LICENSE AGREEMENT
Exhibit
10.1
THIS LICENSE AGREEMENT (“Agreement”) is made effective as of the ___day of September, 2006, by
and between Argyll Biotechnologies, LLC, a closely-held Delaware limited liability company having a
principal office at 0000 Xxxxxxxxx Xxxxxx, Xxxxx 000, Xx Xxxxx, Xxxxxxxxxx, 00000 (“Argyll
Biotech”) and Immunosyn Corporation, a Delaware corporation having a principal office at 0000
Xxxxxxxxx Xxxxxx, Xxxxx 000, Xx Xxxxx, Xxxxxxxxxx 00000 (“Immunosyn”).
In consideration of mutual promises, covenants and representations contained in this
Agreement, the Argyll Biotech and Immunosyn hereby agree as follows:
1. BACKGROUND.
1.1. Argyll Biotech and its predecessors, partners, research and development agents and
consultants (collectively the “Argyll Team”) have identified and are investigating a novel
biopharmaceutical product for the treatment of disease pathologies that adversely affect the human
immune system, either by suppressing the activity of the immune system or by causing the immune
system to aggressively overreact to viral invasive agents. All right, title and interest in and to
that product, including, without limitation, all intellectual property and other intangible rights
in that product are owned by Argyll Biotech.
1.2. Argyll Biotech has assumed the organization, management and administration of the
continued development and refinement of that product, including all financial commitments and
requirements associated with that development and refinement of that product, which is currently
referred to as “SF-1019”. Based on preliminary experiments, the Argyll Team believes that SF-1019
may be an effective treatment product for a plurality of viral and immune system pathologies,
including conditions related to Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”) and
diabetes myelitis, and human immunodeficiency virus. Argyll Biotech intends to develop and procure
regulatory and other approval for the marketing, sale and distribution of a commercial form of
SF-1019.
1.3. Immunosyn was organized and capitalized for the purpose of marketing, distributing and
selling the SF-1019 product and other novel bio-pharmaceutical products throughout the world.
Following its formation and capitalization, Immunosyn has committed to raising a substantial amount
of capital that will be used, in part, to procure licenses for such products and to finance a
marketing and distribution network for those products.
1.4. Argyll Biotech now desires to license to Immunosyn, and Immunosyn now desires to procure
a license from Argyll Biotech, for the marketing, sale and distribution of the SF-1019 product
solely for the treatment of CIPD, diabetic neuropathy and diabetic ulcers pursuant to the terms,
conditions, and limitations described in this Agreement.
2. GRANT OF RIGHTS.
2.1. Subject to the terms and conditions of this Agreement, Argyll Biotech hereby grants to
Immunosyn an exclusive license to market, distribute, sell and promote the SF-1019 product
throughout the world solely for the treatment of CIPD, diabetic neuropathy and diabetic ulcers (the
“Licensed Use”).
2.2. Argyll Biotech shall not grant any rights or licenses to the SF-1019 product, or any
compounds chemically similar to SF-1019, for the Licensed Use to any third party, including,
without limitation, subsidiaries and affiliates of Argyll Biotech.
2.3. (a) Argyll Biotech further grants Immunosyn the non-exclusive, worldwide right to use
any trademarks, service marks, logo, and other source-identifying indicia (the “Trademarks”) that
Argyll Biotech may create for the SF-1019 product, for use in Immunosyn’s Licensed Use. In
connection with such Trademark use, Immunosyn shall permit duly authorized representatives of
Argyll Biotech to inspect, on the premises of Immunosyn, at all reasonable times, the products sold
by Immunosyn under the Trademarks, Immunosyn’s quality control records, and Immunosyn’s facilities
used in or relating to the marketing, distribution or sale of the SF-1019 product to insure
compliance with current Good Manufacturing Practice as defined in Parts 210 and 211 of Title 21 of
the U.S. Code of Federal Regulations, as may be amended from time to time, or any successor
thereto.
(b) Whenever Immunosyn uses the Trademarks Immunosyn shall clearly indicate Argyll Biotech’s
ownership of the Trademarks. At least ten business days prior to any new use of the Trademarks,
Immunosyn shall provide Argyll Biotech with samples of all proposed literature and advertising
using the Trademarks for approval by Argyll Biotech. If no objection is received from Argyll
Biotech within five business days of receipt of such samples, Immunosyn may use the Trademarks in
the manner used in the samples submitted for approval.
(c) If necessary in any country to permit Immunosyn to use the Trademarks, Argyll Biotech
shall make application to register Immunosyn as a permitted user or registered user of the
Trademarks and, if necessary, or if requested by Argyll Biotech, Immunosyn undertakes to join in
such application and to take such action as may be necessary or requested by Argyll Biotech to
implement such application or retain, enforce or defend the Trademarks. If necessary in any country
to maintain Argyll Biotech’s rights in the Trademarks, Immunosyn shall enter into a registered user
agreement or permitted user agreement regulating its use of the Trademarks.
(d) Immunosyn acknowledges that Argyll Biotech is the owner of the Trademarks. Immunosyn shall
not at any time do, cause to be done, or permit any act or thing inconsistent with, contesting or
in any way impairing or tending to impair such ownership. Immunosyn agrees that all use of the
Trademarks by Immunosyn shall inure
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to the benefit of and be on behalf of Argyll Biotech. Immunosyn acknowledges that nothing in this
Agreement shall give Immunosyn any right, title or interest in the Trademarks other than the right
to use the Trademarks in accordance with this Agreement. Immunosyn agrees that it will not
challenge the title or ownership of Argyll Biotech to the Trademarks or attack or contest the
validity of the Trademarks.
(e) Argyll Biotech, in consultation with Immunosyn, shall register and maintain the
Trademarks, or cause the Trademarks to be registered and maintained, in those countries in which
such Trademarks shall be used, at Argyll Biotech’s sole expense. If either party learns of any
actual, alleged or threatened unauthorized use or other infringement of the Trademarks by others in
any country, that party agrees to promptly notify the other party of such unauthorized use or other
infringement. Argyll Biotech shall use reasonable efforts, in its discretion, to retain, enforce or
defend the Trademarks.
(f) To the extent permitted by law, all labeling, packaging, literature, promotional material
and advertising for the SF-1019 product that is marketed, distributed or sold by Immunosyn in any
country shall contain Argyll Biotech’s name and logo with comparable prominence as the name and
logo used by Immunosyn. To the extent practicable, or as required by applicable law to protect the
Trademarks, Immunosyn shall include on any material bearing any Trademarks an acknowledgement that
such Trademark is the property of the Argyll Biotech.
2.4. Immunosyn shall have, and Argyll Biotech hereby grants to Immunosyn, a right of first
offer to enter into additional license agreements or other arrangement with Argyll Biotech for
applications of the SF-1019 product for treatments not included in the Licensed Use, as follows:
(a) In the event that Argyll Biotech is interested in seeking any third party license or
arrangement with respect to treatments other than the Licensed Use, Argyll Biotech shall give
written notice thereof to Immunosyn, together with any and all materials and relevant information
and data regarding such prospective license or arrangement that Argyll Biotech has in its
possession or control. Immunosyn shall have thirty (30) days after receipt of such written notice
and all such information and data to decide whether or not it is interested in entering into
negotiations for such a license or other arrangement with Argyll Biotech for such other uses.
(b) If Immunosyn notifies Argyll Biotech in writing within such 30-day period that it is
interested in negotiating such a license or arrangement, Argyll Biotech shall provide Immunosyn
with written notice of its proposed material terms and conditions of such arrangement (“Proposed
Terms”). The Proposed Terms shall include all material
terms and conditions of such arrangement, including, without limitation, the scope of the proposed
arrangement, the financial terms and any technology or compound quid pro quo expected or sought by
Argyll Biotech. Immunosyn and Argyll Biotech shall promptly commence good faith negotiations
(including a review of all relevant data and
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information of clinical significance relating to such other uses for a period of up to ninety (90)
days after Immunosyn receives such Proposed Terms from Argyll Biotech, in an effort to reach
mutually acceptable material terms and conditions for such arrangement, which material terms and
conditions shall be set forth in a written letter of intent (“Letter of Intent”). During such
90-day period, Argyll Biotech shall not negotiate with any third party a potential license or
arrangement with respect to such other uses.
(c) If, despite each of Immunosyn’s and Argyll Biotech’s good faith efforts, Argyll Biotech
and Immunosyn are not able to agree on such material terms and conditions and do not execute a
Letter of Intent by the end of such 90-day period, then Argyll Biotech may enter into negotiations
with any third party regarding the other uses, provided, however, that the terms and conditions of
any agreement with that third party shall be no more favorable, in the aggregate, to such third
party than the most favorable terms proposed or offered by Argyll Biotech to Immunosyn.
2.5. At any time during the first five (5) years after execution of this Agreement (the
“Option Period”), Immunosyn shall have, and Argyll Biotech hereby grants to Immunosyn, a right of
first negotiation to enter into an arrangement with Argyll Biotech (including, without limitation,
any co-development, co-promotion, research and development, commercialization or intellectual
property license agreement, joint venture, partnership, or other partnering relationship) for the
licensing of any intellectual property or know-how owned by Argyll Biotech, or to which Argyll
Biotech has an exclusive license, involving compounds or products not directly relating to the
SF-1019 product (“License Relationship”).
