AMENDED AND RESTATED LICENSE AGREEMENT
EXHIBIT
10.1
AMENDED
AND RESTATED
This
amended and restated license agreement (the “Agreement”) is made on the 25th day
of October, 2007 effective as of the 26th 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”), either or both of which may be
referred to as a Party or the Parties to this Agreement.
In
consideration of mutual promises, covenants and representations contained in
this Agreement, Argyll Biotech and Immunosyn hereby agree as
follows:
Definitions
“SF-1019”
as used herein shall mean one or more pharmaceutical products for a Licensed
Use
that: (i) is owned by or licensed by Argyll Biotech and described
and/or claimed in U.S. Patent Application, Publication No. 20050042635, entitled
“Prophylactic and Therapeutics Benefits of a New Class of Immune Stimulating
Peptides” including any divisional, continuation, reexamination and reissue
applications and all counter-part national stage applications and any patents
resulting from such applications (collectively the “Xxxxxxxxx Patents”), (ii) is
developed during the term of this Agreement using technology described in the
Xxxxxxxxx Patents and chemically similar to those pharmaceutical products
described and/or claimed in the Xxxxxxxxx Patents; and/or (iii) is a replacement
for or an improvement of a pharmaceutical product defined under (i) or (ii)
of
this paragraph.
“Licensed
Use” as used herein shall refer to the treatment, alleviation, and/or prevention
of a disease or pathological condition in a human or animal, including, but
not
limited to, chronic inflammatory demyelinating polyneuropathy (“CIPD”), diabetic
neuropathy, diabetic ulcers, diabetes myelitis, and human immunodeficiency
virus
infection.
1. BACKGROUND
1.1 Argyll
Biotech has identified and is investigating a novel class of pharmaceutical
products, one of which is referred to as SF-1019, that increases the efficacy
of
the mammalian immune system and the ability of a mammal to resist and/or
overcome a viral infection and immune system disorders.
1.2 Argyll
Biotech has assumed the organization, management and administration of the
continued development of SF-1019, including, but not limited to, all financial
commitments and requirements associated with the necessary analysis of
SF-1019. Based on preliminary experiments, SF-1019 is an effective
treatment for a plurality of viral and immune system disorders including
conditions related to CIDP, diabetes myelitis, and human immunodeficiency virus
infection. Argyll Biotech intends to develop and procure regulatory
and other approval for the marketing, sale and distribution of one or more
commercial forms of SF-1019.
1.3 Immunosyn
was organized and capitalized for the purpose of marketing, distributing and
selling SF-1019 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 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 SF-1019 for the Licensed Use 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 grants to
Immunosyn an exclusive, worldwide commercial license to market, distribute,
sell, and promote SF-1019 solely for the Licensed Use. Unless
expressly stated herein, no other license and rights are granted by Argyll
Biotech.
2.2 Subject
to the terms and conditions of this Agreement, Argyll Biotech hereby grants
to
Immunosyn an exclusive, worldwide license to any and all intellectual property
which is owned by, assigned to or licensed by Argyll Biotech for the sole
purpose of marketing, distribution, sale and promotion of SF-1019 for the
Licensed Use.
2.3 Immunosyn
does not have the right to sublicense the rights granted under Section 2.1
to
any third party including without limitation any subsidiaries or affiliates
of
Argyll Biotech absent the express written agreement of Argyll
Biotech.
2.4 (a) Argyll
Biotech further grants to Immunosyn the non-exclusive, worldwide right to use
trademarks, service marks, logo, and other source-identifying indicia that
Argyll Biotech may create for SF-1019 (the “Trademarks”).
(b) All
use of Trademarks by Immunosyn shall clearly indicate that Argyll Biotech is
the
owner of the Trademarks. At least ten business days prior to any new
use of Trademarks, Immunosyn shall provide Argyll Biotech with samples of
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.
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Immunosyn
agrees that all use of the Trademarks by Immunosyn shall inure 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, as determined in its sole and unfettered discretion, to
retain, enforce or defend the Trademarks.
(f) To
the extent permitted by law, all labeling, packaging, literature, promotional
material and advertising for a SF-1019 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.
2.5 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 which are not part of SF-1019 (“License Relationship”).
(a) In
the event that Argyll Biotech is interested in establishing 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 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 the 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 any third parties as it deems appropriate without any further
obligation to Immunosyn.
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2.6 To
facilitate the marketing, sale and distribution rights licensed to Immunosyn
under this Agreement Argyll Biotech grants to Immunosyn full access to Argyll
Biotech’s research and development files and activities, including without
limitation medicinal chemistry, screening, clinical trial protocols and results,
and other similar materials, relating to SF-1019 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 by others on its
behalf.
