Document:

exv10w19

 

EXHIBIT
10.19

5001
Weston Parkway, Suite 103, Cary, NC 27513 • Phone
919-657-0660 • Fax 919-573-9318 •
www.PharmaDirections.com

THIS CONSULTING AGREEMENT (the “Agreement”) is made and entered into as of 12/9/2005, by and
between Orexigen Therapeutics, located at 12481 High Bluff Drive, San Diego, CA 92130 (“Company”)
and PharmaDirections, Inc., a North Carolina corporation, located at 5001 Weston Parkway, Suite
103, Cary, NC 27513 (“Consultant”).

WITNESSETH:

     WHEREAS, the Company desires to engage Consultant to provide certain services to the Company
of an advisory or consulting nature relating to technical, scientific, regulatory and planning
aspects of the chemistry, analytical, pharmaceutical and formulation development in the drug
development arena for selected compounds of the Company and such other services as may be mutually
agreed upon from time to time by the Company and Consultant (all of the foregoing, collectively,
the “Services”); and

     WHEREAS, Consultant desires to provide the Services to the Company on the terms and for the
compensation set forth herein.

     NOW, THEREFORE, the parties hereto agree as follows:

     1. Engagement. The Company hereby engages Consultant as a nonexclusive consultant to
perform the Services requested by the Company, subject to the terms and conditions of this
Agreement. Consultant hereby accepts such engagement for and in consideration of the compensation
hereinafter provided and agrees to perform the Services in a competent, professional and efficient
manner and in compliance with the terms of this Agreement and any and all applicable laws and
regulations. Consultant acknowledges that the Services to be performed for the Company hereunder
are essential to the Company and shall be set forth by the Company. The Services shall be defined
and mutually agreed to by the Company and Consultant on a Work Order as exemplified in Attachment A
prior to commencement of Services. Consultant shall not delegate or subcontract Consultant’s
Services to any associates or third parties without Company’s prior written consent. Such consent
will be acknowledged by Company’s signature on a work order that lists all consultants who will be
authorized to work on said project.

     2. Term. The term of this Agreement (the “Term”) shall commence on the date hereof
and shall expire on the first anniversary hereof, unless extended by the mutual agreement of the
Company and Consultant; provided that the Company may terminate the Agreement upon thirty (30) days
written notice to Consultant. Sections 4. 5 and 6 shall survive expiration of the Term or
termination of this Agreement for any reason.

     3. Compensation. The Company shall pay fees on a per-project basis as approved on the
corresponding work order. Consultant shall also be entitled to reimbursement from the Company for
all reasonable out-of-pocket expenses incurred by Consultant in connection with the performance of
Services requested by the Company, subject to receipt by the Company of adequate supporting
documentation and not to exceed $500 in the aggregate without the prior written consent of the
Company. All amounts payable by the Company hereunder shall be due thirty (30) days after receipt
of a proper invoice therefore. Travel time in transit shall be compensated at 1/2 the rate above
unless and to the extent that Consultant performs Services while traveling which Services will be
paid at the full rate above. No severance pay, compensation or other benefit shall be paid to
Consultant beyond the last day of the Term.

     4. Proprietary Information. Consultant acknowledges that the Company is
engaged in a continuous program of research, development, testing, marketing and
distribution of therapeutic products and that the Company possesses and will possess
information that has been created, discovered, developed or otherwise become known to
the Company or in which property rights have been or will be
licensed, assigned or
otherwise conveyed to
the Company, which information has and will have commercial value in the business in which the
Company is engaged. All of the aforementioned information is hereinafter

	 	 	 	 	 
	Confidential

	 	Page 1
	 	12/9/2005

 

