Exhibit 10.1

 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

CLINICAL TRIAL AGREEMENT

FOR SYNTHETIC BIOLOGICS, INC.

 

 

THIS CLINICAL TRIAL AGREEMENT (the “Agreement”), effective this 7th day of
August, 2019 (the “Effective Date”), is made by and between Synthetic Biologics,
Inc., a Nevada corporation, having a place of business at 9605 Medical Center
Drive, Suite 270, Rockville, Maryland 20850 (“Sponsor”) and Washington
University, having a place of business at 660 S. Euclid Avenue, St. Louis, MO
63110 (“Institution”). Sponsor and Institution are sometimes individually
referred to herein singly as a “Party” and collectively as the “Parties.”

 

WHEREAS, Sponsor desires that Institution perform the Study, as defined herein
below, under the direction of Erik Dubberke, M.D. (“Principal Investigator”), an
employee of Institution;

 

WHEREAS, Institution has expertise in conducting human clinical trials of
pharmaceutical products in accordance with applicable laws, rules and
regulations;

 

WHEREAS, Institution has access to facilities that are suitable for the
performance of human clinical trials of pharmaceutical products in accordance
with applicable laws; and

 

WHEREAS, Institution has agreed to perform the Study, on the terms and
conditions set forth herein.

 

NOW, THEREFORE, the Parties, intending to be legally bound, have entered into
this Agreement and do specifically agree as follows:

 

1.0STUDY PROTOCOL

 

The scope and nature of the clinical trial to be performed by Institution (the
“Study”) will be in strict accordance with the protocol entitled, ”Phase 1b/2a
Evaluation of the Safety and Tolerability of SYN-004 in Adult Allogenic
Hematopoietic Cell Transplantation Recipients,” which has been provided to
Institution, and any subsequent amendments thereto (the “Protocol”). The
Protocol fully details the clinical research activities and responsibilities to
be undertaken by Institution. The Protocol will be considered final after it is
signed by the Principal Investigator and approved by the pertinent Institutional
Review Board(s) (“IRB”) and/or Ethics Committee(s) (“EC”) (hereinafter, the
“IRB/EC”). Thereafter, the Protocol may be amended only by prior written consent
of Sponsor and subsequent approval of the IRB/EC. In the event of a conflict
between the terms of the Protocol and the terms of this Agreement, the terms of
this Agreement shall prevail for all legal, administrative, and business matters
and the terms of the Protocol shall prevail for all patient care, scientific,
and medical matters.

 

Page 1 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

2.0CONDUCT OF STUDY

 

The Study will be conducted in accordance with applicable laws, rules, and
regulations governing the conduct of clinical trials and pertaining to
investigational drugs, generally accepted good clinical practice and the
conditions specified in the Statement of Investigator, U.S. Food and Drug
Administration (“FDA”) Form 1572, as described in 21 Code of Federal Regulations
(“CFR”) 312.53, which Institution and Principal Investigator shall have signed
and Institution shall have returned to Sponsor prior to the commencement of the
Study. Institution acknowledges and agrees that it is responsible for (A) the
actions, performance, and conduct of the Principal Investigator, and (B)
Principal Investigator’s compliance with all of Principal Investigator’s
obligations set forth in this Agreement. Any failure by the Principal
Investigator to perform or satisfy an obligation herein shall be considered a
breach of this Agreement by Institution. Institution agrees to use its
reasonable efforts to ensure that the Principal Investigator complies fully with
the terms of the Protocol. In the performance of the Study the Institution
specifically represents that it shall, and shall require the Principal
Investigator and all employees engaged in the performance of the Study to:

 

a.Exercise independent medical judgment as to the compatibility of each patient
with Protocol requirements;

 

b.Obtain from each patient in the Study and before the Study subject begins
participating in the Study a signed informed consent form in a form which has
been approved by the IRB/EC and reviewed and approved by Sponsor in accordance
with the Protocol and with 21 CFR Part 50 and/or the International Conference on
Harmonisation Guidelines for Good Clinical Practice as adopted by the FDA (“ICH
GCPs”), as applicable Institution will allow Sponsor and/or their respective
designees to inspect signed informed consent forms or make photocopies thereof
during monitoring visits or audits conducted in accordance with the terms of
this Agreement ;

 

c.Properly perform and direct the Study in accordance with applicable laws, the
Protocol and ICH GCPs and FDA GCPs;

 

d.Ensure that all advertising, recruitment, and training materials developed by
Institution, Principal Investigator, or any of Institution’s employees,
affiliates or agents in connection with the Study will comply with the Protocol,
as well as all applicable laws, regulations, codes and rules, and receive prior
review and approval by Sponsor and the IRB/EC, as applicable;

 

e.Review all patient case report forms (hereinafter “CRFs”) to assure their
accuracy and completeness, and assist Sponsor’s representatives and clinical
monitors upon request in promptly resolving any discrepancies or errors on CRFs
and in performing random audits on original patient records, laboratory reports
or other raw data sources and underlying data recorded on the CRFs (such audits
to be performed in accordance with the terms of this Agreement);

 

f.Submit all Protocol-required data and information to the Sponsor, IRB/EC and
all regulatory authorities, as applicable and undertake all Protocol-required
activities, so that the time schedules set forth in the Protocol and this
Agreement are strictly met;

 

