Clinical Trial Agreement

PHASE II STUDY

 

between

 

NSABP Foundation, Inc.

and

 

Antigen Express, Inc.

 

 

 

TABLE OF CONTENTS

 

RECITALS 3       ARTICLE I DEFINITIONS 3       ARTICLE II SCOPE OF SERVICES 5  
    ARTICLE III STUDY CONDUCT 6       ARTICLE IV FINANCIAL SUPPORT 7      
ARTICLE V SUPPLY, OWNERSHIP, AND DISTRIBUTION OF STUDY DRUG 8       ARTICLE VI
BIOLOGIC RESPOSITORY AND TISSUE COLLECTION 9       ARTICLE VII WARRANTIES AND
DISCLAIMERS 10       ARTICLE VIII AUDITS, MONITORING, SITE QUALIFICATION, AND
ACCESS TO RESEARCH RECORDS 10       ARTICLE IX RECORDS AND REPORTS 10      
ARTICLE X FINANCIAL DISCLOSURE AND CONFLICT OF INTEREST 11     ARTICLE XI
CONFIDENTIAL INFORMATION 12       ARTICLE XII PUBLICATIONS / PRESENTATIONS AND
GENERAL PUBLICITY 14       ARTICLE XIII DATA OWNERSHIP AND INVENTIONS 15      
ARTICLE XIV NOTICE 17       ARTICLE XV INDEMNIFICATION; INSURANCE; LIMITATIONS
OF LIABILITY 18       ARTICLE XVI HUMAN SUBJECTS 20       ARTICLE XVII TERM AND
TERMINATION 20       ARTICLE XVIII AMENDMENTS 21       ARTICLE XIX SEVERABILITY
21       ARTICLE XX INTEGRATION 22     ARTICLE XXI ASSIGNMENT 22       ARTICLE
XXII INDEPENDENT CONTRACTOR 22       ARTICLE XXIII NO TRANSFER OF PROPRIETARY
RIGHTS NOT SPECIFIED 22       ARTICLE XXIV CONFORMANCE WITH LAW AND ACCEPTED
PRACTICE 22       ARTICLE XXV WAIVER 22       ARTICLE XXVI FORCE MAJEURE 23    
  ARTICLE XXVII DEBARMENT 23       ARTICLE XXVIII GOVERNING LAW 23       ARTICLE
XXX ENTIRE AGREEMENT 23       ARTICLE XXXI COUNTERPARTS 23       BINDING
EXECUTION 24

 

 

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APPENDICES

 

 

Appendix A NSABP Protocol entitled, "A Phase II Clinical Trial of Pembrolizumab
in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple
Negative Breast Cancer, (FB-14)," including the sample Informed Consent Form    
Appendix B Budget, Payment Schedule, and Task List     Appendix C NSABP
Ownership of Data/Materials Policy     Appendix D Selected Terms of Agreement
for Disclosure to Sites

 

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CLINICAL TRIAL AGREEMENT

This Clinical Trial Agreement (“Agreement”) is entered into and effective as of
the 20th day of November, 2018 (“Effective Date”), by and between
NSABP Foundation, Inc., a 501(c)(3) non-profit Pennsylvania membership
corporation with its principal office and place of business at Nova Tower 2, Two
Allegheny Center, Suite 1200, Pittsburgh, Pennsylvania 15212-5234 (“NSABP”), and
Antigen Express, Inc., a Delaware corporation with its principal office and
place of business at 33 Redwing Road, Wellesley, MA 02481 (“Antigen Express”).
NSABP and Antigen Express shall hereinafter be referred to individually as
“Party,” and together as “Parties.”

RECITALS

 

WHEREAS, NSABP conducts research and educational activities designed to improve
the outcome for cancer patients via improved therapeutic and prevention
modalities. The activities contemplated by this Agreement are of interest and
benefit to NSABP and Antigen Express, and such activities will further NSABP's
medical research objectives in a manner consistent with its non-profit,
scientific and charitable status;

WHEREAS, Antigen Express is a platform and product-based company developing
proprietary immunotherapeutic vaccine formulations for large, unmet medical
needs, with a focus on antigen-specific stimulation of immunological response;

WHEREAS, NSABP and Antigen Express wish to have NSABP conduct the clinical
research contemplated in this Agreement on behalf of Antigen Express, using
Antigen Express' immunotherapeutic vaccine, AE37 in combination with
pembrolizumab (KeytrudaÒ), for the treatment of metastatic triple negative
breast cancer.

NOW, THEREFORE, the Parties enter into this Agreement with the intent to be
legally bound under the terms and conditions herein set forth.

ARTICLE I

DEFINITIONS

The following terms, whether used in the singular or plural, have the respective
meaning as set forth hereinbelow, as follows:

1.1“AE” or “Adverse Event” shall have the meaning given in the Protocol.

1.2"Antigen Express Study Drug" shall mean the Antigen Express AE37 peptide
immunotherapeutic vaccine.

1.3“Applicable Law” shall have the meaning given in Section 3.2 of this
Agreement.

1.4“Claims” shall have the meaning given in Section 15.1 of this Agreement.

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1.5“Confidential Information” shall have the meaning given in Section 11.1 of
this Agreement.

1.6“CRFs” shall mean the case report forms for the Study and shall include
electronic CRFs (“eCRFs”) and the data contained therein.

1.7“Data” shall mean all data generated by the conduct of the Study. For
purposes of clarity, Data does not include patient medical records (other than
CRFs, Informed Consent Forms, and SAE filings and narratives in respect of
Subjects) or other Participating Site source documentation, which shall remain
the property of the Participating Site.

1.8“Disclosing Party” shall have the meaning given in Section 11.2 of this
Agreement.

1.9“EC/IRB” shall mean the Ethics Committee/Institutional Review Board
established pursuant to 21 CFR Part 56 for the purpose of reviewing clinical
investigations and their equivalents in countries other than the United States.

1.10“FDA” shall mean the United States Food and Drug Administration.

1.11“Good Clinical Practices" or "ICH GCP” shall mean good clinical practices as
adopted by the International Conference on Harmonisation (“ICH”) of Technical
Requirements for Registration of Pharmaceuticals for Human Use Good Clinical
Practices. For clarification for U.S. sites, ICH GCP shall mean as defined in
the most recent version of any FDA rules, regulations and guidelines on good
clinical practice.

1.12“IB” shall mean the clinical investigator brochure for the Antigen Express
Study Drug and/or the Merck Study Drug, to be provided by Antigen Express and
Merck, as applicable, hereunder, as it may be updated and amended from time to
time by Antigen Express or Merck, as the case may be.

1.13“IND” shall mean a claimed Investigational New Drug Application under
21 CFR § 312.

1.14“Indemnitees” shall have the meaning given in Section 15.1 of this
Agreement.

1.15“Informed Consent Form” shall mean the informed consent form that is to be
signed by all Subjects enrolled in the Study, together with any amendments
thereto.

1.16“Investigator” shall mean a licensed health professional who is a qualified
clinical investigator willing and able, and engaged by NSABP or Participating
Sites, in accordance with this Agreement, to conduct a clinical investigation
under the Protocol pursuant to 21 CFR § 312.

1.17“Materials” shall have the meaning set forth in Article VI.

1.18“Merck” means Merck Sharp & Dohme B.V.

