AUTHORIZATION TO PROCEED WITH: PROTOCOL CL05-001
Exhibit 10.2
AUTHORIZATION TO PROCEED WITH: PROTOCOL CL05-001
This Authorization to Proceed Agreement (“Agreement”) is between Advanced Life Sciences, Inc., an Illinois corporation located at 0000 Xxxxx Xxxx, Xxxxxxxxx, XX 00000 (“Customer”) and Quintiles, Inc. located at 0000 Xxxxx Xxxxx Xxxx, Xxxxxxxxxxx, XX 00000(“Quintiles”). The parties agree that, while the parties are attempting to negotiate a comprehensive agreement regarding the above-referenced project (the “Project”), Quintiles shall commence, or continue performing, the following activities relating to the Project (the “Services”):
Start-up Planning, Initial Clinical and Project Management
Case Report Form design and printing
Regulatory Document Review and Approval
Site Selection/Initiation Visits
Investigator Contract Negotiations and Advanced Payments
Biostatistics review of randomization
Enroll Subjects
Shipment of Study Drugs
The Services will be carried out pursuant to the terms and conditions of the Master Services Agreement dated November 21, 2005 between Customer and Quintiles, which are incorporated by reference herein. Customer shall pay Quintiles at Quintiles’ Standard Daily Rates (a copy of which is attached hereto) for Quintiles’ actual time expended on the Services and shall reimburse Quintiles for all costs and expenses Quintiles reasonably incurs in performing the Services, within thirty days of receipt of an itemized invoice. Quintiles’ costs and expenses will be supported by a summary sheet. If the parties enter into a Work Order regarding the Project, all monies paid under this Agreement will be applied toward, and reconciled with, the payments specified in the Work Order. Quintiles may provide such additional preliminary Services as Customer may request and Quintiles may agree in writing to perform. Normally, Quintiles would not perform such activities as executing investigator agreements, shipping drugs, or enrolling or monitoring patients without a fully executed work order; however, in light of the unique circumstances pertaining to this Project, Quintiles will proceed with these activities upon execution of this Authorization to Proceed. All regulatory obligations shall remain Customer’s responsibility. Customer may terminate this Agreement upon thirty days’ written notice for any reason. Quintiles may terminate this Agreement upon thirty days’ written notice if: a) Customer breaches this Agreement; b) a final Work Order is not executed within four months of the date of this Agreement; or, c) the Services performed under this Agreement exceed $600,000 in total fees and costs without execution of a final Work Order.
Upon execution of this Agreement, Customer agrees to pay Quintiles an advance of $90,000, which shall be credited to Customer on the final invoice. If this Agreement is terminated prior to execution of a final Work Order, then any unearned portion of this advance will be refunded, less a thirty-percent retention to offset the costs of reallocating project staff. If any additional money is due under the terms of this Agreement, Customer shall pay Quintiles the money owed within thirty days of receipt of an itemized invoice.
ACCEPTED AND AGREED TO AS OF THE DATE LAST SIGNED BELOW:
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Quintiles, Inc. |
Advanced Life Sciences, Inc. |
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By: |
/s/ Xxxxx Xxxxxx |
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By: |
/s/ Xxxxxxx X. Xxxxxx |
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(signature) |
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(signature) |
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Print Name: |
Xxxxx X. Xxxxxx |
Print Name: Xxxxxxx X. Xxxxxx, Ph.D. |
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Title: |
Vice President |
Title: Chief Executive Officer |
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Date: November 17, 2005 |
Date: November 21, 2005 |
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Date: |
Date: |
0000 Xxxxxxxxx Xxxxxxxx CRO Services Group Standard Rate Schedule
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Category |
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2005 |
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2005 |
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Executive Medical & Technical Consultation, Senior Statistical Consultation |
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366 |
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2,928 |
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Executive Project Management, Senior Regulatory, Senior Medical, Senior Management, Medical Mgmt & Monitoring |
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296 |
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2,368 |
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|
|
|
|
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Safety Review/Analysis |
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266 |
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2,128 |
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|
|
|
|
|
|
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Senior Project Management, Statistical Design, Senior Statistical Planning and Analysis, Quality Assurance, Senior Scientists, Regulatory Consultation, Senior Management |
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236 |
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1,888 |
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Management, Scientist |
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196 |
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1,568 |
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|
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Project Management, Monitoring Management, Site Selection, Statistical Interpretation, Senior Statistical Analysis, Regulatory Support |
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168 |
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1,344 |
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Senior Clinical Monitoring, Statistical Analysis, Statistical and Medical Writing , Regulatory Documentation Preparation |
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142 |
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1,136 |
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Clinical Monitoring, In-house Monitoring, Statistical Programming, Technical Writing, Biostatistics Quality Control, Data Management, Medical Coding |
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116 |
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928 |
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Data Support |
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102 |
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816 |
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Clinical Services Support, Medical Writing Support |
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85 |
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680 |
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IVRS Support |
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78 |
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624 |
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Data Processing, Administrative Support |
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64 |
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512 |
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Call Center Support |
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59 |
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472 |
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Confidential
Executive Consulting rates may exceed those listed above.
Billing rates are subject to change on January 1 of each calendar year, and the new rates will apply thereafter.
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