<PAGE>
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 6, 1998
-------------
ENAMELON, INC.
-----------------
(Exact name of registrant as specified in its charter)
Delaware 0-21595 13-3669775
----------- --------- ------------
(State or Other Jurisdiction (Commission File Number) (IRS Employer Ident. No.)
of Incorporation)
15 Kimball Avenue, Yonkers, New York 10704
-----------------------------------------------------------
(Address of Principal Executive Offices) (Zip Code)
(914) 237-1308
-----------------------------
Registrant's telephone number, including area code
<PAGE>
Item 5. Other Events.
------------
On April 6, 1998, the Registrant finalized an Amendment to Restated
Patent Licence Agreement (the "U.S. Amendment") and an Amendment to Restated
Foreign Patent License Agreement (the "Foreign Amendment") with the American
Dental Association Health Foundation (the "ADAHF"), both of which are effective
as of January 1, 1998. The U.S. Amendment amends the Restated Patent License
Agreement, dated as of June 24, 1992, as amended by the Amendment Agreement
dated as of June 12, 1995 (together, the "License Agreement"), and the Foreign
Amendment amends the Restated Foreign Patent License Agreement, dated as of
November 18, 1992, as amended by the Foreign License Amendment Agreement, dated
as of June 14, 1995 (together, the "Foreign License Agreement").
The License Agreement, as amended by the U.S. Amendment (the "Amended
License Agreement"), grants the Registrant a fully-paid exclusive United States
license to manufacture and sell toothpastes and chewing gum and other food and
confectionery products ("Exclusive Products") using certain ADAHF patents issued
in the United States (the "ADAHF Patented Technology"). Under the Amended
License Agreement, the Registrant will be required to pay a fixed annual royalty
through 2008 of $400,000 with respect to all sales by the Registrant of
Exclusive Products (whether or not they rely upon the ADAHF Patented Technology)
up to $100 million in that year and an additional fixed royalty of $200,000 with
respect to all sales by the Registrant of Exclusive Products exceeding $100
million in that year. The term of the Amended License Agreement expires upon the
last to expire of the ADAHF patents licensed under the Amended License
Agreement, including any continuations, divisions, reexaminations, extensions or
releases thereof.
The Foreign License Agreement, as amended by the Foreign Amendment
(the "Amended Foreign License Agreement"), grants the Registrant a fully-paid
exclusive license to manufacture and sell Exclusive Products using technology
that is the subject matter of foreign patent applications filed by the ADAHF in
certain foreign countries. It also grants the Registrant the non-exclusive right
to manufacture and sell in such countries other products using that technology,
including oral sprays, mouth rinses and professional gels ("Non-Exclusive
Products"). The Amended Foreign License Agreement provides that the Registrant's
payment of royalties under the Amended License Agreement will constitute a
fully-paid license under the Amended Foreign License Agreement with respect to
sales of the Exclusive Products. The royalties payable with respect to sales of
Non-Exclusive Products and other provisions of the Foreign License Agreement
pertaining to Non-Exclusive Products remain unchanged under the Amended Foreign
License Agreement.
The U.S. Amendment and the Foreign Amendment each provides that the
Registrant may assign or sublicense its rights under its licenses with respect
to the Exclusive Products without the consent of the ADAHF, provided that the
Registrant will continue to remain liable for payment of royalties under the
Amended License Agreement. In addition, the ADAHF has waived any claim to
ownership rights in any of the Registrant's patents, and the Registrant has
agreed not to sue the ADAHF or any licensee of the ADAHF licensed to use the
ADAHF patents for infringement of the Registrant's patents, unless the
infringement constitutes a breach of the Registrant's exclusive license under
the two license agreements.
(c) Exhibits.
10.1 Restated Patent License Agreement by and between the
Registrant and the American Dental Association
Health Foundation dated as of June 24, 1992.(1)
10.2 Amendment Agreement by and between the Registrant
and the American Dental Association Health
Foundation dated as of June 12, 1995.(1)
10.3 Amendment to Restated Patent License Agreement
between the Registrant and the American Dental
Association Health Foundation dated as of January 1,
1998.