3. DEVELOPMENT
AND REGULATORY MATTERS
3.1 (a) The
Parties acknowledge that Argyll Biotech is in the process of preparing to submit
an initial regulatory registration application for use of SF-1019 with respect
to a Licensed Use with one or more regulatory bodies, such as the United States
Food and Drug Administration or a 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 privately to Argyll
Biotech 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 SF-1019, its predecessors and cognates, including without
limitation any necessarily related patents, patent applications and
know-how.
(c) During
the term of this Agreement: (i) each Party shall provide to the other
Party any material data or other information relating to SF-1019, including
without limitation any such information relating to patents, patent applications
and know-how, from time to time as such data and information is developed or
acquired by such Party; and (ii) each Party shall deliver to the other Party
all
data relating to SF-1019 studies being conducted by or on behalf of either
Party
promptly after such data 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 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.
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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 may prepare and submit to Immunosyn, a clinical budget containing the
budget for the conduct of proposed clinical development plans for the
development of SF-1019 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 may 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 SF-1019; (ii) the allocation of regulatory
strategy and responsibility for continued development of SF-1019; (iii) the
research and development activities for the development of SF-1019 for calendar
years 2007 through 2009, including the allocation of resources, which shall
be
consistent with the proposed clinical budget for such period; (iv) “go/no go”
decision criteria for each stage of development of SF-1019; (v) timelines for
scientific, medical, regulatory and other activities to be undertaken by Argyll
Biotech for the purpose of obtaining Registrations for SF-1019 in each country
in which SF-1019 will be marketed, distributed and sold for the Licensed Use,
and providing marketing support and developing new indications and formulations
for SF-1019. Every clinical development plan for the relevant period
shall include clinical studies required for approval of new indications within
the Licensed Use.
(c) Argyll
Biotech will be primarily responsible for implementing the regulatory strategy
for SF-1019 in all countries in which SF-1019 will be marketed, sold and
distributed for a Licensed Use, including, without limitation, responsibility
for all regulatory compliance, worldwide safety surveillance, adverse event
reporting and all other necessary support services.
(d) Any
and all changes to any clinical development plan and/or the Clinical Budgets
shall be at the sole and unfettered discretion of Argyll Biotech.
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 SF-1019 for a
Licensed Use in any country. 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.
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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 supply clinical materials necessary for all studies to be
conducted pursuant to the clinical development plans specified
herein. Such clinical materials 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 SF-1019 for a Licensed Use
and promoting the therapeutic profile and benefits of SF-1019 for that use
in
the most commercially beneficial manner. Without limiting the
generality of the foregoing, each such Party shall:
(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 SF-1019;
(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.
(v) Immunosyn
shall permit duly authorized representatives of Argyll Biotech to inspect,
on
the premises of Immunosyn, at all reasonable times, all products sold by
Immunosyn including any products sold or offered for sale under the Trademarks,
Immunosyn’s quality control records, and Immunosyn’s facilities used in or
relating to the marketing, distribution or sale of SF-1019 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.
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3.5 Argyll
Biotech shall be responsible for the one hundred per cent of the development
costs related to SF-1019 for the Licensed Use.
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 as soon a practical: (a) reassess the relevant clinical
development plan to address the regulatory authority’s objections and questions,
(b) provide Immunosyn notice of such developments, (c) from time to time as
additional such developments arise, provide 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.
3.7 Argyll
Biotech shall have the right to immediately suspend the relevant clinical
development activities with respect to SF-1019 for a Licensed Use in the event
that Argyll Biotech determines that there exist significant concerns relating
to
patient safety with respect to a clinical study. Upon making the
determination to suspend such clinical activities, Argyll Biotech shall notify
Immunosyn in writing immediately, but not later than ten (10) business days
after such suspension, 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
SF-1019 for the Licensed Uses 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 SF-1019 and promoting
its therapeutic profile and benefits in the most commercially beneficial
manner.
4.2 (a) In
connection with its responsibilities for distribution, marketing and sales
of
SF-1019 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,
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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 SF-1019 for each
country in which SF-1019 may be marketed and sold for the Licensed Use, which
shall include plans related to the prelaunch, launch, promotion and sales 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 include all 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 have the right to participate in the planning of promotional
materials and promotional activities with respect to SF-1019 for the Licensed
Use. All promotional materials and promotional activities shall be
developed by Immunosyn, with optional 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 to promote SF-1019 for the Licensed Use and any
other use in any country in which regulatory approval for such promotion has
been obtained.
