Exhibit 10.1
AMENDMENT OF LICENSE AND SUPPLY AGREEMENT
WHEREAS, IGI has been granted the exclusive license to certain
proprietary rights and intellectual property (including pursuant to certain
patents) to a lipid vesicle technology for topical dermatologic products
for localized usage at the delivery zone ("the Novasome Technology")
pursuant to a License Agreement between Micro-Pak,, Inc., a wholly owned
subsidiary of Novavax Inc., and Igen, Inc., a wholly owned subsidiary of
IGI, dated December 13, 1995 (the "Novasome License Agreement), a copy of
which is attached hereto as Exhibit A;
WHEREAS, IGI (together with its affiliates, successors and assigns,
IGI), on its own behalf and on behalf of MICRO VESICULAR SYSTEMS, INC (MVS)
and MICRO-PAK, INC. (MPI) and XXXXX XXXXXX INC. (Company) are parties to a
License and Supply Agreement dated as of December 2, 1992, as amended by
IGI and Company on August 26, 1994, and are parties to a Purchase Agreement
dated September 29, 1993 (collectively, "Prior Agreements",attached hereto
as Exhibits B and C, respectively)
WHEREAS, pursuant to the Novasome License Agreement, IGI has
developed and manufactured cosmetic products containing lipid vesicles
("Products")
WHEREAS, pursuant to the Prior Agreements, Lauder has the exclusive
right to purchase Products from IGI for sale in the department store or
specialty store market, and IGI has granted Lauder an exclusive license to
Products for sale in the department store or specialty store market;
WHEREAS, IGI and Company wish to amend the Prior Agreements , under
the terms and conditions set forth herein,
NOW, THEREFORE, it is hereby agreed that:
Capitalized terms used herein, but not otherwise defined shall have
the meanings ascribed to such terms in the Prior Agreements.
1. (a) For purposes of the present amendment, "Novasome Patent
Rights" shall mean all United States and foreign patents and patent
applications currently in force and licensed to IGI under the Novasome
License Agreement, and which patents are necessary for Company's
manufacture, distribution, use or sale of the Products. IGI represents and
warrants that an accurate list of those Novasome Patent Rights are attached
as Appendix A thereto, and further represents that the last-to-expire
patent expires on October 2, 2018
(b) "Field of Use" shall mean the use of the Novasome Patent
Rights solely in connection with the manufacture, distribution, marketing,
use, or sale of a cosmetic Product.
2. (a) IGI hereby converts the exclusive license to the Company
to, and the Company accepts, subject to the terms and conditions of this
Agreement, a non-exclusive, worldwide royalty bearing sublicense to the
Novasome Patent Rights solely
in the Field of Use, to the full end of the term for which the Novasome
Patent Rights are in force, unless sooner terminated as hereinafter
provided.
(b) IGI, for itself and MVS, further grants Company the
right to manufacture, or to have manufactured on its behalf by a third
party, Products under the Novasome Patent Rights.
(c) Commencing on the effective date, Company shall pay IGI
a royalty of five dollars ($5.00)/kilogram for Products manufactured by
Company, up to a maximum of two million dollars ($2,000,000) in royalties
in any Contract Year, a Contract Year being defined as the year following
the Effective Date of this Agreement, or a year following subsequent
anniversaries of the Effective Date. Once two million dollars in royalties
have been paid to IGI in any Contract Year, the royalty payable to IGI
shall be reduced to two dollars ($2.00)/kilogram for the remainder of that
Contract Year. Should IGI have a reasonable basis for asserting that the
royalty volume tracking procedures employed by Company are inadequate, then
IGI shall have the right of requesting a flow meter be installed on
Company's machines to track volumes.
(d) Within thirty (30) days of execution of this Amendment
of Agreement, Company will pay IGI a one-time fee of $100,000, for the
right to fabricate equipment capable of manufacturing Products. This right
shall include the right to fabricate equipment through IGI's equipment
supplier, or through a supplier of Company's choice. There in no limit on
the number of pieces of equipment that may be fabricated under this one-
time payment. However, Company shall inform IGI of any new equipment
produced and the address of where such machines are located.
(e) All non-Product bulk manufacture that IGI produces for
Company shall cease as of June 30, 2004.
(f) IGI will use its best efforts to maintain the Novasome
License and shall not take any action nor fail to take any required action
that would impair the rights of the Company to use the Novasome Patent
Rights in the Field of Use.
(g) As per the terms of the Novasome License Agreement, IGI
was granted a license to the Novasome Technology for a term of 10 years, as
well as an option to extend the exclusive license rights granted therunder,
exercisable in the last year of the initial 10 years license period, upon
payment of an option fee of One Million Dollars ($1,000,000) ("Option to
Extend"). The initial 10 year license granted to IGI under the Novasome
License Agreement expires on or about December 12 2005. IGI expressly
represents and warrants that it shall exercise the Option to Extend and has
already advised Novavax of such intention. IGI further represents and
warrants that it shall have available the financial and/or other resources
to satisfy the Option Fee due and payable on or about December 12, 2005, to
exercise the Option to Extend. No later than sixty (60) days prior to the
expiration of the Novasome License Agreement, IGI shall provide Company
with written confirmation of its exercise of the Option to Extend. Should
IGI fail to exercise the Option, Company shall have the right to extend its
rights hereunder, under substantially the same terms and conditions, by
direct
license from MVS, MPI or other appropriate IGI affiliate, with no further
obligation to IGI.