(a) In the event that Argyll Biotech is interested in establishing such a License Relationship
with a third party during the Option Period, Argyll Biotech shall give written notice thereof to
Immunosyn, together with any and all materials and relevant information and data regarding the
subject matter of such proposed License Relationship that Argyll Biotech has in its possession or
control.
(b) With respect to each such License Relationship, Immunosyn shall have ninety (90) days
after receipt of such written notice and all such information and data to enter into a non-binding
letter of intent with Argyll Biotech containing the proposed material terms of an agreement
regarding such License Relationship. During such 90-day time period, Argyll Biotech shall not
negotiate such a License Relationship with any third party. In the event that Immunosyn and Argyll
Biotech do not enter into a non-binding letter of intent as aforesaid, Argyll Biotech shall be free
to proceed to negotiate with third parties as it deems appropriate without any further obligation
to Immunosyn.
2.6. In order to facilitate the marketing, sale and distribution rights licensed to Immunosyn
under this Agreement Argyll Biotech shall grant to Immunosyn full and unrestricted access to Argyll
Biotech’s research and development files and activities, including without limitation medicinal
chemistry, screening, clinical trial protocols and
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results, and other similar materials, all at such times and under such conditions as the parties
may agree to avoid disruption and interference with the orderly operation of Argyll Biotech’s
research and development.
2.7. All rights not expressly granted in this Agreement are reserved by Argyll Biotech, and
no implied licenses shall be deemed granted to Immunosyn by contract or by law. Without limitation
on the foregoing, Argyll Biotech reserves all rights to make SF-1019 or have SF-1019 made on its
behalf.
3. DEVELOPMENT AND REGULATORY MATTERS
3.1. (a) The Parties acknowledge that the Argyll Team is in the process of preparing to
submit an initial regulatory registration application for use of the SF-1019 product with respect
to the Licensed Use with one or more regulatory bodies, such as the United States Food and Drug
Administration or one or more foreign regulatory bodies (the “Initial Regulatory Filing”). Until
the Initial Regulatory Filing is made and continuing indefinitely thereafter, Argyll Biotech shall
be solely responsible for conducting clinical studies and all other regulatory matters,
manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the
Initial Regulatory Filing, and Argyll Biotech shall use all commercially reasonable efforts
necessary to make such Initial Regulatory Filing. Argyll Biotech shall keep Immunosyn informed as
to the status of such efforts, shall permit Immunosyn to review and comment on the Initial
Regulatory Filing and each subsequent regulatory filing during each filing’s preparation, and shall
consult with Immunosyn regarding the preparation of the Initial Regulatory Filing and each
subsequent filing.
(b) Promptly after the execution date of this Agreement, Argyll Biotech shall deliver to
Immunosyn copies of relevant and material data, studies and other written materials in Argyll
Biotech’s possession as of the execution date of this Agreement relating to the SF-1019 product and
its predecessors and cognates, including without limitation any such materials relating to patents
and know-how.
(c) During the term of this Agreement: (i) each party shall provide to the other parties any
material data or other information relating to the SF-1019 product and its predecessors and
cognates, including without limitation any such information relating to patents and know-how, from
time to time as such data and information is developed or acquired by such party; and (ii) each of
the parties shall deliver to the other party all data and dossiers relating to the SF-1019 product
and its predecessors and cognates or any product and results from any studies being conducted by or
on behalf of either of such
parties in connection therewith promptly after such data and/or dossiers become available.
(d) All such data and information exchanged or required to be exchanged by the Parties
pursuant to this Section 3.1 shall be owned by Argyll Biotech, whether in Argyll Biotech’s
possession or control as of the execution date of this Agreement or developed
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by any party during the term of this Agreement. Argyll Biotech hereby grants Immunosyn the right
to use all such data and information Immunosyn in accordance with its obligations and license
rights under this Agreement.
3.2. Argyll Biotech shall own all regulatory approvals that may result from the Initial
Regulatory Filing or subsequent filings in any country or territory in which such filings are made
(each a “Registration”), including, without limitation, Registrations granting pricing and
reimbursement approvals for any country or territory as the same may be granted or issued by the
appropriate regulatory body for such country or territory.
3.3. (a) Within one hundred eighty (180) days after the execution date of this Agreement,
Argyll Biotech shall prepare and submit to Immunosyn, a clinical budget containing the budget for
the conduct of proposed clinical development plans for the development of the SF-1019 product for
calendar years 2007 through and including 2009, on a calendar year-by-calendar year basis (such
budgets, as modified from time to time, are referred to as “Clinical Budgets”);
(b) Also within one hundred eighty (180) days after the execution date of this Agreement,
Argyll Biotech shall prepare and submit to Immunosyn a clinical development plan for calendar years
2007 through 2009 describing Argyll Biotech’s proposed program for obtaining regulatory approval
for the Licensed Use of SF-1019. Such clinical development plan shall include: (i) a plan for the
rapid and orderly commencement of those clinical and other studies ongoing with respect to the
SF-1019 product; (ii) the allocation of regulatory strategy and responsibility for continued
development of the SF-1019 Product; (iii) the research and development activities of any or all
members of the Argyll Team for the development of the SF-1019 Product for calendar years 2007
through 2009, including the allocation of resources among the Team Members, which shall be
consistent with the proposed clinical budget for such period; (iv) “go/no go” decision criteria for
each stage of development of the SF-1019 product; (v) timelines for scientific, medical, regulatory
and other activities to be undertaken by the Argyll Team for the purpose of obtaining Registrations
for the SF-1019 product in each country in which that Product will be marketed, distributed and
sold for the Licensed Use, providing marketing support and developing new indications and
formulations for the SF-1019 product. Every clinical development plan for the relevant period shall
include clinical studies required for approval of new indications.
(c) Argyll Biotech will be primarily responsible for implementing the regulatory strategy for
the SF-1019 product in all countries in which that product will be marketed, sold and distributed
for the Licensed Use, including, without limitation, responsibility for
all regulatory compliance, worldwide safety surveillance, adverse event reporting and all other
necessary support services.
(d) The license fees payable by Immunosyn (as described below) shall provide sufficient funds
or marketable securities to complete the execution of the clinical
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development plans provided they are developed in accordance with this Section 3.3 (even if such
funding is in excess of the clinical budget). Any change to any clinical development plan after the
development thereof in accordance with this Section 3.3 must be approved by each party to this
Agreement, provided that any such change that (i) alters the number of patients being studied under
the clinical development plan or the type and/or phase of such studies, or (ii) increases the
amount of funding necessary to complete a clinical development plan as a result of any change to
(A) the timing of entry of such patients into studies under such clinical development plan, or (B)
the procedures to be conducted in such studies, in each such case shall relieve Immunosyn of the
funding obligation set forth in the immediately preceding sentence with regard to such revised
clinical development plan only to the extent that such revised clinical development plan requires
funding which exceeds the clinical budget by more than fifteen per cent (15%), unless such increase
is necessary to accommodate Immunosyn’s specific requests for expanding the scope of Argyll
Biotech’s clinical development plan.
3.4. (a) Argyll Biotech shall be responsible for the preparation of all protocols and the
conduct of all activities relating to any Registrations and all Initial and other Regulatory
Filings necessary or desirable to register the SF-1019 product for the Licensed Uses in all
countries. Argyll Biotech shall also conduct all communications with all Regulatory Authorities
during the registration process. During such process, Immunosyn shall collaborate and cooperate
with Argyll Biotech in the preparation and filing of all documents necessary therefore and all
regulatory interactions and compliance with Regulatory Authorities in any country. All regulatory
activities (including without limitation adverse event reporting) in accordance with this Agreement
and the clinical development plans shall be conducted on behalf of Argyll Biotech. Argyll Biotech
shall appoint Immunosyn as its agent for regulatory compliance and all other regulatory activities
for which Immunosyn is responsible.
(b) Argyll Biotech shall cause the Argyll Team to supply all SF-1019 product necessary and/or
desirable for all studies to be conducted pursuant to the clinical development plans. Such SF-1019
product shall be supplied in accordance with, in all material respects, clinical good manufacturing
practices (“cGMP”), at least ninety (90) days prior to the anticipated delivery date for each
shipment thereof.
(c) In connection with performing its obligations pursuant to the clinical development
plans, each of Immunosyn and Argyll Biotech shall use all commercially reasonable efforts to
perform such responsibilities diligently, with the objective of maximizing the sales potential of
the SF-1019 product for the Licensed Use and promoting the therapeutic profile and benefits of the
SF-1019 product for that use in the
most commercially beneficial manner. Without limiting the generality of the foregoing, each such
Party shall:
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(i) cooperate with the other Party to implement the clinical development plans, and such other
activities that, from time to time, Argyll Biotech decides are necessary for the commercial success
of the SF-1019 product;
(ii) use commercially reasonable efforts to perform the work set out for such party to perform
in the clinical development plans;
(iii) conduct all work pursuant to the clinical development plans in good scientific manner,
and in compliance in all material respects with all requirements of applicable laws, rules and
regulations, and all other requirements of any applicable cGMP, good laboratory practice and
current good clinical practice to attempt to achieve the objectives of the clinical development
plans efficiently and expeditiously; and
(iv) maintain records, in sufficient detail and in good scientific manner, which shall be
complete and accurate and shall fully and properly reflect all work done and results achieved in
connection with the clinical development plans in the form required under all applicable laws and
regulations. The other such party shall have the right, during normal business hours and upon
reasonable prior written notice, to inspect and copy all such records at its own expense, so long
as doing so is not unreasonably disruptive. The other such party shall maintain such records and
information contained therein in confidence in accordance with this Agreement and any
confidentiality agreements that may be effective as between the parties hereto, and shall not use
such records or information except to the extent otherwise permitted by this Agreement.
