CORRESP: A correspondence can be sent as a document with another submission type or can be sent as a separate submission.
Published on January 26, 2006
GARY
CURTIS CANNON
ATTORNEY
AT LAW
12341
Briardale Way
San
Diego, CA 92128-5212
____________________
Telephone
(858) 391-9083 Facsimile (858) 391-9084
email:
garycurtiscannon@lawyer.com
January
24, 2006
Jeffrey
Riedler
Assistant
Director
Division
of Corporate Finance
United
States Securities and Exchange Commission
Washington,
D.C. 20549
Re: |
CryoPort,
Inc.
|
Form
10-SB, Amendment 1
Filed
December 19, 2005
File
No.
0-51578
Dear
Mr.
Riedler,
In
response to your comment letter dated January 9, 2006, I have been requested
by
Peter Berry, Chief Executive Officer and President of Cryoport, Inc. (the
“Company”), to respond on behalf of the Company to the SEC comments regarding
the Company’s Form 10-SB/A1 filing. It is CryoPort’s intent to file an Amended
Form 10-SB/A2 concurrently with the submission of this letter. To that end,
I
have provided individual responses to the comments below. Concurrently the
Company will make the electronic filing of Form 10-SB/A2. The Company responses
are in bold type following the restatements of the SEC comments/questions as
follows:
FORM
10-SB
Overview,
page 4
1. |
We
note the revisions pursuant to comment 4, and we reissue the comment
in
part. Please discuss the development status of your disposable shippers.
Discuss the steps you have taken toward developing these products,
and
discuss the steps you will need to take to bring the products to
market.
|
The
Company has inserted the following additional discussion to the
Overview
section on Pages 4 & 5:
“The
proposed disposable products are planned to share many of the characteristics
and basic design details of the currently available reusable products. The
expected shared characteristics include general geometry and shape, similar
liquid capacities and similar thermal performance characteristics. As a result,
much of the market experience gained from the sale of these products is directly
relevant to the usage characteristics of the proposed disposable products.
There
are two general sizes planned. A larger size of approximately 5 liters capacity,
based on a product that has been produced for 4 years, is planned for shipping
larger quantities of material and / or for use when longer holding times are
required. A smaller size of approximately 1 liter capacity is planned for unit
dose shipments, or small quantity shipments, that are direct to the end user
and
thus require shorter holding times. Because the shipment quantity is fairly
small, a shorter holding time capability does not admit an unacceptable
financial risk of product loss. The basis of the migration from reusable status
to disposable status is primarily one of cost; disposability requires a
generally lower cost product. Lower cost is achieved from higher production
quantities, from lower cost materials and from automated manufacturing methods.
The currently ongoing development related to these items is principally focused
on material properties, particularly those properties related to the low
temperature requirement and the vacuum retention characteristics; i.e.,
permeability of the materials. Several different metallic and polymeric
materials have been subjected to testing to this point. One non-traditional
material has been qualified and is available for production subject to the
demand for higher production quantities that will justify the capital
investment. Other materials are currently being evaluated for long term vacuum
retention characteristics by analyzing permeation properties. These are long
term tests that are being conducted by a commercial, well known laboratory.
Further on steps that are required to successfully market the products to a
broad spectrum of potential customers are largely related to a perceived need
to
customize the product characteristics to specific customer’s requirements. This
can only be accomplished once the potential customer is identified and
preliminary discussions are begun relative to the specific needs of that
customer. Items potentially involved at this stage include the required holding
time, the required product capacity, and the impacts of the distribution
environment from in plant packing to end use unpacking. We believe that each
potential customer may have a specific set of needs that can be satisfied from
a
catalog like listing of the generic characteristics of the planned products.
Other advances additional to the development work on the cryogenic container
include both an improved liquid nitrogen retention system and a secondary
protective packaging system. This secondary system has a low cost that lends
itself to disposal. Further, it adds an additional liquid nitrogen retention
capability to further assure compliance with IATA and ICAO regulations that
prohibit egress of liquid nitrogen from the shipping
package.”
