Certain Cell, BV
1
April 25, 2014
2
3
4
Dear Harry and Lloyd:
5
6
7
8
9
10
11
12
13
Please find in the body of this document answers to most of the questions you
sent to our organization initiated by your meeting with the Ministry of Health. As
established in our previous conversation, we still need to extend ourselves to
SMMC (St. Maarten Medical Center) to develop a cooperation agreement
between our two entities. We have addressed in this letter that we will not be
hiring any positions of specialty and will, therefore, not be in any conflict with the
hospital. Any laboratory services that we may require in St. Maarten can be
referred to existing establishments.
14
15
16
17
18
19
20
21
22
23
You have already received the original notarized document authorizing the two of
you to discuss on our behalf any relevant issues as they relate to the public and/or
private sectors. In addition, you have received all the requisite documents from
Monique Rollings that were previously sent over to her by our organization. We
are awaiting authorization from the Ministry before we secure a location, so we
don’t currently have an answer in regards to the anticipated location of our clinic.
The remaining body of this letter addresses the other questions that were asked
in your correspondence with us dated 4/13/2014. Please take note of the
additional attachment with references of cell therapy benefits.
24
25
26
27
28
29
30
31
Page 1 of 7
Certain Cell, BV
1
2
Therapeutic and Medical Services
3
4
5
6
7
8
9
10
11
Our team will employ the highest ethical and medical standards to relieve
suffering from chronic diseases and injury. We will use adult stem cells derived
directly from our patients’ tissues. Therefore, our team will eliminate any risk
associated with embryonic stem cells which we will not use. The stem cells will be
delivered back into the patient’s injured tissues to promote cellular repair and
regeneration. The average length of stay for our clients will be 1 week. A summary
list of therapeutic services is as follows:
12
a.
b.
c.
d.
e.
13
14
15
16
17
18
f.
g.
h.
i.
j.
19
20
21
22
23
adult stem cell sourcing directly from patients tissues
bone and cartilage regeneration
cardiac and vascular regeneration
inflammation mediation
regenerative therapies for muscle, skin, and soft tissue degenerative
diseases
neuronal and sensory organ regeneration
damaged solid organ regeneration,
pulmonary tissue regeneration
transplantation rejection immunomodulation
anti-aging therapeutics
24
25
26
SUPPORTING REFERENCES ATTACHED
27
28
29
30
31
Adult stem cells will be derived from the patients’ tissue samples under a local
anesthetic using standard techniques for harvesting.
32
33
Page 2 of 7
Certain Cell, BV
1
2
Equipment
3
4
5
6
7
Certain Cell, BV will not be importing any equipment to St. Maarten in excess of
NAF 50,000. Our facility will not handle any radioactive or controlled materials
which may be classified as potentially harmful or dangerous.
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
Page 3 of 7
Certain Cell, BV
1
2
Liability
3
4
5
6
7
8
9
The member doctors of Certain Cell, BV will acquire a rider to each existing policy
to ensure that coverage is secured for all procedures provided to patients in St.
Maarten. In addition, we will await the response from the Ministry regarding the
applicable and mandatory coverage on their end. If the Ministry requires
additional coverage, the Certain Cell, BV member doctors will comply 100%.
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
Page 4 of 7
Certain Cell, BV
1
2
3
Summary of Startup Expenses & Operating Budget
4
Startup Expenses
5
The Owners of Certain Cell BV has developed a detailed vision of Startup Expenses as it pertains
to the opening of our clinic in St. Maarten. These estimates do not include expenses that have
already been absorbed which include equipment, trials, and research. The Startup expenses
will be owner-financed and there will remain $150,000 in reserve for contingencies. The
following is a summary of anticipated costs:
6
7
8
9

11
Capital Equipment Expenses – Furniture, Equipment, Fixtures, Phone System, Faxes,
Computers, and Office Equipment
12
$20,500
10

14
Location and Admin Expenses – Lease of Clinic Space (including down payment), Utility
Deposits, Leasehold Improvements, Legal Fees, Insurance, and IT set-up
15
$35,000
13
16

$15,800
17
18

Advertising and Promotional Expenses – Signage, Printing, Advertising
$18,000
19
20
Opening Inventory – Pharmaceuticals, Medical Supplies, and Office Supplies

Other Expenses – Local Licenses, Shipping, and Initial R&D Expenses
21
22
$20,000
23
Total Estimated Startup Costs - $109,300
24
25
26
27
Page 5 of 7
1
Operating Budget
2
Certain Cell, BV anticipates annualized gross revenue of $3.6 million in year one.
This estimate is based upon a self-imposed limit of 10-15 patients/month. The
rationale for limiting our patient base is as follows:
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
 To ensure the safety and satisfaction of services provided to each patient
 To ingratiate our company with the government of St. Maarten, the
community as a whole, and to the local hospital
 To build relationships with local businesses including, but not limited to, the
tourism sector, ancillary medical facilities, and all requisite supply
companies as they relate to our practice needs
 To recruit and train local individuals to serve in our organization. These
individuals will be recruited from the general population and will not be
required to have specialized talents therefore eliminating any conflict of
interest with SMMC or any other already established organizations within
the medical fields of St. Maarten.
 To ensure that patient data is properly gathered, processed, and studied for
the advancement of Cellular Medicine as a whole and for our future patient
base
Certain Cell, BV projects a net income of $1.5 million in year one. Future growth
of the company will be carefully planned only after the establishment that the
above criteria are met. Certain Cell, BV will also develop a charitable arm to
provide treatments for the underserved population and to contribute to local
organizations and to the interests of St. Maarten. While our company is a forprofit venture, it realizes the importance it has to the overall advancement of
Cellular Medicine and to the importance of establishing strong, long-lasting ties
with St. Maarten and its diverse communities.
27
28
29
30
Page 6 of 7
1
2
3
We thank both of you for all your efforts as they relate to our venture. If there are
any items you wish to address or questions you may have to any of our responses,
please let us know.
4
5
6
Sincerely,
7
8
9
10
11
12
13
Directors of Medical and Technology:
Dr. Michael Edwards MD PhD, Plastic and Reconstructive Surgery
Hand and Upper Extremity Surgery / Peripheral Nerve and Regenerative Surgery
Dr. Ray Khan MD Industrial Orthopedics, Regenerative Orthopedics, & Sports
Medicine
Page 7 of 7