5001
Weston Parkway, Suite 103, Cary, NC 27513 • Phone
919-657-0660 • Fax 919-573-9318
• www.PharmaDirections.com

     referred to as “Proprietary Information.” By way of illustration, but without limitation,
“Proprietary Information” includes trade secrets, processes, formulae, compounds and properties
thereof, data, files, records, protocols, research results, reports, computer programs and related
source codes and object codes, improvements, inventions, techniques, marketing plans, strategies,
forecasts, copyrightable material, suppliers, methods and manner of operations, information
relating to the identity, needs and location of all past, present and prospective customers,
suppliers, strategic partners and other third parties who do business with the Company and
information with respect to the internal affairs of the Company and its affiliates. Consultant
expressly agrees that Proprietary Information does not exist in written form only, but may also
include oral, printed, magnetic, electronic, computer-generated or other communications and
information obtained by inspection of tangible objects. Notwithstanding the foregoing,
“Proprietary Information” does not include: (i) information known by or in the possession of
Consultant on a nonconfidential basis prior to its disclosure to Consultant by the Company; (ii)
information ascertainable or obtained from public or published information; (iii) information
received on a nonconfidential basis from a third party that is not under an obligation to the
Company to keep such information confidential or otherwise prohibited from disclosing such
information to Consultant, or (iv) information which is or becomes known to the public (other than
because of a breach of this Agreement).

     5. Consultant’s Covenants. Consultant acknowledges and agrees that (i) the
enforcement of this Agreement is necessary to ensure the preservation, protection and continuity of
the business, competitive advantage and goodwill of the Company and (ii) the products and services
sold and rendered (or to be sold and rendered) by the Company are unique in character and are of
particular significance to the Company and the Company is in a competitive business. In
consideration of Consultant’s consulting engagement by the Company and the compensation received
and to be received by Consultant from the Company from time to time, Consultant hereby agrees as
follows:

          (a) During the Term and for ten (10) years after its expiration or termination for any reason
whatsoever, Consultant will keep in confidence and trust all Proprietary Information and will not
use or disclose any Proprietary Information without the written consent of the Company, except (i)
as may be necessary in the ordinary course of performing the Services or (ii) pursuant to subpoena
or order of any court or governmental body or agency with jurisdiction over Consultant; provided
that (A) notwithstanding the foregoing, the foregoing obligations shall continue beyond ten (10)
years after expiration or termination of the Term with respect to any Proprietary Information for
so long as it constitutes a trade secret of the Company and (B) Consultant shall give the Company
notice of the use or disclosure permitted by Section 5(a)(ii) sufficiently in advance thereof so as
to give the Company a reasonable opportunity to contest such use or disclosure and shall cooperate
with the Company in such efforts. All Proprietary Information (and all patents, trademarks
(whether or not registered), copyrights and other intellectual property rights in connection
therewith) shall be and remain the sole and exclusive property of the Company notwithstanding the
fact that such Proprietary Information may have been disclosed to Consultant in connection with his
performance of the Services. For purposes of this Section 5(a), “Inventions” (as defined in
Section 5(c)) shall also constitute Proprietary Information.

          (b) All documents, records, apparatus, equipment and other physical property, whether or not
pertaining to Proprietary Information, furnished to Consultant by the Company shall be and remain
the sole and exclusive property of the Company and shall be returned to it immediately as and when
requested by the Company.

          (c) All inventions, ideas and deliverables and other work product of Consultant hereunder,
whether or not patentable, that Consultant shall make, conceive, learn or first reduce to practice
during the Term, whether alone or in conjunction with others, in the performance of Services,
during the hours for which he is or is to be compensated by the Company or with the use of the
Company’s materials or facilities or any Proprietary Information (collectively, “Inventions”), and
all patents, copyrights and other intellectual property rights in connection therewith, shall be
the sole and exclusive property of the Company. Such Inventions shall be deemed “works made for
hire” within the meaning of 17 U.S.C. §§

	 	 	 	 	 
	Confidential

	 	Page 2
	 	12/9/2005

 

5001
Weston Parkway, Suite 103, Cary, NC 27513 • Phone
919-657-0660 • Fax 919-573-9318
• www.PharmaDirections.com

101 and 201(b) and are not subject to any retained or reserved license, permit or other right
of Consultant to use such Inventions for any purpose. Consultant hereby: (i) agrees to promptly
disclose all Inventions to the Company; (ii) assigns to the Company any rights it may have or
acquire in the Inventions and associated patents, copyrights and other intellectual property
rights; and (iii) agrees to assist the Company (at the Company’s reasonable expense) in its
acquisition and enforcement of such patents, copyrights and other intellectual property rights in
any and all countries.

