As filed with the Securities and Exchange Commission on June 18, 1997.
Registration No. 333-_____
================================================================================
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
--------------------
FORM S-8
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
------------------
ORPHAN MEDICAL, INC.
(Exact name of registrant as specified in its charter)
Minnesota 41-1784594
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
13911 Ridgedale Drive, Suite 475
Minnetonka, Minnesota 55305
(Address of principal executive offices) (Zip Code)
ORPHAN MEDICAL, INC. 1994 STOCK OPTION PLAN
(Full title of plans)
Copy to:
John Howell Bullion, Chief Executive Officer
13911 Ridgedale Drive, Suite 475
Minnetonka, Minnesota 55305
(Name and address of agent for service)
(612) 513-6900
(Telephone number, including area code, of agent for service)
--------------------
Approximate date of commencement of proposed sale to the public: from
time to time after the effective date of this Registration Statement.
<TABLE>
<CAPTION>
CALCULATION OF REGISTRATION FEE
===================================================================================================================
Proposed
Title of each class Proposed Maximum
of Securities to be Amount to be Maximum Offering Aggregate Offering Amount of
registered Registered(1) Price per Unit(2) Price(2) Registration Fee
- -------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Common Stock
($.01 par value) 300,000 $6.375 $1,912,500 $579.55
- -------------------------------------------------------------------------------------------------------------------
</TABLE>
(1) The number of shares being registered represents the number of shares of
Common Stock that may be issued pursuant to the Orphan Medical, Inc. 1994
Stock Option Plan (the "Plan") in addition to shares previously registered
under the Plan.
(2) Pursuant to Rule 457(h)(1), the proposed maximum offering price per share
and the proposed maximum aggregate offering price are based upon the
average of the high and low prices of the Common Stock as reported by
Nasdaq on June 13, 1997.
Pursuant to General Instruction E of the General Instructions to Form S-8, the
Registration Statement incorporates by reference the Registration Statement on
Form S-8 relating to the Plan and filed with the Securities and Exchange
Commission on April 15, 1996 (File No. 333-03674).
================================================================================
PART II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
Item 3. Incorporation Of Certain Documents By Reference
The Registrant incorporates herein by reference the following documents
or portions of documents, as of their respective dates as filed with the
Securities and Exchange Commission:
(a) The Registrant's Annual Report on Form 10-K for the fiscal
year ended December 31, 1996;
(b) The Registrant's Quarterly Report on Form 10-Q for the quarter
ended March 31, 1997; and
(c) The description of the Company's Common Stock contained in the
Company's Registration Statement on Form S-1, dated March 11,
1996 (File No. 333-2200), and any amendment or report filed to
update such description filed subsequent to the date of this
Prospectus and prior to the termination of the offering of the
Common Stock offered hereby.
All documents filed by the Registrant pursuant to Section 13(a), 13(c),
14 or 15(d) of the Exchange Act of 1934, as amended, subsequent to the date of
this Registration Statement and prior to the filing of a post-effective
amendment which indicates that all securities offered have been sold or which
deregisters all securities then remaining unsold, shall be deemed to be
incorporated by reference into this Registration Statement and to be a part
hereof from the respective dates of filing of such documents.
Item 8. Exhibits
Exhibit
Number Description
- ------ -----------
5.1 Opinion of Dorsey & Whitney LLP regarding legality.
10.1 Agreement between Orphan Medical, Inc. ("OMI") and Chronimed, dated
October 11, 1996, to amend Marketing and Distribution Agreement dated
July 2, 1996 (Incorporated by reference to the corresponding exhibit
number in OMI's Quarterly Report on Form 10-Q for the quarter ended
June 30, 1996, File No. 0-24760)
10.2 Cystadane Agreement between OMI and Chronimed, dated October 1, 1996
(Incorporated by reference to the corresponding exhibit number in OMI's
Quarterly Report on Form 10-Q for the quarter ended September 30, 1996,
File No. 0-24760)
10.3 License Agreement regarding alpha galactosidase A between OMI and
Research Corporation Technologies, Inc., dated March 15, 1996
(Incorporated by reference to the corresponding exhibit number in OMI's
Annual Report on Form 10-K for the year ended December 31, 1996 (the
"1996 Form 10-K"), File No. 0-24760) (1)
10.4 License Agreement regarding 5-flurouracil between OMI and the
University of Miami and its Department of Ophthalmology, dated December
6, 1996 (Incorporated by reference to the corresponding exhibit number
in OMI's 1996 Form 10-K, File No. 0-24760) (1)
10.5 Collaborative Development Agreement regarding clonidine between OMI and
Medtronic, dated November 27, 1996 (Incorporated by reference to the
corresponding exhibit number in OMI's 1996 Form 10-K, File No. 0-24760)
(1)
10.6 Distribution Agreement between OMI and W.A. Butler Company, dated
November 2, 1996 (Incorporated by reference to the corresponding
exhibit number in OMI's 1996 Form 10-K, File No. 0-24760) (1)
23.1 Consent of Ernst & Young LLP.
23.2 Consent of Dorsey & Whitney LLP (included in Exhibit 5.1 to this
Registration Statement).
