EXHIBIT 10.36
AMENDMENT TWO TO THE LICENSE AGREEMENT
BETWEEN SOUTHERN RESEARCH INSTITUTE, THE UAB RESEARCH FOUNDATION
AND INNOVACCINES CORPORATION
DATED AUGUST, 1998
This amendment ("Amendment") is made by and between Southern Research
Institute ("SRI"), The UAB Research Foundation ("UABRF") and DOR Vaccines, Inc.
("DOR") (formerly, Formulation Technologies ("FTI") on the ___ day of February
2003. SRI and The UABRF are sometimes collectively referred to as ("SRI/UABRF")
herein.
RECITALS
WHEREAS, SRI/UABRF have entered into an existing license agreement with
Vaxcel, Inc. ("Vaxcel"), dated August, 1998, relating to Oral Microsphere
Technology (the "License Agreement");
WHEREAS, Vaxcel has entered into an option agreement with Innovax dated
January 27, 1999, to assign Vaxcel's rights under the License Agreement to
Innovax Corporation (the "Option Agreement") and Innovax Corporation desires to
exercise such option;
WHEREAS, Innovax Corporation has changed its name to Innovaccines
Corporation;
WHEREAS, Formulation Technologies, Inc. has changed its name to DOR
Vaccines, Inc.;
WHEREAS, Formulation Technologies, Inc. and SRI have entered into a
Confidentiality Agreement, dated November 20, 2002;
WHEREAS, DOR BioPharma, Inc. ("DOR") sent to SRI/UABRF on November 20,
2002, documentation regarding the assignment of Elan Pharmaceuticals' ("Elan")
interest in the Innovaccines Corporation ("Innovaccines") to DOR Vaccines, Inc.,
a subsidiary of DOR BioPharma, Inc. via its one hundred percent (100%) ownership
of Corporation Technology Development, Inc.;
WHEREAS, DOR desires to revise the License Agreement to expand the
field of use to include pulmonary and nasal administration of microencapsulated
anthrax, ricin and plague Antigens;
WHEREAS, in consideration for the Consent to the Assignment of Elan's
rights in amending the License Agreement ("License Agreement") between Vaxcel
and SRI and UABRF to be assigned to DOR to expand the Field of the License
Agreement to include pulmonary and nasal administration of microencapsulated
anthrax, ricin and plague Antigens;
NOW THEREFORE, in consideration of the foregoing premises and the
mutual promises, covenants, and agreements hereinafter set forth, all parties to
this Amendment Two the parties mutually agree to amend the License Agreement as
follows as of December 20, 2002:
1. Article I, "DEFINITIONS", Section 1.6 shall be amended to read as
follows:
"Fields" shall mean use of the Oral Microsphere Technology for oral
delivery of Antigens to humans and animals, and (i) the exclusive
rights to the pulmonary and
nasal administration of microencapsulated ricin Antigens to humans and
animals, and (ii) the exclusive rights to pulmonary and nasal
administration of microencapsulated plague Antigens to humans and
animals and (iii) the non-exclusive rights to the pulmonary and nasal
administration of microencapsulated anthrax Antigens to humans and
animals . With the exception of pulmonary and nasal administration of
microencapsulated anthrax, ricin and plague Antigens, Fields shall
EXCLUDE other pulmonary and nasal administration of other antigens and
specifically shall NOT include (a) use for the delivery of Antigens
administered via injections, and all other modes of administration:
and (b) use for delivery of compounds which are not Antigens by all
modes of administration.
2. Article I, "DEFINITIONS", Section 1.11 shall be amended to read as
follows:
"Oral Microsphere Technology" shall mean certain inventions, patents,
and patent applications related to oral vaccines comprised of
intestinal-lymphoidal-tissue targetable microcapsules and related to
pulmonary and nasal administration of microencapsulated anthrax, ricin
and plague Antigens, which the entire right, title, and interest in
and to are jointly owned by SRI and UABRF.
3. Section 3.2 Revenue Sharing if DOR Sublicenses the Oral Microsphere
Technology.