Company acknowledges that Consultant possesses certain inventions, processes, databases, software,
know-how, trade secrets, improvements, and other assets, including but not limited to formulations,
products, laboratory analyses, analytical methods, procedures and techniques, procedure manuals,
personnel data, financial information, computer technical expertise and software, which have been
independently developed by Consultant (collectively “Consultant Property”). Sponsor and
Consultant agree that any Consultant Property or improvements thereto which are used, improved,
modified or developed by Consultant under or during the term of this Agreement shall be and remain
the sole and exclusive property of Consultant. Without limiting the generality of the foregoing,
the following items constitute Consultant Property:

Database applications developed by Consultant:

API Inventory Management

Clinical Product Inventory Management

Clinical Trial Material (CTM application)

Contract Tracking

Document Management

Drug Product Inventory Management

Electronic Batch Records

IND Electronic Document

Laboratory Operations Systems Analysis

Laboratory Sample Tracking

PharmaDirections Tracking System

Prototype Tracking

Specifications and Testing Management

Stability Data Management with Trending Analysis

Tools Developed by Consultant:

Audit Checklists

CTM SOPs

Comprehensive Preclinical Development Plans

Due Diligence Checklists

IND Preparation Template

Systems Analysis and Design Process

          (d) Consultant represents that his and his associates’ performance of all the terms of this
Agreement does not and will not breach any agreement to keep in confidence proprietary information
of any other party acquired by Consultant in confidence or in trust prior to Consultant’s
engagement by the Company. Consultant has not entered into, and agrees not to enter into, any
agreement, either written or oral, that conflicts or would conflict with this Agreement or
Consultant’s obligations hereunder.

          (e) Consultant shall not publish any information developed or disclosed by either party in
connection with Consultant’s Services to the Company without the Company’s prior written consent.

	 	 	 	 	 
	Confidential

	 	Page 3
	 	12/9/2005

 

5001
Weston Parkway, Suite 103, Cary, NC 27513 • Phone
919-657-0660 • Fax 919-573-9318
• www.PharmaDirections.com

          (f) Consultant hereby represents and warrants to Company that (i) Consultant has the right to
enter into this Agreement and to transfer the entire right, title and interest in and to the
inventions to the Company as described in Sections 4 and 5 hereof and (ii) it has entered into
contracts with its President and other employees, associates, agents, and representatives, if any,
binding them to terms of confidentiality, noncompetition, assignment of intellectual property,
independent contractor consistent with Sections 4, 5, and 6 of this Agreement and sufficient to
permit Consultant to uphold its obligations hereunder.

          (g) Consultant acknowledges and agrees that any breach of this Section 5 would cause
irreparable damage to the Company and that in the event of such breach or threatened breach, the
Company shall have, in addition to any and all remedies at law, the right to an injunction,
specific performance or other equitable relief to prevent the violation of Consultant’s obligations
hereunder. If, in any judicial proceedings, a court shall refuse to enforce any of the other
separate covenants set forth in this Section 5, then such unenforceable covenant shall be amended
so as to be enforceable or, if deemed appropriate by such court, deemed eliminated from these
provisions for the purpose of those proceedings to the extent necessary to permit the remaining
separate covenants to be enforced.

     6. Independent Contractor.

          (a) Acknowledgments by Consultant. Consultant acknowledges and agrees that: (i)
Consultant will be treated with respect to the Company as an independent contractor and not as an
employee, agent or authorized representative of the Company; (ii) Consultant, in his capacity as
such, shall have no authority to bind the Company to any contract, agreement or obligation
whatsoever; and (iii) the Company will not provide Consultant with any company, individual or group
insurance policy or any other kind of insurance coverage or employee benefit whatsoever.

