EXHIBIT 10.24
LETTER OF AGREEMENT
November 26, 1996
Dr. Xxxxxxxx Xxxxx
University of Washington
Xxxx Xxxxxxxxxx Cancer Research Ctr.
0000 Xxxxxxxx Xx. (M115)
Xxxxxxx Xxxxxxxxxx 00000
RE: Clinical Protocol CR 000-000-00 GENEVAX-Registered
Trademark--HSV (APL 400-024), A Candidate Facilitated DNA
Vaccine: A Phase I Study in Herpes Simplex Virus-2
Negative Volunteers Using Intramuscular Injection With the
Biojector-Registered Trademark- Needle-Free Injection
system
Dear Xx. Xxxxx:
This letter will supersede the August 16, 1996 letter of Agreement that was sent
to you and confirms the agreement between Apollon, Inc. ("SPONSOR") and YOU to
act as Principal Investigator in the performance of the above titled clinical
research ("STUDY").
1. YOU will be the Principal Investigator for this STUDY. As Principal
Investigator, YOU will have overall responsibility for the conduct of the STUDY
and the supervision of all personnel involved with the STUDY.
2. YOU have agreed to conduct the clinical STUDY in accordance with the
STUDY protocol dated August 16, 1996, which will be forwarded to the US Food and
Drug Administration as outlined in YOUR signed FDA 1572 form.
3. Based on YOUR appraisal of availability of qualified potential
patients for entry into the STUDY, it is expected that you can enroll sufficient
number of patients to provide up to 40 qualified patients. Patients will be
divided into groups as defined by the protocol.
4. The SPONSOR agrees to support the STUDY according to the schedule
below. Reimbursements for any procedures, visits or other charges performed
apart from those scheduled by the protocol are subject to approval by the
SPONSOR. Total per
Dr. Xxxxxxxx Xxxxx
November 26, 1996
Page 2
patient cost is $8,6124.23/patient, to be paid in US dollars. Payment will also
be made for patients screened but not treated. A supplemental advertising cost
of $20,000 for radio ads will be paid as a separate payment. The total clinical
study cost is $364,569 (see attached). This does not include the budget for the
local antibody studies, which go directly to Xxxxx Xxxxxx'x program (see
attached).
5. Payment schedule will be the following:
Starting in November, 1996 and ending in January 1998, the following
monthly payment will be made:
- University of Washington: $9,030 (Total over 15 months =
$135,454.00)
- Children's Hospital Medical Center: $8,198.20 (Virology Research
Fund) (Total over 15 months = $209,115)
Final payment of $86,142 (25% of the total grant) will be paid upon
completion and "clean up" of all HSV-1 Negative and Positive subject case report
forms.
NOTE: Patients not completing the study will be prorated according to
procedure/visits completed.
6. YOU agree to maintain complete and up-to-date study records during the
STUDY including Case Report form, drug reconciliation materials and copies of
study related correspondence.
7. In the event YOU fall behind in maintaining YOUR study records, the
SPONSOR reserves the right to retain trained healthcare professionals to assist
in satisfactory completion of the Case Report Forms.
8. Personnel from the SPONSOR will call on YOU periodically to monitor
and determine the status of YOUR STUDY, answer procedural questions, and
retrieve completed Case Report Forms. YOU agree to make these and STUDY
participant records available for comparison with Case Report Forms for review,
completion and/or copying if requested by the Monitor or representatives of the
US FDA.
9. THE STUDY protocol and the data generated from this STUDY are the
property of the SPONSOR and will be maintained as confidential by the
Investigator. The results of this STUDY
Dr. Xxxxxxxx Xxxxx
November 26, 1996
Page 3
may be published or presented at scientific meetings. If this is
envisaged, the Investigator agrees to submit all manuscripts or
abstracts to Apollon prior to submission. This allows the SPONSOR
to protect proprietary information and to provide comments based on
information from other studies that may not yet be available to the
Investigator.
Any formal publication of the STUDY in which input of Apollon personnel
exceeded that of conventional monitoring will be considered as joint
publication by the Investigator and the appropriate Apollon personnel.
Authorship will be determined by mutual agreement between the SPONSOR
and Principal Investigator.
10. The SPONSOR has the right to terminate this Agreement and the STUDY,
for any reason including insufficient patient enrollment, upon either written
notification or oral notice confirmed promptly in writing to the Investigator
where such termination shall be consistent with accepted medical practice. If
the STUDY is discontinued, the funds paid or to be paid will be equitably
adjusted to reflect the number of patients evaluated, approved additional
tests, and the actual cost incurred by YOU.
If this Letter of Agreement is acceptable to you, please sign and date two
original copies in the space provided below, returning
one to us for our records.
Sincerely yours,
/s/ Xxxxxxx X. Xxxxxxxx
________________________________________
Xxxxxxx X. Xxxxxxxx, Xx., Ph.D
PRESIDENT AND CHIEF EXECUTIVE OFFICER
/s/ Xxxxxxxx Xxxxx
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Principal Investigator
12/4/96
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Date
