Filing # 195716800 E-Filed 04/08/2024 03:55:55 PM
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`IN THE CIRCUIT COURT OF THE 11TH
`JUDICIAL CIRCUIT,
`IN AND FOR
`MIAMI-DADE COUNTY, FLORIDA
`
`CASE NO.
`
`
`
`
`
`
`
`ZEO SCIENTIFIX, INC.,
`a Nevada corporation, f/k/a Organicell
`Regenerative Medicine, Inc.,
`
`
`Plaintiff,
`
`
`v.
`
`ASSUREIMMUNE, LLC, a Florida
`limited liability company,
`a/k/a ASSURE IMMUNE L.L.C.,
`AISHA KHAN, an individual, and
`XIUMIN XU, an individual,
`
`Defendants.
`
`_________________________________/
`
`
`
`COMPLAINT
`
`
`
`Plaintiff, ZEO ScientifiX, Inc., f/k/a Organicell Regenerative Medicine, Inc. (“Organicell”
`
`or “ZEO”), sues Defendants, AssureImmune, LLC, a/k/a Assure Immune L.L.C. (“Assure”), Aisha
`
`Khan (“Khan”), and Xiumin Xu (“Xu”), and alleges:
`
`NATURE OF THE ACTION
`
`1.
`
`This case arises from the egregious misconduct and contractual breaches of Assure,
`
`a company that designs FDA clinical trial studies, including consulting services in connection with
`
`the submission of Institutional Review Board (“IRB”) and Investigational New Drug (“IND”)
`
`applications, and the negligence of Assure’s two consultants, Khan and Xu, who acted
`
`incompetently, consistently delivering misguided advice and failing to grasp the true nature of the
`
`work they performed for Organicell.
`
`

`

`2.
`
`The actions of Assure, Khan and Xu caused substantial financial harm to
`
`Organicell, n/k/a ZEO ScientifiX, Inc., a publicly traded, clinical-stage biopharmaceutical
`
`company focused on the development of innovative biological regenerative therapeutics.
`
`3.
`
`Assure agreed to provide consulting services and “expertise” to “assist Organicell
`
`in maximizing the efficacy of its mission”, acknowledgment that Organicell “is relying on the
`
`expertise, experience, advice and direction of Assure associated with critical functional executive
`
`level roles of [Organicell] as it relates to the oversight and management of [Organicell’s]
`
`regulatory, research and development and laboratory operations, consistent with [Organicell’s]
`
`corporate mission and strategies and subject to the resource limitations of [Organicell]”.
`
`4.
`
`Organicell paid Assure compensation exceeding $1 million in consulting fees and
`
`approximately 70 million shares of Organicell common stock were paid by Organicell to Khan
`
`and Xu.
`
`5.
`
`Assure, Khan and Xu, however, failed to honor their contractual and common law
`
`obligations to Organicell. For example, Assure, Khan and Xu selected and designed studies for
`
`Organicell that were unnecessary, excessive, wasteful and costly, causing Organicell to enter into
`
`substantial contractual financial obligations and a resulting squandering of Organicell’s funds.
`
`Some of those studies were designed to produce unnecessary efficacy data of limited practical
`
`value. Most studies involved were never completed. In addition, Assure engaged in activities that
`
`interfered with its contractual commitment to fully engage available time outside of its principals’
`
`full-time work with The University of Miami Miller School of Medicine (“UOM”), and, upon
`
`information and belief, directly competed with the requirement to use all their available time
`
`outside of UOM towards the activities of Organicell and directly competed with the activities of
`
`Organicell, contrary to the agreement. Moreover, to date, Assure has failed to deliver all
`
`- 2 -
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`

