Document:

Exhibit 10.11 Feasibility Study Quotation by and between Kannalife Sciences, Inc. and Catalent Pharma Solutions, LLC.

 

 

Solution for Cannabidiol Softgel Feasibility

 

VERSION: SPQ-KBO-1255.00

 

Prepared for

Kannalife Sciences, Inc.

William Kinney

Chief Scientific Officer

3805 Old Easton Road, Doylestown, PA 18902

(516) 669-3219

wkinney@interamed.com

 

Provided by

Catalent Pharma Solutions

Louis Weiner

Regional Sales Manager

 

 

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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Thank you for choosing a solution from Catalent.

 

Catalyst + Talent. Our name combines these ideas. From drug and biologic development to delivery technologies and supply solutions, we are the catalyst for your success. With over 75 years of experience, we have the deepest expertise, the broadest offerings and the most innovative technologies in brand and generic pharmaceuticals, veterinary medicine, consumer health, and biologics.

 

We help you get more molecules to market faster, solve bioavailability and development challenges, enhance product performance and patient adherence, create the optimal dose form, and drive superior supply chain, manufacturing, and packaging results.

 

Whether you are looking for a single, tailored solution or multiple answers throughout your product's lifecycle, we can improve the total value of your treatments-from discovery to market and beyond.

 

Catalent. More products. Better treatments. Reliably supplied.TM 

 

 

 

	BIOLOGICS

PRE-FORMULATION &

FORMULATION

SOLID STATE SERVICES

PHARMACEUTICAL &

BIOPHARMACEUTICAL

LAB SERVICES 

REGULATORY

CONSULTING

	SOFTGEL TECHNOLOGIES

ZYDIS® & LYOPAN®

FAST DISSOLVE

TECHNOLOGIES

CONTROLLED RELEASE

TECHNOLOGIES

INHALATION

INJECTABLES

	CLINICAL SUPPLY

MANUFACTURING

STERILE FILL/FINISH

PACKAGING SERVICES &

DELIVERY SOLUTIONS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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CONFIDENTIAL

 

Executive Summary

 

This quote outlines the activities to be performed by Catalent Pharma Solutions (Catalent) in support of Cannabidiol. Catalent will perform solubility studies, propose fill formulations, and manufacture pilot scale batches for probe stability for KannaLife Sciences, Inc. (KannaLife).

 

Costs are subject to the final Feasibility and Safety Assessment and assumes the API has special handling requirements. These include cold Drug Product storage for a DEA Schedule I substance until FDA approval.

 

SECTION 1 SCOPE OF WORK

 

Catalent will conduct an API solubility screen in excipients which are suitable to encapsulate a softgel capsule, are known to be well tolerated in animal and human models, and may maximize API concentration and exposure in-vivo. The excipients which show the best performance with the API will be used for prototype fill formulation. Target dose for the product will need to be determined with KannaLife,

 

Prototype fill formulations will be developed to achieve maximum API solubility and dispersion characteristics. Catalent will carry out assay/related substances method evaluation activities assuming that the API method provided by KannaLife Sciences, Inc. is stability Indicating and that there is no interference from formulation excipients.

 

Catalent will manufacture one pilot scale, active non-GMP batch of softgels. Catalent will then perform an informal “probe" stability study for three months at 40°C/75% RH on lab-scale prototype active batch.

 

The project will start once the fully executed quotation and a corresponding purchase order are received by Catalent.

 

SECTION 2 PROJECT ACTIVITIES

 

Catalent will conduct the following project-related activities:

 

2.1Project Initiation 

 

Assign Project Manager and publish communication plans.

 

Identify project team members and outline expectations. 

Provide draft Project Timeline. 

Review the Material Safety Data Sheets {MSDS) and other safety information available from KannaLife to categorize the safety/handling precautions for this product. 

Hold Project Kick-off meeting. 

 

	Estimated Duration (Weeks)

	Estimated Cost ($)

	[****]

	[****]

 

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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2.2DEA Quota 

Catalent will conduct administrative activities to include the following:

 

Prepare necessary paperwork and submit paperwork to the DEA to add product to Catalent's DEA license. 

Apply for quota as needed for this project. 

 

	Estimated Duration (Weeks)

	Estimated Cost ($)

	[****]

	[****]

 

2.3Solubility Evaluation in Cleaning Agents 

 

Catalent will conduct the following:

 

[***************************************************************************************************]

 

	Estimated Duration (Weeks)

	Estimated Cost ($)

	[****]

	[****]

 

2.4Softgel Excipient Solubility Screening Studies 

 

Catalent will conduct an excipient compatibility screening study as follows:

 

[***************************************************************************************************]

 

	Activity and Estimated Duration (Weeks)

	Estimated Cost ($)

	[****]

	[****]

 

2.5Evaluation of Excipient Compatibility Screening Study Samples 

 

[**********************************************************************************************************]

 

	Condition

	Pull Time

	Initial

	[****]

	[****]

	Initial

	X

	-

	-

	40 °C drv

	-

	X

	X

	40 °C spiked with water

	-

	X

	X

	Cost per pull ($)

	[****]

	[****]

	[****]

 

X = appearance and assay

 

	Activity and Estimated Duration (Weeks)

	Estimated Cost ($)

	Sample Preparation [***]

	[****]

	HPLC Analyses [****]

	[****]

	Total

	[****]

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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2.6Prototype Formulation Development 

 

Catalent will conduct the following activities to develop prototype formulations:

 

[***************************************************************************************************]

 

	Activity and Estimated Duration (Weeks)

	Estimated Cost ($)

	Formulation Development for no more than three (3) fill formulations [***]

