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As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 11/17/22 Accustem Sciences Inc. S-1 66:33M M2 Compliance LLC/FA |
Document/Exhibit Description Pages Size
1: S-1 Registration Statement (General Form) HTML 2.16M
2: EX-1.1 Underwriting Agreement or Conflict Minerals Report HTML 517K
3: EX-4.1 Instrument Defining the Rights of Security Holders HTML 17K
10: EX-10.10 Material Contract HTML 171K
11: EX-10.11 Material Contract HTML 17K
4: EX-10.4 Material Contract HTML 25K
5: EX-10.5 Material Contract HTML 35K
6: EX-10.6 Material Contract HTML 34K
7: EX-10.7 Material Contract HTML 34K
8: EX-10.8 Material Contract HTML 23K
9: EX-10.9 Material Contract HTML 24K
12: EX-23.1 Consent of Expert or Counsel HTML 18K
13: EX-FILING FEES Calculation of Filing Fee Tables HTML 25K
19: R1 Cover HTML 57K
20: R2 Consolidated Balance Sheets HTML 106K
21: R3 Consolidated Balance Sheets (Parenthetical) HTML 36K
22: R4 Consolidated Statements of Operations and HTML 68K
Comprehensive Income (Loss)
23: R5 Consolidated Statements of Shareholders' Equity HTML 81K
24: R6 Consolidated Statements of Cash Flows HTML 97K
25: R7 Nature of Business HTML 51K
26: R8 Summary of Significant Accounting Policies HTML 76K
27: R9 Acquisition of Stemprinter Sciences Limited and HTML 34K
Equity Raise
28: R10 Note Payable HTML 27K
29: R11 Equipment HTML 28K
30: R12 License HTML 40K
31: R13 Loss Per Share HTML 68K
32: R14 Share-Based Compensation HTML 189K
33: R15 Related Party Transactions HTML 34K
34: R16 Income Taxes HTML 103K
35: R17 Commitments and Contingencies HTML 24K
36: R18 Subsequent Events HTML 27K
37: R19 Summary of Significant Accounting Policies HTML 118K
(Policies)
38: R20 Equipment (Tables) HTML 24K
39: R21 Loss Per Share (Tables) HTML 65K
40: R22 Share-Based Compensation (Tables) HTML 162K
41: R23 Income Taxes (Tables) HTML 92K
42: R24 Nature of Business (Details Narrative) HTML 71K
43: R25 Summary of Significant Accounting Policies HTML 25K
(Details Narrative)
44: R26 Acquisition of Stemprinter Sciences Limited and HTML 39K
Equity Raise (Details Narrative)
45: R27 Note Payable (Details Narrative) HTML 33K
46: R28 Schedule of Property and Equipment (Details) HTML 26K
47: R29 Equipment (Details Narrative) HTML 21K
48: R30 License (Details Narrative) HTML 27K
49: R31 Schedule of Loss Per Share (Details) HTML 46K
50: R32 Schedule of Computation of Diluted Net Loss Per HTML 25K
Share (Details)
51: R33 Schedule of Stock Option Activity (Details) HTML 75K
52: R34 Schedule of Stock Based Compensation Expenses HTML 26K
(Details)
53: R35 Schedule of Stock Valuation Assumptions (Details) HTML 44K
54: R36 Schedule of Warrants Outstanding (Details) HTML 52K
55: R37 Share-Based Compensation (Details Narrative) HTML 82K
56: R38 Related Party Transactions (Details Narrative) HTML 48K
57: R39 Schedule of Domestic and Foreign Components of HTML 30K
Loss Before Income Taxes (Details)
58: R40 Schedule of Reconciliation Provision for Income HTML 31K
Taxes (Details)
59: R41 Schedule of Deferred Income Tax Assets (Details) HTML 27K
60: R42 Income Taxes (Details Narrative) HTML 28K
61: R43 Subsequent Events (Details Narrative) HTML 41K
64: XML IDEA XML File -- Filing Summary XML 102K
62: XML XBRL Instance -- forms-1_htm XML 1.34M
63: EXCEL IDEA Workbook of Financial Reports XLSX 104K
15: EX-101.CAL Inline XBRL Taxonomy Extension Calculation XML 109K
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Linkbase Document -- acut-20220930_pre
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acut-20220930
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66: ZIP XBRL Zipped Folder -- 0001493152-22-032755-xbrl Zip 780K
Exhibit 10.10
FIRST AMENDMENT
