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UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA
CASE NO. 20-21601-CIV-WILLIAMS
UNITED STATES OF AMERICA,
Plaintiff,
vs.
GENESIS II CHURCH OF HEALTH
AND HEALING;
MARK GRENON,
JOSEPH GRENON;
JORDAN GRENON; and
JONATHAN GRENON,
Defendants.
_________________________________/
ORDER OF PERMANENT INJUNCTION
Plaintiff, the United States of America, by its undersigned attorneys, having
filed a Complaint for Injunction against Mark Grenon and Joseph Grenon,
individuals (collectively, “Defendants”), and this Court having considered such
arguments and supporting evidence filed by Defendants, and it appearing that
Defendants are violating the Federal Food, Drug, and Cosmetic Act (“FDCA” or the
“Act”), 21 U.S.C. § 301 et seq., and, unless restrained by order of this Court, will
continue to violate the Act:
After considering the foregoing, it is therefore, ORDERED AND
ADJUDGED that:
1.

This Court has jurisdiction over this action under 21 U.S.C. § 332(a)

and 28 U.S.C. §§ 1331, 1337, and 1345.

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2.

The Complaint states a cause of action against Defendants under

the FDCA, 21 U.S.C. §§ 301 et seq.
3.

Defendants violate the FDCA, 21 U.S.C. § 331(d), by introducing or

delivering for introduction into interstate commerce and/or causing the introduction
or delivery for introduction into interstate commerce unapproved new drugs.
4.

Defendants violate the FDCA, 21 U.S.C. § 331(a), by introducing or

delivering for introduction into interstate commerce and/or causing the introduction
or delivery for introduction into interstate commerce drugs, as defined by 21 U.S.C.
§ 321(g), that are misbranded within the meaning of 21 U.S.C. § 352(a) and (f)(1).
5.

Defendants violate the FDCA, 21 U.S.C. § 331(k), by causing drugs

to become misbranded within the meaning of 21 U.S.C. § 352(a) and (f)(1), while
such drugs are held for sale after shipment of components or the finished product
in interstate commerce.
6.

For the purposes of this Order, the following definitions shall apply:
A.

“The Facility” means 2014 Garden Lane, Bradenton, Florida

B.

“Current

34205-5274.

genesis2church.ch,

Websites”

means

newg2sacraments.org,

the

following

g2churchnews.org,

websites:
g2voice.is,

mmstestimonials.co, and g2worldwidemissions.org, as well as any other
website(s) and social media account(s) currently in existence that are registered
to, owned by, controlled by, or under the direction of any Defendant.

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C.

“Future Websites” means any future website(s) or social

media account(s) that are registered to, owned by, controlled by, or under the
direction of any Defendant.
D.

“MMS products” refers to Defendants’ products called MMS,

Sacramental Cleansing Water, Miracle Mineral Solution, MMS1, G2Church
Sacramental, G2Church Sacrament, products sold as part of Defendants’ “g2kit2,”
and any other of Defendants’ products that, when used as directed, contain
chloride dioxide.
7.

Upon entry of this Order, Defendants and each and all of their

directors, officers, agents, representatives, employees, attorneys, successors and
assigns, and any and all persons or entities in active concert or participation with
any of them who have received actual notice of this Order by personal service or
otherwise are permanently restrained and enjoined under 21 U.S.C. § 332(a), and
the inherent equitable authority of this Court, from directly or indirectly labeling,
holding, and/or distributing any drug, including but not limited to MMS, unless and
until:
A.

For all of Defendants’ drugs, Defendants have an approved

new drug application (“NDA”) or an abbreviated new drug application (“ANDA”),
pursuant to 21 U.S.C. § 355(b), (j), or an investigational new drug application
(“IND”) in effect pursuant to 21 U.S.C. § 355(i), for such drugs;
B.