Section 3.2(i) is deleted and replaced by the following:
(i) For all sublicensing agreements executed by DOR for the Oral
Microsphere Technology, DOR will receive 67% of Revenue and
Southern will receive 33% of Revenue.
The language of Section 3.2(ii) is deleted in its entirety. The
parties recognize there will not be any reduction in the overall SRI
portion of the Revenue under Section 3.2(i).
4. New Section 3.3 Minimum Annual Payments Royalties.
Section 3.3(i) Years 2002 and beyond (oral vaccines)
As to oral vaccines, if the royalty paid by DOR to SRI under Article
3.1 and the royalty portion of Revenue in years 2002 and beyond by DOR
to SRI under Article 3.2 after commercialization of a Vaccine(s) by a
Sublicensee(s) ("Royalty Revenue") during each twelve month calendar
period starting the Year 2002 shall be less than the minimum royalty
amounts ("Minimum Royalties) specified below, DOR agrees to pay SRI an
amount equal to the difference between the Minimum Royalties specified
below and the Royalties paid by DOR to SRI during such twelve month
period. The Minimum Royalties shall be one hundred thirty thousand
dollars ($130,000) for the Year 2002 to be paid December 31, 2002.
Thereafter, the Minimum Royalties shall be increased by ten thousand
dollars ($10,000) in each successive twelve-month period until all
valid Oral Microsphere Technology Patents expire.
Section 3.3(ii) Years 2003 and beyond (ricin vaccines)
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As to ricin and the exclusive rights to pulmonary and nasal
administration of microencapsulated ricin Antigens, if the royalty
paid by DOR to SRI under Article 3.1 and the royalty portion of
Revenue in years 2003 and beyond by DOR to SRI under Article 3.2 after
commercialization of a Vaccine(s) by a Sublicensee(s) ("Royalty
Revenue") during each twelve month calendar period starting the Year
2003 shall be less than the minimum royalty amounts ("Minimum
Royalties) specified below, DOR agrees to pay SRI an amount equal to
the difference between the Minimum Royalties specified below and the
Royalties paid by DOR to SRI during such twelve month period. The
Minimum Royalties shall be one hundred twenty thousand dollars
($120,000) for the Year 2003 to be paid December 31, 2003.
Thereafter, the Minimum Royalties shall be increased by ten thousand
dollars ($10,000) in each successive twelve-month period until all
valid Oral Microsphere Technology Patents expire.
Section 3.3(iii) Years 2003 and beyond (plague vaccines)
As to plague and the exclusive rights to pulmonary and nasal
administration of microencapsulated plague Antigens, if the royalty
paid by DOR to SRI under Article 3.1 and the royalty portion of
Revenue in years 2003 and beyond by DOR to SRI under Article 3.2 after
commercialization of a Vaccine(s) by a Sublicensee(s) ("Royalty
Revenue") during each twelve month calendar period starting the Year
2003 shall be less than the minimum royalty amounts ("Minimum
Royalties) specified below, DOR agrees to pay SRI an amount equal to
the difference between the Minimum Royalties specified below and the
Royalties paid by DOR to SRI during such twelve month period. The
Minimum Royalties shall be one hundred twenty thousand dollars
($120,000) for the Year 2003 to be paid December 31, 2003.
Thereafter, the Minimum Royalties shall be increased by ten thousand
dollars ($10,000) in each successive twelve-month period until all
valid Oral Microsphere Technology Patents expire.
Section 3.3(ii) Years 2003 and beyond (anthrax vaccines)
As to anthrax and the non-exclusive rights to pulmonary and nasal
administration of microencapsulated anthrax Antigens, if the royalty
paid by DOR to SRI under Article 3.1 and the royalty portion of
Revenue in years 2003 and beyond by DOR to SRI under Article 3.2 after
commercialization of a Vaccine(s) by a Sublicensee(s) ("Royalty
Revenue") during each twelve month calendar period starting the Year
2003 shall be less than the minimum royalty amounts ("Minimum
Royalties) specified below, DOR agrees to pay SRI an amount equal to
the difference between the Minimum Royalties specified below and the
Royalties paid by DOR to SRI during such twelve month period. The
Minimum Royalties shall be sixty thousand dollars ($60,000) for the
Year 2003 to be paid December 31, 2003.
