EXHIBIT 10.41
This Agreement is entered into by and between Xxxxxx Xxxxxxxxx
University through its Department of Department of Medicine, with an address at
Office of Research Administration, 0000 Xxxxxx Xxxxxx, XXX, X-0, Xxxxxxxxxxxx,
XX 00000, hereinafter called "Institution," and DOR BioPharma a corporation with
its principal office and place of business at 00000 Xxxxxxx Xxxxx, Xxxx Xxxxxx,
XX 00000, hereinafter called "Sponsor."
BACKGROUND
The research program contemplated by this Agreement is of mutual
interest and benefit to the Institution and to the Sponsor and will further the
Institution's instructional and research objectives in a manner consistent with
its status as a non-profit, tax-exempt, educational institution.
This Agreement is effective as of the first day of April 1, 2003
("Effective Date").
RECITALS
Institution and Sponsor are entering into this Agreement since Sponsor
desires to fund the research of Xx. Xxxxx Xxxxxxx of Institution's Department of
Medicine in certain specific areas. Sponsor desires to support such research
conducted by Institution in accordance with the terms and conditions of this
Agreement. The research program contemplated by this Agreement is of mutual
interest to Sponsor and Institution and furthers the educational, scholarship
and research objectives of Institution as a nonprofit, tax-exempt, educational
institution, and may benefit both Sponsor and Institution through the creation
or discovery of new inventions.
In consideration of the promises and mutual covenants contained herein,
and intending to be legally bound hereby, the parties hereto agree as follows:
ARTICLE 1. DEFINITIONS
1.1 Institution Intellectual Property means all inventions whether patentable or
not conceived and reduced to practice in the conduct of the Sponsored Research
during the term of this Agreement, including all United States and foreign
patent applications claiming said patentable inventions, including any
divisional, continuation, continuation-in-part (to the extent that the claims
are directed to said patentable inventions), and foreign equivalents thereof, as
well as any patents issued thereon or reissues or reexaminations thereof.
Institution Intellectual Property also includes all significant copyrightable
software created in the conduct of the Sponsored Research during the term of
this Agreement.
1.2 Principal Investigator means Xx. Xxxxx Xxxxxxx who has agreed to serve as
faculty investigator for the Sponsored Research and shall be responsible for the
conduct, supervision and administration of the Sponsored Research.
1.3 Research Results means all data and information that are generated in the
performance of the Sponsored Research during the term of this Agreement.
Research Results expressly excludes Institution Intellectual Property.
1.4 Sponsored Research means the research program described in Attachment A to
this Agreement.
ARTICLE 2. SPONSORED RESEARCH
2.1 Institution shall commence the Sponsored Research after the Effective Date
of this Agreement and upon payment by Sponsor of any funds owed, and shall use
good faith efforts to conduct such Sponsored Research substantially in
accordance with the terms and conditions of this Agreement. Sponsor acknowledges
that Institution and the Principal Investigator shall have the freedom to
conduct and supervise the Sponsored Research in a manner consistent with
Institution's educational and research missions.
2.2 If the services of the Principal Investigator become unavailable to
Institution for any reason, Institution shall be entitled to designate another
member of its faculty who is acceptable to Sponsor to serve as the Principal
Investigator of the Sponsored Research. If a substitute Principal Investigator
has not been designated within sixty (60) days after the original Principal
Investigator ceases his or her services under this Agreement, either party may
terminate this Agreement upon written notice thereof to the other party, subject
to the provisions of ARTICLE 15.
ARTICLE 3. TERM OF AGREEMENT
3.1 The initial term of this Agreement shall begin on the Effective Date of this
Agreement and shall end on April 1, 2004 unless terminated sooner pursuant to
ARTICLES 2 or 15 hereof. This Agreement may be extended or renewed only by
mutual written Agreement executed by duly authorized representatives of the
parties.
ARTICLE 4. REIMBURSEMENT OF COSTS, PAYMENT
4.1 Sponsor shall reimburse Institution for all direct and indirect costs
incurred in the conduct of the Sponsored Research in an amount not to exceed the
total annual amount of $297,000 as set forth in Attachment A. Sponsor
acknowledges that this amount is a good faith estimate only and not a guarantee
of the cost to conduct the Sponsored Research. If at any time Institution
determines that it will require additional funds for the Sponsored Research, it
shall notify Sponsor and provide an estimate of the additional amount. Sponsor
shall not be liable for any costs in excess of the amount of $5,000 unless it
has agreed in writing to provide additional funds.