Page 2 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

g.Record all adverse events on the Adverse Events page(s) of the CRF in
accordance with the Protocol. In the event of serious adverse events (“SAEs”),
as defined in the Protocol and applicable regulations, Institution shall
promptly and fully comply with all the notification procedures, time frames and
requirements stated in the Protocol. If the Protocol does not identify the
party(s) that is to be notified of SAEs, then the Institution shall promptly
notify Sponsor, by both telephone and telefax, of all SAEs within 24 hours of
becoming aware of the occurrence. In the event of SAEs that are immediately
life-threatening or that result in death, the Institution shall immediately
notify the party(s) specified in the Protocol by both telephone and telefax, and
if the Protocol does not identify the parties who are to be notified of SAEs,
the Institution shall immediately notify the Sponsor by both telephone and
telefax. Investigator will promptly notify Sponsor and/or their respective
designee, of any other safety information, that is not a serious adverse event,
and information regarding drug experience associated with the Study or the Study
Drug as specified in the Protocol;

 

h.Maintain records of patient identification, clinical observations, laboratory
tests, and drug receipt and disposition as specified in the Protocol.
Institution shall maintain all such records for the Study until the later of:
(i) such period required by federal, state, national and local laws and
regulations; (ii) two (2) years following the date a New Drug Application is
approved for the Study Drug that is the subject of the Study; or (iii) two (2)
years after the Investigational New Drug Application for such Study Drug is
terminated or withdrawn. During the time periods stated in (i) – (iii) above,
Institution shall not destroy any such records until it has obtained Sponsor’s
prior written permission to do so. After such time period has elapsed,
Institution shall be free to dispose of the records as it sees fit so long as it
has provided Sponsor with sixty (60) days’ notice of disposal or destruction of
records and an opportunity within such sixty (60) day period to take possession
of such records;

 

i.Cooperate with Sponsor and its agents (including, without limitation, its
designated clinical research organization) in all of their efforts to monitor
the Study, including but not limited to allowing direct access to records that
are maintained as Electronic Medical Records or in Institution’s clinical files.
Any such access will be upon reasonable advanced notice and at mutually
agreeable times during Institution’s normal business hours; it being agreed that
ten (10) business days is reasonable advance notice. The Institution reserves
the right to restrict access to patient areas and may require Sponsor to meet
certain standards required by applicable laws or Institution policy for access
to records or patient care areas. The Sponsor will, and will cause its agents
and representatives to, use and disclose any patient information in accordance
with the patient’s informed consent form and applicable laws and regulations. No
access to Institution’s financial records will be provided;

 

Page 3 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

j.Promptly notify Sponsor of any FDA regulatory inspections of which it becomes
aware relating to the Study. If legally permissible and practicable, Sponsor
shall be permitted to be present at any such inspections and shall have the
opportunity to provide, review, and comment on any responses that may be
required;

 

k.Ensure that all clinical data is accurate, complete, and legible, and promptly
and fully disclosed to and produced for the inspection and use of Sponsor or its
agents in accordance with Section 2.0(i) above; and

 

l.Supply to Sponsor or its agents written notice documenting continuing IRB/EC
review. Institution and Principal Investigator will provide Sponsor or its
designee with a copy of IRB’s approval of Institution’s, Principal
Investigator’s and study personnel’s conduct of the Study at Institution and/or
at Institution’s affiliated hospitals, including approval of the Protocol, the
informed consent form to be executed by all Study subjects enrolled by
Institution and Principal Investigator in the Study and the HIPAA authorization,
including any amendments to the foregoing, together with all relevant
correspondence with the IRB regarding such approval and/or the Study.

 

3.0STAFF AND FACILITIES

 

a.The Study shall be carried out at the Institution and/or its affiliated
hospitals and under the review of an appropriate IRB/EC and under the
supervision of the Principal Investigator;

 

b.Institution represents that it has or has access to adequate staff and
facilities to complete the Study in a timely manner in accordance with the terms
of the Protocol and this Agreement, and that Institution, Principal
Investigator, and all of Institution’s employees, facilities, affiliates or
agents that will be used in connection with the Study have all necessary
licenses, permits and certifications under all applicable laws, regulations,
codes, and rules;

 

c.Institution represents that it is not party to, and Institution represents
that, during the Term of this Agreement, it will not enter into any agreement to
provide services which would prevent its ability to complete the Study in a
timely manner and no additional interventional research may be conducted on
Study subjects during any exclusion period specified in the Protocol unless it
is approved in advance by Sponsor in writing. Sponsor will be notified in
writing of additional interventional research to be conducted on Study Subjects
after the Exclusion Period until the end of the Study;

 

d.Except where Sponsor has otherwise expressly agreed in writing, Institution
shall arrange and pay for all necessary laboratory and other facilities,
equipment, supplies and physicians and clinical support staff required to
discharge its obligations under the Study;

 

e.All matters, terms and payments of compensation, benefits and other conditions
of engagement of any nature for the Institution’s staff and any other support
used in the Study shall be solely a matter between Institution and such
individuals, regardless of whether such individuals are considered employees,
agents or independent contractors of Institution;

 

Page 4 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

f.Institution represents that: (i) the Principal Investigator is not currently
involved in any litigation, and it is unaware of any pending litigation
proceedings relating to Principal Investigator’s role in the conduct of a
clinical trial for any third party; and (ii) it has not received any warnings
from the FDA (or any equivalent oversight body in a country other than the
United States) relating to services the Principal Investigator has provided to
third parties during the conduct of a clinical trial;

 

g.Institution represents that the Principal Investigator has executed the
signature page of the Protocol and this Agreement, and that Institution shall
require that the Principal Investigator shall comply with all applicable terms
of this Agreement, including, without limitation, federal and state laws and
regulations governing record keeping, Study conduct, receipt and disposition of
Study Drug, disclosure requirements, and the obtaining of an informed consent
from patients participating in the Study;

 

h.Institution represents that it will properly supervise its employees and
agents, and other persons performing the Study under its direction and shall
require that such persons comply with the terms of this Agreement; and

 

4.0REIMBURSEMENT

 

