Exhibit 10.1
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
AMENDMENT NO. 1 TO OTC LICENSE AGREEMENT
     This Amendment No. 1 (the “Amendment”) to the OTC License Agreement dated
October 17, 2006 (the “License”), between Schering-Plough Healthcare Products,
Inc. (“Schering”) and Santarus, Inc. (“Santarus”) is made as of July 24, 2009
(the “Effective Date”).
RECITALS
     WHEREAS, Marketing Approval for the first Licensed Product has not yet been
received; and
     WHEREAS, as a result, Schering may launch the first Licensed Product on a
date that is later than the date set forth in the diligence provisions of the
License; and
     WHEREAS, Schering and Santarus desire to amend certain terms of the License
to account for those circumstances, as set forth herein.
     NOW, THEREFORE, for and in consideration of the covenants, conditions, and
undertakings hereinafter set forth, the Parties agree as follows:
AGREEMENT
     1. Amendment of Section 3.3.3. Section 3.3.3 of the License is hereby
amended by adding to the end, “Notwithstanding the foregoing, it is agreed that,
should Schering receive Marketing Approval for its first Licensed Product [***],
then, for purposes of this Section 3.3.3, the twelve month period for measuring
Marketing Commitment shall be deemed to commence on [***].”
     2. Amendment of Section 3.7.2 (Diligence Milestone 4). Diligence Milestone
4 set forth in Section 3.7.2 of the License is hereby amended by restating it in
its entirety as follows:

         
“4.
  First Commercial Sale of the first Licensed Product in the      by [***]”
 
  Territory    

     3. Amendment of Section 3.7.3(a). Section 3.7.3(a) of the License is hereby
amended by adding to the beginning of the second sentence, “Except as provided
in Section 3.7.3(c),”.
     4. Amendment of Section 3.7.3. Section 3.7.3 of the License is hereby
amended by adding a new subsection (c) as follows:
     “(c) Failure to Achieve First Commercial Sale. In the event that Schering
fails to achieve First Commercial Sale of the first Licensed Product in the
Territory by [***] (if Marketing Approval is received on or before [***]) or
within [***] after receipt of Marketing Approval (if Marketing Approval is
received on or after [***]), then Schering shall pay to
 

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Santarus a fee of [***] (US$[***]) within thirty (30) days thereafter, which
amount shall be non-refundable and non-creditable against other amounts due to
Santarus. Provided that Schering has made the payment specified in this
Section 3.7.3(c), Schering shall have a sixty (60) day cure period with respect
to failure to achieve Diligence Milestone 4 by the specified date, after which
Santarus shall have the right to terminate this Agreement in accordance with
Section 3.7.3(a).”
     5. Amendment of Section 5.2 (Milestone Payments). Milestone 4 set forth in
Section 5.2 of the License is hereby amended by restating it in its entirety as
follows:

         
“4.
  First time in which either (a) Net Sales of Licensed   US$[***]”
 
  Products in the Territory reach or exceed US$[***], as measured    
 
  beginning on the date of First Commercial Sale and ending on the    
 
  first anniversary of that date, or (b) annual Net Sales of    
 
  Licensed Products in the Territory reach or exceed at least    
 
  US$[***].    

     6. Amendment of Section 5.2 (Proviso 7). Proviso 7 set forth in Section 5.2
of the License is hereby amended by restating it in its entirety as follows:
     “(7) Annual Net Sales for Milestones 4(b) through 7 shall be measured on a
calendar year basis; provided, however, that, if the Annual Net Sales amounts
set forth for each of Milestones 4(b) through 7 are achieved prior to the fourth
calendar quarter of the applicable calendar year, then the corresponding
milestone amounts shall be due following the applicable calendar quarter in
which such Annual Net Sales are achieved. For purposes of example only, in the
event that the annual Net Sales exceed $[***] for the first time during the
third calendar quarter of a given calendar year, the corresponding milestone
amount of $[***] would be due following the end of such calendar quarter. The
Net Sales amount for Milestone 4(a) only shall be measured during the twelve
(12) month period beginning on the date of First Commercial Sale by Schering in
the Territory; provided, however, that, if the Net Sales amount set forth for
Milestone 4(a) is achieved prior to the end of the twelve (12) month period,
then the milestone amount shall be due following the applicable month in which
such Net Sales are achieved. Payments for Milestones 4(b) through 7 shall be
made thirty (30) days following the end of the applicable calendar quarter in
which such Annual Net Sales are achieved and payment for Milestone 4(a) shall be
made thirty (30) days following the end of the applicable month in which such
Net Sales are achieved. It is understood that Santarus is not entitled to
payment under both Milestones 4(a) and 4(b).”
     7. Miscellaneous.
          a. Except for the amendments set forth herein, all other terms and
conditions of the License shall remain in full force and effect.
          b. This Amendment, and the License as amended by this Amendment,
constitutes the entire agreement between the Parties with respect to its subject
matter and supersedes all previous agreements, whether written or oral.
 

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          c. Capitalized terms used but not otherwise defined herein shall have
the meanings assigned to them in the License.
          d. The validity, performance, construction and effect of this
Amendment shall be governed by the laws of the State of New York, United States
of America, without regard to conflicts of law principles.
     IN WITNESS WHEREOF, the Parties have duly executed this Amendment as of the
Effective Date.
SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.

         
By: 
 /s/ Nancy Miller - Rich    
 
 
 
     
Name: 
Nancy Miller - Rich    
 
 
 
     
Title:
GVP New Ventures & Strategic Commercial Development    
 
 
 
   

SANTARUS, INC.

          By:   /s/ Gerald T. Proehl         Name:   Gerald T. Proehl       
Title:   President and CEO     

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