Document:

exv10w11

 

EXHIBIT 10.11

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 the

LICENSE AGREEMENT

dated as of March 31, 2004

     THIS AMENDMENT NO. 1 (the “FIRST AMENDMENT”), dated and effective as of the 22nd day
of December, 2004, to that certain LICENSE AGREEMENT dated as of March 31, 2004 (the
“AGREEMENT”), by and between DUKE UNIVERSITY, a nonprofit educational and research
institution organized under the laws of North Carolina (“DUKE”), and OREXIGEN
PHARMACEUTICALS, INC., a Delaware corporation (hereinafter “OREXIGEN”). Unless otherwise
defined herein, capitalized terms used but not defined herein shall have the meaning set forth in
the AGREEMENT and the AGREEMENT shall be amended to incorporate any additional definitions provided
for in this FIRST AMENDMENT, including definitions in the recitals hereto.

     WHEREAS, OREXIGEN and CYPRESS BIOSCIENCE, INC., a Delaware corporation (“CYPRESS”),
intend to enter into that certain LICENSE AGREEMENT (the “CYPRESS AGREEMENT”), pursuant to
which OREXIGEN shall grant a SUBLICENSE (the “CYPRESS SUBLICENSE”) to CYPRESS, subject to
this FIRST AMENDMENT, and CYPRESS is a signatory to this FIRST AMENDMENT solely for the purposes of
Section 2 of this FIRST AMENDMENT;

     WHEREAS, DUKE and OREXIGEN desire to amend the AGREEMENT as set forth herein;

     NOW, THEREFORE, in consideration of the premises and the mutual agreements hereinafter set
forth, the parties hereby agree as follows:

     1. Amendment to Section 1.19. Section 1.19 of the AGREEMENT is hereby amended to read
in its entirety as follows:

     1.01 “NET SALES” shall mean:

	 	(a)	 	in the case of DUKE LICENSED PRODUCTS and OREXIGEN LICENSED
PRODUCTS, OREXIGEN’S (and/or those of SUBLICENSEES, as the case may be)
revenues received from sale and/or lease of the subject DUKE LICENSED PRODUCTS
and/or OREXIGEN LICENSED PRODUCTS; and
	 
	 	(b)	 	in the case of DUKE LICENSED PROCESSES and OREXIGEN LICENSED
PROCESSES, OREXIGEN’S (and/or those of SUBLICENSEES, as the case may be)
revenues received from sale and/or lease of the subject DUKE LICENSED PROCESSES
and/or OREXIGEN LICENSED PROCESSES; and

 1 of 7

 

	 	(c)	 	in the case of DUKE LICENSED SERVICES and OREXIGEN LICENSED SERVICES,
revenue received by OREXIGEN (and/or SUBLICENSEES, as the case may be) for
provision of the subject DUKE LICENSED SERVICE and/or OREXIGEN LICENSED
SERVICE to a THIRD PARTY.

and each of (a) (b), and (c), above shall be less the sum of the following:

	 	(w)	 	discounts allowed in amounts customary in the trade;
	 
	 	(x)	 	sales, tariff duties and/or use taxes directly imposed and with
reference to particular sales;
	 
	 	(y)	 	outbound transportation prepaid or allowed; and
	 
	 	(z)	 	amounts allowed or credited on returns.

