DURA PHARMACEUTICALS INC/CA
S-1/A, 1997-12-16
PHARMACEUTICAL PREPARATIONS
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<PAGE>
   
   AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON DECEMBER 16, 1997
    
 
                                             REGISTRATION NO. 333-37673/37673-01
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549
                         ------------------------------
   
                                AMENDMENT NO. 5
                                  TO FORM S-1
    
                             REGISTRATION STATEMENT
                                     UNDER
                           THE SECURITIES ACT OF 1933
                            ------------------------
                    SPIROS DEVELOPMENT CORPORATION II, INC.
 
             (Exact name of registrant as specified in its charter)
 
<TABLE>
<S>                              <C>                            <C>
           DELAWARE                          5122
 (State or other jurisdiction    (Primary Standard Industrial   (I.R.S. Employer
              of                 Classification Code Number)     Identification
incorporation or organization)                                      Number)
</TABLE>
 
        7475 LUSK BOULEVARD, SAN DIEGO, CALIFORNIA 92121 (619) 457-2553
 (Address and telephone number, including area code, of registrant's principal
                               executive offices)
                         ------------------------------
   
                                AMENDMENT NO. 5
                                  TO FORM S-3
    
                             REGISTRATION STATEMENT
                                     UNDER
                           THE SECURITIES ACT OF 1933
                            ------------------------
                           DURA PHARMACEUTICALS, INC.
             (Exact name of registrant as specified in its charter)
 
<TABLE>
<S>                              <C>                            <C>
           DELAWARE                          5122                  95-3645543
 (State or other jurisdiction    (Primary Standard Industrial   (I.R.S.Employer
              of                 Classification Code Number)     Identification
incorporation or organization)                                      Number)
</TABLE>
 
        7475 LUSK BOULEVARD, SAN DIEGO, CALIFORNIA 92121 (619) 457-2553
 
         (Address, including zip code, and telephone number, including
            area code, of registrant's principal executive offices)
 
            CAM L. GARNER                           DAVID S. KABAKOFF
    Chairman, President and Chief             Chairman, President and Chief
          Executive Officer                         Executive Officer
      DURA PHARMACEUTICALS, INC.            SPIROS DEVELOPMENT CORPORATION II,
                                                           INC.
         7475 Lusk Boulevard                  c/o Dura Pharmaceuticals, Inc.
     San Diego, California 92121                   7475 Lusk Boulevard
            (619) 457-2553                     San Diego, California 92121
                                                      (619) 457-2553
 (Name, address, including zip code,       (Name, address, including zip code,
            and telephone                             and telephone
number, including area code, of agent     number, including area code, of agent
             for service)                              for service)
 
                         ------------------------------
 
                                   COPIES TO:
 
        FAYE H. RUSSELL, ESQ.                       MARK KESSEL, ESQ.
   BROBECK, PHLEGER & HARRISON LLP                 SHEARMAN & STERLING
   550 West "C" Street, Suite 1300                 599 Lexington Avenue
     San Diego, California 92101                 New York, New York 10022
            (619) 234-1966                            (212) 848-4000
 
                         ------------------------------
 
        APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
AS SOON AS PRACTICABLE AFTER THE EFFECTIVE DATE OF THIS REGISTRATION STATEMENT.
                         ------------------------------
 
    * If the securities being registered on this form are being offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box: /X/
 
    If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering: / /
 
    If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering: / /
 
   
    If this Form is a post-effective amendment filed pursuant to Rule 462(d)
under the Securities Act, check the following box and list the Securities Act
registration number of the earlier effective registration statement for the same
offering: / /
    
 
    If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box: / /
                         ------------------------------
 
    THE REGISTRANTS HEREBY AMEND THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANTS
SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THE REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION ACTING PURSUANT TO SAID SECTION 8(A)
MAY DETERMINE.
 
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
 
* SOLELY WITH RESPECT TO THE FORM S-3.
<PAGE>
                                   SIGNATURES
 
   
    PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, SPIROS
DEVELOPMENT CORPORATION II, INC. HAS DULY CAUSED THIS REGISTRATION STATEMENT TO
BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED, THEREUNTO DULY AUTHORIZED, IN THE
CITY OF SAN DIEGO, COUNTY OF SAN DIEGO, STATE OF CALIFORNIA, ON THE 16TH DAY OF
DECEMBER, 1997.
    