-2-
<PAGE>
10.4 Restated Foreign Patent License Agreement by and
between the Registrant and the American Dental
Association Health Foundation dated as of November
18, 1992.(1)
10.5 Foreign License Amendment Agreement by and between
the Registrant and the American Dental Association
Health Foundation dated as of June 14, 1995.(1)
10.6 Amendment to Restated Foreign Patent License
Agreement between the Registrant and the American
Dental Association Health Foundation dated as of
January 1, 1998.
(1) Incorporated herein by reference from Exhibits to
Registrant's Registration Statement on Form S-1
(File No. 333-06455), declared effective on October
24, 1996.
-3-
<PAGE>
SIGNATURE
---------
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
ENAMELON, INC.
(Registrant)
Date: April 14, 1998 By: /s/ Dr. Steven R. Fox
-----------------------------
Dr. Steven R. Fox
Chief Executive Officer
-4-
<PAGE>
EXHIBIT INDEX
Exhibit No. Description
- ----------- -----------
10.1 Restated Patent License Agreement by and between the Registrant and
the American Dental Association Health Foundation dated as of June 24,
1992.(1)
10.2 Amendment Agreement by and between the Registrant and the American
Dental Association Health Foundation dated as of June 12, 1995.(1)
10.3 Amendment to Restated Patent License Agreement between the Registrant
and the American Dental Association Health Foundation dated as of
January 1, 1998.
10.4 Restated Foreign Patent License Agreement by and between the
Registrant and the American Dental Association Health Foundation dated
as of November 18, 1992.(1)
10.5 Foreign License Amendment Agreement by and between the Registrant and
the American Dental Association Health Foundation dated as of June 14,
1995.(1)
10.6 Amendment to Restated Foreign Patent License Agreement between the
Registrant and the American Dental Association Health Foundation dated
as of January 1, 1998.
(1) Incorporated herein by reference from Exhibits to Registrant's
Registration Statement on Form S-1 (File No. 333-06455), declared
effective on October 24, 1996.
-5-
<PAGE>
EXHIBIT 10.3
AMENDMENT TO RESTATED PATENT LICENSE AGREEMENT
<PAGE>
AMENDMENT TO RESTATED PATENT LICENSE AGREEMENT
Amendment to Restated Patent License Agreement ("Amendment"), dated as
of January 1, 1998, between Enamelon, Inc., a Delaware corporation (the
"LICENSEE"), and the American Dental Association Health Foundation, a
not-for-profit corporation organized under the law of Illinois (the "LICENSOR").
Preliminary Statements
----------------------
WHEREAS, the LICENSOR and the LICENSEE heretofore entered into a
Restated Patent License Agreement, as amended by the Amendment Agreement, dated
as of June 12, 1995, copies of which are appended hereto as Exhibit A (together,
the "PLA"); and
WHEREAS, the LICENSOR and the LICENSEE desire to amend and clarify the
terms and conditions of the PLA for the purpose, inter alia, of simplification
of recording, accounting and making royalty payments;
In consideration of the foregoing and the mutual covenants in this
Amendment, the parties hereto hereby agree as follows:
Section 1. The first sentence of Article I, Section 1 of the PLA is
---------
hereby amended to read in its entirety as follows:
1. LICENSOR hereby grants and agrees to grant to LICENSEE, for
the term of the U.S. PATENT FILINGS, an exclusive license, with a right
to sublicense, throughout the United States and the territories thereof,
to make, have made, sell, use, induce use of and/or contribute to use of
the INVENTIONS for use in dentifrices (including toothpastes, tooth
cleaning gels and tooth cleaning powders), confections, foods and
chewing gums only (collectively, "EXCLUSIVE PRODUCTS"), subject to those
rights granted under the GOVERNMENT LICENSES, and subject to those
rights retained by LICENSOR in the following paragraphs and the
unrestricted right of LICENSOR to grant other licenses for other types
of products ("EXCLUSIVE LICENSE").