	[****]

	Assay Testing of Fill Formulations [***]

	[****]

	Total

	[****]

 

 

2.7Compendial Moisture (Karl-Fischer) Method Evaluation 

 

Catalent will carry out KF method evaluation activities to include the following:

 

[***************************************************************************************************]

 

	Estimated Duration (Weeks)

	Estimated Cost ($)

	[****]

	[****]

 

2.8Assay /Related Substances {RS) Method Evaluation 

 

Catalent will carry out the following assay/related substances method evaluation activities assuming that the API method provided by KannaLife Sciences, Inc. is stability indicating and that there is no interference from formulation excipients:

 

[***************************************************************************************************]

 

	Activity and Estimated Duration (Weeks) 

	Estimated Cost ($)

	Assay/Related Substances Method Evaluation [***]

	[****]

	Method Optimization [***]

	[****]

	Total

	[****]

 

*If method optimization is required, an additional cost will be incurred and additional time will be required. Additional costs are not included in the Total Estimated Project Cost

 

2.9Pilot Batch Manufacture (non-CGMP) Encapsulation 

 

Catalent will conduct the following activities to encapsulate one (1) pilot scale batch of cannabldiol softgels using the lead fill formulation determined in Section 2.6. and a single gel formula proposed by Catalent.

 

[***************************************************************************************************]

 

	Activity and Estimated Duration (Weeks) 

	Estimated Cost ($)

	Gel Selection [***]

	[****]

	Manufacture of One (1) Active Softgel Pilot Scale Batch [***]

	[****]

	Drying Study [***] 

	[****]

	Packaging of Active Batches [***]

	[****]

	Total

	[****]

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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2.10Informal Stability Study 

 

[***************************************************************************************************]

 

Three-Month Informal Stability (one (1) prototype active batch)

 

	Storage Condition

	Interval (Months)

	Initial

	1

	2

	3

	Initial

	X*

	-

	-

	-

	25°C/60%RH

	-

	(X)

	(X)

	(X)

	30°C/65%RH

	-

	(X)

	(X)

	(X)

	40°C/75%RH

	-

	X

	X

	X

	Cost per pull ($)

	[****]

	[****]

	[****]

	[****]

 

[***************************************************************************************************]

 

	Estimated Duration (Weeks) 

	Estimated Cost ($)

	[****]

	[****]

 

2.11Formulation Development Summary Report 

 

[***************************************************************************************************]

 

	Activity and Estimated Duration (Weeks) 

	Estimated Cost ($)

	[****]

	[****]

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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SECTION 3 COST PROPOSAL

 

3.1Project Costs 

 

Total Estimated Project Cost

 

	Section Reference

	Activity

	Estimated Cost($)

	2.1.

	[****]

	[****]

	2.2.

	[****]

	[****]

	2.3.

	[****]

	[****]

	2.4.

	[****]

	[****]

	2.5.

	[****]

	[****]

	2.6.

	[****]

	[****]

	2.7.

	[****]

	[****]

	2.8.

	[****]

	[****]

	2.9.

	[****]

	[****]

	2.10.

	[****]

	[****]

	2.11.

	[****]

	[****]

	[****]

	[****]

 

3.2Revisions to Pricing 

 

Catalent reserves the right to revise quoted costs for any project as a result of initial scope change, planned deviations, revisions In specifications, modifications of test methods, undocumented requirements, retesting, requirements outside of Catalent SOPs, or any unforeseen difficulty in executing the project. In addition, the quoted costs are subject to annual review to account for changes in inflation, increased overhead charges, etc. Any additional work will be performed based on written agreement from KannaLife and will be documented on a Catalent Quotation Amendment Record (QAR).

 

This quote is valid for 60 days. After which Catalent may withdraw the proposal or review the costs. 

 

SECTION 4 INVOICING AND PAYMENT TERMS

 

4.1Invoicing Terms 

 

Catalent will issue invoices for milestones completed. Where a milestone may include multiple batches, each batch will be invoiced when completed along with the in-process release testing costs, etc. If a draft report is issued an invoice will be generated for the report and KannaLife will have 10 business days to return comments to Catalent. Following the 10 day period, if comments are received after issuance of the final report, KannaLife will be billed for the time required to complete changes and reissue the report.

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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4.2Payment Terms 

 

Payments toward all invoices are due upon receipt of the invoice and are non-refundable. Any applicable wire transfer fees must be included in the payment Issued to Catalent. All shipments are EXW (Incoterms 2010) St. Petersburg, FL. Remit all payments to:

 

Physjcal U.S.Mail Remittance

Catalent Pharma Solutions - St. Petersburg

 

Overnight Remittance vja Courier

J.P. Morgan Chase

ATTN: Catalent Pharma Solutions 

 

Electronic Wire I ACH Instructions

J.P. Morgan Chase

 

Swift Code: ########## (for international payments only)

 

FBO: Catalent Pharma Solutions

 

SECTION 5 SCHEDULING/DELIVERABLES

 

5.1Samples/Materials 

 

If available, KannaLife will provide all samples/materials necessary to perform this project. The samples/materials should arrive at Catalent with all proper documentation. If samples/materials are not available, upon request from KannaLife, Catalent will purchase all samples/materials necessary to perform the project. Where standard materials, such as excipients or columns are required, or needed to maintain the Project timeline, Catalent will purchase such materials. Catalent will invoice KannaLife monthly at cost plus reasonable and customary acquisition and handling costs for any material purchased as described above. Non-standard or special instrumentation or equipment required solely for this project will be invoiced to KannaLife following KannaLife's approval.

