Document:

mdvn-ex1015_541.htm

Exhibit 10.15

Fourth Amendment To

Exclusive License Agreement

Between

The Regents of the University of California

and

Medivation, Inc and Medivation Prostate Therapeutics, Inc

For

UC Agreement Control No. 2006-04-0085

 

 

 

FOURTH AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
UC Agreement Control No. 2006-04-0085

This Fourth Amendment to Exclusive License Agreement (“Fourth Amendment”), dated as of July 17, 2007, is made by and among The Regents of the University of California, a California corporation (“The Regents”), Medivation, Inc., a Delaware corporation (“Medivation”), and Medivation Prostate Therapeutics, Inc., a Delaware corporation and subsidiary of Medivation (“MPT”) (Medivation and MPT together “Licensee”).

BACKGROUND

	
A.
	
The Regents, Medivation and MPT are parties to an Exclusive License Agreement, dated as of August 12, 2005 (the “Exclusive License Agreement”), as amended on November 4, 2005, May 8, 2006 and June 12, 2007.

	
B.
	
Medivation has supported research in Dr. Michael E. Jung’s laboratory at UCLA under a Sponsored Research Agreement with an Effective Date of August 12, 2005 (the “Sponsored Research Agreement”).

	
C.
	
An invention has been developed at UCLA in the performance of the Sponsored Research Agreement, which is disclosed in UC Case No 2007-139 entitled “Additional Thiohydantoin Androgen Receptor Antagonists for Prostate Cancer Treatment,” by Michael E. Jung and Dongwon Yoo, employees of The Regents, Charles L. Sawyers, an employee of Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of the University of California, Los Angeles at the time the invention was made, and Chris Tran, an employee of HHMI at the time the invention was made.

	
D.
	
The Sponsored Research Agreement grants Medivation the first right to negotiate for a license to inventions made by The Regents in the performance of the Sponsored Research Agreement, and Medivation has exercised its right and wishes to obtain an exclusive license to the invention noted in the preceding clause.

	
E.
	
Medivation as the parent corporation of MPT will benefit directly from the agreements made herein.

	
F.
	
The parties mutually intend to enter into this Fourth Amendment to amend the terms of the Exclusive License Agreement, as specified below.

THEREFORE, the parties hereby agree as follows:

	
1.
	
Paragraph 1.1 (“Regents’ Patent Rights”) is deleted and replaced with the following, which is amended to include “UC Case No. 2007-139” in the parenthetical at the end of the paragraph:

	
 
	
1.1
	
“Regents’ Patent Rights” means The Regents’ interest in the claims of the United States patents and patent applications, corresponding foreign patents and patent applications (requested under Paragraph 7.3 herein), and any reissues, extensions, substitutions, continuations, divisions, and continuation-in-part 

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applications (but only those claims in the continuation-in-part applications that are entirely supported in the specification and entitled to the priority date of the parent application) based on the patent applications listed in Appendix A (UC Case Nos. 2003-279-2, 2004-129, 2005-438, 2006-260, 2006-537 and 2007-139). 

	
2.
	
Appendix A (Regents’ Patent Rights) is deleted and replaced with the Appendix A attached to this Fourth Amendment, which is amended to include the patent applications to be filed under UC Case No. 2007-139.

	
3.
	
In consideration for the addition of the patent rights of UC Case No. 2007-139 to the Exclusive License Agreement, Licensee will pay to The Regents a fee of two thousand five hundred dollars ($2,500) within thirty (30) days of the Effective Date of this Fourth Amendment.  In addition, Licensee will pay a one-time milestone fee of twenty-five thousand dollars ($25,000) upon issuance of the first patent under UC Case No 2007-139 that would cover a Licensed Product.

	
4.
	
Except for the amendments specifically referenced above, all other terms of the Exclusive License Agreement shall remain unchanged and in full force and effect.

The Regents, Medivation and MPT have executed this Amendment in duplicate originals by their authorized officers on the dates written below:

 

		
	
MEDIVATION, INC.
	
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

 

	
By
	
/s/ CP Machado
	
 
	
By
	
/s/ Claire T. Wake

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
Name
	
 
	
C. Patrick Machado
	
 
	
Name
	
 
	
Claire T. Wake, Ph.D.