          (b) Tax Matters. Because Consultant is an independent contractor, the Company will
not withhold from any compensation paid to Consultant any amounts for federal or state income
taxes, or social security (FICA) for Consultant, nor will the Company pay any social security or
unemployment tax with respect to Consultant. Such taxes are the responsibility of Consultant.
Consultant agrees to indemnify and hold the Company (including its employees, officers, directors,
agents, subsidiaries or affiliates) harmless from and against any damage, claim, assessment,
interest charge or penalty incurred by or charged to the Company as a result of any claim, cause of
action or assessment by any federal or state government or agency for any nonpayment or late
payment by Consultant of any tax or contribution based upon compensation paid hereunder.

     7. Notices. All notices or other communications which are required to be given,
served or sent by one party to the other party pursuant to this Agreement shall be in writing and
shall be hand delivered, sent by nationally-recognized overnight courier with charges prepaid or
mailed by certified mail, return receipt requested, postage prepaid, addressed as follows:

	 	 	 
	If to the Company:	 	If to Consultant:
	Orexigen Therapeutics, Inc.

	 	PharmaDirections, Inc.
	Attn: Anthony McKinney

	 	Attn: Dr. Richard Soltero
	12481 High Bluff Drive

	 	PO Box 5789
	San Diego, CA 92130

	 	Cary, NC 27512
	USA

	 	USA

Each party may designate by notice in writing a new address to which any such notice or other
communication may thereafter be delivered, given or sent. Notices or other communications (i)
delivered by hand shall be deemed to have been received upon delivery, (ii) sent by overnight
courier shall be

	 	 	 	 	 
	Confidential

	 	Page 4
	 	12/9/2005

 

5001
Weston Parkway, Suite 103, Cary, NC 27513 • Phone
919-657-0660 • Fax 919-573-9318
• www.PharmaDirections.com

deemed to have been received on the next business day following deposit therewith and (iii) sent by
mail shall be deemed to have been received three (3) days following deposit in the mail (or, if
earlier in each such case, upon actual receipt).

     8. Assignment. Neither this Agreement or any interest herein or any rights hereunder
shall be sold or assigned by Consultant, nor shall any of the Services and duties of Consultant
hereunder be delegated to any person, associate, firm or corporation, without the prior written
consent of the Company.

     9. Miscellaneous.

          (a) The provisions of this Agreement may not be waived, altered, amended or repealed, in whole
or in part, except with the written consent of the Company and Consultant.

          (b) This Agreement shall be governed by and construed in accordance with the laws of the State
of North Carolina (USA), without regard to the principles of conflicts of laws thereof.

          (c) This Agreement may be executed in two counterparts (which may, but need not be, be
transmitted by facsimile signatures), each of which shall be deemed an original and both of which
together shall constitute one and the same instrument.

          (d) In case any one or more of the provisions contained in this Agreement or the other
agreements executed in connection with the transactions contemplated hereby for any reason shall be
held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other provision of this Agreement or such other agreements,
but this Agreement or such other agreements, as the case may be, shall be construed and reformed to
the maximum extent permitted by law.

          (e) This Agreement represents the entire agreement of the parties with respect to the subject
matter hereof and supersedes in its entirety any and all prior written or oral agreements or
understandings with respect thereto.

          (f) This Agreement shall inure to the benefit of Consultant and his or her heirs, successors,
associates, personal representatives and assigns. Consultant acknowledges that the services to be
rendered by him or her thereunder are unique and personal in nature. Accordingly, Consultant may
not assign any of his or her rights or delegate any of his or her duties or obligations under this
Agreement. The Company shall have the right to assign this Agreement to any successor of all or
any substantial part of its business or assets, and any such successor shall be bound by all the
provisions hereof.

          IN WITNESS WHEREOF, the parties have executed this Agreement as of the date and year first
above written.

	 	 	 	 	 	 
	Orexigen Therapeutics	 	PharmaDirections, Inc.	 
	 