 

5.2Termination or Cancellation 

 

Either party may terminate the project or any portion thereof at any time by providing 30 days written notice. Upon receipt of any such notice of termination, Catalent will promptly scale down the affected portion of the project and avoid (or minimize, where non-cancelable) any further related expenses. 

 

If this project is cancelled by KannaLlfe for any reason within their control or terminated by the KannaLife, Catalent will invoice KannaLife the cost of any sample/materials, work performed before cancellation or termination date, reference materials, equipment and supplies purchased by Catalent specifically for the project.

 

5.3Project Notes and Assumptions 

 

KannaLife shall pay for all product batches, including batches that do not conform to applicable specifications, unless all methods and processes associated with the manufacture, testing, and storage of that product have been fully validated in accordance with generally accepted standards of the pharmaceutical industry. 

 

The costs associated with optional testing have not been included in the total estimated project cost.

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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SECTION 6 VERSION HISTORY

 

6.1Revisions 

 

	Version

	Revisions

	00

	New Issue

 

SECTION 7 PROJECT APPROVAL AND AUTHORIZATION

 

Pursuant to the Standard Terms and Conditions, as defined herein, between Catalent and KannaLife, KannaLife agrees to the project details as set forth in this Quotation.

 

	KannaLife Sciences, Inc.

	 

	Catalent Pharma Solutions, LLC

	 

	 

	 

	Dean Petkanas

	 

	 

	Title

	 

	Aris Gennadios, Ph.D.

	 

	 

	 

	Chief Executive Officer

	 

	President, Softgel Technologies

	Title

	 

	Title

	 

	 

	 

	January 22, 2015

	 

	16DEC2014

	Date

	 

	Date

 

Please sign and return a copy of the Quotation Approval Page via fax to

###############################

 

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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CONFIDENTIAL

 

Catalent Standard Terms and Conditions

 

A.Expiration. This Quotation is valid for 30 days from the date hereof, and becomes binding if signed and delivered by both parties during that period. 

 

B.Audits. Client may conduct one quality assurance facility audit every other year at no cost. Additional audits will be invoiced separately at the current rate for such services unless such audit is for cause. 

 

C.Regulatory Inspections. Catalent will promptly notify Client of any regulatory inspections directly relating to the services performed under this Quotation (the "Project"). Client shall reimburse Catalent for reasonable and documented costs associated with such regulatory inspections. 

 

D.Changes. Catalent may revise the prices provided in this Quotation (i) if Client's requirements or any Client-provided information is inaccurate or Incomplete; (ii) if Client revises Catalent's responsibilities or the Project specifications, Instructions, procedures, assumptions, processes, test protocols, test methods or analytical requirements; or (iii) for such other reasons set forth in this Quotation. Any revision to this Quotation shall be set forth in a Quotation Amendment Request ("QAR") signed by both parties in accordance with Section V. 

 

E.Payments. Catalent will invoice Client as set forth in this Quotation. Catalent charges a late payment fee of 11⁄2% per month for payments not received by the date specified in this Quotation (or if no date is specified, within 30 days of Invoice date). Failure to bill for interest due shall not be a waiver of Catalent's right to charge interest. 

 

F.Taxes. All sales, use, gross receipts, compensating, value-added or other taxes, duties, licenses or fees (excluding Catalent's net income and franchise taxes) assessed by any tax jurisdiction arising from the Project are the responsibility of Client, whether paid by Catalent or Client. 

 

G.Hazardous Materials. Client warrants to Catalent that no specific safe handling Instructions are applicable to any Client-supplied materials, except as disclosed to Catalent in writing by the Client in sufficient time for review and training by Catalent prior to delivery. Where appropriate or required by law, Client will provide a Material Safety Data Sheet for all Client-supplied materials and finished product. 

 

H.Delivery. (i) Catalent shall deliver all products and other materials EXW (Incoterms 2010) Catalent's facilities. To the extent not already held by Client, title shall pass to Client upon such tender of delivery. If Catalent provides storage services, title and risk of loss shall pass to Client upon transfer to storage. (ii) In the event Catalent arranges shipping or performs similar loading and/or logistics services for Client at Client's request , such services are performed by Catalent at Client's expense and on Client's behalf as a convenience to Client only and does not alter subsection (i) above. 

 

I.Limitations of Liability. CATALENT'S TOTAL LIABILITY UNDER THIS QUOTATION SHALL IN NO EVENT EXCEED THE TOTAL FEES PAID UNDER THIS QUOTATION OR QAR, RESPECTIVELY (BUT EXCLUDING FEES AND COSTS FOR PROCURING COMPARATOR DRUG). CATALENT SHALL HAVE NO LIABILITY UNDER THIS QUOTATION OR QAR FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED API OR CLIENT-SUPPLIED MATERIALS, WHETHER OR NOT INCORPORATED INTO FINISHED PRODUCT. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF PERFORMANCE UNDER THIS QUOTATION OR QAR, INCLUDING WITHOUT LIMITATION LOSS OF REVENUES, PROFITS OR DATA, WHETHER IN CONTRACT OR IN TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 

 

 

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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CONFIDENTIAL

 

J.Confidentialitv. All information disclosed by a party in connection with this Quotation shall be confidential information, unless such information is (i) already known to the receiving party, on a non-confidentlal basis, as evidenced by written records; (ii) Independently developed or discovered by the receiving party without the use of the disclosing party's confidential information, as evidenced by written records; (iii) in the public domain, other than through the fault of the receiving party; or (iv) disclosed to the receiving party by a third party not in breach of a duty of confidentiality owed to the disclosing party. Neither party shall, without the other party's prior written consent, use the confidential information of the other party or disclose such information except (a) to provide to employees of the receiving party or its affiliated entities who require such information to perform such party's obligations under this Quotation, or (b) as required to be disclosed by law, or court or administrative order; provided that the receiving party first gives prompt written notice thereof to the disclosing party. This undertaking shall survive for 7 years following the date of this Quotation. 