Section 2. Article I, Section 1 of the PLA is hereby amended by deleting
---------
all sentences after the first sentence.
Section 3. Article I, Section 2 of the PLA is hereby amended by deleting
---------
the last sentence of such Section.
Section 4. Article I of the PLA is hereby amended by deleting Sections 3
---------
and 5 thereof and renumbering Section 4 as Section 3 and Section 6 as Section 4.
<PAGE>
Section 5. Article II, Section 1 of the PLA is hereby amended to
---------
read in its entirety as follows:
1. In consideration of a fully-paid EXCLUSIVE LICENSE, LICENSEE
shall pay LICENSOR, commencing with the calendar year 1998 and for each
calendar year thereafter through and including the calendar year 2008, a
ROYALTY equal to the aggregate amount of Four Million Four Hundred
Thousand Dollars ($4,400,000.00) and, if applicable, up to an additional
maximum of Two Million Two Hundred Thousand Dollars ($2,200,000.00) in
accordance with the following schedule:
Four Hundred Thousand Dollars ($400,000.00) per calendar year with
respect to all of LICENSEE'S SALES OF EXCLUSIVE PRODUCTS in such
calendar year up to One Hundred Million Dollars, such annual payment to
be disbursed to LICENSOR in equal quarterly installments on or before
the last day of March, June, September and December of each calendar
year; and
An additional payment of Two Hundred Thousand Dollars ($200,000.00) per
calendar year with respect to all of LICENSEE'S SALES OF EXCLUSIVE
PRODUCTS in such calendar year exceeding One Hundred Million Dollars
($100,000,000.00), if any, such additional payment to be disbursed to
LICENSOR on or before the last day of January of the subsequent calendar
year.
Section 6. Article II of the PLA is hereby amended to delete Section 2
---------
thereof and to renumber Sections 3 and 4 thereof as Sections 2 and 3.
Section 7. Article II, Section 3 of the PLA (as renumbered pursuant to
---------
Section 6 hereof) is hereby amended to read in its entirety as follows:
3. "SALES OF EXCLUSIVE PRODUCTS" shall mean the total annual
sales of EXCLUSIVE PRODUCTS by the Company, domestic and foreign, as
reported by the Company in its audited annual financial statements or,
if not separately reported, as determined by the Company in accordance
with generally accepted accounting principles and certified by the
Company's auditors. Such sales of EXCLUSIVE PRODUCTS shall include all
sales of EXCLUSIVE PRODUCTS, whether patented or unpatented and whether
specifically licensed by LICENSOR hereunder or not, but shall not
include sales of mouthwashes, other oral care products, and other items
or products not included in the term EXCLUSIVE PRODUCTS as defined in
this Agreement.
<PAGE>
Section 8. Article II, Sections 5 through 9 of the PLA are hereby
---------
deleted in their entirety.
Section 9. Article III, Section 2 of the PLA is hereby amended in
---------
its entirety to read as follows:
2. LICENSEE agrees that on or before the last day of January of
each year commencing on January 31, 1999, and ending on January 31,
2009, it will furnish LICENSOR with a written statement specifying the
amount of its net sales during the preceding year.
Section 10. The third sentence of Article V, Section 1 of the PLA is
----------
hereby amended in its entirety to read as follows:
If LICENSOR deems legal action to be necessary, LICENSEE shall assist
LICENSOR in said legal action at LICENSOR'S expense, and LICENSOR shall
take reasonable steps to keep LICENSEE advised of the progress of the
lawsuit.
Section 11. Article VIII, Section 2 of the PLA is hereby amended in
----------
its entirety to read as follows:
2. Any FIELD DEVELOPMENTS which are made by LICENSOR alone and
which are patentable shall be licensed to LICENSEE under the terms of
this Agreement, and no additional ROYALTY shall be due with respect
thereto.
Section 12. The last two sentences of Article VIII, Section 3 of the PLA
----------
are hereby deleted and the following sentence is hereby added to the end of such
Section:
This free license may be assigned, transferred or sublicensed by
LICENSEE in its sole discretion.