This FIRST AMENDMENT (“First Amendment”) is dated as of November 9, 2022 (the “First Amendment Effective Date”) by and between, on one side, AccuStem Sciences Inc. (“AccuStem”) having a place of business at 5 Penn Plaza, Floor 19, New York, NY 10001 and, on the other side, Istituto Europeo di Oncologia Srl (“IEO”) having its registered office at Via Filodrammatici 10, 20121 Milan, Italy, IFOM, the AIRC Institute for Molecular Oncology ETS (“IFOM”) having its registered office at Via Adamello, 16-20139 Milano (IT), TTFactor Societa Benefit a r.l. (“TTFactor” or “TTF”) having its registered office at Via Adamello, 16-20139 Milan (Italy), and Università degli Studi di Milano having its registered office at via Festa del Perdono 7,20122 Milan (Italy) (“Università”) (collectively, “Licensors”). AccuStem and Licensors are referred to individually as a “Party” and together as the “Parties”.
BACKGROUND
WHEREAS, Tiziana Life Sciences PLC on one side and, on the other side, TTFactor Srl, on behalf of IFOM and IEO, and separately Università, entered into a license agreement dated June 24, 2014 (such agreement, as amended on 12th July 2017, the “License Agreement”);
WHEREAS, AccuStem is a Delaware company having a place of business at 5 Penn Plaza, Floor 19, New York, NY 10001;
WHEREAS, effective on June 23, 2022 AccuStem succeeded in Tiziana Life Sciences PLC’s contractual position with respect to the License Agreement and has assumed and been assigned all rights and obligations of Tiziana Life Science PLC;
WHEREAS, TTF is no longer operating on behalf of IEO. For the avoidance of doubt any reference to Licensor in the License Agreement and in this First Amendment shall be intended as referred to IEO, IFOM, TTF and Università.
WHEREAS, AccuStem has required an extension of the terms set forth in Exhibit 1 and Licensor is willing to grant such extension under the terms and conditions of this First Amendment, which furthermore includes certain clarifications with respect to the License Agreement;
NOW, THEREFORE, IN CONSIDERATION of the mutual covenants set forth in this First Amendment, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
| 1. | All terms and conditions of the Agreement not modified by this First Amendment shall continue in full force and effect in accordance with their terms. All capitalized terms not otherwise defined herein shall have the same definition as in the Agreement. |
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| 2. | Amendment to Section 1 - Definitions. | |
| 2.1 Annex 1 to this First Amendment includes the list of the Licensed Patents (including the patented Improvement generated prior to the First Amendment, as agreed upon by the Parties). No non-patented Improvements have been generated prior to the First Amendment. | ||
| 2.2 The definition of “Improvements” under Section 1.6 shall be replaced by the following: | ||
| “Improvement means any improvement, enhancement or modification of or to any technology claimed in the Licensed Patents, and or discovery concerning any development, manufacture, use or testing of any technology claimed or described in the Licensed Patents made by Licensor in the performance of the research until the First Amendment Effective Date”. | ||
| Any reference to the Licensed Patents within the Agreement shall include the patent rights covering the Improvements. | ||
| 3. | Amendment to Section 2.4 - Sharing of Information. Section 2.4 shall be replaced by the following: “Licensor will exercise reasonable efforts to share information, technology, know how directly related to the Licensed Product and Licensed Patents which is necessary or useful in enabling Licensee to practice and exploit the Licensed Patents in the Field, or which relates to the development, manufacture, use or sale of a Licensed Product in accordance with the terms of this Agreement. The information, technology or know-how that is shared pursuant to this section shall comply with all obligations and requirements of the European General Data Protection Regulation (EU 2016/679)”. | |
| 4. | Amendment to Section 3.2 - Diligence. Section 3.2 shall be replaced by the following: | |
