Document:

EX-10.58

 EXHIBIT 10.58 

CONFIDENTIAL TREATMENT REQUESTED 

AMENDMENT NO. 1 TO SUBLICENSE AGREEMENT 

This Amendment is made as of the 30th day of November 1998, between TITAN PHARMACEUTICALS, INC., a corporation organized under the laws of the
State of Delaware and having its principal offices at 400 Oyster Point Blvd., Suite 505, South San Francisco, CA 94080 U.S.A. (hereinafter “TITAN”), and NOVARTIS PHARMA A.G., a corporation organized under the laws of Switzerland and having
its principal offices at Lichtstrasse 35, CH 4002, Basel, Switzerland (hereinafter “NOVARTIS”). 
 WITNESSETH 

WHEREAS, the parties have entered into that certain Sublicense Agreement, effective as of November 20. 1997 (the “Principal
Agreement”), whereby, among other things, TITAN granted to NOVARTIS an exclusive sublicense relating to a compound known as Iloperidone; and 

WHEREAS, by this Amendment the parties desire to amend the Principal Agreement. 

NOW THEREFORE, in consideration of the premises and the mutual covenants contained herein, and for other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound, the pasties hereto agree as follows: 
 1. The
term “Agreement”, as used and defined in the Principal Agreement, shall mean the Principal Agreement as amended by this Amendment. Terms defined in the Principal Agreement and not otherwise defined herein are used herein as defined in the
Principal Agreement. 
 2. Except as otherwise provided herein, the terms and provisions of the Principal Agreement shall be unchanged and
shall continue in full force and effect. 
 3. Appendix A to the Principal Agreement is hereby amended in its entirety to be and read in the
form attached as Appendix A to this Amendment. 
 4. This Amendment may be executed in any number of counterparts, each of which should be
deemed to be an original, but all of which together shall constitute one and the same Amendment. 

 CONFIDENTIAL TREATMENT REQUESTED 

 

 IN WITNESS WHEREOF, the parties hereby intending to be legally bound have caused this
Amendment to be executed and delivered by their proper and duly authorized officers as of the day and year first above written. 
  

									
	NOVARTIS PHARMA A.G.				TITAN PHARMACEUTICALS, INC.
					
	By:		 /s/ Olivier Bassi    /s/ James S. New
				By:		 /s/ Louis R. Bucalo

					
	Date: 		August 27, 1999				Date: 		November 30, 1998

 CONFIDENTIAL TREATMENT REQUESTED 

 

 APPENDIX A 

PATENTS AND PATENT APPLICATIONS (PER SECTION 1.17) 

(As amended per Amendment No. 1 to Sublicense Agreement) 
  

															
	 Country
	  	 Patent Appl. No.
	  	 Filing Date
	  	 Type
	  	 Status
	  	 Patent No.
	  	 Issue Date
	  	 Expiration

Date

		  		  		  		  		  		  		  	
		  		  		  		  		  		  		  	
		  		  		  		  		  		  		  	

 **** 

  

	****	CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS. 

 CONFIDENTIAL TREATMENT REQUESTED 

 

															
	 Country
	 	 Patent Appl. No.
	 	 Filing Date
	 	 Type
	 	 Status
	 	 Patent No.
	 	 Issue Date
	 	 Expiration

Date

		 		 		 		 		 		 		 	
		 		 		 		 		 		 		 	
		 		 		 		 		 		 		 	

 **** 

  

	****	CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS. 

 CONFIDENTIAL TREATMENT REQUESTED 

 

															
	 Country
	 	 Patent Appl. No.
	 	 Filing Date
	 	 Type
	 	 Status
	 	 Patent No.
	 	 Issue Date
	 	 Expiration

Date

		 		 		 		 		 		 		 	
		 		 		 		 		 		 		 	
		 		 		 		 		 		 		 	

 **** 

  

	****	CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.EX-10.59

 EXHIBIT 10.59 

CONFIDENTIAL TREATMENT REQUESTED 

AMENDMENT NO. 2 TO SUBLICENSE AGREEMENT 

THIS AMENDMENT to the Sublicense Agreement effective as of November 20, 1997 (the “Sublicense Agreement”) is made as of
April 10, 2001 by and between TITAN PHARMACEUTICALS, INC., a corporation organized under the laws of the State of Delaware and having its principal office at 400 Oyster Point Blvd., Suite 505, South San Francisco, CA 94080 (hereinafter
“TITAN”), and NOVARTIS PHARMA A.G., a corporation organized under the laws of Switzerland and having its principal office at Lichtstrasse 35, CH 4002 Basel, Switzerland (hereinafter “NOVARTIS”). Capitalized terms used in this
Amendment shall have the same meanings set forth in the Sublicense Agreement. 
 WITNESSETH: 

WHEREAS, TITAN and NOVARTIS desire to amend the Sublicense Agreement to add Japan to the scope of the sublicense and to incorporate certain
related modifications to the terms and conditions thereof. 
 NOW THEREFORE, in consideration of the mutual covenants and agreements
hereinafter set forth, the parties hereby agree as follows: 
 1. Definitions. Section 1.21 of the Sublicense Agreement is
hereby deleted in its entirety and replaced with the following: 
 “1.21 “TERRITORY” shall mean all countries
and territories of the world; provided that any country(ies) in which this Sublicense Agreement is terminated shall be removed from the scope of this definition.” 

