Exhibit 10.1

 

CONSULTING SERVICES AGREEMENT

 

This Consulting & Retainer Agreement ("Agreement") is made effective as of March
30, 2020 (“Effective Date”), by and between a business entity known as Assure
Immune L.L.C. (“Assure”) with a mailing address of 1011 Sunnybrook, Suite 900,
Miami, Florida, 33140 and a business entity known as Organicell Regenerative
Medicine, Inc. with a mailing address of 4045 Sheridan Ave, Suite 239, Miami,
Florida, 33140 ("Client").

 

WHEREAS, Assure became a wholly owned subsidiary of AX Biotech, LLC, a Florida
based biotechnology companies. AX Biotech, LLC in September of 2015 and
relocated it from Boca Raton, Florida to Miami, Florida;

 

WHEREAS, after its acquisition by AX Biotech, Assure’s business is focused on
the distribution of the industry’s highest quality cells and tissues to enable
the development of life saving drugs and therapies to commercial/pharmaceutics
and academic investigators;

 

WHEREAS, Assure provides extensive services in submitting IRB and IND
applications for clients and in developing Quality Assurance & Quality Control
program for clients to establish top quality laboratory operations in order to
maintain quality assurance and compliance with all regulatory requirements of
FDA, FACT, CLIA, AABB and all other relevant governing organizations
(“Regulatory Agencies”);

 

WHEREAS, Ms. Khan and Ms. Xu are the co-owners of AX Biotech LLC, and the sole
principal executives of Assure;

 

WHEREAS, Organicell is a publicly traded Client committed to the research,
development and the manufacturing of new biologic medicines, with a focus on
current and potential regenerative therapeutics;

 

WHEREAS, Organicell’s mission is to transform regenerative medicine by
continuing to combine perinatal derived biologics and Exosome technology with
other synergistic therapies and become the healthcare technology incubator for
biologic medicine; and

 

WHEREAS, Assure’s expertise in regulatory compliance associated with
biotechnology products can assist Organicell in maximizing the efficacy of its
mission;

 

NOW THEREFORE in consideration of the foregoing and of the mutual covenants set
forth below and other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, Assure and Organicell, intending to
be legally bound hereby, agree as follows:

 

I.       Services. Assure agrees to provide the following services ("Services")
to the Client:

 

A)        Advising and assisting in assuring that Organicell is in compliance
with regulations of the Regulatory Agencies and other requirements governing the
Client’s research & development (new products, IND applications and clinical
trials) and ongoing laboratory and processing operations;

 

B)        Assist and facilitate Organicell’s ongoing efforts with respect to
Organicell’s already approved IRB’s, and identified pending additional IRB’s for
IND’s to be submitted for other identified indications being performed by
selected investigators named in the relevant studies and/or medical partners
(i.e. Hospital for Special Surgery & Mayo Clinic), including the assistance in
clinical monitoring of patients;

 

C)        Advise and Assist in developing, preparing and submitting patent
applications for certain qualifying products, trademarks, and/or protocols;

 

D)       Continue to provide all other required services to Organicell in
connection with its objectives to apply for, perform and complete clinical
trials for the purpose of obtaining FDA approval for its current and future
products and indications, and/or to maintain compliance with the all applicable
Regulatory Agencies in connection with its current operations, including
research and development, manufacturing, clinical monitoring and/or Quality
Assurance and Control.

 

II. Term. The Services shall commence upon the execution of this Agreement. This
Agreement has a term of 3 years, with an initial term of one (1) year and
automatic annual renewals for two (2) additional annual periods, unless written
notice is provided by either party 45 days prior to the applicable termination
date.

 

 

 

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III. Payment. In consideration for the Services provided, Assure is to be paid
the amounts of cash and common stock compensation as provided in Exhibit A:

 

IV. Expenses. Assure shall bear their own legal, accounting and other fees and
expenses incurred in connection with the Agreement, whether or not it is
executed.

 

V. Return of Records. Upon termination of this Agreement, Assure shall deliver
all records, notes, and data of any nature that are in Assure’s possession or
under Assure's control and that are of the Client's property or relate to
Client's business.

 

VI. Disputes. If any dispute arises under this Agreement, Assure and the Client
shall negotiate in good faith to settle such dispute. If the parties cannot
resolve such dispute themselves, then either party may submit the dispute to
mediation by a mediator approved by both parties. If the parties cannot agree
with any mediator or if either party does not wish to abide by any decision of
the mediator, they shall submit the dispute to arbitration by any mutually
acceptable arbitrator, or the American Arbitration Association (AAA). The costs
of the arbitration proceeding shall be borne according to the decision of the
arbitrator, who may apportion costs equally or in accordance with any finding of
fault or lack of good faith of either party. If either party does not wish to
abide by any decision of the arbitrator, they shall submit the dispute to
litigation.