In consideration for performance of the Study, Sponsor will compensate
Institution in accordance with the Budget and Payment Schedule attached as
Exhibit A, which the Parties agree is intended to represent fair market value in
full consideration of the research services to be performed by Institution
hereunder in accordance with the Protocol. The Parties further agree that the
terms of this Agreement are not determined in a manner that takes into account
the volume or value of any referrals or business, if any, otherwise generated
between the Parties. Institution will make reasonable efforts to complete the
Study within the maximum budget set forth on said Exhibit A (the “Budget”) and
will not commit to any expenses in excess of such maximum amount without
Sponsor’s prior written consent. If, prior to completion of the Study, this
Agreement is terminated in accordance with Article 11 hereof for any reason
other than by Sponsor for cause, Sponsor shall pay such amount for the research
services and non-cancelable expenses documented and/or actually
rendered/incurred by Institution/Principal Investigator hereunder in accordance
with the Protocol prior to termination as determined in the manner set forth in
Exhibit A. If Sponsor terminates this Agreement for cause, Sponsor shall have no
obligation to pay Institution for those items set forth in the Budget that are
incurred after the date such termination becomes effective or for such services
that were not performed in accordance with the Protocol, and Institution shall,
upon written request, promptly refund to Sponsor all advance payments made by
Sponsor under the Budget as set forth below and not yet spent by Institution
(without limitation of any other rights Sponsor may have in law or equity). Only
research service expenditures that are agreed to be compensated under Exhibit A
will be compensated upon termination, and Sponsor shall not be responsible for
any lost profits or lost opportunities. Final payment will be made after the
Institution completes all study activities as they pertain to the primary
outcomes and Sponsor has received all patient data and any corresponding queries
in an acceptable form, and if requested, all other Confidential Information as
defined in Article 5 hereof.

 

Page 5 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

A taxpayer identification number for Institution shall be provided to Sponsor
before a payment will be issued. Should the Study or this Agreement terminate
prematurely, any payments made by Sponsor exceeding the documented actual amount
earned or non-cancellable expenses incurred in accordance with the Budget will
be promptly returned upon written request.

 

Institution shall be solely responsible for ensuring that its practices, and
those of the Principal Investigator, with respect to billing, coding or
otherwise seeking reimbursement directly or indirectly from any third party,
including patients, insurance companies, governmental entities, or others in
connection with any Institution or Principal Investigator activities or services
performed in accordance with the Study are fully compliant with all applicable
laws and third party billing requirements, and Sponsor shall not be liable for
any payment or non-payment by any third party. Institution acknowledges and
agrees that Sponsor has not provided and will not provide advice with respect to
such billing, coding, or reimbursement.

 

5.0CONFIDENTIAL INFORMATION

 

All non-public information (including, but not limited to, electronically stored
or transmitted information), materials (including, but not limited to, the Study
Drug), and documents provided to either Party to the other Party or its agents
under this Agreement and during the course of the Study, including preclinical
data, case report forms (before they are completed), Protocol, investigator’s
brochure, and verbal and written information, will be kept strictly confidential
in accordance with the terms of this Section 5.0 and shall be confined to the
receiving Party personnel involved in conducting the Study who have a need to
know such information in order to conduct the Study, have been advised of the
confidential nature of such information and are required to comply with the
confidentiality and nondisclosure obligations contained herein.

 

In addition, all reports and/or information, including but not limited to, CRFs
or Study progress reports will constitute confidential information of Sponsor
and will not be provided by the Institution to any parties not involved in the
conduct of the Study, other than to Sponsor and its agents or as permitted by
Article 7 (Publication) of this Agreement.

 

All confidential information as described in this Article 5 shall hereinafter be
referred to as “Confidential Information”. Such Confidential Information shall
be and remain the confidential and proprietary property of the disclosing Party;
provided that Study Data (as defined in Article 6) that constitutes Confidential
Information shall be deemed the Confidential Information of Sponsor. Sponsor
shall have no restrictions on use or disclosure of Study Data. Notwithstanding
the foregoing, Principal Investigator and Institution may use and disclose Study
Data for the purposes of future research and for its own research, educational
and patient care purposes or programs so long as such use is not in concert with
industry partners or in collaboration or partnership with a competitor of
Sponsor and so long as it is not used to create a product that competes with a
product of Sponsor and neither will use or permit others to use Study Data for
the commercial benefit of any third party.

 

Page 6 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

During the Study and for a period of seven (7) years after the termination,
abandonment or completion of the Study at all facilities, the receiving Party
shall maintain in strict confidence all of the disclosing Party’s Confidential
Information and not disclose or disseminate to any third party (other than in
the case of Institution, its affiliated hospitals) or use for any purpose other
than the performance of the Study, or as required for regulatory or legal
purposes, any of the same. The foregoing obligation of nondisclosure shall not
apply to information that:

 

a.Is or becomes publicly available, through no fault of the receiving Party, to
any of the receiving Party’s employees, affiliates or agents;

 

b.Is disclosed to the receiving Party by a third party who, to receiving Party’s
knowledge, is entitled to disclose such information not subject to any
obligation of confidence to the disclosing Party;

 

c.Is already known to the receiving Party prior to disclosure hereunder, as
shown by receiving Party’s prior written records;

 

d.Is necessary to be included in any patient’s written informed consent form (to
the extent necessary for purposes of such approval and/or inclusion; and
provided that the disclosing Party shall be entitled to review and revise as
appropriate such informed consent form or any modification thereof prior to use
by Institution, subject to subsequent approval by the IRB/EC and with the
understanding that the ultimate contents of the informed consent is within the
purview of the IRB/EC, as per applicable law);