Thereafter, the Minimum Royalties shall be increased by ten thousand
dollars ($10,000) in each successive twelve-month period until all
valid Oral Microsphere Technology Patents expire.
5. New Section 3.13
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DOR shall immediately pay SRI an up front, non-refundable payment of
one hundred seventy five thousand dollars ($175,000) on the date of
execution of the letter of intent executed between SRI/UABRF and
DOR/DOR/Innovaccines on December 20, 2002, and one hundred seventy
five thousand dollars ($175,000) on the date of execution of this
Amendment Two to the License Agreement for the consent to assignment
of Elan's rights to DOR and for expansion of the Field.
6. Section 4.7 Manufacture and Supply of the Oral Microsphere Technology.
Section 4.7(i) is deleted and replaced with the following:
(i) At DOR's and/or sublicensees' cost and expense, SRI will have the
first right but not the obligation, to supply DOR and/or the
sublicensee(s) with the Oral Microsphere Technology manufactured
according to specifications under Good Manufacturing Practices
("GMP") as defined by FDA for both preclinical and/or clinical
testing ("Phase One, Two and Three"). However, nothing in this
Agreement shall obligate DOR and/or the sublicensee(s) to source
the Oral Microsphere Technology from SRI for preclinical and/or
clinical testing if the cost, quality, speedy and other factors
are not, in DOR and/or the sublicensee(s)' sole good faith
judgment, in the best interest of the Development Program, in
which case, DOR and/or the sublicensee(s) have the right to
source the Oral Microsphere Technology for preclinical and/or
clinical testing from persons other than SRI.
7. Section 4.12 Commercialization of At Least Two (2) Products under the
License Agreement.
DOR shall use its reasonable best efforts to commercialize at least
two (2) Products under the License Agreement within five (5) years
from the effective date of this Amendment Two to the License
Agreement.
8. Section 4.13 Scientific Advisory Agreement
(i) A Scientific Advisory Agreement shall be entered in with SRI for
three (3) years in which SRI shall provide to DOR an advisor to
assist DOR in its development of the Product as defined in this
License Agreement and/or other Products being developed by DOR.
DOR shall pay Fifty Thousand Dollars ($50,000) per annum payment
quarterly in advance said Scientific Advisory Agreement. Said
Scientific Advisory Agreement shall be defined by a mutual
agreement between the parties on a yearly basis. In particular,
the parties shall within thirty (30) days prior to the end of
year have an agreement as to the scope of said agreement.
(ii) DOR shall immediately issue to SRI and/or UABRF fully vested
options to acquire Two Hundred Thousand (200,000) Shares of DOR
common stock which is the parent corporation for DOR vested over
a ten (10) year period at an excess price of thirty-five cents
($.35) per share. The above options are based upon the continued
performance of SRI as it relates to the Scientific Agreement
referenced herein as well as the other obligations under this
License Agreement.
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9. Minimum Product, Process and Manufacturing Development
DOR shall provide SRI with a minimum of two hundred and fifty thousand
dollars ($250,000) of non-refundable sponsored research for the four
(4) calendar years ending 2003, 2004, 2005 and 2006. Said sponsored
research payment shall be made on or before March 1 of each year. The
Parties shall, within 30 days prior to March 1 of each year, determine
the objectives of the research program for each applicable year.
10. Termination:
The following language shall be added to Section 8.2(ii) of the
License Agreement:
DOR shall have the ability to termination any or all of the above
mentioned Field under Section 3.3(ii), 3.3 (iii) of this Amendment,
foreging any minimum royalty payments.
IN WITNESS WHEREOF, the parties have executed this Amendment Two to
the License Agreement by their duly authorized representatives for good and
valuable consideration.
SOUTHERN RESEARCH INSTITUTE THE UAB RESEARCH FOUNDATION
By________________________________ By_______________________________
Title ____________________________ Title ____________________________
Date _____________________________ Date _____________________________
DOR VACCINES, INC.
By________________________________
Title ____________________________
Date _____________________________
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