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Exhibit 10.123
A COOPERATIVE RESEARCH AND DEVELOPMENT
AGREEMENT
Between
BioDelivery Sciences International Inc
2501 Aerial Center Parkway, Suite 205
Morrisville, NC 27560
(Cooperator)
and
Walter Reed Army Institute of Research
503 Robert Grant Avenue
Silver Spring, MD 20910-7500
(Laboratory)
Article 1. Background
1.00 This Agreement is entered into under the authority of the
Federal Technology Transfer Act of 1986, 15 U.S.C. 3710a, et
seq ., between the Cooperator and the Laboratory, the parties
to this Agreement.
1.01 Laboratory, on behalf of the U.S. Government, and
Cooperator desire to cooperate in research and development on
"Evaluation of the cochleate technology to deliver non orally
bioavailable drugs via the oral route in the treatment diseases
like malaria and leishmaniasis" according to the attached Scope
of Work described in Appendix A hereto (the " SOW ").
NOW, THEREFORE, the parties agree as follows:
Article 2. Definitions
2.00 The following terms are defined for this Agreement as
follows:
2.01 "Agreement" means this cooperative research and development
agreement.
2.02 "Invention" and "Made" have the meanings set forth in Title
15 U.S.C. Section 3703(9) and (10).
2.03 "Proprietary Information" means information marked with a
proprietary legend or otherwise identified in writing by a party
(or orally identified, provided that written confirmation be
promptly provided) which embodies trade secrets developed at
private expense or which is confidential business or financial
information, provided that such information:
(i) is not generally known, or which becomes generally known or
available during the period of this Agreement from other sources
without obligations concerning their confidentiality;
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(ii) has not been made available by the owners to
others without obligation concerning its
confidentiality;
(iii) is not already available to the receiving party without
obligation concerning its confidentiality; and
(iv) is not independently developed by or on behalf of the
receiving party, without reliance on the information received
hereunder.
2.04 "Subject Data" means all recorded information first
produced in the performance of this Agreement.
2.05 "Subject Invention" means any Invention Made as a
consequence of, or in relation to, the performance of work under
this Agreement.
Article 3. Research Scope and Administration
3.00 Scope of Work . Research performed under this
Agreement shall be performed in accordance with the SOW
incorporated as a part of this Agreement at Appendix A. It is
agreed that any descriptions, statements, or specifications in the
SOW shall be interpreted as goals and objectives of the services to
be provided under this Agreement and not requirements or
warranties. Laboratory and Cooperator will endeavor to achieve the
goals and objectives of such services; however, each party
acknowledges that such goals and objectives, or any anticipated
schedule of performance, may not be achieved.
3.01 Review of Work . Periodic conferences shall be held
between the parties for the purpose of reviewing the progress of
work. It is understood that the nature of this research is such
that completion within the period of performance specified, or
within the limits of financial support allocated, cannot be
guaranteed. Accordingly, all research will be performed in good
faith.
3.02 Principal Investigator . Any work required by the
Laboratory under the SOW will be performed under the supervision of
COL Alan Magill , Division Director, Division of
Experimental Therapeutics, Walter Reed Army Institute of Research,
503 Robert Grant Avenue, Silver Spring, Maryland 20910-7500: Phone:
301-319-9959; Email: Alan.Magill@us.army.mil who, as co-principal
investigator has responsibility for the scientific and technical
conduct of this project on behalf of the Laboratory. Any work
required by the Cooperator under the SOW will be performed under
the supervision of Dr. Raphael J. Mannino, Chief
Scientific Officer and Executive Vice President, BioDelivery
Sciences International, Inc, 4 Bruce Street, Newark, New Jersey
07103; Phone: 973-972-8018; Email rjmannino@bdsinternational.com
who, as co-principal investigator has responsibility for the
scientific and technical conduct of this project on behalf of the
Cooperator.
3.03 Scope Change . If at any time the co-principal
investigators mutually determine that the research data dictates a
substantial change in the direction of the work, the parties shall
make a good faith effort to agree on any necessary change to the
SOW and make the change by written notice to the address listed in
section 12.07 Notices .
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3.04 Final Report . The parties shall
prepare a final report of the results of this project within six
months after completing the SOW.
Article 4. Ownership and Use of Physical
Property
4.01 Ownership of Materials or Equipment . All materials
or equipment (" Materials ") developed or acquired under
this Agreement by the parties shall be the property of the party
which developed or acquired the property, except that government
equipment provided by Laboratory (1) which through mixed
funding or mixed development must be integrated into a larger
system, or (2) which though normal use at the termination of
the Agreement has a salvage value that is less than the return
shipping costs, shall become the property of Cooperator.
4.02 Use of Provided Materials . Both parties agree that
any Materials and/or Proprietary Information relating to them which
were provided by one party to the other party will be used for
research purposes only. The Materials and/or Proprietary
Information shall not be sold, offered for sale, used for
commercial purposes, or be furnished to any other party without
advance written approval from the providing party’s official
signing this Agreement or from another official to whom the
authority has been delegated, and any use or furnishing of material
shall be subject to the restrictions and obligations imposed by
this Agreement .