3.5. Argyll Biotech shall be responsible for the one hundred per cent of the development
costs related to the SF-1019 product for the Licensed Use and all other uses, and no additional
fees other than the License Fee (described herein) shall be due and owing from Immunosyn in respect
of such costs.
3.6. In the event that registration of an Initial Regulatory Filing is denied or is
materially delayed by the relevant regulatory authority, then Argyll Biotech shall (a) immediately
reassess the relevant clinical development plan to address the regulatory authority’s objections
and questions, (b) immediately give Immunosyn notice of such developments, (c) from time to time as
additional such developments arise, promptly give Immunosyn notice of such additional developments,
and (d) keep Immunosyn reasonably informed of all deliberations regarding all such developments.
As used in this Section 3.6, a material delay is a delay arising from a requirement set forth by
the regulatory authority that Argyll Biotech conduct additional clinical studies not conducted in
connection with the submission of the Initial Regulatory Filing. In the event of a material delay,
Argyll Biotech shall apply its sound scientific, commercial and regulatory
judgment with all deliberate speed to determine whether or not it is in the best interest of
both of Immunosyn and Argyll Biotech to go forward with the conduct of any additional clinical
studies required by the regulatory authority. Upon reaching such determination,
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Argyll Biotech shall redirect (without increasing) the existing overall clinical budget as
necessary to undertake such studies and to cause such studies to be undertaken.
3.7. Argyll Biotech shall have the right to immediately suspend the relevant clinical
development activities with respect to the SF-1019 product for the Licensed Use or for any other
particular indication, formulation or dosage form in the event that Argyll Biotech, in good faith,
determines that there exists significant and urgent concerns relating to patient safety with
respect to such clinical studies. Upon making the determination to suspend such clinical
activities, Argyll Biotech shall notify Immunosyn in writing immediately of any such suspension and
the reasons therefore. Argyll Biotech shall then promptly determine what actions should be taken
with respect to such clinical activities. Once a determination is made with respect to the
appropriate actions to be taken, Argyll Biotech shall review and re-evaluate the relevant clinical
development plan and the clinical budget and make any changes necessary to implement such actions.
3.8. Each party shall be responsible for, and hereby assumes, any and all risks of personal
injury or property damage attributable to the negligent or willful acts or omissions of such party
or its affiliates, including their respective directors, officers, employees and agents and for the
activities and obligations of such party pursuant to this Section 3.
4. DISTRIBUTION AND PROMOTION.
4.1. Immunosyn shall use all commercially reasonable efforts to launch, promote and sell the
SF-1019 product for the Licensed Use in each country in which regulatory approval for such Licensed
Use is obtained and to perform such responsibilities diligently, with the objective of maximizing
the sales potential of the SF-1019 product and promoting its therapeutic profile and benefits in
the most commercially beneficial manner.
4.2. (a) Except as provided in Section 4.4 and subject to the overall direction and control
of Argyll Biotech, Immunosyn and its wholly owned subsidiaries shall be responsible for, and shall
have the rights granted under Section 2.1.
(b) In connection with its responsibilities for distribution, marketing and sales of the
SF-1019 product for the Licensed Use, Immunosyn shall provide all sales force (including, without
limitation, sales administration and training), order entry, customer service, reimbursement
management, medical affairs, medical information, marketing (including all advertising and
promotional expenditures), warehousing, physical
distribution, invoicing, credit and collections, production forecasting and other related
facilities and services necessary or desirable for such distribution, marketing and sales.
4.3. Immunosyn shall prepare proposed-marketing and promotional plans for the SF-1019 product
for each country in which that product may be marketed and sold for the
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Licensed Use, which shall include plans related to the prelaunch, launch, promotion and sales of
the product and which shall include but not be limited to pricing strategy, sales targets,
forecasts for the number of sales representatives, copies of promotional materials, and a
reasonably descriptive overview of the marketing and advertising campaigns proposed to be conducted
(the “Marketing Plans”). Immunosyn shall provide copies of the proposed Marketing Plans to Argyll
Biotech for Argyll Biotech’s review and comment as soon as practicable after preparation and as
frequently as may be required based upon Immunosyn’s usual marketing campaign cycles, but in no
case less that once each calendar year. Immunosyn shall in good faith give due consideration to
comments received from Argyll Biotech on any such Marketing Plan, and will provide Argyll Biotech
with a copy of the final Marketing Plan as soon as it is available. The Parties intend and expect
that, except for the first Marketing Plan to be prepared after execution of this Agreement, each
subsequent Marketing Plan for each calendar year will be finalized no later than the first day of
December of the immediately preceding calendar year. Any such final Marketing Plan may be reviewed
and revised in accordance with Immunosyn’s usual internal practices, provided that Argyll Biotech
shall be provided copies of the proposed revisions, and given the same opportunity to comment and
consideration as provided to Argyll Biotech for the initial Marketing Plans.
4.4. Argyll Biotech shall be entitled to participate in the planning of promotional materials
and promotional activities with respect to the SF-1019 product for the Licensed Use. All
promotional materials and promotional activities shall be developed by Immunosyn, with input from
Argyll. Such activities may include symposia, key opinion leader events, and similar such events.
Prior to finalizing such promotional materials and promotional activities, Immunosyn shall include
Argyll Biotech in its internal circulation of information regarding such promotional materials and
events during the development of such promotional materials and any event related materials and
upon the finalization of such materials.
4.5. Argyll Biotech shall have the right, at its election and at its sole expense, to promote
the SF-1019 product for the Licensed Use and any other use in any country in which regulatory
approval for such promotion has been obtained (the “Co-Promotion Option”).
(a) In the event that Argyll Biotech exercises its Co-Promotion Option, Argyll Biotech shall
be entitled, at its sole expense, to have its sales force and medical liaison personnel participate
in the promotion of the SF-1019 product. Argyll Biotech shall give Immunosyn written notice of such
exercise at least six months prior to the date Argyll Biotech intends to begin its co-promotion
activities.
(b) Argyll Biotech will be included in, and be allowed to participate in, all promotional
activities being conducted by Immunosyn pursuant to the then current Marketing Plan, including
participation in symposia, key opinion leader events, and the like. Immunosyn shall provide Argyll
Biotech’s sales force with all promotional materials
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License Agreement September, 2006
Argyll Biotechnologies LLC
Immunosyn Corporation
Argyll Biotechnologies LLC
Immunosyn Corporation
and support services to the same extent available to Immunosyn’s sales force. Argyll Biotech shall
reimburse Immunosyn for Immunosyn’s incremental costs and expenses associated with providing such
materials and services to Argyll Biotech’s sales force.
(c) Should Argyll Biotech exercise its Co-Promotion Option, it is nonetheless understood that
Immunosyn will retain the exclusive rights to market, sell and distribute the SF-1019 product for
the Licensed Use throughout the world, so that the Argyll Biotech’s right and obligation to promote
would be in the nature of a co-promotion arrangement in which Argyll Biotech promotes such
Products, but sales continue to be made by Immunosyn.
(d) In the event that Immunosyn reasonably believes that Argyll Biotech has (i) materially
failed to competently co-promote the SFG-1019 product, (ii) materially failed to promote the
product consistent with the direction provided by the then-current marketing plan, or (iii)
experienced a pattern of violating any applicable laws, and/or applicable regulations in connection
with its promotion of the product, where there is a reasonable chance of reoccurrence of one or
more of the violations comprising such pattern, (each a “Co-Promotion Problem”), then Immunosyn
shall provide Argyll Biotech with written notice of such claim including specification of the
respects in which Immunosyn believes such a Co-Promotion Problem has occurred with reasonable
particularity. Thereafter all of Argyll Biotech’s rights to co-promote the product under this
Section 4.5 shall be suspended for a period of time which shall last for a minimum of three months
but shall not exceed six months.
4.6. From and after the execution date of this Agreement, each of Argyll Biotech and
Immunosyn shall be responsible for its own distribution costs, sales costs, marketing costs,
general and administrative costs, and/or other operating income/expense items.
5. LICENSE FEES
5.1. As consideration to Argyll Biotech for the rights granted to Immunosyn under this
Agreement, Immunosyn shall issue to Argyll Biotech one hundred forty seven million (147,000,000)
shares of common stock in Immunosyn, as described in the Private Placement Memorandum dated August
2006 (the “License Fee”);
5.2. If and to the extent that the proceeds received by Argyll Biotech from the disposition
of Immunosyn’s stock issued under Section 5.1, herein, net of all fees, taxes and expenses, are
insufficient to fund Argyll Biotech’s clinical budget for obtaining regulatory approval for sale of
SF-1019 in the United States and the United Kingdom
(“Development Completion”), Immunosyn shall pay a royalty to Argyll Biotech equal to three and
one-half per cent (3 1/2%) of its gross receipts (the “Royalty Fee”) from sales of the SF-1019
product for the Licensed Use until Argyll Biotech’s said development costs have been reimbursed in
full.