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`proprietary and confidential materials in Assure’s possession to Organicell relating to Organicell’s
`
`business as specifically required by the agreement.
`
`JURISDICTION, PARTIES, VENUE, AND CONDITIONS PRECEDENT MET
`
`6.
`
`This is an action for damages in which the amount in controversy exceeds
`
`$50,000.00, exclusive of interest, attorney’s fees and costs.
`
`7.
`
`Plaintiff, ZEO, is a Nevada corporation, with its principal place of business in
`
`Broward County, Florida. ZEO was formerly known as Organicell.
`
`8.
`
`Defendant, Assure, is a Florida limited liability company, with its principal place
`
`of business in Palm Beach County, Florida. Assure became a wholly owned subsidiary of AX
`
`Biotech, LLC in September of 2015. AX Biotech is owned by Khan and Xu.
`
`9.
`
`Defendant, Khan, is an individual over the age of eighteen, and upon information
`
`and belief, resides in Broward County, Florida. Khan is the Executive Director, Laboratory
`
`Operations of UOM.
`
`10. Defendant, Xu, is an individual over the age of eighteen, and upon information and
`
`belief, resides in Miami-Dade County, Florida. Xu is the Director, Laboratory Services of UOM.
`
`11. Venue is proper in this County because of the mandatory venue provision in the
`
`agreement at issue and this County is where the cause of action accrued.
`
`12. All conditions precedent to filing this action, including any required notices or
`
`demands, have been performed, have occurred, or have been excused or waived.
`
`13.
`
`Prior to filing this action, Plaintiff participated in a more than 10-hour in-person
`
`settlement meeting attended by all parties, their representatives and attorneys, and also a multi-
`
`hour mediation session conducted by an independent mediator selected by Defendants. Despite
`
`Plaintiff’s lengthy, multiple, good faith efforts to resolve this dispute, the parties could not reach
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`- 3 -
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`a resolution. Although the subject Consulting Agreement includes language referring to arbitration
`
`(non-binding), it remains uncertain whether non-binding arbitration is required (“If either party
`
`does not wish to abide by any decision of the arbitrator, they shall submit the dispute to litigation”),
`
`and/or whether non-binding arbitration is necessary given the pre-litigation history of this matter.
`
`Additionally, the absence of established case law in Florida renders uncertain the effect of non-
`
`binding arbitration on the tolling of statutes of limitations. Accordingly, due to the ongoing running
`
`of the statutes of limitations on Plaintiff’s claims, Plaintiff files this Complaint in good faith to
`
`protect and preserve its rights and remedies. Further, because Khan and Xu are not parties to the
`
`Consulting Agreement, the dispute resolution procedure contained therein do not apply to them.
`
`14.
`
`Plaintiff has retained the undersigned law firm as its attorneys and has agreed to
`
`pay the firm legal expenses and costs, including attorney’s fees, incurred in this action.
`
`COUNT I - BREACH OF CONTRACT AND THE
`IMPLIED COVENANTS OF GOOD FAITH AND FAIR DEALING
`(Against Assure)
`
`This is an action against Assure for breach of contract and the implied covenants of
`
`15.
`
`good faith and fair dealing.
`
`16.
`
`Plaintiff realleges and incorporates by reference paragraphs 1-8 and 11-14 above,
`
`as if fully set forth herein.
`
`17. As of March 30, 2020, Organicell and Assure entered into a Consulting Agreement
`
`(the “Agreement”). The Agreement was amended in part. A true and correct copy of the Agreement
`
`and its amendments are attached as Composite Exhibit A.
`
`18.
`
`Pursuant to the Agreement, Assure agreed to, inter alia, provide Organicell with
`
`certain consulting services and refrain from other activities. In exchange, Organicell agreed to pay
`
`Assure certain compensation.
`
`- 4 -
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`

