[PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIALITY UNDER RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. A COPY OF THIS
AGREEMENT WITH THIS EXHIBIT INTACT HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.]
FIRST AMENDMENT TO
EXCLUSIVE LICENSE AGREEMENT
FOR
SELECTED APPLICATIONS OF COATED NANOCRYSTALLINE PARTICLES
BETWEEN
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
AND
▇▇▇-▇▇▇▇▇▇▇ TECHNOLOGIES INC.
UC CASE NO. 89-204
FIRST AMENDMENT TO THE EXCLUSIVE LICENSE AGREEMENT
FOR SELECTED APPLICATIONS OF COATED NANOCRYSTALLINE PARTICLES
This amendment ("Amendment") is effective this 26th day of October,
1999, by and between The Regents of the University of California ("The
Regents"), a California corporation, having its statewide administrative
offices at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇,
and ▇▇▇-▇▇▇▇▇▇▇ Technologies Inc. ("Licensee"), a Wyoming corporation, having
a principal place of business at ▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇.
RECITALS
Whereas, Licensee and The Regents entered into a license agreement
entitled "Exclusive License Agreement for Selected Applications of Coated
Nanocrystalline Particles," effective on June 18, 1997, having U.C. Agreement
Control Number ▇▇▇▇-▇▇-▇▇▇▇ ("License Agreement"), covering licensure to
Licensee by The Regents of rights in certain inventions developed by ▇▇. ▇▇▇
▇▇▇▇▇▇▇▇▇ et al. at the University of California, Los Angeles and covered by
Patent Rights (as defined in the License Agreement);
Whereas, although Licensee and The Regents both agree that the other
party has substantially complied with the terms of the License Agreement,
changed circumstances have necessitated that certain other provisions of the
License Agreement be modified and amended;
Whereas, Licensee has requested that The Regents amend certain
provisions in the License Agreement to a more financial and time feasible
schedule; and
Whereas, The Regents is willing to amend the License Agreement to
reflect such request.
Now, Therefore, in consideration of the foregoing and the mutual
promises and covenants contained herein, the parties hereto agree as follows:
1. Paragraph 1.6 (Definitions) of the License Agreement is deleted in its
entirety and replaced with the following:
"1.6 Drug Delivery System" means coated nanocrystalline
particles used in pharmaceutical preparations to facilitate
the therapeutic delivery of insulin in humans."
2. Paragraph 1.7 (Definition) of the License Agreement is deleted in its
entirety and replaced with the following:
"1.7 [reserved]."
3. Paragraph 1.8 (Definitions) of the License Agreement is deleted in its
entirety and replaced with the following:
"1.8 "Field" means Vaccine Adjuvant, Virus Vaccine
Construct, and Drug Delivery System."
4. Paragraph 1.13 (Definitions) is added to the License Agreement
as follows:
"1.13 "Project" means the Vaccine Adjuvant project specified
in Subparagraph 5.9a, ▇▇▇▇▇▇▇ ▇▇▇▇ Vaccine project specified in
Subparagraph 5.9b, Herpes 2 Vaccine project specified in Subparagraph
5.9c, HIV Vaccine project specified in Subparagraph 5.9d, and Insulin
project specified in Subparagraph 5.9e."
5. Paragraph 4.5 (Royalties) of the License Agreement is deleted in its
entirety and replaced with the following:
"4.5 Beginning in the year 2004, Licensee will pay to The
Regents a minimum annual royalty in the amounts and at the times set
forth below:
2004 $ 50,000
2005 $ 100,000
2006 $ 150,000
2007 $ 200,000
2008 $ 400,000
2009 $ 600,000
2010 $ 800,000
2011 $ 1,500,000
2
In each succeeding calendar year after the year 2011, Licensee will pay
a minimum annual royalty of One Million Five Hundred Thousand Dollars
($1,500,000) and thereafter for the life of this Agreement. This
minimum annual royalty will be paid to The Regents by February 28 of
the year following accrual of the royalties and will be credited
against the earned royalty due and owing for the calendar year in which
the minimum payment was made."