Development
of International Programs and Markets, Page 10
2. |
We
reissue comment 10 in part. Please disclose whether the 10-day hold
time
referenced in this section is a static hold time or a functional hold
time.
|
In
order to further clarify the specification of static hold time in comparison
to
the functional hold time of the Company’s shippers the following has been
inserted in the section Development
of International Programs and Markets
now located on page 11:
“The
maximum guaranteed temperature hold time of our 5 liter shipper is 16 days
which
is quoted under perfect and ideal conditions when in a "static” (i.e.
stationary) condition only. The functional (in shipping use) hold time of this
same 5 liter shipper is 10 days. Functional hold times are intended to be an
indication only of how many days a shipper can be expected
to hold its temperature when subjected to normal shipping
usage.”
-2-
Sales
and Marketing, Page 14
3. |
We
note your response to comment 11, and we reissue the comment. Please
identify in your filing your South American sales agent, and state
the
amount of revenues this agent accounted for. We note filing as an exhibit
the agreement with this agent would “create difficulties.” Please note
that if the agreement falls under Item 601(b)(10) of Regulation S-B,
it
must be filed regardless of your preference to keep it confidential.
Therefore, please either file the agreement as an exhibit or provide
us
with an analysis as to why this agreement is not required to be filed
under Item 601(b)(10) of Regulation S-B. Please note that if you file
it,
you may request confidential treatment for the immaterial sensitive
terms
by following the procedure outlined in Rule 24b-2 of the Exchange Act
and
Staff Legal Bulletin 1, which can be found at .
|
The
Company has inserted the following sentence in the Sales
and Marketing
section now found on page 15:
“The
Company’s South American agent is CryoPort Systems Ltda. in Sao Paulo, Brazil
and all South American revenues reported have been generated by this agent
in
the Brazilian market.”
Management
would prefer not to file the agreement as an exhibit for the following
reasons:
§ |
It
is a straightforward sales agent agreement that has been in existence
for
more than 3 years and pre-dates current management.
|
§ |
The
agreement is “too generous” as negotiated by previous management with
respect to the following:
|
-
The term of the agreement is 10 years.
-
The agreement is exclusive.
-
The territory is too vast and unrealistic - (all of South
America).
-
The agreement offers a 17% commission to the agent.
-
The agreement has no performance metrics in place.
§ |
Management
does not intend to duplicate these terms in any future agreements and
intends to renegotiate this agreement at the earliest
opportunity.
|
Current
management has and is only establishing and negotiating shorter term,
non-exclusive agreements with performance metrics and lower levels of agent
commissions in more limited territories. Management believes that filing this
agreement could create difficulties with other current and future selling agent
agreements.
-3-
Manufacturing,
page 18
4. |
We
note that in response to comment 15, you state, “It is believed that any
of the currently used manufacturers could be replaced within a short
period of time…” This statement appears to contradict a sentence in the
previous paragraph that reads, “For some components, however, there are
relatively few alternative sources of supply and the establishment
of
additional or replacement suppliers may not be accomplished quickly.”
Please reconcile. It appears you should identify the suppliers that
would
be difficult to replace.
|
In
order to clarify its position for replacement of supply sources, the Company
has
modified the discussion in the Manufacturing
section now located on page 19 as follows:
“For
some components, however, there are relatively few alternate sources of supply
and the establishment of additional or replacement suppliers may not be
accomplished immediately, however, the Company has identified alternate
qualified suppliers which the Company believes could replace existing suppliers.
Should this occur, the Company believes the maximum disruption of production
could be a short period of time, on the order of approximately four to six
weeks. The Company anticipates that this will initially be the case with the
outer shell the Company is developing for its disposable
shipper.”