1.19“Merck Agreement” means the Clinical Trial Collaboration and Supply
Agreement by and among Merck and Antigen Express made as of June 28, 2017 as the
same may be amended from time to time in accordance with the terms thereof.

1.20"Merck Study Drug" shall mean Pembrolizumab, a humanized anti-human PD-1
monoclonal antibody.

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1.21“NDA” shall mean a New Drug Application under the Federal Food, Drug and
Cosmetic Act, as amended.

1.22“Other Inventions” shall have the meaning given in Section 13.4 of this
Agreement.

1.23“Participating Sites” shall mean Research Collaborators and their respective
Research  Site(s) that are participating in the Study

1.24“Protocol” or “FB-14” shall mean the NSABP protocol entitled “A Phase II
Clinical Trial of Pembrolizumab in Combination with the AE37 Peptide Vaccine in
Patients with Metastatic Triple Negative Breast Cancer,” and will be interpreted
to include all modifications and amendments made in accordance with this
Agreement, as well as the original Protocol and sample patient Informed Consent
Form attached hereto as Appendix A and incorporated into this Agreement by this
reference, and other Protocol related documents necessary for the effective
communications of the Protocol.

1.25“Receiving Party” shall have the meaning given in Section 11.2 of this
Agreement.

1.26“Research Collaborator” shall mean an entity where a Subject is seen,
consented, treated and/or data is collected and completed for the Study, which
entity is the official designated lead institution of a research collaborator
through a collaborative arrangement with NSABP and is participating in the
Study.

1.27“Research Site(s)” shall mean a site that is cooperating with a Research
Collaborator and, through that cooperation, is participating in the Study.

1.28“SAEs” shall have the meaning given in the Protocol.

1.29“Sponsor” shall mean Antigen Express.

1.30“Study” shall mean all work to be carried out pursuant to the Protocol and
this Agreement.

1.31“Study Drugs” shall mean the Antigen Express Study Drug and the Merck Study
Drug.

1.32“Study Drug Inventions” shall have the meaning given in Section 13.1.

1.33“Study Personnel” shall mean the personnel conducting the Study at
Participating Sites, including Investigators.

1.34“Subject(s)” shall mean those individuals who provide their informed consent
and participate in the Study.

All other capitalized terms used herein shall have the meaning expressly
ascribed to them herein.

ARTICLE II

SCOPE OF SERVICES

2.1               NSABP will conduct the Study in accordance with (a) the
Protocol; (b) this Agreement; and (c) all Applicable Law.

2.2               This Agreement is not intended to be an exclusive contract and
shall not limit the freedom of the Parties or any individuals participating in
this work to engage in other research or other activities. NSABP and Antigen
Express both retain the right to collaborate with other entities to conduct the
types of clinical trials contemplated by this Agreement.

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2.3               Antigen Express is the holder of the IND for the Study.

2.4Norman Wolmark, M.D., shall be the NSABP Principal Investigator.

2.5               NSABP will enter into signed, written contracts with its
Research Collaborators who wish to participate in the Study to (a) require that
all Study Personnel are qualified to conduct the Study; (b) require that the
Study is conducted under the direction of the applicable Investigators at a
Participating Site and under the direction of the NSABP Principal Investigator
and with the prior approval and on-going review of all appropriate and necessary
review authorities; (c) obligate Research Collaborators, who shall obligate
their respective Research Sites, to terms and conditions with respect to the
Study that are required pursuant to this Agreement; and (d)  comply with
Applicable Law. For clarification purposes, references herein to contractual
obligations of Participating Sites shall include the requirement that each
Research Collaborator impose such obligations upon its Research Sites.

2.6               Antigen Express shall use commercially reasonable efforts to
timely perform its obligations hereunder (a) in a good and scientific manner;
(b) in accordance with all standard laboratory and clinical practices; and
(c) in compliance with all Applicable Law.

2.7               The Parties acknowledge and agree that Pembrolizumab is to be
provided free of charge by Merck for purposes of the Study. NSABP acknowledges
and agrees that Antigen Express has entered into the Merck Agreement for the
supply of Pembrolizumab. Antigen Express will direct Merck to deliver the Merck
Study Drug to NSABP’s designated drug distributor. The Parties agree that, if
for any reason, the Merck Study Drug is not available for the Study, the Study
will not be conducted and either Party may terminate this Agreement in
accordance with Article XVIII.

ARTICLE III

STUDY CONDUCT

3.1Antigen Express’s willingness to provide the Study funding and supply the
Antigen Express Study Drug pursuant to this Agreement is predicated upon (a) its
review of, and the mutual agreement of the Parties with respect to, the
Protocol; (b) Subject enrollment and Study progress in accordance with Appendix
B, and (c) the terms and conditions of this Agreement.

3.2The Study will be performed in accordance with the terms and conditions
contained herein, the terms and conditions of the Protocol, and all applicable
laws, rules, regulations, and guidelines including but not limited to those
regulations promulgated by the FDA including 21 CFR 312, as applicable, federal
and state privacy and patient confidentiality laws, and ICH Good Clinical
Practices (collectively, “Applicable Law”).

 

3.3Antigen Express acknowledges that NSABP does not consider itself a
HIPAA-covered entity; however, NSABP shall collect, use, store, access, and
disclose personal health information (as that term is defined in HIPAA) (“PHI”)
collected from Subjects only as permitted by the IRB approved Informed Consent
Form or HIPAA authorization form obtained from a Subject. Antigen Express agrees
that, to the extent Antigen Express and any Antigen Express designee has access
to PHI, Antigen Express and such Antigen Express designee shall collect, use,
store, access, and disclose PHI collected from Subjects only as permitted by the
IRB approved Informed Consent Form or HIPAA authorization form obtained from a
Subject. Any IRB approved Informed Consent Form or any HIPAA authorization form
shall expressly permit Antigen Express to share Data with Merck. In order for
Antigen Express to share or provide any Data that includes PHI with Merck,
Antigen Express shall first obligate Merck to store, use, process, and handle
any such Data with PHI only as permitted by the IRB approved Informed Consent
Form or HIPAA authorization form.

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3.4NSABP or Antigen Express may at any time suggest amendments to the Protocol
as may appear desirable; such amendments shall be discussed between Antigen
Express and NSABP and (except as set forth below) such amendments may be made
binding only upon mutual, signed written amendment to the Protocol. If such
amendments are requested by Antigen Express and have been agreed to by NSABP,
and such amendments increase or decrease the costs of the Study, NSABP will
submit to Antigen Express a written estimate of the difference in costs arising
from the amendments requested by Antigen Express and Antigen Express, at its
discretion, shall decide whether NSABP shall implement such amendments. If such
amendments are requested by NSABP, NSABP will submit to Antigen Express a
written estimate of the difference in costs arising from the amendments
requested by NSABP and Antigen Express, at its sole discretion, shall decide
whether it will pay any increased costs. Notwithstanding anything to the
contrary, if NSABP reasonably believes that generally accepted standards of
clinical research and/or medical practice, or other appropriate concerns,
justify an amendment to the Protocol such amendment shall become effective
thirty (30) days after Antigen Express’s receipt of notice thereof from NSABP.
Amendments to the Protocol shall result in a description of the impact the
amendment will have on the schedule of financial support, if any. NSABP shall
require that the Protocol and Informed Consent Form, and amendments thereto, be
submitted to the appropriate EC/IRBs. NSABP will make all required submissions
to the IND in connection with any amendment to the Protocol made pursuant to
this Section 3.4.