5. Paragraph 5.7 (Due Diligence) of the License Agreement is deleted in
its entirety and replaced with the following:
"5.7 Licensee must hire the following key employees or
independent contractors by the designated dates:
------------------------------------------------------------ ------------------ --------------------------------------
Position Description # Req. Hiring Target Date
------------------------------------------------------------ ------------------ --------------------------------------
Director, Research & Development 1 December 1, 1996
Senior Vaccine Development Specialist 1 June 30, 1997
Senior Pharmaceutical Development Specialist 1 June 30, 1997
Process Development Scientist 1 April 30, 1997
Quality Control/Assurance Manager 1 December 31, 1997
Information Management Systems Specialist 1 December 31, 1997
Regulatory Specialist 1 December 31, 1998
6. Paragraph 5.8 (Due Diligence) of the License Agreement is deleted in
its entirety and replaced with the following:
"5.8 In the hiring of key employees or independent contractors
designated in Paragraph 5.7 above, Licensee will use the criteria set forth
and hire qualified candidates.
3
7. Sub-paragraph 5.9a (Due Diligence) of the License Agreement is deleted
in its entirety and replaced with the following:
5.9a Vaccine Adjuvant Project
-------------------------------------------------------------------------------------------------
MILESTONES # TARGET DATE
-------------------------------------------------------------------------------------------------
1: Produce a Patent Product comprising Vaccine Adjuvant for test September 30, 1997
purposes
-------------------------------------------------------------------------------------------------
2: Produce a test model for a Patent Product comprising Vaccine February 28, 1998
Adjuvant
-------------------------------------------------------------------------------------------------
3: Complete toxicity testing for a Patent Product comprising Vaccine September 30, 1998
Adjuvant
-------------------------------------------------------------------------------------------------
4: Enter into strategic alliances or sublicenses for the development of a January 31, 2000
Patent Product comprising Vaccine Adjuvant
-------------------------------------------------------------------------------------------------
5: Submit IND in the United States and the foreign regulatory
counterpart in Europe and Japan for a Patent Product comprising
Vaccine Adjuvant
-------------------------------------------------------------------------------------------------
6: Begin Phase I Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Vaccine Adjuvant
-------------------------------------------------------------------------------------------------
7: Begin Phase 2/3 Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Vaccine Adjuvant
-------------------------------------------------------------------------------------------------
8: File for marketing approval in the United States, Germany, France,
England, and Japan for a Patent Product comprising Vaccine Adjuvant
-------------------------------------------------------------------------------------------------
9: Introduce a Patent Product comprising Vaccine Adjuvant to the
market in the United States, Germany, and France within 6 months from
marketing approval
-------------------------------------------------------------------------------------------------
10: Fill market demand in each country within 6 months of introduction
for a Patent Product comprising Vaccine Adjuvant
-------------------------------------------------------------------------------------------------
[Portions of this Exhibit have been omitted pursuant to a request for
confidentiality under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A copy of this agreement with this Exhibit intact
has been filed separately with the Securities and Exchange Commission.]
