Exhibit 10.4
CONFIDENTIAL TREATMENT REQUESTED
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WITH RESPECT TO CERTAIN PORTIONS HEREOF
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DENOTED WITH "***"
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Evaluation Agreement and Option to License
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This Evaluation Agreement and Option to License (the "Agreement") is
made and entered into as of September 5, 2002 (the "effective Date"), by and
between BioDelivery Sciences International, Inc., with a business address at
Adm. Xxxx. #0, 000 X. Xxxxxx Xxx., Xxxxxx, Xxx Xxxxxx 00000, XXX ("BDSI') and
******************, with a principal place of business at *****************.
WHEREAS:
1. BDSI is licensed under United States and foreign federal and state
laws to make, use, and/or sell certain inventions described in United States
Patent Numbers 4,663,161; 4,871,488; 5,643,574; 5,834,015; 5,840,707; 5,994,318;
6,153,217; and other U.S. and foreign counterparts, continuation,
continuation-in-part, and divisional applications;
2. BDSI commercializes these inventions using products bearing the
trademark BIORAL(TM);
3. BDSI desires to provide ****** with the raw materials and the know
how to make Cochleate Vehicle Preparations (CVPs) as described in the
aforementioned patents and patent applications; and
4. *****, represented by **********, desires to manufacture CVPs and to
perform studies on the efficacy of CVPs as delivery vehicles for
process-sensitive ingredients in companion animal foods, and to evaluate the
potential for licensing or sub-licensing from BDSI the right to use CVPs in
companion animal foods;
NOW, THEREFORE, for and in consideration of the premises, the parties
hereto hereby agree as follows;
1. Definitions
1.1 "CVPs" shall mean cochleate preparations prepared according to methods
described in U.S. Patent Numbers 4,663,161; 4,871,488; 5,643,574;
5,834,015; 5,840,707; 5,994,318; 6,153,217 and their U.S. and foreign
counterparts, continuation, continuation-in-part, and divisional
applications; containing process-sensitive ingredients for companion
animal food use, with know-how provided by BDSI.
1.2 "Confidential Information" shall mean information disclosed by either
***CONFIDENTIAL TREATMENT REQUESTED***
Note: The portions hereof for which confidential
treatment are being requested are denoted with "*****".
party for the purpose of preparing cochleate formulations for use in
companion animal foods or human foods and shall include, but not be
limited to, manufacturing processes, production techniques, research
and testing materials, test results and data, business and research
plans, engineering drawings, contract documents, formulas,
formulations, and/or specifications for CVPs and/or food products.
1.3 "Evaluation" shall mean *************************************.
1.4 "Evaluation Period" shall mean that period of time necessary to
adequately perform the Evaluation defined in Section 1.4.
2. Research Collaboration
2.1 BDSI will provide to ***** soy-derived phosphatidylserine at its cost
to manufacture the product. ***** will provide at least one
process-sensitive ingredient, as well as manufacturing facilities and
personnel to encochleate the process-sensitive ingredient with
instruction and know how from BDSI and to incorporate the encochleated
process-sensitive ingredient into a finished `food product.
2.2 BDSI and ***** will jointly conduct the Research Plan ("RP") outlined
in Appendix A.
2.3 ***** will pay all reasonable expenses associated with the RP as
outlined in Appendix B.
3. Confidentiality of Information
3.1 All information designated as Confidential Information by the
disclosing party at the time of disclosure (1) shall be maintained in
confidence by the receiving party, (2) shall not be used for any
purpose except as permitted in this Agreement, and (3) shall not be
disclosed to any third party without the prior written consent of the
disclosing party.
3.2 The receiving party shall use the same level of care to prevent the use
or disclosure of Confidential Information of the disclosing party as it
exercises in protecting its own Confidential Information, provided,
however, that at all times this level of care shall be no less than the
reasonable standard of care.
3.3 The receiving party shall disclose Confidential Information of the
disclosing party to only those employees, agents, consultants,
collaborators, or other third parties whose services are necessary for
performance of the RP and who have a duty to maintain the
confidentiality of the Confidential Information as the result of a
written agreement with either the receiving party or the disclosing
party.
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***CONFIDENTIAL TREATMENT REQUESTED***
Note: The portions hereof for which confidential
treatment are being requested are denoted with "*****".
3.4 The confidentiality and non-use obligations of this Agreement shall not
apply to:
(a) information and materials which at the time of disclosure are in
the public domain; (b) information and materials which, after
disclosure, become part of the public domain by publication or
otherwise, except by breach of this Agreement; (c) information and
materials for which the receiving party can establish reasonable proof
of possession at the time of disclosure; (d) information and materials
which are subsequently and independently developed for the receiving
party by persons who have had no access to the Confidential
Information; (e) information and materials which the receiving party
shall independently receive from a third party who has the legal right
to disclose them; or (f) information and materials which are required
by law to be disclosed, provided, however, that the receiving party
shall provide to the disclosing party sufficient notice of the
requirement to disclose Confidential Information to allow the
disclosing party request a protective order or other appropriate remedy
in a court of competent jurisdiction.
