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SEC Comment Letter for Vyteris Holdings (Nevada), Inc. (CIK 0001139950) — Jan 19, 2005

Vyteris Holdings (Nevada), Inc. (CIK 0001139950)
Date: Jan. 19, 2005 · CIK: 0001139950 · Accession: 0000000000-05-003193

AI Filing Summary & Sentiment

File numbers found in text: 000-32741, 333-120411, 333-120435

Date
December 17, 2004
Author
Not clearly detected
Form
UPLOAD
Company
Vyteris Holdings (Nevada), Inc. (CIK 0001139950)

Letter

December 17, 2004 MAIL STOP 0511 Mr. Michael McGuiness Chief Financial Officer Treasure Mountain Holdings, Inc. 13-01 Pollitt Drive Fair Lawn, New Jersey 07410

Re: Treasure Mountain Holdings, Inc. File No. 333-120411 File No. 000-32741 Vyteris Holdings, Inc. File No. 333-120435 Registration Statement on Form SB-2 Filed November 12, 2004

Dear Mr. McGuiness:

We have reviewed your filing and have the following comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not raise additional comments.

Please understand that the purpose of our review process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.

General

1. We note that no proxy or information statement was filed for the merger with Vyteris, Inc., and the Treasure Mountain Schedule 14F- indicates that "[s]tockholders of Treasure Mountain will not vote upon the Merger." Please supplementally explain whether there was a vote by the shareholders of Treasure Mountain Holdings as to the merger. If not, please explain why supplementally. In this regard, if no vote was required under state law for the merger, it would appear that a vote may have been required for the increase in securities necessary to effect the merger. See Note A to Schedule 14A. Please explain. 2. Please supplementally provide the basis for the issuance of 45 million shares of common stock of Treasure Mountain Holdings, Inc. to Vyteris control persons to partially effect the merger with Vyteris and the basis for those shares being able to vote on the reincorporation merger.

3. Please supplementally describe how the reincorporation merger of Treasure Mountain Holdings into Vyteris Holdings will comply with the Securities Act of 1933. We note that Rule 145 of the Securities Act excludes from the definition of offer, offer to sell or sale, a merger in which the sole purpose of the transaction is to change an issuer`s domicile. We further note that it appears that the reincorporation merger is for the purpose of reincorporation into Delaware and increasing the number of shares in order to effect the combination with Vyteris, Inc.

4. We note the disclosure in the prospectus summary that "[t]he reincorporation merger was effected on , 2004" and the disclosure on page 97 of the prospectus which states that "[O]n , 2004, the stockholders of Treasure Mountain Holdings approved the reincorporation merger and on , 2004, the reincorporation merger was consummated." Please explain why the company is seeking to register the resale of the Treasure Mountain common stock if the reincorporation merger will be consummated before the selling security holder offering begins. Please note that this comment assumes the reincorporation merger does not require registration under the 1933 Act, which may not be the case.

5. Please provide a timeline of the events that include the consummation of the merger between Vyteris, Inc. and the subsidiary of Treasure Mountain Holdings and the consummation of the merger between Treasure Mountain Holdings and Vyteris Holdings.

Prospectus Cover Page

6. We note that there is currently no active trading market for your common stock. Given this, please revise your cover page and plan of distribution to provide that selling security holders will sell the common stock and warrants at fixed prices, which are quantified in your prospectus, until there is an active trading market for the securities and thereafter at prevailing market prices or privately negotiated prices. See Item 16 of Schedule A to the Securities Act of 1933.

Table of Contents Explanatory Note

7. We note that the information in the explanatory note is in all capital letters. All capital letters impede the readability of the disclosure. Please revise. Further, please revise other statements in all capital letters, like your risk factor subheadings and the introduction to "Selected Financial Data."

Prospectus Summary Our Business

8. Please revise the Summary section, Management Discussion and Analysis section and the Description of Business section to comply with the requirements of Rule 421 of Regulation C. Please use definite concrete everyday words. In the Summary and Description of Business, you employ many technical terms and jargon that may be confusing and difficult for an average reader to understand. For example, you include terms and phrases such as "intelligent . . . transdermal drug delivery," "small molecule," "peptide," "protein therapeutics," "electrotransport," "iontophoresis," etc. Please do not include technical terms or jargon in the forepart of your prospectus, including your summary. Please remove unnecessary technical terms or jargon from the body of the prospectus. Where technical terms or jargon have to be used later in the filing, please explain them in ordinary, everyday language when first used.