	
Title
	
 
	
Senior Vice President and CFO
	
 
	
Title
	
 
	
Assistant Director, Licensing

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
Date
	
8 Aug 07
	
 
	
Date
	
July 19, 2007

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
MEDIVATION PROSTATE THERAPEUTICS, INC

	
 
	
 
	
 
	
 

	
By
	
/s/ CP Machado
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 
	
 

	
Name
	
 
	
C. Patrick Machado
	
 
	
 
	
 

	
Title
	
 
	
Senior Vice President and CFO
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 
	
 

	
Date
	
 
	
8 Aug 07
	
 
	
 
	
 

 

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APPENDIX A
(Fourth Amendment)

REGENTS’ PATENT RIGHTS

UC Case No. 2003-279-2

United States Patent Application No. 10/583,280 filed December 16, 2004

Australian Patent Application No, 2004-305075 filed December 16, 2004

Canadian Patent Application No 2550447 filed December 16, 2004

European Patent Application No. 04814409.1 filed December 16, 2004

Hong Kong Patent Application No. 7103115.7 filed December 16, 2004

Japanese Patent Application No. 2006-545417 filed December 16, 2004

New Zealand Patent Application No. 548209 filed December 16, 2004

All of the above based on PCT Patent Application No. US04/42221 “Method and Materials for Assessing Prostate Cancer Therapies,” filed December 16, 2004, based on US Provisional Patent Application No. 60/531,091 filed on December 19, 2003 and assigned to The Regents.  The inventors are Charles L, Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents, and Charlie D. Chen and Derek S. Welsbie, employees of The Regents.

UC Case No. 2004-129

United States Patent Application No., 10/590,445 filed February 23, 2005

Australian Patent Application No. 2005-232526 filed February 23, 2005

New Zealand Patent Application No. 550102 filed February 23, 2005

All of the above based on PCT Patent Application No. US05/05529 “Methods and Materials for Assessing Prostate Cancer Therapies and Compounds,” filed February 23, 2005, based on US Provisional Patent Application No. 60/547,101 filed February 24, 2004 and assigned to The Regents.  The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie, employees of The Regents, and Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents.

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UC Case No. 2005-438

United States Patent Application No. 11/433,829 filed March 29, 2006

The above based on PCT Patent Application No. PCT/US06/11417 “Novel Androgen Receptor Inhibitors with Minimal Agonistic Activities,” filed on March 29, 2006, based on US Provisional Patent Application No. 60/680,835 filed May 13, 2005 and assigned to The Regents.  The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie, employees of The Regents, and Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents.  This application, together with the patent application pertaining to UC Case No. 2004-129, cover the compounds identified as RD1 through RD138, inclusive, on Exhibit A attached to the First Amendment.

PCT Patent Application No. PCT/US06/11417 (also includes UC Case Nos. 2006-260 & 2006-537) titled “Diarylthiohydantoin Compounds” was filed March 29, 2006 and assigned to The Regents.  The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen, Derek Welsbie and Dongwon Yoo, employees of The Regents, and Charles L. Sawyers, an employee of Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of the University of California, Los Angeles, and John Wongvipat and Chris Iran, employees of HHMI.

UC Case No. 2006-260

US Provisional Patent Application No. 60/750,351 filed December 15, 2005 and US Provisional Patent Application No. 60/756,552 filed January 6, 2006, both titled “Selected Diarylthiohydantoin Compounds,” filed January 6, 2006 (both were subsequently rolled into PCT Patent Application No PCT/US06/11417), and both assigned to The Regents.  The inventors are Michael E Jung, Samedy Ouk and Charlie D. Chen, employees of The Regents, and Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents, and John Wongvipat and Chris Tian, employees of HHMI.

UC Case No. 2006-537 

United States Patent Application No. 11/730,168 filed March 29, 2007

The above based on PCT Patent Application No. PCT/US07/07854 “Diarylthiohydantoin Compounds” filed on March 29, 2007, based on US Provisional Patent Application No. 60/786,837 filed March 29, 2006 and assigned to The Regents.  (This invention was also filed as part of PCT Patent Application No. PCT/US06/11417, listed under UC Case No 2005-438 above).  The inventors are Michael E .Jung and Dongwon Yoo, employees of The Regents, and Charles L. Sawyers, an employee of Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of the University of California, Los Angeles, and Chris Tran, an employee of HHMI.

UC Case No. 2007-139 

US Provisional Patent No. [TBD] to be filed “Additional Thiohydantoin Androgen Receptor Antagonists for Prostate Cancer Treatment.”  The inventors are Michael E. Jung and Dongwon Yoo, employees of The Regents, and Charles L. Sawyers, an employee of HHMI and a member of the faculty of the University of California, Los Angeles, and Chris Iran, employee of HHMI.

