Exhibit 10.10
Government Funding Fee Agreement
This Agreement ("Agreement") is made and entered into as of the 5 day of April,
2004 between Xxxxx Xxxxx (the "Finder") and Advaxis, Inc. (the "Company").
1. Background: Finder believes he may be able to arrange for Company
government funded clinical studies for LM LLO E7 or other Advaxis
products so as to minimize Advaxis' cash burn rate in demonstrating
the potential of the Listeria system with LM LLO E7 or other Advaxis
products in human phase I clinical trials and in clinical trials of
cervical cancer or other cancers. The parties have agreed that
Finder will attempt to assist Company in obtaining such government
funding ("Government Clinical Trial Sponsorship") for Clinical
Trials to be conducted for the Company (such clinical trials testing
Company products or constructs and sponsored by government through
the efforts of Finder: " Government Sponsored Clinical Trial").
2. Equity Compensation: If Finder successfully arranges Government
Sponsored Clinical Trial, Company shall grant Finder a non qualified
common stock option grant with that number of common stock option
equal to (a) 4% (four percent) of the Economic Value of the
Government Clinical Trial Sponsorship divided by (b) $100. The
options are exercisable at $100 per share. For purpose of this
agreement, "Economic Value" of Government Clinical Trial Sponsorship
will be determined according to a formula specified in Exhibit A.
The grant will be made upon final formal approval of the Government
Clinical Trial Sponsorship. The terms of Company's option plan for
outside consultants shall apply, however once the options are
granted, the Consultant will have no requirement to exercise the
options if the Consulting arrangement is terminated and the
Consultant will be free to exercise these options at his discretion
regardless of any ongoing relationship with Advaxis. For example: if
Finder arranges Government Clinical Trial Sponsorship for a Phase II
study, with 50 patients with outpatient settings, the Economic Value
per Exhibit A shall be $1,100,000. In that case, Finder shall
receive 440 options exercisable at $100 per share. On a post 100:1
split basis this will be 44,000 options at $1.00 per share.
3. Exclusion of other transactions: It is hereby agreed and understood
that this agreement covers only Government Clinical Trial
Sponsorship obtained directly through the efforts of Finder and will
not entitle Finder to receive any fees in connection with any other
funding or transactions including but not limited to : (a) equity or
debt financing of any type, (b) NIH grants obtained by or applied
for by Company directly or with its partners, (c) joint ventures,
licensing, vendor financing, (d) mergers, acquisition, sale of
assets (e) clinical studies conducted by Approved Investors and
funded by Company, or (f) sale of securities of any kind by Company
(g) government manufacturing process development and pre clinical
and toxicology support under the NIH and/or RAID program.
4. Term: This agreement will expire on April 5, 2005 and thereafter
will renew on a month-to-month basis unless cancelled in writing by
either party. Upon termination or non-renewal of this agreement
Consultant will maintain a list of Investigators that will be
approached to conduct these trials, provided however that such
Investigators are pre
approved by Company in writing, in advance. Exhibit B, as amended
from time to time, in writing, contains the list of Company approved
Investigators ("Approved Investigators").
5. Post termination government sponsored clinical studies: If any such
Approved Investigator agrees to conduct government sponsored
clinical studies with an Advaxis product within six months of
termination of this Agreement, and such Government Clinical Trial
Sponsorship is obtained by Company, then Finder shall be entitled to
full compensation as set out in section 2 upon the final written
approval of Government Clinical Trial Sponsorship.
6. Subsequent clinical trial sponsorship: If consultant is successful
in arranging a phase I Government Clinical Trial Sponsorship as
specified in this agreement, then subsequent Government Sponsored
Clinical Trials with the same Approved Investigators testing the
same product or construct will be subject to the terms of this
agreement provided that: (a) such subsequent Government Sponsored
Clinical Trial is approved by the government and initiated within 12
months of the completion of any previous clinical trial covered
under this agreement, and (b) such subsequent Government Clinical
Trial Sponsorship is obtained directly through current or previous
efforts of Finder. For the purpose of clarity, this paragraph is
designed to enable the Finder to receive fair compensation for
obtaining Government Sponsored Clinical Trial for phase I trials and
subsequent trials should the phase I trials be completed
successfully and subsequent phase I, II, and III trials proceed in a
natural progression as a result of the Finders work in establishing
initial government funding for the initial phase I program.
7. Entire agreement; dispute: This Agreement constitutes the entire
agreement between the parties with respect to the subject matter
hereof. This Agreement may not be amended, modified or waived,
except in writing signed by both parties. This Agreement may be
executed in counterparts. Should a dispute arise between the parties
under or relating to this Agreement, each party agrees that prior to
initiating any formal proceeding against the other (except when
injunctive relief is appropriate), the parties will each designate a
representative for purposes of resolving the dispute. If the
parties' representatives are unable to resolve the dispute within
ten business days, the dispute shall be settled by mediation and
then, if necessary, by arbitration under the then-current commercial
arbitration rules of the American Arbitration Association. The
location of the proceeding shall be Princeton, NJ. Judgment upon any
award rendered by the arbitrator may be entered by any State or
Federal court having jurisdiction thereof.
8. Assignment. This Agreement may not be assigned by any party without
written consent
9. Non Exclusive. The Company may from time to time: (i) engage other
persons and entities to act as consultants to the Company and
perform services for the Company, including services that are
similar to the ones described herein; and (ii) enter into agreements
similar to this Agreement with other persons or entities, in all
cases without the necessity of obtaining approval from Consultant.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to
be
duly executed on the day of the year first above written.
ADVAXIS, INC. FINDER
By: /s/ J. Xxxx Xxxxxx By: /s/ Xxxxx Xxxxx
------------------------------- -------------------------------
Name: Name:
Title:
Exhibit A
Economic Value of Government Sponsored Clinical Trials
Phase I
Fixed costs
Biostatistic Analyses $300,000
Pharmacokinetic Analyses $150,000
Variable costs
Cost per patient if outpatient $ 10,000
Cost per patient if inpatient
or extended stay/observation $ 14,000
Total cost 450,000 plus number of enrolled patients X 10,000 or 14,000 dependent
on type of study.
Phase II trials (about 30 to 50 patients)
Fixed costs
Biostatistic Analyses $400,000
Pharmacokinetic Analyses $200,000
Variable costs
Cost per patient if outpatient $ 10,000
Cost per patient if inpatient
or extended stay/observation $ 14,000
Total cost 600,000 plus number of enrolled patients X 10,000 or 14,000 dependent
on type of study.
Phase III trials (about 300-400 patients)
Fixed costs
Biostatistic Analyses $700,000
Pharmacokinetic Analyses $400,000
Variable costs
Cost per patient if outpatient $ 10,000
Cost per patient if inpatient
or extended stay/observation $ 14,000
Total cost 1,100,000 plus number of enrolled patients times $10,000 or $14,000
dependent on type of study.
Exhibit B
Approved Investigators
XXXXXXX XXXXX
UNIVERSITY OF SOUTHERN CALIFORNIA
XXXXXXXX XXXXXXX
XXXXX XXXXXXX UNIVERSITY
XXXXXX XXXXXX
NCI