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License Agreement September, 2006
Argyll Biotechnologies LLC
Immunosyn Corporation
Argyll Biotechnologies LLC
Immunosyn Corporation
5.3. All payments to Argyll Biotech shall be final and non-refundable, regardless of any
termination or suspension or this Agreement.
6. PAYMENTS AND REPORTS.
6.1. Commencing with Immunosyn’s first commercial sale of SF-1019 (“First Commercial Sale”)
and continuing until Development Completion, Immunosyn shall submit to Argyll Biotech monthly
statements which shall set forth the amount of its gross sales of the SF-1019 product and the
calculation of Royalty Fees due on such gross sales for such month (the “Royalty Reports”).
6.2. Immunosyn shall submit its Royalty Reports on the fifth business day following the close
of such month (closed in accordance with Immunosyn’s then standard practices) with sufficient
detail to enable Argyll Biotech to determine the facts relied upon by Immunosyn in calculating the
Royalty Fee.
6.3. Immunosyn shall make all payments required under this Agreement as directed by Argyll
Biotech from time to time in U.S. Dollars. Whenever conversion of payments from any foreign
currency shall be required, such conversion shall be at the rate of exchange used by Immunosyn for
its own financial reporting purposes at such time without taking into account the effect of any
hedging transactions by Immunosyn or its Affiliates.
6.4. Immunosyn, Argyll Biotech and each such party’s respective affiliates shall keep
complete and accurate records pertaining to the sale of SF-1019 product. Argyll Biotech or
Immunosyn (the “Audited Party”) shall permit an independent, certified public accountant appointed
by the other party (the “Auditing Party”) and reasonably acceptable to the Audited Party, at
reasonable times and upon reasonable notice but not more often than two times each calendar year,
to examine such records as may be necessary to determine the correctness of any report or payment
made under this Agreement, including statements by Argyll Biotech concerning the amount owed, if
any, for Development Completion, to determine the consistency of actual expenditures versus the
budgeted expenditures set forth in any clinical budget and/or any marketing budget, as the case may
be, or obtain information as to the determination of aggregate net sales, operating profit or loss,
development costs, distribution costs, sales costs, marketing costs, general and administrative
costs and other operating income/expense. Results of any such examination shall be made available
to all parties except that said independent, certified public accountant shall verify to the
Auditing Party such amounts and shall disclose no other information revealed in such audit.
6.5. The Auditing Party shall bear the full cost of the performance of any audit requested by
the Auditing Party except as hereinafter set forth. If, as a result of any inspection of the books
and records of the Audited Party, it is shown that payments made by Immunosyn to Argyll Biotech
under this Agreement were less than the amount which
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should have been paid, then Immunosyn shall make all payments required to be made to eliminate any
discrepancy revealed by said inspection within 30 days after Argyll Biotech’s demand therefore.
Furthermore, if the payments made were less than 95% of the amount that should have been paid
during the period in question, Immunosyn shall also reimburse Argyll Biotech for the reasonable
costs of such audit. Similarly, if an audit reveals that Argyll Biotech overstated the amount owed
for Development Completion by more than 5%, then Argyll Biotech shall reimburse Immunosyn for the
reasonable costs of such audit.
7. MANUFACTURE AND SUPPLY.
7.1. Commencing on the execution date of this Agreement and thereafter during the term of
this Agreement, Argyll Biotech (or its affiliates) shall be responsible for the manufacture of all
requirements of SF-1019 for clinical and commercial use pursuant to this Agreement, including,
without limitation, all product labeling and other package inserts and materials required by the
applicable Regulatory Authorities. Argyll Biotech shall use commercially reasonable efforts to
ensure that all services, facilities and goods used in connection with such manufacture comply with
the applicable Manufacturing Standards in effect from time to time.
7.2. Argyll Biotech shall supply Immunosyn with all of Immunosyn’s requirements for SF-1019
for commercial use (which shall be deemed to include all of the requirements of Immunosyn’s
distributors), and Immunosyn shall purchase from Argyll Biotech all of such requirements for
SF-1019. Immunosyn shall place orders for the requirements of its distributors, and either have
Argyll Biotech ship directly to such distributors or to Immunosyn for its reshipment to such
distributors.
7.3. The purchase price for all SF-1019 product supplied by Argyll Biotech to Immunosyn
pursuant to this Section 7 for commercial use shall be determined by Argyll Biotech in its
reasonable discretion to include its fully burdened manufacturing cost, research and development
expense, administrative overhead and standard xxxx-up customary for similar products and
manufacturers within Argyll Biotech’s industry, xxxx-up which shall be agreed to by both parties.
In the event the parties fail to reach agreement on Argyll Biotech’s xxxx-up, after direct
in-person negotiations between the parties’ chief executive officers, a determination of the
appropriate “standard xxxx-up” will be referred to arbitration in accordance with this agreement.
7.4. (a) All quantities of the SF-1019 product supplied by Argyll Biotech pursuant to this
Section 7 will comply in all material respects with the specifications agreed upon by the parties
and all applicable Manufacturing Standards and shall adhere in all material
respects to all applicable governmental laws and regulations relating to the manufacture, sale
and shipment of each shipment of the SF-1019 product at the time it is shipped by Argyll Biotech
hereunder.
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(b) Argyll Biotech shall conduct, or cause to be conducted, quality control testing of SF-1019
prior to shipment, in accordance with the agreed-upon specifications and applicable Manufacturing
Standards as are in effect from time to time and such other quality control testing procedures
adopted by Argyll Biotech from time-to-time (collectively, the “Testing Methods”). Initially and
until decided otherwise, the Testing Methods shall include and Argyll Biotech shall undertake all
FDA required release testing. Argyll Biotech shall retain records pertaining to such testing. Each
shipment of SF-1019 hereunder shall be accompanied by a certified quality control protocol and
certificate of analysis for each lot of SF-1019 therein as well as such customs and other
documentation as is necessary or appropriate.
(c) Immunosyn shall have the right, at reasonable times and upon reasonable notice, to
inspect all facilities at which SF-1019 is manufactured pursuant to this Section 7 for compliance
with cGMP, subject to existing agreements with third party manufacturers.
7.5. (a) Immunosyn may test or cause to be tested SF-1019 supplied under this Section 7 in
accordance with Immunosyn’s customary procedures within 30 days of its receipt at Immunosyn’s
facility or that its designee. Immunosyn or its designee shall have the right to reject any
shipment of SF-1019 made to it under this Agreement that does not meet the agreed-upon
specifications and applicable Manufacturing Standards in any material respects when received by it
at such destination when tested in accordance with the Testing Methods. All claims by Immunosyn of
non-conforming SF-1019 shall be deemed waived unless made by Immunosyn in writing and received by
Argyll Biotech within such 30-day period.
(b) All claims of non-conforming SF-1019 shall be accompanied by a report of analysis
(including a sample of the SF-1019 from the batch analyzed) of the allegedly non-conforming SF-1019
that shall have been made by Immunosyn or its designee, using the Testing Methods. Argyll Biotech
shall promptly undertake its own analysis of such sample after receiving such claim and report from
Immunosyn. If, after its own analysis, Argyll Biotech does not confirm such non-conformity, it
shall submit the disputed SF-1019 to an independent testing laboratory, to be agreed upon by
Immunosyn, for testing in accordance with the Testing Methods. The findings of such laboratory
shall be binding on the Parties, absent manifest error. Expenses of such independent testing shall
be borne by either Immunosyn or Argyll Biotech depending on which such Party initial findings are
contradicted by the independent laboratory. In the event that any SF-1019 shipment or batch thereof
is ultimately agreed or found not to meet the agreed upon specifications and/or applicable
Manufacturing Standards, Argyll Biotech agrees to replace such shipment or batch with conforming
SF-1019 and pay for all reasonable out-of-pocket
expenses incurred by Immunosyn and Argyll Biotech in connection with shipping and/or storing such
replacement SF-1019 and storing the non-conforming SF-1019. Such replacement shipment of SF-1019
shall be treated as a new, additional shipment of SF-1019 (that will be separately invoiced by
Argyll Biotech) for all purposes, including
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measuring its conformity to the agreed upon specifications and applicable Manufacturing Standards
and Immunosyn’s payment for such additional shipment. Immunosyn shall return any such rejected
shipment to Argyll Biotech if so instructed by Argyll Biotech, at Argyll Biotech’s expense. In the
event that any SF-1019 shipment or batch thereof is ultimately agreed or found to meet the agreed
upon specifications and applicable Manufacturing Standards, Immunosyn shall accept and pay for such
shipment or batch.
(c) Upon Argyll Biotech’s receipt of a claim that a shipment or batch thereof of SF-1019 does
not meet the agreed upon specifications and/or applicable Manufacturing Standards, Argyll Biotech
shall use commercially reasonable efforts to replace such shipment or batch thereof with an
additional shipment of SF-1019 that does conform to such standards as soon as practicable.