 

e.Is required by applicable law to be disclosed to federal, state or local
authorities; provided that, in the event that the receiving Party receives a
non-routine request to disclose any Confidential Information under this
subsection, to the extent permitted by law, the receiving Party shall: (i)
promptly notify the disclosing Party of the existence, terms, and circumstances
surrounding such a request; (ii) consult with the disclosing Party on the
advisability of taking steps to lawfully resist or narrow that request; (iii) if
disclosure of Confidential Information is required, furnish only such portion
which is legally required to be disclosed, and, if requested by the disclosing
Party prior to such disclosure, mark any such disclosure as FOIA-exempt, to the
extent applicable; and (iv) cooperate with the disclosing Party in its efforts
to obtain an order or other reliable assurance that confidential treatment will
be accorded to that portion of information that is required to be disclosed;

 

Page 7 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

f.Can be documented to have been independently developed at the receiving Party
by someone not involved in the Study and not privy to the Confidential
Information; or

 

g.Is published by the receiving Party in accordance with Article 7 (Publication)
herein.

 

Notwithstanding anything to the contrary herein, all individually identifiable
patient health information (including information relating to patients and/or
Study patients whose identities may be ascertained by the exercise of reasonable
effort through investigation or through use of other public or private
databases) ("PHI") shall be treated as confidential by the Parties in accordance
with all applicable federal, national, state and local laws, rules and
regulations governing the confidentiality and privacy of PHI, including, without
limitation, the Health Insurance Portability and Accountability Act of 1996 and
any regulations and official guidance promulgated thereunder (collectively,
"HIPAA"); and the Parties agree to take such additional steps and/or to
negotiate such amendments to this Agreement as may be required to ensure that
the Parties are and remain in compliance with HIPAA.

 

6.0REPORTS AND STUDY DATA

 

Institution shall prepare, maintain and retain all: Protocol-required
documentation, records, case report forms, laboratory worksheets, data queries,
protocols, raw data, specimens, test articles, control materials, slides,
reports or other work product generated in the performance of the Study whether
in written, electronic, video or other tangible form including, without
limitation, the completed CRFs, Study Drug inventory records, laboratory
records, worksheets, reports, radiologic examinations, observations, signed
informed consent forms (collectively the “Study Data”) in a timely, accurate,
complete, and legible manner in the form described in the Protocol and
Applicable Laws. Sponsor shall be the sole owner of the Study Data; provided
that Principal Investigator and Institution each may use such Study Data for its
own research, educational and patient care purposes or programs so long as such
use is not in concert with industry partners or in collaboration or partnership
with a competitor of Sponsor and so long as it is not used to create a product
that competes with a product of Sponsor and neither will use or permit others to
use Study Data for the commercial benefit of any third party. Notwithstanding
the foregoing, all original patient medical records are and shall remain the
property of Institution and are specifically excluded from the definition of
Study Data; however, if requested, Sponsor shall have a right to review such
patient medical records in accordance with the terms of this Agreement. During
the Study and in accordance with the terms of Section 2.0(i) of this Agreement,
Sponsor or Sponsor’s representatives shall be provided and have the right to
review, verify, and copy all Study Data including, without limitation,
radiographs, ECG tracings, original reports of laboratory tests and examination
findings, and all other notes, charts, reports, or memoranda relating to
patients enrolled in the Study. Promptly (but no later than sixty (60) days
after completion or termination of the Study, Institution shall cause Principal
Investigator to complete and submit to Sponsor or its designated agent all
outstanding case report forms and data queries resulting from the Study and
shall transfer to Sponsor all Study Data. Raw data in paper or magnetic form
will be retained by Principal Investigator in compliance with regulatory
requirements. The Institution shall complete data entry on a CRF or to respond
to any queries within the timelines provided for in the Protocol.

 

Page 8 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

7.0PUBLICATION

 

Notwithstanding any other provisions of this Agreement, upon completion of the
Study and submission of the data to the appropriate regulatory agencies which
shall occur within thirty (30) business days after completion of the Study and
database lock or earlier termination of the Study, Principal Investigator shall
have the right to publish its own results of the Study; provided, however, that
Sponsor shall have the right to review any proposed publication, including oral
presentations and abstracts, that utilize data or results generated from the
Study. Institution shall cause Principal Investigator to submit a complete copy
of the proposed publication to Sponsor at least sixty (60) days prior to
presentation or submission to any third party (the “Review Period”). Sponsor
shall review the publication and give its comments to the Institution within the
Review Period. Institution shall cause Principal Investigator to comply with
Sponsor’s requests to delete references to Sponsor’s Confidential Information
(except Study results) and shall consider Sponsor’s other comments (with the
understanding that ultimate editorial control belongs to the Principal
Investigator). Upon any revision of publication in response to Sponsor’s
comments, the Principal Investigator shall submit the final version of the
publication to Sponsor for its information prior to presenting or submitting the
publication to the publisher. In any event, Institution shall require Principal
Investigator and any co-authors employed by Institution to withhold publication
an additional sixty (60) days to permit Sponsor to obtain patent protection if
Sponsor so requests. Institution shall require compliance of any
subinvestigators, employee, other individual or subcontractor involved in the
Study with the provisions of this paragraph. Institution and Principal
Investigator shall give the Sponsor appropriate credit and/or recognition for
co-authorship in accordance with academic standards for contributions made by
Sponsor, subject to the Sponsor’s prior consent. Sponsor shall adhere to ICMJE's
requirement on clinical trial registration and represents and warrants that the
Study is registered accordingly prior to the recruitment of the first Study
subject.