24.1 Power of Attorney.
(1) Pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended,
confidential portions of these Exhibits were deleted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.
Item 9. Undertakings
A. Post-Effective Amendments
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made,
a post-effective amendment to this registration statement:
(i) To include any prospectus required by section 10(a)(3) of
the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising
after the effective date of the registration statement (or the
most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental
change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar
value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form
of prospectus filed with the Commission pursuant to Rule
424(b) under the Securities Act if, in the aggregate, the
changes in volume and price represent no more than a 20%
change in the maximum aggregate offering price set forth in
the "Calculation of Registration Fee" table in the effective
registration statement; and
(iii) To include any material information with respect to the
plan of distribution not previously disclosed in the
registration statement or any material change to such
information in the registration statement;
Provided, however, that paragraphs A(1)(i) and A(1)(ii) do not apply if
the registration statement is on Form S-3, Form S-8 or Form F-3, and
the information required to be included in a post-effective amendment
by those paragraphs is contained in periodic reports filed with or
furnished to the Securities and Exchange Commission by the registrant
pursuant to section 13 or section 15(d) of the Securities Exchange Act
of 1934 that are incorporated by reference in the registration
statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the
termination of the offering.
B. Subsequent Documents Incorporated by Reference
The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial BONA FIDE offering thereof.
C. Claims for Indemnification
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers, and controlling persons of
the registrant pursuant to the foregoing provisions, or otherwise, the
registrant has been advised that, in the opinion of the Securities and Exchange
Commission, such indemnification is against public policy as expressed in the
Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant will, unless in
the opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Act and will
be governed by the final adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that it meets all
of the requirements for filing on Form S-8 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Minnetonka, State of Minnesota, on June 18, 1997.
ORPHAN MEDICAL, INC.
By /s/ John Howell Bullion
----------------------------
John Howell Bullion
Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the date indicated.
<TABLE>
<CAPTION>
Name Title Date
---- ----- ----
<S> <C> <C>
/s/ John Howell Bullion Chief Executive Officer, June 18, 1997
- ---------------------------------- Secretary (principal executive,
John Howell Bullion financial and accounting officer)
and Director
* Director June 18, 1997
- ----------------------------------
William B. Adams
* Director June 18, 1997
- ----------------------------------
Maurice R. Taylor, II
* President and Director June 18, 1997
- ----------------------------------
Bertram A. Spilker, Ph.D., M.D.
* Director June 18, 1997
- ----------------------------------
Lawrence C. Weaver, Ph.D.,
D.Sc. (Hon.)
* Director June 18, 1997
- ----------------------------------
W. Leigh Thompson, Ph.D. M.D.
* Director June 18, 1997
- ----------------------------------
William M. Wardell, Ph.D., M.D.
*By: /s/ John Howell Bullion
-----------------------------
John Howell Bullion
Attorney-in-fact
</TABLE>
EXHIBIT INDEX
Exhibit Number Description Page
- -------------- ----------- ----
5.1 Opinion of Dorsey & Whitney LLP regarding legality
10.1 Agreement between Orphan Medical, Inc. ("OMI") and
Chronimed, dated October 11, 1996, to amend Marketing
and Distribution Agreement dated July 2, 1996
(Incorporated by reference to the corresponding
exhibit number in OMI's Quarterly Report on Form 10-Q
for the quarter ended June 30, 1996, File No. 0-24760)
10.2 Cystadane Agreement between OMI and Chronimed, dated
October 1, 1996 (Incorporated by reference to the
corresponding exhibit number in OMI's Quarterly Report
on Form 10-Q for the quarter ended September 30, 1996,
File No. 0-24760)
10.3 License Agreement regarding alpha galactosidase A
between OMI and Research Corporation Technologies,
Inc., dated March 15, 1996 (Incorporated by reference
to the corresponding exhibit number in OMI's Annual
Report on Form 10-K for the year ended December 31,
1996 (the "1996 Form 10-K"), File No. 0-24760) (1)
10.4 License Agreement regarding 5-flurouracil between OMI
and the University of Miami and its Department of
Ophthalmology, dated December 6, 1996 (Incorporated by
reference to the corresponding exhibit number in OMI's
1996 Form 10-K, File No. 0-24760) (1)
10.5 Collaborative Development Agreement regarding
clonidine between OMI and Medtronic, dated November
27, 1996 (Incorporated by reference to the
corresponding exhibit number in OMI's 1996 Form 10-K,
File No. 0-24760) (1)
10.6 Distribution Agreement between OMI and W.A. Butler
Company, dated November 2, 1996 (Incorporated by
reference to the corresponding exhibit number in OMI's
1996 Form 10-K, File No. 0-24760) (1)
23.1 Consent of Ernst & Young LLP
23.2 Consent of Dorsey & Whitney LLP (included in
Exhibit5.1 to this Registration Statement)
24.1 Power of Attorney
(1) Pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended,
confidential portions of these Exhibits were deleted and filed separately
with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
EXHIBIT 5.1
[LETTERHEAD OF DORSEY & WHITNEY LLP]
June 17, 1997
Orphan Medical, Inc.