3.5Antigen Express shall sponsor an IND application with the FDA and will
cross-reference appropriate INDs held by Merck and Antigen Express. The Parties
acknowledge and agree that this is a combo-IND as the Antigen Express Study Drug
is an immunotherapeutic vaccine, which falls under the Center for Biologics
Evaluation and Research ("CBER"), while the Merck Study Drug is a drug that
falls under the Center for Drug Evaluation and Research ("CDER"). NSABP shall
perform the regulatory required filings on behalf of Antigen Express. NSABP
shall copy Antigen Express on all regulatory filings and communications in
respect of the IND. Antigen Express shall provide to, and shall require Merck to
provide to, NSABP all necessary documentation and information required in
support of such IND filings and reporting. Antigen Express shall approve any IND
filings and reporting prior to NSABP submitting such documents, with the
exception of SAEs due to the required timing of filings. NSABP will provide
Antigen Express any SAEs filings promptly after submission to the FDA. NSABP
shall provide Antigen Express with a copy of the IND application and the letter
issued by the FDA, which references the IND application number, and other
communications regarding the IND. Without limitation, Article XI shall apply to
any Confidential Information Antigen Express supplies directly to NSABP in
support of the IND.

ARTICLE IV

FINANCIAL SUPPORT

4.1In consideration for NSABP’s activities pursuant to this Agreement, including
those obligations specifically undertaken by NSABP as shown in the Task List
attached hereto as Appendix B (“Budget, Payment Schedule, and Task List”),
Antigen Express agrees to pay to NSABP a total sum as set forth in Appendix B in
accordance with the terms and conditions set forth in Appendix B.

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4.1.1The total amount payable, as set forth in Appendix B. assumes completed
enrollment in the Study and 12-month accrual of not less than 29 evaluable
Subjects, or such greater number ultimately determined appropriate to reach the
Study endpoints using an intent to treat analysis at a level of statistical
significance.

4.1.2Antigen Express shall not be obligated to make any payments to NSABP in
excess of the amount set forth in Appendix B unless Antigen Express and NSABP
agree to such excess amount in writing.

4.2If Antigen Express requests the attendance of NSABP staff and/or Study
Personnel at any meeting necessary to provide information regarding the Study or
one or both of the Study Drugs, Antigen Express shall reimburse NSABP for
reasonable and necessary travel and lodging expenses incurred by such personnel
to attend such meeting(s) and that have been specifically approved in advance in
writing by Antigen Express. Antigen Express shall make such reimbursements
within thirty (30) days of receiving acceptable detailed documentation of such
expenses.

4.3The Parties agree that the compensation being paid to NSABP under this
Agreement constitutes the fair market value for the activities to be conducted
hereunder. No amounts paid under this Agreement are intended to be for, nor
shall they be construed as an offer or payment made in exchange for any explicit
or implicit agreement to purchase, prescribe, recommend, or provide a favorable
formulary status for any Antigen Express product or service.

4.4It is expected that for all items required under the Protocol for which
Antigen Express has agreed to provide compensation, Antigen Express will be the
sole source of monetary compensation. Accordingly, NSABP shall inform its
Research Collaborators that they shall not charge any Subject nor submit claims
to, or otherwise seek reimbursement from, third party payers or any federal
healthcare program for the Study Drugs or any examinations, tests or procedures
paid by Antigen Express under the Protocol, nor shall they include the cost of
the Study Drugs in any cost report to third party payers.

ARTICLE V

SUPPLY, OWNERSHIP AND DISTRIBUTION OF STUDY DRUG

5.1Study Drug Supply. Without charge to NSABP, Antigen Express shall, and shall
require Merck to, use commercially reasonable efforts to ensure timely, safe,
and accurate shipment of the Antigen Express Study Drug and the Merck Study
Drug, respectively, for use solely in the Study and in accordance with the
Protocol, in quantities sufficient to meet the requirements of the Study. For
clarification purposes, references in this Article V to contractual obligations
of Antigen Express shall include the requirement that Antigen Express imposes
such obligations upon Merck.

5.1.1Antigen Express (including, as applicable, through Antigen Express' drug
distributor vendor), at its expense, shall take commercially reasonable steps to
assure appropriate supply, handling and storage up to the point of delivery to
NSABP’s contracted drug distributor of the Study Drugs, in accordance with the
terms of this Agreement, the Protocol, and any Applicable Law relating thereto.

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5.1.2Antigen Express represents and warrants to NSABP that the Study Drugs are
manufactured under Good Manufacturing Practices.

5.1.3Antigen Express will provide Certificates of Analysis to NSABP for each lot
of finished Study Drugs provided. Upon request of NSABP copies of documentation
of shipment of the Study Drugs to NSABP’s drug distributor will be provided to
NSABP by Antigen Express.

5.1.4NSABP shall obligate all Participating Sites to maintain accurate records
of all Study Drugs received, dispensed, and destroyed in accordance with the
Protocol and to store all Study Drugs in accordance with labeled conditions in a
secure and locked location to prevent theft or misuse.

5.1.5Title to and ownership of all Antigen Express Study Drug and Merck Study
Drug provided hereunder shall remain with Antigen Express and Merck,
respectively.

5.1.6In the event that Antigen Express or any regulatory agency orders a recall
or withdrawal of the Study Drugs (a “Recall”), Antigen Express agrees to
reimburse NSABP all reasonable fees that NSABP is obligated to pay NSABP’s drug
distributor to the extent related to such Recall. The Parties agree to cooperate
fully with each other in effecting any Recall.

5.2Study Drug Distribution.

5.2.1Antigen Express will ship, or have shipped, the Study Drugs to NSABP’s drug
distributor in appropriately marked containers in accordance with
21 CFR § 312.6. NSABP will contract with its drug distributor for the
redistribution of the Study Drugs to Participating Sites in accordance with
Applicable Law. NSABP will obligate its drug distributor to (a) store and
distribute the Study Drugs according to the labeled conditions, (b) distribute
the Study Drugs only to Participating Sites in countries where the Study is
approved in accordance with Applicable Law, and (c) to maintain complete and
accurate records of the Study Drugs shipment, receipt, disposition, return and
destruction, as applicable.

5.3Disposition of Unused Supplies. Following termination or completion of the
Study, any unused Study Drugs shall be handled as described in the Protocol and
NSABP's written instructions.

5.4Continued Supply. If medically appropriate, at the time the Protocol closes
early to accrual, Study Drugs shall continue to be supplied in accordance with
this Article V to Subjects receiving the Study Drugs, until completion of
treatment as prescribed in the Protocol.

ARTICLE VI

BIOLOGIC REPOSITORY AND BIOSPECIMEN COLLECTION

Under the terms and conditions set forth in this Article VI, Antigen Express
and/or NSABP may agree to design specific research projects in the Study, which
require the collection of all serum, blood, tissue or other biospecimen samples
obtained in connection with the Study ("the Materials"). Such research projects
shall be expressly set forth in specific prospective clinical research designs
in the Protocol, included in the Informed Consent Form for the Study, and
addressed in this Agreement. In addition, if agreed to by the Parties, and to
the extent expressly set forth in the Protocol, and in conformance with
Applicable Law, NSABP will make its Biologic Repository available for storage of
such Materials. Nothing in this Agreement obligates either Party to do anything
with respect to any such research projects.