8. Sub-paragraph 5.9b (Due Diligence) of the License Agreement is deleted
in its entirety and replaced with the following:
5.9b ▇▇▇▇▇▇▇ ▇▇▇▇ Vaccine Project
-------------------------------------------------------------------------------------------------
MILESTONES # TARGET DATE
-------------------------------------------------------------------------------------------------
1: Produce a Patent Product comprising Virus Vaccine Construct for the December 31, 1997
▇▇▇▇▇▇▇ ▇▇▇▇ application
-------------------------------------------------------------------------------------------------
2: Test a pilot vaccine consisting of a Patent Product comprising Virus June 30, 1998
Vaccine Construct for the ▇▇▇▇▇▇▇ ▇▇▇▇ application
-------------------------------------------------------------------------------------------------
3: Complete pre-clinical tests on a Patent Product comprising Virus December 31, 1998
Vaccine Construct for the ▇▇▇▇▇▇▇ ▇▇▇▇ application
-------------------------------------------------------------------------------------------------
4: Submit IND in the United States and the foreign regulatory
counterpart in Europe and Japan for a Patent Product comprising Virus
Vaccine Construct for the ▇▇▇▇▇▇▇ ▇▇▇▇ application
-------------------------------------------------------------------------------------------------
5: Begin Phase I Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Virus Vaccine Construct for the ▇▇▇▇▇▇▇ ▇▇▇▇ application
-------------------------------------------------------------------------------------------------
6: Begin Phase 2 Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Virus Vaccine Construct for the ▇▇▇▇▇▇▇ ▇▇▇▇ application
-------------------------------------------------------------------------------------------------
7: Begin Phase 3 Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Virus Vaccine Construct for the ▇▇▇▇▇▇▇ ▇▇▇▇ application
-------------------------------------------------------------------------------------------------
8: File for marketing approval in the United States, Germany, France,
England, and Japan for a Patent Product comprising Virus Vaccine
Construct for the ▇▇▇▇▇▇▇ ▇▇▇▇ application
-------------------------------------------------------------------------------------------------
9: Introduce a Patent Product comprising Virus Vaccine Construct for
the ▇▇▇▇▇▇▇ ▇▇▇▇ application to the market in the United States,
Germany, France, England, and Japan within 6 months from marketing
approval
-------------------------------------------------------------------------------------------------
10: Fill market demand in each country within 6 months of introduction
for a Patent Product comprising Virus Vaccine Construct for the ▇▇▇▇▇▇▇
▇▇▇▇ application
-------------------------------------------------------------------------------------------------
[Portions of this Exhibit have been omitted pursuant to a request for
confidentiality under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A copy of this agreement with this Exhibit intact
has been filed separately with the Securities and Exchange Commission.]
9. Sub-paragraph 5.9c (Due Diligence) of the License Agreement is deleted
in its entirety and replaced with the following:
5.9c Herpes 2 Vaccine Project
-------------------------------------------------------------------------------------------------
MILESTONES # TARGET DATE
-------------------------------------------------------------------------------------------------
1: Produce a Patent Product comprising Virus Vaccine Construct for the February 28, 1998
Herpes 2 application
-------------------------------------------------------------------------------------------------
2: Test a pilot vaccine consisting of a Patent Product comprising Virus August 31, 1998
Vaccine Construct for the Herpes 2 application
-------------------------------------------------------------------------------------------------
3: Complete pre-clinical tests on a Patent Product comprising Virus February 28, 1999
Vaccine Construct for the Herpes 2 application
-------------------------------------------------------------------------------------------------
4: Submit IND in the United States and the foreign regulatory
counterpart in Europe and Japan for a Patent Product comprising Virus
Vaccine Construct for the Herpes 2 application
-------------------------------------------------------------------------------------------------
5: Begin Phase I Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Virus Vaccine Construct for the Herpes 2 application
-------------------------------------------------------------------------------------------------
6: Begin Phase 2 Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Virus Vaccine Construct for the Herpes 2 application
-------------------------------------------------------------------------------------------------
7: Begin Phase 3 Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Virus Vaccine Construct for the Herpes 2 application
-------------------------------------------------------------------------------------------------
8: File for marketing approval in the United States, Germany, France,
England, and Japan for a Patent Product comprising Virus Vaccine
Construct for the Herpes 2 application
-------------------------------------------------------------------------------------------------
9: Introduce a Patent Product comprising Virus Vaccine Construct for
the Herpes 2 application to the market in the United States, Germany,
France, England, and Japan within 6 months from marketing approval
-------------------------------------------------------------------------------------------------
10: Fill market demand in each country within 6 months of introduction
for a Patent Product comprising Virus Vaccine Construct for the Herpes
2 application
-------------------------------------------------------------------------------------------------
[Portions of this Exhibit have been omitted pursuant to a request for
confidentiality under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A copy of this agreement with this Exhibit intact
has been filed separately with the Securities and Exchange Commission.]
