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Neurobiological Technologies 10-K 2005 Documents found in this filing:
Exhibit 10.16
*** Text omitted and filed separately Confidential Treatment Requested under 17 C.F.R. §§200.80 (b)(4) and 240.24b-2
Project Contract for Protocol NTI 0302
This Project Contract is entered into between Neurobiological Technologies, Inc. (“NTI”) and ICON Clinical Research, L. P., (“ICON”) as of the 1st day of January 2005 (the “Effective Date”) pursuant to the Master Services Agreement between the parties dated as of the 1st day of December 2003 (the “Master Agreement”). Except as modified by this Project Contract, the terms and conditions of the Master Agreement are incorporated herein by reference and shall govern the performance of the parties’ duties under this Project Contract. Capitalized terms used herein and not otherwise defined are used as defined in the Master Agreement.
negligible cost to ICON because the licensed property is proprietary or sublicenseable by ICON, which licenses ICON hereby grants.
Attn: Heather McLaughlin Clinical Project Manager 3260 Blume Dave, Suite 500 Richmond, CA 94806 Phone: 510-262-1730 Fax: 510-262-0204 Email: heatherm@ntii.com
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All payments should be forwarded to ICON pursuant to:
ICON Clinical Research, L. P. Attn.: David Peters, Vice President of Finance P.O. Box 82-8268 Philadelphia, PA 19182-8268 Tax I.D. Number: 52-2133696
IN WITNESS WHEREOF, the parties hereto have executed this Project Contract as of the dates stated below.
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Exhibit A Proposal
Project assumptions as developed by ICON are presented in the following pages and reflect our understanding of NTI’s expectations for this study. These assumptions are the basis for the cost estimate provided and any changes in these assumptions may result in modification of the estimates provided.
Timelines
Sites/Patients
Translations
Standard Operating Procedures (SOPs)
Study Specifications
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Timelines
Study Information
System Development
Reporting
System Maintenance
Documentation
Project Management
Interactive Voice Response System (IVRS)
Reporting
Project assumptions as developed by ICON are presented in the following pages and reflect our understanding of NTI’s expectations for this study. These assumptions are the basis for the costs provided. Any changes in these assumptions may result in a modification of the costs provided.
Timelines
Sites/Patients
Standard Operating Procedures (SOPs)
ICON will assign a project team to facilitate the conduct of this study.
Project Manager
ICON proposes Tracey Metez as the Project Manager for this study. She will be allocated 2.5% to the 0302 study and will be based in the North Wales, PA office. Project responsibilities include the following:
Investigator Grants Manager
Investigator Payments Administrator
Investigator Payments Assistant
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ICOTrack/ ICONomics
Grant Administration
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ICONomics Set-Up
Completing the detailed screens found in ICONomics Set-Up is the first step in setting up the payment process for a study in ICONomics. The system stores all the study-specific details of the payment schedules, types of payments that will be made for a given study, and standard defaults for all payment information. It also stores all investigator specific information for a study. This information includes items such as: the investigator name and address, payee and tax ID number for the investigator, the required currency for the site, any percentage breakouts of payments for a site to multiple payees, and the specifically negotiated payment details for the various elements of the study that the investigator will be performing.
Once the initial set-up is completed by the Information Systems staff, the payment amount details for the investigator, patient, and visit level payments, if applicable, are entered. Basic investigator site and demographic information is imported from the study’s ICOTrack database. This data cannot be edited on ICONomics Set-Up screens. Using the study’s investigator list, additional data entry is performed in two steps. First, the standard default information for schedules and all payments are entered. Once that is complete, the specific investigator level detail based on negotiated contracts is then entered. Only those authorized to work with this level of payment detail will have edit access to these data entry screens. Once the fields are entered and proofed, they are locked. Any changes to the fields are then recorded in a full audit trail.
