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SEC Company Response from Cryoport, Inc. (CYRX) (CIK 0001124524) (CYRX) — Jan 26, 2006

Cryoport, Inc. (CYRX) (CIK 0001124524)
Date: Jan. 26, 2006 · CIK: 0001124524 · Accession: 0001144204-06-002835

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Referenced dates: January 9, 2006

Date
Jan. 26, 2006
Author
Director
Form
CORRESP
Company
Cryoport, Inc. (CYRX) (CIK 0001124524)

Letter

Division of Corporate Finance United States Securities and Exchange Commission 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

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 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

Show Raw Text
CORRESP
1
filename1.htm

      Unassociated Document

    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