No deductions to NET SALES shall be made for commissions paid to individuals whether
they are associated with independent sales agencies or regularly employed by
OREXIGEN (and/or SUBLICENSEES, as the case may be) and on its payroll, or for cost
of collections. DUKE LICENSED PRODUCTS, OREXIGEN LICENSED PRODUCTS, DUKE LICENSED
PROCESSES, OREXIGEN LICENSED PROCESSES, DUKE LICENSED SERVICES, and OREXIGEN
LICENSED SERVICES shall be considered “sold” when the consideration for provision
thereof is received by OREXIGEN (and/or SUBLICENSEES, as the case may be). DUKE
LICENSED PRODUCTS, OREXIGEN LICENSED PRODUCTS, DUKE LICENSED PROCESSES, OREXIGEN
LICENSED PROCESSES, DUKE LICENSED SERVICES, and OREXIGEN LICENSED SERVICES used by
OREXIGEN (and/or SUBLICENSEES, as the case may be) for clinical field trials,
provided as free-of-charge-samples for distribution to customers or end users, or
for OREXIGEN’s own internal non-commercial research (and/or SUBLICENSEES, as the
case may be) shall not be included in NET SALES.

Except as provided below, if a DUKE LICENSED PRODUCT, DUKE LICENSED PROCESS or a
DUKE LICENSED SERVICE is sold in combination with another active component or
components not otherwise claimed in the DUKE PATENT RIGHTS, and OREXIGEN (or any
appertaining SUBLICENSEE) does not pay a royalty for such component that will result
in a reduced RUNNING ROYALTY pursuant to Section 3.01(b), then the NET
SALES, for purposes of determining royalties on the combination, will be calculated
by multiplying the NET SALES of the combination by the fraction A/(A+B), where A is
the invoice price of the DUKE LICENSED PRODUCT, DUKE LICENSED PROCESS or DUKE
LICENSED SERVICE if sold separately and B is the total invoice price of any other
active component or components in the combination if sold separately. If the DUKE
LICENSED PRODUCT, DUKE LICENSED PROCESS or DUKE LICENSED SERVICE and

 2 of 7

 

the other active component or components in the combination are not sold separately,
the NET SALES, for purposes of determining royalties on the combination, will be
calculated by multiplying the NET SALES of the combination by the fraction
determined by mutual agreement of the parties, that reflects the relative
contribution in value that the DUKE LICENSED PRODUCT, DUKE LICENSED PROCESS or DUKE
LICENSED SERVICE contained in the combination makes to the total value of such
combination to the end user.

     2. Amendment to Section 2.04. Section 2.04 is amended by adding the following
to the end of Section 2.04:

It is understood and acknowledged that OREXIGEN and Cypress Bioscience, Inc. a
Delaware corporation (“CYPRESS”) have entered into a certain License Agreement,
dated effective January 3, 2005, pursuant to which OREXIGEN grants a SUBLICENSE to
CYPRESS (such License Agreement hereinafter referred to as “CYPRESS AGREEMENT”).
Pursuant to the provisions of this Section 2.04, DUKE hereby agrees that the
SUBLICENSE granted to CYPRESS under the CYPRESS AGREEMENT shall be further
sublicenseable without approval from DUKE, provided that CYPRESS and each of its
appertaining SUBLICENSEES wishing to enter into another a SUBLICENSE AGREEMENT to
sublicense its rights determine in good faith that to do so is in the best interest
of the parties involved, including DUKE, and is not to the unreasonable and/or
disproportionate detriment of DUKE as compared to CYPRESS and/or the subject
SUBLICENSEE(S). Pursuant to the provisions of this Section 2.04, DUKE
hereby approves of assignment of the CYPRESS AGREEMENT (as it applies to the DUKE
PATENT RIGHTS) to DUKE in the event this AGREEMENT is terminated, and acknowledges
that termination of this AGREEMENT shall not affect the exclusivity of the CYPRESS
SUBLICENSE, provided that, at the time of any such termination of this AGREEMENT,
CYPRESS is not in breach of any of the material obligations under the CYPRESS
AGREEMENT that flow to CYPRESS as a SUBLICENSEE under this AGREEMENT. In addition,
DUKE agrees that, effective upon such assignment of the CYPRESS AGREEMENT to DUKE,
the royalty and milestone payment terms under the CYPRESS AGREEMENT payable by
CYPRESS shall be replaced in their entirety by the royalty and milestone payment
terms under Section 3.01(f) and (g) of this AGREEMENT (and no other
payments shall be payable under Section 3.01 of the CYPRESS AGREEMENT or
Section 3.01 of this AGREEMENT), and CYPRESS shall assume a pro rata sharing
of DUKE PATENT RIGHTS EXPENSES incurred after the date of assignment of the CYPRESS
AGREEMENT to DUKE with other SUBLICENSEES (if any), such pro rata sharing to reflect
the scope and relative value of the rights under the DUKE PATENT RIGHTS granted to
each SUBLICENSEE as determined in good faith by DUKE in consultation with each
SUBLICENSEE.