Item
2. Management’s Discussion and Analysis or Plan of Operations, page
28
Liquidity
of Capital Resources, page 28
5. |
We
note your response to comment 26 and reissue the comment. Please be
aware
that you are required to disclose all information that is material
to
investors, regardless of any commercial harm disclosure might
cause.
|
· |
Please
identify the vaccine manufacturers that are using your product in clinical
trials, and identify the “two large, and well established manufacturing
companies” with whom you are currently
negotiating.
|
· |
Please
file all agreements you have entered into with the above parties and
discuss the agreements’ material terms in your filing. If you do not
believe the agreements and their terms are not material to investors,
please explain to us why not.
|
· |
We
note that in a May 11, 2005 press release, you stated Cell Genesys
purchased over 100 of your “reusable lightweight shippers with a projected
need over the coming months for several hundred more.” Subsequently, in a
July 27, 2005 press release, you refer to a customer that purchased
100
reusable shippers and was scheduled to purchase an additional 400 units
through April 2006. This press release described this relationship
as
“exciting… as we believe this customer has a number of products in their
pipeline that will be able to benefit by using CryoPort shippers in
the
future.” Please disclose this relationship in your filing. It would appear
to affect your disclosure under items 101, 303, and 601 of Regulation
S-B.
Also, tell us whether Cell Genesys is one of the parties referenced
in the
first bullet point above.
|
-4-
The
vaccine manufacturers that have purchased the Company’s products are Cancervax,
Cell Genesys and Argos Therapeutics. All sales are made on purchase order basis
only and the Company has no pending purchase orders with these vaccine
manufacturers at this time.
Since
negotiations are still underway with two large potential manufacturing partners
management believes that nothing will be served by disclosing the names of
these
companies to any potential investor since nothing has yet been agreed and since
both companies are well known disclosing their names could in fact have a
“misleading” effect on any potential investors evaluation of the
Company.
No
agreements have been entered into with any of the above referenced companies
other than confidentiality and non-disclosure agreements.
Cell
Genesys is one of the parties referred to in bullet point one and is the party
referred to in the July 2005 press release. Subsequent to the May 11, 2005
press
release, Cell Genesys requested that the Company refrain from using their name
in any future press release without their explicit permission in order to
protect their confidentiality. In compliance with the customer’s request, the
Company is not using the customer’s name in the Form
10-SB/A2.
At the time of the July 2005 release, the Company did not have permission from
Cell Genesys to use their name in the release and therefore did not specify
the
customer’s name.
Critical
Accounting Policies, page 32
6.
|
Regarding
prior comment thirty on Section V. of Financial Reporting Release
72,
please tell us how, for each of your critical accounting estimates
or
assumptions, you have discussed the following or revise your disclosure
to
discuss the following:
|
· |
how
accurate the estimate/assumption has been in the
past;
|
· |
how
much the estimate/assumption has changed in the
past;
|
· |
specific
sensitivity of the estimate/assumption to change, based on other outcomes
that are reasonably likely to occur and would have a material effect;
and
|
· |
quantitative
information about the estimate/assumption, when it is reasonably available
and will provide material information for
investors.
|
In
response to comment 6, the Company has inserted additional information to the
introductory paragraph in the section Critical
Accounting Policies
now located on page 33 of the Form 10-SB/A2 as follows:
“Actual
results may differ from these estimates under different assumptions or
conditions, however, in the past the estimates and assumptions have been
materially accurate and have not required any significant changes. Specific
sensitivity of each of the estimates and assumptions to change based on other
outcomes that are reasonably likely to occur and would have a material effect
is
identified individually in each of the discussions of the critical accounting
policies described below. Should the Company experience significant changes
in
the estimates or assumptions which would cause a material change to the amounts
used in the preparation of the Company’s financial statements, material
quantitative information will be made available to investors as soon as it
is
reasonably available.”