 

Page 9 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

8.0DRUG STORAGE AND RETURN OF STUDY MATERIALS

 

SYN-004(ribaxamase) (quantities provided for use in the Study, the “Study Drug”)
and any comparator drugs provided in connection with the Study shall be used by
the Institution solely for the purpose of completing the Study according to the
Protocol. The Institution shall keep all Study Drug and any comparator drugs in
a locked, secured area at all times and maintain complete, up-to-date records
showing receipt, dispensing and returns of the Study Drug and any comparator
drugs as required by the Protocol, and applicable federal, state and local laws,
regulations, and rules. Institution agrees that it: (i) will use the Study Drug
or any comparator drugs provided by Sponsor pursuant to this Agreement only in
the Study and for no other purposes; and (ii) will not knowingly and
purposefully charge or collect payment of any type from patients, insurance
companies, governmental entities, or others for the Study Drug or any comparator
drugs provided to Institution by Sponsor hereunder. If such payment is
erroneously collected, Institution shall promptly refund the patient, insurance
company, governmental entity, or other payer. Upon completion of the Study, all
unused Study Drug, compounds, drugs, devices, equipment and related materials
and all copies of Sponsor Confidential Information that were furnished to the
Institution shall be, at the expense of Sponsor, returned to the Sponsor or
destroyed with a written notice of destruction returned to the Sponsor.
Notwithstanding the foregoing, Institution may retain one copy of Sponsor
Confidential Information in a secure location for purposes of identifying
Institution’s obligations under this Agreement.

 

 

9.0INDEPENDENT CONTRACTOR

 

The relationship of Sponsor and Institution and Sponsor and Principal
Investigator under this Agreement is that of independent contractors, and this
Agreement shall not, and is not intended to, make the Parties partners, joint
venturers or agents of one another. Neither Party, including the Principal
Investigator, shall have the power to bind or obligate the other Party.

 

Page 10 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

10.0NON-DEBARMENT/NON-EXCLUSION

 

Institution represents that neither Institution, nor Principal Investigator, nor
to its knowledge any of Institution’s employees, affiliates or agents performing
the Study have ever been: (i) debarred, under Section 306(a) or (b) of the
Generic Drug Enforcement Act of 1992; (ii) excluded from participation in
federal health care programs; or (iii) debarred from federal contracting.
Institution represents that it and Principal Investigator have never been and,
to the best of its knowledge after due inquiry, none of its employees,
affiliates or agents has ever been (a) threatened to be debarred or excluded or
(b) indicted for a crime or otherwise engaged in conduct for which a person can
be so debarred or excluded. Institution will promptly notify Sponsor in the
event of any such debarment, exclusion, conviction, threat or indictment, and at
Sponsor’s option, this Agreement shall terminate effective as of the date of
such debarment, exclusion, conviction, threat or indictment. The terms of the
preceding sentence shall survive the termination or expiration of this
Agreement.

 

11.0TERM AND TERMINATION

 

This Agreement shall be effective as of the Effective Date and shall continue
until completion of all obligations herein, including receipt by Sponsor or its
designated agent of all Study Data, Confidential Information (except the one (1)
archival copy permitted to be retained) and any corresponding queries in a form
reasonably acceptable to Sponsor, or until termination as set forth below.

 

This Agreement may be terminated prior to completion as established above on
written notice if any of the following conditions occur:

 

a.By either Party, effective immediately, if the authorization and approval to
conduct the Study is withdrawn by the FDA or other governmental or regulatory
authority, or by Sponsor if Sponsor is unable to obtain authorization and
approval to conduct the Study;

 

b.By either Party, effective immediately, if the emergence of any adverse
reaction or side effect with the Study Drug administered in the Study is of such
magnitude or incidence in the opinion of either the Institution or Sponsor to
support termination, subject to Institution’s obligations under Section 2(g) of
this Agreement;

 

c.By Sponsor, effective immediately, if the Institution fails to perform the
Study in accordance with the terms of the Protocol, this Agreement, or
applicable laws or regulations including FDA or ICH GCP guidelines, or the
Institution or Principal Investigator become debarred or excluded or become
subject to a threat of debarment or exclusion;

 

d.By either Party if the other Party otherwise breaches this Agreement and such
breaching Party fails to cure the breach within thirty (30) days after receipt
of written notice from the non-breaching Party specifying in detail the nature
of the breach;

 

Page 11 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

e.By Sponsor, upon fourteen (14) days written notice; or

 

f.By Institution upon fourteen (14) days written notice if Principal
Investigator becomes unable to perform or complete the Study and the Parties
have not, prior to the expiration of such fourteen (14) day period, agreed to an
alternative Principal Investigator. Institution shall use reasonable efforts to
find a replacement Principal Investigator with similar qualifications as the
Principal Investigator being replaced.

 

After termination for any reason, both Parties shall continue activities under
this Agreement solely as deemed necessary by mutual agreement of the Parties
based on reasonable medical judgment to protect the health of patients
participating in the Study.

 

12.0PATENT RIGHTS AND INVENTIONS

 

For purposes of this Article 12, “Invention” means any discovery or invention,
whether or not patentable, conceived, made, or developed as a result of
conducting the Study, or made using the Study Drug or Sponsor Confidential
Information, together with all intellectual property rights relating thereto.
Inventions shall include, but not be limited to, processes, compositions,
methods, software, tangible research products, formulas and techniques, patents,
and copyrights, and any improvements related thereto. It is recognized and
understood that the inventions and technologies, existing prior to execution of
this Agreement, of Sponsor or Institution are their separate property,
respectively, and are not affected by this Agreement (including, but not limited
to the Confidential Information) and neither Sponsor nor Institution shall have
any claims to or rights in such existing inventions and technologies of the
other, even where Study Data generated under the Study is used to support patent
applications regarding such existing inventions.

 

Institution and Principal Investigator shall promptly disclose in writing to
Sponsor all Inventions, including, without limitation, those Inventions made by:
(a) employees, subcontractors, agents, affiliates, and related personnel
(including, but not limited to postgraduate students and other students) of
Institution and/or (b) the Principal Investigator and subinvestigators.