     3. Amendment to Section 3.01. Section 3.01 of the
AGREEMENT is hereby amended by adding subsection (f) thereto, which
provides as follows:

 3 of 7

 

	 	(f)	 	Royalty on NET SALES by CYPRESS. For any NET SALES of DUKE
LICENSED PRODUCTS, DUKE LICENSED PROCESSES, and DUKE LICENSED SERVICES by
CYPRESS (and any appertaining SUBLICENSEES thereof, as the case may be), the
provisions of this Section 3.01(f) shall apply instead of
Section 3.01(b), and the DUKE RUNNING ROYALTY in connection with
such NET SALES by CYPRESS shall be as follows:

	 	 	 
	Royalty Rate	 	Annual NET SALES Levels
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]

	 	 	 	The applicable DUKE RUNNING ROYALTY rate for a particular NET SALES level
shall apply only to such NET SALES level. Therefore, as an example, if NET
SALES for a particular calendar year were [***].
	 
	 	 	 	Notwithstanding the foregoing, if CYPRESS (and/or appertaining SUBLICENSEES
thereof, as the case may be) obtains from any THIRD PARTY any licenses
and/or sublicenses for patent rights in order to practice DUKE PATENT RIGHTS
in the FIELD OF USE or in order to develop, make, have made, use, import,
offer for sale, sell, import, export or provide DUKE LICENSED PRODUCTS, DUKE
LICENSED PROCESSES, and/or DUKE LICENSED SERVICES (as the case may be), then
OREXIGEN (and/or CYPRESS and/or CYPRESS’ appertaining SUBLICENSEES, as the
case may be) shall be entitled to credit its/their payment of additional
running royalties to such THIRD PARTY(IES), if any, on DUKE LICENSED
PRODUCTS, DUKE LICENSED PROCESSES, and/or DUKE LICENSED SERVICES (as the
case may be)

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 4 of 7

 

	 	 	 	against the DUKE RUNNING ROYALTY for the subject DUKE LICENSED PRODUCTS,
DUKE LICENSED PROCESSES, and/or DUKE LICENSED SERVICES (as the case may be)
in the appertaining country(ies) during the appertaining time period,
provided that in no event shall the amount otherwise payable to DUKE as DUKE
RUNNING ROYALTY be reduced by more than [***] percent ([***]%) for the
subject DUKE LICENSED PRODUCTS, DUKE LICENSED PROCESSES, and/or DUKE
LICENSED SERVICES (as the case may be) in the appertaining country(ies)
during the appertaining time period.

     Section 3.01 is hereby further amended by adding subsection (g) thereto, which
provides as follows:

	 	(g)	 	Milestone payments to DUKE relating to the CYPRESS
AGREEMENT. As regards milestones payments relating to the CYPRESS
AGREEMENT and any SUBLICENSES thereof of any of the rights to DUKE PATENT
RIGHTS;, the provisions of this Section 3.01(g) shall apply instead of
Section 3.01(d). OREXIGEN (or CYPRESS as regards any of the following
milestones that may occur for the first time after the effective date of an
assignment of the CYPRESS AGREEMENT (as it applies to DUKE PATENT RIGHTS) to
DUKE) shall pay DUKE the following one-time, non-creditable, non-refundable
payments within [***] ([***]) days of the first occurrence (by CYPRESS and/or
any of its SUBLICENSEES) of each of the following milestones as relates to any
DUKE LICENSED PRODUCT:

	 	 	 	[***]

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 5 of 7

 

               [***]

     It is understood and agreed that milestone payments expressly identified above in subsections
(i)-(vii) of this Section 3.01(g) shall [***] and, thus, such milestone payments shall
[***].