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ARTICLE VII

WARRANTIES AND DISCLAIMERS

EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER OF THE PARTIES MAKES
ANY, AND EACH HEREBY DISCLAIMS AND NEGATES ANY AND ALL REPRESENTATIONS AND
WARRANTIES (EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE), WHETHER WRITTEN OR ORAL,
EXPRESSED OR IMPLIED, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT,
INCLUDING ANY AND ALL IMPLIED WARRANTIES OF QUALITY, PERFORMANCE,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE, THE PATENTABILITY,
VALIDITY, SCOPE, OR ENFORCEABILITY OF THE RIGHTS GRANTED HEREIN, AND/OR THE
NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.

ARTICLE VIII

AUDITS
AND ACCESS TO RESEARCH RECORDS

8.1At mutually agreeable times NSABP will give Antigen Express, Merck, and their
designees access to all records and documentation maintained by NSABP (however
stored) relating to the Study for audit purposes. NSABP will also make those
records available for the purposes of any audit by a regulatory authority.

8.2Antigen Express may arrange in advance with the NSABP Principal Investigator
and NSABP to conduct co-audits of Participating Sites during normal business
hours. Antigen Express and NSABP agree to use commercially reasonable efforts to
limit such audits to one day or less in length. Notwithstanding the above, NSABP
or Antigen Express may conduct for cause audits where the immediate need to
assure Subject safety, data integrity, or regulatory compliance exists or as
required to address FDA or other government requests with as little as
forty-eight (48) hours' notice. Notwithstanding anything to the contrary, the
Parties agree and acknowledge that any visit to a Participating Site may be
subject to that Participating Site’s policies and procedures, such as those for
patient confidentiality and privacy, security, safety, and the like. The Parties
agree to comply with any such policies and procedures of any such Participating
Site while at such Participating Site’s facilities of which a Party is informed.

 

8.3NSABP will obligate Research Collaborators to make their records or documents
available for the purposes of any audit by a regulatory authority.

 

8.4The Parties agree to treat any information obtained in any audit or during
any visit as Confidential Information subject to Article 11 hereunder.

 

ARTICLE IX

RECORDS AND REPORTS

9.1NSABP, or its designated representative shall perform the following
recordkeeping and reporting obligations in a timely and accurate fashion in
accordance with NSABP's standard procedures and Applicable Law, as follows:

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(a)preparation and maintenance of complete and accurate written records,
accounts, notes, reports, and data of the Study; and

(b)preparation and submission to Antigen Express of CRFs for each Subject.

9.2Each Party will provide to the other Party copies of all Study communications
exchanged by the Party and the FDA, the Office for Human Research Protection
(“OHRP”), or other regulatory agency, including any that characterize any
analyses or conclusions of Study Data or which otherwise cite an opinion about
the Study rendered by NSABP.

9.3Adverse Reactions and SAEs.

9.3.1Antigen Express shall, and shall require Merck to, promptly provide NSABP
with relevant IB updates, significant safety information, including without
limitation those serious and unexpected suspected adverse reactions (as defined
by FDA regulations) for the Antigen Express Study Drug and the Merck Study Drug,
respectively, (from any source) and other relevant information upon which the
Parties may mutually agree.

9.3.2As related to the Antigen Express Study Drug, NSABP agrees to report all
serious and unexpected suspected adverse reactions that emerge during the Study
to the FDA according to 21 CFR § 312.32, to other regulatory agencies and the
appropriate EC/IRB as required by Applicable Law within the requisite applicable
timeframes and will concurrently forward all such reports to Antigen Express.

9.3.3As related to the Merck Study Drug, the IND will be filed with a request
for a waiver that exempts Merck from any requirement to notify the FDA of any
suspected unexpected serious adverse reactions related to the administration of
the Merck Study Drug in any clinical study other than as part of the Study. In
the event such waiver is not granted, Antigen Express will sponsor the Study
under its extant IND for the Antigen Express Drug (with a right of reference to
the IND for the Merck Study Drug).

9.4NSABP agrees to maintain adequate and accurate records as required under
21 CFR § 312.62 relating to the disposition of the Investigational New Drug and
the treatment of Subjects in the Study, if applicable. Prior to discarding such
records, NSABP will notify Antigen Express of pending destruction, at which time
Antigen Express may elect, at its own expense, to maintain the records until the
requirements of marketing applications in other territories have been met. NSABP
shall provide Antigen Express with interim Study status reports (e.g., toxicity
reports, monthly accrual reports, site status information) in accordance with
Appendix B.

9.5NSABP shall register the Study with www.ClinicalTrials.gov.

ARTICLE X

FINANCIAL DISCLOSURE AND CONFLICT OF INTEREST

NSABP shall collect financial disclosure statements from each Investigator
sufficient to allow Antigen Express to submit complete and accurate
certification or disclosure statements required under 21 CFR Part 54. In the
event Antigen Express decides to file the results and Antigen Express Study Data
with the FDA and/or another health authority in support of a marketing
authorization, NSABP will reasonably assist Antigen Express in meeting its
certification and disclosure obligations including, without limitation, by
providing Antigen Express with the financial disclosure statements and assisting
Antigen Express in collecting any missing information from Investigators.

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ARTICLE XI

CONFIDENTIAL INFORMATION

11.1“Confidential Information” shall mean all information and materials related
to the Study (whether owned by a Disclosing Party or by a third party to whom
such Disclosing Party owes an obligation of confidence) disclosed by a
Disclosing Party to a Receiving Party, including (without limitation) the Study
Protocol, case report forms, the IB, proprietary technology, procedures,
formulations, protocols, patient information or identifiers, know-how, clinical
data, specifications, documents and related Study materials, techniques,
processes, biospecimens, products samples, apparatus, research plans, business
plans, or identity of potential collaborators.

11.2The Parties may disclose to each other (including their respective agents
and representatives and to Participating Sites and their respective agents and
representatives) Confidential Information to aid in effecting or completing
performance of the Study under this Agreement. Confidential Information, whether
written, electronic, or verbal, disclosed by either Party hereunder
(the “Disclosing Party”) to the other (the “Receiving Party”) shall be treated
as confidential by the Receiving Party for a period of five (5) years following
completion or closure of the Study to accrual. All such disclosures of
Confidential Information shall be in writing or other tangible form and shall be
prominently marked with the legend “CONFIDENTIAL” or “CONFIDENTIAL INFORMATION”
or the like. If disclosed orally or in other than documentary or electronic
form, Confidential Information shall be reduced to a tangible form within
thirty (30) days thereafter and a copy of such tangible form, bearing the
foregoing confidentiality legend, shall be provided to the designated
representative of the Receiving Party. Notwithstanding the foregoing, failure by
a Party to mark any item "Confidential" or reduce an item to writing does not
constitute a designation of non-confidentiality when the confidential nature is
readily apparent to a reasonable observer from context and subject matter. The
Receiving Party further agrees not to disclose to others or use for any purpose,
other than as reasonably necessary for performance of the Study or exercise of
rights under this Agreement, Confidential Information disclosed pursuant to this
Agreement. These obligations of non-disclosure and non-use shall not apply to
information:

(a)that is or becomes publicly available through no fault of the Receiving
Party;

(b)that is already independently known to the Receiving Party hereunder prior to
receipt from the Disclosing Party hereunder, as shown by its prior written
records or is independently developed by the Receiving Party without use of any
Confidential Information received from the Disclosing Party; or

(c)that subsequent to its disclosure hereunder, is disclosed to the Receiving
Party on a non-confidential basis by a third party with the legal right to do
so.