Within eight (8) calendar days after the entry of this Order,

Defendants shall submit to FDA for its review and approval a recall strategy for all

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of Defendants’ MMS products, including components, raw and in-process
materials, and finished products, that were distributed by Defendants from January
1, 2010, through and including the date of entry of this Order. The recall strategy
shall include, but not be limited to, customer notifications, public warning, methods
for conducting effectiveness checks, and plans for the disposition of recalled
products. Within five (5) calendar days after receiving FDA’s approval of the recall
strategy, Defendants shall initiate a recall of all MMS distributed product in
accordance with such recall strategy.

Within thirty (30) calendar days after

initiating the recall, Defendants will complete the recall and shall destroy, under
FDA’s supervision (which may be done by e-mail or other virtual means as FDA
determines to be appropriate) and in accordance with the procedures provided in
Paragraph 8, all of their MMS products, including components, raw and in-process
materials, and finished products that are held and/or were distributed by
Defendants from January 1, 2010, through and including the date of entry of this
Order. Defendants shall bear the costs of destruction and the costs of FDA’s
supervision;
C.

If FDA determines it to be necessary, FDA representatives

inspect the Facility to determine whether the requirements of this Order have been
met and whether Defendants are operating in conformity with this Order, the Act,
and its implementing regulations;
D.

Defendants have reimbursed FDA for the costs of all FDA

inspections, investigations, supervision, analyses, examinations, and reviews that

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FDA deems necessary to evaluate Defendants’ compliance with Paragraph 7, at
the rates set forth in Paragraph 15; and
E.

FDA notifies Defendants in writing that they appear to be in

compliance with the requirements set forth in Paragraphs 7.A – B and 7.D of this
Order. In no circumstance shall FDA’s silence be construed as a substitute for
written notification.
8.

Within fifteen (15) business days after completing the recall of all

distributed MMS products as described in Paragraph 7.B, Defendants shall give
notice to FDA that, under FDA’s supervision (which may be done by e-mail or other
virtual means as FDA determines to be appropriate), Defendants are prepared to
destroy all MMS products (including components, raw and in-process materials,
and finished products) in Defendants’ possession, custody, or control. Defendants’
notice shall specify the proposed time, place, and method of destruction.
Defendants shall not commence or permit any other person to commence
destruction until they have received written authorization from FDA to commence
the destruction. Within fifteen (15) business days after receiving authorization from
FDA to commence destruction, Defendants shall, under FDA supervision (which
may be done by e-mail or other virtual means as FDA determines to be
appropriate), complete the destruction in compliance with this Order. Defendants
shall not dispose of any such products in a manner contrary to the provisions of
the Act, any other federal law, or the laws or any state or Territory, as defined in

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the Act, in which the products are disposed. Defendants shall bear the costs of
destruction and FDA’s supervision.
9.

Defendants shall retain, at their expense, an independent person or

persons (the “Auditor”) who is qualified by education, training, and experience to
determine whether Defendants’ labels, labeling, promotional material, Current
Websites, and Future Websites cause Defendants’ drugs, including but not limited
to MMS, to be unapproved new drugs and misbranded drugs; whether Defendants
are directly or indirectly responsible for labeling, holding, or distributing drugs,
including but not limited to MMS; and whether Defendants directly or indirectly do
any acts that causes drugs to become misbranded while they are held for sale after
shipment of one or more of their components in interstate commerce. The Auditor
shall be without personal or financial ties (other than a consulting agreement
between the parties) to any Defendant or any of Defendants’ affiliates (including,
but not limited to, any entities that Defendants identify as “chapters”), officers or
employees, or immediate families. Defendants shall notify FDA in writing of the
identity of the Auditor within ten (10) business days after retaining such Auditor.
A.

The Auditor shall conduct audit inspections of Defendants’

Current Websites, Future Websites, the Facility, and any other location(s) at which
Defendants, now or in the future, directly or indirectly engage in labeling, holding,
and/or distributing drugs, no less frequently than once every six (6) months for a
period of no less than five (5) years. The first audit shall occur not more than six
(6) months after entry of this Order.