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`19. Assure materially breached the Agreement by, inter alia:
`
`
`
`a.
`
`Selecting and conducting studies that were overdesigned, unnecessary and
`
`costly, which also led to scientifically unsound results.
`
`For example, Assure designed a Phase 1/2 study for COVID LH that was budgeted to cost
`
`approximately $1.3MM, while typical safety Phase 1 studies cost $250k-$300k. The cost disparity
`
`resulted from measuring over 45 additional endpoints, adopting randomized, blinded, and
`
`controlled aspects rare in early studies. These extra endpoints were uninterpretable due to the small
`
`sample size.
`
`FDA approval was based on a maximum of 15 patients receiving the biologic (the study
`
`also called for 15 patients that were to receive placebo), a standard Phase 1 size. The biologic’s
`
`risk aligned with FDA-accepted levels for Phase 1 studies. Non-safety endpoints were minimally
`
`invasive, posing negligible added risk. The FDA does not factor study cost into approval decisions,
`
`focusing only on incremental patient risk.
`
`While a randomized, double-blind, controlled design does not increase patient risk, it
`
`significantly raises study execution costs and time to completion. Despite endpoint findings, with
`
`only 15 treated patients, the FDA still mandates a legitimate Phase 2 (with 100 or more patients).
`
`This resulted in a wasted $700,000 for the COVID LH study, a recurring issue in study protocols
`
`designed by Assure. Assure also designed a Phase 1/2 study for COPD that was budgeted to cost
`
`approximately $1.8MM and a Phase 1/2 study for OA that was budgeted to cost approx. $1.3MM.
`
`The Agreement required Assure to provide “expertise” to “assist Organicell in maximizing
`
`the efficacy of its mission,” and acknowledged that Organicell “is relying on the expertise,
`
`experience, advice and direction of Assure associated with critical functional executive level roles
`
`of [Organicell] as it relates to the oversight and management of [Organicell’s] regulatory, research
`
`- 5 -
`
`

`

`and development and laboratory operations, consistent with [Organicell’s] corporate mission and
`
`strategies and subject to the resource limitations of [Organicell]. Assure failed to comply with its
`
`contractual obligations in this regard.”
`
`In addition, the studies Assure designed were for Phase 1 trials, not Phase 2 trials. They
`
`were not Phase 2 simply because they are named “Phase 1/2”. Phase 2 studies are done to help
`
`optimize the dose of the biologic, provide hypotheses to test that help to design the much more
`
`important Phase 3 studies and add to the safety information first provided in a properly designed
`
`Phase 1. All the studies that Assure helped to design had sample sizes that were so small they had
`
`virtually no chance to provide any efficacy information. Any efficacy analysis that could be
`
`attempted had more of a chance to mislead the true efficacy given the substantially underpowered
`
`studies (most Phase 2 studies typically have over 100 subjects, these studies had between 20-30,
`
`where half were controls). In addition, the studies had a “randomized” design unnecessary for a
`
`Phase 1 study and were inappropriate for a study of only ~20-30 patients. This not only increased
`
`the cost of the studies - but also reduced by 50% the number of subjects receiving the therapy and
`
`reduced the useful safety data generated by the studies.
`
`Often, there were many more outcome variables than subjects. All this shows a lack of
`
`introductory statistical study design knowledge. The result: overdesigned, overly complicated
`
`execution and overpriced studies that provide no more reliable information than a Phase 1 safety
`
`study does. An actual appropriate Phase 1 design would have been approximately 1/3 to 1/4 the
`
`cost.
`
`Three of the four choices of clinical indications for the IND’s were in areas that included
`
`extremely complicated patients clinically. Here, the sample size needed to be even larger to
`
`account for this complexity to identify any efficacy. For a company the size of Organicell, it was
`
`- 6 -
`
`