Section 13. Article VIII of the PLA is hereby amended by adding thereto
----------
a new Section 7, which shall read in its entirety as follows:
7. In further consideration of the covenants and undertakings by
LICENSEE, LICENSOR waives any and all claim to ownership rights in the
following U.S. patents and patent applications and any continuations,
divisions, reissues, re-examinations and corresponding foreign patents
and applications thereof:
U.S. Patent No. 5,571,502
U.S. Patent No. 5,605,675
U.S. Patent No. 5,603,922
U.S. Patent No. 5,645,853
U.S. Patent No. 5,628,429
U.S. Patent No. 5,614,175
<PAGE>
Notwithstanding the foregoing, LICENSEE covenants not to sue LICENSOR or
any licensee of LICENSOR licensed to make, have made, sell, use, induce
use of and/or contribute to use of the INVENTIONS for infringement of
the aforesaid patents unless the conduct of said LICENSOR or any such
licensee of LICENSOR constitutes a breach of the EXCLUSIVE LICENSE.
Further, LICENSEE covenants not to sue LICENSOR with respect to the
aforesaid patents for manufacture and use for research and testing
purposes, including laboratory research and clinical trials.
Section 14. Article IX, Section 1 of the PLA is amended in its
----------
entirety to read as follows:
1. To protect the rights of privacy and/or publicity of
LICENSOR'S inventors, assignors, employees, officers and directors; to
protect the trademark and trade name rights of LICENSOR and its
affiliates; to prevent confusion regarding sponsorship of any given
product or technique of LICENSEE; and to preclude imposition of any
warranty, guarantee or other liability or potential liability upon
LICENSOR, its employees, assignors, affiliates, officers, and directors;
LICENSEE agrees that aside from (1) the patent notice provided for by 34
U.S.C. section 287, (2) any rights which may be conferred by
certification of a product by an affiliate of LICENSOR, (3) disclosures
concerning this Agreement or the INVENTIONS, MATERIALS or UNITS required
by law, or (4) an express prior written consent of LICENSOR, LICENSEE
will not use the name of any employee, assignor, officer or director or
the business name or identification or LICENSOR or its affiliates, or
use any certification mark of LICENSOR or its affiliates, in advertising
or promotional materials, educational materials, publications, fliers,
brochures and other public descriptions relating to UNIT(S) and/or
MATERIAL(S).
Section 15. Article IX, Section 3 of the PLA is hereby deleted in its
----------
entirety and Sections 4 through 7 thereof are hereby renumbered as Sections 3
through 6.
Section 16. Article IX, Section 5 of the PLA (as renumbered pursuant to
----------
Section 15 hereof) is hereby amended in its entirety to read as follows:
5. This AGREEMENT shall inure to the benefit of and will be
binding upon LICENSOR and LICENSEE, and their respective successors and
assigns. No assignment of this AGREEMENT, however, shall relieve
LICENSEE of the obligation to pay, or cause to be paid, ROYALTIES to
LICENSOR under this AGREEMENT.
Section 17. The terms "this Agreement," "hereof," "hereunder," and words
----------
of like meaning appearing in the PLA shall mean and refer to the PLA as amended
hereby.
Section 18. Except as otherwise amended by this Amendment, the PLA shall
----------
remain in full force and effect, and LICENSOR and LICENSEE hereby reaffirm each
of their respective agreements, covenants and obligations set forth therein.
<PAGE>
IN WITNESS WHEREOF, the undersigned have caused this Amendment to be
executed by their duly authorized officers as of the date first above written.
ENAMELON, INC.
By: /s/Dr. Steven R. Fox
----------------------------------
Dr. Steven R. Fox, Chairman
AMERICAN DENTAL ASSOCIATION
HEALTH FOUNDATION
By: /s/Dr. John S. Zapp
----------------------------------
Dr. John S. Zapp
Title: Executive Director
-------------------------------
<PAGE>
EXHIBIT 10.6
AMENDMENT TO RESTATED FOREIGN PATENT LICENSE AGREEMENT
<PAGE>
AMENDMENT TO RESTATED FOREIGN PATENT LICENSE AGREEMENT
Amendment to Restated Foreign Patent License Agreement ("Amendment"),
dated as of January 1, 1998, between Enamelon, Inc., a Delaware corporation (the
"LICENSEE"), and the American Dental Association Health Foundation, a
not-for-profit corporation organized under the law of Illinois (the "LICENSOR").
