EXHIBIT 10(m)
[CLINICAL TRIALS AGREEMENT BETWEEN THE COMPANY AND
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES]
Clinical Trials Agreement Protocal DMID 96-091
SIGA Pharmaceuticals, Inc.-NIAID 6/2/97
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
CLINICAL TRIALS AGREEMENT
FOR STUDIES DONE WITH THE DIVISION OF
MICROBIOLOGY AND INFECTIOUS DISEASES
BASED ON
PROTOCOL DMID 96-091
SAFETY, TRANSMISSIBILITY AND DOSE-RESPONSE IN HUMANS OF A
GROUP A STREPTOCOCCAL VACCINE GP 1223 COMPRISING THE HUMAN COMMENSAL BACTERIUM
STREPTOCOCCUS GORDONII ENGINEERED TO EXPRESS THE CONSERVED REGION OF THE M
PROTEIN OF
STREPTOCOCCUS PYOGENES
IN COLLABORATION WITH
SIGA PHARMACEUTICALS, INC.
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Clinical Trials Agreement Protocol DMID 96-091
SIGA Pharmaceuticals, Inc.-NIAID 6/2/97
The Division of Microbiology and Infectious Diseases (DMID), National Institute
of Allergy and Infectious Diseases (NIAID), and SIGA Pharmaceuticals, Inc.,
located at 000 Xxxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000, have agreed to cooperate
on the conduct of a clinical trial whose designation of Protocol DMID 96-091 for
Streptococcus gordonii GP 1223 vaccine, entitled "Safety, Immunogenicity,
Transmissibility and Dose-Response in Humans of a Group A Streptococcal Vaccine
GP 1223 Comprising the Human Commensal Bacterium Streptococcus gordonii
Engineered to Express the Conserved Region of the M Protein of Streptococcus
pyogenes."
The DMID, NIAID believes that this clinical trial can be efficiently conducted
by taking advantage of the established clinical trial site network, Vaccine and
Treatment Evaluation Units which is uniquely positioned to coordinate the
efforts of a staff of program and data managers, scientists, physicians,
statisticians and regulatory experts. Thus, the agreement whose terms and
conditions under which the protocol will be conducted and which are outlined
below reflects this belief.
The understanding by both parties to the agreement is as follows:
1. INVESTIGATIONAL NEW DRUG APPLICATION (IND) SPONSORSHIP
The NIAID shall be responsible for the submission of an IND covering
Protocol DMID 96-091. The IND shall satisfy all of the requirements of the
United States Food and Drug Administration (U.S. FDA). A letter granting
cross reference to SIGA Pharmaceuticals, Inc.'s FDA files which pertain to
S. gordonii GP 1223 vaccine shall be supplied by SIGA Pharmaceuticals,
Inc., and, in return, the NIAID will also supply a letter, if requested,
granting cross reference to the NIAID'S IND to SIGA Pharmaceuticals, Inc.
A. Monitoring
The IND Holder shall be responsible for clinical site monitoring and
the quality assurance of all data. Monitoring shall be done in
compliance with U.S. FDA Good Clinical Practices Guidelines.
Representatives of SIGA Pharmaceuticals, Inc. shall have the right
with the coordination of the IND Holder to visit the clinical site
with the IND Holder.
B. Adverse Experience Reporting
Adverse experience reports shall be collected by the IND Holder according
to the procedures outlined in the protocol.
The IND holder shall assume total responsibility for the reporting of
such adverse events to the FDA with a copy to SIGA Pharmaceuticals,
Inc.
The IND holder shall report all serious and life threatening adverse
events observed in this clinical trial to FDA and SIGA
Pharmaceuticals, Inc., on a timely basis consistent with Federal
Regulations 21 CFR 312.32. All other adverse experiences shall be
reported by IND holder to FDA and SIGA Pharmaceuticals, Inc. on a
timely basis consistent with Federal Regulations 21 CFR 312.33 for the
Annual Report. Specific provisions for reporting adverse experiences
to agencies outside the U.S. shall be provided for as required.
SIGA Pharmaceuticals, Inc. shall, in a timely manner and during the
term of this trial, provide the DMID, NIAID with any information it
now has or may obtain in the future regarding the safety and/or the
toxicity of S. gordonii GP 1223 vaccine.
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2. PROTOCOL TEAM
Development and management of the protocol, evaluation of data, proposal of
amendments, recommendations for early termination, etc. shall be the
responsibility of the Protocol Team. The membership shall include the
study PI, co-investigators, representatives from the DMID, NIAID, SIGA
Pharmaceuticals, Inc. and the persons involved with statistical and data
analysis from the study.