 

Ownership of any Inventions shall be in accordance with inventorship which shall
be determined in accordance with U.S. patent law.

 

Institution agrees to ensure that each of its employees, subcontractors and
agents rendering services hereunder, including, without limitation, the
Principal Investigator, are familiar with and shall have an obligation to abide
by the terms of this Article 12. Institution shall ensure that each of its
employees and any subcontractors or agents performing any part of the Study,
shall assign all Inventions and intellectual property rights therein created,
discovered, or generated by such personnel as a result of performing the Study
to Institution so that Institution can comply with its obligations under this
Article 12, and Institution shall promptly obtain such assignments.

 

Page 12 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

The parties shall jointly own all by-products and derivatives of
Protocol-required biological samples including, without limitation, tissue
samples and blood samples, provided by or taken from any patient in connection
with such patient’s participation in the Study (“Biological Samples”). The
parties shall jointly own all Study Data resulting from the use and testing of
any and all Biological Samples. Principal Investigator and Institution each may
use such Study Data for its own research, educational and patient care purposes
or programs so long as such use is not in concert with industry partners or in
collaboration or partnership with a competitor of Sponsor and so long as it is
not used to create a product that competes with a product of Sponsor and neither
will use or permit others to use Study Data for the commercial benefit of any
third party.

 

The foregoing obligations shall continue beyond the termination of this
Agreement with respect to Inventions and shall be binding upon Institution and
Institution’s employees and agents.

 

Institution shall grant and hereby grants to Sponsor an option to negotiate for
an exclusive worldwide, sublicensable (through multiple tiers as negotiated by
the parties) license to practice Institution’s rights to any Invention owned by
Institution. The license agreement will contain terms and conditions, including
without limitation, terms consistent with industry standard for similar
licenses. Sponsor hereby grants to Institution a non-exclusive, royalty-free
license to practice Sponsor’s rights to any Invention owned by Sponsor for
internal, non-commercial purposes for the purpose of performing the Study.

 

13.0INDEMNIFICATION; LIMITATION OF LIABILITY

 

Sponsor shall indemnify, defend, and hold harmless Institution, its affiliated
hospitals, its IRB, Principal Investigator and their respective affiliates,
agents, officers, directors and employees (“Institution Indemnitees”) from and
against any and all loss, damage, cost, claim or liability (collectively,
“Claims”) resulting from (i) the use by or on behalf of a Sponsor Indemnitee of
the results of the Study, (ii) a Sponsor Indemnitee’s negligence or willful
misconduct, or (iii) a subject’s participation in the Study. Sponsor’s
obligation to indemnify and hold harmless Institution Indemnitees under this
Section shall be reduced only if and only to the extent the losses are
ultimately adjudged to have been caused by the negligence or intentional
misconduct of an Institution Indemnitee, an Institution Indemnitee’s failure to
follow any Applicable Laws, an Institution Indemnitee’s failure to comply with
this Agreement, the Protocol or other written instructions or recommendations
provided by or on behalf of Sponsor or Sponsor designee to the Institution
Indemnitees provided that such instructions are not in conflict with the
Protocol unless the conflicting instructions are related to the safety, welfare,
or well-being of the patient, treatment of the Study subject prior to or outside
of the Study, failure to obtain informed consent from the Study subject using
the then current informed consent form in the form approved by Sponsor (provided
that the injury is related to the failure of not getting informed consent), or
unauthorized warranties or representations made by an Institution Indemnitee
concerning the Study Drug or a comparator drug (provided that the injury is
related to the unauthorized warranties or representations made by an Institution
Indemnitee concerning the Study Drug or a comparator drug) (each, an “Excluding
Condition”).

 

Page 13 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Institution shall indemnify and hold harmless Sponsor and its affiliates,
agents, officers, directors and employees (“Sponsor Indemnitees”) from and
against any and all loss, damage, cost, claim or liability found to result from
an Excluding Condition.

 

The Party seeking indemnification shall promptly notify the indemnifying Party
in writing of all claims for which indemnification is sought and allow the
indemnifying Party to handle such claims (including settlement negotiations);
provided, however, that the indemnifying Party shall not have the right to agree
to any settlement pursuant to which liability or culpability on the part of the
indemnified Party or its Indemnitees is acknowledged. The indemnified Party
shall cooperate fully with the indemnifying Party in its handling of all claims.
A failure to promptly notify of any claim will serve to reduce the indemnity
rights of the party seeking indemnification only if and only to the extent such
failure materially prejudiced the indemnifying party’s actual defense of the
claim.

 

Sponsor agrees to reimburse Institution for the reasonable and necessary medical
expenses for medical treatment of an adverse reaction that is the direct result
of administering the Study Drug pursuant to and in compliance with the Protocol,
unless due to the negligence or intentional misconduct of an Institution
Indemnitee, the use of the Study Drug by any Institution Indemnitee in any
manner not in compliance with the Protocol, or breach of this Agreement, the
Protocol or any applicable law, rule or regulation by an Institution Indemnitee.
Provided that, if any patients are Medicare or Medicaid beneficiaries, the
Parties shall comply with the reporting and other applicable requirements under
Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA)
relating to agreeing to pay for patient’s study injuries, if applicable.