-5-
Part
F/S - Financial Statements, page F-1
Audited
Financial Statements, page F-1
Notes
to Consolidated Financial Statements, Page F-6
7. |
Please
disclose the following about all equity instruments issued prior to
your
shares being traded on the pink sheets or all equity instruments during
any period where your estimates of the fair value of your common stock
differed materially from the prices reported on the pink
sheets:
|
· |
the
nature and date of the issuance;
|
· |
the
number of shares issued or issuable upon exercise of the
instrument;
|
· |
the
per share amount paid or exercise price;
|
· |
your
estimate of the fair value of any common stock issuable upon
exercise;
|
· |
the
nature of your relationship with the
recipient;
|
· |
the
amount of any compensation or interest
expense;
|
· |
the
nature and terms of any concurrent transactions; and
|
· |
the
significant factors contributing to the changes in your estimate of
fair
value and to material differences between your estimate and any prices
reported on the pink sheets.
|
In
response to the above comment and based on teleconference discussions with
Keira
Ino and Oscar Young on January 18, 2006, the Company has revised the stock
purchases table now located on page 49 of the 10-SB/A2 to include the warrants
and options issued during the fiscal years ended March 31, 2005 and 2004.
Additionally we summarized the information into quarterly totals. The table
now
includes the information requested as follows:
Fiscal
2005
|
||||||||||||||||||||||
Common
Stock
|
Warrants
|
Options
|
||||||||||||||||||||
$ |
Shares
|
Avg
Price
|
Issued
|
Ex.
Price
|
Issued
|
Ex.
Price
|
||||||||||||||||
Qtr
1
|
$
|
141,000
|
235,000
|
$
|
0.60
|
318,334
|
$
|
0.30
|
150,000
|
$
|
0.80
|
|||||||||||
Qtr
2
|
174,343
|
4,358,575
|
$
|
0.04
|
-
|
-
|
643,613
|
$
|
0.04
|
|||||||||||||
Qtr
3
|
382,866
|
6,046,450
|
$
|
0.06
|
20,375
|
$
|
0.75
|
40,375
|
$
|
0.68
|
||||||||||||
Qtr
4
|
991,875
|
1,322,497
|
$
|
0.75
|
82,132
|
$
|
0.75
|
-
|
-
|
|||||||||||||
$
|
1,690,084
|
11,962,522
|
420,841
|
833,988
|
-6-
Fiscal
2004
|
||||||||||||||||||||||
Common
Stock
|
Warrants
|
Options
|
||||||||||||||||||||
$
|
|
Shares
|
Avg
Price
|
Issued
|
Ex.
Price
|
Issued
|
Ex.
Price
|
|||||||||||||||
Qtr
1
|
$
|
136,984
|
273,968
|
$
|
0.50
|
20,000
|
$
|
0.75
|
250,000
|
$
|
0.50
|
|||||||||||
Qtr
2
|
10,000
|
20,000
|
$
|
0.50
|
-
|
-
|
-
|
-
|
||||||||||||||
Qtr
3
|
163,000
|
263,337
|
$
|
0.62
|
-
|
-
|
775,000
|
$
|
0.60
|
|||||||||||||
Qtr
4
|
150,000
|
283,333
|
$
|
0.53
|
-
|
-
|
-
|
-
|
||||||||||||||
$
|
459,984
|
840,638
|
20,000
|
1,025,000
|
As
indicated by the table above, the Company had sufficient fair market value
indication through recent sales of shares to unrelated parties to base the
exercise prices of warrants and options for each issuance. As disclosed in
Note
11 of the Company’s March 31, 2005 Consolidated Financial Statements, the
warrants issued for $0.30 during Q1 2005 and for $0.075 during Q3 and Q4 of
2005
were connected to the sales of the same amounts of shares of common stock for
$0.60 and $0.75 per share respectively. All options were issued with exercise
prices comparable to recent sales prices of common stock. Additionally, no
issuances of warrants or options were made during the three months prior to
the
March 2005 Share Exchange Agreement.
