Exhibit 10.11
START-UP AGREEMENT
THIS START-UP AGREEMENT (this “SUA”) is made effective as of the Effective Date (defined below) by and between Pathos AI, Inc., having its principal offices at ▇▇▇ ▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (referred to as "Sponsor") and Tempus Compass, LLC with a place of business at ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇. Chicago, IL 60654, and its Affiliates (collectively referred to as "Tempus Compass").
Sponsor desires to retain Tempus Compass to provide the services described in the Budget Proposal dated 21May2024 ("Services") attached hereto as Exhibit A, in support of the Protocol No. entitled, “A Phase 1b/2a, Multicenter, Open-Label Study of Pocenbrodib as Monotherapy and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)” ("Study").
Sponsor hereby authorizes Tempus Compass to proceed with tasks associated with the preparation and initiation of the Study, notwithstanding the fact that a formal agreement has not yet been executed by the parties.
1.Commencement of Services and Term
1.1Upon signature of this SUA by both parties, Tempus Compass will proceed with the initial Services required for conduct of the Study, provided, however, no Study product will be shipped or already on site, and no subjects screened or dosed during the term of this SUA. The parties recognize that this SUA is necessary to commence the Study within the proposed timelines; provided, however, Sponsor and Tempus Compass agree that a signed definitive agreement is necessary to proceed with the Study beyond the initial preparation and initiation services. The parties will negotiate in good faith to execute a definitive agreement relating to the Services no later than ninety (90) days from the Effective Date as may be extended by the mutual agreement of the parties (the "Negotiation Period"). For the Purposes of this SUA, “Effective Date” means the date upon which the board of directors of Tempus AI, Inc. (Affiliate and parent company of Tempus Compass, LLC) approves the transaction memorialized in this SUA.
2.1In the event that a definitive agreement for the Study is not executed prior to the conclusion of the Negotiation Period, this SUA shall continue in effect unless terminated in accordance with this Section 2.1. Either party may terminate this SUA at any time during the Negotiation Period with written notice to the other party. This SUA may be terminated or expire as described above without either party incurring any further liability to the other party except as described below. At the expiration or termination of this SUA, any regulatory obligations assumed by Tempus Compass are immediately transferred back to Sponsor.
3.1Upon the execution of this SUA, Sponsor will advance funding (“SUA Funds”) to Tempus Compass in the amount of $1,709,326 for application to Tempus Compass direct professional Service fees (excluding VAT or applicable taxes).
3.2In the event Tempus Compass earns fees in excess of the SUA Funds, Sponsor will be invoiced for the Services performed by Tempus Compass in accordance with Exhibit A. Invoices will be prepared monthly with payment due thirty (30) days from the receipt of the invoice. Expenses incurred during the Negotiation Period will be invoiced to Sponsor monthly as incurred with payment due thirty (30) days from the receipt of the invoice. Any amounts paid under this SUA shall be applied to the definitive agreement. Even in the event a definitive agreement is not executed or this SUA is terminated by either party, Sponsor shall compensate Tempus Compass for all Services performed and expenses incurred.
3.3If any SUA Funds are unused at the time of the execution of the subsequent definitive agreement, the remaining SUA Funds will be applied to the amounts required under the definitive agreement.
3.4In the event a definitive agreement is not executed or this SUA is terminated prior to the conclusion of the Negotiation Period, any remaining SUA Funds balance will be credited to Sponsor within thirty (30) days following the completion of a final reconciliation of all Services and expenses. Sponsor may audit the expense documentation at any time following the execution of the SUA and up to one (1) year following completion of the Services performed by Tempus Compass.
3.5All invoices shall be paid by wire transfer or ACH in accordance with the instructions provided by Tempus Compass. Sponsor waives its right to dispute such invoice(s) on such account. If a dispute arises between the Parties in respect of any part of an invoice, Sponsor must pay all undisputed portions of the invoice within the stipulated invoice period.