4.2 Payments are to be made as follows: twenty-five percent (25%) of the award
($74,250) due upon execution of this agreement and the remaining seventy-five
percent (75%) of the award ($222,750) due every three (3) months in advance in
the amount of ($74,250) from execution of this agreement. All payments shall
clearly identify the Principal Investigator and Sponsored Research. All payments
are to be made by check payable in United States dollars, to "Xxxxxx Xxxxxxxxx
University", and sent to:
Xxxxxx Xxxxxxxxx University
Office of Technology Transfer
0000 Xxxxxx Xxxxxx
XXX, X-00
Xxxxxxxxxxxx, XX 00000
4.3 Title to any equipment, laboratory animals, or any other materials made or
acquired with funds provided under this Agreement shall vest in Institution, and
such equipment, animals, or materials shall remain the property of Institution
following termination of this Agreement.
ARTICLE 5. RECORDS AND REPORTS
5.1 Principal Investigator shall maintain records of the results of the
Sponsored Research and shall provide Sponsor with reports of the progress and
results of the Sponsored Research in accordance with Attachment A.
5.2 Institution shall maintain records of the use of the funds provided by
Sponsor and shall make such records available to Sponsor upon reasonable notice
during Institution's normal business hours, but not more frequently than each
anniversary of the Effective Date.
ARTICLE 6. SPONSOR'S RIGHTS IN RESEARCH RESULTS AND REPORTS
6.1 Sponsor shall have the right to use Research Results disclosed to Sponsor in
records and reports for any reasonable purpose. Sponsor shall need to obtain a
license to use Research Results from Institution if such use would infringe any
copyright or any claim of a patent application or issued patent owned by
Institution.
6.2 Institution and the Principal Investigator hereby grant Sponsor a
royalty-free, nontransferable, non-exclusive right to copy, reproduce and
distribute any research reports furnished to Sponsor under this Agreement.
Sponsor may not charge fees for said research reports, use said research reports
for advertising or promotional activities, or alter or modify said research
reports without the prior written permission of Institution.
ARTICLE 7. INTELLECTUAL PROPERTY
7.1 Institution shall retain all right, title and interest in and to the
Institution Intellectual Property and any patents, copyrights, software and
tangible research materials and other intellectual property related thereto.
7.2 Principal Investigator shall provide Institution and Sponsor a written
disclosure of any Institution Intellectual Property whether patentable or not.
Sponsor shall advise Institution in writing, no later than thirty (30) days
after receipt of such disclosure, whether it requests Institution to file and
prosecute patent applications related to such Institution Intellectual Property
at Sponsor's expense. If Sponsor does not request Institution to file and
prosecute such patent applications, Institution may proceed with such
preparation and prosecution at its own cost and expense; but such patent
applications shall be excluded from Sponsor's option under Section 7.5 hereof.
7.3 Institution shall control the preparation and prosecution of all patent
applications and the maintenance of all patents related to Institution
Intellectual Property. With regard to any patent applications filed at the
request and expense of Sponsor, Institution will consult with Sponsor on patent
prosecution. Sponsor shall reimburse Institution upon receipt of invoice for all
documented expenses incurred in connection with the filing and prosecution of
the patent applications and maintenance of the patents that Sponsor has
requested Institution to prosecute under Section 7.2 hereof.
7.4 Principal Investigator shall provide Institution and Sponsor a written
disclosure of any copyrightable software created in the conduct of the Sponsored
Research during the term of this Agreement that Principal Investigator
reasonably considers to be scientifically valuable.
7.5 In consideration of Sponsor's funding of the Sponsored Research and payment
for
intellectual property expenses as provided in Section 7.3, Institution grants
Sponsor a first option to negotiate to acquire a license on commercially
reasonable terms to practice Institution Intellectual Property. Institution and
Sponsor will negotiate in good faith to determine the terms of a license
Agreement as to each item of Institution Intellectual Property for which Sponsor
has agreed to make payment for intellectual property expenses as provided for in
Section 7.3, if any. If Sponsor and Institution fail to execute a license
Agreement within six (6) months after disclosure of the Institution Intellectual
Section 7.3, Institution shall be free to license the Institution Intellectual
Property to any party upon such terms as Institution deems appropriate, without
any further obligation to Sponsor.
7.6 Any license granted to Sponsor pursuant to Section 7.5 hereof shall be
subject to Institution's right to use and permit other non-profit organizations
to use Institution Intellectual Property for educational and research purposes
and, if applicable, to the rights of the United States government reserved under
Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C. 200-212, and any
regulations issued thereunder.