 

K.Intellectual Property. For purposes hereof, "Client IP" means all intellectual property and embodiments thereof owned by or licensed to Client as of the date hereof or developed by Client other than in connection with the Project; "Catalent IP" means all intellectual property and embodiments thereof owned by or licensed to Catalent as of the date hereof or developed by Catalent other than in connection with the Project; "Invention" means any intellectual property developed by either party in connection with the Project; "API Inventions" means any Invention that relates exclusively to the Client IP or Client's patented API; and "Process Inventions" means any Invention, other than an API Invention, that relates exclusively to the Catalent IP or relates to developing, formulating, manufacturing, filling, processing, packaging, analyzing or testing pharmaceutical products generally. All Client IP and API Inventions shall be owned solely by Client and no right therein is granted to Catalent under this Quotation except for use in performing the Project. All Catalent IP and Process Inventions shall be owned solely by Catalent and no right therein is granted to Client under this Quotation. All Inventions to generic API (other than API Inventions and Process Inventions), if any, shall be owned jointly by Catalent and Client. The parties shall cooperate to achieve the allocation of rights to Inventions anticipated herein and each party shall be solely responsible for costs associated with the protection of its intellectual property. 

 

L.Warranties. Catalent will perform the Project in accordance with the written specifications and Project instructions expressly set forth or referenced in this Quotation and United States current Good Manufacturing Practices or current Good Laboratory Practices, as applicable. THE WARRANTIES SET FORTH IN THIS ARTICLE ARE THE SOLE AND EXCLUSIVE WARRANTIES MADE BY CATALENT TO CLIENT, AND CATALENT MAKES NO OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NONINFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE. 

 

M.Client Obligations. Unless otherwise agreed to by the parties in writing, Client Is solely responsible at its cost and expense to (i) provide complete and accurate scientific data regarding the Project; (ii) deliver to Catalent all Client-supplied materials; (iii) prepare all submissions to regulatory authorities and obtain Catalent's prior written consent (which will not be unreasonably withheld) before identifying Catalent in such regulatory submissions; (iii) if applicable, review and approve all in-process and finished product test results to ensure conformity of such results with the product specifications, regardless of which party is responsible for finished product release; and (iv) perform such other obligations of Client set forth In this Quotation. 

 

N.Regulatory Compliance. Catalent shall obtain and maintain all permits and licenses with respect to general facility operations in the jurisdiction in which Catalent performs the services. Client shall be responsible at its cost to obtain and maintain all other regulatory approvals, authorizations, certifications and permits relating to Client-supplied materials and Client product, including without limitation those relating to the import, export, use, distribution and sale of Client-supplied materials and Client product. Client shall reimburse Catalent for any payments Catalent is required to make to any regulatory authority resulting directly from Catalent's formulation, development, manufacturing, processing, filling, packaging, storing or testing of Client's product or Client-supplied materials (including without limitation any payments or fees Catalent is required to make pursuant to the Generic Drug User Fee Act of 2012, if applicable). Catalent shall not be obligated to perform any services which would involve any countries that are targeted by the comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or United States. 

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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CONFIDENTIAL

 

O.Indemnification. Client will indemnify, defend and hold harmless Catalent, its affiliates and their respective directors, officers, employees and agents against any third-party claim arising directly or indirectly from (i) the manufacture, promotion, marketing, distribution or sale of, or use of or exposure to, the product, API and Client-supplied materials that are the subject of the Project, (ii) the negligence or willful misconduct of Client, (iii) the breach of this Quotation by Client, or (iv) the use of any intellectual property, materials or other information provided by Client to Catalent; in each case, including but not limited to costs associated with responding to subpoenas and giving testimony relating to disputes between Client and third parties. Catalent will indemnify, defend and hold harmless Client from any third-party claim arising directly or indirectly from the negligence or willful misconduct of Catalent or the breach of this Quotation by Catalent. 

 

P.Right to Dispose and Settle. If Catalent requests in writing from Client direction with respect to disposal of products, materials, equipment, samples or other Items belonging to Client and is unable to obtain a response from Client within a reasonable time period after making reasonable efforts to do so, Catalent may In its sole discretion (i) dispose of all such items and (ii) set-off any and all amounts due to Catalent or any of its affiliates from Client against any credits Client may hold with Catalent or any of its affiliates. 

 

Q.Force Majeure. Neither party will be liable for any failure to perform or for delay in performance resulting from any cause beyond its reasonable control, including without limitation acts of God, fires, floods or weather, strikes or lockouts, factory shutdowns, embargoes, wars, hostilities or riots, or shortages in transportation . If the cause continues unabated for 90 days, then both parties shall meet to discuss and negotiate in good faith what modifications to this Quotation should result from such cause. 

 

R.Use and Disposal. Client represents and warrants to Catalent that Client will hold, use and/or dispose of products and other materials provided by Catalent in accordance with all applicable laws, rules and regulations. Client grants Catalent full authority to use any Client-supplied materials for purposes of the Project. 

 

S.Record Retention. Unless the parties otherwise agree in writing, Catalent will retain batch, laboratory and other technical records for the minimum period required by applicable law.  

 

T.Independent Contractor. The relationship of the parties is that of independent contractors and not of joint venturers, co-partners, employer/employee or principal/agent. 

