AGREEMENT
THIS AGREEMENT is made and entered into this 5th day of March, 1999, by
and between AIDS RESEARCH Alliance (ALLIANCE), a California nonprofit public
benefit corporation having an office at 000X Xxxxx Xxx Xxxxxxx Xxxxxxxxx, Xxxx
Xxxxxxxxx, Xxxxxxxxxx 00000, and Steroidogenesis Inhibitors International
Corporation (SII), a Nevada corporation having an office at 0000 X. Xxxxxxxx
Xxxx, Xxxxx 000-X, Xxx Xxxxx. XX 00000.
I. Purpose
This agreement is intended to enable Alliance and SII to obtain an
initial evaluation, through a trial to be conducted by Alliance in accordance
with a protocol that has been approved by both parties, of the positive and
negative effects on human subjects of an experimental drug developed by SII and
known as Anticort. SII will provide sufficient quantities of Anticort for the
trial. Alliance will conduct and compile the results of the trial in accordance
with this agreement and the protocol.
II. Anticort Trial Protocol
The Anticort trial shall be conducted in accordance with this agreement
and the protocol (the Protocol) approved by both Alliance and SII attached as
Exhibit A hereto. No modification, revision or amendment to the Protocol shall
be valid or effective for any purpose unless in writing and duly executed by
both Alliance and SII in the same manner as the Protocol attached as Exhibit A
hereto.
III. Delivery of Anticort
Throughout the course of the trial, SII shall deliver to Alliance such
quantities of Anticort as are, in the judgment of Alliance, sufficient to enable
Alliance to conduct the trial in accordance with the Protocol. All Anticort
delivered to Alliance shall have been manufactured, finished and filled in
accordance with the Good Manufacturing Practice regulations promulgated by the
United States Food and Drug Administration in Title 21 of the Code of Federal
Regulations, and packaged in a condition that permits consumption by humans in
accordance with all applicable laws and regulations of the State of California.
IV. Implementation of the Protocol
(a) Upon receipt of Anticort from SII in accordance with Section III
Alliance shall, subject to sections IV and XI, make all reasonable
efforts to implement the Protocol.
SII shall consult and cooperate with Alliance on all aspects of and at
all times during the course of the Anticort trial.
(b) SII shall be responsible for payment of the costs of conducting the
Anticort trial in accordance with this section IV and section XI.
Alliance and SII agree that, based on the best information available to
each of them as of the execution of this agreement, the total costs of
the Anticort trial are, unless adjusted or revised in accordance with
paragraph (c) of this section IV, not expected to exceed the amount
shown on the budget attached as Exhibit B to this agreement. SII shall,
upon execution of this agreement, pay to Alliance the sum of
$226,885.75, representing an initial installment payment of thirty-five
percent (35%) of the total costs projected in the attached budget. The
balance of the budget amount shall be placed in an escrow account at the
bank of Alliance's direction. Interest earned while the funds are in the
escrow account shall accrue to the benefit of SII. Funds may be
withdrawn from the escrow account by Alliance in the amount equal to the
percentage of such costs, as adjusted or revised pursuant to paragraph
(c) of this section IV upon reaching the milestones indicated in the
following table:
Amount (unless
Installment % of Total budget amended per
Number Budget section IV) Due Upon
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Enrollment of the first
2 5% $32,412.25 cohort of patients (the
first dose level of the
study - per the protocol)
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Completion of Week 4
3 5% $32,412.25 (Day 21) of the first
cohort.
--------------------------------------------------------------------------------------------------
Enrollment of the second
4 5% $32,412.25 cohort of patients (the
second dose level of the
study - per the protocol)
--------------------------------------------------------------------------------------------------
Completion of Week 4
5 5% $32,412.25 (Day 21) of the second
cohort.
--------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------
Enrollment of the third
6 5% $32,412.25 cohort of patients (the
third dose level of the
study - per the protocol)
--------------------------------------------------------------------------------------------------
Completion of Week 4
7 5% $32,412.25 (Day 211) of the third
cohort.