4.1Sponsor will defend, indemnify, save and hold harmless Tempus Compass and its directors, officers, employees, and agents from and against any third party claims, demands, suits, actions, causes of action, losses, damages, fines and liabilities, including reasonable attorneys' fees to the extent that they arise out of or in connection with or attributable to the performance of the Services, except any claim to the extent that it is determined to have resulted from the negligence or intentional misconduct on the part of Tempus Compass or its employees.
5.1During the term of the Study and for at least one (1) year thereafter, Sponsor will maintain product liability insurance underwritten by a reputable insurer which: (i) is appropriate for the Study; (ii) does not contain exclusions that would preclude claims by participating Study participants which arise from the Study in relation to the test materials where the Study participant has reasonably complied with the Protocol; and
(iii) provides coverage for claims relating to the test materials or Study in amounts required by applicable law and sufficient to cover claims of Study participants engaged in the Study. If Tempus Compass requests in writing, Sponsor will produce a certificate of insurance for inspection.
6.1"Confidential Information", means all proprietary and confidential information provided orally, in writing, or as observed on visits to facilities and which relate to new or existing products and/or business operations, including, without limitation, study protocols, product development plans, standard operating procedures, pricing information, business methods, trade secrets, business processes, business plans, inventions, techniques, information provided by third parties (including pricing by third party providers) or other third party information provided to disclosing party under an obligation of confidentiality, and other information not readily available to the public relating to the disclosing party including discussions regarding subject matter of potential future services. To the extent practical, Confidential Information shall be disclosed in documentary or tangible form and marked "Confidential" or "Proprietary". In the case of disclosures in non-documentary form, made orally or by visual inspection, the disclosing party shall confirm in writing the fact and general nature of each such disclosure within thirty (30) days after it is made. Notwithstanding the foregoing, it is agreed that failure to mark documents or reduce oral disclosures to writing shall not alleviate the receiving party of its obligations under this SUA if the disclosed information would reasonably be considered confidential based upon the nature of the information or the circumstances surrounding its disclosure.
6.2The parties will exchange Confidential Information during the term of this SUA which is not available to the public and each party (a) will use the same level of efforts it uses to maintain its own Confidential Information in confidence, but no less than a reasonable degree of care, and (b) will not use or disclose such Confidential Information to any third parties, except disclosures to the receiving party's employees, agents and representatives or to third parties whose services are required for the performance of this SUA.
6.3Each party must employ reasonable and appropriate procedures to prevent unauthorized publication or disclosure of Confidential Information, except to the extent that it may be required by applicable law to disclose the information.
6.4If it is reasonably necessary for a receiving party to disclose the disclosing party's Confidential Information to a third party in order to perform under this SUA, the receiving party will obtain written approval from the disclosing party for the third party disclosure, and will obtain a written agreement limiting the disclosure by and use of the Confidential Information by the third party.
6.5If the disclosing party so requests in writing, the receiving party will, at the option and expense of the disclosing party, return or destroy the Confidential Information, except that in any event the receiving party may retain a single copy of the Confidential Information and related materials in its archives for the purposes of demonstrating or ensuring its compliance with this SUA or applicable law, provided that such archival copy will remain subject to the restrictions of this SUA.
6.6The confidentiality provisions contained in this SUA continue to have effect for five (5) years after the expiry or other termination of the remainder of this SUA.
6.7The confidential provisions of this Section 6 do not apply to any part of the Confidential Information which (a) is known to the receiving party at the time it was obtained from the disclosing party, (b) is acquired by the receiving party from a third party that did not obtain such information directly or indirectly from the disclosing party while under an obligation not to disclose it, (c) is or becomes published or otherwise enters the public domain other than by violation of this SUA by the receiving party, (d) is independently developed by or for the receiving party without reference to or reliance upon the information provided by the disclosing party, (e) is required to be disclosed by the receiving party to comply with applicable law, provided that the receiving party provides prompt written notice of such disclosure to the disclosing party and cooperates with the disclosing party's reasonable and lawful actions to avoid and/or minimize the extent of such disclosure, or (f) is used or disclosed with the written consent of the disclosing party.
