Amendment Number 2 to Patent License Agreement -Exclusive Evaluation Option License dated November 17, 2023 between National Institute of Health and Curative Biotechnology, Inc. (f/k/a Connectyx Technologies Holdings Group)
Exhibit 10.32
CONFIDENTIAL -NIH
Second Amendment of L-009-2021-0 Final Curative Biotechnology November 17, 2023
Model 10-2015 Page 1 of 10
PUBLIC HEALTH SERVICE
Amendment
This Agreement is based on the model Amendment Agreement adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of the PHS within the Department of Health and Human Services (“HHS”).
This Cover Page identifies the Parties to this Agreement:
The US Department of Health and Human Services, as represented by National Cancer Institute an Institute or Center (hereinafter referred to as the “IC”) of the NCI and Curative Biotechnology hereinafter referred to as the “Licensee”, having offices at 1825 NW Corporate Boulevard, Suite 110, Boco Raton, FL 33431, created and operating under the laws of Florida.
Tax ID No.: 26-1412177
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Second Amendment of L-009-2021-0 Final Curative Biotechnology November 17, 2023
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SECOND AMENDMENT TO L-009-2021-0
This is the second amendment (“Second Amendment”) of the agreement by and between the IC and Licensee having an effective date of October 15, 2020 and having IC Reference Number L-009-2021-0, and as amended under IC Reference Number L-009-2021-1 with an effective date of October 15, 2022 (collectively, the “Agreement”). This Second Amendment, having IC Reference Number L-009-2021-2 includes, in addition to the amendments made below, 1) a Signature Page, 2) Attachment 1 (Royalty Payment Information), 3) Attachment 2 (New Appendix D: Benchmarks and Performance), 4) Attachment 3 (New Appendix E: Commercial Evaluation Plan).
WHEREAS, the IC and the Licensee desire that the Agreement be amended a second time as set forth below in order to “extend the Agreement by an additional one (1) year and update the related Benchmarks, Performance, and Evaluation Plan for the additional time.”
NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein, the IC and the Licensee, intending to be bound, hereby mutually agree to the following:
1) Appendix D of the Agreement is hereby deleted in its entirety and replaced with the new Appendix D attached herein as Attachment 2. The parties acknowledge that the first two Benchmarks in Attachment 2 have been completed by Licensee as of the execution date of this Second Amendment.
2) Appendix E of the Agreement is hereby deleted in its entirety and replaced with the new Appendix E attached herein as Attachment 3.
3) Paragraph 13.1 of the Agreement is hereby deleted in its entirety and replaced with the following: This Agreement shall become effective as of the Effective Date unless the provisions of Paragraph 14.14 are not fulfilled and shall expire four (4) years from its Effective Date. Within sixty (60) days of the termination or expiration of this Agreement, unless an IC Exclusive or Non-exclusive Commercial Patent License has been executed for the Licensed Patent Rights in the Licensed Field(s) of Use, as stipulated in Paragraph 3.3 of this Agreement, the Licensee shall return all Materials and Licensed Products to the IC or provide the IC with written certification of their destruction. The Licensee further agrees that it shall be responsible for the destruction of any remaining Materials and Licensed Products from the Third Party Contractor(s) to the Licensee, and the Licensee shall obtain written certification from the Third Party Contractor(s) that any remaining Materials or Licensed Products in their possession have been destroyed and to provide IC with a copy of said written notification within sixty (60) days of the termination or expiration of this Agreement.
4) Within sixty (60) days of the execution of this Second Amendment, the Licensee shall pay the IC the noncreditable, non-refundable patent reimbursement royalty of five thousand US Dollars ($5,000.00) as referenced in the prior Agreement, and payment options may be found in Attachment 2.
5) In the event any provision(s) of the Agreement is/are inconsistent with Attachment 1 and/or 2, such provision(s) is/are hereby amended to the extent required to avoid such inconsistency and to give effect to the shipping and payment information in such Attachment 1 and/or 2.
6) All terms and conditions of the Agreement not herein amended remain binding and in effect.