(a) Argyll
Biotech shall have the right to have its sales force and medical liaison
personnel participate in the promotion of SF-1019 throughout the
world.
(b) Argyll
Biotech will be included in, and have the right 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 and support services to the same extent available
to Immunosyn’s sales force. Argyll Biotech shall not be required to
reimburse Immunosyn for Immunosyn’s incremental costs and expenses associated
with providing such materials and services to Argyll Biotech’s sales
force.
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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 (3.5%) of its
gross receipts (the “Royalty Fee”) from sales of SF-1019 for the Licensed Use
until Argyll Biotech’s said development costs have been reimbursed in
full.
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 thereafter, Immunosyn shall submit to Argyll Biotech monthly
statements which shall set forth the amount of its gross sales of SF-1019 and
the calculation of Royalty Fees due on such gross sales for such month (the
“Royalty Reports”). For the purpose of this Agreement, any
compassionate use of SF-1019 in any country shall not be construed as commercial
sale as used herein.
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 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
shall keep complete and accurate records pertaining to the sale of
SF-1019. Immunosyn shall permit an independent, certified public
accountant appointed by Argyll Biotech and reasonably acceptable to Immunosyn,
at reasonable times and upon reasonable notice but not more often than two
times
each calendar year, to examine such records as may be
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necessary
to determine the correctness of any report or payment made under this Agreement,
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 Argyll Biotech such amounts and shall disclose no
other information revealed in such audit.
6.5 Immunosyn
shall bear the full cost of the performance of any audit requested by Argyll
Biotech except as hereinafter set forth. If, as a result of any
inspection of the books and records Immunosyn, it is shown that payments made
by
Immunosyn to Argyll Biotech under this Agreement were less than the amount
which
should have been paid, then Immunosyn shall within thirty days thereafter make
all payments required to be made to eliminate any discrepancy revealed by said
inspection plus all 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 use good faith efforts to 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 It
is
agreed by the Parties that the purchase price of SF-1019 sold by Argyll Biotech
to Immunosyn shall be forty percent (40%) of the “Gross Sales Price” (as
defined) of SF-1019. The “Gross Sales Price” shall be determined as
the price at which SF-1019 is advertised for sale to a third party consumer
by
Immunosyn or Immunosyn’s affiliates or sublicensees as permitted under Section
2.3. The Gross Sales Price shall be determined by mutual agreement of
the Parties; provided, however, that in no event shall it be less than 2.5
times
Argyll Biotech’s fully burdened manufacturing cost, research and development
expenses, administrative overhead and standard-xxxx up customary for similar
products and manufacturers. Notwithstanding the preceding sentence,
the Parties may agree to a lesser Gross Sales Price and even a Gross Sales
Price
of zero for the sale of SF-1019 to third parties for research and/or
compassionate use purposes. The purchase price of SF-1019 by
Immunosyn under the License Agreement for any sale or use that would not
constitute a sale to a third party consumer shall be determined solely by Argyll
Biotech.
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7.4 (a) All
quantities of SF-1019 supplied by Argyll Biotech pursuant to this Section 7
will
comply in all material respects with 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
SF-1019 at the time shipped by Argyll Biotech hereunder.
(b) At
its sole and unfettered discretion, Argyll Biotech may conduct, or cause to
be
conducted, quality control testing of SF-1019 prior to shipment, in accordance
appropriate
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 Product(s) 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
shall 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 of 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 and materially accepted 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 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 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, Immunosyn may submit the disputed SF-1019 to an
independent testing laboratory, to be agreed upon by Argyll Biotech, 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 for which
Argyll Biotech is responsible under this Agreement, Argyll Biotech agrees to
replace such shipment or batch with conforming SF-1019. Immunosyn
shall promptly return any such rejected shipment to Argyll Biotech at Argyll
Biotech’s expense. In the event that any SF-1019 shipment or batch
thereof is ultimately found to meet the agreed upon specifications and
applicable Manufacturing Standards, Immunosyn shall accept and pay for such
shipment or batch.
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(c) Upon
Argyll Biotech’s receipt and confirmation that 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 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 maintains that, to the best 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 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 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 owns all right, title and interest in and to any and all the
intellectual property that relates to this Agreement and Immunosyn’s activities
hereunder subject. All new or useful process, manufacture, compound,
composition of matter, improvements,
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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
SF-1019 (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 exclusively 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 a SF-1019
(“Immunosyn Inventions”). Immunosyn shall promptly take any action
reasonably necessary or desired by Argyll Biotech, and at its own expense,
to
confirm Argyll Biotech’s ownership of such Inventions and also all Immunosyn
Inventions.