7.6. The Parties acknowledge and agree that Argyll Biotech currently obtains SF-1019 through
contractual arrangements with a third party manufacturer. Upon the execution and delivery of this
Agreement, Argyll Biotech shall and hereby does represent and warrant that, to the knowledge of
Argyll Biotech, it is not in breach under any such contracts and that data and information provided
to Immunosyn by Argyll Biotech relating to such contracts is accurate and complete in all material
respects and contains no material errors or omissions.
7.7. (a) Argyll Biotech shall notify Immunosyn (i) as promptly as possible, but in no event
more than ten days after Argyll Biotech’s receipt of a firm order for SF-1019 from Immunosyn, or
(ii) immediately upon becoming aware that Argyll Biotech is unable to supply the quantity of
SF-1019 to Immunosyn that Argyll Biotech is required to supply hereunder, if Argyll Biotech is
unable to supply such quantities of SF-1019. In such event, Argyll Biotech shall implement all
commercially reasonable efforts to remedy such shortage, including through the use of third party
manufacturers for all or a portion of such quantities of SF-1019, as determined are necessary by
Argyll Biotech and Immunosyn.
(b) In the event that Argyll Biotech is unable to supply Immunosyn’s requirements of SF-1019
due to force majeure or otherwise, Argyll Biotech shall allocate the SF-1019 that Argyll Biotech
has in inventory and that Argyll Biotech is able to produce among the quantities of all such
requirements, so that Immunosyn receives at least its proportionate share of such available
supplies, as determined from reasonable forecasts (taking into consideration past sales and sales
performance against forecast) and orders for SF-1019.
7.8. All purchases by Immunosyn shall be made pursuant to written purchase orders which shall
be accepted by Argyll provided they comply with the terms of this Agreement. The printed terms on
any purchase order or order acknowledgement which would otherwise modify, supplement or affect the
terms of this Agreement shall be of no force or effect. Argyll shall not be required to deliver
quantities which have not been
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scheduled by Immunosyn in written forecasts submitted to Argyll at least three months prior to the
expected date of delivery. All shipments shall be delivered by Argyll at its place of
manufacturing, and Immunosyn shall be responsible for arranging and payment of all costs of
shipment and delivery to destination, including export and import.
8. OWNERSHIP; PATENTS; TRADEMARKS.
8.1. Argyll Biotech shall have all right, title and interest in and to the patents, know-how,
and trademarks related in any manner whatsoever to the development, manufacture, marketing,
distribution, sale, import, use or support of SF-1019, whether in existence on the execution date
of this Agreement or developed during the term of this Agreement, subject only to the rights
granted to Immunosyn pursuant to this Agreement. All new or useful process, manufacture, compound,
composition of matter, improvements, discoveries, claims, formulae, processes, trade secrets,
technologies and know-how, to the extent relating to, derived from and useful for the manufacture,
use or sale of the SF-1019 Product (including, without limitation, the formulation, delivery or use
thereof in the commercial marketplace), including, without limitation, synthesis, preparation,
recovery and purification processes and techniques, control methods and assays, chemical data,
toxicological and pharmacological data and techniques, clinical data, medical uses, product forms
and product formulations and specifications, whether patentable or unpatentable, that is conceived
or first reduced to practice or demonstrated to have utility during the term of this Agreement,
including all documentation thereof in written or electronic media (collectively, the “Inventions”)
developed by any party or jointly by Argyll Biotech and Immunosyn shall be owned by Argyll Biotech,
except for Inventions developed solely by Immunosyn which have general utility in connection with
other products and/or compounds in addition to the SF-1019 product, but only to the extent of their
utility for products other than SF-1019, in which case Immunosyn shall own such Inventions
(“Immunosyn Inventions”). To the extent necessary to effectuate the foregoing, Immunosyn shall
take any action reasonably necessary to confirm Argyll Biotech’s ownership pursuant to the
foregoing.
8.2. (a) Argyll Biotech shall have full responsibility for, and shall control the preparation
and prosecution of, all patent applications and the maintenance of all patents relating to the
SF-1019 technology throughout the world. In connection therewith, Argyll Biotech shall generally
consult with Immunosyn on all future filings with respect to patents and the prosecution and
maintenance of such patents, including where appropriate or reasonably requested by Immunosyn,
providing copies to Immunosyn of any such filings made to, and written communications received
from, any patent office relating, in whole or in part, to patents. Argyll Biotech shall pay all
costs and expenses of filing, prosecuting and maintaining patents covering Inventions arising from
the SF-1019
technology. Immunosyn shall have full responsibility for, and shall control the preparation
and prosecution of, all patent applications and the maintenance of all patents relating to
Immunosyn Inventions throughout the world. In connection therewith, Immunosyn shall generally
consult with Argyll Biotech on all future filings with respect
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to such patents and the prosecution and maintenance of such patents, including where appropriate or
reasonably requested by Argyll Biotech, providing copies to Argyll Biotech of any such filings made
to, and written communications received from, any patent office relating, in whole or in part, to
such patents. Immunosyn shall pay all costs and expenses of filing, prosecuting and maintaining
patents covering Immunosyn Inventions. Notwithstanding the foregoing, Argyll Biotech shall not have
the right to file patent applications or maintain patents for Immunosyn Inventions, regardless of
whether such Immunosyn Inventions relate to the SF-1019 technology. Argyll Biotech shall have a
perpetual, worldwide, royalty free license, including the right to sublicense and grant
sublicensing rights to third parties, for all Immunosyn Inventions for the purpose of using,
improving, manufacturing (including the right to have made), importing and selling SF-1019,
including all of its improved versions.
(b) The parties agree to cooperate with each other to execute all lawful papers and
instruments, to make all rightful oaths and declarations and to provide consultation and assistance
as may be necessary in the preparation, prosecution, maintenance and enforcement of all such
patents and patent applications pursuant to this Agreement.
8.3. (a) If any party learns of an infringement, unauthorized use, misappropriation or
ownership claim or threatened infringement or other such claim (any of the foregoing, an
“infringement”) by a third party with respect to any SF-1019 technology or any trademark in any
territory throughout the world, such party shall promptly notify the other parties and shall
provide such other parties with available evidence of such infringement.
(b) Argyll Biotech shall have the first right, but not the duty, to institute patent or
trademark infringement actions against third parties based on any SF-1019 technology or trademark.
If Argyll Biotech does not institute an infringement proceeding against an offending third party
within 180 days of learning of such infringement or, in the event that a third party files a
paragraph IV certification relating to any patent pursuant to 21 U.S.C. ss.355(j)(2)(A)(vii)(IV) of
the Hatch/Waxman Act (or any successor statute), if Argyll Biotech does not institute an
infringement proceeding against such third party within 30 days of receipt of notice of such
paragraph IV certification, Immunosyn shall have the right, but not the duty, to institute such an
action with respect to any infringement by such third party; provided that Immunosyn may not enter
into any settlement, consent judgment or other voluntary final disposition of such action which
adversely effects any SF-1019 technology or trademark without the prior written consent of Argyll
Biotech, which will not be unreasonably withheld. The costs and expenses of any such action
(including fees of attorneys and other professionals) shall be borne by the
party instituting the action, or, if the parties elect to cooperate in instituting and maintaining
such action, such costs and expenses shall be borne by the parties in such proportions as they may
agree in writing. Each party shall execute all necessary and proper documents, take such actions as
shall be appropriate to allow the other party to institute and prosecute such infringement actions
and shall otherwise cooperate in the
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institution and prosecution of such actions (including, without limitation, consenting to being
named as a nominal party thereto). Each party prosecuting any such infringement actions shall keep
the other party reasonably informed as to the status of such actions. Any award paid by a third
party as a result of such an infringement action (whether by way of settlement or otherwise) shall
be applied first to reimburse the parties for all costs and expenses incurred by the parties with
respect to such action on a pro rata basis and, if after such reimbursement any funds shall remain
from such award, they shall be allocated as follows: (i) if Argyll Biotech has instituted and
maintained such action alone, Argyll Biotech shall be entitled to retain such remaining funds; (ii)
if Immunosyn has instituted and maintained such action alone, Immunosyn shall be entitled to retain
such remaining funds; or (iii) if the parties have cooperated in instituting and maintaining such
action, the parties shall allocate such remaining funds between themselves in the same proportion
as they have agreed to bear the expenses of instituting and maintaining such action.