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B.

At the conclusion of each audit inspection, the Auditor shall

prepare a detailed written audit report (“Audit Report”) analyzing whether
Defendants are in compliance with this Order and identifying any deviations from
such requirements and shall provide a list of all materials reviewed, including all
websites and social media, as well as copies of all such materials (“Audit Report
Observations”).
C.

Each Audit Report shall contain a written certification that the

Auditor: (1) has personally reviewed all of Defendants’ product labels, labeling,
Current Websites, and Future Websites; (2) personally certified whether the
product labels, labeling, Current Websites, and Future Websites make claims that
cause Defendants’ MMS products or other products to be drugs within the meaning
of the Act; (3) personally certified whether Defendants are directly or indirectly
labeling, holding, or distributing Defendants’ MMS products or other products that
are drugs within the meaning of the Act; and (4) personally certified whether
Defendants are directly or indirectly doing any acts that cause drugs to become
misbranded while they are held for sale after shipment of one or more of their
components in interstate commerce.
D.

The Audit Reports shall be delivered contemporaneously to

Defendants and FDA by courier service, overnight delivery service, or e-mail, no
later than ten (10) business days after the date the Audit Report is completed. In
addition, Defendants shall maintain the Audit Reports in separate files at
Defendants’ Facility and at any other location(s) at which Defendants, now or in

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the future, directly or indirectly engage in labeling, holding, and/or distributing
drugs, and shall promptly make the Audit Reports available to FDA upon request;
and
E.

If an Audit Report contains any observations indicating that

Defendants are violating any provision of this Order or the Act or its implementing
regulations, Defendants shall immediately cease such activity.
10.

Upon entry of this Order, Defendants, and all of their directors,

officers, agents, representatives, employees, attorneys, successors and assigns,
and any and all persons or entities in active concert or participation with any of
them, are permanently restrained and enjoined under 21 U.S.C. § 332(a) from
directly or indirectly doing or causing to be done any of the following acts:
A.

Violating 21 U.S.C. § 331(d), by introducing or delivering for

introduction into interstate commerce new drugs that are neither approved
pursuant to 21 U.S.C. § 355 nor exempt from approval;
B.

Violating 21 U.S.C. § 331(a), by introducing or delivering into

interstate commerce drugs that are misbranded within the meaning of 21 U.S.C.
§ 352(a) and/or (f)(1); and
C.

Violating 21 U.S.C. § 331(k), by causing drugs that

Defendants hold for sale after shipment of components or finished product in
interstate commerce to become misbranded within the meaning of 21 U.S.C.
§ 352(a) and/or (f)(1); and

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D.

Failing

to

implement

and

continuously

maintain

the

requirements of the Act, its implementing regulations, and this Order.
11.

If, at any time after this Order has been entered, FDA determines,

based on the results of an inspection, a review of Defendants’ products, product
labels, labeling, Current Websites, Future Websites, a report prepared by the
Auditor, or any other information, that Defendants have failed to comply with any
provision of this Order, have violated the Act or its implementing regulations, or
that additional corrective actions are necessary to achieve compliance with this
Order, the Act, or its applicable regulations, FDA may, as and when it deems
necessary, notify Defendants in writing of the noncompliance and order
Defendants to take appropriate corrective action, including, but not limited to,
ordering Defendants to immediately take one or more of the following actions:
A.

Cease labeling, holding, and/or distributing any or all drugs;

B.

Recall, at Defendants’ expense, any drug that is an

unapproved new drug, a misbranded drug, or otherwise in violation of this Order,
the Act, or its implementing regulations;
C.

Revise, modify, expand, or continue to submit any reports or

plans prepared pursuant to this Order;
D.

Submit additional reports or information to FDA as requested;

E.

Issue a safety alert; and/or

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F.