11.3In the event Antigen Express, or its designees, or Merck, or its designees
shall come into contact with a Subject’s Study records, Antigen Express, or its
designees, shall, and Antigen Express will require Merck, or its designees to,
hold in confidence the identity of the Subject, and shall comply with Applicable
Law regarding the confidentiality of such records as if these records were
patient medical records.

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11.4Confidential Information shall not be disclosed by the Receiving Party
without prior written approval of the Disclosing Party to any third party, which
approval shall not be unreasonably withheld or delayed, except as set forth in
this Article XI or, if required by the FDA or any other applicable governmental
or regulatory agency having the authority to make such a demand or to any court
of law pursuant to a subpoena, or a judicial order, or as permitted by
Applicable Law. NSABP and Antigen Express agree to contact the other Party prior
to the release of any Confidential Information pursuant to this Section 11.3 and
allow the other Party to exhaust any legal action it may take to prevent or
limit the disclosure and, at Disclosing Party's request, shall cooperate with
the Disclosing Party to seek a protective order or other appropriate remedy. In
the event the Receiving Party hereunder finds it necessary to disclose
Confidential Information of the Disclosing Party to a proper governmental
authority, if permitted by Applicable Law, it shall first notify the Disclosing
Party hereunder and the Parties shall endeavor to agree upon a mutually
satisfactory way to disclose such Confidential Information as is necessary for
this limited purpose and required by Applicable Law. Nothing herein shall
prevent a Party from complying with a legal obligation to disclose Confidential
Information of the other Party so long as the Receiving Party:

(a)to the extent practicable, provides the Disclosing Party prompt notice of the
Receiving Party’s perceived obligation of disclosure and intent to disclose (or
to resist disclosure);

(b)cooperates with the Disclosing Party's lawful attempts to prevent or limit
the disclosure or obtain protection for such Confidential Information; and;

(c)only disclosing that portion of Confidential Information that is legally
required to disclose.

11.5Receiving Party must within thirty (30) days, upon written request of a
Disclosing Party (a) return all Confidential Information in its possession or
control to the Disclosing Party; or (b) destroy or delete all Confidential
Information in its possession or control. Notwithstanding the foregoing, the
Receiving Party may retain one (1) physical copy of such Confidential
Information for archival and legal purposes and electronic back-up and/or
archival storage copies made in accordance with the Receiving Party’s standard
document retention procedures solely for purposes of disaster recovery and
compliance with such policies. When Receiving Party has complied with its
obligations described above, upon request by Disclosing Party, it shall confirm
to Disclosing Party, in writing that it has returned, destroyed or deleted all
Confidential Information.

11.6Permitted Disclosures.

11.6.1Receiving Party may provide Disclosing Party’s Confidential Information to
its directors, employees, consultants, contractors and agents. NSABP may
provide, or permit Participating Sites to provide, Confidential Information to
(a) Research Collaborators and their Research Sites, (b) EC/IRBs and Study
Personnel, and (c) applicable accreditation organizations (including their
respective agents and representatives). In each case, Confidential Information
may (i) be provided on a need-to-know basis, and (ii) provided that the
Receiving Parties thereof are subject to written obligations, or bound by
institutional policies, of confidentiality and non-use with regard to such
Confidential Information that are the same or substantially the same as those
contained hereunder.

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11.6.2Notwithstanding the foregoing, Participating Sites may disclose
Confidential Information: (a) to the applicable EC/IRB(s) or other necessary
oversight or governmental or regulatory authority as required by Applicable Law,
and (b) to obtain informed consent from patients who may wish to enroll in a
Study, provided, however, that such Confidential Information shall only be
disclosed to the extent necessary and will not be provided in response to
unsolicited inquiries by telephone or to individuals who are not eligible Study
candidates.

11.6.3A Participating Site may disclose Confidential Information to the extent
such disclosure is necessary for the medical treatment of a Subject in an
emergency and is unable to provide prior notice of the disclosure, so long as
NSABP provides notice to Antigen Express of such disclosure promptly after NSABP
becomes aware of such disclosure, and such disclosure only includes such
Confidential Information as is medically necessary for such medical treatment.

11.7The terms and conditions of this Agreement shall be deemed the
Confidential Information of NSABP, subject to this Article XI. Notwithstanding
the foregoing, Antigen Express acknowledges that pass-through provisions for
NSABP contracts with its Research Collaborators may allow disclosure of the
terms and conditions of such contracts pursuant to institutional policies or
Applicable Law.

ARTICLE XII

PUBLICATIONS / PRESENTATIONS AND GENERAL PUBLICITY

12.1Notwithstanding the obligations of confidentiality and non-use set forth
below, NSABP will be free to publish and present the results of the Study
subject to the following conditions: Antigen Express will be furnished with a
copy of any proposed publication, presentation, or abstract of previously
unpublished Data relating to the Study conducted under this Agreement for review
and comment, thirty (30) days prior to such submission for publication or
presentation (collectively, "Review Period"). Such Review Period does not begin
until receipt of the proposed publication, presentation, or abstract by Antigen
Express. Antigen Express shall have the Review Period to respond with any
requested revisions, including without limitation the deletion of Antigen
Express Confidential Information (which shall be deemed to include Merck's
Confidential Information), other than the results of the Study, and revisions to
protect any existing or future patents. NSABP shall act in good faith upon such
requested revisions, except NSABP shall delete any Antigen Express Confidential
Information (which shall be deemed to include Merck Confidential Information),
other than the results of the Study, from such proposed publication. At the
expiration of such Review Period, NSABP may proceed with the submission for
publication, presentation, or abstract; provided, however, that in the event
Antigen Express has notified NSABP in writing during the Review Period that
Antigen Express reasonably believes that prior to such publication,
presentation, or abstract it must take action to protect its intellectual
property interests, such as the filing of a patent application claiming an
invention or a trademark registration application, NSABP shall either (1) delay
such publication, presentation, or abstract for an additional seventy-five (75)
days or until the foregoing action(s) have been taken, whichever shall first
occur; or (2) if NSABP is unwilling to delay the publication, presentation, or
abstract, NSABP will remove from the publication, presentation, or abstract the
information which Antigen Express has specified it reasonably believes would
jeopardize its intellectual property interests. Under certain circumstances, a
shorter review period may be granted in writing by Antigen Express.

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12.2Notwithstanding anything to the contrary in this Agreement, in the event
that neither NSABP nor Antigen Express publishes a manuscript on the primary
endpoint of the Study within eighteen (18) months after the occurrence of the
Study primary endpoint events or after the early termination of the Study,
whichever occurs first, Participating Sites, or multiple Participating Sites,
will have the right to publish or present with respect to the applicable
Participating Sites’ own Study-related data provided that any such Participating
Sites first comply with the strictures applicable to NSABP in section 12.1
above.