4
10. Sub-paragraph 5.9d (Due Diligence) of the License Agreement is deleted
in its entirety and replaced with the following:
5.9d HIV Vaccine Project
-------------------------------------------------------------------------------------------------
MILESTONES # TARGET DATE
-------------------------------------------------------------------------------------------------
1: Produce a Patent Product comprising Virus Vaccine Construct for the January 31, 1998
HIV vaccine application
-------------------------------------------------------------------------------------------------
2: Test a pilot vaccine consisting of a Patent Product comprising Virus December 31, 1998
Vaccine Construct for the HIV vaccine application
-------------------------------------------------------------------------------------------------
3: Complete pre-clinical tests on a Patent Product comprising Virus May 31, 1999
Vaccine Construct for the HIV vaccine application
-------------------------------------------------------------------------------------------------
4: Submit IND in the United States and the foreign regulatory
counterpart in Europe and Japan for a Patent Product comprising Virus
Vaccine Construct for the HIV vaccine application
-------------------------------------------------------------------------------------------------
5: Begin Phase I Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Virus Vaccine Construct for the HIV vaccine application
-------------------------------------------------------------------------------------------------
6: Begin Phase 2 Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Virus Vaccine Construct for the HIV vaccine application
-------------------------------------------------------------------------------------------------
7: Begin Phase 3 Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Virus Vaccine Construct for the HIV vaccine application
-------------------------------------------------------------------------------------------------
8: File for marketing approval in the United States, Germany, France,
England, and Japan for a Patent Product comprising Virus Vaccine
Construct for the HIV vaccine application
-------------------------------------------------------------------------------------------------
9: Introduce a Patent Product comprising Virus Vaccine Construct for
the HIV vaccine application to the market in the United States,
Germany, France, England, and Japan within 6 months from marketing
approval
-------------------------------------------------------------------------------------------------
10: Fill market demand in each country within 6 months of introduction
for a Patent Product comprising Virus Vaccine Construct for the HIV
vaccine application
-------------------------------------------------------------------------------------------------
[Portions of this Exhibit have been omitted pursuant to a request for
confidentiality under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A copy of this agreement with this Exhibit intact
has been filed separately with the Securities and Exchange Commission.]
11. Sub-paragraph 5.9e (Due Diligence) of the License Agreement is deleted
in its entirety and replaced with the following:
5.9e Insulin Project
-------------------------------------------------------------------------------------------------
MILESTONES # TARGET DATE
-------------------------------------------------------------------------------------------------
1: Produce a Patent Product comprising Drug Delivery System for the May 31, 1998
insulin application
-------------------------------------------------------------------------------------------------
2: Test a clinical material consisting of a Patent Product comprising May 31, 1999
Drug Delivery System for the insulin application
-------------------------------------------------------------------------------------------------
3: Complete pre-clinical tests on a Patent Product comprising Drug October 31, 1999
Delivery System for the insulin application
-------------------------------------------------------------------------------------------------
4: Submit IND for Phase 1 Clinical Trials for use of calcium phosphate
nanoparticles (CAP) as adjuvant or carrier in inhaled or other insulin
application
-------------------------------------------------------------------------------------------------
5: Submit IND in the United States and the foreign regulatory
counterpart in Europe and Japan for a Patent Product comprising Drug
Delivery System for the insulin application
-------------------------------------------------------------------------------------------------
6: Begin Phase I Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Drug Delivery System for the insulin application
-------------------------------------------------------------------------------------------------
7: Begin Phase 2 Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Drug Delivery System for the insulin application
-------------------------------------------------------------------------------------------------
8: Begin Phase 3 Clinical Trials in the United States and the foreign
regulatory counterpart in Europe and Japan for a Patent Product
comprising Drug Delivery System for the insulin application
-------------------------------------------------------------------------------------------------
9: File for marketing approval in the United States, Germany, France,
England, and Japan for a Patent Product comprising Drug Delivery
System for the insulin application
-------------------------------------------------------------------------------------------------
10: Introduce a Patent Product comprising Drug Delivery System for
the insulin application to the market in the United States, Germany,
France, England, and Japan within 6 months from marketing approval
-------------------------------------------------------------------------------------------------
11: Fill market demand in each country within 6 months of introduction
for a Patent Product comprising Drug Delivery System for the insulin
application
-------------------------------------------------------------------------------------------------
[Portions of this Exhibit have been omitted pursuant to a request for
confidentiality under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A copy of this agreement with this Exhibit intact
has been filed separately with the Securities and Exchange Commission.]