Take any other corrective actions as FDA, in its discretion,

deems necessary to bring Defendants into compliance with this Order, the Act, or
its implementing regulations.
This remedy shall be separate and apart from, and in addition to, any other
remedy available to the United States under this Order or under the law.
12.

Upon receipt of any order issued by FDA pursuant to Paragraph 11,

Defendants shall immediately and fully comply with the terms of FDA’s order. Any
cessation of operations or other action described in Paragraph 11 shall continue
until Defendants receive written notification from FDA that Defendants appear to
be in compliance with this Order, the Act, and its implementing regulations, and
that Defendants may resume operations. The cost of FDA inspections, sampling,
testing, travel time, and subsistence expenses to implement the remedies set forth
in this paragraph shall be borne by Defendants at the rates specified in Paragraph
15.
13.

Representatives of FDA shall be permitted, without prior notice and

as and when FDA deems necessary, to inspect the Facility, any other location(s)
at which Defendants, now or in the future, directly or indirectly engage in labeling,
holding, and/or distributing any drug, and Defendants’ operations, collect samples,
and, without prior notice, take any other measures necessary to monitor and
ensure continuing compliance with the terms of this Order, the Act, and all
applicable regulations. During such inspections, FDA representatives shall be
permitted: immediate access to Defendants’ Facility and/or other place(s) of

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business, including but not limited to all buildings or other structures, equipment,
raw ingredients, in-process or unfinished and finished materials and products,
containers, labeling, and other promotional material therein; to take photographs
and make video recordings; to take samples of Defendants’ raw ingredients,
finished and unfinished materials and products, containers, and labeling; and
examine and copy all records relating to the receipt, labeling, holding, and
distribution of any and all of Defendants’ products and their components. The
inspections shall be permitted upon presentation of a copy of this Order and
appropriate credentials. The inspection authority granted by this Order is separate
and apart from, and in addition to, the authority to make inspections under the Act,
21 U.S.C. § 374.
14.

Defendants shall promptly provide any information or records to FDA

upon request regarding the labeling, holding, or distributing (directly or indirectly)
of Defendants’ drugs, including MMS. Defendants shall submit to FDA, at the
street addresses specified in Paragraph 22 and within ten (10) calendar days after
such request, a copy of the materials FDA requests, on CD-ROM or DVD. Such
requested materials may include, but are not limited to: a list of all locations where
any of Defendants’ products, including MMS, are held; a list of all of Defendants’
websites and any other media that are registered to, owned by, controlled by, or
under the direction of any Defendant; and/or downloaded copies of any and all of
Defendants’ websites, product labeling and promotional materials, and any other

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media that are registered to, owned by, controlled by, or under the direction of any
Defendant.
15.

Defendants shall reimburse FDA for the costs of all FDA inspections,

investigations, supervision, analyses, examinations, and reviews that FDA deems
necessary to evaluate Defendants’ compliance with any part of this Order,
including all transportation and associated costs for FDA investigators and experts,
at the standard rates prevailing at the time the costs are incurred. As of the date of
entry of this Order, these rates are: $101.00 per hour or fraction thereof per
representative for inspection and investigative work; $121.06 per hour or fraction
thereof per representative for analytical or review work; $0.575 per mile for travel
expenses by automobile; government rate or the equivalent for travel by air or
other means; and the published government per diem rate for subsistence
expenses where necessary. In the event that the standard rates applicable to FDA
supervision of court-ordered compliance are modified, these rates shall be
increased or decreased without further order of the Court.
16.

Within five (5) business days after the entry of this Order, Defendants

shall post a copy of this Order in a common area at the Facility and at any other
location at which Defendants conduct business and shall ensure that this Order
remains posted for as long as this Order remains in effect. Within ten (10) business
days after entry of this Order, Defendants shall provide to FDA an affidavit, from a
person with personal knowledge of the facts stated therein, stating the fact and
manner of compliance with this paragraph.

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17.