4. Warranties
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4.1 ***** warrants that it will use all Materials received from BDSI
necessary to manufacture CVPs, and/or to complete the RP, in compliance
with all applicable federal, state and local laws and regulations.
4.2 ***** warrants that it follows appropriate guidelines for the care and
use of animals enrolled in research protocols, and that Material
received from BDSI will be used exclusively `for the purpose of
manufacturing the CVPs, and evaluating the CVPs under the RP, unless
additional use is agreed to in writing by both parties.
4.3 BDSI warrants that it either owns by assignment, or holds by exclusive
license from the legal assignee(s), the rights to make, use, and/or
sell inventions described in United States Patents numbers 4,663,161;
4,871,488; 5,643,574; 5,834,015; 5,840,707; 5,994,318; 6,153,217; and
other U.S. and foreign counterparts, continuation,
continuation-in-part, and divisional applications.
4.4 BDSI warrants that it will perform its necessary legal obligations to
maintain its tights to make, use, and/or sell the inventions described
in the aforementioned patents and to sub-license those rights to
*****, and that it will hold harmless and indemnify ***** from any
reasonable costs, including court costs and attorney's fees, for any
cause of action for patent infringement that may arise from *****
authorized use of CVPs under this Agreement and the RP described
herein should BDSI fail to maintain its license to the inventions
claimed in United States Patents numbers 4,663,161; 4,871,488;
5,643,574; 5,834,015; 5,840,707; 5,994,318; 6,153,217; and other U.S.
and foreign counterparts, continuation, continuation-in-part, and
divisional applications.
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***CONFIDENTIAL TREATMENT REQUESTED***
Note: The portions hereof for which confidential
treatment are being requested are denoted with "*****".
4.5 Neither ***** nor BDSI make any warranty or representation as to the
purity, activity, safety, accuracy, or usefulness of the Material,
Information or results of the Evaluation.
5. Ownership of Technology
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5.1 New inventions and discoveries, whether patentable or not, may be
developed as a result of performance of the activities described in the
RP. The parties acknowledge that the practice of such inventions and
discoveries may be subject to a license for the rights to make, use,
and/or sell the inventions as claimed in United States Patents numbers
4,663,161; 4,871,488; 5,643,574; 5,834,015; 5,840,707; 5,994,318;
6,153,217; and other U.S. and foreign counterparts, continuation,
continuation-in-part, and divisional applications.
5.2 Inventions created as a result of performance of the RP of this
Agreement that are invented solely by employees of BDSI shall be the
property of BDSI. BDSI shall have a right to license to third parties
any resulting patent rights to such invention without prior written
consent from *****.
5.3 Inventions created as a result of performance of the RP of this
Agreement that are invented solely by employees of ***** shall be the
property of *****. ***** shall have a right to license to third parties
any resulting patent tights to such invention without prior written
consent from BDSI.
5.4 Inventions created as a result of performance of the RP of this
Agreement that are invented jointly by employees of BDSI and ***** will
be owned jointly by BDSI and *****, with ***** having exclusive rights
to use the invention under any jointly-owned issued patent, subject to
any pre-existing patent rights that shall dominate, for the purpose of
producing companion animal foods and related companion animal products
and BDSI having exclusive rights to all other claimed uses for the
invention. ***********************************************.
5.5 For solely owned inventions, the party holding ownership shall have the
right to prepare and prosecute appropriate patent applications at its
own expense. For jointly owned inventions, the parties shall divide the
costs of preparation and prosecution of appropriate patent applications
equally, provided, however, that either party may choose not to
participate in the preparation and prosecution of any patent describing
a jointly-owned invention and will have no obligation for costs
associated with any patents filed by the other party. Should either
party choose not to pay its share of the reasonable costs associated
with preparation, prosecution, and maintenance of any patent
application claiming a jointly-owned invention under this Agreement,
that party will relinquish ownership of the patent tights defined by
those claims to the other party and will cooperate fully to provide the
necessary information and data to prepare and prosecute such patent
application.
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***CONFIDENTIAL TREATMENT REQUESTED***
Note: The portions hereof for which confidential
treatment are being requested are denoted with "*****".
The party retaining ownership of the rights under the patent as
described in this Section 5.5 shall have the right to license to third
parties any patent rights described by the claims of that patent
without prior consent of the other party.
6. Disclosure of Research Data and Results
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6.1 Subject to Section 1.4 and Section 3 of this Agreement, data collected
as a result of performance of the RP by ***** will be provided to BDSI
and data collected by BDSI will be provided to *****. Such data may
include protocols, records of formulations, manufacturing processes,
and experimental results.
7. Legal Relationship Between the Parties
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7.1 The relationship between ***** and BDSI under this Agreement is that of
independent collaborators, and the Agreement shall not be deemed to
establish a joint venture or partnership between ***** and BDSI.
7.2 Neither party to this Agreement shall act as the employee or agent of
the other and neither party may bind the other to any contract with any
third party.