2. Grant. Section 2.1(f) is hereby deleted in its entirety and replaced with the following 

“2.1(f) TITAN and its AFFILIATES and SUBLICENSEES shall be entitled to utilize the PATENTS and KNOW-HOW in the FIELD
within the TERRITORY for the development and manufacture of COMPOUND and PRODUCT for marketing, distribution and sale outside of the TERRITORY (those countries where NOVARTIS’ rights under this Sublicense Agreement have been terminated). 

3. Payments and Royalties. 

a. Section 3.1 of the Sublicense Agreement is hereby amended by deleting subsection (d) in its entirety and adding the following new
subsections (d), (e) and (f): 
 “(d) An upfront license fee of **** shall be paid by NOVARTIS to TITAN in cash
within **** of both parties execution of this Amendment Agreement. An additional license fee of **** shall be payable by NOVARTIS to TITAN within **** after submission by TITAN to 

  

	****	CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS. 

 CONFIDENTIAL TREATMENT REQUESTED 

 

 NOVARTIS of an Invoice one time only upon annual NET SALES in **** reaching
****. 
 “(e) Upon submission by TITAN to NOVARTIS of an Invoice therefor, a milestone payment of **** shall be payable
one time only by NOVARTIS to TITAN as follows: (i) **** shall be paid in cash upon receipt by NOVARTIS, its AFFILIATE or SUBLICENSEE of notification from the **** that PRODUCT is approved for **** in **** by NOVARTIS, its AFFILIATE or
SUBLICENSEE (or their designee) for schizophrenia or other psychiatric disorders; and (ii) **** shall be paid in cash within **** after receipt of such notification. The **** payment provided for herein shall, unless otherwise expressly
provided for herein, be non-refundable. 
 “(f) NOVARTIS shall notify TITAN in writing **** prior to NOVARTIS’
estimated achievement of each milestone event described in Sections 3.1(b), 3.1(c)(i) and 3.1(e) above. Upon the receipt of such notification, TITAN shall send NOVARTIS an Invoice for the milestone payment due as a result of the achievement of such
milestone event, and NOVARTIS shall make each such payment within **** of the achievement of the milestone event for which payment is due. 

b. Section 3.3 of the Sublicense Agreement is hereby deleted in its entirety and replaced with the following: 

“3.3(a) As consideration for the sublicense granted to NOVARTIS in this Sublicense Agreement with respect to all of the
TERRITORY ****, NOVARTIS shall pay to TITAN, in those countries where, and for the period, PATENTS claiming a priority date of May 19,1989 and December 29, 1989 in a particular country in the TERRITORY **** for which a patent had been
granted validly claiming Iloperidone or the manufacture, formulation or the use thereof for use in the FIELD exist: (i) a **** percent (****%) royalty on annual NET SALES of PRODUCT in the TERRITORY **** up to ****, and (ii) a **** percent
(****%) royalty on annual NET SALES of PRODUCT in the TERRITORY **** in excess of ****; in each case on NOVARTIS’, its AFFILIATES’ and SUBLICENSEES’ annual NET SALES of PRODUCT in the TERRITORY ****. 

(b) As consideration for the sublicense granted to NOVARTIS in this Sublicense Agreement with respect to ****, NOVARTIS shall
pay to TITAN: (i) a **** percent (****%) royalty on annual NET SALES of PRODUCT in **** up to Twenty Million Dollars ($20,000,000), and (ii) a **** percent (****%) royalty on annual NET SALES of PRODUCT in **** in excess of ****

  
 2 

 

	****	CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS. 

 CONFIDENTIAL TREATMENT REQUESTED 

 

 ****; in each case on NOVARTIS’, its AFFILIATES’ and SUBLICENSEES’ annual NET
SALES of PRODUCT in ****. 
 4. Development. Section 5.5 of the Sublicense Agreement is hereby amended by deleting the second
sentence of the paragraph. 
 5. Exchange of Information and Confidentiality. Section 6.3 of the Sublicense Agreement is hereby
amended by deleting the second sentence of the paragraph. 
 6. Appendix A. The following patents shall be added to Appendix A: 

 

													
	 ****
		****		****		****		****		****		****
	 ****
		****		****		****						

 7. Effectiveness. This Amendment shall be deemed effective as of the date hereof. 

8. Miscellaneous. 
 a.
Agreement Amended. Subject to the provisions of this Section 7, this Amendment shall be deemed to be an amendment to the Sublicense Agreement. All references to the Sublicense Agreement in any other document, instrument, agreement or
writing hereafter shall be deemed to refer to the Sublicense Agreement as amended hereby. 
 b. Successors and Assigns. This
Amendment shall be binding upon and inure to the benefit of TITAN and NOVARTIS and their respective successors and assigns. 
 c.
Governing Law. This Amendment shall be deemed to have been made in the State of New York and its form, execution, validity, construction and effect shall be determined in accordance with the laws of the State of New York (without regard to
New York’s or any other jurisdictions’s conflict of laws principles). 

  
 3 

 

	****	CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS. 

 EXHIBIT 10.59 

CONFIDENTIAL TREATMENT REQUESTED 
  

 IN WITNESS WHEREOF, the parties hereby have executed this Agreement by proper persons
thereunto duly authorized. 
  

					
	NOVARTIS PHARMA A.G.
		
	By:		 /s/ Markus Goebel    /s/ Gisela Schelling

	Name:		Markus Goebel		    Gisela Schelling
	Title:		Head Nervous System		    Legal Counsel
			BD&L		
	
	TITAN PHARMACEUTICALS, INC.
		
	By:		 /s/ Louis R. Bucalo M.D.

	Name:		Louis R. Bucalo, M.D.
	Title:		Chairman, President and CEO

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