 

WITHOUT LIMITING THE INDEMNIFICATION OBLIGATIONS,CONFIDENTIALITY OBLIGATIONS OR
INTELLECTUAL PROPERTY OBLIGATIONS HEREUNDER, NOTWITHSTANDING THE FOREGOING,
NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INDIRECT, CONSEQUENTIAL, LOSS
OF PROFITS, OR OTHER DAMAGES SUFFERED BY THE OTHER PARTY, ANY LICENSEE, OR ANY
OTHERS RESULTING FROM THE USE OF THE RESEARCH, STUDY DATA OR ANY INVENTION OR
PRODUCT ARISING FROM THE STUDY, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR (A) WORK STOPPAGE, LOST
DATA, LOST PROFITS OR ANY OTHER RELIANCE OR EXPECTANCY, DIRECT OR INDIRECT, OR
(B) SPECIAL OR CONSEQUENTIAL DAMAGES, OF ANY KIND.

 

Page 14 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

INSTITUTION AND PRINCIPAL INVESTIGATOR EACH UNDERSTAND AND AGREE THAT THE STUDY
DRUG IS EXPERIMENTAL IN NATURE AND THAT NO WARRANTY, EITHER EXPRESS OR IMPLIED,
IS MADE BY SPONSOR NOR ANY OTHER PARTY REGARDING THE STUDY DRUG EXCEPT THAT THE
STUDY DRUG HAS BEEN MANUFACTURED IN ACCORDANCE WITH APPLICABLE LAW.

 

Institution shall maintain in full force and effect during the term of this
Agreement a policy or program of insurance or self-insurance at levels
sufficient to support the indemnification and contractual obligations set forth
in this Agreement. Upon request, Institution will provide evidence of its
insurance or self-insurance and will provide Sponsor thirty (30) days prior
written notice of any cancellation of its coverage. Sponsor shall maintain in
full force and effect during the term of this Agreement adequate liability
insurance coverage to maintain its ability to cover its indemnification and
contractual responsibilities hereunder, provided that such insurance shall not
be less than $2,000,000 per occurrence and $5,000,000 aggregate. Sponsor shall
provide evidence of such insurance upon request. At least thirty (30) days prior
to any loss or reduction in such insurance coverage, Sponsor shall notify
Institution. The specified minimum insurance coverages and limits outlined above
do not constitute a limitation on Sponsor’s liability or obligation to indemnify
or defend Institution and any other Indemnitees under this Agreement.

 

14.0COMPLETE AGREEMENT

 

This Agreement constitutes the sole, full and complete Agreement by and between
the Institution and Sponsor and supersedes all other written and oral agreements
and representations between the Institution and Sponsor with respect to the
Study. No amendments, changes, additions, deletions or modifications to or of
this Agreement shall be valid unless reduced to writing and signed by the
Parties. Any requests for changes or amendments or other notices or
communications concerning this Agreement should be in writing and shall be
deemed to have been given when mailed by U.S. Mail postage prepaid or bonded
courier and forwarded to the following:

 

To Synthetic Biologics, Inc.:  Steven Shallcross, CEO, CFO    Synthetic
Biologics, Inc.    9605 Medical center Drive, Suite 270    Rockville, Maryland
20850      With a copy to:  Leslie Marlow, Esq    Gracin & Marlow, LLP    The
Chrysler Building, 26th Floor    405 Lexington Avenue    New York, New York
10174

 

Page 15 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

To Institution:  Washington University    Joint Research Office for Contracts   
One Brookings Drive, CB 1054    St. Louis, MO 63130    Attn: Dubberke/P19-07190
     With a copy to:  Washington University    660 S. Euclid Ave., CB 8009   
St. Louis, MO 63110    Attn: Dubberke/P19-07190

 

 

Page 16 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

15.0BINDING EFFECT

 

This Agreement shall be binding upon the Parties, their legal representatives,
successors and assigns. The obligations of the Parties contained in Articles 2h,
2j, 3f, 4 (Reimbursement), 5 (Confidential Information), 6 (Reports and Work
Product), 7 (Publication), 8 (Drug Storage and Return of Study Materials), 9
(Independent Contractor), 10 (Non-Debarment/Non-Exclusion), 12 (Patent Rights
and Inventions), 13 (Indemnification; Limitation of Liability), 14 (Complete
Agreement), 15 (Binding Effect), 16 (Release of Information), 17 (Financial
Disclosure) and 18 (Applicable Law) shall survive the termination or expiration
of this Agreement.

 

16.0RELEASE OF INFORMATION

 

To the extent allowable by law, Sponsor may use, refer to, and disseminate
reprints of scientific, medical and other published articles relating to the
Study which disclose the name of Institution and/or Principal Investigator or
any subinvestigators, consistent with applicable copyright laws. Neither Party
shall otherwise use the name of the other Party or the Principal Investigator or
any subinvestigators in connection with any advertising or promotion of any
product or service without the prior written permission of such Party or the
Principal Investigator as appropriate. Each Party agrees that it will not
disclose the terms of this Agreement to any third party without the permission
of the other Party. Institution may acknowledge in general terms the existence
of this Agreement and Institution’s receipt of financial support from Sponsor
without Sponsor’s prior approval. Moreover, this provision shall not be
construed so as to prohibit the Institution or the Principal Investigator from
identifying Sponsor in any publication in accordance with this Agreement.
Notwithstanding anything to the contrary contained herein, Sponsor may make
public the amount of funding provided hereunder for the conduct of the Study and
may identify Institution as a site at which the Study was conducted and may
identify those individuals responsible for conducting the Study, including the
Principal Investigator as part of this disclosure. Institution represents that
it has or shall obtain the Principal Investigator’s consent to this disclosure

 

17.0FINANCIAL DISCLOSURE

 

So that Sponsor may fulfill its certification and other financial disclosure
obligations under 21 CFR Part 54 to the United States Food and Drug
Administration and such other laws and regulations as may from time to time be
or become applicable with respect thereto, Institution shall cause Principal
Investigator and each sub-investigator to provide financial disclosures to
Sponsor or its designated agent prior to commencing the Study, and more
frequently as Sponsor may request from time to time. During the time the Study
is being conducted and for one (1) year thereafter, Institution shall cause
Principal Investigator and each subinvestigator to update such forms promptly
and provide same to Sponsor or its agent: (i) whenever any change occurs in the
information disclosed by a previous form such that such form is no longer
truthful and accurate, or (ii) as may be requested by Sponsor or its agent when
the financial information required to be disclosed by an applicable regulatory
authority changes. By completing a disclosure, the Principal Investigator and
the subinvestigators shall certify that the disclosure supplied is truthful and
accurate. In addition, prior to the commencement of the Study, the Principal
Investigator shall have completed, signed, and delivered to Sponsor a Statement
of Investigator, Form FDA-1572, as described in 21 C.F.R. § 312.53.