     Section 3.01 is hereby further amended by adding subsection (h) thereto, which
provides as follows:

     (h) Royalty on SUBLICENSE REVENUES due to DUKE relating to the CYPRESS AGREEMENT. It
is understood and agreed that because the provisions of Section 3.01(g) apply to milestones
achieved by either CYPRESS

     and/or any of its SUBLICENSEES, no royalty [***] on SUBLICENSE REVENUES associated with the
CYPRESS AGREEMENT and/or CYPRESS’ SUBLICENSEES’ SUBLICENSES.

     4. Extent of Amendment. Except as amended hereby, all provisions of the AGREEMENT
shall remain in full force and effect.

[This space left blank intentionally.]

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 6 of 7

 

     5. Counterparts. This FIRST AMENDMENT may be executed in a number of identical
counterparts, each of which for all purposes is to be deemed an original.

     IN WITNESS WHEREOF, the parties hereto have executed this FIRST AMENDMENT on the dates set
forth below.

	 	 	 	 	 	 	 	 	 
	DUKE UNIVERSITY	 	 	 	OREXIGEN THERAPEUTICS, INC.
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Robert L. Taber
	 	 	 	By:
	 	/s/ John F. Crowley
	 

	 	 
	 	 	 	 	 	 
	Robert L. Taber, Ph.D.	 	 	 	John F. Crowley
	Vice Chancellor, Science and
Technology Development	 	 	 	President and Chief Executive Officer
	 
	 	 	 	 	 	 	 	 
	Date: 12/21/04	 	 	 	Date: 12/22/04

Acknowledged and Agreed With Respect

To Only Section 2 of this FIRST AMENDMENT:

CYPRESS BIOSCIENCE, INC.

	 	 	 	 
	 	 
	By:  	/s/ Jay D. Kranzler
 	 
	Jay D. Kranzler, M.D., Ph.D. 	 
	President and Chief Executive Officer 	 

Date: 1/3/05

 7 of 7exv10w12

 

EXHIBIT 10.12

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. 2

to the

LICENSE AGREEMENT

dated as of March 31, 2004

     THIS AMENDMENT NO. 2 (the “AMENDMENT NO. 2”), dated and effective as of the 27th day
of July, 2006, to that certain LICENSE AGREEMENT dated as of March 31, 2004, as amended by that
certain AMENDMENT NO. 1 dated as of December 22, 2004 (collectively referred to herein as the
“LICENSE AGREEMENT”), by and between DUKE UNIVERSITY, a nonprofit educational and research
institution organized under the laws of North Carolina (“DUKE”), and OREXIGEN THERAPEUTICS,
INC., a Delaware corporation (hereinafter “OREXIGEN”). Unless otherwise defined herein,
capitalized terms used but not defined herein shall have the meaning set forth in the AGREEMENT,
and the AGREEMENT shall be amended to incorporate any additional definitions provided for in this
AMENDMENT NO. 2, including definitions in the recitals hereto.