8. License of Patent Rights
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8.1 This Agreement provides ********************* the CVP technologies
described under the aforementioned patents for the purpose of
evaluating, under the RP, the use of the technology for the production
of companion animal foods containing process-sensitive ingredients.
********************************* No other license, implied or
otherwise, is conveyed by BDSI to ***** as a result of this Agreement.
8.2 *****************************************************************.
8.3 The parties agree that the license provided for under Section 8.2 of
this Agreement will include ***** potential use of the technology to
incorporate a variety of process-sensitive ingredients, or cargo
molecules, into ***************. Since many of these ingredients are as
yet not specifically identified, but will be identified in future
research, ***** and BDSI agree that the license will incorporate terms
to allow the addition of newly-designated cargo molecules upon request
by ***** and approval by BDSI for specific cargo molecules or
categories of cargo molecules.
9. Entirety of Terms, Assignment of Agreement, and Enforcement of
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Provisions
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9.1 This Agreement constitutes the entire agreement of the parties with
respect to the subject matter hereof and shall not be modified except
by subsequent mutual written agreement of the parties.
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***CONFIDENTIAL TREATMENT REQUESTED***
Note: The portions hereof for which confidential
treatment are being requested are denoted with "*****".
9.2 Neither party may assign or otherwise transfer this Agreement and the
rights acquired hereunder without the written consent of the other
party. Any authorized assignee must agree in writing to be bound by the
terms of the Agreement
9.3 The provisions of this Agreement ate separable, and in the event that
any provisions of this Agreement are determined to be invalid or
unenforceable under any controlling body of law, such invalidity or
unenforceability shall not in any way affect the validity or
enforceability of the remaining provisions hereof.
9.4 This Agreement and any amendment hereto may be executed in counterparts
and all of such counterparts taken together shall be deemed to
constitute one and the same instrument.
10. Notice
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10.1 All notices or other communications required or permitted to be made or
given hereunder shall be deemed so made or given hand-delivered or sent
in writing by registered or certified mail, postage prepaid and
return-receipt requested, or by a nationally-recognized courier service
guaranteeing next-day delivery, charges prepaid, and properly addressed
to such other party as set forth above or at such other address as may
be specified by either party hereto by written notice similarly sent or
delivered.
10.2 Notices or other communications directed to BDSI shall be sent to the
attention of Xxxxxxx Xxxxxxx, Ph.D. at BDSI, 000 X. Xxxxxx Xxx., XX
00000, XXX or to such other designee or at such other address as may be
later designated in writing by the BDSI.
10.3 Notices or other communications directed to ***** shall be sent to the
attention of *****or to such other designee or at such other address as
may be later designated in writing by the *****.
11. Indemnification
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11.1 To the extent that any claim against either party to this Agreement is
caused by negligence or acts on the part of the other party which
violate the laws or regulations of the United States Government or the
State of ***** or New Jersey, that party shall indemnify, defend and
hold the other party and its affiliates harmless from and against all
costs, claims, suits, expenses (including reasonable attorney fees) and
damages incurred by or rendered against that party and its Affiliates.
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***CONFIDENTIAL TREATMENT REQUESTED***
Note: The portions hereof for which confidential
treatment are being requested are denoted with "*****".
11.2 The indemnification provisions provided by Section 11.1 shall not apply
to the extent that such claims are caused by the negligence or
misconduct of the Party or its Affiliates seeking indemnification.
12. Termination
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12.1 Either party may terminate this Agreement by giving sixty (60) days
prior written notice thereof to the other party, provided, however,
that the obligation to maintain the confidentiality of Confidential
Information shall survive termination of the Agreement and shall
continue for a period of five years from the effective date of the
Agreement.
12.2 ***** may terminate this Agreement immediately upon notice, whether
provided by BDSI or by constructive means such as a news service or
publication, that BDSI has terminated its license to rights under the
aforementioned patents or that BDSI has failed to perform its
obligations under the license, resulting in termination of the license.
At no time will ***** be obligated to continue the RP or Evaluation in
the event that BDSI no longer has rights to sublicense the technology
described in U.S. Patent Numbers 4,663,161; 4,871,488; 5,643,574;
5,834.015; 5,840,707; 5,994,318; 6,153,217 and their U.S. and foreign
counterparts, continuation, continuation-in-part, and divisional
applications.
13. Choice of Law
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13.1 This Agreement shall be governed by and construed in accordance with
the laws of the state of New York, without regard to principles of
conflicts of Jaws applicable in such jurisdiction. Any dispute under
this Agreement shall be decided in the federal or state courts within
the State of New York.
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***CONFIDENTIAL TREATMENT REQUESTED***
Note: The portions hereof for which confidential
treatment are being requested are denoted with "*****".
IN WITNESS WHEREOF, the parties hereto have duly executed this
Agreement as of the effective Date by their Authorized representatives.
BIODELIVERY SCIENCES
INTERNATIONAL, INC.
/s/ Xxxxx X'Xxxxxxx
___________________________ Date:_______
Xxxxx X'Xxxxxxx, M.D.
*****
___________________________ Date:_______
*****
___________________________ Date:_______
*****
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