| “Licensee will, itself or through its Affiliates or Sublicensees, at all times exercise commercially reasonable efforts to develop and commercialize one or more Licensed Products at a level of effort and resources that is consistent with the effort which a reputable company of the size and resources of Licensee would apply to a product of comparable potential at a comparable stage of development. Licensee shall use commercially reasonable efforts to achieve the milestone events set forth in Exhibit 1 within the terms identified therein for each applicable milestone event”. | ||
| 5. | Amendment to Section 5 – Sponsored Research. The following shall be added at the end of section 5: “ The Parties acknowledge and agree that the Sponsored Research (i.e. the research activities as described in the Research Plan) was completed prior to the First Amendment Effective Date and that no further obligations shall be fulfilled by the Licensors and/nor by the Licensors’ scientists under the Research Plan. |
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| 6. | Section 11.4 – Voluntary Termination. The following sentence shall be added to Section 11.4: “Licensor shall be entitled to terminate the Agreement forthwith upon written notice to Licensee in the event that Licensee fails to meet a milestone event identified in Exhibit 1 within the applicable term set forth in such Exhibit 1. Notwithstanding the foregoing, IEO agrees to reasonably extend any such milestone of 6 months (or further extension as the Parties will agree upon) provided AccuStem has been diligent in accordance with Section 3.2”. | |
| 7. | Section 12.1 – Notices. The addresses and other contact information for the Parties in Section 12.1 shall be replaced by the following: | |
| If to Licensor: | ||
| Istituto Europeo di Oncologia Srl | ||
| Att. Amministratore Delegato | ||
| Via G. Ripamonti 435, 20141 Milan (Italy) | ||
| Certified Email: direzione.amministrativaieo@legalmail.it, cc: renato.galasso@ieo.it, saverio.minucci@ieo.it, marzia.fumagalli@ieo.it, tto@ieo.it. | ||
| IFOM, the AIRC Institute for Molecular Oncology ETS | ||
| Att. Direttore Generale | ||
| Via Adamello, 16-20139 Milan (Italy) | ||
| Certified Email: ifomfondazione@pec.it, cc: luciano.baielli@ifom.eu, tto-team@ifom.eu | ||
| TTFactor Societa Benefit a r.l. | ||
| Att. Presidente | ||
| Via Adamello, 16-20139 | ||
| Certified email: ttfactor@legalmail.it, cc: tto-team@ifom.eu | ||
| Universita degli Studi di Milano | ||
| Att. Dr. Roberto Tiezzi | ||
| Direzione Innovazione e Valorizzazione delle Conoscenze | ||
| Via Fesda del Perdono 7 – 20122 Milan (Italy) | ||
| Certified Email: unimi@postecert.it, cc: tto@unimi.it | ||
| If to Accustem: | ||
| Att. Wendy Blosser | ||
| 5 Penn Plaza, Floor 19, New York, NY 10001 | ||
| Email: wendy@accustem.com, cc: ielrifi@cooley.com, jfessler@sheppardmullin.com |
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| 8. | Exhibit 1. Exhibit 1 shall be replaced in its entirety by the following : | |
| “1. Submission of an application for approval or clearance of the Licensed Product to a regulatory body in the US or another country within 36 months from the First Amendment Effective Date. | ||
| 2. Approval for commercial distribution of the Licensed Product by a regulatory body in the US or equivalent approval in another country within 60 months from the First Amendment Effective Date. | ||
| 3. First Commercial Sale of the Licensed Product within 60 months from the First Amendment Effective Date. | ||
| For the avoidance of doubt, Licensed Product referenced in sentence 1 and 2 may be a Laboratory Developed Test rather than an FDA-approved IVD test”. | ||