While the DMID, NIAID will endeavor to control the distribution of the
protocol document itself, SIGA Pharmaceuticals, Inc. acknowledges that a
list of all protocols which are open to patient enrollment are available
(with abstracts) to the public under the Freedom of Information Act.
3. STUDY SITES
The DMID, NIAID will utilize trial sites under Government Contract for the
studies described in the protocol.
The NIAID will ensure that the protocol will be conducted at Clinical Trial
Sites according to the U.S. FDA Good Clinical Practices Guidelines.
4. CASE REPORT FORM (CRF) DEVELOPMENT
The Protocol team shall assume responsibility for the development and
subsequent revisions, if any, of CRFs with appropriate review and approval
by the DMID, NIAID.
5. DATA COLLECTION, MANAGEMENT, ANALYSIS AND REPORTING
The DMID, NIAID shall assume responsibility for the collection, management,
analysis, and initial reporting of all data obtained from the trial. SIGA
Pharmaceuticals, Inc. may utilize data and reports from this study for any
legitimate business or regulatory purpose.
Information which may be released to the public or which may have
significant impact on SIGA Pharmaceuticals, Inc.'s approval of S. gordonii
GP 1223 vaccine for commercial sale shall not be released without prior
discussion of the information with SIGA Pharmaceuticals, Inc. except to the
extent required by Federal Law.
SIGA Pharmaceuticals, Inc., after appropriate consultation with the DMID,
NIAID, may provide information regarding the trial to governmental
organizations (e.g., FDA, SEC, etc.).
6. VACCINE SUPPLY AND DISTRIBUTION
The DMID, NIAID shall provide SIGA Pharmaceuticals, Inc. with an estimate
of the quantity of S. gordonii GP 1223 vaccine that will be required to
complete the protocol. SIGA Pharmaceuticals, Inc. shall provide this
quantity of vaccine to the DMID, NIAID without charge. The NIAID shall be
responsible for distributing S. gordonii GP 1223 vaccine as well as any
other vaccine used in the trial to the trial sites. The timing of the
delivery and the quantities of the vaccine shipped to repository or study
sites shall be mutually agreed upon. The DMID, NIAID shall not provide any
of the vaccine to a third party (other than the specific trial sites)
without the prior written consent of SIGA Pharmaceuticals, Inc.
SIGA Pharmaceuticals, Inc., shall provide the DMID, NIAID with necessary
Material Safety Data Sheet (MSDS) for S. gordonii GP1223 vaccine together
with any specific storage or shipping instructions.
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7. CONFIDENTIALITY/PROPRIETARY INFORMATION
The DMID, NIAID shall treat as confidential/proprietary any preclinical,
clinical, or formulation data that SIGA Pharmaceuticals, Inc. marks
"Confidential" including but not limited to the Investigator's Brochure and
the protocol. Such information is the sole and exclusive property of SIGA
Pharmaceuticals, Inc. during the period of this Agreement and subsequent
thereto. Likewise, all information which is disclosed visually or orally
and subsequently confirmed as Confidential Information in writing within
ten (10) working days after first disclosure will be held as Confidential
Information.
Confidential/Proprietary Information means confidential scientific,
business, or financial information provided that such information:
is not publicly known or available from other sources who are not
under a confidentiality obligation to the source of the information;
has not been made available by its owners without a confidentiality
obligation;
is not already known by or available to the receiving Party without a
confidentiality obligation; or does not relate to potential hazards or
cautionary warnings associated with the production, handling, or use
of the subject matter of this Agreement
8. TRIAL DATA
All raw data obtained from the trial shall be the property of the Clinical
Trial Site that produces the data. These data shall not be released to the
public except to the extent required by law. No persons or party other
than SIGA Pharmaceuticals, Inc., its contractor, and/or its designate shall
have any rights to review and/or use the raw data obtained from the trial
for purposes of filing an NDA without the permission of SIGA
Pharmaceuticals, Inc.
Where applicable, the grouped data shall be controlled by the NIAID and
shall not be released to the public without appropriate consultation with
SIGA Pharmaceuticals, Inc. However, SIGA Pharmaceuticals, Inc. retains the
right to access and utilize the data for all legitimate business or
regulatory purposes.
Upon completion of the study, SIGA Pharmaceuticals, Inc. will be provided
with a copy of the complete analysis data set and other raw data as
required in a machine-readable format to be determined jointly.