 
                                SPIROS DEVELOPMENT CORPORATION II, INC.
 
                                By:            /s/ DAVID S. KABAKOFF
                                     -----------------------------------------
                                                 DAVID S. KABAKOFF
                                              CHAIRMAN, PRESIDENT AND
                                              CHIEF EXECUTIVE OFFICER
 
    PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THIS
REGISTRATION STATEMENT HAS BEEN SIGNED OF BEHALF OF SPIROS DEVELOPMENT
CORPORATION II, INC. BY THE FOLLOWING PERSONS IN THE CAPACITIES AND ON THE DATES
INDICATED.
 
   
          SIGNATURE                        TITLE                   DATE
- ------------------------------  ---------------------------  ----------------
 
                                Chairman, President and
    /s/ DAVID S. KABAKOFF         Chief Executive Officer      December 16,
- ------------------------------    (Principal Executive             1997
      DAVID S. KABAKOFF           Officer)
 
                                Vice President and Chief
              *                   Financial Officer            December 16,
- ------------------------------    (Principal Financial and         1997
         ERLE T. MAST             Accounting Officer)
 
              *
- ------------------------------  Director                       December 16,
        CAM L. GARNER                                              1997
 
   */s/  DAVID S. KABAKOFF
- ------------------------------
    BY: DAVID S. KABAKOFF,
       ATTORNEY-IN-FACT
 
    
 
                                      II-6
<PAGE>
                                   SIGNATURES
 
   
    PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, DURA
PHARMACEUTICALS, INC. CERTIFIES THAT IT HAS REASONABLE GROUNDS TO BELIEVE THAT
IT MEETS ALL OF THE REQUIREMENTS FOR FILING ON FORM S-3 AND HAS DULY CAUSED THIS
REGISTRATION STATEMENT TO BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED, THEREUNTO
DULY AUTHORIZED, IN THE CITY OF SAN DIEGO, COUNTY OF SAN DIEGO, STATE OF
CALIFORNIA, ON THE 16TH DAY OF DECEMBER, 1997.
    
 
<TABLE>
<S>                             <C>  <C>
                                DURA PHARMACEUTICALS, INC.
 
                                BY:              /S/ CAM L. GARNER
                                     -----------------------------------------
                                                   CAM L. GARNER
                                              CHAIRMAN, PRESIDENT AND
                                              CHIEF EXECUTIVE OFFICER
</TABLE>
 
    PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THIS
REGISTRATION STATEMENT HAS BEEN SIGNED ON BEHALF OF DURA PHARMACEUTICALS, INC.
BY THE FOLLOWING PERSONS IN THE CAPACITIES AND ON THE DATES INDICATED.
 
   
<TABLE>
<CAPTION>
          SIGNATURE                        TITLE                   DATE
- ------------------------------  ---------------------------  ----------------
 
<C>                             <S>                          <C>
                                Chairman, President and
      /s/ CAM L. GARNER           Chief Executive Officer      December 16,
- ------------------------------    (Principal Executive             1997
        CAM L. GARNER             Officer)
 
                                Senior Vice President,
                                  Finance and
     /s/ JAMES W. NEWMAN          Administration, and Chief    December 16,
- ------------------------------    Financial Officer                1997
       JAMES W. NEWMAN            (Principal Financial and
                                  Accounting Officer)
 
    /s/ DAVID S. KABAKOFF
- ------------------------------  Executive Vice President       December 16,
      DAVID S. KABAKOFF           and Director                     1997
 
              *                 Senior Vice President,
- ------------------------------    Sales and Marketing, and     December 16,
       WALTER F. SPATH            Director                         1997
 
              *
- ------------------------------  Director                       December 16,
        JAMES C. BLAIR                                             1997
 
              *
- ------------------------------  Director                       December 16,
      HERBERT J. CONRAD                                            1997
</TABLE>
    