 

If the dispute is submitted to litigation, each Party agrees that it shall bring
any legal action or proceeding to enforce or interpret the terms and conditions
of this Agreement or to collect any monies under it, exclusively in the courts
of the State of Florida, Miami-Dade county (the "Chosen Courts"). EACH PARTY
HERETO HEREBY KNOWINGLY, VOLUNTARILY, INTENTIONALLY AND IRREVOCABLY WAIVES, TO
THE FULLEST EXTENT PERMITTED BY APPLICABLE LEGAL REQUIREMENTS, THE RIGHT TO
TRIAL BY JURY IN ANY ACTION OR PROCEEDING BASED ON OR WITH RESPECT TO THIS
AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY OR RELATING OR
INCIDENTAL HERETO.

 

Notwithstanding the agreement to arbitrate disputes, any alleged breach of this
Agreement may be remedied by an injunction issued by a court of proper
jurisdiction. Such remedy shall not be in place of any other remedy available to
the Client or Assure. In the event an injunction is issued in favor of the
Client or Assure, Client or Assure will reimburse Assure or Client respectively
for all legal fees and costs incurred relating to the injunction.

 

VII. Liability Insurance. Assure agrees to bear all responsibility for the
actions related to themselves and their employees or personnel under this
Agreement. In addition, Assure agrees to obtain comprehensive liability
insurance coverage in case of bodily injury, personal injury, property damage,
contractual liability, and cross-liability. In addition, Assure shall be
required to have liability insurance equal to a single-limit of $1,000,000.00.

 

VIII. Legal Notice. All notices required or permitted under this Agreement shall
be in writing and shall be deemed delivered when delivered electronically and
deposited in the United States Postal Service via priority mail. All notices
required or permitted under this Agreement shall be sent to:

 

TO Organicell:

 

Albert Mitrani

Albert@organicell.com

Tel: 760 709 2510

 

Ian Bothwell

ian@organicell.com

Tel: 310 200 9741

 

TO Assure:

 

Aisha Khan

akhan@assureimmune.com

Tel: 305 783 8548

 

Xiumin Xu

Xiumin@assureimmune.com

Tel: 561 221 7522

 

 

 

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IX. Non-Compete. During the term of this Agreement, and for the maximum term
allowed under State and Federal laws following its termination, Assure shall not
engage in any activity that would compete in any way whatsoever with the
activities of the Client in which Assure was or is involved, or where Assure
gained confidential or sensitive information of the Client, directly or
indirectly through the delivery of the Services.

 

X. Non-Solicitation. During the term of this Agreement, and for the maximum term
allowed under State and Federal laws following its termination (“Solicitation
Period”), Assure shall not, without the written consent of the Client, directly
or indirectly, solicit or attempt to solicit any person who was:

 

(a) A customer of the Client as of the date of this Agreement was terminated;

 

(b) A customer of the Client at any time within the Solicitation Period
immediately before the date of the termination of this Agreement;

 

(c) Solicited as a prospective customer by the Client at any time during the
provision of Services under this Agreement, should Assure have had knowledge of
this pursuit; or

 

(d) An employee, contractor or partner of the Client as of the date this
Agreement was terminated or within the one-year period immediately before the
date of the termination of this Agreement.

 

XI. Waiver of Contractual Right. The failure of either party to enforce any
provision of this Agreement shall not be construed as a waiver or limitation of
that party's right to subsequently enforce and compel strict compliance with
every provision of this Agreement.

 

XII. Independent Contractor Status. Assure, under the code of the Internal
Revenue (IRS), is an independent contractor and neither Assure’s employees or
contract personnel are, or shall be deemed, the Clients’ employees. In its
capacity as an independent contractor, Assure agrees and represents:

 

a.) Assure has the right to perform Services for others during the term of this
Agreement;

 

b.) Assure has the sole right to control and direct the means, manner, and
method by which the Services required under this Agreement will be performed;
Assure shall select the routes taken, starting and ending times, days of work,
and order the work that performed;

 

c.) Assure has the right to hire assistant(s) as subcontractors or to use
employees to provide the Services under this Agreement.

 

d.) Neither Assure nor Assure’s employees or personnel shall be required to wear
any uniforms provided by the Client;

 

e.) Neither Assure nor Assure’s employees or personnel shall receive any
training from the Client for the professional skills necessary to perform the
Services required by this Agreement; and

 

f.) Neither Assure nor Assure’s employees or personnel shall be required by the
Client to devote full-time to the performance of the Services required by this
Agreement.