Preliminary Statements
----------------------
WHEREAS, the LICENSOR and the LICENSEE heretofore entered into a
Restated Foreign Patent License Agreement, dated from the 18th day of November
1992, as amended by the Foreign License Amendment Agreement, dated as of June
14, 1995, copies of which are appended hereto as Exhibit A (together the "FPLA
"); and
WHEREAS, the LICENSOR and the LICENSEE desire to amend and clarify the
terms and conditions of the FPLA for the purpose, inter alia, of simplification
----- ----
of recording, accounting and making royalty payments;
In consideration of the foregoing and the mutual covenants in this
Amendment, the parties hereto hereby agree as follows:
Section 1. Article II, Section 1 of the FPLA is hereby amended to
---------
read in its entirety as follows:
1. LICENSOR hereby grants and agrees to grant to LICENSEE, during
the term of this Agreement, a license under the above-identified FOREIGN
APPLICATIONS and FOREIGN PATENTS within the LICENSED TERRITORY, to make,
have made, sell, use, induce use of and/or contribute to use of the
INVENTIONS subject to those rights that have been or will be granted to
the United States government by licenses in the form of Exhibit B, and
countervailing requirements of applicable foreign law. In the fields of
dentifrices (including toothpastes, tooth cleaning gels and tooth
cleaning powders), confections, foods and chewing gums (collectively,
"EXCLUSIVE PRODUCTS"), LICENSEE'S license shall be exclusive to the
extent permitted by law in each of the LICENSED TERRITORIES, except that
LICENSOR retains at all times for itself and its RELATED COMPANIES for
research and testing purposes, including laboratory research and
clinical trials, but not the right to commercially sell or use the
INVENTIONS in the EXCLUSIVELY LICENSED FIELDS. In all fields of the
INVENTIONS other than the EXCLUSIVELY LICENSED FIELDS, the license
granted hereunder shall be non-exclusive.
<PAGE>
Section 2. Article II, Section 2 of the FPLA is hereby amended to
---------
read in its entirety as follows:
2. The license hereunder with respect to the NON-EXCLUSIVELY
LICENSED FIELDS shall not be assigned, transferred or sublicensed by
LICENSEE except with the prior written consent of LICENSOR. Such
permission shall not be unreasonably withheld by LICENSOR. LICENSEE
shall have the right to assign, transfer or sublicense the license
hereunder with respect to the EXCLUSIVELY LICENSED FIELDS in its
absolute discretion.
Section 3. Article II, Section 3 of the FPLA is hereby amended by
---------
deleting the first sentence and the first five words of the second sentence of
such Section.
Section 4. Article II, Section 8 of the FPLA is hereby amended in
---------
its entirety to read as follows:
8. LICENSOR hereby grants LICENSEE an option and right of first
refusal for a limited license under future patents and applications for
INVENTIONS and MATERIAL for all territories not within the LICENSED
TERRITORIES or the United States or its territories or possessions. The
option and right of first refusal hereunder are also limited in that
they apply only in the EXCLUSIVELY LICENSED FIELDS. Before licensing
another party in any territory other than the LICENSED TERRITORIES or
the United States under future patents or patent applications for
EXCLUSIVE PRODUCTS embodying MATERIAL, LICENSOR shall provide LICENSEE
with written notice of its intention to pursue license negotiations.