7) The terms and conditions of this Second Amendment shall, at the IC’s sole option, be considered by the IC to be withdrawn from the Licensee’s consideration and the terms and conditions of this Second Amendment, and the Second Amendment itself, to be null and void, unless this Second Amendment is executed by the Licensee and a fully executed original is received by the IC within sixty (60) days from the date of the IC’s signature found at the Signature Page.
8) This Second Amendment is effective on October 15, 2023 upon execution by all parties.
SIGNATURES BEGIN ON NEXT PAGE
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Second Amendment of L-009-2021-0 Final Curative Biotechnology November 17, 2023
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SECOND AMENDMENT TO L-009-2021/0
SIGNATURE PAGE
In Witness Whereof, the parties have executed this Second Amendment on the dates set forth below. Any communication or notice to be given shall be forwarded to the respective addresses listed below. For the IC:
| Richard U. Rodriguez, MBA | |
| Date | |
| Associate Director |
Technology Transfer Center
National Cancer Institute
National Institutes of Health
Address for Agreement notices and reports:
E-mail: ***@*** (preferred)
Mail: License Compliance and Administration
Monitoring & Enforcement
Office of Technology Transfer
National Institutes of Health
6701 Rockledge Drive, Suite 700, MS 7788
Bethesda, Maryland 20892 U.S.A.
(For courier deliveries please check https://www.ott.nih.gov/licensing/license-noticesreports)
11-30-2023
Richard U.
Rodriguez -S
Digitally signed by
Richard U. Rodriguez -S
Date: 2023.11.30
15:11:18 -05’00’
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For the Licensee (Upon information and belief, the undersigned expressly certifies or affirms that the contents of any statements of the Licensee made or referred to in this document are truthful and accurate.):
__________________________________________ __________________
Signature of Authorized Official Date
Paul Michaels
Printed Name
Chief Executive Officer
Title
I. Official and Mailing Address for Agreement notices:
Paul Michaels
Name
Chief Executive Officer
Title
Mailing Address
Curative Biotechnology
1825 NW Corporate Boulevard, Suite 110
Boca Raton, FL 33431
Email Address: ***@***
Phone: 561 ###-###-####
Fax: 561 ###-###-####
II. Official and Mailing Address for Financial notices (the Licensee’s contact person for royalty payments):
Paul Michaels
Name
Chief Executive Officer
Title
Mailing Address:
***@***
1/2/2024
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Curative Biotechnology
1825 NW Corporate Boulevard, Suite 110
Boca Raton, FL 33431
Email Address: ***@***
Phone: 561 ###-###-####
Fax: 561 ###-###-####
Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or imprisonment). DocuSign Envelope ID: 47926600-0730-41A3-AFFF D229E0A0399A ***@***
ATTACHMENT 1 – ROYALTY PAYMENT INFORMATION
New Payment Options Effective March 2018
The License Number MUST appear on payments, reports and correspondence.
Credit and Debit Card Payments: Credit and debit card payments can be submitted for amounts up to $24,999. Submit your payment through the U.S. Treasury web site located at:
https://www.pay.gov/public/form/start/28680443.
Automated Clearing House (ACH) for payments through U.S. banks only
The IC encourages its licensees to submit electronic funds transfer payments through the Automated Clearing House (ACH). Submit your ACH payment through the U.S. Treasury web site located at:
https://www.pay.gov/public/form/start/28680443. Please note that the IC “only” accepts ACH payments through this U.S. Treasury web site.
Electronic Funds Wire Transfers: The following account information is provided for wire payments. In order to process payment via Electronic Funds Wire Transfer sender MUST supply the following information within the transmission:
Drawn on a U.S. bank account via FEDWIRE:
Please provide the following instructions to your Financial Institution for the remittance of Fedwire payments to the NIH ROYALTY FUND.