Within ten (10) business days after the entry of this Order,

Defendants shall provide a copy of this Order by personal service or certified mail
(return receipt requested) to each and all of their directors, officers, agents,
representatives, employees, attorneys, successors and assigns, and any and all
persons or entities in active concert or participation with any of them (“Associated
Persons”) and shall post this Order on Current Websites and Future Websites.
Within twenty (20) business days after the date of entry of this Order, Defendants
shall provide to FDA an affidavit stating the fact and manner of their compliance
with this paragraph, including identifying the names, addresses, and positions of
all persons who have received a copy of this Order and websites on which the
Order has been posted.
18.

In the event that any of the Defendants becomes associated with any

additional Associated Person(s) at any time after entry of this Order, Defendants
shall within ten (10) business days after the commencement of such association:
(a) provide a copy of this Order, by personal service or certified mail (restricted
delivery, return receipt requested), to such Associated Person(s); and (b) provide
to FDA an affidavit stating the fact and manner of compliance with this paragraph,
identifying the names, addresses, and positions of all Associated Persons who
received a copy of this Order pursuant to this paragraph.
19.

Defendants shall notify FDA in writing at least fifteen (15) business

days before any change in ownership, name, or character of their business that
occurs after entry of this Order, including an incorporation, reorganization, creation

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of a subsidiary, relocation, dissolution, bankruptcy, assignment, sale, or any other
change in the structure or identity of Genesis II Church of Health and Healing, or
the sale or assignment of any business assets, such as the Facility, other buildings
or structures, equipment, or inventory that may affect obligations arising out of this
Order. Defendants shall provide a copy of this Order to any prospective successor
or assign at least twenty (20) business days prior to any sale or assignment.
Defendants shall furnish FDA with an affidavit of compliance with this paragraph
no later than ten (10) business days prior to such assignment or change in
ownership.
20.

Defendants shall notify FDA in writing, at least ten (10) business days

before the creation of a new website or link or reference, direct or indirect, to
another website or other source that conveys information about MMS or any other
of Defendants’ drugs. Defendants shall post a copy of this Order, in accordance
with Paragraph 17, on any websites created after entry of this Order that convey
information about Defendants’ MMS products or other drugs. Within ten (10)
calendar days after the creation of any new websites, Defendants shall provide to
FDA an affidavit of compliance, stating the fact and manner of compliance with the
provisions of this Paragraph.
21.

In accordance with the procedures described in subparagraphs A-D

of this Paragraph, Defendants shall pay equitable disgorgement to an escrow fund
for the purpose of satisfying claims from all purchasers who purchased MMS from
or through Defendants since January 1, 2010.

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A.

Within fifteen (15) business days of the entry of this Order,

Defendants shall promptly provide, to the Special Master appointed by the Court
(whose services shall be paid by Defendants) and to Plaintiff, a financial statement
disclosing the amount of revenue Defendants have obtained from sales or
distribution of MMS from January 1, 2010, through the date of this Order, along
with all supporting records sufficient to determine: (1) the identities, addresses,
and phone numbers of the individuals and entities who purchased MMS by or
through Defendants from January 1, 2010 through the date of this Order; (2) the
dates and quantities of MMS ordered and the price paid for such products,
including any costs of shipping paid by the purchasers (less any refunds already
paid by Defendants to such purchasers); and (3) an accounting of gains and
expenses related to the manufacturing, packaging, holding, distribution, sales, and
promotion of MMS. These records shall include, but not be limited to, state and
federal tax returns; bank records; shipping records; sales invoices; accounting
records, including certified financial statements; truthful and fully-executed copies
of Department of Justice Form OBD-500; and any other records as the Court may
request. Within twenty (20) business days after the entry of this Order, Defendants
shall each file with the Court an affidavit stating the fact and manner of compliance
with this Paragraph. In the event such records cannot be provided by Defendants,
an affidavit explaining the inability to produce some or all of the records shall be
filed with Court within twenty (20) business days of the entry of this Order.