Within thirty (30) days of receipt of the notice, LICENSEE must exercise
its option and right of first refusal hereunder. If LICENSEE chooses to
accept a license with respect to a territory, other than the LICENSED
TERRITORIES or the United States, it will do so under the terms of this
Agreement. LICENSEE may exercise its option to obtain a license from
LICENSOR on the same terms as this Agreement for a territory or
territories other than the LICENSED TERRITORIES and the United States at
any time during the life of the FOREIGN APPLICATIONS or FOREIGN PATENTS
issued thereunder, assuming that LICENSOR has not granted an exclusive
license for the territory after LICENSEE'S failure to exercise its right
of first refusal hereunder.
<PAGE>
Section 5. Article III, Section 1 of the FPLA is hereby amended to
---------
read in its entirety as follows:
1. The payment by LICENSEE of royalties under the Restated Patent
License Agreement, dated from the 24th day of June 1992, between
LICENSOR and LICENSEE, as amended by the Amendment Agreement, dated as
of June 12, 1995, and the Amendment to Restated Patent License
Agreement, dated as of January 1, 1998 (such Restated Patent License
Agreement, as amended, being referred to herein as the "PLA"), shall be
in consideration of a fully-paid license hereunder with respect to the
EXCLUSIVELY LICENSED FIELDS, including, without limitation, all licenses
in the EXCLUSIVELY LICENSED FIELDS in the territories licensed pursuant
to Section 8 of Article II hereof. In consideration of the license
hereunder with respect to the NON-EXCLUSIVELY LICENSED FIELDS, LICENSEE
agrees to pay to LICENSOR a quarterly royalty payment of 7% of the basis
specified hereinafter, payable for each CALENDAR QUARTER within one
month after the end of that CALENDAR QUARTER; provided, however, that
the quarterly royalty payment payable by LICENSEE to LICENSOR with
respect to the NON- EXCLUSIVELY LICENSED FIELDS in connection with net
sales corresponding to UNITS made, sold, used or otherwise disposed of
by a JOINT VENTURE shall be 4%. Anything in this Agreement to the
contrary notwithstanding, the provisions of Sections 2, 3, 4, 5, 7, and
9 of Article III hereof and Sectiuon 4 of Article IV hereof shall apply
only to the license granted hereunder with respect to the NON-
EXCLUSIVELY LICENSED FIELDS, and the provisions of the PLA with respect
to the calculation and payment of royalties shall apply in all respects
to the license granted hereunder with respect to the EXCLUSIVELY
LICENSED FIELDS.
Section 6. Article IV, Section 1of the FPLA is hereby amended to read in
---------
its entirety as follows:
1. Unless terminated as herein provided, this AGREEMENT shall
extend (a) until the PLA terminates; or (b) until the expiration of the
last to expire of any FOREIGN PATENT licensed hereunder; or (c) until
LICENSOR abandons or permits to lapse all FOREIGN APPLICATIONS and
FOREIGN PATENTS licensed hereunder, whichever comes first. In the case
of abandonment or lapse, LICENSOR will promptly notify LICENSEE of the
pertinent abandonment or lapse.
Section 7. The third sentence of Article V, Section 1 of the FPLA is
---------
hereby amended in its entirety to read as follows:
If LICENSOR deems legal action to be necessary, LICENSEE shall assist
LICENSOR in said legal action at LICENSOR'S expense, and LICENSOR shall
take reasonable steps to keep LICENSEE advised of the progress of the
lawsuit.
<PAGE>
Section 8. Article VII, Section 2 of the FPLA is hereby amended in
---------
its entirety to read as follows:
2. Any FIELD DEVELOPMENTS which are made by LICENSOR alone and
which are patentable shall be licensed to LICENSEE under the terms of
this Agreement, and no additional ROYALTY shall be due with respect
thereto.
Section 9. The last two sentences of Article VII, Section 3 of the FPLA
---------
are hereby deleted and the following is hereby inserted in lieu thereof:
This free license with respect to the EXCLUSIVELY LICENSED FIELDS may be
assigned, transferred or sublicensed by LICENSEE in its sole discretion.
This free license with respect to the NON-EXCLUSIVELY LICENSED FIELDS
shall not be assigned, transferred or sublicensed by LICENSEE except
with the prior express written consent of LICENSOR. Such permission
shall be granted or withheld at the sole option of LICENSOR.