12. Sub-paragraphs 5.9f, 5.9g and 5.9h (Due Diligence) are deleted in their
entirety from the License Agreement.
13. Paragraph 5.11 (Due Diligence) of the License Agreement is deleted in
its entirety and replaced with the following:
"5.11 The Regents shall have the right and option to either (1)
terminate this Agreement when Licensee fails to meet due diligence provisions
for any three of the five projects specified under Projects, as defined in
Paragraph 1.13 above; or (2) reduce the exclusive license granted to
non-exclusive licenses for each project specified under Projects, as defined
in Paragraph 1.13 above, when Licensee fails to meet due diligence provisions
for that particular project, subject to the notice and opportunity to repair
provisions of Paragraph 9.1."
14. Paragraph 9.1 (Termination by the Regents) of the License Agreement is
deleted in its entirety and replaced with the following:
5
"9.1 Subject to Paragraph 5.11, if Licensee should violate or fail
to perform any term or covenant of this Agreement, then The Regents may give
written notice of such default ("Notice of Default") to Licensee. If Licensee
should fail to repair such default within sixty (60) days after the date such
notice takes effect, The Regents will have the right to terminate this
Agreement and the licenses herein by a second written notice ("Notice of
Termination") to Licensee. If a Notice of Termination is sent to Licensee,
this Agreement will automatically terminate on the date such notice takes
effect. Such termination will not relieve Licensee of its obligation to pay
any royalty or license fees owing at the time of such termination and will
not impair any accrued right of The Regents. These notices will be subject to
Article 18 (Notices)."
15. Paragraph 18.1 (Notices) of the License Agreement is deleted in its
entirety and replaced with the following:
"18.1 Any notice or payment required to be given to either party
will be deemed to have been properly given and to be effective:
18.1a on the date of delivery if delivered in person;
18.1b on the date of mailing if mailed by first-class
certified mail, postage paid; or
18.1c on the date of mailing if mailed by any global express
carrier service that requires the recipient to sign the
documents demonstrating the delivery of such notice of
payment;
to the respective addresses given below, or to another address as designated
in writing by the party changing its prior address.
In the case of Licensee: ▇▇▇-▇▇▇▇▇▇▇ Technologies, Inc.
▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
President & CEO
In the case of The Regents: The Regents of the University of California
Office of the President
Office of Technology Transfer
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: Executive Director
Office of Technology Transfer
Referring to: U.C. Case No. 89-204
6
In Witness Whereof, both The Regents and the Licensee have executed
this Amendment, in duplicate originals, by their respective officers hereunto
duly authorized, on the day and year hereinafter written.
▇▇▇-▇▇▇▇▇▇▇ THE REGENTS OF THE
TECHNOLOGIES INC. UNIVERSITY OF CALIFORNIA
By /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ By /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
------------------------------------ --------------------------------
(Signature) (Signature)
Name ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Name ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
----------------------------------
Title President & CEO Title Executive Director,
---------------------------------- Research Administration
and Technology Transfer
Date 10/22/99 Date 10/26/99
---------------------------------- ------------------------------
Approved as to legal form: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇ 10/22/99
---------------------------------
▇▇▇▇▇ ▇. ▇▇▇▇▇ Date
University Counsel
Office of General Counsel
7