(c) Immunosyn shall have the first right, but not the duty, to institute patent infringement
actions against third parties based on the use of Immunosyn Inventions which are used in the
development, use, manufacture, distribution, promotion and/or sale of the SF-1019 product. If
Immunosyn does not institute an infringement proceeding against an offending third party within 180
days of learning of such infringement or, in the event that a third party files a paragraph IV
certification relating to any Immunosyn Inventions pursuant to 21 U.S.C. ss.355(j)(2)(A)(vii)(IV)
of the Hatch/Waxman Act (or any successor statute), if Immunosyn does not institute an infringement
proceeding against such third party within 30 days of receipt of notice of such paragraph IV
certification, Argyll Biotech shall have the right, but not the duty, to institute such an action
with respect to any infringement by such third party; provided that Argyll Biotech may not enter
into any settlement, consent judgment or other voluntary final disposition of such action which
adversely effects any Immunosyn Inventions without the prior written consent of Immunosyn, which
will not be unreasonably withheld. The costs and expenses of any such action (including fees of
attorneys and other professionals) shall be borne by the party instituting the action, or, if the
parties elect to cooperate in instituting and maintaining such action, such costs and expenses
shall be borne by the parties in such proportions as they may agree in writing. Each party shall
execute all necessary and proper documents, take such actions as shall be appropriate to allow the
other party to institute and prosecute such infringement actions and shall otherwise cooperate in
the institution and prosecution of such actions (including, without limitation, consenting to being
named as a nominal party thereto). Each party prosecuting any such infringement actions shall keep
the other party reasonably informed as to the status of such actions. Any award paid by a third
party as a result of such an infringement action (whether by way of settlement or otherwise) shall
be applied first to reimburse the parties for all costs and expenses incurred by the parties with
respect to such action on a pro rata basis and,
if after such reimbursement any funds shall remain from such award, they shall be allocated as
follows: (i) if Immunosyn has instituted and maintained such action alone, Immunosyn shall be
entitled to retain such remaining funds; (ii) if Argyll Biotech has instituted and maintained such
action alone, Argyll Biotech shall be entitled to retain such
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remaining funds; or (iii) if the parties have cooperated in instituting and maintaining such
action, the parties shall allocate such remaining funds between themselves in the same proportion
as they have agreed to bear the expenses of instituting and maintaining such action.
8.4. (a) In the event of the institution or threatened institution of any suit by a third
party against Immunosyn for patent or trademark infringement involving the manufacture, use,
distribution, sale or marketing of the SF-1019 product, Immunosyn shall promptly notify Argyll
Biotech in writing of such suit. Argyll Biotech shall be required to diligently defend such suit at
its own expense shall control the defense of such action and, subject to Section 8.4(c), shall be
responsible for all damages incurred as a result thereof and shall indemnify Immunosyn in
connection therewith. Immunosyn hereby agrees to assist and cooperate with Argyll Biotech, at
Argyll Biotech’s reasonable request and expense, in the defense of any suit related to the SF-1019
Technology or trademarks (including, without limitation, consenting to being named as a nominal
party thereto). During the pendency of such action and thereafter, Immunosyn shall continue to
make all payments due under this Agreement. If Argyll Biotech finally prevails and receives an
award from such third party as a result of such action (whether by way of judgment, award, decree,
settlement or otherwise), such award shall be retained entirely by Argyll Biotech.
(b) In the event of the institution or threatened institution of any suit by a third party
against Immunosyn for patent infringement involving the Immunosyn Inventions which are used in the
development, use, manufacture, distribution, promotion and/or sale of the SF-1019 product,
Immunosyn shall promptly notify Argyll Biotech in writing of such suit. Immunosyn shall be required
to diligently defend such suit at its own expense, shall control the defense of such action and
shall be responsible for all payment of damages incurred as a result thereof (or payment of any
license fees incurred in connection with any license obtained by the parties from such third
party); provided that (A) to the extent that such suit relates to Immunosyn Inventions used solely
by Argyll Biotech, Argyll Biotech shall diligently defend such suit at its own expense, shall
control the defense of such action and shall be responsible for all payment of damages incurred as
a result thereof (or payment of any license fees incurred in connection with any license obtained
by Argyll Biotech from such third party) and (B) to the extent that such suit relates to Immunosyn
Inventions used by both Immunosyn and Argyll Biotech, the parties shall cooperate in the defense
of such action and shall be responsible for payment of damages incurred as a result thereof (or
payment of any license fees incurred in connection with any license obtained by the parties from
such third party) on a basis which is proportionate to their relative usage (as reflected by sales
and similar objective criteria) of such Immunosyn Inventions. In the event that a party is solely
responsible for
defending an action involving Immunosyn Inventions, the other party shall assist and cooperate with
such party, at such party’s reasonable request and expense. If a party which is solely responsible
for defending an action involving Immunosyn Inventions finally prevails and receives an award from
such third party as a result of such action
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(whether by way of judgment, award, decree, settlement or otherwise), such award shall be retained
entirely by such party. If the parties cooperate in the defense of an action involving Immunosyn
Inventions pursuant to (B) above and such parties finally prevail and receive an award from such
third party as a result of such action (whether by way of judgment, award, decree, settlement or
otherwise), such award shall be shared on an equitable basis by the parties.
(c) In the event that Argyll Biotech (A) determines that a license under third party patents
or trademarks should be obtained to avoid infringement of such third party patents or trademarks in
order to make, have made, use or sell the SF-1019 product in any country(ies) in the world, or
royalties should be paid to such third party in respect of sales of such product anywhere in the
world, or (B) if Argyll Biotech or Immunosyn finally loses and is required to pay damages or an
award to a third party as a result of an action commenced under Section 8.4(a) (whether by way of
judgment, award, decree, settlement or otherwise); then the Royalty and purchase price for the
SF-1019 Product due from Immunosyn to Argyll Biotech pursuant to Sections 5.1 shall be increased by
an amount sufficient to reimburse Argyll Biotech for the amount of such damages within a period
not to exceed three years.
9. PUBLICATION; CONFIDENTIALITY
9.1. The parties recognize that each may wish to publish the results of their work (or the
work of any Argyll Team member) relating to the subject matter of this Agreement. However, the
parties also recognize the importance of acquiring patent protection. Consequently, subject to any
applicable laws or regulations obligating any party to do otherwise, any proposed publication by
any party (including the Argyll Team members) shall comply with this Section 9. All publications,
whether written or oral, shall be prepared in accordance with the joint publication strategy
established and approved jointly by Argyll Biotech and Immunosyn. At least 45 days before a
manuscript is to be submitted to a publisher, the publishing party will provide the other party
with a copy of the manuscript. If the publishing party wishes to make an oral presentation, it will
provide the other party with a summary of such presentation at least 30 days before such oral
presentation and, if an abstract is to be published, 30 days before such abstract is to be
submitted. Any oral presentation, including any question period, shall not include any Confidential
Information (as defined below) unless the parties otherwise mutually agree in writing in advance of
such oral presentation.
9.2. Argyll Biotech and Immunosyn will each review the manuscript, abstract, text or any
other material provided to it under Section 9.1 to determine whether patentable subject matter is
disclosed. The non-publishing party will notify the publishing party
within 30 days of receipt of the proposed publication if the non-publishing party, in good
faith, determines that patentable subject matter is or may be disclosed, or if, in good faith, it
believes Confidential Information is or may be disclosed. If it is determined by the non-publishing
party that patent applications should be filed, the publishing party shall delay
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its publication or presentation for a period not to exceed 60 days from the non-publishing party’s
receipt of the proposed publication or presentation to allow time for the filing of patent
applications covering patentable subject matter. In the event that the delay needed to complete the
filing of any necessary patent application will exceed the 60-day period, the parties will discuss
the need for obtaining an extension of the publication delay beyond the 60-day period. If it is
determined in good faith that Confidential Information or proprietary information is being
disclosed, the parties will consult in good faith to arrive at an agreement on mutually acceptable
modifications to the proposed publication or presentation to avoid such disclosure.
9.3. The parties agree to the terms of the Confidentiality and Non Disclosure Agreement
annexed to this Agreement as Attachment “A”. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing, the parties agree that, during the term of this Agreement
and for ten years thereafter, the receiving party, its affiliates and its licensees shall ensure
that their respective employees, officers, directors and other representatives shall keep
completely confidential and not publish or otherwise disclose and not use for any purpose any
information furnished to it or them by the disclosing party, its affiliates or its licensees or
developed under or in connection with this Agreement, including the terms of this Agreement, except
to the extent that it can be established by the receiving party by competent proof that such
information: (i) was already known to the receiving party, other than under an obligation of
confidentiality, at the time of disclosure by the disclosing party; (ii) was generally available to
the public or otherwise part of the public domain at the time of its disclosure to the receiving
party; (iii) became generally available to the public or was otherwise part of the public domain
after its disclosure and other than through any act or omission of the receiving party in breach of
this Agreement; or (iv) was disclosed to the receiving party, other than under an obligation of
confidentiality, by a third party who had no obligation to the disclosing party not to disclose
such information to others (all such information to which none of the foregoing exceptions applies,
shall be deemed “Confidential Information”).
9.4. The restrictions contained in Section 9.3 shall not apply to Confidential Information
that: (i) is submitted by the recipient to governmental authorities to facilitate the issuance of
regulatory approval for the SF-1019 Product, provided that reasonable measures shall be taken to
assure confidential treatment of such information; (ii) is provided by the recipient to third
parties under confidentiality provisions at least as stringent as those in this Agreement, for
consulting, manufacturing development, manufacturing, external testing, or marketing trials; or
(iii) is otherwise required to be disclosed in compliance with applicable laws or regulations or
order by a court or other regulatory body having competent jurisdiction; provided that if a party
is required to make any such disclosure of disclosing party’s Confidential Information such party
will, except where impracticable for necessary disclosures (for example, to physicians conducting
studies or to health authorities), give reasonable advance notice to the disclosing party of such
disclosure requirement and, except to the extent inappropriate in the case of patent applications,
will use its best efforts to secure confidential treatment of
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such Confidential Information required to be disclosed.