 

XIII. Payment of Taxes. Under this Agreement, the Client shall not be
responsible for:

 

a.) Withholding FICA, Medicare, Social Security, or any other Federal or State
withholding taxes from Assure’s payments to employees or personnel or make
payments on behalf of Assure;

 

b.) Making Federal and/or State unemployment compensation contributions on
Assure’s behalf; and

 

XIV. Employees' Compensation. Assure shall be solely responsible for the
following if it is applicable:

 

 

 

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a.) Employee Benefits. Assure understand and agree that they are solely
responsible and shall be liable to all benefits that are provided to their
employees including, but not limited to, retirement plans, health insurance,
vacation time-off, sick pay, personal leave, or any other benefit provided.

 

b.) Unemployment Compensation. Assure shall be solely responsible for the
unemployment compensation payments on behalf of their employees and personnel.
Assure shall not be entitled to unemployment compensation with the Services
performed under this Agreement.

 

c.) Workers’ Compensation. Assure shall be responsible for providing all
workers' compensation insurance on behalf of their employees. If Assure hire
employees to perform any work under this Agreement, Assure agrees to grant
workers' compensation coverage to the extent required by law. Upon request by
the Client, Assure must provide certificates proving workers' compensation
insurance at any time during the performance of the Services.

 

XV. Indemnity. Assure and Client shall both release, defend, indemnify, and hold
harmless the Client and Assure and their officers, agents, and employees from
all suits, actions, or claims of any character, name, or description including
reasonable attorney fees, brought on account of any injuries or damage, or loss
(real or alleged) received under this Agreement.

 

XVI. Confidentiality & Proprietary Information. Assure acknowledge that it will
be necessary for the Client to disclose certain confidential and proprietary
information to Assure in order for Assure to perform their duties under this
Agreement. Assure acknowledge that disclosure to a third (3rd) party or misuse
of this proprietary or confidential information would irreparably harm the
Client. Accordingly, Assure will not disclose or use, either during or after the
term of this Agreement, any proprietary or confidential information of the
Client without the Client's prior written permission except to the extent
necessary to perform the Services on the Client's behalf.

 

Proprietary or confidential information includes, but is not limited to:

 

a.) The written, printed, graphic, or electronically recorded materials
furnished by Client for Assure to use;

 

b.) Any written or tangible information stamped "confidential," "proprietary,"
or with a similar legend, or any information that Client makes reasonable
efforts to maintain the secrecy of, including, but not limited to, strategic
plans, product information, cost information, technical information, business
plans or policies, concepts, ideas, concepts, experimental and research data;
service techniques and protocols, business and marketing plans; information
relating to financial information, pricing, cost and sales information,
contractual arrangements (and other information about a party to this
agreement), any of its subsidiaries’ and their affiliates’ actual and
prospective employees, customers, suppliers and vendors, patents and patent
applications, inventions and improvements (whether patentable or not),
development projects, computer software and related documentation and materials,
designs, practices, processes, methods, know-how, techniques and other facts
relating to the actual or planned business operations of a party to this
agreement, its subsidiaries and Affiliates; and all other trade secrets and
information of a confidential and proprietary nature; and

 

c.) Information belonging to customers and suppliers of the Client about whom
Assure gained knowledge as a result of Assure’s Services to the Client.

 

d.) Confidential Information does not, however, include information that Assure
can demonstrate: (i) is now, or hereafter becomes, through no breach of this
Agreement on the part of the Receiving Party, generally known or available to
the public; (ii) was known by the Receiving Party before receiving such
information from Disclosing Party; (iii) is hereafter rightfully obtained by
Receiving Party from a third party, without breach of any obligation to
Disclosing Party; or (iv) is independently developed by Receiving Party without
use of or reference to the Confidential Information by persons who had no access
thereto.

 

Upon termination of Assure’s Services to the Client, or at the Client's request,
Assure shall deliver all materials to the Client in Assure’s possession relating
to the Client's business. Assure acknowledge any breach or threatened breach of
confidentiality under this Agreement will result in irreparable harm to the
Client for which damages would be an inadequate remedy. Therefore, the Client
shall be entitled to equitable relief, including an injunction, in the event of
such breach or threatened breach of confidentiality. Such equitable relief shall
be in addition to Client's rights and remedies otherwise available at law.

 

 

 

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Furthermore, proprietary information, under this Agreement, shall include:

 

e.) The product of all work performed under this Agreement ("Organicell
Product"), including without limitation all notes, reports, documentation,
drawings, computer programs, inventions, creations, works, devices, models,
works-in-progress and deliverables, will be the sole property of the Client, and
Assure hereby assign to the Client all right, title, and interest therein,
including, but not limited to, all audiovisual, literary, moral rights and other
copyrights, patent rights, trade secret rights, and other proprietary rights
therein. Assure retain no right to use the Organicell Product and agrees not to
challenge the validity of the Client's ownership in the Organicell Product;

 

f.) Assure hereby assigns to the Client all right, title, and interest in any
and all photographic images and videos or audio recordings made by the Client
during Assure’s work for them, including, but not limited to, any royalties,
proceeds, or other benefits derived from such photographs or recordings; and

 

g.) The Client will not be entitled to use Assure’s name and/or likeness in
advertising and other materials prior a writing approval from Assure.