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B.

Within twenty-five (25) business days of entry of this Order,

Defendants shall pay to an escrow fund managed and identified by the Special
Master, the amount disclosed in subparagraph A., above. The Special Master will
administer and effectuate the payment of refunds to purchasers who request them
from the escrow fund until October 31, 2020.
C.

Within twenty-five (25) business days of entry of this Order,

Defendants shall prominently display the following notice on Defendants’ Current
Websites, and provide it by mail to all persons and entities that have purchased
MMS by or through Defendants since January 1, 2010:

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NOTICE
You have been identified as an individual who has purchased MMS from
Genesis II Church of Health and Healing. The organization and certain
individuals associated with it are the defendants in a legal action brought
against them by the United States Government to enforce the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. § 301 et. seq.) in the United States District
Court for the Southern District of Florida.
The Court has found the defendants liable for unlawfully distributing MMS
because it is an unapproved new drug and is a misbranded drug. MMS is a
misbranded drug, in part, because its labeling and promotional material falsely
represented the product as safe and effective for treating various diseases,
when in fact there is no substantial evidence that MMS is safe and effective to
treat any disease whatsoever.
As a result, the Court has ordered Defendants to provide refunds to those
purchasers of MMS who request them. In order to obtain a refund, you must
request a refund from the Court-appointed Special Master by email or U.S. mail
using the contact information below, no later than October 31, 2020. In your
request, you must include the following information:
1.
2.
3.
4.
5.
6.

Name
Address
Phone Number
Email
Approximate date(s) of your MMS purchase(s)
Approximate amount paid for MMS purchases (less any refund
received).
CONTACT INFORMATION
XXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXX

You can expect to receive funds once your purchase information is verified.

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D.

On November 15, 2020, the Special Master shall return the

portion of the remaining escrow fund that the Special Master determines
represents legitimate business expenses, that is, expenses that Defendants
incurred independent of supporting or powering Defendants’ unlawful distribution
of MMS. On that same date, the Special Master will pay any remaining funds in
the escrow fund to the United States Treasury.
E.

Upon entry of this Order, Defendants and Associated Persons

shall immediately refrain from disposing of or transferring any assets that may
interfere with implementation of this disgorgement provision. In addition,
Defendants and Associated Persons are prohibited from destroying, discarding,
altering, transferring, or otherwise making unavailable any documents and records
in electronic format or otherwise within the custody or control of Defendants or
Associated Persons.
22.

All notifications, correspondence, and communications to FDA

required by the terms of this Order shall be addressed to: Director, Office of
Pharmaceutical Operations Division II, 4040 North Central Expressway, Suite 300,
Mail Code HFR-SW100, Dallas, Texas 75204, and shall also be sent by e-mail to
ORAPHARM2_RESPONSES@fda.hhs.gov.
23.

Should the United States bring and prevail in a contempt action to

enforce the terms of this Order, Defendants shall, in addition to other remedies,
reimburse the United States for its attorneys’ fees (including overhead),

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investigational and analytical expenses, expert witness fees, and court costs
relating to such contempt proceedings.
24.

Defendants shall abide by the decisions of FDA, and FDA’s decisions

shall be final. All decisions conferred upon FDA in this Order shall be vested in
FDA’s discretion and, if contested, shall be reviewed by this Court under the
arbitrary and capricious standard set forth in 5 U.S.C. § 706(2)(A). Review by the
Court of any FDA decision rendered pursuant to this Order shall be based
exclusively on the written record before FDA at the time the decision was made.
No discovery shall be taken by either party.
25.

This Court retains jurisdiction over this action and the parties thereto

for the purpose of enforcing and modifying this Order and for the purpose of
granting such additional relief as may be necessary or appropriate.
DONE AND ORDERED in chambers in Miami, Florida, this 3rd day of
August, 2020.

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