cordexa Responsibilities and Charges within this Transaction Document are based on the Key Assumptions below:
Key Assumptions. This description of Services and WildCard's pricing to perform the Services are based on the following key assumptions. Deviation from these assumptions may require an adjustment to price, the solution architectural description, the proposed implementation plan, the service standards, and the description of Services. -------------------------------------------------------------------------------- Program Name UGT Card -------------------------------------------------------------------------------- Program Anticipated Live Date June 2003 -------------------------------------------------------------------------------- Initial Card Stock Order -------------------------------------------------------------------------------- Card/Account Branding Novus/Discover on the back of Cards -------------------------------------------------------------------------------- Card/Account Type - Some are Non-Reloadable, Others are Reloadble -------------------------------------------------------------------------------- Card/Virtual Account Acceptance Only Authorized as Select Merchants -------------------------------------------------------------------------------- Card Fulfillment TBD - Oberthur will Manufacture Cards -------------------------------------------------------------------------------- PIN Notification Method. No PIN -------------------------------------------------------------------------------- Card Account Design Physical, Custom Cards -------------------------------------------------------------------------------- Card Accounts Issued During Year One 250,000 -------------------------------------------------------------------------------- Card Accounts Issued During Year Two 500,000 -------------------------------------------------------------------------------- Card Accounts Issued During Year Three 1,000,000 -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- Card Account Ordering Method Written Request to WildCard -------------------------------------------------------------------------------- Value Load Frequency One or Two Times as Configured -------------------------------------------------------------------------------- Value Load Source EFT from Client -------------------------------------------------------------------------------- Value Load Method Pre-Determined by Client ----------------------------------------------------------------------...
Key Assumptions. The following are key assumptions on which the Fees in this Schedule are based: Data Center • Pricing assumes software listed in Attachment L to the Agreement. Additional software requirements will incur additional charges if discovered after the Effective Date. • ACS will be allowed to install and execute SOFT AUDIT to validate software inventory. • Symetra will retain responsibility for copying Symetra Data at the Xxxxxxx data center from both physical tape and the VSM to ACS VTS and physical drives temporarily installed at the RDC for migration purposes. • Safeco ACF2 security database with Symetra Data will be provided to ACS for migration purposes. • ACS will be allowed to use full system lift methodology to perform the transition from the Safeco data center to the ACS data center. • Channel and DASD requirements for migration purposes at Safeco data center are retained expenses. • Assumes Symetra data will be segregated by DASD volumes to support full volume dumps. • Safeco and Symetra will provide necessary IT configuration and architectural information in ACS-requested format required to establish the new Symetra IT Mod 04 Confidential Information Table of Contents Symetra Life Insurance Company (Symetra) Schedule 3—Fees infrastructure, thus simplifying configuration of new enterprise equipment and environment. • Pricing for hot site includes 300 MIPS, 1.2GB DASD, one hundred twenty (120) shared servers, one (1) email retention server, disaster recovery analyst travel and seventy-two (72) hours annual test time. • Processor utilization is defined as physical machine utilization taken from the SMF type-70 records as reported by IBM’s “RMF CPU Summary Report”. SMF records are recorded on a fifteen (15)-minute interval (ninety-six (96) intervals each day) and report the average processor utilization during the interval. • Baseline configuration is defined as an IBM Z890 system configured for 410 MIPS offered capacity. [***] Dollars ($[***]) monthly fee for twelve (12) months post transition that will serve as ‘term insurance’ for capability to increase to 489 MIPS with option to renew term insurance annually. Upon direction by Symetra to discontinue the 489 MIP option, ACS will reduce recurring xxxxxxxx by [***] Dollars ($[***]) per month. • To increase mainframe capacity to a 489 MIP Mainframe processor, a High-Utilization-Week is defined as five (5) consecutive non-holiday weekdays (Monday through Friday) with average CPU utilization of seventy perc...