9.5. Each party shall use, and cause each of its affiliates and its licensees to use, any
Confidential Information obtained by such party from the disclosing party, its affiliates or its
licensees, pursuant to this Agreement or otherwise, solely in connection with the activities or
transactions contemplated hereby.
9.6. Each party shall be entitled, in addition to any other right or remedy it may have, at
law or in equity, to an injunction, without the posting of any bond or other security, enjoining or
restraining the disclosing party, its affiliates and/or its licensees from any violation or
threatened violation of this Section 9.
10 REPRESENTATIONS AND WARRANTIES.
10.1. Each party represents and warrants to the other parties, as of the execution date of
this Agreement, that:
(a) Such party is duly organized, validly existing and in good standing under the laws of the
jurisdiction of its incorporation and has full corporate power and authority to enter into this
Agreement and to carry out the provisions hereof;
(b) Such party has taken all corporate action necessary to authorize the execution and
delivery of this Agreement and the performance of its obligations under this Agreement and has full
power and authority to enter into this Agreement and perform its obligations under this Agreement;
and
(c) This Agreement has been duly executed by such party and constitutes a valid and legally
binding obligation of such party, enforceable in accordance with its terms, subject to and limited
by: (i) applicable bankruptcy, insolvency, reorganization, moratorium, and other laws generally
applicable to creditors’ rights; and (ii) judicial discretion in the availability of equitable
relief.
(d) Such party is not required to obtain the consent, approval, order, or authorization of any
third party, or complete any registration, qualification, designation, declaration or filing with,
any federal, state, local, or provincial governmental authority, in connection with the execution
and delivery of this Agreement and the performance by such party of its obligations under this
Agreement, including, without limitation, the grant of rights to the other parties pursuant to this
Agreement, or such party has done so; and
(e) The execution and delivery of this Agreement, and the performance by such other party of
its obligations under this Agreement, including without limitation the grant of rights to the other
parties pursuant to this Agreement, will not: (i) conflict with, nor result in any violation of or
default under any such instrument, judgment, order, writ, decree, contract or provision; (ii) give
rise to any event that results in the creation of any
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lien, charge or encumbrance upon any assets of such party or the suspension, revocation,
impairment, forfeiture or non-renewal of any material permit, license, authorization or approval
that applies to such party, its business or operations or any of its assets or properties; or (iii)
conflict with any rights granted by such party to any third party or breach any obligation that
such party has to any third party.
10.2. Argyll Biotech represents and warrants to Immunosyn, as of the execution date of this
Agreement, that:
(a) Argyll Biotech is the owner of, or has exclusive rights to, all of the patents and
trademarks in existence necessary to produce and manufacture the SF-1019 product for the Licensed
Use, and has the exclusive right to grant the rights granted under this Agreement therefor. To the
knowledge of Argyll Biotech, all of such patents and trademarks are valid, in full force and effect
and have been maintained to date, and are not the subject of any interference or opposition
proceedings;
(b) To the knowledge of Argyll Biotech, Argyll Biotech (i) is not aware of any asserted or
unasserted claims, interferences, oppositions or demands of any third party against the SF-1019
technology or the trademarks in existence as of the execution date of this Agreement; and (ii) to
the knowledge of Argyll Biotech, the Parties’ practice of any invention claimed in such patents or
the exercise of any rights to the SF-1019 technology or the trademarks as contemplated by this
Agreement will not infringe any patent or other intellectual property right of any third party;
(c) To the knowledge of Argyll Biotech, Argyll Biotech has rights to all of the know-how
relating to the manufacture and use of the SF-1019 product in existence on the execution date of
this Agreement and the right to grant all rights with respect thereto granted to Immunosyn pursuant
to this Agreement;
(d) To the knowledge of Argyll Biotech, Immunosyn’s marketing, sale and distribution of the
SF-1019 product for the Licensed Use, in accordance with the terms of this Agreement, would not
infringe upon or conflict with any patent or other proprietary rights of any third party; and
(e) To the knowledge of Argyll Biotech, all of the data and information provided to Immunosyn
by Argyll Biotech relating to the SF-1019 technology and the trademarks is accurate and complete in
all material respects and contains no material errors or omissions.
10.3. Only to the extent Argyll Biotech’s representations and warranties set forth in Section
10.2(e) are true and correct, Immunosyn represents and warrants to Argyll Biotech, as of the
execution date of this Agreement, that it has utilized its own scientific, marketing and
distribution expertise and experience to analyze and evaluate both the scientific and commercial
value of SF-1019 product and has solely relied on such
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analysis and evaluations in deciding to enter into this Agreement.
11 RECALL; INDEMNIFICATION.
11.1. In the event that either party learns that any regulatory authority in any country has
alleged or proved that the SF-1019 product does not comply with applicable rules and regulations in
such country, it shall notify the other party immediately. Argyll Biotech shall conduct any
appropriate investigation and shall make a determination as to the disposition of any such matter.
If Immunosyn is required or if Argyll Biotech should deem it appropriate to recall any SF-1019
product, Argyll Biotech shall bear the costs and expenses associated with such recall, unless the
predominant cause of such recall results from Immunosyn’s willful wrongdoing or negligence, in
which case Immunosyn shall bear all costs and expenses associated with such recall.
11.2. Immunosyn shall indemnify, defend and hold harmless Argyll Biotech, the Argyll Team,
and their respective affiliates, and their respective directors, officers, employees and agents,
from and against any and all liabilities, damages, losses, costs and expenses (including the
reasonable fees of attorneys and other professionals) to the extent arising out of or resulting
from:
(a) negligence, recklessness or wrongful intentional acts or omissions of Immunosyn or its
affiliates, and their respective directors, officers, employees and agents, in connection with the
work performed by Immunosyn under the clinical development plans or the fulfillment of Immunosyn’s
obligations under the marketing plans; or
(b) any use, distribution or sale of the SF-1019 product by Immunosyn or its affiliates or due
to any negligence, recklessness, or wrongful intentional acts or omissions by or strict liability
of, Immunosyn or its affiliates and their respective directors, officers, employees and agents.
11.3. Argyll Biotech shall indemnify, defend and hold harmless Immunosyn and its affiliates,
and their directors, officers, employees and agents, from and against any and all liabilities,
damages, losses, costs and expenses (including the reasonable fees of attorneys and other
professionals) to the extent arising out of or resulting from:
(a) negligence, recklessness or wrongful intentional acts or omissions of Argyll Biotech, the
Argyll Team, or their respective affiliates, and their respective directors, officers, employees
and agents, in connection with Argyll Biotech’s fulfillment of its obligations under the clinical
development plans or the fulfillment of Argyll Biotech’s rights or obligations under the marketing
plans;
(b) failure of SF-1019 to meet the agreed upon specifications and/or applicable Manufacturing
Standards or use of SF-1019 products or promotion of that product not in conformity with product
labeling, by Argyll Biotech, the Argyll Team, or their respective
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affiliates, or due to any negligence, recklessness or wrongful intentional acts or omissions by, or
strict liability of, Argyll Biotech, the Argyll Team, or their respective affiliates, and their
respective directors, officers, employees and agents; or
(c) any breach of any representation or warranty made by Argyll Biotech under Section 10.1 or
10.2.
11.4. In the event that any person (an “Indemnitee”) entitled to indemnification under
Section 11.2 or 11.3 is seeking such indemnification, such Indemnitee shall inform the indemnifying
party of the claim as soon as reasonably practicable after such Indemnitee receives notice of such
claim, shall permit the indemnifying party to assume direction and control of the defense of the
claim (including the sole right to settle it at the sole discretion of the indemnifying party,
provided that such settlement does not impose any obligation on, or otherwise adversely affect, the
Indemnitee or any of the other parties) and shall cooperate as requested (at the expense of the
indemnifying party) in the defense of the claim.
11.5. As the parties intend complete indemnification, all costs and expenses incurred by an
Indemnitee in connection with enforcement of Sections 11.2 and 11.3 shall also be reimbursed by the
indemnifying party.
12 TERM; TERMINATION.
12.1. This Agreement shall become effective as of the execution date of this Agreement and,
unless earlier terminated pursuant to the other provisions of this Section 12, shall expire on the
date on which the sale of the SF-1019 product ceases to be covered by a valid patent claim owned by
Argyll covering SF-1019 in any country.
12.2. Argyll Biotech may, without prejudice to any other remedies available to it at law or
in equity, terminate this Agreement in the event that Immunosyn shall have materially breached or
defaulted in the performance of any of its material obligations hereunder, and such default shall
have continued for 180 days after written notice thereof was provided to Immunosyn by Argyll
Biotech (or, if such default cannot be cured within such 180-day period, if Immunosyn Party does
not commence and diligently continue actions to cure such default during such 180-day period). Any
such termination shall become effective at the end of such 180-day period unless Immunosyn has
cured any such breach or default prior to the expiration of such 180-day period (or, if such
default cannot be cured within such 180-day period, if Immunosyn has commenced and diligently
continued actions to cure such default). The right of Argyll Biotech to
terminate this Agreement, as provided in this Section 12.2 shall not be affected in any way by
its waiver or failure to take action with respect to any previous default.