--------------------------------------------------------------------------------------------------
Enrollment of the fourth
8 5% $32,412.25 cohort of patients (the
fourth dose level of the
study - per the protocol)
--------------------------------------------------------------------------------------------------
Completion of Week 4
9 5% $32,412.25 (Day 21) of the fourth
cohort.
--------------------------------------------------------------------------------------------------
Completion of Week 11
10 10% $64,824.5 (Day 70) of all patients
in all four cohorts.
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Delivery of all study data
11 (final) 10% $64,824.5 and the study report, as
provided for in the
Protocol.
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(c) The amount of costs projected in the budget may be adjusted or
revised at such times and in such amounts as may be agreed upon
by Alliance and SII in connection with any modification,
revision or amendment to the Protocol. Study participants who
drop out of the study prior to completion will be replaced with
additional participants. Such replacements, if there are any,
shall increase the budget accordingly. Alliance shall be paid on
a pro-rata basis for any participants who drop out of the study,
pursuant to the visit-based, line-item budget. Any augmentations
to the budget necessitated by the replacement of drop-outs shall
be paid in the 10th installment, prior to the final delivery of
the study data and study report.
(d) SII may rely on the clinical study monitor hired by SII to
monitor this study to verify that budget milestones have been
reached.
V. Representations and Warranties By SII
SII hereby represents and warrants to Alliance that it has clear and
unencumbered legal right and title to the use of Anticort, and that the delivery
to Alliance of Anticort and the use of Anticort pursuant to this agreement does
not and will not constitute a breach, infringement or other invasion of the
rights of any other individual, corporation or other entity to own, license,
exploit, possess or use for any purpose Anticort or any other substance, product
or tangible thing which any third party may claim Anticort is derived from or is
in any way related to.
VI. Audits or Investigations
For a period commencing with the execution of this agreement and
continuing through the end of the fifth anniversary of the date on which the
administration of Anticort to a human subject during the Anticort trial last
occurred, Alliance and SII each agree to notify the other within three business
days of the receipt of any inquiry from, or notice of an audit or investigation
of the Anticort trial by, any federal, state or local regulatory or enforcement
agency, and shall consult with each other prior to responding to any such
inquiry, audit or investigation.
VII. Ownership and Publication of Data, Results and Papers
(a) Subject to paragraphs (b), (c) and (d) of this section VII, all
writings of any kind and description delivered by either party to the other
concerning Anticort, or containing data from or results of the Anticort trial,
shall be owned by the author thereof and shall not be disclosed or delivered to
any third party for any purpose, other than pursuant to an order from a court of
competent jurisdiction, without the express written consent of the owner.
(b) Notwithstanding paragraph (a) of this section VII, Alliance or SII
may prepare formal research papers concerning the Anticort trial on a joint or
independent basis provided, however, (i) that each party shall provide due
credit for and acknowledgment of the role played by the other in the design and
implementation of the Anticort trial, (ii) that each party preparing a paper on
an independent basis shall provide the other with thirty (30) calendar days
notice in advance of the initial submission thereof, on a formal or informal
basis, to a publication, academic institution, professional society or other
organization and shall, upon request by written notice received at least three
(3) calendar days prior to the date for such initial submission, permanently
delete from the manuscript of such paper all reference to or credit for the
participation of the other party and (iii) upon request by written notice from
SII to Alliance of an intent to file a patent application for or in any way
relating to Anticort. Alliance shall delay the initial submission of any paper
for a period of ninety (90) days from receipt of such notice.
(c) Notwithstanding paragraph (a) of this section VII, each party may,
upon the express written consent of the other party, disclose the existence of
the Anticort trial and the participation of the other party therein through one
or more communications to third parties.