 

U.Publlcitv. Neither party will make any press release or other public disclosure regarding this Quotation or the transactions contemplated hereby without the other party's express prior written consent, except as required by applicable law, by any governmental agency or by the rules of any stock exchange on which the securities of the disclosing party are listed, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or public disclosure. 

 

V.Amendment & Precedence. These Standard Terms and Conditions constitute a part of the Quotation to which they are attached (collectively, "this Quotation"); provided, that these Standard Terms and Conditions supersede any conflicting terms and conditions set forth In the Quotation to which they are attached or any other document, including Client purchase order. This Quotation constitutes the entire understanding between the parties, and supersedes any contracts, agreements or understandings (oral or written) of the parties, with respect to the Project. No term of this Quotation may be amended except upon written agreement signed by both parties. 

 

W.Dispute Resolution. If a dispute arises between the parties in connection with this Quotation, the respective presidents or Senior Executives of Catalent and Client shall first attempt to resolve the Dispute. If such parties cannot resolve the dispute, such dispute shall be resolved In the jurisdiction of the defendant party by binding arbitration in accordance with the then existing commercial arbitration rules of International Institute for Conflict Prevention and Resolution, 575 Lexington Avenue, 21st Floor, New York, NY 10022. 

 

X.Survival. Subject to execution, the rights and obligations of Client and Catalent in Articles E, F, I, J, K, O, S, U, W, X and Y of these Standard Terms and Conditions shall survive termination or expiration of this Quotation. 

 

Y.Governing Law. This Quotation shall be governed by and construed under the laws of the State of New Jersey, USA, excluding its conflict of law provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Quotation. 

Catalent - US Version 08AUG2013

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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We serve 49 of the top 50 pharmaceutical and 36 of the top 50 biotech companies.

 

We support thousands of innovative prescription, generics, and consumer health companies.

 

We operate 20+ global sites across 100+ markets.

 

We create expert solutions from over 1,000 scientists, including key opinion leaders in drug development and delivery.

 

We support 40% of recent new U.S. drug approvals.

 

We manufacture or package 100 billion units annually.

 

We are the Industry leader in drug delivery technology.

 

We use a multi-faceted approach to solve bioavailability and patient adherence challenges.

 

We provide end-to-end biologics technologies, from gene expression to fill/finish.

 

We offer fully-integrated medication supply chain solutions.

 

We have a proven track record in regulatory compliance in all key jurisdictions.

 

We are fully dedicated to high standards of quality, cGMP leadership, and LEAN operational excellence.

 

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [ * * * ]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

13STOCK
PURCHASE AGREEMENT

 

This
Stock Purchase Agreement is dated as of December 21, 2018 (this “Agreement”) by and among Non-Invasive Monitoring
Systems, Inc., a Florida corporation (the “Company”), and the purchasers whose names and addresses are set
forth on the signature pages hereto (each, a “Purchaser” and collectively, the “Purchasers”).

 

WHEREAS,
the Company desires to sell to each Purchaser, and each Purchaser desires to purchase from the Company, shares of the Company’s
common stock, par value $0.01 per share (the “Common Stock”), on the terms and subject to the conditions set
forth in this Agreement (the “Transaction”).

 

NOW,
THEREFORE, in consideration of the premises and the mutual covenants contained in this Agreement and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the parties
agree as follows:

 

Article
I.

 

Purchase
and Sale of Common Stock

 

1.1
Purchase and Sale of the Shares. Subject to the terms and conditions hereof, the Company hereby agrees to issue and sell
an aggregate of _________ shares (the “Shares”) to the Purchasers at a purchase price of $0.07 per share
(“Per Share Purchase Price”). Each Purchaser hereby agrees to purchase from the Company the number of shares
set forth on such Purchaser’s signature page hereto (with respect to such Purchaser, the “Purchaser Shares”),
for an aggregate purchase price equal to the number of Purchaser Shares purchased by such Purchaser multiplied by the Per Share
Purchase Price (such product, the “Purchase Price”).

 

1.2
Closing; Deliverables. The closing of the issuance and sale of the Shares (the “Closing”) shall take
place at the Company’s offices in Miami, Florida on the date hereof (the “Closing”). At Closing, (A)
the Company shall deliver to each Purchaser a copy of the Company’s instructions to its transfer agent instructing the transfer
agent to deliver one or more stock certificates evidencing the Shares, inclusive of such restrictive and other legends as set
forth in Section 5.1, and (B) each Purchaser shall pay to the Company the Purchase Price by wire transfer of immediately
available U.S. funds in accordance with instructions furnished in writing by the Company to such Purchaser.

 

Article
II.

 

Additional
Agreements

 

The
Company and each Purchaser shall cooperate and use their respective commercially reasonable efforts to take or cause to be taken
all actions, and do or cause to be done all things, necessary, proper or advisable under this Agreement and applicable laws and
regulations to consummate and make effective the sale of the Shares as soon as practicable, including preparing and filing as
promptly as practicable all documentation to effect all necessary applications, notices, petitions, filings and other documents
and to obtain as promptly as practicable all permits, consents, approvals and authorizations necessary or advisable to be obtained
from any third party and/or any governmental entity in order to consummate the sale or any of the other transactions contemplated
by this Agreement.

 

    	 	 	 

    	 

    

 

Article
III.