Key Assumptions. The 51st State Responsibilities and Charges within this Transaction Document are based on the Key Assumptions below:
Key Assumptions. IBM's estimates to perform the Statement of Work, are based on the following key assumptions. Deviations that arise during the proposed project will be managed through the procedure described in the Project Change Control Procedure section of the Procedures Manual.
Key Assumptions. As of the Effective Date, the following items shall be deemed Key Assumptions which were used to prepare the initial Development Plan, the Regulatory Plan and the Commercialization Plan and associated Payment Schedule agreed upon by the Parties: • The budget and associated Payment Schedule are estimates based on activities that are currently planned in the long term for support clinical trials has been provided and are subject to change based on the assumptions listed below and may be modified in the future as the scope of the project becomes more fully defined. Abbott and Epizyme will agree upon modification of the scope and budget of long-term activities according to the terms of this agreement. Overall Program Assumptions Included in Current Proposal Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of three pages were omitted. [**]. EXHIBIT C REGULATORY PLAN Epizyme and Abbott will actively cooperate in the regulatory process for the development and global regulatory registration of the Diagnostic Test. The regulatory process includes the development of regulatory strategy, the sharing of regulatory information and data and the submission and liaison with global Regulatory Authorities. Abbott will serve as the formal sponsor of any submissions to global Regulatory Authorities that pertain to the Diagnostic Test, and therefore will be ultimately responsible for the submission of such required documentation per the jointly agreed timelines; provided, however, that the preparation, including strategy, for such submissions will be done in cooperation and consultation with Epizyme and Epizyme shall have the right to attend and participate in all meetings between Abbott and Regulatory Authorities relating to the co-development of the Diagnostic Test. Activities included in the regulatory process that are subject to this regulatory plan include the following: • Routine interactions of Abbott and Epizyme regulatory representatives to share regulatory information relevant to the agreed strategy for development and registration of the Diagnostic Test. • Abbott will inform Epizyme about any inspections from Regulatory Authorities related to the Diagnostic Test and will provide reports of any findings to Epizyme. • [**]. • [**]. • [**]. • Epizyme and Abbott will jointly develop a timeline and priority list for regulatory submissions. The timeline will include submission dates and anticipated approval dates for...
Key Assumptions. 1. Client will manage all communications with investors upon introduction by Consultant or regarding any investment in the Company, with Consultant assisting as requested with marketing and public relations guidance.
Key Assumptions. This Statement of Work, and IBM's estimates to perform the Statement of Work, are based on the following key assumptions. Deviations that arise during the proposed project will be managed through the procedure described in "Appendix B. Project Change Control Procedure". IBM will provide and staff an IBM Project Office for SSP/OASiS, which may be remote to SSP/OASiS and the TouchPort "installed at" locations. The IBM Project Office will manage pre- and post-implementation issues including after installation end user support (help desk) problem escalations concerning the availability (uptime) of each TouchPort. IBM will provide Level 1 & 2 End User Support Services (help desk), 24hr x7 day coverage, via IBM provided toll free call-in number. End User Support staffing will be matched to call volumes. All Level 3 problems will be escalated to the SSP/OASiS support staff in Sarasota, FL. IBM will provide "hot swap" depot hardware replacement and repair services after installation, at any TouchPort "installed at" location covered by this agreement and serviced next day by UPS, Federal Express or Airborne with coverage to be next business day. IBM will provide an on-site technician to perform the swap out. "Installed at" locations not serviced by these express delivery service providers will be serviced by IBM on a best efforts basis. IBM's target objective, for covered devices, for repair or replacement of a failed TouchPort, TouchPort peripheral, data network cabling, or network related hardware is 72 hrs or less. IBM will xxxx SSP/OASiS a monthly service charge (MSC) for the above described support services according to Scenarios "A", "B", and "C" schedule of charges included and made part of this Statement of Work.
Key Assumptions. The financial market assessment will depend on key assumptions derived from industry feedback and typical reefer truck operating procedures. These assumptions will be used to evaluate the economics of this technology and to determine the potential market penetration.