Fedwire Field Tag Fedwire Field Name Required Information
{1510} Type/Subtype 1000
{2000} Amount (enter payment amount)
{3400} Receiver ABA routing number* 021030004
{3400} Receiver ABA short name TREAS NYC
{3600} Business Function Code CTR (or CTP)
{4200} Beneficiary Identifier (account number) (enter 12 digit gateway account #) 875080031006
{4200} Beneficiary Name (enter agency name associated with the Beneficiary Identifier) DHHS / NIH (75080031)
{5000} Originator (enter the name of the originator of the payment) COMPANY NAME
{6000} Originator to Beneficiary Information – Line 1 (enter information to identify the purpose of the payment) ROYALTY
{6000} Originator to Beneficiary Information – Line 2 (enter information to identify the purpose of the payment) LICENSE NUMBER
{6000} Originator to Beneficiary Information – Line 3 (enter information to identify the purpose of the payment) INVOICE NUMBER
{6000} Originator to Beneficiary Information – Line 4 (enter information to identify the purpose of the payment)
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Fedwire
Field Tag Fedwire Field Name Required Information Notes:
*The financial institution address for Treasury’s routing number is 33 Liberty Street, New York, NY 10045. Agency Contacts: Office of Technology Transfer (OTT) (301) 496-7057 ***@*** Drawn on a foreign bank account via FEDWIRE:
The following instructions pertain to the Fedwire Network. Deposits made in US Dollars (USD). Should your remitter utilize a correspondent US domestic bank in transferring electronic funds, the following Fedwire instructions are applicable. Fedwire Field Tag Fedwire Field Name Required Information
{1510} Type/Subtype 1000
{2000} Amount (enter payment amount)
{3100} Sender Bank ABA routing number (enter the US correspondent bank’s ABA routing number)
{3400} Receiver ABA routing number* 021030004
{3400} Receiver ABA short name TREAS NYC
{3600} Business Function Code CTR (or CTP)
{4200} Beneficiary Identifier (account number)** (enter 12 digit gateway account #) 875080031006
{4200} Beneficiary Name (enter agency name associated with the Beneficiary Identifier) DHHS / NIH (75080031)
{5000} Originator (enter the name of the originator of the payment) COMPANY’S NAME
{6000} Originator to Beneficiary Information – Line 1 (enter information to identify the purpose of the payment) ROYALTY
{6000} Originator to Beneficiary Information – Line 2 (enter information to identify the purpose of the payment) LICENSE NUMBER
{6000} Originator to Beneficiary Information – Line 3 (enter information to identify the purpose of the payment) INVOICE NUMBER
{6000} Originator to Beneficiary Information – Line 4 (enter information to identify the purpose of the payment) Notes:
*The financial institution address for Treasury’s routing number is 33 Liberty Street, New York, NY 10045.
**Anything other than the 12 digit gateway account # will cause the Fedwire to be returned – SWIFT CODE: FRNYUS33
Agency Contacts:
Office of Technology Transfer (OTT) (301) 496-7057 ***@***
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Checks
All checks should be made payable to “NIH Patent Licensing” Checks drawn on a U.S. bank account and sent by US Postal Service should be sent directly to the following address:
National Institutes of Health
P.O. Box 979071
St. Louis, MO 63197-9000
Checks drawn on a U.S. bank account and sent by overnight or courier should be sent to the following address:
US Bank
Government Lockbox SL-MO-C2GL
3180 Rider Trail S.
Earth City, MO 63045
Phone: (800) 495-4981
Checks drawn on a foreign bank account should be sent directly to the following address:
National Institutes of Health
Office of Technology Transfer
License Compliance and Administration
Royalty Administration
6701 Rockledge Drive
Suite 700, MSC 7788
Bethesda, Maryland 20892
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ATTACHMENT 2 – NEW APPENDIX D: BENCHMARKS AND PERFORMANCE The Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark, shall notify the IC that the Benchmark has been achieved.
I. Select at least one lead ADC candidate within eighteen (18) months of the Effective Date of the Agreement.
II. Raise at least at total of $500,000.00 within twenty-two (22) months of the Effective Date of the Agreement.
III. Initiate preclinical IND-enabling studies within forty-two (42) months of the Effective Date of the Agreement.
IV. Initiate minipig studies within forty-four (44) months months of the Effective Date of the Agreement.
V. FDA preIND briefing book submitted and meeting set within forty-eight (48) months of the Effective Date of the Agreement.