 
                                      II-7
<PAGE>
   
<TABLE>
<CAPTION>
          SIGNATURE                        TITLE                   DATE
- ------------------------------  ---------------------------  ----------------
 
<C>                             <S>                          <C>
              *
- ------------------------------  Director                       December 16,
     JOSEPH C. COOK, JR.                                           1997
 
              *
- ------------------------------  Director                       December 16,
        DAVID F. HALE                                              1997
 
              *
- ------------------------------  Director                       December 16,
      GORDON V. RAMSEIER                                           1997
 
              *
- ------------------------------  Director                       December 16,
       CHARLES G. SMITH                                            1997
 
     */s/  CAM S. GARNER
- ------------------------------
      BY: CAM L. GARNER,
       ATTORNEY-IN-FACT
</TABLE>
    
 
                                      II-8
<PAGE>
                                 EXHIBIT INDEX
 
   
<TABLE>
<CAPTION>
 EXHIBIT
 NUMBER                                                  DESCRIPTION
- ---------  -------------------------------------------------------------------------------------------------------
<C>        <S>
   1.1++   Form of U.S. Purchase Agreement.
   1.2++   Form of International Purchase Agreement.
   3.1++   Certificate of Incorporation of Spiros Corp. II.
   3.2++   By-laws of Spiros Corp. II.
   3.3++   Amended and Restated Certificate of Incorporation of Spiros Corp. II (to be effective immediately prior
           to closing).
   3.4++   Amended and Restated By-laws of Spiros Corp. II (to be effective immediately prior to closing).
   4.1++   Purchase Option (included in Exhibit 3.3).
   4.2++   Form of Warrant Agreement, including form of Warrant.
   4.3++   Form of Warrant (included in Exhibit 4.2).
   4.4+++  Specimen Unit Certificate.
   4.5+++  Specimen Stock Certificate for Dura Common Stock.
   4.6+++  Specimen Stock Certificate for Spiros Corp. II Common Stock.
   4.7+++  Specimen Stock Certificate for Spiros Corp. II Special Shares.
   5.1++   Opinion of Brobeck, Phleger & Harrison LLP as to legality of the securities being registered, including
           consent.
   8.1+    Opinion of Brobeck, Phleger & Harrison LLP as to certain tax matters, including consent.
  10.1++   Form of Technology License Agreement.
  10.2++   Form of Development Agreement.
  10.3++   Form of Albuterol and Product Option Agreement.
  10.4++   Form of Manufacturing and Marketing Agreement.
  10.5++   Form of Services Agreement.
  10.6++   Spiros Corp. II 1997 Stock Option Plan.
  10.7++   Form of Spiros Corp. II Notice of Grant of Stock Option
  10.8++   Form of Spiros Corp. II Stock Option Agreement
  10.9++   Form of Addendum to Stock Option Agreement
  10.10++  Form of Spiros Corp. II Indemnification Agreement for Directors.
  10.11++  Form of Spiros Corp. II Indemnification Agreement for Officers.
  23.1++   Consent of Brobeck, Phleger & Harrison LLP (included in Exhibits 5.1 and 8.1).
  23.2++   Consent of Deloitte & Touche LLP, Independent Auditors.
  23.3++   Consent of Kleinfeld, Kaplan and Becker, regulatory counsel.
  24.1++   Powers of Attorney.
  27.1++   Financial Data Schedule of Spiros Corp. II.
</TABLE>
    
 
- ------------------------
 
   
+   As amended.
    
 
++  Previously filed.
 
   
+++ Previously filed and incorporated herein by reference in the Company's
    Registration Statement on Form 8-A, File No. 333-37673/37673-01 filed on
    December 11, 1997.
    

<PAGE>

                                                                   EXHIBIT 8.1

                               December 16, 1997



Dura Pharmaceuticals, Inc.
7475 Lusk Boulevard
San Diego, California 92121

Spiros Development Corporation II, Inc.
7475 Lusk Boulevard
San Diego, California 92121

Ladies and Gentlemen:

     We have acted as counsel to Dura Pharmaceuticals, Inc., a Delaware 
corporation ("Dura"), and, in certain limited matters, to Spiros Development 
Corporation II, Inc., a Delaware corporation ("Spiros Corp. II"), in 
connection with the offering ("Offering") of units consisting of one share of 
the Callable Common Stock of Spiros Corp. II ("Spiros Corp. II Common Stock") 
and one warrant ("Warrant") to purchase one-fourth of one share of the Common 
Stock of Dura (the "Units"), pursuant to Spiros Corp. II's and Dura's 
Registration Statement on Forms S-1/S-3 (the "Registration Statement").