     WHEREAS, the parties desire to amend the LICENSE AGREEMENT to include additional patent
applications as “OREXIGEN PATENT RIGHTS” under the LICENSE AGREEMENT, and to provide a complete
list of “DUKE PATENT RIGHTS” as of the date of this AMENDMENT NO. 2;

     NOW THEREFORE, in consideration of the premises and the mutual covenants contained herein, the
parties hereto agree as follows:

     1. Amendment of Section 1.05.

	 	1.05	 	“DUKE PATENT RIGHTS” shall mean the patents, patent applications listed in
APPENDIX A (including those patent applications referred to in APPENDIX A as “INITIAL
DUKE PATENT APPLICATIONS”), together with all divisionals, continuations,
continuations-in-part (but only to the extent that the subject matter of each such
continuation-in-part is described in and enabled by the disclosure of said INITIAL DUKE
PATENT APPLICATIONS), re-examinations, reissues, substitutions, or extensions thereof
and patents issuing therefrom in the United States and non-U.S. jurisdictions.
Notwithstanding the foregoing or anything else to the contrary in this AGREEMENT, DUKE
PATENT RIGHTS shall not include those patents and/or patent applications which, during
the term of this agreement, cease to be DUKE PATENT RIGHTS pursuant to Section 6.01 or
Section 6.03. It is understood and agreed that subject matter that is PATENTABLY
DISTINCT defined below) from the subject matter described within the INITIAL DUKE
PATENT APPLICATIONS is not within the scope of the DUKE PATENT RIGHTS even though that
PATENTABLY DISTINCT subject matter may fall within one or more claims of said INITIAL
DUKE PATENT APPLICATIONS. PATENTABLY DISTINCT improvements relating
to the subject matter of INITIAL DUKE PATENT APPLICATIONS shall not be considered
DUKE PATENT RIGHTS. As used herein, “PATENTABLY

 

 

	 	 	 	DISTINCT” subject matter is subject
matter that is novel and unobvious over subject matter described within INITIAL DUKE
PATENT APPLICATIONS.

     2. Amendment of Section 1.12.

	 	1.12	 	“OREXIGEN PATENT RIGHTS” shall mean the patent applications listed on APPENDIX
H hereto (including the OREXIGEN PROVISIONAL), as well as any patents hereafter issuing
from such applications, together with all divisions, continuations,
continuations-in-part (but only to the extent that the subject matter of each such
continuation-in-part application is described in and enabled by the disclosure of said
patent applications or other related patent applications owned, in part or in whole by
OREXIGEN, for which Dr. Gadde and/or Dr. Krishnan is/are an inventor/inventors in
accordance with appertaining patent law/regulations as a result of inventive
contributions made in his/her position as an employee/employees of DUKE),
re-examinations, reissues, substitutions, or extensions thereof and patent issuing
therefrom in the United States and non-U.S. jurisdictions.

     3. Extent of Amendment. Except as amended hereby, all provisions of the LICENSE
AGREEMENT shall remain in full force and effect.

     4. Counterparts. This AMENDMENT NO. 2 may be executed in a number of identical
counterparts, each of which for all purposes is to be deemed an original.

     IN WITNESS WHEREOF, the parties hereto have executed this AMENDMENT NO. 2 on the dates set
forth below.

	 	 	 	 	 	 	 	 	 	 	 
	DUKE UNIVERSITY	 	 	 	OREXIGEN THERAPEUTICS, INC.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Robert L. Taber
	 	 	 	By:
	 	/s/ Gary D. Tollefson	 	 
	 

	 	 

Robert L. Taber, Ph.D.
	 	 	 	 	 	 

Gary D. Tollefson, M.D., Ph.D.
	 	 
	 

	 	Vice Chancellor, Science and
Technology Development
	 	 	 	 	 	President and Chief Executive Officer	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date: 07/27/06	 	 	 	Date: 07/27/06	 	 

2

 

APPENDIX A

DUKE PATENT RIGHTS

U.S. APPLICATIONS

[***]

[***]

[***]

PCT APPLICATIONS

[***]

INTERNATIONAL APPLICATIONS

[***]

[***]

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.

1

 

APPENDIX B

OREXIGEN PATENT RIGHTS

U.S. APPLICATIONS

[***]

PCT APPLICATIONS

[***]

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.

2

 

INTERNATIONAL APPLICATIONS

[***]

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.

3

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00114-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00114-of-00352.parquet"}]]