 

Representations
and Warranties of the Company

 

The
Company represents and warrants to the Purchasers as of the date hereof as follows:

 

3.1
Authorization of Agreements, etc. The execution and delivery by the Company of this Agreement, the performance by the Company
of its obligations hereunder, and the issuance, sale and delivery of the Shares have been duly authorized by all requisite corporate
action and will not result in any violation of, be in conflict with, or constitute a default under, with or without the passage
of time or the giving of notice: (a) any provision of the Company’s Articles of Incorporation, as amended, or Bylaws, as
amended; (b) any provision of any judgment, decree or order to which the Company is a party or by which it is bound; (c) any material
contract or agreement to which the Company is a party or by which it is bound (as defined in Item 601(b)(10) of Regulation S-K
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)); or (d) any statute, rule or governmental
regulation applicable to the Company, except for such violations, conflicts or defaults as would not individually or in the aggregate
have a material adverse effect on the Company.

 

3.2
Valid Issuance of Common Stock. The Shares have been duly authorized and, when issued, sold and delivered in accordance
with this Agreement for the Purchase Price, will be validly issued, fully paid and nonassessable and will be free and clear of
all liens, charges and encumbrances (collectively, “Encumbrances”) of any nature whatsoever except for (i)
restrictions on transfer under this Agreement and under applicable Federal and state securities laws and (ii) Encumbrances created
by a Purchaser.

 

3.3
Validity. This Agreement has been duly executed and delivered by the Company and constitutes the legal, valid and binding
obligation of the Company, enforceable in accordance with its terms except (i) as limited by applicable bankruptcy, insolvency,
reorganization, moratorium, and other laws of general application affecting enforcement of creditors’ rights generally,
and (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies.

 

3.4
Brokers and Finders. Neither the Company nor any of its subsidiaries, officers, directors or employees has employed any
broker or finder or incurred any liability for any brokerage fees, commissions or finders’ fees in connection with the Transaction.

 

    	 	2	 

    	 

    

 

Article
IV.

 

Representations
and Warranties of Each Purchaser

 

Each
Purchaser, severally and not together with any other Purchaser, represents and warrants to the Company as of the date hereof as
follows:

 

4.1
Authorization of Agreements, etc. Such Purchaser has full right, power, authority and capacity to enter into this Agreement
and to consummate the transactions contemplated hereby, and the execution and delivery by such Purchaser of this Agreement and
the performance by such Purchaser of its obligations hereunder have been duly authorized by all requisite corporate or other action
and will not result in any violation of, be in conflict with, or constitute a default under, with or without the passage of time
or the giving of notice: (a) any provision of such Purchaser’s organizational documents as currently in effect (if such
Purchaser is not a natural person); (b) any provision of any judgment, decree or order to which such Purchaser is a party or by
which it is bound; (c) any material contract or agreement to which such Purchaser is a party or by which it is bound; or (d) any
statute, rule or governmental regulation applicable to such Purchaser.

 

4.2
Validity. This Agreement has been duly executed and delivered by such Purchaser and constitutes the legal, valid and binding
obligation of such Purchaser, enforceable against such Purchaser in accordance with its terms except (i) as limited by applicable
bankruptcy, insolvency, reorganization, moratorium, and other laws of general application affecting enforcement of creditors’
rights generally and (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other
equitable remedies.

 

4.3
Investment Representations.

 

(a)
At the time such Purchaser was offered the Purchaser Shares, it was, and at the date hereof it is, and on each date on which it
receives the Purchaser Shares it will be, an “accredited investor” as defined by Rule 501(a) of Regulation D promulgated
under the Securities Act of 1933, as amended (the “Securities Act”), and, if Purchaser is other than a natural
person, was not organized for the specific purpose of acquiring the Purchaser Shares and is not required to be registered as a
broker-dealer under Section 15 of the Exchange Act;

 

(b)
Such Purchaser is knowledgeable, sophisticated and experienced in financial and business matters and has sufficient knowledge
and experience in investing in companies similar to the Company so as to be able to evaluate the risks and merits of its investment
in the Purchaser Shares and it is able financially to bear the economic risks of its investment in the Purchaser Shares and is
able to afford a complete loss of such investment;

 

(c)
The Purchaser Shares being purchased by such Purchaser hereunder are being acquired for such Purchaser’s own account solely
for the purpose of investment and not with a present view to, or for sale in connection with, any distribution or resale thereof.
If Purchaser is other than a natural person, such Purchaser is acquiring the Purchaser Shares in the ordinary course of its business.
Such Purchaser does not have any agreement or understanding, directly or indirectly, with any person to distribute any of the
Purchaser Shares;

 

    	 	3	 

    	 

    

 

(d)
Such Purchaser understands and acknowledges that:

 

(i)
the Shares have not been registered under the Securities Act or any state securities laws and are being offered and sold in reliance
upon specific exemptions from the registration requirements of the Securities Act and state securities laws, and the Company is
relying upon the truth and accuracy of, and such Purchaser’s compliance with, the representations, warranties, covenants,
agreements, acknowledgments and understandings of such Purchaser contained in this Agreement in order to determine the availability
of such exemptions and the eligibility of such Purchaser to acquire the Purchaser Shares;

 

(ii)
the Purchaser Shares must be held by such Purchaser indefinitely unless a subsequent disposition thereof is registered under the
Securities Act or is exempt from such registration; and

 

(iii)
the Purchaser Shares will bear a legend substantially in the form set forth in Section 5.1, and the Company will make a
notation on its transfer books to such effect;

 

(e)
Such Purchaser is not purchasing the Purchaser Shares as a result of any advertisement, article, notice or other communication
regarding the Purchaser Shares published in any newspaper, magazine or similar media or broadcast over television or radio or
presented at any seminar or any other general solicitation or general advertisement. Such Purchaser further acknowledges that
he, she or it, or his, her or its affiliate, has a pre-existing relationship with the Company, such as as a holder of currently
outstanding securities of the Company;

 