`

`important to choose clinical indications where the pathophysiology is better understood and
`
`matches what is known of the mechanism of action of the biologic. This would optimize the
`
`probability of success, especially important in a company with limited resources. This was not
`
`done for the studies Assure designed.
`
`The COVID studies were misguided because there was limited knowledge regarding many
`
`of the clinical issues these patients have. Also, regarding COVID, patient availability was always
`
`changing making it difficult to recruit patients when there was a predictable downturn in incidence.
`
`The COVID Long Haul study was even more misguided because the definition of Long Haul was
`
`not yet set, and the incidence was even more volatile.
`
`
`
`The COPD study was also an inappropriate choice because the patients must be enrolled
`
`exactly in the right time course of the disease for any efficacy analysis. Too soon, and the biologic
`
`has little possibility of showing efficacy. Too late in the course of the disease, where the lung tissue
`
`is severely damaged, also provides no real possibility of identifying efficacy for any treatment.
`
`Most of the work and money to put together these IND applications, or the attempt to execute these
`
`overly complicated studies, was wasted;
`
`
`
`b.
`
`Failing to properly advise Organicell on the regulatory requirements
`
`governing its research and development initiatives, including new product development, IND
`
`applications, and clinical trials;
`
`
`
`c.
`
`Failing to assist and facilitate Organicell’s ongoing efforts concerning its
`
`approved IND’s and IRBs, hindering its progress in obtaining necessary approvals for its research;
`
`
`
`d.
`
`Failing to provide all required services to Organicell in connection with its
`
`objectives to apply for, perform, and complete clinical trials for FDA approval of current and future
`
`products and indications;
`
`- 7 -
`
`

`

`
`
`e.
`
`Failing to provide proper expertise, experience, advice, and direction
`
`associated with critical executive-level roles at Organicell, consistent with Organicell’s corporate
`
`mission and strategies, particularly in overseeing and managing Organicell’s regulatory, research
`
`and development, and laboratory operations;
`
`
`
`f.
`
`Failing to dedicate the necessary work-related time to Organicell-related
`
`efforts in accordance with the Agreement, undermining the progress of Organicell’s research and
`
`development activities;
`
`
`
`
`
`g.
`
`Inadequate oversight, review, guidance (as their expertise would suggest)
`
`in the Company’s need to draw-up and negotiate contracts with each clinical site, data safety
`
`monitoring board (“DSMB”), and Contract Research Organization (“CRO”), which proved to be
`
`unnecessary and contrary to industry practices, and resulted in significant costs. It is rare for
`
`companies the size of Organicell to negotiate separate engagement contracts with individual
`
`clinical sites and DSMB’s. This was done for each study started under Assure. Each contract
`
`required substantial legal expense, and the company had little to no experience negotiating such
`
`contracts. The way this is almost always done is to first choose a qualified CRO and have them
`
`negotiate these contracts. Having the CRO contract the sites and DSMB’s is crucial, not only
`
`because they have the experience and infrastructure to negotiate the contracts, but they typically
`
`have significant experience in choosing the right clinical sites. The success or failure of studies are
`
`significantly contingent on having the right clinical sites participate. Many of the clinical sites
`
`chosen for Organicell’s studies were not appropriate for the study they were asked to execute. As
`
`a result, recruitment was predictably low, and the quality of the data was below standard;
`
`
`
`h.
`
`Failing to adequately contribute to obtaining INDs from the FDA, with
`
`Organicell having to take on much of the workload;
`
`- 8 -
`
`

`

`
`
`i.
`
`Engaging in activities that interfered with the commitment to fully engage
`
`their available time outside of their full-time work with UOM, and, upon information and belief,
`
`directly competing with the activities of Organicell through its work for Frontier Biologics, a
`
`competitor of Organicell;
`
`
`
`
`
`
`
`
`
`j.
`
`k.
`
`Failing to provide ROFR on future projects; and
`
`Failing to deliver all proprietary and confidential materials to Organicell in
`
`Assure’s possession relating to Organicell’s business as specifically required by the Agreement.
`
`20.
`
`In addition to its breach of the express terms of the Agreement, Assure also
`
`breached the implied covenants of good faith and fair dealing arising from the Agreement.
`
`21.
`
`Florida law recognizes the implied covenants of good faith and fair dealing in every
`
`contract. The implied covenants of good faith and fair dealing require that neither party act in a
`
`manner contrary to the reasonable expectations of the other party and imposes upon each party the
`
`duty to do nothing destructive of the other party’s right to enjoy the fruits of a contract. As alleged
`
`above, Assure acted contrary to the reasonable expectations of Organicell and its actions and
`
`inactions prevented Organicell from enjoying the full benefit of the Agreement.
`
`22. As a direct result of Assure’s breach of the Agreement and the implied covenants
`
`of good faith and fair dealing, Plaintiff suffered substantial damages.
`
`
`
`WHEREFORE, Plaintiff, ZEO ScientifiX, Inc., f/k/a Organicell Regenerative Medicine,
`
`Inc., demands judgment for damages against Defendant, AssureImmune, LLC, a/k/a Assure
`
`Immune L.L.C., including the value of all benefits furnished to Assure under the Agreement,
`
`including paid consulting fees and stock, and other damages sustained by Organicell, prejudgment
`
`interest, court costs, and such other and additional relief as the Court deems just and proper.
`
`- 9 -
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`