4mdvn-ex1016_542.htm

Exhibit 10.16

 

FIFTH AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
UC Agreement Control No. 2006-04-0085

This Fifth Amendment to Exclusive License Agreement (“Fifth Amendment”), dated as of October 21, 2009, is made by and among The Regents of the University of California, a California corporation (“The Regents”), Medivation, Inc., a Delaware corporation (“Medivation”), and Medivation Prostate Therapeutics, Inc., a Delaware corporation and subsidiary of Medivation (“MPT”) (Medivation and MPT together “Licensee”).

BACKGROUND

	
A.
	
The Regents, Medivation and MPT are parties to an Exclusive License Agreement, dated as of August 12, 2005 (the “Exclusive License Agreement”), as amended on November 4, 2005, May 8, 2006, June 12, 2006 and July 17, 2007.

	
B.
	
Medivation intends to grant an exclusive sublicense under the Exclusive License Agreement to the Designated Sublicensee (as defined in the Exclusive License Agreement as amended below).

	
C.
	
The parties mutually intend to enter into this Fifth Amendment to amend the terms of the Exclusive License Agreement, as specified below.

THEREFORE, the parties hereby agree as follows:

	
1.
	
Article 1 is amended by the addition of the following new Paragraphs 1.15, 1.16 and 1.17:

	
 
	
1.15
	
“Designated Sublicense” means the Sublicense granted by Licensee to the Designated Sublicensee.

	
 
	
1.16
	
“Designated Sublicense Agreement” means the agreement entered into by Licensee and the Designated Sublicensee pursuant to which the Designated Sublicense is granted.

	
 
	
1.17
	
“Designated Sublicensee” means any Sublicensee that Licensee and The Regents agree in writing is a Designated Sublicensee for the purposes of this Agreement.

	
2.
	
Article 3 (Sublicenses) is amended to include a new Paragraph 3.6:

	
 
	
3.6
	
If this Agreement is terminated for any reason other than (a) a termination by The Regents pursuant to Article 12 due to a material breach by Licensee of any material term or covenant of this Agreement, which material breach is caused by a material breach of a material term or covenant of the Designated Sublicense Agreement by the Designated Sublicensee, or (b) a termination by 

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The Regents pursuant to Paragraph 6.3 for a failure by Licensee to perform any of the terms of such Paragraph, in all cases except (a) and (b), Paragraph 3.5 will not apply, and instead this Paragraph 3.6 will apply: For as long as the Designated Sublicensee Agreement remains in effect, the Designated Sublicense will survive and remain in full force and effect on an exclusive basis, and from and after the effective date of such termination with respect to Licensee, the Designated Sublicensee will be deemed to have the rights of Licensee under this Agreement and will become responsible for fulfilling all of Licensee’s obligations and covenants under this Agreement that arise as a result of the exercise by the Designated Sublicensee of such Sublicense, including all financial terms.

	
3.
	
Paragraphs 6.3d and 6.3e are deleted and replaced with the following:

	
 
	
6.3d
	
First application to market a Licensed Product to be filed in the U.S. or EU by the eleventh (11th) anniversary of the date of this Agreement.

	
 
	
6.3e
	
First Commercial Sale of a Licensed Product by the thirteenth (13th) anniversary of the date of this Agreement.

	
4.
	
Article 7 (Patent Filing, Prosecution and Maintenance) is amended to include the following new Paragraph 7.8:

	
 
	
7.8
	
The Regents represents that as of October 21, 2009, except as requested by Medivation in a notice provided pursuant to Paragraph 7.3, The Regents has not filed patent applications claiming or covering the Invention or corresponding with the Regents’ Patent Rights in any foreign country, and that all of the foreign patents and patent applications claiming or covering the Invention or corresponding with the Regents’ Patent Rights are subject to this Agreement (and are within the scope of the licenses and rights granted in Paragraphs 2.1 and 3.1).  Notwithstanding the foregoing, no representation is made pursuant to this Section 7.8 with respect Patent No. 10/590,445, which The Regents is prosecuting in the United States without funding by Medivation.

	
5.
	
The second sentence of Paragraph 8.1 is amended to include the following at the end of such sentence:

	
 
	

	
. . . except that Licensee may notify a Sublicensee or Affiliate thereof of such infringement without consent of The Regents.

	
6.
	
Paragraph 8.2 is renumbered as Paragraph 8.2a.  The third sentence of such Paragraph is deleted and replaced with the following:

	
 
	

	
If joinder of The Regents is required by applicable law to perfect or maintain jurisdiction with respect to any such suit, then subject to approval of the Board of Regents of the University of California, The Regents will join such suit, will consent to the jurisdiction of federal or state courts with respect to 

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such suit, and will not oppose joinder in such suit, including on grounds of sovereign immunity.  In the event of such required joinder, Licensee will pay any costs incurred by The Regents arising out of such suit, including but not limited to, any legal fees of counsel that The Regents selects and retains to represent it in the suit.