(f)
Such Purchaser acknowledges that the Company has made available to such Purchaser all documents and information that such Purchaser
has requested relating to an investment in the Purchaser Shares, and such Purchaser has been afforded: (i) the opportunity to
discuss this investment with, to ask such questions as it has deemed necessary of, and to receive answers from, representatives
of the Company concerning the terms and conditions of the offering of the Purchaser Shares and the merits and risks of investing
in the Purchaser Shares; (ii) access to information about the Company and its subsidiaries and their respective financial condition,
results of operations, business, properties, management and prospectus sufficient to enable it to evaluate its investment; and
(iii) the opportunity to obtain such additional information that the Company possesses or can acquire without unreasonable effort
or expense that is necessary to make an informed investment decision with respect to the Purchaser Shares; and

 

(g)
Such Purchaser has, in connection with its decision to purchase the Purchaser Shares, relied solely upon the representations and
warranties of the Company contained in this Agreement.

 

4.4
Risk of Loss. Such Purchaser understands that its investment in the Purchaser Shares involves a significant degree of risk,
including a risk of total loss of such Purchaser’s investment, and such Purchaser has full cognizance of and understands
all of the risk factors related to its purchase of the Purchaser Shares, including, but not limited to, those set forth in the
Annual, Quarterly and Current Reports filed by the Company with the Securities and Exchange Commission. Such Purchaser understands
that no representation is being made as to the future value of the Purchaser Shares.

 

    	 	4	 

    	 

    

 

4.5
Confidentiality. Such Purchaser understands that this Agreement, the information contained in all materials provided to
such Purchaser by the Company and its representatives, including any information conveyed orally, in connection with the transactions
contemplated hereunder (collectively “Confidential Information”), is strictly confidential and proprietary
to the Company and is being provided to such Purchaser solely for such Purchaser’s confidential use in connection with the
transactions contemplated hereunder. Such Purchaser agrees to use the Confidential Information solely for the purpose of evaluating
a possible investment in the Shares, and such Purchaser acknowledges that it is prohibited from distributing, divulging or discussing
any Confidential Information, in whole or in part, with any person, except such Purchaser’s financial, investment or legal
advisors (such persons, “Authorized Advisors”), solely to the extent necessary for such Authorized Advisors
to assist such Purchaser with its proposed investment in the Purchaser Shares. To the extent that such Purchaser provides, directly
or indirectly, any Confidential Information to any Authorized Advisor, such Purchaser shall (a) ensure that such Authorized Advisor
maintain the confidentiality of the Confidential Information to the same extent applicable to Purchaser as set forth in this Section
4.5 and (b) be responsible for any breaches of this Section 4.5 by its Authorized Advisors. Confidential Information
does not include any information that is or becomes publicly available through no fault of such Purchaser, or that such Purchaser
is required to disclose pursuant to applicable law, regulation or legal process; provided, however, that if such
Purchaser or any Authorized Advisor is requested or ordered to disclose any Confidential Information pursuant to any court or
other government order or any other applicable legal procedure, it shall provide the Company with prompt notice of any such requirement
and the terms of and circumstances surrounding such requirement so that the Company may seek an appropriate protective order or
other remedy, or waive compliance with the terms of this Section 4.5, and such Purchaser or such Authorized Advisor will
provide such cooperation, at Company’s expense, with respect to obtaining a protective order or other remedy as the Company
will request.

 

4.6
Brokers and Finders. Such Purchaser has not employed any broker or finder or incurred any liability for any brokerage fees,
commissions or finders’ fees in connection with the Transaction.

 

Article
V.

 

Miscellaneous

 

5.1
Transfer Restrictions. Each Purchaser acknowledges and understands, severally and not jointly, that (i) the Shares may
only be disposed of in compliance with state and federal securities laws and (ii) in connection with any transfer of Shares, other
than pursuant to an effective registration statement or pursuant to an available exemption from the registration requirements
of the Securities Act (including Rule 144) to the Company or to an affiliate of such Purchaser, the Company may require the transferor
thereof to provide to the Company an opinion of counsel selected by the Company, the form and substance of which opinion shall
be reasonably satisfactory to the Company, to the effect that such transfer does not require registration of such transferred
Shares under the Securities Act. As a condition of transfer, any such transferee shall agree in writing to be bound by the terms
of this Agreement and shall have the rights of a Purchaser under this Agreement. Any transfer or purported transfer of the Shares
in violation of this section shall be void.

 

    	 	5	 

    	 

    

 

5.2
Legend. Each certificate that represents Shares shall have conspicuously endorsed thereon a legend in substantially the
following form:

 

This
shares of common stock evidenced by this certificate have not been registered under the Securities Act of 1933, as amended (the
“Securities Act”), or any state securities laws. Such shares may not be offered or transferred by sale, assignment,
pledge or otherwise unless (a) a registration statement for the resale of such shares under the Securities Act is currently effective
or (b) the Company has received an opinion of counsel, which opinion is satisfactory to the Company, to the effect that such registration
is not required under the Securities Act or relevant state securities laws.

 

5.3
Brokerage. Each party hereto will indemnify and hold harmless the other against and in respect of any claim for brokerage
or other commissions relative to this Agreement or to the Transaction, based in any way on agreements, arrangements or understandings
made or claimed to have been made by such party with any third party.

 

5.4
Assignment; Parties in Interest. All representations, covenants and agreements contained in this Agreement by or on behalf
of any of the parties hereto shall bind and inure to the benefit of the respective successors and permitted assigns of the parties
hereto whether so expressed or not. No party may assign all or any portion of such party’s rights or obligations under this
Agreement without the prior written consent of, in the case of an assignment by a Purchaser, the Company, and in the case of an
assignment by the Company, Purchasers acquiring a majority of the Shares hereunder. This Agreement is intended for the benefit
of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision
hereof be enforced by, any other person or entity.

