Exhibit 6.3
FIRST AMENDMENT TO
SUB-LICENSE AGREEMENT
BETWEEN
BIODELIVERY SCIENCES INTERNATIONAL, INC.
AND
BIORAL NUTRIENT DELIVERY, LLC
This First Amendment to Sub-License Agreement, effective as of April 1,
2003, is to the Sub-License Agreement (the "Sub-License Agreement") entered into
by and between BioDelivery Sciences International, Inc. ("BDSI") and Bioral
Nutrient Delivery, LLC (the "BND") (each, individually, a "Party" and
collectively, the "Parties") dated effective as of April 1, 2003. All
capitalized terms used but not defined in this amendment shall having the
meanings ascribed to such terms in the Sub-License Agreement.
The Parties, pursuant to Section 11.6 of the Sub-License Agreement,
hereby agree to amend the Sub-License Agreement as follows:
1. Amendment to Recitals. The recital clauses to the Sub-License
Agreement are hereby amended by deleting them in their entirety and replacing
them with the following:
"WHEREAS, BDSI has rights to certain Licensed Technology (hereinafter
defined) relating to cochleates, cochleate derivatives, geodes, and
proteoliposomes, and nano-encapsulation;
WHEREAS, BND recognizes that the Licensed Technology represents a
valuable means of delivering for the use and/or sale in the delivery of
Nutrients (hereinafter defined) in the personal care product and processed food
and beverage industries for both human and Animal (hereinafter defined)
consumption;
WHEREAS, BDSI has limited resources and currently wishes to focus on
developing its Licensed Technology in the pharmacological and medical
application fields;
WHEREAS, BND wishes to enter into an exclusive sublicense agreement
(with the right of BND to further sublicense as provided for herein) with BDSI
for all opportunities in the personal care product and processed food and
beverage industries for both human and Animal consumption which utilizes the
Licensed Technology and/or Licensed Patents in the Field (hereinafter defined)
from BDSI in order to seek opportunities to develop relationships with
Sublicensees (hereinafter defined) with the capability to research, develop and
commercialize Consumable Products (hereinafter defined) made in accordance
therewith; and
WHEREAS, BDSI is willing to grant such sublicenses to BND under the
terms and conditions set forth in this Agreement."
2. Amendment to Definition of "Consumable Products". Section 1.5 is
hereby amended by deleting it in its entirety and replacing it with the
following:
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"1.5 "Consumable Products" shall mean any cochleate, cochleate
derivative, geodate and/or proteoliposome combined with a Nutrient developed for
human or Animal use or consumption that is: (i) based upon, derived from,
identified through or related to any Licensed Technology; and (ii) covered by
one or more Licensed Patents and would infringe a Valid Claim thereof."
3. Amendment to Definition of "Field". Section 1.7 is hereby amended by
deleting it in its entirety and replacing it with the following:
"1.7 "Field" shall mean delivery of Consumable Products to all living
systems for personal care, processed food or beverage applications for both
human and Animal consumption. Consumable Products in personal care applications
include, for example, shampoos, conditioners, soaps, deodorants, hair dyes, hair
care products, body washes, wipes, shaving products, perfumes, cosmetics,
cleansers, toothpaste, and mouthwashes."
4. Amendment to Definition of "Licensed Technology". Section 1.10 is
hereby amended by deleting it in its entirety and replacing it with the
following:
"1.10 "Licensed Technology" shall mean any and all non-patented,
proprietary information, including, but not limited to, all patentable and
non-patentable inventions, improvements, discoveries, claims, formulae,
processes, methods, trade secrets, technologies, data and know-how owned,
licensed or controlled by BDSI or to which BDSI has the right to grant licenses
or sublicenses before or during the term of this Agreement related to the
cochleate, cochleate derivatives, proteoliposome, geode and nano-encochleation
technology described in Exhibit B hereto or derived from any Sponsored Research
Program (hereinafter defined)."
5. Amendment to Definition of "Nutirent". Section 1.12 is hereby
amended by deleting it in its entirety and replacing it with the following:
"1.12 "Nutrient" shall mean anything added to foodstuffs, beverages,
and personal care products, and thought to be health promoting or consumer
satisfying including vitamins, minerals, anti-oxidants, phytochemicals,
zoochemicals, GRAS-designated chemicals, fatty acids, and flavorings. Nutrients
however, does not include nutraceuticals, supplements, vitamin products, and
over-the-counter and prescription pharmaceuticals."
6. Amendment to Section 3.1. Section 3.1 is hereby amended by deleting
it in its entirety and replacing it with the following:
"3.1 Grant of License. Subject to the terms and conditions of this
Agreement, BDSI hereby grants to BND an exclusive license throughout the
Territory, with the right to grant sublicenses (subject to Sections 3.4 and
3.5), to make, use or sell Licensed Products in the Field. In addition, subject
to the terms and conditions of this Agreement, BDSI hereby grants to BND an
exclusive license throughout the Territory, with the right to grant sublicenses
(subject to Sections 3.4 and 3.5), to use BDSI's registered BIORAL trademark
and/or BDSI's GEODE, NANOGEODE and BIOGEODE trademarks in connection with the
creation of Consumable Products in the Field."
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7. Amendment to Section 3.3. Section 3.3 is hereby amended by deleting
it in its entirety and replacing it with the following:
"3.3 Primary Purpose; Consumable Product Approval; Trademark Approval.
It is understood and agreed that the primary purpose of this Agreement is to
enable BND to seek out and secure arrangements with Sublicensees who will, in
turn, sublicense the Licensed Technology from BND to create Consumable Products.
It is not intended that BND will itself develop, manufacture, produce,
distribute, market or sell any Consumable Products. However, in the event that
BND seeks to develop or sublicense a Consumable Product, prior to developing or
sublicensing such Consumable Product, BND will notify BDSI in writing regarding
the identity of such Consumable Product and BND's intent to develop or
sublicense the same ("Product Development Notification"). BDSI shall notify BND
in writing of its consent to BND's request to develop a Consumable Product
within sixty (60) days of receipt of a Product Development Notification. In the
event that BDSI fails to provide a written response to BND within such 60-day
period, then BDSI shall be deemed to have consented to BND's request to develop
a Consumable Product. BND agrees that such consent may be granted or withheld in
BDSI's sole discretion. In addition, from time to time at the request of BDSI,
BND and any Sublicensees will provide to BDSI specimens of use of BDSI's
trademarks, and BDSI shall have the right to make reasonable modification or
similar requests related to use of such trademark."
8. Amendment to Section 6.3. Section 6.3 is hereby amended by deleting
it in its entirety and replacing it with the following:
"6.3 Notification of Infringement. If either Party learns of an
infringement or threatened infringement by a Third Party of any Licensed Patent
granted hereunder within the Territory, such Party shall promptly notify the
other Party and shall provide such other Party with available evidence of such
infringement. Section 6.4 shall then be applicable."
9. No Further Amendment. Except as amended hereby, the Sub-License
Agreement shall remain unchanged and in full force and effect.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to
Sub-License Agreement to be executed by their duly authorized representatives.
BIODELIVERY SCIENCES INTERNATIONAL, INC.
/s/ ▇▇▇▇▇▇▇ ▇. ▇'▇▇▇▇▇▇▇, ▇▇.
By: __________________________________
Name: ▇▇▇▇▇▇▇ ▇. ▇'▇▇▇▇▇▇▇, ▇▇., M.D.
Title: President and CEO
BIORAL NUTRIENT DELIVERY, LLC
/s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
By: __________________________________
Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
Title: Secretary, Treasurer and CFO
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