`

`COUNT II – NEGLIGENCE
`(Against Khan and Xu)
`
`This is an action against Khan and Xu for negligence.
`
`Plaintiff realleges and incorporates by reference paragraphs 1-6 and 8-14 above, as
`
`23.
`
`24.
`
`if fully set forth herein.
`
`25. Khan and Xu are not parties to the Consulting Agreement.
`
`26. Khan and Xu, in their individual capacities, undertook work for Organicell and
`
`were directly given Organicell common stock in exchange.
`
`27. Ny undertaking work for Organicell and performing the work in their individual
`
`capacities, Khan and Xu had a duty of care to Assure. Khan and Xu were expected to perform their
`
`services with the same level of care, skill, and diligence that would be expected of reasonably
`
`competent professionals in their field.
`
`28. Khan and Xu breached the duty of care to Organicell by:
`
`
`
`a.
`
`Selecting and conducting studies that were overdesigned, unnecessary and
`
`costly, which also led to scientifically unsound results.
`
`For example, Assure designed a Phase 1/2 study for COVID LH that was budgeted to cost
`
`approximately $1.3MM, while typical safety Phase 1 studies cost $250k-$300k. The cost disparity
`
`resulted from measuring over 45 additional endpoints, adopting randomized, blinded, and
`
`controlled aspects rare in early studies. These extra endpoints were uninterpretable due to the small
`
`sample size.
`
`FDA approval was based on a maximum of 15 patients receiving the biologic (the study
`
`also called for 15 patients that were to receive placebo), a standard Phase 1 size. The biologic’s
`
`risk aligned with FDA-accepted levels for Phase 1 studies. Non-safety endpoints were minimally
`
`- 10 -
`
`

`

`invasive, posing negligible added risk. The FDA does not factor study cost into approval decisions,
`
`focusing only on incremental patient risk.
`
`While a randomized, double-blind, controlled design does not increase patient risk, it
`
`significantly raises study execution costs and time to completion. Despite endpoint findings, with
`
`only 15 treated patients, the FDA still mandates a legitimate Phase 2 (with 100 or more patients).
`
`This resulted in a wasted $700,000 for the COVID LH study, a recurring issue in study protocols
`
`designed by Assure. Assure also designed a Phase 1/2 study for COPD that was budgeted to cost
`
`approximately $1.8MM and a Phase 1/2 study for OA that was budgeted to cost approx. $1.3MM.
`
`The Agreement required Assure to provide “expertise” to “assist Organicell in maximizing
`
`the efficacy of its mission,” and acknowledged that Organicell “is relying on the expertise,
`
`experience, advice and direction of Assure associated with critical functional executive level roles
`
`of [Organicell] as it relates to the oversight and management of [Organicell’s] regulatory, research
`
`and development and laboratory operations, consistent with [Organicell’s] corporate mission and
`
`strategies and subject to the resource limitations of [Organicell]. Assure failed to comply with its
`
`contractual obligations in this regard.”
`
`In addition, the studies Assure designed were for Phase 1 trials, not Phase 2 trials. They
`
`were not Phase 2 simply because they are named “Phase 1/2”. Phase 2 studies are done to help
`
`optimize the dose of the biologic, provide hypotheses to test that help to design the much more
`
`important Phase 3 studies and add to the safety information first provided in a properly designed
`
`Phase 1. All the studies that Assure helped to design had sample sizes that were so small they had
`
`virtually no chance to provide any efficacy information. Any efficacy analysis that could be
`
`attempted had more of a chance to mislead the true efficacy given the substantially underpowered
`
`studies (most Phase 2 studies typically have over 100 subjects, these studies had between 20-30,
`
`- 11 -
`
`