 

5.5
Notices. All notices, requests, consents, demands, and other communications under this Agreement shall be in writing and
shall be deemed to have been duly given on the date of service if served personally on the party to whom notice is to be given,
on the date of transmittal of services via facsimile to the party to whom notice is to be given (with a confirming copy delivered
within 24 hours thereafter), or on the third day after mailing if mailed to the party to whom notice is to be given, by first
class mail, registered or certified, postage prepaid, or overnight mail via a nationally recognized courier providing a receipt
for delivery and properly addressed as follows:

 

	If
    to the Company:	 	Non-Invasive
    Monitoring Systems, Inc.
	 	 	4400
    Biscayne Blvd.
	 	 	Miami,
    FL 33137
	 	 	Attn:
    James Martin, Chief Financial Officer
	 	 	Fax:
    (305) 575-6016
	 	 	 
	If
    to the Purchaser:	 	To
    the address specified on the signature page hereto.

 

Any
party may change its address for purposes of this paragraph by giving notice of the new address to each of the other parties in
the manner set forth above.

 

    	 	6	 

    	 

    

 

5.6
Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Florida for
all purposes and in all respects, without regard to the conflict of law provisions of such state that would cause the laws of
another jurisdiction to apply. The parties hereto acknowledge and agree that venue and jurisdiction for any claim, suit or controversy
related to or arising out of this Agreement shall lie in the state or federal courts located in Miami-Dade County, Florida. THE
PARTIES HEREBY WAIVE THE RIGHT TO JURY TRIAL OF ANY MATTERS ARISING OUT OF THIS AGREEMENT OR THE CONDUCT OF THE RELATIONSHIP BETWEEN
THEM.

 

5.7
Entire Agreement. This Agreement constitutes the sole and entire agreement of the parties with respect to the subject matter
hereof.

 

5.8
Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but
all of which together shall constitute one and the same instrument. Facsimile or other electronically scanned and transmitted
signatures, including by email attachment, shall be deemed originals for all purposes of this Agreement.

 

5.9
Amendments and Waivers. This Agreement may be amended or modified, and provisions hereof may be waived, only by a written
instrument executed by the Company and each Purchaser.

 

5.10
Severability. If any provision of this Agreement shall be declared void or unenforceable by any judicial or administrative
authority, the validity of any other provision and of the entire Agreement shall not be affected thereby.

 

5.11
Construction. The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be
deemed to limit or affect any of the provisions hereof. The language used in this Agreement will be deemed to be the language
chosen by the parties to express their mutual intent, and no rules of strict construction will be applied against any party.

 

5.12
Representations. Each Purchaser agrees that, except for the representations and warranties contained in Article III,
the Company makes no other representations or warranties, and the Company hereby disclaims any other representations or warranties
made by itself or any of its directors, officers employees, investment bankers, financial advisors, attorneys, accountants, agents
and other representatives (collectively, “Representatives”), with respect to the execution and delivery of
this Agreement, notwithstanding the delivery or disclosure to any other party or any other party’s Representatives of any
document or other information with respect to any one or more of the foregoing. Without limiting the generality of the foregoing,
and notwithstanding any otherwise express representations and warranties made by the Company in this Agreement, each Purchaser
agrees that none of the Company, its subsidiaries or any of their respective Representatives makes or has made any representation
or warranty with respect to (i) any projections, forecasts, estimates, plans or budgets or future revenues, expenses or expenditures,
future results of operations (or any component thereof), future cash flows (or any component thereof) or future financial condition
(or any component thereof) of the Company or any of its subsidiaries or the future business, operations or affairs of the Company
or any of its subsidiaries heretofore or hereafter delivered to or made available to it, or (ii) any other information, statements
or documents heretofore or hereafter delivered to or made available to it with respect to the Company or any of its subsidiaries
or the business, operations or affairs of the Company or any of its subsidiaries, except to the extent and as expressly covered
by a representation and warranty made in this Agreement.

 

[signature
pages follow]

 

    	 	7	 

    	 

    

 

IN
WITNESS WHEREOF, the undersigned has caused this Agreement to be executed by its duly authorized representative as of the
date and year first above written.

 

	 	NON-INVASIVE
    MONITORING SYSTEMS, INC.
	 	 	 
	 	By:	 
	 	Name:	James
    J. Martin
	 	Title:	Chief
    Financial Officer

 

[Company
Signature Page to Securities Purchase Agreement]

 

    	 	 	 

    	 

    

 

IN
WITNESS WHEREOF, the undersigned has caused this Agreement to be executed by their duly authorized representatives as of the
date and year first above written.

 

	 	 	PURCHASER:
	 	 	 	 
	If
    a corporation or other entity:	 	 
	 	 	(name
    of corporation or entity)
	 	 	 	 
	 	 	By:	           
	 	 	Name:	 
	 	 	Title:	 

 

	If
    an individual:	 	By:	 

	 	 	Name
    (Please Print):	 

 

	 	 	 
	 	 	(Name
    of co-purchaser, if any):
	 	 	 	 
	Number
    of Purchaser Shares:	 	 
	 	 	 	 
	Contact
    Information:	 	Address:	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 	 
	 	 	Telephone:	 
	 	 	Facsimile:	 
	 	 	E-mail:	 

 

	Social
    Security Number or Tax Identification Number of the Registered Holder listed above:	 	 

 

[Purchaser
Signature Page to Stock Purchase Agreement]

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