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ATTACHMENT 3 – NEW APPENDIX E: COMMERCIAL EVALUATION PLAN
ATTACHMENT 4 – COMMERCIAL EVALUATION PLAN Progress since the execution of the Agreement:
| ● | Using BioReliance Labs, Licensee manufactured an anti-NCAM monoclonal antibody research cell bank (RCB) and completed testing of the RCB to certify its usability for Good Manufacturing Practice (GMP) manufacturing. |
| ● | The RCB was shipped to Azenta for long-term storage. |
| ● | Licensee contracted with APC Ltd., a contract development and manufacturing company (CDMO), to perform the process and analytical development of anti-NCAM bulk drug substance and anti-NCAM (mAb) bulk drug product. The work is scheduled to begin during the second quarter of 2024. |
| ● | APC Ltd. developed a procedure to reproducibly grow the RCB from frozen stock. This method is capable of producing bench-scale amounts of monoclonal antibodies. Licensee has demonstrated the generated material is a monoclonal antibody that recognizes NCAM. |
| ● | Licensee contracted with CDMO Creative Biolabs to manufacture anti-NCAM bulk drug substance, anti- NCAM (mAb) bulk drug product, and PBD-conjugated anti-NCAM finished drug product. Work is scheduled to begin during the second quarter of 2024. |
| ● | All non-GMP work used for proof-of-concept studies will be conducted at Emory University. |
| ● | No Good Laboratory Practice (GLP) work is planned for 2024 until/unless positive proof of principal animal data from Emory University studies. 2024 development plan |
| ● | Licensee will work with Creative Biolabs to process and analytically develop small scalable batches of non-GMP materials. |
| ○ | Licensee estimates six months for development activities and the manufacture of a large stock of materials to proceed with testing in minipigs - est. $250,000. | |
| ○ | Storage and shipping from Creative Biolabs - est. $250/mo. |
| ● | Licensee will continue RCB storage at Azenta Life Sciences during proof of concept work. $250/mo. |
| ● | Licensee will perform proof of concept drug substance and ADC-drug non-GMP development stability for both rodents and minipigs. It is estimated that this will take six months. - est. $125,000 |
| ● | Initiation of the world’s first endogenous minipig brain tumor model proof of principle study at Emory. Anticipated start in the first quarter of 2024. Pigs to survive as long as ethics protocol allows. |
| ● | Draft of Meeting Request (MR) and pre-IND Briefing Book (largely an investigator and preclinical document, including Chemistry, Manufacturing, and Controls) - 2 months (with e-Pub) anticipated to begin during the fourth quarter of 2024. Timing here obviously contingent on the length of survival of the pigs. We want them to survive as long as possible.. |
| ○ | Cost for the Regulatory SME (or group) writing the pIND, and e-Pub group for the MR and pre- IND BB and electronic gateway system (ESG) submission to FDA - est. $100,000 (includes Reg SME or group providing their electronic template costs for the pIND BB). | |
| ○ | Submission will be time and substance dependent on the end-of-life studies in mini pigs. |
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Post 2024 Development plan:
| ● | If Go/No Go study on minipigs is positive, then Licensee will proceed with the completion of GLP or GMP small batch to repeat the required pre-filing in vivo and in vitro tests for FDA IND filing. Chemistry, Manufacturing, and Controls process to mirror the processes detailed in the pre-IND briefing book. |
| ● | Licensee will continue with the confirmation of the target indication, focusing on newly diagnosed solid tumor glioblastoma. Licensee will not proceed forward with pediatric indications. |
| ● | Development of clinical protocol documents at Emory. |
| ● | Nick Boulis at Emory will likely be the PI for the first in human study as he has developed the CED technology that will be used in the surgical delivery of the drug. He is currently using the technique (which will be first in human) in his minipig model. This will likely be initiated during the first quarter of 2025 following FDA and Emory IND submissions and approvals. |
| ● | We anticipate filing applications for accelerated approval programs at FDA, which are being investigated and require POP and manufacturing success before filing. |