`

`where half were controls). In addition, the studies had a “randomized” design unnecessary for a
`
`Phase 1 study and were inappropriate for a study of only ~20-30 patients. This not only increased
`
`the cost of the studies - but also reduced by 50% the number of subjects receiving the therapy and
`
`reduced the useful safety data generated by the studies.
`
`Often, there were many more outcome variables than subjects. All this shows a lack of
`
`introductory statistical study design knowledge. The result: overdesigned, overly complicated
`
`execution and overpriced studies that provide no more reliable information than a Phase 1 safety
`
`study does. An actual appropriate Phase 1 design would have been approximately 1/3 to 1/4 the
`
`cost.
`
`Three of the four choices of clinical indications for the IND’s were in areas that included
`
`extremely complicated patients clinically. Here, the sample size needed to be even larger to
`
`account for this complexity to identify any efficacy. For a company the size of Organicell, it was
`
`important to choose clinical indications where the pathophysiology is better understood and
`
`matches what is known of the mechanism of action of the biologic. This would optimize the
`
`probability of success, especially important in a company with limited resources. This was not
`
`done for the studies Assure designed.
`
`The COVID studies were misguided because there was limited knowledge regarding many
`
`of the clinical issues these patients have. Also, regarding COVID, patient availability was always
`
`changing making it difficult to recruit patients when there was a predictable downturn in incidence.
`
`The COVID Long Haul study was even more misguided because the definition of Long Haul was
`
`not yet set, and the incidence was even more volatile.
`
`
`
`The COPD study was also an inappropriate choice because the patients must be enrolled
`
`exactly in the right time course of the disease for any efficacy analysis. Too soon, and the biologic
`
`- 12 -
`
`

`

`has little possibility of showing efficacy. Too late in the course of the disease, where the lung tissue
`
`is severely damaged, also provides no real possibility of identifying efficacy for any treatment.
`
`Most of the work and money to put together these IND applications, or the attempt to execute these
`
`overly complicated studies, was wasted;
`
`
`
`b.
`
`Failing to properly advise Organicell on the regulatory requirements
`
`governing its research and development initiatives, including new product development, IND
`
`applications, and clinical trials;
`
`
`
`c.
`
`Failing to assist and facilitate Organicell’s ongoing efforts concerning its
`
`approved IND’s and IRB’s, hindering its progress in obtaining necessary approvals for its research;
`
`
`
`d.
`
`Failing to provide proper expertise, experience, advice, and direction to
`
`Organicell;
`
`
`
`e.
`
`Failing to dedicate the necessary work-related time to Organicell-related
`
`efforts in accordance with the Agreement, undermining the progress of Organicell’s research and
`
`development activities;
`
`
`
`
`
`f.
`
`Inadequate oversight, review, guidance (as their expertise would suggest)
`
`in the Company’s need to draw-up and negotiate contracts with each clinical site, data safety
`
`monitoring board (“DSMB”), and Contract Research Organization (“CRO”), which proved to be
`
`unnecessary and contrary to industry practices, and resulted in significant costs. It is rare for
`
`companies the size of Organicell to negotiate separate engagement contracts with individual
`
`clinical sites and DSMB’s. This was done for each study started under Assure. Each contract
`
`required substantial legal expense, and the company had little to no experience negotiating such
`
`contracts. The way this is almost always done is to first choose a qualified CRO and have them
`
`negotiate these contracts. Having the CRO contract the sites and DSMB’s is crucial, not only
`
`- 13 -
`
`

