Exhibit 6.2
THE UNIVERSITY OF KANSAS
FIXED-PRICE AGREEMENT FOR RESEARCH
1. Introduction
This agreement, effective June 15, 1996, by and between the University of
Kansas, Lawrence, Kansas (hereinafter referred to as the UNIVERSITY), an
educational institution of the State of Kansas, and NexMed (hereinafter referred
to as CONTRACTOR) is made under the following terms.
2. Scope of Work
The UNIVERSITY will perform the scope of work as described in the proposal
entitled, "Development of Dermal Devices & Formulations" which forms the basis
of this research grant and is incorporated in to this agreement as Attachment A.
3. Duration
The investigation covered by this agreement shall extend for a period of
12 months, beginning on July 1, 1996 and continuing through June 30, 1997, and
is subject to renewal by mutual agreement.
4. Costs and Payments
(a) The CONTRACTOR agrees to pay to the UNIVERSITY a fixed price amount of
$20,000.00 to cover the partial cost of all direct labor, supervision, supplies,
equipment, materials, other operating and incidental expenses, and indirect
costs necessary for the execution of work.
(b) Budget transfers between categories is at the discretion of the
Project Director.
(c) Payment will be made by the CONTRACTOR to the UNIVERSITY in advance.
(d) Title to equipment purchased or built with these funds to perform the
investigation shall be vested in the UNIVERSITY upon completion of the work.
5. Indemnification
CONTRACTOR shall indemnify and hold harmless the UNIVERSITY, its agents
and employees from any and all claims of every kind including all costs of
defense arising out of the performance of this agreement.
6. Warranty
The UNIVERSITY agrees that the information provided to CONTRACTOR under
this agreement will be reasonably accurate in accordance with scientifically
accepted standards. The University disclaims all warranties including all
implied warranties of merchantability and fitness for a particular purpose.
7. Nature of Relationship
The UNIVERSITY is an independent contractor amid shall not act as an agent
for the CONTRACTOR, nor shall it be deemed to be an employee of the CONTRACTOR
for any purposes whatsoever. The CONTRACTOR shall not enter into any agreement
nor incur any obligations on behalf of the UNIVERSITY nor commit the UNIVERSITY
in any manner without the prior written consent of the UNIVERSITY.
8. Publications
The UNIVERSITY reserves the right to publish any results of its research
at the conclusion of the investigation conducted under this agreement. The
UNIVERSITY will submit
to the CONTRACTOR the text of any written disclosure of the results of the
investigation at least six (6) weeks in advance of any disclosure of the
results. The UNIVERSITY will consider any suggestions concerning the disclosure,
but is not bound to incorporate such suggestions in any publications.
9. Publicity
Neither the CONTRACTOR nor the University shall use the name of the other
or the name of any of its staff on any unpublished information or in any
publicity or advertisement, whether with respect to this agreement or any other
related matter, without prior written approval.
10. Extension
The parties may agree to continue the investigation beyond the termination
date for additional periods under terms provided for in writing and approved by
both parties. Such an agreement must be reached not less than 30 days prior to
the original termination date.
11. Termination
Either party may terminate this agreement provided written notification is
received by the other party 30 days prior to the proposed termination date. The
UNIVERSITY will return to CONTRACTOR all funds which have not been expended or
irrevocably encumbered at that time.
12. Patents
If patentable discoveries result from research sponsored by this
agreement, patent rights will be vested proportionately as determined by
subsequent negotiations and mutual agreement. In consideration of CONTRACTOR
transferring five thousand shares of NexMed common stock to the UNIVERSITY, the
UNIVERSITY acknowledges CONTRACTOR'S sole rights to those technologies listed in
Appendix B which CONTRACTOR owns and which are subject to further development
under the scope of work as described in Appendix A.
13. Assignment
UNIVERSITY may re-assign this agreement in whole or in part to the
University of Kansas Center for Research for administrative purposes.