9. We note that the company has had no revenues form the sale of its products and has incurred significant losses. Please provide a more balanced presentation at the beginning of the summary that includes this information.

10. We note the statement that "[w]e believe the control and convenience enabled by our technology has the potential to: improve therapeutic outcomes; reduce side effects; increase patient compliance; and improve overall cost-effectiveness of drug therapies." Supplementally, please provide us with reasonable support and summarize the support later in the prospectus. If a reasonable basis cannot be provided, the statement should be removed.

11. We note the paragraph that begins with the assertion "[w]e have identified over 90 other FDA-approved drugs to which our drug delivery technology might be applied." We further not the statement that "our technology may offer significant therapeutic economic or lifestyle advantages over existing drug delivery methods." Supplementally, please provide us with reasonable support and summarize the support later in the prospectus. If a reasonable basis cannot be provided, the statement should be removed.

Risk Factors

12. Please substantially revise most of your risk factor subheadings to state the material risk to potential investors. In this regard, your headings should disclose the consequences to the investor or to the company, should the risk materialize. For example, most of your subheadings merely state facts or describe uncertainties and do not adequately reflect the risks that follow. Please revise your subheadings to state succinctly the risks. In addition, please revise the risk factor narratives to state succinctly the risks and only that those risks disclosed in the subheadings.

13. We note the statement in risk factor two, that "[i]f we are unable to raise sufficient capital to timely repay our obligations under the working capital facility, the lender -each of whom are affiliated with our principal stockholder - will be entitled to enforce their lien and take title to substantially all of our assets." It would appear that this disclosure should be presented as a separate risk factor. In addition, the company could include the disclosure in note 4 to the financial statements regarding the company`s default on previous promissory notes.

14. In risk factor five, we note the statement that "[w]e may not be successful in obtaining regulatory approval for additional products or in engaging strategic partners to finance and manage the sales and marketing of such other products." This disclosure appears to be a separate risk factor or risk factors from that of risk factor five in which the company has not generated any revenue from sales of its products. It would be more appropriate to revise risk factor five to discuss the problems of the past and the possibility of failure in the immediate future of selling LidoSite and the impact that failure would have on the company and its investors. Further, please add a separate risk factor to address the other products.

15. We note that the narrative in risk factor 13 is long and contains information that could be discussed in other parts of the prospectus, such as the business section. Please revise risk factor 13 accordingly and revise other risk factors where the narratives are long and where the information could be discussed in more appropriate parts of the prospectus.

16. We note the last risk factor regarding forward looking statements. Please remove this information from the Risk Factors section and disclose the information in a separate section of the prospectus, immediately following the Risk Factors section.

Management`s Discussion and Analysis of the Financial Condition and Results of Operations of Vyteris, Inc. Overview of Vyteris

17. We note the reference in this section to the term "from inception." At the beginning of the section please provide the date of inception. 18. We believe your MD&A section could benefit from an expanded "Overview" section that offers investors an introductory understanding of Vyteris and the matters with which management is concerned primarily in evaluating the company`s financial condition and operating results. A good introduction, accordingly, might include a discussion of the following: the economic or industry- wide factors relevant to the company; a discussion of how the company earns or expects to earn revenues and income; the identity of the company`s primary business lines, location(s) of operations and principal services; and insight into material opportunities, challenges, risks, and material trends and uncertainties. To the extent known, provide insight into challenges, risks and opportunities of which management is aware and discuss any actions being taken to address the same. For a more detailed discussion of what is expected in both this subheading and the MD&A section in general, please refer to: <http://www.sec.gov/rules/interp/33- 8350.htm>. See also, Item 303 of Regulation S-B.

19. Please revise your overview to discuss the merger between Vyteris and the subsidiary of Treasure Mountain, the date the merger was consummated, the nature of consideration exchanged, the method of accounting for the merger and that the results of operations and financial position presented here are those of Vyteris, Inc.