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
that relate to Inventions 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 that are directly related to Immunosyn activities hereunder, 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, in its sole and unfettered discretion, pay all costs and expenses
of filing, prosecuting and maintaining patents covering Inventions derived
from
the development of SF-1019. 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 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 have
the right to file patent applications or maintain patents for Immunosyn
Inventions that relate in any way to SF-1019. Argyll Biotech shall
have a perpetual, worldwide, royalty free and no-cost license, including the
right to sublicense and grant sublicensing rights to third parties, for all
Immunosyn Inventions for the purpose of using, offering for sale, 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.
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8.3 (a) If
Immunosyn 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 SF-1019 or any
related technology, or to any Trademark in any territory throughout the world,
Immunosyn shall promptly notify Argyll Biotech and shall promptly provide Argyll
Biotech 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. 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.3550)(2)(A)(vii)(IV) of the Hatch/Waxman
Act (or any successor statute), if Argyll Biotech notifies Immunosyn that it
does not intend to institute an infringement proceeding against such third
party, 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 SF-1019 or any
Trademark without the prior written consent of Argyll Biotech. 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 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 SF-1019. 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.3550)(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
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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 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 only
the
manufacture, use, distribution, sale or marketing of XX-0000, Xxxxxxxxx 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 in good
faith assist and cooperate with Argyll Biotech, in the defense of any suit
related to SF-1019 or any Trademark (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 SF-1019 Product(s), 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
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Biotechnologies LLC
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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 (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 to make, have made, use or sell SF-1019
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 SF-1019 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
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 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
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Biotechnologies LLC
Immunosyn
Corporation
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 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 as set
forth in this Section. Except to the extent expressly authorized by
this Agreement or otherwise agreed in writing, the Parties agree that, during
the term of protection for Confidential Information (as defined below) received
from the other Party shall be ten (10) years from the date of
receipt. 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 SF-1019 unless
such submission is submitted in confidence, 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 such Confidential Information required to
be
disclosed.
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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 Party, 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;
(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
Party
pursuant to this Agreement, or such Party has done so;
(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 Party 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 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
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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; and
(f) all
data and information provided by one Party to the other Party is accurate and
complete in all material respects and contains no material errors or
omissions.
10.2 To
the best of its knowledge, Argyll Biotech represents and warrants to Immunosyn,
as of the execution date of this Agreement, that:
(a) Argyll
Biotech believes that it is the owner of, or has exclusive rights to, all of
the
patents and Trademarks necessary to produce and manufacture SF-1019 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
proceeding except as otherwise disclosed;
(b) Argyll
Biotech (i) is not aware of any asserted or unasserted claims, interferences,
oppositions or demands of any third party against SF-1019 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 SF-1019 or the Trademarks as
contemplated by this Agreement do not infringe any patent or other intellectual
property right of any third party; and
(c) except
as otherwise disclosed, Argyll Biotech has rights to all of the know-how
relating to the manufacture and use of SF-1019 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.
10.3 To
the best of its knowledge, Immunosyn represents and warrants to Argyll Biotech,
as of the execution date of this Agreement, that:
(a) Immunosyn: (i)
is not aware of any asserted or unasserted claims, interferences, oppositions
or
demands of any third party against it with regard to the patents and trademarks
necessary to market, distribute, sell, and promote SF-1019 for the Licensed
Use;
and (ii) to the knowledge of Immunosyn, the Parties’ practice of any invention
claimed in such patents or the exercise of any rights to SF-1019 or the
Trademarks as contemplated by this Agreement do not infringe any patent or
other
intellectual property right of any third party;
(b) Immunosyn
has rights to all of the know-how relating to marketing, distribution, sale
and
promotion of SF-1019 in existence on the execution date of this Agreement
pursuant to this Agreement;
(c) Immunosyn’s
marketing, sale and distribution of SF-1019 for the Licensed Use, in accordance
with the terms of this Agreement, do not infringe upon or conflict with any
patent or other proprietary rights of any third party; and
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(d) all
of the data and information provided to Argyll Biotech by Immunosyn relating
to
SF-1019 and the Trademarks is accurate and complete in all material respects
and
contains no material errors or omissions.