7.1Except for the work product that is the proprietary property of Tempus Compass, all work, information, data and materials provided by Sponsor to Tempus Compass or generated hereunder shall remain the exclusive proprietary property of Sponsor. To the extent necessary for Sponsor to achieve its objectives under the Study and reap the benefit of this SUA, Tempus Compass hereby provides Sponsor a perpetual, irrevocable, and royalty-free license to the proprietary property of Tempus Compass, LLC that may be embedded in the proprietary property of Sponsor.
8.1This SUA will in all events and for all purposes be governed by and construed in accordance with the law of Illinois, except in the case of a conflict of laws provision which would apply the law of another jurisdiction.
9.Acknowledgment of Competitive Bidding. The Parties acknowledge and agree that the pricing for Services set forth under this Agreement were the result of a competitive bidding process and good faith negotiation. No additional inducement was offered, discussed, or agreed to by the Parties other than the discounts resulting from the competitive bidding process and good faith negotiation.
10.1This SUA may be executed in two (2) or more counterparts, which taken together will constitute a single legal document. This SUA may be executed by electronic signatures and such signatures will be deemed to bind each party as if they were originals.
[Signature page to follow]
IN WITNESS WHEREOF, authorized representatives of the parties have executed this SUA as of the Effective Date first written above.
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PATHOS AI, INC |
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Tempus Compass, LLC |
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BY: TEMPUS AI, INC. |
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ITS MANAGING MEMBER |
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By: |
/s/ ▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇ |
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By: |
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Name: |
▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇ |
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Name: |
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Title: |
chief operating officer |
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Title: |
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Exhibit A
Schedule of Services*/Estimated Budget
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Unit Number |
Unit Name |
Unit Basis |
SUA # of Units |
SUA Direct Unit Cost |
SUA Total Directs |
1 |
REGULATORY AFFAIRS & INVESTIGATOR SERVICES |
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$63,573 |
1.02 |
RegOps Management & Oversight Through Last Site Activated |
month |
3 |
$8,080.00 |
$24,240 |
1.11 |
Site Identification and Feasibility |
site identified |
15 |
$1,204.00 |
$18,060 |
1.12 |
Master ICF Development |
master ICF |
1 |
$2,320.00 |
$2,320 |
1.14 |
Collection and Review of Essential Documents |
site |
2 |
$2,527.50 |
$5,055 |
1.16 |
Initial IRB/EC Submissions |
site |
2 |
$1,767.00 |
$3,534 |
1.18 |
eTMF Set-up |
study |
1 |
$3,496.25 |
$3,496 |
1.25 |
Site Contract and Budget Management |
site |
2 |
$3,434.00 |
$6,868 |
2 |
PROJECT MANAGEMENT |
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$116,534 |
2.02 |
Project Management Plan - Initial |
plan |
1 |
$3,446.00 |
$3,446 |
2.04 |
Project Management: Start-Up Period Period |
month |
3 |
$37,696.00 |
$113,088 |
3 |
STUDY MEETINGS AND TRAINING |
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$95,430 |
3.02 |
Study Kick-off Meeting - Face-to-Face |
meeting |
1 |
$26,264.00 |
$26,264 |
3.03 |