Section 10. Article VII of the FPLA is hereby amended by adding thereto
----------
a new Section 7, which shall read in its entirety as follows:
7. In further consideration of the covenants and undertakings by
LICENSEE, LICENSOR waives any and all claim to ownership rights in the
following U.S. patents and patent applications and any continuations,
divisions, reissues, re-examinations and corresponding foreign patents
and applications thereof:
U.S. Patent No. 5,571,502
U.S. Patent No. 5,605,675
U.S. Patent No. 5,603,922
U.S. Patent No. 5,645,853
U.S. Patent No. 5,628,429
U.S. Patent No. 5,614,175
Notwithstanding the foregoing, LICENSEE covenants not to sue LICENSOR or
any licensee of LICENSOR licensed to make, have made, sell, use, induce
use of and/or contribute to use of the INVENTIONS for infringement of
the aforesaid patents unless the conduct of said LICENSOR or any such
licensee of LICENSOR constitutes a breach of the license hereunder with
respect to the EXCLUSIVELY LICENSED FIELDS. Further, LICENSEE covenants
not to sue LICENSOR with respect to the aforesaid patents for
manufacture and use for research and testing purposes, including
laboratory research and clinical trials.
<PAGE>
Section 11. Article VIII, Section 1 of the FPLA is amended in its
----------
entirety to read as follows:
1. To protect the rights of privacy and/or publicity of
LICENSOR'S inventors, assignors, employees, officers and directors; to
protect the trademark and trade name rights of LICENSOR and its
affiliates; to prevent confusion regarding sponsorship of any given
product or technique of LICENSEE; and to preclude imposition of any
warranty, guarantee or other liability or potential liability upon
LICENSOR, its employees, assignors, affiliates, officers, and directors;
LICENSEE agrees that aside from (1) the patent notice provided for by 34
U.S.C. section 287, (2) any rights which may be conferred by
certification of a product by an affiliate of LICENSOR, (3) disclosures
concerning this Agreement or the INVENTIONS, MATERIALS or UNITS required
by law, or (4) an express prior written consent of LICENSOR, LICENSEE
will not use the name of any employee, assignor, officer or director or
the business name or identification or LICENSOR or its affiliates, or
use any certification mark of LICENSOR or its affiliates, in advertising
or promotional materials, educational materials, publications, fliers,
brochures and other public descriptions relating to UNIT(S) and/or
MATERIAL(S).
Section 12. Article VIII, Section 5 of the FPLA is hereby amended in
----------
its entirety to read as follows:
5. This AGREEMENT shall inure to the benefit of and will be
binding upon LICENSOR and LICENSEE, and their respective successors and
assigns. The license under this AGREEMENT with respect to the
NON-EXCLUSIVELY LICENSED FIELDS shall not be assignable without the
prior written permission of LICENSOR, except that LICENSEE may assign
such license to any other company in which LICENSEE or Dr. Steven R. Fox
owns more than 50% of the voting stock. Written permission of LICENSOR
for other assignments of the license with respect to the NON-EXCLUSIVELY
LICENSED FIELDS will not be unreasonably withheld.
Section 13. The terms "this Agreement," "hereof," "hereunder," and words
----------
of like meaning appearing in the FPLA shall mean and refer to the FPLA as
amended hereby.
Section 14. Except as otherwise amended by this Amendment, the FPLA
----------
shall remain in full force and effect, and LICENSOR and LICENSEE hereby reaffirm
each of their respective agreements, covenants and obligations set forth
therein.
<PAGE>
IN WITNESS WHEREOF, the undersigned have caused this Amendment to be
executed by their duly authorized officers as of the date first above written.
ENAMELON, INC.
By: /s/Dr. Steven R. Fox
------------------------------------
Dr. Steven R. Fox, Chairman
AMERICAN DENTAL ASSOCIATION
HEALTH FOUNDATION
By: /s/Dr. John S. Zapp
------------------------------------
Dr. John S. Zapp
Title: Executive Director
---------------------------------