ARTICLE 8. CONFIDENTIALITY
8.1 If Sponsor desires to furnish any confidential information to the
Institution it must be directly related to the Study, disclosed to the
Institution by Sponsor in writing and conspicuously marked as confidential and
proprietary at the time of disclosure, or, if disclosed visually or orally, is
stated to be confidential and proprietary at the time of disclosure and
confirmed by a written summary describing the information in reasonable detail
delivered by Sponsor to Institution within fifteen (15) days after disclosure.
Sponsor shall not disclose confidential information to the Institution unless it
is necessary to the Study. Institution shall protect Sponsor's Confidential
Information with the same degree of care as Institution's own confidential
information. Institution shall not be obligated to accept any confidential
information from Sponsor.
8.2 In order to preserve the patentability of Institution Intellectual Property,
Sponsor shall maintain Institution Intellectual Property and information
provided pursuant to the Sponsored Research (whether oral or written) as
confidential and shall not disclose such information to any third party until
the publication of such information by the Principal Investigator or until
Institution provides Sponsor with written verification that all desirable
patentable inventions have been protected, whichever occurs sooner.
ARTICLE 9: PUBLICATIONS
The Principal Investigator and Institution shall be free to publish and
present the Research Results with certain provisions.
i. At least thirty (30) days prior to submitting a
manuscript or abstract for publication or
presentation Principal Investigator will submit to
Sponsor a copy of the abstract, manuscript or
presentation for review and comment, which comments
will be given due consideration by Principal
Investigator. Sponsor shall have thirty (30) days to
review and respond to Institution with comments. In
addition, Principal Investigator shall delay any
proposed publication/presentation an additional sixty
(60) days in the event Sponsor so requests in writing
to enable Sponsor to secure patent or other
proprietary protection of any inventions or
discoveries in such publication/presentation.
ii. Any such publication or presentation shall
acknowledge, as appropriate, the contribution of
Sponsor, its employees, agents and representatives.
ARTICLE 10. DISCLAIMER OF WARRANTIES
10.1 INSTITUTION MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AS TO ANY MATTER
WHATSOEVER, INCLUDING, WITHOUT LIMITATION, WARRANTIES WITH RESPECT TO THE
CONDUCT, COMPLETION, SUCCESS OR PARTICULAR RESULTS OF THE SPONSORED RESEARCH, OR
THE CONDITION, OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE
OF THE SPONSORED RESEARCH OR ANY INSTITUTION INTELLECTUAL PROPERTY OR RESEARCH
RESULTS OR THAT USE OF THE INSTITUTION INTELLECTUAL PROPERTY OR RESEARCH RESULTS
WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER INTELLECTUAL
PROPERTY RIGHT OF A THIRD PARTY. INSTITUTION SHALL NOT BE LIABLE FOR ANY DIRECT,
INDIRECT, CONSEQUENTIAL, PUNITIVE OR OTHER DAMAGES SUFFERED BY SPONSOR OR ANY
OTHER PERSON RESULTING FROM THE SPONSORED RESEARCH OR THE USE OF ANY INSTITUTION
INTELLECTUAL PROPERTY, ANY RESEARCH RESULTS OR ANY PRODUCTS RESULTING THEREFROM.
ARTICLE 11. USE OF THE INSTITUTION'S OR SPONSOR'S NAME (ADVERTISING)
The Institution and the Sponsor will obtain prior written permission
from each other before using the name, symbols and/or marks of the other in any
form of publicity in connection with the Sponsored Research. This shall not
include legally required disclosure by the Institution or Sponsor that
identifies the existence of the Agreement. Further, Sponsor's use of the name,
symbols and/or marks of Institution, or names of Institution's employees, shall
be limited to identification of Institution as the Sponsored Research site and
the Sponsored Research staff as participants in the Sponsored Research.
ARTICLE 12. NOTICES
Any notice shall be sent to the following addresses, with a copy also
sent to the designated facsimile number. Notice shall be effective on the date
of receipt.
Institution: Xxxxxx Xxxxxxxxx University
Office of Research Administration
0000 Xxxxxx Xxxxxx
XXX, X-0
Xxxxxxxxxxxx, XX 00000
Attention: Director
FAX: 000-000-0000
Sponsor: DOR BioPharma, Inc.