 

Page 17 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

In addition, Institution agrees that Institution and/or Principal Investigator
and any subinvestigators, as applicable: (a) will be required to disclose the
existence and nature of this Agreement, as may be required by any Institution
formulary and/or clinical guidance committee(s) (or such committee in which
Principal Investigator or any subinvestigator participates as a member, an
advisor and/or in a similar capacity); and (b) Principal Investigator and any
subinvestigators will be required to comply with any applicable institutional
conflict of interest, disclosure, or approval policies. If applicable and
permitted by Institution policies, Institution agrees to provide to Sponsor
copies of any such applicable Institution policies or guidelines.

 

18.0APPLICABLE LAW

 

The parties agree to remain silent on the issue of governing law.

 

19.0WAIVER AND SEVERABILITY

 

Failure to insist upon compliance with any of the terms and conditions of this
Agreement shall not constitute a general waiver or relinquishment of any such
terms or conditions, and the same shall remain at all times in full force and
effect. If any part of this Agreement is held unenforceable, the rest of the
Agreement will nevertheless remain in full force and effect.

 

20.0ASSIGNMENT

 

Institution shall not subcontract, assign or transfer any of its rights or
obligations under this Agreement without the written consent of Sponsor. In the
event that Sponsor does so consent, then any agreement entered into by
Institution with the permitted third party subcontractor, assignee, or
transferee shall, at a minimum, provide for ownership and allocation of
intellectual property rights and for obligations of confidentiality of
information, record-keeping, access, and rights to data that are consistent with
the intent and terms of this Agreement. Institution shall remain liable for the
performance of any of its obligations hereunder that it delegates to a
subcontractor, assignee, or transferee. Sponsor shall not subcontract, assign or
transfer any of its rights or obligations under this Agreement without providing
prior notification of such to Institution.

 

Page 18 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

21.0POWER AND AUTHORITY

 

Institution represents to Sponsor that Institution has the full right, power and
authority and legal capacity to enter into this Agreement, and the execution,
delivery and performance of this Agreement by Institution does not constitute a
breach of any order, judgment, agreement or instrument to which Institution is a
party. Sponsor represents to Institution that Sponsor has the full right, power
and authority and legal capacity to enter into this Agreement, and the
execution, delivery and performance of this Agreement by Sponsor does not
constitute a breach of any order, judgment, agreement or instrument to which
Sponsor is a party.

 

22.0COUNTERPARTS

 

This Agreement may be executed in one or more counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and the
same instrument.

 

23.0ACCREDITATION BY THE ASSOCIATION FOR ACCREDITATION OF HUMAN RESEARCH
PROTECTION PROGRAMS (“AAAHRP”) REQUIRED LANGUAGE

 

During and for a period of at least two (2) years after the completion of the
Study, Sponsor shall promptly report to the Principal Investigator any
information that could directly and materially affect the health or safety of
past or current Study subjects or influence the conduct of the Study, including
but not limited to the Study results and information in site monitoring reports
and data safety monitoring committee reports as required by the Protocol. In
each case, the Principal Investigator and Institution shall be free to
communicate these findings to each Study subject and the IRB.

 

ACCEPTED AND AGREED TO:

 

SYNTHETIC BIOLOGICS, INC.:

 

/s/Steven A. Shallcross  August 7, 2019 (Signature)  Date      Name: Steven A.
Shallcross  Title: Chief Executive Officer           [INSTITUTION]:        
/s/Melanie Roewe, JD  July 30,2019 (Signature)  Date      Name: Melanie Roewe,
JD  Title: Associate Vice Chancellor for Joint Research Office of Contracts

 

Page 19 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Read and acknowledged:

 

PRINCIPAL INVESTIGATOR:

 

 

/s/ Erik Dubberke  July 29, 2019 (Signature)  Date

 

Name: Erik Dubberke

 

Page 20 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

Exhibit A

 

 

 

 

 

Page 21 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

      Activity Costs Includes [*****] [*****] [*****] [*****] [*****] [*****]
[*****] [*****] [*****] [*****] [*****] [*****] [*****] [*****] [*****] [*****]
[*****] [*****] [*****] [*****]               Proposed payment schedule:    
Milestone 1: execution of contract $483,487   Milestone 2: IRB approval $593,078
  Milestone 3: approval to start enrollment for cohorts 3 and 4 $1,073,342  
Milestone 4: approval to start enrollment for cohorts 5 and 6 $805,006  
Milestone 5: completion of all study activities as they pertain to the primary
outcomes and receipt by Synthetic Biologics of all patient data and any
corresponding queries in an acceptable form, and if requested, all other
Confidential Information as defined in Article 5 of the attached Clinical Trial
Agreement of which this is Exhibit A. $268,335   Total $3,223,248  

 

Page 22 of 23 

PORTIONS HEREIN IDENTIFIED BY [*****] HAVE BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE THE EXCLUDED INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

 

Notes:                 [*****]                 [*****]                 [*****]  
              [*****]                 [*****]          

 

Page 23 of 23