4.03 Laboratory Chemical Inventory System (CIS ) The
Materials and/or Proprietary Information received from Cooperator
and data derived as a result of this collaboration will be entered
into an access limited, password-protected Chemical Inventory
System (CIS) database that is maintained within the Division of
Experimental Therapeutics at Recipient Laboratory. The database
permits the Division of Experimental Therapeutics at the Laboratory
to screen all chemical structures within CIS for their potential
utility in the diagnosis, prevention or treatment of diseases. The
Cooperator’s Material (s) and/or Proprietary Information
received under this Agreement will be included within the CIS, will
be retained therein and, if the Cooperator does not inform the
Laboratory that the materials should be returned to the Cooperator
at the time of expiration of this Agreement, may be subject to in
silico screening that may be outside the use addressed in the SOW
and/or may take place beyond the expiration date of this Agreement.
Laboratory will promptly notify Collaborator if screening
identifies a potential new use for a Cooperator’s Material(s)
and/or Proprietary Information.
4.04 Retention of Information entered into the CIS . If
screening of Cooperator’s Material(s) and/or Proprietary
Information via the CIS was initiated by a third party, and such
screening identifies one of the Cooperator’s Material(s) that
is proprietary or identifies Proprietary Information of the
Cooperator, then Laboratory will inform Cooperator of the nature of
the Material(s) and/or Proprietary Information (including, as
applicable, the chemical structure of the compound of interest) and
the reason for which it was screened. If Cooperator expresses
interest in future collaboration on the compound, the Laboratory
will also notify third party of interest of the Cooperator. In such
cases, Cooperator, Laboratory and the third party will determine a
mechanism to exchange information related the compound and the
screen.
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Article 5. Financial
Obligation
5.00 Funding . The parties shall each be individually
responsible for funding its own respective researchers throughout
this Agreement, including laboratory facilities, salaries, overhead
and indirect costs, etc. Each party may determine at its own
discretion, the amount of resources, personnel, materials or funds
it will devote to the work under this Agreement.
5.01 Expenses . The parties shall each be individually
responsible for expenses incurred by their respective researchers.
Neither party shall be liable or obligated to any third party
contractual agreement undertaken by the other party.
Article 6. Patent Rights
6.00 Reporting . The parties shall promptly report to
each other all Subject Inventions reported to either party by its
employees. All Subject Inventions Made during the performance of
this Agreement shall be listed in the Final Report required by this
Agreement.
6.01 Cooperator Employee Inventions . Laboratory waives
any ownership rights the U.S. Government may have in Subject
Inventions Made by Cooperator employees and agrees that Cooperator
shall have the option to retain title in Subject Inventions Made by
Cooperator employees. Cooperator shall notify Laboratory promptly
upon making this election and agrees to timely file patent
applications on Cooperator’s Subject Invention at its own
expense. Cooperator agrees to grant to the U.S. Government on
Cooperator’s Subject Inventions a nonexclusive,
nontransferable, irrevocable, paid-up license in the patents
covering a Subject Invention, to practice or have practiced,
throughout the world by, or on behalf of the U.S. Government. The
nonexclusive license shall be evidenced by a confirmatory license
agreement prepared by Cooperator in a form satisfactory to
Laboratory.
6.02 Laboratory Employee Inventions . Laboratory shall
have the initial option to retain title to, and file patent
application on, each Subject Invention Made by its employees. The
Laboratory agrees to grant an exclusive license to any Subject
Invention Made by its employees under this Agreement to which it
has ownership to the Cooperator in accordance with Title 15 U.S.
Code Section 3710a, on terms negotiated in good faith. Any
invention arising under this Agreement is subject to the retention
by the U.S. Government of nonexclusive, nontransferable,
irrevocable, paid-up license to practice, or have practiced, the
invention throughout the world by or on behalf of the U.S.
Government.
6.03 Joint Inventions . Any Subject Invention patentable
under U.S. patent law which is Made jointly by Laboratory employees
and Cooperator employees under the SOW shall be jointly owned by
the parties. The parties shall discuss together a filing strategy
and filing expenses related to the filing of the patent covering
the Subject Invention. If a party decides not to retain its
ownership rights to a jointly owned Subject Invention, it shall
offer to assign such rights to the other party, whereupon, if such
offer is accepted, the parties shall negotiate a mutually
acceptable assignment agreement.
6.04 Government Contractor Inventions . If Laboratory
contractors are used at any
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time during the term of this Agreement to fulfill
Laboratorys’ obligation under this Agreement, the Laboratory
will notify the Cooperator in writing prior to initiating work with
a contract agency. At that time, Cooperator and Laboratory will
determine by modification of this Agreement the mechanism by which
the Laboratory will fullfill its obligation to provide an exclusive
license on any subject invention to the cooperator.
6.05 Filing of Patent Applications . The party having the
right to retain title to, and file patent applications on, a
specific Subject Invention may elect not to file patent
applications, provided it so advises the other party within 90 days
from the date it reports the Subject Invention to the other party.
Thereafter, the other party may elect to file patent applications
on the Subject Invention and the party initially reporting the
Subject Invention agrees to assign its ownership interest in the
Subject Invention to the other party subject to the retention by
the party assigning ownership of a nonexclusive, irrevocable,
paid-up license to practice, or have practiced, the Subject
Invention throughout the world.
6.06 Patent Expenses . The expenses attendant to the
filing of patent applications shall be borne by the party filing
the patent application. Each party shall provide the other party
with copies of the patent applications it files on any Subject
Invention along with the power to inspect and make copies of all
documents retained in the official patent application files by the
applicable patent
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