14. This document constitutes the entire agreement between the CONTRACTOR and
the UNIVERSITY with respect to this research investigation. Any modification of
this agreement shall be in writing and shall be signed by both parties.
In witness whereof, the UNIVERSITY OF KANSAS and NexMed have executed this
agreement as of the date first above written.
NEXMED THE UNIVERSITY OF KANSAS
/s/ Xxxxxx Xxx /s/ Xxx Xxxxxxxx
---------------------------- ---------------------------------
Name: Xxxxxx Xxx Xxx Xxxxxxxx
Title: Vice-President Director
Research Support & Grants Administration
2
APPENDIX A
RESEARCH PLAN
One of the primary limitations of transdermal drug delivery is the natural
barrier function of the skin that prevents most drugs from passing through the
skin in an efficacious manner. Many approaches have been used to increase the
permeability of the skin. These include the use of physical (e.g. iontophoresis,
electroporation, occlusion (hydration), etc.) and chemical (penetration
enhancers, chemical modification, etc.) methods.
NexMed has acquired the rights to an electronic device to treat herpes
infections of the skin and mouth. NexMed is negotiating a licensing agreement
with Odontex to use several biodegradable penetration enhancers developed at the
University of Kansas.
The primary research objectives of this program include:
1. A significant objective of the work will involve testing, evaluation
and further development of the electronic device for treating herpes infections
of the skin and mouth.
2. Prototype topical formulations will be prepared utilizing appropriate
biodegradable enhancers and useful topical vehicles and excipients. The in-vitro
permeation of drug substances from prototype formulations will be evaluated
initially using a shed snake skin diffusion model developed in our laboratories.
The effect of formulation variables such as pH, vehicle composition (choice of
excipients) and enhancer concentration on the permeation of the drug substances
chosen for evaluation will be determined.
3. The physical and chemical stability of selected formulations will be
evaluated.
4. Local irritation and toxicity studies may be conducted with selected
formulations.
It is anticipated that most of the studies listed above will be performed
by visiting scientists whose salaries and some supply and equipment needs will
be provided by NexMed.
APPENDIX B
[Letterhead of X. X. Xxxxxx and Associates, Inc., Consultant to the Company]
June 10, 1996
Xxxxxx Xxxxxxx, Ph.D.
Professor
School of Pharmacy
Department of Pharmaceutical Chemistry
University of Kansas
HIGUCHI BIOSCIENCES CENTER
0000 Xxxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxx 00000
Dear Xx. Xxxxxxx:
NexMed, Inc. is excited about the prospect of continuing the development of
pharmaceutical and cosmetic products based on novel transdermal penetration
enhancers discovered by you and your colleagues at the Higuchi Biosciences
Center (HBC) in Lawrence, Kansas. NexMed, Inc. firmly believes that the best way
to successfully accomplish the transfer of the basic penetration enhancer
technology to the product development stage is to occupy laboratory space and
conduct the development activities at the Higuchi Biosciences Center.
NexMed, Inc. recognizes that the Higuchi Biosciences Center is part of the
University of Kansas, a state supported public institution. It is, therefore,
very important that the University of Kansas and NexMed, Inc. are in agreement
regarding the know-how and intellectual property resulting from product
development activities conducted by NexMed, Inc. employees in HBC laboratories
that solely occupied by NexMed, Inc. In this regard, all development activities
conducted in the NexMed, Inc. occupied laboratories must be private and
confidential. All know-how and intellectual property developed as a result of
development activities conducted by NexMed, Inc. employees in the NexMed, Inc.
occupied laboratory must be the sole property of NexMed, Inc. and without
encumbrances or claims by the University of Kansas or employees of the
University of Kansas.
NexMed, Inc. states that the laboratories at the Higuchi Biosciences Center will
be used for the development of new pharmaceutical, cosmetic and device products
based on intellectual property and know-how that NexMed, Inc. owns or has
acquired rights as stated below.