`

`because they have the experience and infrastructure to negotiate the contracts, but they typically
`
`have significant experience in choosing the right clinical sites. The success or failure of studies are
`
`significantly contingent on having the right clinical sites participate. Many of the clinical sites
`
`chosen for Organicell’s studies were not appropriate for the study they were asked to execute. As
`
`a result, recruitment was predictably low, and the quality of the data was below standard; and
`
`
`
`
`
`g.
`
`Failing to adequately contribute to obtaining INDs from the FDA, with
`
`Organicell having to take on much of the workload.
`
`29. As a direct and proximate result of Khan and Xu breach of their duties to Organicell,
`
`Plaintiff suffered substantial damages.
`
`
`
`WHEREFORE, Plaintiff, ZEO ScientifiX, Inc., f/k/a Organicell Regenerative Medicine,
`
`Inc., demands judgment for damages against Defendants, Aisha Khan, and Xiumin Xu, jointly and
`
`severally, including all shares of Organicell common stock delivered to Khan and Xu, all fees paid
`
`to Khan and Zu, and all other damages sustained by Organicell, prejudgment interest, court costs,
`
`and such other and additional relief as the Court deems just and proper.
`
`
`Dated: April 8, 2024
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`- 14 -
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`BERGER SINGERMAN LLP
`Attorneys for Plaintiff, ZEO ScientifiX, Inc.,
`f/k/a Organicell Regenerative Medicine, Inc.
`201 East Las Olas Boulevard
`Suite 1500
`Fort Lauderdale, Florida 33301
`Telephone: (954) 525-9900
`Facsimile: (954) 523-2872
`
`By: s/Jeffrey S. Wertman
`Jeffrey S. Wertman
`Florida Bar No. 003093
`JWertman@bergersingerman.com
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` 12877626-5
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`Email Designation per Fla. R. Jud.
` Admin 2.516:
` JWertman@bergersingerman.com
` DRT@bergersingerman.com
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`COMPOSITE EXHIBIT A
`COMPOSITE EXHIBIT A
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`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;
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`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 developmentoflife saving
`drugs and therapies to commercial/pharmaceutics and academic investigators;
`
`WHEREAS,Assure provides extensive services in submitting [RB and IND applications for
`clients and in developing Quality Assurance & Quality Control program forclients to establish top
`quality laboratory operations in order to maintain quality assurance and compliance with all
`regulatory requirements ofFDA, FACT, CLIA, AABBandall 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;
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`. 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
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`WHEREAS, Assure’s expertise in regulatory compliance associated with biotechnology
`products can assist Organicell in maximizing the efficacy of its mission;
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`NOW THEREFOREin consideration of the foregoing and ofthe mutual covenantsset 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,
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`Services. Assure agrees to provide the following services ("Services") to the Client:
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`Advising and assisting in assuring that Organicell is in compliance with regulations of the
`A)
`Regulatory Agencies and other requirements governing the Client’s research & development (new
`products, IND applications and clinical trials) and ongoing laboratory and processing operations;
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`Assistandfacilitate Organicell’s ongoing efforts with respect to Organicell’s already approved
`B)
`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;
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`Advise and Assist in developing, preparing and submitting patent applications for certain
`C)
`qualifying products, trademarks, and/or protocols;
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`Continue to provide all other required services to Organicell in connection with its objectives
`D)
`to apply for, perform and complete clinical trials for the purpose of obtaining FDA approval forits
`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.
`
`Il, Term, The Services shall commence upon the execution of this Agreement. This
`Agreementhas 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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`IIL. Payment, In consideration for the Services provided, Assure is to be paid the amounts of
`cash and commonstock 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, whetherornotit 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 mediatoror 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 offault orlack of good faith of eitherparty. If either party does not wish to abide by any
`decision of the arbitrator, they shall submit the disputeto litigation.
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`If the dispute is submitted to litigation, each Party agrees that it shall bring any legal action or
`proceedingto enforceorinterpret the terms and conditions ofthis Agreementorto collect any monies
`underit, exclusively in the courts of the State of Florida, Miami-Dade county (