UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):September 27, 2004
SANTARUS, INC.
(Exact Name of Registrant as Specified in its Charter)
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| Delaware | | 0-50651 | | 33-0734433 |
(State or Other Jurisdiction
of Incorporation) | | (Commission
File Number) | | (IRS Employer
Identification No.) |
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| 10590 West Ocean Air Drive, Suite 200, San Diego, CA | | 92130 |
| (Address of Principal Executive Offices) | | (Zip Code) |
Registrant’s telephone number, including area code:(858) 314-5700
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (seeGeneral Instruction A.2. below):
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| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 1.01. Entry into a Material Definitive Agreement.
On September 27, 2004, Santarus, Inc. (the “Company”) entered into a Manufacturing and Supply Agreement with OSG Norwich Pharmaceuticals, Inc., a Delaware corporation (the “Agreement”). Under the terms of this non-exclusive Agreement, OSG Norwich Pharmaceuticals has agreed to manufacture commercial quantities of the Company’s Zegerid™ 20mg and 40mg Capsules product, which is currently under development and is an immediate-release formulation of omeprazole. The Company recently initiated pivotal clinical trials evaluating Zegerid™ 20mg and 40mg Capsules. If the trials are successful, the Company plans to file a new drug application seeking U.S. marketing approval for this product.
The Agreement provides for an initial four-year term beginning upon commencement of commercial manufacturing and thereafter continues in force indefinitely unless terminated with 18 months written notice. The Company can also terminate the Agreement, effective immediately, at any time if it decides to no longer market the product, in the event any governmental agency takes any action that prevents the Company from importing, exporting, purchasing or selling the product or in the event of certain regulatory proceedings involving the manufacturer. Either party may terminate the Agreement if the other party fails to perform any material term of the Agreement and fails to cure such breach within a specified time period, subject to prior written notice.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| | SANTARUS, INC.
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| Date: October 1, 2004 | By: | /s/ Gerald T. Proehl | |
| | | Name: | Gerald T. Proehl | |
| | | Title: | President and Chief Executive Officer | |
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