00000 Xxxxxxx Xxxxx
Xxxx Xxxxxx, XX 00000
Attention: Xx. Xxxxxx Xxxx
Phone: 000-000-0000
Fax: 000-000-0000
Principal Investigator: Xx. Xxxxx Xxxxxxx
ARTICLE 13. INDEMNIFICATION
Sponsor agrees to indemnify, defend and hold harmless the
Institution, its trustees, officers, agents and employees and/or Principal
Investigator from any and all liabilities for personal injury (including death)
or property damage arising out of or in connection with performance of the
Sponsored Research.
A. The obligation of indemnification under this section shall not
apply to the extent that liabilities are caused by the
negligence or willful misconduct of the Principal Investigator
or any other employee of Institution.
B. Institution must promptly notify Sponsor of any claim or suit
against any party to be indemnified hereunder, must allow
Sponsor to have full control of any disposition or settlement
of such claim or suit, and must fully cooperate with Sponsor
regarding such disposition or settlement.
C. Sponsor shall not dispose or settle any claim admitting
liability on the part of the Institution without Institution's
prior consent.
ARTICLE 14. INSURANCE
Sponsor will maintain during the performance of this Agreement a policy
or policies of comprehensive general liability Insurance at levels sufficient to
support the indemnification obligations in this Agreement.
This includes broad form and contractual liability and product
liability, in a minimum amount of $1,000,000 per single occurrence and
$3,000,000 in the aggregate with respect to personal injury, bodily injury and
property damage. Sponsor will provide Institution with a certificate of
insurance evidencing such coverage at the request of Institution.
ARTICLE 15. TERMINATION
A. This Agreement may be terminated by either party for any
reason upon thirty (30) days prior written notice.
B. Upon the effective date of expiration or termination, there
shall be an accounting conducted by the Institution. Within
thirty (30) days after receipt of the final accounting for the
Sponsored Research, Sponsor will make payment to the
Institution for:
i. All services rendered and monies expended by
the Institution until the date of
termination not yet paid for; and
ii. Non-cancelable obligations, including any
costs associated with termination, incurred
for the Sponsored Research by the
Institution prior to the effective date of
termination.
C. Termination of this Agreement by either party shall not affect
the rights and obligations of the parties accrued prior to the
effective date of the termination. The rights and duties under
ARTICLES 4, 7, 8, 9,11,12,13, and 14 survive the termination
or expiration of this Agreement.
ARTICLE 16. APPLICABLE LAW
This Agreement shall be governed by the laws of the Commonwealth of
Pennsylvania, without regard to its principles of conflict of law.
ARTICLE 17. NO AGENCY
The parties, in rendering performance under this Agreement, are each
acting and shall act solely as independent contractors. Neither party shall
undertake by this Agreement or otherwise to perform any obligation of the other
party, whether by regulation or contract. In no way shall either party be
construed as the agent or to be acting as the agent of the other party in any
respect, any other provisions of this Agreement notwithstanding. Neither party
shall enter into any Agreement or incur any obligations on behalf of the other
party, nor commit the other party in any manner without such party's prior
written consent. Neither party shall be deemed an employee of the other for the
purposes of any employee benefit programs, income tax withholding, FICA taxes,
unemployment benefits, or otherwise.
ARTICLE 18. NO ASSIGNMENT
The Agreement may not be assigned or otherwise transferred, nor, except
as expressly provided hereunder, may any right or obligations hereunder be
assigned or transferred by a party; provided, however, that Sponsor may assign
the Agreement and its rights and obligations hereunder to an Affiliate or in
connection with the transfer or sale of all or substantially all of its assets
related to the technology or its business or in the event of its merger or
consolidation or change in control or similar transaction. Except as otherwise
set forth herein, any permitted assignee shall assume all obligations of its
assignor under this Agreement.
ARTICLE 19. FORCE MAJEURE
Neither party shall be liable for any failure to perform as required by
this Agreement to the extent such failure to perform is due to circumstances
reasonably beyond such party's control, including, without limitation, labor
disturbances or labor disputes of any kind, accident, failure of any
governmental approval required for full performance, civil disorders or
commotions, acts of aggression, acts of God, energy or other conservation
measures imposed by law or regulation, explosions, failure of utilities,
mechanical breakdowns, material shortages, disease, or other such occurrence.
ARTICLE 20. DEBARMENT
Institution will not use in any capacity the services of any
individual, corporation, partnership or association which:
(1) has been debarred under 21 U.S.C. 335a
(2) disqualified as a clinical investigator under the provision of
21 C.F.R. 312.70.
In the event that Institution becomes aware of the debarment or
disqualification of any such individual, corporation, partnership or association
providing services under this Agreement, Institution shall notify Sponsor.