CRA Training Meeting - Teleconference |
meeting |
1 |
$6,048.00 |
$6,048 |
3.04 |
Sponsor Teleconferences: Start-Up Period |
meeting |
12 |
$1,821.00 |
$21,852 |
3.12 |
Internal Team Teleconferences: Start-Up Period |
meeting |
12 |
$1,547.00 |
$18,564 |
3.16 |
CRA Team Meetings: Start-Up Period & Phase 1b Dose Escalation |
meeting |
3 |
$1,506.00 |
$4,518 |
3.23 |
Initial Team Member Training |
training |
1 |
$18,184.00 |
$18,184 |
4 |
CLINICAL OPERATIONS & MONITORING |
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$46,745 |
4.02 |
Clinical Team Lead: Start-Up Period Period |
month |
3 |
$11,844.00 |
$35,532 |
4.11 |
Risk Based Monitoring Plan Development |
version |
1 |
$1,605.00 |
$1,605 |
4.20 |
Trial Portal - Set Up |
study |
1 |
$5,400.00 |
$5,400 |
4.25 |
Site Evaluation Visits - Phone |
visit |
4 |
$1,052.00 |
$4,208 |
5 |
DATA MANAGEMENT & BIOMETRICS OVERSIGHT |
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$310,830 |
5.01 |
Develop and Review Data Collection Forms (mock CRF) |
development form |
50 |
$347.75 |
$17,388 |
5.02 |
Develop and Review Data Validation Specifications |
edit check / manual listing |
600 |
$60.25 |
$36,150 |
5.03 |
Develop and QC EDC Database (form) |
development form |
50 |
$345.00 |
$17,250 |
5.04 |
Program and Test Edit Checks |
edit check |
600 |
$57.50 |
$34,500 |
5.05 |
Program and Test Custom Functions |
per Custom Function |
45 |
$862.50 |
$38,813 |
5.06 |
Program and Test Manual Listings |
manual listing |
25 |
$4,177.00 |
$104,425 |
5.07 |
Program and Test Custom Reports |
Report |
2 |
$10,563.00 |
$21,126 |
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Unit Number |
Unit Name |
Unit Basis |
SUA # of Units |
SUA Direct Unit Cost |
SUA Total Directs |
5.09 |
Prepare and Review CRF Completion Guidelines |
development form |
50 |
$120.50 |
$6,025 |
5.10 |
Prepare and Review Annotated CRF |
development form |
50 |
$241.00 |
$12,050 |
5.11 |
Develop and Review Data Management Plan |
document |
1 |
$4,820.00 |
$4,820 |
5.12 |
Integrated Data Review Plan (IDRP) Development |
plan |
1 |
$2,378.00 |
$2,378 |
5.13 |
EDC UAT |
development form |
50 |
$180.75 |
$9,038 |
5.14 |
Setup Coding Dictionary |
dictionary |
2 |
$3,434.25 |
$6,869 |
6 |
BIOSTATISTICS |
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$16,360 |
6.01 |
Sponsor TCs – Start Up Biostatistics |
Per month |
3 |
$378.79 |
$1,136 |
6.06 |
Internal Team TCs – Start Up Biostatistics |
Per month |
3 |
$419.74 |
$1,259 |
6.11 |
Study Training – Biostatistics Team |
Per hour |
6 |
$381.58 |
$2,289 |
6.14 |
Data Cleaning Plan |
Per Plan |
1 |
$2,275.52 |
$2,276 |
6.15 |
Data Cleaning Programming |
Per initial program |
1 |
$6,887.05 |
$6,887 |
6.17 |
Biostatistical Project Management |
Per month |
3 |
$837.61 |
$2,513 |
7 |
PHARMACOVIGILANCE |
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$16,418 |
7.01 |
Pharmacovigilance Set-Up |
project |
1 |
$6,037.00 |
$6,037 |
7.03 |
Safety Database Set-up |
project |
1 |
$2,236.00 |
$2,236 |
7.19 |
Pharmacovigilance Lead |
months |
3 |
$2,715.00 |
$8,145 |
9 |
GRANT MANAGEMENT |
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$8,100 |
9.01 |
Payment Set Up per Site |
site |
2 |
$1,500.00 |
$3,000 |
9.02 |
Payment Management & Oversight |
month |
3 |
$1,700.00 |
$5,100 |
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Total Direct Fees |
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$673,991 |
Total Pass-Through and Medidata EDC Total Investigator Grants |
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$110,844 $924,491 |
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Total Budget |
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$1,709,326 |
*Additional Services may be rendered by agreement of the Parties.