	 	 	 	 	 
	By:

	 	/s/ Anthony McKinney
	 	/s/ Richard Soltero	 
	 

	 	 
	 	 
	 

	 	Anthony McKinney
	 	Dr. Richard Soltero	 
	 

	 	COO
	 	President

	 	 	 	 	 
	Confidential

	 	Page 5
	 	12/9/2005

 

5001
Weston Parkway, Suite 103, Cary, NC 27513 • Phone
919-657-0660 • Fax 919-573-9318
• www.PharmaDirections.com

EXHIBIT A

Work Order

	 	 	 	 	 
	Submitted to:

	 	 	Date: 11/7/06

Scope

Personnel Involved

Deliverables

Fees

Agreed and Accepted

PharmaDirections, Inc.

SAMPLE – DO NOT SIGN

	 	 	 	 	 
	 

	 	 
	 	 
	Richard Soltero, PhD

	 	Date
	 	Date
	President
	 	 	 	 

	 	 	 	 	 
	Confidential

	 	Page 6
	 	12/9/2005exv10w20

 

EXHIBIT 10.20

January 17, 2007

Dr. Richard Soltero

President

PharmaDirections, Inc.

5001 Weston Parkway, Suite 103

Cary , NC 27513

	 	 	 
	Re:

	 	Extension of Consulting Agreement with Orexigen
	 

	 	Therapeutics, Inc. dated December 9, 2005

Dear Rick:

We refer to the Consulting Agreement dated as of December 9, 2005 (the “Consulting Agreement”)
between Orexigen Therapeutics, Inc. and PharmaDirections, Inc. As you know, the Term of the
Consulting Agreement was set to expire on December 9, 2006. Notwithstanding the foregoing, both
parties have continued to work under the terms of the Consulting Agreement following this
expiration and as such desire to memorialize their mutual intent to extend the Term until December
31, 2007. Capitalized terms used herein and not otherwise defined herein shall have the meanings
set forth in the Consulting Agreement.

It is hereby agreed by you and us that:

	 	(a)	 	Section 2 should be amended and replaced in its entirety to read as follows:
	 
	 	 	 	“The term of this Agreement (the “Term”) shall commence on the date hereof and shall expire on
December 31, 2007, unless extended by the mutual agreement of the Company and Consultant; provided
that the Company may terminate the Agreement upon thirty (30) days written notice to Consultant.
Sections 4, 5 and 6 shall survive expiration of the Term of termination of this Agreement.”
	 

	 	(b)	 	The Consulting Agreement, as amended by this letter amendment, is and shall continue to be
in full force and effect and is hereby in all respects ratified and confirmed.

If you agree to the terms and provisions hereof, please evidence such agreement by executing and
returning a copy of the counterpart of this letter by pdf attachment to amckinney@orexigen.com or
by facsimile to 858-436-8650, followed by one (1) counterpart of this letter amendment sent by mail
or courier to Orexigen Therapeutics, Inc., 12481 High Bluff Drive, Suite 160, San Diego, CA 92130,
Attention of Anthony McKinney. This letter amendment shall become effective as of the date first
above written when and if counterparts of this letter amendment shall have been executed by us and
you.

This letter amendment may be executed in any number of counterparts and by any combination of the
parties hereto in separate counterparts, each of which counterparts shall be an original and all of
which taken together shall constitute one and the same letter amendment, and this letter amendment
shall be governed by the laws of the State of North Carolina.

Very truly yours,

	 
	/s/
Anthony A. McKinney

Anthony A. McKinney

Chief Operating Officer

APPROVED AND ACCEPTED THE 17th DAY OF JANUARY, 2007:

	 	 	 
	PharmaDirections, Inc.

	 
	 
	 	 
	By:  
	/s/ Dr. Richard Soltero
	 
	 	 	 
	Name: Richard Soltero
	 
	Title: President
	 

Orexigen Therapeutics Inc.

12481 High Bluff Drive, Suite 160, San Diego CA 92130

Office: 858-436-8600

Fax: 858-436-8650

www.orexigen.com

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