9. FDA MEETING
With respect to any discussions with FDA involving data obtained from this
trial, IND holder shall take the initiative in arranging meetings with the
FDA. Formal meetings with the FDA concerning the trial data shall be
discussed and agreed upon by SIGA Pharmaceuticals, Inc. and the DMID, NIAID
in advance. SIGA Pharmaceuticals, Inc. shall have the right to attend all
formal meetings with the FDA. The IND holder shall provide SIGA
Pharmaceuticals, Inc. with written summaries of all substantive telephone
discussions with the FDA.
10. PUBLICATIONS POLICY
Any publications based on the results of the trial shall conform to the
conditions in the "Advance Understanding" in the contract with the
University of Maryland, Contract N01 AI45251: "The content of any abstract
or manuscript containing data generated under this contract
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shall be submitted for review by the NIAID Project Officer before
submission for public presentation or publication including presentations
at a scientific meeting which includes abstracts. Preprints and reprints
of these shall be sent to the Project Officer."
Additional clauses within the contract state that all publications shall
acknowledge NIAID support and be submitted to the Project Officer for
review prior to publication. The Project Officer shall have access to all
data generated with the support of this contract. SIGA Pharmaceuticals,
Inc. shall receive copies of any abstract or manuscript prior to their
submission for publication with sufficient time for review and comment.
11. INDEMNIFICATIONS AND DISPUTES
No indemnification for damages is provided for under this agreement. Each
party shall be liable for damages it incurs as a result of its own
activities under this agreement.
Any dispute arising under this Agreement which is not disposed of by
agreement of the parties shall be submitted jointly to the signatories of
this Agreement. If the signatories are unable to jointly resolve the
dispute within thirty (30) days after notification thereof, the Assistant
Secretary of Health (or his/her designee) shall propose a resolution.
Nothing in this section shall prevent any Party from pursuing any and all
administrative and/or judicial remedies which may be available.
12. ENDORSEMENT
SIGA Pharmaceuticals, Inc. acknowledges that the involvement of the DMID,
NIAID in the trial shall not be construed as an endorsement by the DMID,
NIAID or the National Institutes of Health (NIH) for S. gordonii GP1223
vaccine. However, this does not prohibit SIGA Pharmaceuticals, Inc. to
reference or use publications and reports based on the trial for legitimate
business and regulatory purposes.
13. PROVISION OF FINANCIAL SUPPORT TO NIAID CLINICAL TRIALS
SIGA Pharmaceuticals, Inc. shall not provide separate funding to any sites
participating in the trial for any aspect of the study without the prior
written approval of the DMID, NIAID.
14. UNILATERAL TERMINATION
Either DMID, NIAID or the Collaborator may unilaterally terminate this
entire Agreement at any time by giving written notice at least sixty (60)
days prior to the desired termination date.
The Parties agree that should this Agreement be terminated, the Protocol
will nonetheless be completed if medically appropriate.
Neither party may transfer or assign this Agreement or any rights or
obligations under this Agreement.
If this Agreement is terminated, SIGA Pharmaceuticals, Inc. shall receive
copies of all data, reports and other information related to this clinical
trial and any unused vaccine. The obligations under Paragraphs # 1B
(Adverse Experience Reporting), #2 (Protocol Team, as it relates to the
distribution of the Protocol); #5 (Data Collection, Management, Analysis
and Reporting, as it relates to the release of information); #8 (Trial
Data), #10 (Publications Policy) and #11 (Indemnification and Disputes)
shall survive the termination of this Agreement. In addition, the
Confidentiality provisions of Paragraph #7 will expire three years from the
date this agreement is terminated.
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If you agree with the terms of this Clinical Trials Agreement for Protocol DMID
96-091 entitled "Safety, Immunogenicity, Transmissibility and Dose-Response in
Humans of a Group A Streptococcal Vaccine GP1223 Comprising the Human Commensal
Bacterium Streptococcus gordonii Engineered to Express the Conserved Region of
the M Protein of Streptococcus pyogenes," please have your authorized
representative sign below. An additional signed original is enclosed for your
records.
/s/ Xxxx X. Xx Xxxxxxxx 6/26/97
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Xxxx X. Xx Xxxxxxxx (Date)
Division Director
National Institute of Allergy and Infectious Diseases
National Institutes of Health
/s/ Xxxxxx X. Xxxxxxxx 6/27/97
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Office of Technology Development (Date)
National Institute of Allergy and Infectious Diseases
National Institutes of Health
/s/ Xxxxx xx Xxxxx 6/27/97
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Xxxxx xx Xxxxx (Date)
President & CEO
SIGA Pharmaceuticals, Inc.
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