13911 Ridgedale Drive, Suite 475
Minnetonka, Minnesota 55305
Ladies and Gentlemen:
We have acted as counsel to Orphan Medical, Inc., a Minnesota
corporation (the "Company"), in connection with a Registration Statement on Form
S-8 relating to the sale by the Company from time to time of up to 300,000
shares of Common Stock, $.01 par value per share, of the Company (the "Shares"),
issuable pursuant to awards granted under the Company's 1994 Stock Option Plan.
We have examined such documents and have reviewed such questions of law
as we have considered necessary and appropriate for the purposes of the opinions
set forth below.
In rendering our opinions set forth below, we have assumed the
authenticity of all documents submitted to us as originals, the genuineness of
all signatures and the conformity to authentic originals of all documents
submitted to us as copies. We have also assumed the legal capacity for all
purposes relevant hereto of all natural persons and, with respect to all parties
to agreements or instruments relevant hereto other than the Company, that such
parties had the requisite power and authority (corporate or otherwise) to
execute, deliver and perform such agreements or instruments, that such
agreements or instruments have been duly authorized by all requisite action
(corporate or otherwise), executed and delivered by such parties and that such
agreements or instruments are the valid, binding and enforceable obligations of
such parties. As to questions of fact material to our opinions, we have relied
upon certificates of officers of the Company and of public officials.
Based on the foregoing, we are of the opinion that the Shares have been
duly authorized and, upon issuance, delivery and payment therefor in accordance
with the terms of the Plan, will be validly issued, fully paid and
nonassessable.
Our opinions expressed above are limited to the laws of the State of
Minnesota.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement.
Very truly yours,
/s/ Dorsey & Whitney LLP
EXHIBIT 23.1
CONSENT OF ERNST & YOUNG LLP
We consent to the incorporation by reference in the Registration Statement (Form
S-8) pertaining to the Orphan Medical, Inc. 1994 Stock Option Plan of our report
dated January 31, 1997, with respect to the financial statements of Orphan
Medical, Inc. included in its Annual Report (Form 10-K) for the year ended
December 31, 1996.
/s/ Ernst & Young LLP
Minneapolis, Minnesota
June 12, 1997
EXHIBIT 24.1
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below hereby constitutes and appoints John Howell Bullion, his or her
true and lawful attorney-in-fact and agent, with full power of substitution and
resubstitution, for him or her and in his or her name, place and stead, in any
and all capacities to sign a Registration Statement on Form S-8 of Orphan
Medical, Inc. (the "Company") relating to the Company's 1994 Stock Option Plan,
and any and all amendments thereto, including post-effective amendments, and to
file the same, with all exhibits thereto and other documents in connection
therewith, with the Securities and Exchange Commission and with such state
securities commissions and other agencies as necessary; granting unto said
attorney-in-fact and agent, full power and authority to do and perform to all
intents and purposes as he or she might or could do in person, hereby ratifying
and confirming all that said attorney-in-fact and agent, or the substitutes for
such attorney-in-fact and agent, may lawfully do or cause to be done by virtue
hereof.
Name Title Date
---- ----- ----
/s/William B. Adams Director June 4, 1997
- -------------------------------
William B. Adams
/s/ Maurice R. Taylor, II Director June 3, 1997
- -------------------------------
Maurice R. Taylor, II
/s/ Bertram A. Spilker President and Director June 2, 1997
- -------------------------------
Bertram A. Spilker, Ph.D., M.D.
/s/ Lawrence C. Weaver Director June 3, 1997
- -------------------------------
Lawrence C. Weaver, Ph.D.,
D.Sc. (Hon.)
/s/ W. Leigh Thompson Director June 7, 1997
- -------------------------------
W. Leigh Thompson, Ph.D. M.D.
/s/ William M. Wardell Director June 12, 1997
- -------------------------------
William M. Wardell, Ph.D., M.D.