12.3Neither Party shall mention or otherwise use (nor authorize others to use)
the name, trademark, trade name, logo or names of the employees of the other
Party in any publication, press release or promotional material without the
prior written approval of the other Party; provided, however, that Antigen
Express shall have the right to identify NSABP as the group responsible for
conducting the Study. Antigen Express agrees that its use of the name, symbols,
and/or marks of NSABP, or names of NSABP’s employees, shall be limited to
identification of NSABP and its Research Collaborators and subcontractor's staff
as collaborators with NSABP. Antigen Express will not use, nor authorize others
to use, the name, symbols, or marks of NSABP in any advertising or publicity
material or make any form of representation or statement, which would constitute
an express or implied endorsement by NSABP of the Antigen Express Study Drug
without prior written approval from NSABP. Likewise, NSABP shall not use the
name of Antigen Express or the marks of Antigen Express in such a manner without
the written permission of Antigen Express. Antigen Express agrees to allow the
following information to appear on NSABP’s and/or Participating Site’s Clinical
Trials Directory website: the identification of Antigen Express, as the Sponsor
of the Study, Study title, Study status, trial type, Study phase, Study category
and subcategory, Study objectives and designs, conditions treated, treatment(s)
or intervention(s), key eligibility criteria and exclusion criteria; provided,
however, that such information includes no additional information beyond the
information Antigen Express posts on its own website or on
www.clinicaltrials.gov.

ARTICLE XIII

DATA OWNERSHIP AND INVENTIONS

13.1NSABP shall not acquire, as a result of the Study, and nothing transfers by
operation of this Agreement, any proprietary rights in the Study Drugs or any
patent right, copyright or other proprietary right that Antigen Express or Merck
owns as of the Effective Date. Any inventions or discoveries (whether patentable
or not) relating to the Antigen Express Study Drug ("AE Study Drug
Invention(s)") or the Merck Study Drug ("Merck Study Drug Invention(s)") and
conceived or made during the performance of the Study (collectively, hereinafter
“Study Drug Invention(s)”), by NSABP, Participating Sites or Study Personnel,
alone or jointly with others, shall be solely owned by Antigen Express or Merck,
respectively.

13.2NSABP shall, and will contractually obligate Participating Sites and Study
Personnel to (through NSABP), promptly notify Antigen Express of any Study Drug
Inventions. “Contractually obligate,” as used in Article XIII, means that NSABP
will include contractual provisions with its Research Collaborators requiring
them to obligate Participating Sites and Study Personnel to perform the
specified action(s). NSABP hereby assigns and will assign, and will
contractually obligate Participating Sites and Study Personnel to, assign and
agree to assign, any and all of their rights, title and interest in Study Drug
Inventions to Antigen Express or Merck, as applicable. Upon Antigen Express’
request, NSABP shall take, and shall contractually obligate Participating Sites
and Study Personnel to take, at Antigen Express’ or Merck's expense, such
actions as Antigen Express or Merck reasonably deems necessary or appropriate to
obtain patent or other proprietary protection in Antigen Express’ or Merck's
name, as applicable, with respect to the applicable Study Drug Inventions, and
shall execute and deliver, and shall contractually obligate Participating Sites
and Study Personnel to execute and deliver, all reasonably requested
applications, assignments, and other documents and take such other measures as
Antigen Express or Merck reasonably requests, in order to record Antigen
Express’ or Merck's rights, as applicable, in the applicable Study Drug
Inventions.

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13.3All Data generated or obtained in connection with the Study, and all
proprietary rights to the foregoing, shall be owned by Antigen Express and/or
Merck. All Materials generated or obtained in connection with the Study, and all
proprietary rights to the foregoing, shall be owned by NSABP and be subject to
the NSABP Ownership of Data/Materials Policy attached as Appendix C except to
the extent such policy conflicts with the terms of this Agreement. NSABP agrees
to treat such Data as Confidential Information of Antigen Express pursuant to
Article XI prior to public release of the Data in accordance with the terms of
this Agreement. Antigen Express agrees to treat the Materials as Confidential
Information of NSABP pursuant to Article XI. Antigen Express hereby grants to
Subject to Article XI, NSABP (and NSABP may grant to Participating Sites) a
perpetual, irrevocable, world-wide, royalty-free, non-exclusive right and
license to use the Data for non-commercial research, scientific, and educational
purposes. Subject to Article XI, NSABP hereby grants to Antigen Express a
royalty-free, non-exclusive right and license to use the Materials to perform
the Study. Notwithstanding Article XI, Antigen Express shall have the right to
use the Data for regulatory purposes in its sole discretion. NSABP agrees not to
use the Data for an NDA, supplemental NDA, or any other regulatory submission
relating to a regulatory approval for the Study Drugs by others.

13.4With respect to any inventions or discoveries (whether patentable or not)
(i) conceived or made in the performance of the Study, or (ii) from the use of
Data or Materials (or data or materials derived therefrom), by NSABP,
Participating Sites or Study Personnel, alone or jointly with others, that are
not conceived in the course of NSABP’s performance of the Study that do not
constitute Study Drug Inventions (“Other Inventions”) shall have the
determination of the ownership of such Other Inventions by inventorship (as
determined by U.S. patent law)., even if they arise from research using Data
and/or Materials, or data and/or materials derived therefrom, obtained in
connection with the Study. The Parties agree that for purposes of this Article
XIII, performance of sub-studies conducted by NSABP and/or Antigen Express with
such Data and/or Materials shall not be deemed performance of the Study, unless
any such sub-study is expressly and specifically defined in the Protocol as a
sub-study within the Study.

13.5NSABP shall promptly notify Antigen Express of any Other Inventions, and
will contractually obligate its Participating Sites and Study Personnel to,
promptly notify NSABP of any Other Inventions.

13.6Antigen Express agrees to, and has obtained from Merck the agreement to,
grant to NSABP, NSABP Principal Investigator, Participating Sites, Investigators
and/or Study Personnel who conceived or actually reduced to practice the Study
Drug Invention(s) or Joint Study Drug Invention(s) the right to use such Study
Drug Invention or Joint Study Drug Invention for internal non-commercial
academic/educational clinical, and research purposes of NSABP and/or the
Participating Site.

13.7NSABP hereby grants, and will obligate its Participating Sites and Study
Personnel (for this Section 13.7, each an "Institution") to grant, to Antigen
Express:

13.7.1a royalty-free, perpetual license to use Other Inventions solely for
Antigen Express’ internal research purposes, provided that the license granted
under this Section does not include the right to use Other Inventions to make,
have made, sell, offer for sale, import or export any products or services, and

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13.7.2an option to negotiate to obtain an exclusive royalty-bearing, worldwide
license, including the right to sublicense, to Institution’s interest in Other
Inventions. Antigen Express’ option under this section may be exercised at any
time during a period of 180 days (the “Option Period”) after the written
submission to Antigen Express of each such Other Invention by notice in writing
from Antigen Express to Institution. Upon Antigen Express’ exercise of its
option with regard to any particular Other Invention, Institution and Antigen
Express will negotiate in good faith in an attempt to reach a license agreement
satisfactory to all interested parties (the “Negotiation Period”). Unless
extended by the written mutual consent of the interested parties, the Option
Period and the Negotiation Period shall not exceed twelve (12) months in the
aggregate. If Antigen Express fails to exercise an option during an Option
Period or the interested parties fail to conclude an exclusive license to any
Other Invention within the applicable Negotiation Period, Institution shall have
no further obligation to Antigen Express hereunder with regard to Institution’s
interest in such Other Inventions.