| 9. | Additional Payment. In consideration for the extension of the terms granted under Section 9 above, the Parties further agree that (i) AccuStem shall make a $175,000 payment (“Additional Payment”) to Licensor as set forth in (ii) below within 30 days of AccuStem having executed a financing of more than $1,000,000 in total equity or convertible security financing(s), irrespectively of such financing being disbursed to Licensee in one or several instalments; provided that AccuStem shall provide immediate written notice to Licensor upon the achievement of such condition; and (ii) a portion of the Additional Payment equal to $125,000 shall be paid to IEO as reimbursement of the costs borne by IEO in relation to the support and activities performed at data transfer to AccuStem prior to the First Amendment Effective Date, and the remaining $50,000 shall be paid in shares proportional to the share of ownership on the Licensed Patents to each of IEO, IFOM and Università. | |
| 10. | Miscellaneous. This First Amendment may be executed in counterparts, each of which shall constitute an original and all of which, when taken together, shall constitute one instrument. No modification or amendment to this First Amendment shall be effective unless in writing signed by the duly authorized representative of both parties. |
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IN WITNESS WHEREOF, the Parties hereto have caused this First Amendment to be executed by their duly authorized representatives, as set forth below.
| AccuStem Sciences Inc. | Istituto Europeo di Oncologia | |||
| By: | /s/ Wendy Blosser | By: | /s/ Mauro Melis | |
| Name: | Wendy Blosser | Name: | Mauro Melis | |
| Title: | CEO | Title: | Chief Executive Officer | |
| IFOM, the AIRC Institute | Università degli Studi di Milano | |||
| Of Molecular Oncology ETS | ||||
| By: | /s/ Luciano Baielli | By: | /s/ Elio Franzini | |
| Name: | Luciano Baielli | Name: | Elio Franzini | |
| Title: | Title: | University Rector | ||
| TTFactor Societa Benefit a r.l. | ||||
| By: | /s/ Luciano Baielli | |||
| Name: | Luciano Baielli | |||
| Title: | Consigliere Delegato | |||
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Annex 1 – Licensed Patents
Cooley Docket No. |
Title/Mark | Application No. | Application Date | Registration No. | Registration Date | Case Status | Country | Category Description | ||||||||
| ACSC-001/001WO | METHODS AND KITS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | PCT/EP2017/064937 | 6/19/2017 | Expired | Patent Cooperation Treaty | National | ||||||||||
| ACSC-001/C01US | METHODS AND KITS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17/816,210 | 7/29/2022 | Pending | United States of America | Continuation | ||||||||||
| ACSC-001/D01EP | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 6/19/2017 | Closed | European Patent Office | Divisional | |||||||||||
| ACSC-001/F01EP | METHODS AND KITS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 16175354.6 | 6/20/2016 | Abandoned | European Patent Office | National | ||||||||||
| ACSC-001/F02EP | METHODS AND KITS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 16188855.7 | 9/14/2016 | Abandoned | European Patent Office | National |
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Cooley Docket No. |
Title/Mark | Application No. | Application Date | Registration No. | Registration Date | Case Status | Country | Category Description | ||||||||
| ACSC-001/N01AT | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Austria | EP National Stage | ||||||||
| ACSC-001/N01BE | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Belgium | EP National Stage | ||||||||
| ACSC-001/N01CA | METHODS AND KITS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 3025860 | 6/19/2017 | Pending | Canada | PCT National Phase | ||||||||||
| ACSC-001/N01CH | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Switzerland | EP National Stage | ||||||||
| ACSC-001/N01DE | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Germany | EP National Stage | ||||||||
| ACSC-001/N01EP | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | EP Granted | European Patent Office | PCT National Phase |