ARTICLE 21. MULTIPLE COUNTERPARTS
This Agreement may be executed in one or more counterparts, all of
which shall be deemed an original and all of which when taken together shall
constitute one and the same instrument.
ARTICLE 22. SECTION HEADINGS: EXHIBITS
The section and subsection headings used herein are for reference and
convenience only, and shall not enter into the interpretation hereof. The
exhibits referred to herein and attached hereto, or to be attached hereto, are
incorporated herein to the same extent as if set forth in full herein.
ARTICLE 23. NEUTRAL CONSTRUCTION
The parties to this Agreement agree that this Agreement was negotiated
fairly between them at arm's length and that the final terms of this Agreement
are the product of the parties' negotiations. Each party warrants and represents
that it has sought and received legal counsel of its own choosing with regard to
the contents of this Agreement and the rights and obligations affected hereby.
The parties agree that this Agreement shall be deemed to have been jointly and
equally drafted by them, and that the provisions of this Agreement therefore
should not be construed against a party or parties on the grounds that the party
or parties drafted or was more responsible for drafting the provision(s).
ARTICLE 24. NO WAIVER
No delay or omission by either party hereto to exercise any right or
power occurring upon any noncompliance or default by the other party with
respect to any of the terms of this Agreement shall impair any such right or
power or be construed to be a waiver thereof. The terms and conditions of this
Agreement may be waived or amended only in writing and only by the party that is
entitled to the benefits of the term(s) or condition(s) being waived or amended.
A waiver by either of the parties hereto of any of the covenants, conditions, or
Agreements to be performed by the other shall not be construed to be a waiver of
any succeeding breach thereof or of any covenant, condition, or Agreement herein
contained (whether or not the provision is similar). Unless stated otherwise,
all remedies provided for in this Agreement shall be cumulative and in addition
to and not in lieu of any other remedies available to either party at law, in
equity, or otherwise.
ARTICLE 25. UNENFORCEABILITY
If any provision of this Agreement or any word, phrase, clause,
sentence, or other portion thereof should be held to be unenforceable or invalid
for any reason, then provided that the essential consideration for entering into
this Agreement on the part of any party is not unreasonably impaired, such
provision or portion thereof shall be modified or deleted in such manner as to
render this Agreement as modified legal and enforceable to the maximum extent
permitted under applicable laws.
ARTICLE 26. ENTIRE AGREEMENT
Each party to this Agreement acknowledges that this Agreement
constitutes the entire Agreement of the parties with regard to the subject
matters addressed in this Agreement, that this Agreement supersedes all prior or
contemporaneous Agreements, discussions, or representations, whether oral or
written, with respect to the subject matter of this Agreement, and that this
Agreement cannot be varied, amended, changed, waived, or discharged except by a
writing signed by all parties hereto. Each party to this Agreement further
acknowledges that no promises, representations, inducements, Agreements, or
warranties, other than those set forth herein, have been made to induce the
execution of this Agreement by said party, and each party acknowledges that it
has not executed this Agreement in reliance on any promise, representation,
inducement, or warranty not contained herein.
ARTICLE 27. AUTHORITY TO ENTER INTO AGREEMENT
The parties and their representatives signing this Agreement hereby
acknowledge and represent that the representatives signing this Agreement are
duly authorized agents of the parties hereto and are authorized and have full
authority to enter into this Agreement on behalf of the parties for whom they
are signing.
In Witness whereof, the parties hereto have executed this Agreement in duplicate
by proper persons thereunto duly authorized.
Institution Sponsor
By: By:
--------------------------- --------------------------
(signature) (signature)
------------------------------ ------------------------------
(print or type name) (print or type name)
Title: Title:
------------------------ ------------------------
Date: Date:
------------------------- -------------------------
Attachment A
SUMMARY OF SPONSORED RESEARCH
1) Work Scope
2) Details of Program - See Appendix
Principal Investigator:
1) Name:
2) Phone Number:
Representative of Sponsor:
1) Name:
2) Phone Number:
Period of Performance:
Report Schedule:
Final report within thirty (30) days after termination
Budget:
Direct costs
Indirect costs
--------------
Total costs
Payment Schedule:
Date Payment Due Amount of Payment Due
---------------- ---------------------
1.Upon signature 1.
2. 2.
3. 3.
4. 4.
5.