(d) Notwithstanding paragraph (a) of this section VII, Alliance
expressly acknowledges and agrees that any and all patents, patent applications,
intellectual property and any and all inventions, discoveries, indications,
treatments, improvements, new technologies or other developments, whether
patentable or unpatentable and regardless of whether copyrightable (the
"Discoveries"), resulting from or arising out of the Anticort trial shall at all
times be and remain the sole and exclusive property of SII, and that Alliance
and its employees or agents shall execute and deliver to SII all instruments
required to confirm, convey or assign exclusive ownership of the Discoveries in
or to SII. SII hereby grants to Alliance a royalty-free nonexclusive right to
use the Discoveries in the course of the Anticort trial and in any research
undertaken by Alliance in the future on a nonprofit basis, and to publish its
findings with respect thereto in accordance with paragraph (b) of this
section VII.
VIII. Indemnification
SII and Alliance shall each indemnify, defend and save harmless the
other, and the directors, officers, employees and agents thereof, from and
against any and all liability, losses, damages errors and omissions and/or
expense arising from or relating to the Anticort trial, including, but not
limited to, defense costs and legal fees, as follows:
(a) SII shall indemnify Alliance from and against all claims for
damages for personal injury arising from, resulting or allegedly resulting from
the Anticort trial including, without limitation, bodily injury, emotional
distress, death, or other personal injury of any kind or description provided
that such personal injury is not attributable to the negligence or wrongful act
of Alliance or its agents and employees. Negligence or wrongful act shall
include the conduct of research contrary to the Protocol in one or more material
respects.
(b) Alliance shall indemnify SII from and against all claims for
damages for personal injury arising from, resulting or allegedly resulting from
the Anticort trial attributable to the negligence or wrongful act of Alliance
or its agents and employees including, without limitation, bodily injury,
emotional distress, death, or other personal injury of any kind or description.
Negligence or wrongful act shall include the conduct of research contrary to the
Protocol in one or more material respects.
(c) SII shall indemnify Alliance from and against all claims by third
parties for damages for or injunction against property damage arising from,
resulting or allegedly resulting from the Anticort trial including, without
limitation, any past, present or future damage to any property belonging to or
in the care, custody or control of Alliance, SII or any third party, including
physical damage
to or loss of real property or tangible personal property, or any past, present
or future damage to or impairment of intangible property, including intellectual
property protected or allegedly protected by patent, patent pending, trademark,
copyright or common law or any claim of right under a patent, patent pending,
trademark, copyright or common law.
(d) SII shall indemnify Alliance from and against all claims or
expenses in or arising from any civil or criminal proceeding or inquiry brought
or commenced by any governmental agency arising from or relating to the Anticort
trial, unless such claims or proceedings arise from or are attributable to the
negligence or wrongful act of Alliance or its agents or employees. Negligence or
wrongful act shall include the conduct of research contrary to the Protocol in
one or more material respects.
IX. Disclaimer of Alliance Liability
SII agrees that Alliance, and the directors, officers, employees or
agents of Alliance, shall not be liable to and owe no duty to SII for any losses
incurred by SII and the directors, officers, employees or agents of SII
resulting from or incurred under this agreement including, without limitation,
bodily injury, death, personal injury, or any past, present or future damage to
any property, including physical damage to or loss of property belonging to SII
while such property is in the care, custody or control of Alliance, or any past,
present or future damage to or impairment of intangible property, including
intellectual property protected or allegedly protected by patent, patent
pending, trademark, copyright or common law or any claim of right under a
patent, patent pending, trademark, copyright or common law.
X. Insurance
Alliance and SII each hereby represent and warrant to the other that it
currently maintains comprehensive general liability insurance, including errors
and omissions or professional malpractice liability insurance, in the amounts of
not less than $1,000,000 per occurrence and $2,000,000 aggregate. Without
limiting the indemnification obligations of each party pursuant to section VIII,
or the disclaimer of Alliance liability pursuant to section IX, each of Alliance
and SII shall, for a period of two years commencing with the execution of this
agreement, (i) maintain insurance coverage at or above the current occurrence
and aggregate limits of the policies specified in the first sentence of this
section IX and (ii) obtain endorsements naming the other as an additional
insured under each such policy.