20. Please summarize and analyze the fees to be paid to B. Braun pursuant to the marketing agreement between the company and B. Braun.

21. Please summarize and analyze the company`s royalty obligations to Becton Dickinson.

22. Please clarify the statement "and $239,000 through the sale of our New Jersey net operating losses."

Inception through June 30, 2004 Revenues

23. Expand the Revenues paragraph to discuss the reasons for the year-to-year changes in revenue for the annual and subsequent interim periods. Provide a brief description of how you recognize revenue.

24. Please disclose the principal terms, such as fees, of the agreement between the company and a pharmaceutical company, in this or another appropriate location in the prospectus.

Years Ended December 31, 2002 and 2003

25. Please compare the revenue received during 2002 and 2003.

Six Month Period Ended June 30, 2003 and 2004

26. Please compare the revenue received in the six month period of 2003 and 2004.

27. Please describe in greater detail the statement "[t]he increase in 2004 reflects the efforts undertaken by us in devising and executing our strategy to raise additional capital to support our development."

Liquidity and Capital Resources

28. Management`s Discussion and Analysis should discuss the judgments and uncertainties that affect the application of your critical accounting policies and the likelihood that materially different amounts could be reported under different conditions or using different assumptions. Repeating the accounting policies footnote, in full or in part, is not consistent with the staff`s guidance concerning the disclosure of critical accounting estimates. Please revise.

29. We would consider quick capital to be a non-GAAP financial measure in that it excludes amounts that are included in the most directly comparable measure, i.e., working capital, calculated and presented in accordance with GAAP. It is not clear to the staff from your disclosures why quick capital would be useful to management or meaningful to investors as a measure of liquidity considering it excludes your most significant liabilities. Explain why you believe quick capital is not a non-GAAP measure, why you excluded your most significant liabilities from the calculation of a liquidity measure, and explain the specific reasons why you believe this measure provides useful information to investors regarding your liquidity and financial condition. Refer to Item 10(h) of Regulation S-B. Explain also what arrangements or side agreements, if any, were entered into with Spencer Trask concerning the defaulted notes prior to the actual conversion of the notes in September 2004. We may have further comment upon review of your response.

30. Please explain in greater detail the company`s use of $34.9 million in cash in operating activities.

31. Please revise your disclosure to comply with the Commission`s recent MD&A guidance. See Commission Guidance Regarding Management`s Discussion and Analysis of Financial Condition and Results of Operations, Release Nos. 33-8350, Section IV.A. (December 19, 2003) at http://www.sec.gov/rules/interp/33-8350.htm. In this regard, please provide considerably more detailed information on your cash requirements and anticipated sources of funding.

Our Business Overview

32. We note the disclosure regarding the initial development of two other products. Please include the reasonable basis that your drug delivery technology may significantly improve the effectiveness of those already marketed drugs.

33. We note the disclosure regarding the agreement entered into by the company with a leading pharmaceutical company in women`s health. Please disclose the name of the company and in the appropriate subsection please describe the principal terms of the agreement. Please file the agreement as an exhibit.

Technology Overview of Electrotransport

34. We note the statement that "we believe that their applications are limited to a small number of drug compounds." Please include the reasonable basis for your belief.

Products

35. We note the disclosure that the company has signed a worldwide marketing and license agreement with B. Braun for the LidoSite product. Please describe the principal terms of the agreement and file the agreement as an exhibit.

36. Please describe in detail the immediate distribution methods of the initial products. See Item 101(b)(2) of Regulation S-B. Please include how the product(s) will be distributed from manufacturer to customers. Will the products require storage? Will the company or B. Braun be responsible for distribution? Please explain.

37. Please provide the names of principal suppliers as required by Item 101(b)(5) of Regulation S-B.

Additional Product Pipeline

38. For each proposed product, please disclose the remaining steps before marketing approval, including the anticipated time frame for those steps.