 

ARTICLE XIV

NOTICE

Any notice required or permitted hereunder related to this Agreement shall be in
writing and shall be deemed given as of the date it is: (a) delivered by hand;
(b) by overnight courier; (c) delivered by facsimile (with transmission
confirmed); or (d) received by the Party to receive such notice by registered or
certified mail, postage prepaid, return receipt requested, and addressed as set
forth below, or to such other address as is subsequently specified in writing.

 

If to NSABP: With a copy to: Joan Beyer Goldberg, MPH Norman Wolmark, M.D. Chief
Executive Officer Chairman NSABP Foundation, Inc. NSABP Foundation, Inc Nova
Tower 2 Nova Tower 2 Two Allegheny Center, Suite 1200 Two Allegheny Center,
Suite 1200 Pittsburgh, PA 15212-5234 Pittsburgh, PA 15212-5234     If to Antigen
Express: With a copy to: Antigen Express, Inc. 33 Redwing Road Generex
Biotechnology Corporation Wellesley, MA 02481 4145 North Service Road, Suite 200
  Burlington, Ontario, Canada L7L 6A3   Attention: Mark Fletcher     Executive
Vice-President & General Counsel                          

 

Any change(s) to the list in this Article XIV will be communicated in writing to
the other Party, pursuant to the terms of this Article XIV.

 17 

 

ARTICLE XV

INDEMNIFICATION; INSURANCE; LIMITATIONS OF LIABILITY

15.1Antigen Express Indemnification. Antigen Express shall defend, indemnify,
and hold harmless the NSABP Principal Investigator, NSABP, Participating Sites,
and their respective officers, employees, IRBs, contractors, and agents
(collectively the “NSABP Indemnitees”), from any and all liabilities, expenses
including attorneys' fees, claims, actions, or suits, including (without
limitation) those for personal injury or death (the “Claims”):

(a)related to the use of the Antigen Express Study Drug used in accordance with
the Study and written instructions/information provided by Antigen Express to
NSABP or through NSABP to any third party including participants in connection
with the Study;

(b)related to the use of the Antigen Express Study Drug in accordance with the
Protocol and/or written instructions/information supplied or distributed to
third parties (including the general public) by Antigen Express in connection
with the Antigen Express Study Drug;

(c)related to any claimed design defect, manufacturing defect, contamination or
adulteration, or failure to warn relating to the Antigen Express Study Drug.

REGARDLESS OF WHETHER THE SAME ARE CAUSED, IN WHOLE OR IN PART, BY THE
CONCURRENT NEGILGENCE OF THE INDEMNITEES; PROVIDED, HOWEVER:

(i)that NSABP Indemnitees conduct the Study in accordance with Protocol
requirements and written instructions delivered by Antigen Express concerning
administration of the Antigen Express Study Drug and the Merck Study Drug and
applicable ICH GCP guidelines;

(ii)that such loss does not arise out of, in the case of NSABP, the breach of
this Agreement by the NSABP or, in the case of the Participating Site
Indemnitees, the negligence or willful malfeasance of any Indemnitees;

(iii)that Antigen Express is promptly notified in writing of any written
complaint or claim, or any serious injury relating to any loss subject to this
indemnification; and,

(iv)that Antigen Express shall have the right to select defense counsel and to
direct the defense or settlement of any such claim or suit. Notwithstanding the
foregoing, this Section 15.1(iv) shall apply to state universities or
institutions only to the extent allowed under applicable state law.

15.2Merck Indemnification. Antigen Express represents and warrants that under
the terms of the Merck Agreement, Merck has agreed to defend, indemnify and hold
harmless Antigen Express, its affiliates, and its and their employees,
directors, subcontractors and agents from and against any liability to the
extent such liability was directly caused by:

(a)negligence or willful misconduct on the part of Merck (or any of its
affiliates, or its and their employees, directors, subcontractors or agents;

(b)a breach on the part of Merck of any of its representations and warranties or
any other covenants or obligations of Merck under the Merck Agreement; or

(c)       a breach of Applicable Law by Merck.

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15.3Antigen Express shall provide diligent defense against or settlement of any
Claims, whether such Claims are rightfully or wrongfully brought or filed.

15.4Any Claim, to the extent found by a court of competent jurisdiction to have
resulted from the negligence or willful malfeasance of an Indemnitee, is
excluded from the Antigen Express indemnity obligations under this Agreement to
such extent. Deviations, defined as single event variations from the terms of
Protocol which would not have a significant deleterious effect on the research
or on the participant that may arise out of necessity, do not constitute
negligence or willful malfeasance or a violation of the requirements of Section
15.1(i) and/or Section 15.1(ii) above.

15.5The NSABP Indemnitee(s) shall reasonably cooperate with Antigen Express and
its legal representatives in the investigation and defense of any Claim covered
under this Agreement. In the event a Claim is or may be asserted, NSABP shall
have the right to select and to obtain representation by separate legal counsel.
Legal counsel selected by NSABP may participate in any settlement negotiations
or legal proceedings subject to Article XV, but Indemnitor(s) shall retain the
right to direct the settlement or defense of any Claim, subject to the NSABP
Indemnitee’s consent and to the extent allowed under state law for Participating
Sites that are state universities and institutions, which consent shall not be
unreasonably withheld or delayed. If NSABP, or Participating Sites that are
state universities and institutions, exercises such right, all costs and
expenses incurred by NSABP, or such Participating Sites, for such separate
counsel shall be borne by NSABP, or such Participating Site.

15.6Selected Terms of Agreement for Disclosure to Sites. Attached as Appendix C
to this Agreement is a listing of Selected Terms of Agreement for Disclosure to
Sites. NSABP may provide a copy of Appendix D to Research Collaborators and/or
subcontractors as reasonably deemed necessary or helpful by NSABP in connection
with negotiating the terms of agreements with Research Collaborators and/or
subcontractors for performance of the Study.

15.7Antigen Express warrants that it maintains a policy or program of insurance
or self-insurance at levels sufficient to support the indemnification obligation
assumed herein. Upon request, Antigen Express will provide evidence of its
insurance.

15.8Each of the Participating Sites is responsible for maintaining, at its own
expense and throughout the term of this Agreement, insurance as it deems
appropriate to protect its liabilities and contractual obligations. However,
failure of any Participating Site to have insurance coverage, ability to obtain
insurance coverage or any inadequacy of insurance coverage shall not relieve or
decrease liabilities, if any, of the Parties or that Participating Site under
this Agreement. It is understood that NSABP, including its agents, Participating
Sites, and subcontractors, is not responsible for the acts or omissions of
Antigen Express. A program of self-insurance will suffice for compliance with
this provision.