ICONomics Tracking
After the ICONomics Set-Up activities are completed, the information is then used to generate and track payments made throughout the course of the study. Based on the details of the study provided on the set-up questionnaire completed by the project manager, various payment triggers and details are established. Once this is done, a request for payment based on the items that need to be paid is then made. The designated member of the clinical team would then review the requested payments and approve or disapprove them as needed. Once approval has been received, the payment details for each site are generated. The payment details are then given to the Finance Department where the information is then uploaded into the ICON Financial System. Checks are then produced for the identified payees for the amounts specified from ICONomics. The ICON Financial System then produces a data file with check numbers, dates, and site information that is then downloaded into ICONomics to update all the line items that were paid, noting the check number and date on which they were paid. Once this is done, a detailed report is generated that will accompany the check to the payee. Copies of these reports and checks are then also filed appropriately in the Finance Department.
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Exhibit B
Cost and Payment Schedule
Estimates of ICON professional fees and pass-through costs for this study are presented on the following pages. These projected costs are reflective of the study assumptions presented in Exhibit B. Should the study assumptions change, or upon finalization and ICON review of the protocol and CRF, the estimates provided herein may require modification.
ICON incorporates an annual increase into its staff charge out rates to account for salary increases, cost of living increases, benefits, and competition for staff within the industry. Therefore, ICON has blended staff charge out rates across the lifetime of the study. The blending of rates has been ‘weighted’ and is in direct correlation to the timelines presented herein. If the timelines require modification this will impact the rates accordingly.
As a goodwill gesture to NTI, ICON has kept its rates at those used for 2003, with no annual increase included. This special allowance applies to studies 0302 and 0303. ICON has also included discounts for SAP creation and edit check programming and development, due to similarities between this study and NTI study 0303.
Estimated costs representing the total proposed budget for this project are presented in the table below.
Data Management (DataFax) Costs
Biostatistics Costs
IVRS Costs
Grant Administration Costs
Data Management (Data Fax) & Biostatistics Payment Schedule
IVRS Payment Schedule
50% of system development fee is payable upon signature of final agreement. The remainder is payable when the system becomes operational. If enrollment is delayed, 25% of the monthly fee will be assessed for telephone and system maintenance. If applicable, travel expenses for set-up meeting will be pass-through.
The monthly fee will be assessed until IVRS is no longer required. A minimum number of months will be billed (66% of total number of months proposed) if all patients complete early. The monthly fee includes all telecom, telephone and fax charges. No additional pass-through costs will be assessed.
The cost for Investigator Meetings’ does not include pass-through expenses such as airfare, meals, etc. Additionally, the estimated cost includes 4 hours preparation, 8 hours of travel and a one-day meeting. Each additional day = $1,000.00
Grant Administration Payment Schedule
The ICOTrack/ICONomics Set-up fee is payable upon signature of final agreement. Project Manager, Grant Administration and ICOTrack/ICONomics Maintenance fees will be invoiced monthly for actual units incurred based on the costs outlined in the Grant Administration Cost Estimate section.
Exhibit C
Transfer of Obligations
Neurobiological Technologies, Inc., as sponsor of the Protocol/Project Contract, hereby transfers responsibilities for the following obligations and ICON Clinical Research, L. P. hereby assumes such obligations, in accordance with 21 C.F.R. section 312.52.
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Exhibit D
NTI Key Personnel
Clinical Project Manager 3260 Blume Drive, Suite 500 Richmond, CA 94806 Phone: 510-262-1730 Fax: 510-262-0204 Email: heatherm@ntii.com
ICON Key Personnel
Senior Biostatistician ICON Clinical Research, L. P. 555 Twin Dolphin Road Redwood City, CA 94065 Phone: 650-620-2134 Fax: 650-559-1536 Email: arthurs@iconus.com
Senior Database Administrator ICON Clinical Research, L. P. 555 Twin Dolphin Road Redwood City, CA 94065 Phone: 650-620-2163 Fax: 650-559-1536 Email: jonesc@iconus.com
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