3. IGI represents that to its best knowledge, it is not currently
in breach, nor has it received notice from any granting party that it is in
breach, of any provision of the Novasome License Agreement. To IGI's
knowledge and belief there are no licenses, options, restrictions, liens,
rights of third parties, disputes, royalty obligations, proceedings or
claims relating to, affecting, or limiting its rights or the rights of the
Company under this Agreement with respect to, or which may lead to a claim
of infringement or invalidity regarding, any part or all of the Novasome
Patent Rights and their use as contemplated in the underlying patent
applications as presently drafted. IGI further warrants that Company's
manufacture of Products utilizing Novasome Technology and Company's sale
and distribution of Products will not infringe upon any US or foreign
patent or violate any valid rights of any person or any applicable law,
rule or violation.
4. This Amendment of Agreement shall continue in force and effect
for a period of three years from the Effective Date, automatically renewed
thereafter on a yearly basis, unless otherwise terminated as provided
herein, during the term of the Novasome License Agreement, including any
period of time granted pursuant to the exercise of the Option to Extend.
The Agreement may be terminated upon the earlier to occur of (a) the
expiration, invalidation or abandonment of the last to expire Novasome
Patent Right that applies to the Products, (b) Company's ninety (90) day
written notice to IGI that it elects to discontinue its sale of Products,
(c) at Company's option, as provided in Paragraph 7(b) of the License and
Supply Agreement.
5. Those Articles, or pertinent portions thereof, in the Prior
Agreements that are not inconsistent with the amended terms herein remain
in full force and effect and are incorporated herein by reference. These
Articles include, but are not necessarily limited to Articles 5, 6, 7, 8, 9
and 10 of the License and Supply Agreement.
6. The addresses for notice for each party shall be as follows:
To Xxxxx Xxxxxx:
Xxxxx Xxxxxx Companies
000 Xxxxx Xxxxxxx Xxxx
Xxxxxxxx, XX 00000
Attention: Senior Vice-President, Global Manufacturing and
Distribution
Fax: (000)000-0000
With copy to:
Legal Department
000 Xxxxxxxx Xxxx
Xxxxxxxx, XX 00000
Fax: (000)000-0000
To IGI:
IGI Inc.
X.X. Xxx 000
Xxxxx Xxxx and Lincoln Avenue
Buena, New Jersey
Attn: Xxxxx Xxxxxxx, CEO
Fax:
MVS and MPI hereby acknowledge the foregoing Agreement between IGI and
Company and agree that, by execution of such Agreement by IGI, MVS and MPI
are bound by the provisions herein.
7. The Effective Date of this Agreement shall be July 1, 2004.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement
by proper persons thereunto duly authorized.
Name Xxxxx Xxxxxxx CEO.
IGI Inc.
/s/ Xxxxx Xxxxxxx
------------------------------------
Xxxxx Xxxxxxx
Date November 16, 2004
Xxxxx Xxxxxx Inc.
By: /s/ Xxxxxx X. Xxxxxxxxx
--------------------------------
Xxxxxx X. Xxxxxxxxx
Title: Senior Vice President,
Global Mfg.
-----------------------------
APPENDIX A
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United States Patent 4,853,228
Xxxxxxx , et al. August 1, 1989
Method of manufacturing unilamellar lipid vesicles
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United States Patent 4,855,090
Xxxxxxx Xxxxxx 0, 0000
Xxxxxx of producing high aqueous volume multilamellar vesicles
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United States Patent 4,895,452
Yiournas , et al. January 23, 1990
Method and apparatus for producing lipid vesicles
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United States Patent 4,911,928
Xxxxxxx March 27, 1990
Paucilamellar lipid vesicles
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United States Patent 5,147,723
Xxxxxxx September 15, 1992
Paucilamellar lipid vesicles
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United States Patent 5,160,669
Xxxxxxx , et al. November 3, 1992
Method of making oil filled paucilamellar lipid vesicles
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Page 1 of 2
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United States Patent 5,234,767
Xxxxxxx August 10, 1993
Hybrid paucilamellar lipid vesicles
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United States Patent 5,260,065
Mathur , et al. November 9, 1993
Blended lipid vesicles
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United States Patent 5,439,967
Xxxxxx Xxxxxx 0, 0000
Xxxxxxxxx glycol stearate vesicles
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United States Patent 5,474,848
Xxxxxxx December 12, 1995
Paucilamellar lipid vesicles
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United States Patent 5,628,936
Xxxxxxx May 13, 1997
Hybrid paucilamellar lipid vesicles
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United States Patent 5,643,600
Mathur July 1, 0000
Xxxxx vesicles containing avocado oil unsaponifiables
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United States Patent 5,756,014
Mathur May 26, 1998
Heat resistant lipid vesicles
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Page 2 of 3
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United States Patent
6,251,425
Mathur , et al.
June 26,2001
Glucoside Paucilamellar Vesicles
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Page 3 of 3