Parkinson`s Disease

39. W

Show Raw Text
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

December 17, 2004

MAIL STOP 0511

Mr. Michael McGuiness
Chief Financial Officer
Treasure Mountain Holdings, Inc.
13-01 Pollitt Drive
Fair Lawn, New Jersey 07410

Re:	Treasure Mountain Holdings, Inc.
File No. 333-120411
File No. 000-32741
Vyteris Holdings, Inc.
File No. 333-120435
Registration Statement on Form SB-2
      Filed November 12, 2004

Dear Mr. McGuiness:

      We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments.  If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary.  Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.

      Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects.  We welcome
any questions you may have about our comments or on any other
aspect
of our review.  Feel free to call us at the telephone numbers
listed
at the end of this letter.

General

1. We note that no proxy or information statement was filed for
the
merger with Vyteris, Inc., and the Treasure Mountain Schedule 14F-
1
indicates that "[s]tockholders of Treasure Mountain will not vote
upon the Merger."  Please supplementally explain whether there was
a
vote by the shareholders of Treasure Mountain Holdings as to the
merger.  If not, please explain why supplementally.  In this
regard,
if no vote was required under state law for the merger, it would
appear that a vote may have been required for the increase in
securities necessary to effect the merger.  See Note A to Schedule
14A.  Please explain.
2. Please supplementally provide the basis for the issuance of 45
million shares of common stock of Treasure Mountain Holdings, Inc.
to
Vyteris control persons to partially effect the merger with
Vyteris
and the basis for those shares being able to vote on the
reincorporation merger.

3. Please supplementally describe how the reincorporation merger
of
Treasure Mountain Holdings into Vyteris Holdings will comply with
the
Securities Act of 1933.  We note that Rule 145 of the Securities
Act
excludes from the definition of offer, offer to sell or sale, a
merger in which the sole purpose of the transaction is to change
an
issuer`s domicile.  We further note that it appears that the
reincorporation merger is for the purpose of reincorporation into
Delaware and increasing the number of shares in order to effect
the
combination with Vyteris, Inc.

4. We note the disclosure in the prospectus summary that "[t]he
reincorporation merger was effected on  ,  2004" and the
disclosure
on page 97 of the prospectus which states that "[O]n  ,   2004,
the
stockholders of Treasure Mountain Holdings approved the
reincorporation merger and on   ,  2004, the reincorporation
merger
was consummated."  Please explain why the company is seeking to
register the resale of the Treasure Mountain common stock if the
reincorporation merger will be consummated before the selling
security holder offering begins.  Please note that this comment
assumes the reincorporation merger does not require registration
under the 1933 Act, which may not be the case.

5. Please provide a timeline of the events that include the
consummation of the merger between Vyteris, Inc. and the
subsidiary
of Treasure Mountain Holdings and the consummation of the merger
between Treasure Mountain Holdings and Vyteris Holdings.

Prospectus Cover Page

6. We note that there is currently no active trading market for
your
common stock.  Given this, please revise your cover page and plan
of
distribution to provide that selling security holders will sell
the
common stock and warrants at fixed prices, which are quantified in
your prospectus, until there is an active trading market for the
securities and thereafter at prevailing market prices or privately
negotiated prices.  See Item 16 of Schedule A to the Securities
Act
of 1933.

Table of Contents
Explanatory Note

7. We note that the information in the explanatory note is in all
capital letters.  All capital letters impede the readability of
the
disclosure.  Please revise.  Further, please revise other
statements
in all capital letters, like your risk factor subheadings and the
introduction to "Selected Financial Data."

Prospectus Summary
Our Business

8. Please revise the Summary section, Management Discussion and
Analysis section and the Description of Business section to comply
with the requirements of Rule 421 of Regulation C.  Please use
definite concrete everyday words.  In the Summary and Description
of
Business, you employ many technical terms and jargon that may be
confusing and difficult for an average reader to understand.  For
example, you include terms and phrases such as "intelligent . . .
transdermal drug delivery," "small molecule," "peptide," "protein
therapeutics," "electrotransport," "iontophoresis," etc.   Please
do
not include technical terms or jargon in the forepart of your
prospectus, including your summary.  Please remove unnecessary
technical terms or jargon from the body of the prospectus. Where
technical terms or jargon have to be used later in the filing,
please
explain them in ordinary, everyday language when first used.