     In connection with this opinion, we have examined the Registration 
Statement and related Prospectuses, Dura's Amended and Restated Certificate 
of Incorporation, as amended through the date hereof, Dura's bylaws, as 
amended through the date hereof, Spiros Corp. II's Certificate of 
Incorporation (including a copy of the Amended and Restated Certificate of 
Incorporation to be filed by Spiros Corp. II immediately prior to the closing 
of the Subscription Offering), and Spiros Corp. II's bylaws, as amended 
through the date hereof. We have also reviewed the originals, or copies 
certified to our satisfaction, of the Technology License Agreement, the 
Development Agreement, the Manufacturing and Marketing Agreement, the 
Services Agreement, the Albuterol and Product Option Agreement and such other 
agreements (the "Agreements") and such records, documents, certificates, 
memoranda and other instruments as in our judgment are necessary or 
appropriate to enable us to render the opinion expressed below (the 
"Documents"). We are relying (without any independent investigation thereof) 
upon the truth and accuracy of the statements, covenants, representations and 
warranties set forth in the Registration Statement, the Agreements and the 
Documents.

     In rendering the opinions set forth below, we have relied (or will rely) 
upon the following additional representations and assumptions:

<PAGE>

Dura Pharmaceuticals, Inc.                                    December 16, 1997
Spiros Development Corporation II, Inc.                                  Page 2


     1.  The form of Agreements and Documents supplied to us that we reviewed 
         in connection with rendering opinions hereunder will be validly
         executed in substantially the same form in which they have been filed
         as exhibits to the Registration Statement and will be binding and 
         enforceable in accordance with their terms.

     2.  All parties will perform under such Agreements in accordance with 
         their terms.

     3.  There are no other or further agreements which would alter, amend or 
         otherwise materially affect the relationships created by or described
         in the above listed Agreements and Documents or described in the
         Registration Statement.

     Our opinions represent only our best judgment regarding the application 
of federal income tax laws under the Internal Revenue Code of 1986, as 
amended (the "Code"), existing judicial decisions, administrative regulations 
and published rulings and procedures. Our opinion is not binding upon the 
Internal Revenue Service or the courts, and there is no assurance that the 
Internal Revenue Service will not successfully assert contrary positions. 
Furthermore, no assurance can be given that future legislative, judicial 
decisions or administrative changes, applicable either on a prospective or 
retroactive basis, might not materially alter our opinions. Nevertheless, we 
undertake no responsibility to advise you of any new developments in the 
application or interpretation of the federal income tax laws.

     Based on and subject to the foregoing, we are of the opinion that the 
statements in the Registration Statement and the Prospectuses (as amended and 
supplemented through the date of issuance) under the captions "United States 
Federal Income Tax Consequences" and "United States Taxation of Non-U.S. 
Persons," to the extent they constitute matters of law or legal conclusions 
with respect thereto, have been prepared or reviewed by us and are correct in 
all material respects.

     We express no opinion as to any other tax issues affecting persons 
acquiring, holding or disposing of the Units, the Spiros Corp. II Common 
Stock, the Warrants or the Common Stock of Dura issuable upon exercise of the 
Warrants or Dura's Purchase Option (as defined in the Registration Statement) 
or any other party to any of the Agreements, nor does our opinion address 
state, local or foreign tax consequences that may result from the 
transactions.

<PAGE>

Dura Pharmaceuticals, Inc.                                    December 16, 1997
Spiros Development Corporation II, Inc.                                  Page 3


     We consent to the use of this opinion as an exhibit to the Registration 
Statement. 

                                       Respectfully,

                                       /s/ Brobeck, Phleger & Harrison LLP

                                       BROBECK, PHLEGER & HARRISON LLP


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