 

This section shall survive for a period of three (3) years following the
termination of this Agreement.

 

XVII. Intellectual Property Ownership.

 

Assure agrees that all intellectual property or products developed or created by
the Client during the course of performing work for or on behalf of Client
(collectively, the "Organicell Product") will belong exclusively to Client.
Assure agrees to automatically assign, at the time of creation of the Organicell
Product, without any requirement of further consideration, any right, title, or
interest Assure may have in such Organicell Product, including any copyrights,
patents, patentable material, trade secrets, trademarks or other intellectual
property rights pertaining thereto. Upon request of Client, and at Client’s sole
expense, Client will execute such relevant documents as may be necessary to
perfect Client's interest or assignment in such intellectual property or
products.

 

XVIII. Assignment and Delegation. Assure may assign rights and may delegate
duties under this Agreement to other individuals or entities acting as a
subcontractor ("Subcontractor"). Assure recognizes that they shall be liable for
all work performed by the Subcontractor and shall hold the Client harmless of
any liability in connection with their performed work.

 

Assure shall be responsible for any confidential or proprietary information that
is shared with the Subcontractor in accordance with this section. If any such
information is shared by the Subcontractor to third (3rd) parties, Assure shall
be made liable.

 

XIX. Governing Law. This Agreement shall be governed under the laws in the State
of Florida.

 

XX. Severability. This Agreement shall remain in effect in the event a section
or provision is unenforceable or invalid. All remaining sections and provisions
shall be deemed legally binding unless a court rules that any such provision or
section is invalid or unenforceable, thus, limiting the effect of another
provision or section. In such case, the affected provision or section shall be
enforced as so limited.

 

XXI. Additional Terms and Conditions.

 

A. Scope of Services. The Parties agree that Assure Contracts are intended to
provide that Assure perform their services to Organicell to the fullest extent
reasonably practical. Assure are aware that the Client is relying on the
expertise, experience, advice and direction of Assure associated with critical
functional executive level roles of the Client as it relates to the oversight
and management of the Client’s regulatory, research and development and
laboratory operations, consistent with the Client’s corporate mission and
strategies and subject to the resource limitations of the Client.

 

B. Non-disparagement. Both Assure and the Client agree not to disparage the
other party, and the other party's officers, directors, employees, shareholders
and agents, in any manner likely to be harmful to them or their business,
business reputation or personal reputation; provided that both Assure and the
Client will respond accurately and fully to any question, inquiry or request for
information when required by legal process.

 

 

 

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XXII. Counterparts. This Agreement may be executed in one or more counterparts,
each of which shall be deemed to be an original, but all of which shall
constitute one agreement. Photocopies, facsimile transmissions, or email
transmissions of Adobe portable document format files (also known as "PDF"
files) of signatures shall be deemed original signatures and shall be fully
binding on the Parties to the same extent as original signatures.

 

XXIII. Amendments; Waivers. This Agreement may not be modified, amended or
supplemented except by a written instrument signed by the Parties. In addition,
no waiver of any provision of this Agreement shall be binding unless set forth
in a writing signed by the Parties. Any waiver shall be limited to the
circumstance or event specifically referenced in the written waiver document and
shall not be deemed a waiver of any other term of this Agreement or of the same
circumstance or event upon any recurrence thereof.

 

XXIV. Headings. Section and other headings contained in this Agreement are for
reference purposes only and are not intended to describe, interpret, define, or
limit the scope, extent, or intent of this Agreement or any provision hereof.

 

XXV. Entire Agreement. This Agreement, along with any attachments or addendums,
represents the entire agreement between the parties. Therefore, this Agreement
supersedes any prior agreements, promises, conditions, or understandings between
the Client and Assure.

 

Signature Page Follows

 

 

 

 

 

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IN WITNESS WHEREOF, and intending to be legally bound hereby, Assure and the
Client hereby execute the foregoing Agreement.

 

ORGANICELL REGENERATIVE MEDICINE, INC.

 

BY: _______________________________ Date ________________

Name:______________________________

Title:_______________________________

 

ASSURE IMMUNE L.L.C.

 

BY: _______________________________ Date ________________

Name:______________________________

Title:_______________________________

 

BY: _______________________________ Date ________________

Name:______________________________

Title:_______________________________

 

 

 

 

 

 

 

 

 

 

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