12.3. Immunosyn shall have the right to terminate this Agreement in the event that it
determines, in its reasonable discretion and after thorough review and analysis, that there
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exists a significant concern regarding a regulatory or patient safety issue that would seriously
impact the long term viability of the SF-1019 product. The Agreement shall immediately terminate
upon a non-rebutted, conclusive finding by Immunosyn that there exists a significant concern
regarding a regulatory or patient safety issue that would seriously impact such long term
viability. In the event of such termination, any remaining obligation of Immunosyn to pay the
Royalty shall immediately terminate and Argyll Biotech shall have no claim therefore; provided,
however, that Argyll Biotech shall have no liability in such event to return or repay any portion
of the License Fee previously paid to it by Immunosyn.
12.4. If this Agreement expires pursuant to its terms or is terminated by any party pursuant
to this Section 12, in addition to any other remedies available to the parties at law or in equity:
(i) Immunosyn shall promptly transfer to Argyll Biotech copies of all data, reports, records and
materials in their possession or control that relate to the SF-1019 Product and return to Argyll
Biotech all relevant records and materials in its possession or control containing Confidential
Information of Argyll Biotech (provided that Immunosyn may keep one copy of such Confidential
Information of Argyll Biotech for archival purposes only); and (ii) Argyll Biotech shall promptly
return to Immunosyn all relevant records and materials in Argyll Biotech’s possession or control
containing Confidential Information of Immunosyn (provided that the Argyll Biotech may keep one
copy of such Confidential Information of Immunosyn for archival purposes only).
13 FORCE MAJEURE.
13.1. Neither of the parties shall be held liable or responsible to the other party nor be
deemed to be in default under, or in breach of any provision of, this Agreement for failure or
delay in fulfilling or performing any obligation of this Agreement when such failure or delay is
due to force majeure, and without the fault or negligence of the party so failing or delaying. For
purposes of this Agreement, force majeure is defined as causes beyond the control of the party,
including, without limitation, acts of God; acts, regulations, or laws of any government; war;
civil commotion; destruction of production facilities or materials by fire, flood, earthquake,
explosion or storm; labor disturbances; epidemic; and failure of public utilities or common
carriers. In such event Argyll Biotech or Immunosyn, as the case may be, shall immediately notify
the other party of such inability and of the period for which such inability is expected to
continue. The party giving such notice shall thereupon be excused from such of its obligations
under this Agreement as it is thereby disabled from performing for so long as it is so disabled and
the 30 days thereafter. To the extent possible, each party shall use reasonable efforts to minimize
the duration of any force majeure.
14 DISPUTE RESOLUTION.
14.1. Subject to the arbitration agreement in Section 14.2, the federal and state courts
having jurisdiction over San Diego County, California shall have exclusive jurisdiction
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and venue over all judicial proceedings involving the parties under this Agreement. Both parties
agree to the exclusive personal jurisdiction of said courts.
14.2. In the event of any dispute arising out of or related in any way whatsoever to this
Agreement, the parties agree to submit all such disputes to a confidential, binding arbitration in
accordance with California law in the City of San Diego. A party may initiate arbitration by
serving the other party with written notice making reference to this Agreement, describing the
dispute to be arbitrated, and naming its arbitrator. The party receiving the notice shall respond
in writing within fourteen (14) business days by naming its arbitrator and describing any
additional disputes or counterclaims it wishes to have resolved. The two parties’ arbitrators
shall then appoint a third arbitrator who shall serve as the chairman of the proceedings. In the
event the party receiving the initial notice fails to nominate its arbitrator within the specified
time period, the arbitrator appointed by the party initiating the arbitration shall serve as the
sole arbitrator with power to make a decision and render a binding award. All arbitrators
appointed in accordance with this Agreement shall be experienced in the field of licensing
biotechnology, and the chairman shall be an attorney having experience litigating in said field.
The award may be confirmed by any court having jurisdiction over the parties.
15 MISCELLANEOUS.
15.1. Nothing in this Agreement is intended or shall be deemed to constitute a partnership,
agency, employer-employee or joint venture relationship between the parties. No Party shall incur
any debts or make any commitments for the other, except to the extent, if at all, specifically
provided herein.
15.2. No party shall be entitled to assign its rights or delegate its obligations hereunder
without the express written consent of the other party, except that Argyll Biotech may assign its
rights and transfer its duties hereunder, without the consent of Immunosyn, to (A) a directly or
indirectly wholly-owned subsidiary of Argyll Biotech, or (B) to any assignee of all or
substantially all of its business (or that portion of its overall business of which this Agreement
is a part (e.g. all of its biopharmaceutical business).
15.3. Any books and records to be maintained under this Agreement by a party or its
affiliates shall be maintained in accordance with generally accepted accounting principles.
15.4. Solely to the extent necessary to allow any party to use it rights and perform its
obligations under this Agreement, each party hereby grants to the other party and its affiliates
the rights to use patents, know-how and Immunosyn Inventions (as applicable)
in accordance with this Agreement. Each party shall execute, acknowledge and deliver such
further instruments, and do all such other acts, as may be necessary or appropriate in order to
carry out the purposes and intent of this Agreement.
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15.5. (a) Any notice, request or other communication required or permitted to be given under
or in connection with this Agreement shall be deemed to have been sufficiently given if in writing
and personally delivered or sent by certified mail (return receipt requested), facsimile
transmission (receipt verified), or overnight express courier service (signature required),
prepaid, to the party for which such notice is intended, at the address set forth for such party
below:
In the case of Argyll Biotech, to:
Argyll Biotechnologies, LLC
0000 Xxxxxxxxx Xxxxxx
Xxxxx 000
Xx Xxxxx, XX 00000
0000 Xxxxxxxxx Xxxxxx
Xxxxx 000
Xx Xxxxx, XX 00000
ATTN: Xxxxxxx Xxxx, CFO
In the case of Immunosyn, to:
Immunosyn Merger Corporation
0000 Xxxxxxxxx Xxxxxx
Xxxxx 000
Xx Xxxxx, Xxxxxxxxxx 00000
0000 Xxxxxxxxx Xxxxxx
Xxxxx 000
Xx Xxxxx, Xxxxxxxxxx 00000
ATTN: Xxxx Xxxxxx, President
or to such other address for such party as it shall have specified by like notice to the other
Party, provided that notices of a change of address shall be effective only upon receipt thereof.
If notice is delivered personally or by facsimile transmission, the date of delivery shall be
deemed to be the date on which such notice or request was given. If sent by overnight express
courier service, the date of delivery shall be deemed to be the next business day after such notice
or request was deposited with such service. If sent by certified mail, the date of delivery shall
be deemed to be the third business day after such notice or request was deposited with the U.S.
Postal Service.
15.6. Except as otherwise provided herein, Argyll Biotech and Immunosyn shall not have any
right, express or implied, to use in any manner the name or other designation of the other or any
other trade name, trademark or logos of the other party for any purpose in connection with the
performance of this Agreement.
15.7. Except as otherwise provided herein, neither Argyll Biotech no Immunosyn shall make any
public announcement concerning this Agreement or the subject matter hereof without first consulting
with the other party and providing such party with a reasonable opportunity to comment on such
proposed public announcement.
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15.8. A waiver by any party of any of the terms and conditions of this Agreement in any
instance shall not be deemed or construed to be a waiver of such term or condition for the future,
or of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements
contained in this Agreement shall be cumulative and none of them shall be in limitation of any
other remedy, right, undertaking, obligation or agreement of any party.
15.9. Nothing in this Agreement shall be deemed to permit a party to export, reexport or
otherwise transfer any SF-1019 product sold under this Agreement without compliance with applicable
laws.
15.10. When possible, each provision of this Agreement will be interpreted in such manner as
to be effective and valid under applicable law, but if any provision of this Agreement is held to
be prohibited by or invalid under applicable law, such provision will be ineffective only to the
extent of such prohibition or invalidity, without invalidating the remainder of this Agreement,
provided such invalid term is not fundamental to the Parties’ Agreement.
15.11. No amendment, modification or supplement of any provisions of this Agreement shall be
valid or effective unless made in writing and signed by a duly authorized officer of each party.
15.12. This Agreement shall be governed by and interpreted in accordance with the laws of the
State of California as if the dispute arose in California between citizens of California without
regard to any conflicts of law principles that might otherwise apply.
15.13. This Agreement constitutes the entire agreement between the parties with respect to
the subject matter of this Agreement and supersedes all prior agreements and understandings, both
oral and written, between the parties with respect to the subject matter of this Agreement.
15.14. All of the terms and provisions of this Agreement shall be binding upon, inure to the
benefit of and be enforceable by the parties hereto and their respective permitted successors and
assigns.
15.15. This Agreement may be executed simultaneously in any number of counterparts, any one
of which need not contain the signature of more than one party but all such counterparts taken
together shall constitute one and the same agreement.
IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed by its duly
authorized representative as of the day and year first above written.
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| ARGYLL BIOTECHNOLOGIES, LLC |
||||
| By: | ||||
| Xxxxx X. Xxxxxx | ||||
| CEO | ||||
| IMMUNOSYN CORPORATION |
||||
| By: | ||||
| Xxxx Xxxxxx | ||||
| President | ||||
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