11. RECALL
AND INDEMNIFICATION
11.1 In
the event that either Party learns that any regulatory authority in any country
has alleged or proved that SF-1019 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, 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 and its respective
affiliates, and 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 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;
(b) any
use, distribution or sale of SF-1019 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; or
(c) 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 or
its
affiliates and respective directors, officers, employees and agents, in
connection with the work performed by Argyll Biotech under the clinical
development plans or the fulfillment of Argyll Biotech’s obligations under the
marketing plans; or
(b) due
to any negligence, recklessness or wrongful intentional acts or omissions by,
or
strict liability of, Argyll Biotech or its affiliates, and their respective
directors, officers, employees and agents.
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11.4 In
the event that any person (an “Indemnitee”) entitled to indemnification under
Sections 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
AND TERMINATION
12.1 This
Agreement shall become effective as of the date set forth above and, unless
earlier terminated pursuant to the other provisions of this Section 12, shall
expire on the later of (i) 10 years from the date when SF-1019 is commercially
sold, or (ii) from the date on which the sale of SF-1019 ceases to be covered
by
a valid claim within a patent which is licensed to Immunosyn by Argyll Biotech
pursuant to Section 2.2, on a country-by-country, and product-by-product
basis.
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 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 to Argyll
Biotech’s complete satisfaction 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 exists a significant concern regarding a regulatory or patient safety
issue that would seriously impact the long-term viability of
SF-1019. 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.
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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 SF-1019, and return to Argyll Biotech
all
records and materials in its possession or control containing Confidential
Information of Argyll Biotech or Confidential Information of Immunosyn that
relates in any way to SF-1019 (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. LIMITATION
OF LIABILITY
13.1 IN
NO EVENT SHALL A PARTY BE LIABLE TO THE OTHER PARTY FOR ANY LOST PROFITS, LOST
SAVINGS, OR OTHER INCIDENTAL, INDIRECT, SPECIAL, OR CONSEQUENTIAL DAMAGES OR
FOR
ANY CLAIM BY ANY OTHER PARTY, INCLUDING WITHOUT LIMITATION, LOST PROFITS,
RESULTING FROM EXERCISE OF THIS LICENSE OR MANUFACTURE, SALE, OR USE OF THE
INVENTION OR PRODUCTS OR INTELLECTUAL PROPERTY LICENSED HEREUNDER EVEN IF A
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING OUT OF OR
IN
CONNECTION WITH THE GRANTING OR USE OF THE SUBLICENSE HEREUNDER THAT EXCEED
ANY
PAYMENTS RECEIVED FROM A PARTY.
13.2 Argyll
Biotech makes no representation, warrants, either express or implied, or
covenants hereunder regarding this license and the products licensed
hereunder. The inventions and technology licensed hereunder are
provided without a warranty of merchantability or fitness for a particular
purpose or any other warranty, express or implied. Argyll Biotech
makes no representation or warranty that the products and/or services licensed
hereunder will not infringe any patent or other proprietary right or confer
by
implication, estoppel or otherwise any license or rights under any patents
or
other intellectual property of Argyll Biotech other than as expressly stated
herein.
14. FORCE
MAJEURE
14.1 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.
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15. DISPUTE
RESOLUTION
15.1 Subject
to the arbitration agreement in Section 15.2, the federal and state courts
having jurisdiction over San Diego County, California shall have exclusive
jurisdiction and venue
over all judicial proceedings involving the Parties under this
Agreement. Both Parties agree to the exclusive personal jurisdiction
of said courts.
15.2 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 maybe confirmed by any court having jurisdiction over the
Parties.
16. MISCELLANEOUS
16.1 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.
16.2 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).
16.3 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.
16.4 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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16.5 (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
Attn: Xxxxxxx
Xxxx, CFO
In
the
case of Immunosyn, to:
Immunosyn
Corporation
0000
Xxxxxxxxx Xxxxxx
Xxxxx
000
Xx
Xxxxx,
Xxxxxxxxxx 00000
Attn:
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.
16.6 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.
16.7 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 except
as
may be required by the U.S. securities laws.
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16.8 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.
16.9 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.
16.10 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 Agreement.
16.11 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.
16.12 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.
16.13 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.
16.14 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.
16.15 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.
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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.
| ARGYLL BIOTECHNOLOGIES, LLC | |||
|
|
By:
|
/s/ Xxxxx X. Xxxxxx | |
| Xxxxx X. Xxxxxx | |||
| CEO | |||
| IMMUNOSYN CORPORATION | |||
|
Date
|
By:
|
/s/ Xxxxxxx X. Xxxxxxx | |
| Xxxxxxx X. Xxxxxxx | |||
| President | |||
26