Note
2
- Summary of Significant Accounting Policies, page F-7
8. |
As
it is unclear from your disclosures and your response to our prior
comment
38, please revise your disclosures to describe the process for and
the
significant assumptions used in estimating the fair value of you common
stock in each of the situations listed in that comment. In addition,
as
was requested in that comment please tell us how you considered the
value
implied by any sales of your stock to unrelated third
parties.
|
Furthermore,
once your stock began trading on the pink sheets, please further justify to
us
how the trading price was not representative of the fair value of your common
stock. In so doing, please clarify the extent to which your estimates of fair
value differ from the trading price and to which you have different classes
of
stock.
Finally,
please tell us the specific provisions within GAAP that support the estimates
you made when your stock was trading on the pink sheets and address how those
estimates are consistent with: paragraph 10(a) of APB 25, paragraph 395 of
SFAS
123, and paragraphs 47 and 48 of SFAS 128. In so doing, please tell us whether
you should have and if you considered paragraph 3(a) of SFAS 115, which appears
to suggest that the fair value of your stock was readily determinable when
prices are available in the over-the-counter market and public reported by
the
National Quotation Bureau, which appear to have subsequently become the pink
sheets.
-7-
The
Company has not made any issuances of warrants or options subsequent to the
March 2005 Share Exchange Agreement that required the Company’s application of
fair market valuation other than the estimate of the value of the in-the-money
options disclosed in Item
6 - Executive Compensation
now on page 46 of the Form 10-SB/A2. For this disclosure calculation, a fair
market value of $0.75 was used as the average share price, which is
representative of the contemporaneous cash sales of the Company’s common stock
to unrelated third parties during the previous 12 months.
Interim
Financial Statements, page F-24
9. |
Please
update your financial statements through September 30, 2005, pursuant
to
Part F/S of Form 10-SB and item 310(g) of Regulation
S-B.
|
The
Company has incorporated the September 30, 2005 financial statements previously
submitted in its 10Q-SB filing on December 23, 2005 into the form 10-SB/A2
as
requested in comment 9.
Background
of Company Officers and Directors
On
December 15, 2005, the board of directors expanded the number of seats on the
board from 5 to 7, per its authorization to do so under the current Bylaws.
The
board then filled the vacancies with two new directors Stephen L. Scott and
Thomas S. Fischer, PhD. The Company has inserted the bios of Mr. Scott and
Dr.
Fischer in the Background of Company Officers and Directors section on Page
44
and 45. The following are the bios inserted:
“Thomas
S. Fischer, PhD, has over 20-years experience as a healthcare executive with
a
special emphasis on using information, analytic tools and technology to solve
problems and improve operations. Currently retired, he consults in the
healthcare sector. Dr. Fischer previously served as Senior Vice President and
Chief Administrative Officer at Blue Shield of California from 1997 to 1999,
and
as Senior Vice President, Chief Information Officer from 1994 to 1997. Prior
to
Blue Shield, he held senior management positions with Kaiser Foundation Health
Plan, Inc. for 12 years. Dr. Fischer obtained his Doctor of Philosophy in
Mathematics from the University of Nebraska and his Bachelor of Science and
Master of Science degrees from Portland State University.”
“Stephen
L. Scott is a management and organizational consultant with over 20-years
experience with diverse manufacturing businesses, including a specific
background with developmental stage companies. Since 1996, Mr. Scott has been
President of Technology Acquisition Group, providing expertise in corporate
growth planning, strategic partner development, finance, operations, team
building, product opportunity identification, corporate re-engineering and
mergers and acquisitions. In addition to early stage and small companies, he
has
performed projects with Fortune 1000 firms such as IBM, GE, AT&T,
Bristol-Myers Squibb, Warner-Lambert, Johnson & Johnson and Ayerst-Wyeth.
Mr. Scott received his Juris Doctorate and Masters of Business Administration
degrees from National University and his Bachelor of Science degree from the
University of Akron. “
-8-
Should
you wish to discuss our responses, please contact me immediately.
Sincerely,
/s/
Gary
Curtis Cannon
Gary
Curtis Cannon
Attorney
at Law
GCC/dc
Cc: |
CryoPort,
Inc.
|
Corbin
& Company, LLP
File
-9-