9. We note that the company has had no revenues form the sale of
its
products and has incurred significant losses.  Please provide a
more
balanced presentation at the beginning of the summary that
includes
this information.

10. We note the statement that "[w]e believe the control and
convenience enabled by our technology has the potential to:
improve
therapeutic outcomes; reduce side effects; increase patient
compliance; and improve overall cost-effectiveness of drug
therapies." Supplementally, please provide us with reasonable
support
and summarize the support later in the prospectus.  If a
reasonable
basis cannot be provided, the statement should be removed.

11. We note the paragraph that begins with the assertion "[w]e
have
identified over 90 other FDA-approved drugs to which our drug
delivery technology might be applied."  We further not the
statement
that "our technology may offer significant therapeutic economic or
lifestyle advantages over existing drug delivery methods."
Supplementally, please provide us with reasonable support and
summarize the support later in the prospectus.  If a reasonable
basis
cannot be provided, the statement should be removed.

Risk Factors

12. Please substantially revise most of your risk factor
subheadings
to state the material risk to potential investors.  In this
regard,
your headings should disclose the consequences to the investor or
to
the company, should the risk materialize.  For example, most of
your
subheadings merely state facts or describe uncertainties and do
not
adequately reflect the risks that follow.  Please revise your
subheadings to state succinctly the risks.  In addition, please
revise the risk factor narratives to state succinctly the risks
and
only that those risks disclosed in the subheadings.

13. We note the statement in risk factor two, that "[i]f we are
unable to raise sufficient capital to timely repay our obligations
under the working capital facility, the lender -each of whom are
affiliated with our principal stockholder - will be entitled to
enforce their lien and take title to substantially all of our
assets."  It would appear that this disclosure should be presented
as
a separate risk factor.  In addition, the company could include
the
disclosure in note 4 to the financial statements regarding the
company`s default on previous promissory notes.

14. In risk factor five, we note the statement that "[w]e may not
be
successful in obtaining regulatory approval for additional
products
or in engaging strategic partners to finance and manage the sales
and
marketing of such other products."  This disclosure appears to be
a
separate risk factor or risk factors from that of risk factor five
in
which the company has not generated any revenue from sales of its
products.  It would be more appropriate to revise risk factor five
to
discuss the problems of the past and the possibility of failure in
the immediate future of selling LidoSite and the impact that
failure
would have on the company and its investors.  Further, please add
a
separate risk factor to address the other products.

15. We note that the narrative in risk factor 13 is long and
contains
information that could be discussed in other parts of the
prospectus,
such as the business section.  Please revise risk factor 13
accordingly and revise other risk factors where the narratives are
long and where the information could be discussed in more
appropriate
parts of the prospectus.

16. We note the last risk factor regarding forward looking
statements.  Please remove this information from the Risk Factors
section and disclose the information in a separate section of the
prospectus, immediately following the Risk Factors section.

Management`s Discussion and Analysis of the Financial Condition
and
Results of Operations of Vyteris, Inc.
Overview of Vyteris

17. We note the reference in this section to the term "from
inception."  At the beginning of the section please provide the
date
of inception.
18. We believe your MD&A section could benefit from an expanded
"Overview" section that offers investors an introductory
understanding of Vyteris and the matters with which management is
concerned primarily in evaluating the company`s financial
condition
and operating results.  A good introduction, accordingly, might
include a discussion of the following:  the economic or industry-
wide
factors relevant to the company; a discussion of how the company
earns or expects to earn revenues and income; the identity of the
company`s primary business lines, location(s) of operations and
principal services; and insight into material opportunities,
challenges, risks, and material trends and uncertainties.  To the
extent known, provide insight into challenges, risks and
opportunities of which management is aware and discuss any actions
being taken to address the same.  For a more detailed discussion
of
what is expected in both this subheading and the MD&A section in
general, please refer to: <http://www.sec.gov/rules/interp/33-
8350.htm>.  See also, Item 303 of Regulation S-B.

19. Please revise your overview to discuss the merger between
Vyteris
and the subsidiary of Treasure Mountain, the date the merger was
consummated, the nature of consideration exchanged, the method of
accounting for the merger and that the results of operations and
financial position presented here are those of Vyteris, Inc.