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Cooley Docket No. |
Title/Mark | Application No. | Application Date | Registration No. | Registration Date | Case Status | Country | Category Description | ||||||||
| ACSC-001/N01ES | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Spain | EP National Stage | ||||||||
| ACSC-001/N01FI | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Finland | EP National Stage | ||||||||
| ACSC-001/N01FR | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | France | EP National Stage | ||||||||
| ACSC-001/N01GB | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | United Kingdom | EP National Stage | ||||||||
| ACSC-001/N01IT | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Italy | EP National Stage | ||||||||
| ACSC-001/N01LU | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Luxembourg | EP National Stage |
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Cooley Docket No. |
Title/Mark | Application No. | Application Date | Registration No. | Registration Date | Case Status | Country | Category Description | ||||||||
| ACSC-001/N01NL | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Netherlands | EP National Stage | ||||||||
| ACSC-001/N01NO | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Norway | EP National Stage | ||||||||
| ACSC-001/N01SE | METHODS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 17732078.5 | 6/19/2017 | 3472345 | 8/11/2021 | Registered | Sweden | EP National Stage | ||||||||
| ACSC-001/N01US | METHODS AND KITS COMPRISING GENE SIGNATURES FOR STRATIFYING BREAST CANCER PATIENTS | 16/308,564 | 6/19/2017 | 11,441,191 | 9/13/2022 | Registered | United States of America | PCT National Phase | ||||||||
| ACSC-002/001WO | METHODS AND KITS FOR DETERMINING THE RISK OF BREAST CANCER RECURRENCE | PCT/EP2021/062176 | 5/7/2021 | Published | Patent Cooperation Treaty | National | ||||||||||
| ACSC-002/F01EP | METHODS AND KITS FOR DETERMINING THE RISK OF BREAST CANCER RECURRENCE | 20173612.1 | 5/8/2020 | Abandoned | European Patent Office | National |
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Cooley Docket No. |
Title/Mark | Application No. | Application Date | Registration No. | Registration Date | Case Status | Country | Category Description | ||||||||
| ACSC-002/N01CA | METHODS AND KITS FOR DETERMINING THE RISK OF BREAST CANCER RECURRENCE | 3173152 | 5/7/2021 | Pending | Canada | PCT National Phase | ||||||||||
| ACSC-002/N01EP | METHODS AND KITS FOR DETERMINING THE RISK OF BREAST CANCER RECURRENCE | 21724660.2 | 5/7/2021 | Not yet filed | European Patent Office | PCT National Phase | ||||||||||
| ACSC-002/N01US | METHODS AND KITS FOR DETERMINING THE RISK OF BREAST CANCER RECURRENCE | 17/907,601 | 5/7/2021 | Pending | United States of America | PCT National Phase | ||||||||||
| ACSC-002/P01US | METHODS AND KITS FOR DETERMINING THE RISK OF BREAST CANCER RECURRENCE | Closed | United States of America | Provisional | ||||||||||||
| ACSC-003/P01US | METHODS FOR PREDICTING CANCER RISK | Not yet filed | United States of America | Provisional |
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| This ‘S-1’ Filing | Date | Other Filings | ||
|---|---|---|---|---|
 | ||||
| Filed on: | 11/17/22 | None on these Dates | ||
| 11/9/22 | ||||
| 6/23/22 | ||||
| 6/24/14 | ||||
| List all Filings | ||||
As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 3/22/24 Accustem Sciences Inc. 10-K 12/31/23 58:4.8M M2 Compliance LLC/FA 4/28/23 Accustem Sciences Inc. 10-K/A 12/31/22 12:482K M2 Compliance LLC/FA 2/15/23 Accustem Sciences Inc. 10-K 12/31/22 53:4.4M M2 Compliance LLC/FA 1/19/23 Accustem Sciences Inc. S-1/A 57:7M M2 Compliance LLC/FA |
As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 12/03/21 Accustem Sciences Inc. 8-K:1,2,3,512/01/21 7:813K M2 Compliance LLC/FA 3/12/21 Accustem Sciences Inc. 20FR12G 8:2.2M Donnelley … Solutions/FA |