XI. Termination
Either Alliance or SII may, at any time, advise the other by written
notice that implementation or completion of the Protocol, or performance of this
agreement, has become
impossible due to circumstances beyond the control of the party giving such
notice. This agreement and the Anticort trial shall terminate thirty (30)
calendar days following such notice. In the event of termination pursuant to
this section XI, the obligations of Alliance shall be limited to (i) returning
to SII all Anticort then currently in the possession of Alliance, (ii) executing
and delivering to SII all instruments required to effect compliance by Alliance
with its obligations pursuant to paragraph (d) of section VII and (iii)
providing SII with copies of all papers, tapes, disks, diskettes or other
tangible materials currently in its possession that would have been provided to,
or would have become the basis for other papers to be provided to, SII pursuant
to section VII of this agreement and the Protocol provided, however, that
Alliance shall have no obligation to create or in any way edit any papers,
tapes, disks, diskettes or other tangible documents, writings or other
materials. In the event of termination pursuant to this section XI, Alliance
shall be entitled to payment for, and SII shall pay within ten (10) business
days of receipt of an invoice therefor, all direct and indirect costs actually
incurred by Alliance in connection with the Anticort trial which, as of the date
of termination, remain unreimbursed through one or more of the installments
already paid by SII pursuant to section IV. Alliance and SII expressly agree and
acknowledge that, notwithstanding the termination of this agreement pursuant to
this section XI, the provisions of sections VI, VIII, X and XI shall survive and
remain in effect in accordance with their respective terms.
XII. Use of Parties Names
Alliance and SII will obtain prior written permission from each other
before using the name, symbols and/or trademarks of the other party in any form
of publicity. This shall not include legally required disclosure by Alliance or
SIT that identifies the existence of this Agreement.
XIII. Waivers
No waiver by either party of a breach of any provision of this
agreement shall constitute a waiver of any other breach of such provision.
Failure of either party to enforce at any time, or from time to time, any
provision of this agreement shall not be construed as a waiver thereof.
XIV. Entire Agreement and Construction With Protocol
This agreement shall constitute the complete and exclusive statement of
the understanding of the parties concerning their respective rights and
obligations arising from, relating to or concerning the Anticort trial. In the
event of any conflict or inconsistency between this agreement and the Protocol,
the provisions of this agreement shall govern and shall be given conclusive
effect.
XV. Modifications
No modification, amendment, waiver or release of any provision of this
agreement or of any right, obligation, claim or cause of action arising
hereunder shall be valid or binding for any purpose unless in writing and duly
executed by both Alliance and SII in the same manner as this agreement.
XVI. Governing Law
This agreement shall be governed by and construed in accordance with
the laws of the State of California.
XVII. Notices
All notices by either party to the other hereunder, including notice of
a change in the address information set forth below, shall be in writing and
shall be delivered either by first class mail, postage prepaid, or by facsimile
transmission during regular weekday business hours which shall be effective only
upon receipt by the sender of confirmation by telephone of the date and time of
receipt thereof from a full time employee of the recipient, and shall be
addressed as follows:
Alliance: AIDS RESEARCH Alliance
Attention: Xxxxxxx Xxxxx, CEO
000X Xxxxx Xxx Xxxxxxx Xxxxxxxxx
Xxxx Xxxxxxxxx, XX 00000
Fax: (000) 000-0000
SII: Steroidogenesis Inhibitors International Corporation
Attention: Xxxxxx Xxxxx, M.D.
President
0000 Xxxxxxxx Xxxx, Xxxxx 000-X
Xxx Xxxxx, XX 00000
Fax: (000) 000-0000
IN WITNESS WHEREOF, each of Alliance and SII have caused this agreement
to be subscribed in its behalf by its duly authorized officer on the day, month
and year first above written.
AIDS RESEARCH ALLIANCE SII CORPORATION
By /s/ Xxxxxxx X. Xxxxx By /s/ Xxxxxx Xxxxx, M.D.
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Xxxxxxx X. Xxxxx Xxxxxx Xxxxx, M.D.
Chief Executive Officer President