1. Pharmaceutical products that utilize transdermal penetration technology
described in issued patents owned by NexMed, Inc.
2. Pharmaceutical and cosmetic products that utilize transdermal penetration
technology described by issued patents, including patent filings, which
NexMed,Inc. has acquired rights.
3. Pharmaceutical and cosmetic products that utilize the know-how of its
employees.
4. Pharmaceutical devices that utilize technology described in issued patents
or patent applications owned or rights acquired by NexMed, Inc.
5. Pharmaceutical devices that utilize the know-how of its employees.
Once again, I am looking forward to our continued scientific collaboration.
Very best regards,
/s/ Xxxxx X. Xxxxxx
------------------------------
Xxxxx X. Xxxxxx, Ph.D.
Consultant to NexMed.
2
[Letterhead of the Company]
August 6, 1996
Xx. Xxx Xxxxxxxx
Director, Research Support & Grants Administration
University of Kansas
0000 Xxxxxxxx Xxxxxx, Xxxx 000
Xxxxxxxx, XX 00000
VIA FAX TRANSMISSION: (000) 000-0000
Dear Xx. Xxxxxxxx:
This is to confirm our phone conversation regarding the Fixed-Price Agreement
for Research signed last month between our two organizations.
We agreed that "Appendix B" as indicated in paragraph 12 of the
Agreement to be the June 10, 1996 letter written by Xx. Xxxxx X.
Xxxxxx. Xx. Xxxxxx'x letter summarizes the technologies and know-hows
to which the Contractor has sole rights.
Please acknowledge your agreement by signing and returning one copy of this fax
to us. Thank you for your attention concerning this matter.
Sincerely,
/s/ Xxxxxx Xxx
--------------------------------
Xxxxxx Xxx
Vice President
NexMed, Inc.
On behalf of the University of Kansas, I acknowledge that "Appendix B"
as indicated in paragraph 12 of the Agreement signed with NexMed, Inc.
to be the letter written by Xx. Xxxxx X. Xxxxxx to Xx. Xxxxxx Xxxxxxx,
Professor of Pharmacy, Department of Pharmaceutical Chemistry. Higuchi
Biosciences Center, on June 10, 1996.
/s/ Xxx Xxxxxxxx Date: 8-7-96
--------------------------------
Director
Research Support & Grants Administration
The University of Kansas
Fixed-Price Agreement for Research
Subcontract Modification #1
November 22, 1996
This document modifies the Fixed-Price Agreement for Research between the
University of Kansas and NexMed, Inc., which was effective on June 15, 1996 for
work under the direction of Xxxxxxxxx Xxxxxx Xxxxxxx. The project is entitled
"Development of Dermal Devices and Formulations." Subcontract Modification 1
extends the agreement for an additional period of two months and provides
supplemental funds in the amount of $13,100.00. The following wording replaces
language in the original Fixed-Price Agreement for Research:
Section 3. Duration
The investigation covered by this agreement shall extend for a period
beginning on June 15, 1996 and continuing through August 31, 1997, and is
subject to renewal by mutual agreement.
Section 4. Costs and Payments
(a) The CONTRACTOR agrees to pay to the UNIVERSITY a fixed-price amount of
$33,100.00 to cover the partial cost of all direct labor, supervision, supplies,
equipment, materials, other operating and incidental expenses, and indirect
costs necessary for the execution of the work.
All other terms and conditions of the Fixed-Price Agreement for Research,
effective June 15, 1996, remain in force.
NEXMED THE UNIVERSITY OF KANSAS
/s/ Xxxxxx Xxx /s/ Xxx Xxxxxxxx
-------------------------------- -----------------------------------
Name: Xxxxxx Xxx Xxx Xxxxxxxx
Title: Vice-President Director
Research Support & Grants Administration
Date: December 2, 1996 Date: 12-11-96