20. Please summarize and analyze the fees to be paid to B. Braun
pursuant to the marketing agreement between the company and B.
Braun.

21. Please summarize and analyze the company`s royalty obligations
to
Becton Dickinson.

22. Please clarify the statement "and $239,000 through the sale of
our New Jersey net operating losses."

Inception through June 30, 2004
Revenues

23. Expand the Revenues paragraph to discuss the reasons for the
year-to-year changes in revenue for the annual and subsequent
interim
periods.  Provide a brief description of how you recognize
revenue.

24. Please disclose the principal terms, such as fees, of the
agreement between the company and a pharmaceutical company, in
this
or another appropriate location in the prospectus.

Years Ended December 31, 2002 and 2003

25. Please compare the revenue received during 2002 and 2003.

Six Month Period Ended June 30, 2003 and 2004

26. Please compare the revenue received in the six month period of
2003 and 2004.

27. Please describe in greater detail the statement "[t]he
increase
in 2004 reflects the efforts undertaken by us in devising and
executing our strategy to raise additional capital to support our
development."

Liquidity and Capital Resources

28. Management`s Discussion and Analysis should discuss the
judgments
and uncertainties that affect the application of your critical
accounting policies and the likelihood that materially different
amounts could be reported under different conditions or using
different assumptions.  Repeating the accounting policies
footnote,
in full or in part, is not consistent with the staff`s guidance
concerning the disclosure of critical accounting estimates.
Please
revise.

29. We would consider quick capital to be a non-GAAP financial
measure in that it excludes amounts that are included in the most
directly comparable measure, i.e., working capital, calculated and
presented in accordance with GAAP.  It is not clear to the staff
from
your disclosures why quick capital would be useful to management
or
meaningful to investors as a measure of liquidity considering it
excludes your most significant liabilities.  Explain why you
believe
quick capital is not a non-GAAP measure, why you excluded your
most
significant liabilities from the calculation of a liquidity
measure,
and explain the specific reasons why you believe this measure
provides useful information to investors regarding your liquidity
and
financial condition.  Refer to Item 10(h) of Regulation S-B.
Explain
also what arrangements or side agreements, if any, were entered
into
with Spencer Trask concerning the defaulted notes prior to the
actual
conversion of the notes in September 2004.  We may have further
comment upon review of your response.

30. Please explain in greater detail the company`s use of $34.9
million in cash in operating activities.

31. Please revise your disclosure to comply with the Commission`s
recent MD&A guidance.  See Commission Guidance Regarding
Management`s
Discussion and Analysis of Financial Condition and Results of
Operations, Release Nos. 33-8350, Section IV.A. (December 19,
2003)
at http://www.sec.gov/rules/interp/33-8350.htm.    In this regard,
please provide considerably more detailed information on your cash
requirements and anticipated sources of funding.

Our Business
Overview

32. We note the disclosure regarding the initial development of
two
other products.  Please include the reasonable basis that your
drug
delivery technology may significantly improve the effectiveness of
those already marketed drugs.

33. We note the disclosure regarding the agreement entered into by
the company with a leading pharmaceutical company in women`s
health.
Please disclose the name of the company and in the appropriate
subsection please describe the principal terms of the  agreement.
Please file the agreement as an exhibit.

Technology
Overview of Electrotransport

34. We note the statement that "we believe that their applications
are limited to a small number of drug compounds."  Please include
the
reasonable basis for your belief.

Products

35. We note the disclosure that the company has signed a worldwide
marketing and license agreement with B. Braun for the LidoSite
product.  Please describe the principal terms of the agreement and
file the agreement as an exhibit.

36. Please describe in detail the immediate distribution methods
of
the initial products.  See Item 101(b)(2) of Regulation S-B.
Please
include how the product(s) will be distributed from manufacturer
to
customers.  Will the products require storage?  Will the company
or
B. Braun be responsible for distribution?  Please explain.

37. Please provide the names of principal suppliers as required by
Item 101(b)(5) of Regulation S-B.

Additional Product Pipeline

38. For each proposed product, please disclose the remaining steps
before marketing approval, including the anticipated time frame
for
those steps.

Parkinson`s Disease

39. W