	
7.
	
Article 8 (Patent Infringement) is amended to include the following new Paragraph 8.2b:

	
 
	
8.2b
	
Notwithstanding anything contained in this Article 8 to the contrary, if the Infringement Notice is predicated on the receipt of a notice of certification sent or filed pursuant to the U.S. “Drug Price Competition and Patent Term Restoration Act” of 1984, including pursuant to 21 U.S.C. 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV), or any equivalent or similar notice or certification in any foreign jurisdiction, claiming that the patent is invalid or unenforceable or claiming that the patent will not be infringed by the Manufacture, use, marketing or sale of a product for which an application under the act is filed, then the Licensee may institute suit within the applicable timeframe required by law and may, if required to perfect or maintain jurisdiction with respect to such suit, name The Regents as a co-plaintiff in such suit, subject to approval of the Board of Regents of the University of California.  In such circumstance, The Regents will use best efforts to obtain the approval of the Board of Regents of the University of California within 30 days of the Infringement Notice, and will notify Licensee no later than such 30th day whether the Board of the Regents of the University of California will grant such approval. Prior to initiating the suit, the Licensee will consult with The Regents to obtain its input with respect to the proposed suit, and will consider such input in good faith.  Without limitation to the foregoing and subject to approval of the Board of Regents of the University of California, The Regents agree to cooperate with respect to such suit if named as a co-plaintiff, including by participating as a party plaintiff in any such suit, joining in such suit, consenting to the jurisdiction of federal or state courts, and not opposing joinder, including on grounds of sovereign immunity.  The Regents may voluntarily join any such suit initiated solely by the Licensee at the Regents’ own expense, but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of the Licensee’s suit or any judgment rendered in the suit.  If The Regents is named by the Licensee as a co-plaintiff in such a suit pursuant to the first sentence of this Paragraph 8.2b, then the Licensee will pay any costs incurred by The Regents arising out of such suit, including but not limited to, any legal fees of counsel that The Regents selects and retains to represent it in the suit.  The Regents hereby acknowledges that the rights conferred on the Licensee pursuant to Paragraphs 8.1 and 8.2 may be exercised by a Sublicensee designated by the Licensee (including the Designated Sublicensee).

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8.
	
Article 30 is amended by the addition of the following new Paragraph 30.2:

	
 
	
30.2
	
The Designated Sublicensee is an intended third-party beneficiary of this Agreement and certain of its provisions, including Paragraph 3.6, are for the benefit of the Designated Sublicensee and are enforceable by the Designated Sublicensee in its own name.

	
9.
	
Except for the amendments specifically referenced above, all other terms of the Exclusive License Agreement remain unchanged and in full force and effect.

The Regents, Medivation and MPT have executed this Amendment in duplicate originals by their authorized officers on the dates written below:

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

		
	
By 
	
/s/Claire T. Wake

	
 
	
 

	
Name: 
	
Claire T. Wake

	
Title: 
	
Assistant Director, Licensing

	
 
	
 

	
Date:
	
October 21, 2009

MEDIVATION, INC.

		
	
By 
	
/s/ C. Patrick Machado

	
 
	
 

	
Name: 
	
C. Patrick Machado

	
Title: 
	
CFO

	
 
	
 

	
Date:
	
21 Oct 09

MEDIVATION PROSTATE THERAPEUTICS, INC.

		
	
By 
	
/s/ C. Patrick Machado

	
 
	
 

	
Name: 
	
C. Patrick Machado

	
Title: 
	
CFO

	
 
	
 

	
Date:
	
21 Oct 09

 

 

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9.
	
Except for the amendments specifically referenced above, all other terms of the Exclusive License Agreement remain unchanged and in full force and effect.

The Regents, Medivation and MPT have executed this Amendment in duplicate originals by their authorized officers on the dates written below:

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

		
	
By 
	
 

	
 
	
 

	
Name: 
	
 

	
Title: 
	
 

	
 
	
 

	
Date:
	
 

MEDIVATION, INC.

		
	
By 
	
/s/ C. Patrick Machado

	
 
	
 

	
Name: 
	
C. Patrick Machado

	
Title: 
	
CFO

	
 
	
 

	
Date:
	
21 Oct 09

MEDIVATION PROSTATE THERAPEUTICS, INC.

		
	
By 
	
/s/ C. Patrick Machado

	
 
	
 

	
Name: 
	
C. Patrick Machado

	
Title: 
	
CFO

	
 
	
 

	
Date:
	
21 Oct 09

 

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