15.9NSABP SHALL NOT BE LIABLE BEFORE OR AFTER TERMINATION OF THIS AGREEMENT
UNDER ANY CONTRACT, STRICT LIABILITY, NEGLIGENCE, STATUTORY, OR OTHER LEGAL OR
EQUITABLE THEORY:

15.9.1FOR ANY DIRECT, SPECIAL INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES
RELATED TO ANY PRODUCT, MATERIAL, EQUIPMENT, DATA, SERVICE, OR OTHER ITEM, IF
ANY, PROVIDED HEREUNDER, OR ANY PRODUCT, MATERIAL, EQUIPMENT, SERVICE, OR ITEM,
IF ANY, SUPPLIED TO THIRD PARTIES BY ANTIGEN EXPRESS AS A RESULT OF THE RESEARCH
CONDUCTED UNDER STUDY; OR

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15.9.2FOR COST OF PROCUREMENT OF SUBSTITUTE SERVICES OR ANY SPECIAL, INCIDENTAL,
OR CONSEQUENTIAL DAMAGES RELATED TO ANY OBLIGATIONS UNDER THIS AGREEMENT.

ARTICLE XVI

HUMAN SUBJECTS

16.1Informed consent of the Subjects shall be obtained in accordance with
45 CFR Part 46. Related EC/IRB review and approval of Protocol, including the
Informed Consent Form, shall be obtained in accordance with 21 CFR Part 56. The
patient consent and/or HIPAA authorization form(s) as approved by the EC/IRB
shall disclose that documentation may be provided to representatives of Antigen
Express, the FDA, or other regulatory agencies and that patient identifying
information will be removed prior to submission thereto. Subject to Applicable
Law, during audits of the Study at NSABP, Participating Sites, or their
designated agents and representatives, Antigen Express shall have the right to
review informed consent forms to assure that they conform to Applicable Law.

16.2If a Subject suffers an adverse reaction, illness, or injury which was
directly caused by the Antigen Express Study Drug, Antigen Express will
reimburse for the reasonable and necessary costs of diagnosis and treatment of
any Subject’s injury, including hospitalization, but only to the extent such
expenses are not attributable to (a) the negligence, recklessness, or willful
misconduct of a participating Investigator, a Participating Site or its
officers, agents, consultants, contractors, or employees; (b) a material failure
to follow Protocol not required for medical treatment of a Subject; or (c) the
natural progression of an underlying or pre-existing condition or events, unless
exacerbated by participating in the Study.

ARTICLE XVII

TERM AND TERMINATION

17.1           This Agreement shall be effective upon the Effective Date and
shall continue until the completion of the obligations of this Agreement.

17.2This Agreement may be terminated by either Party, immediately upon prior
written notice to the other Party, if any of the following conditions occur.

17.2.1Immediately upon written notice to the other Party:

17.2.1.1if the authorization and approval to perform the Study in the United
States is withdrawn by the FDA;

17.2.1.2if human and/or toxicology test results, in the reasonable opinion of
either Antigen Express or NSABP, are of such magnitude and/or frequency of
incidence as to support termination of the Study;

17.2.1.3if the emergence of any adverse reaction or side-effect of any drug
administered in the Study or a modification to the Protocol raises safety issues
of such magnitude and/or incidence in the reasonable opinion of either Antigen
Express or NSABP to support termination of the Study;

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17.2.1.4If the manufacture of the Antigen Express Study Drug or Merck Study Drug
ceases and/or the supply of the Antigen Express Study Drug or Merck Study Drug
has been exhausted.

17.2.2Either Party shall have the right to terminate this Agreement in the event
the other Party remains in material breach of any Section of this Agreement
after thirty (30) days to cure any such material breach after its receipt of
notice of same in writing from the other Party.

17.3NSABP shall have the right to terminate this Agreement in the event Antigen
Express fails to pay an undisputed amount due to NSABP hereunder within
forty-five (45) days after being notified by NSABP that it is in arrears of
payments due hereunder; or

17.4Obligations Upon Termination. If this Agreement is terminated for any
reason, the Study shall be discontinued in accordance with the provisions of the
Protocol, this Agreement, and in a manner designed to preserve Subject safety
and data integrity. Both Parties shall take all reasonable steps to cooperate
with the other to wind-down the Study in an efficient, safe, and cost-effective
manner. The need for any continued Subject safety monitoring and the appropriate
manner to cease conducting Study procedures will be reasonably determined by
NSABP in accordance with Applicable Law. In addition, payments will be made to
NSABP by Antigen Express for reasonable costs incurred for all NSABP services
performed up to the time of termination in accordance with this Agreement, and
for any reasonable, non-cancelable expenses related to the Study. Such amounts
shall take into account any payments previously made to NSABP hereunder.

17.5Survival. No expiration or termination of this Agreement will release the
Parties from their rights or obligations accrued prior to expiration or the
effective date of termination. The rights and duties under (a) Sections 2.6,
4.1, 4.2, 4.3, 4.4, 5.1; (b) Articles VIII, IX, XI, XII, XIII, XV, XVI, XXIV,
XXV, and XXVII; and (c) Appendix B will survive the expiration or termination of
this Agreement.

ARTICLE XVIII

AMENDMENTS

This Agreement may be extended, renewed, or otherwise amended at any time only
by the mutual prior written consent of Parties hereto.

ARTICLE XIX

SEVERABILITY

If any provision(s) of this Agreement is or becomes invalid, is ruled illegal by
any court of competent jurisdiction, or is held unenforceable, the
unenforceability thereof shall not affect the remainder of this Agreement which
shall remain in full force and effect and enforceable in accordance with its
terms. Further, it is the intention of the Parties that in lieu of each such
provision, which is invalid, illegal, or unenforceable, there shall be a new
provision as similar as possible in economic and business objective intended by
the Parties for such invalid, illegal, or unenforceable provision, but which
substituted provision shall be valid, legal, and enforceable.

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ARTICLE XX

INTEGRATION

Appendices identified within this Agreement are incorporated in this Agreement
by reference.

ARTICLE XXI

ASSIGNMENT

21.1Neither Party hereto may assign, cede, or otherwise transfer any of its
rights or obligations under this Agreement without the prior written consent of
the other Party; which consent may not be unreasonably withheld; provided,
however, that without such consent either Party may freely assign this Agreement
in connection with the transfer or sale of all, or substantially all, of its
assets or business, or its merger or consolidation with another company.
Notwithstanding the above, either Party may assign this Agreement in whole or in
part to any wholly-owned subsidiary or its affiliate without consent of the
other Party.

21.2This Agreement shall inure to the benefit of, and be binding upon, each
Party signatory hereto, its successors, and permitted assigns. No assignment
shall relieve either Party of the performance of any accrued obligation, which
such Party may then have under this Agreement. Any permitted assignee will
assume the rights and obligations of its assignor under this Agreement.

ARTICLE XXII

INDEPENDENT CONTRACTOR

The relationship of the Parties to this Agreement is that of independent
contractors. Neither Party is authorized or empowered to act as an agent for the
other for any purpose save and except as expressly provided for in this
Agreement, and shall not on behalf of the other enter into any contract,
warranty, or representation as to any matter. Neither Party shall be bound by
the acts or conduct of the other, except as provided by the terms of this
Agreement.

ARTICLE XXIII

NO TRANSFER OF PROPRIETARY RIGHTS NOT SPECIFIED

It is agreed that neither Antigen Express nor NSABP transfers to the other by
operation of this Agreement any patent right, copyright, or other proprietary
right of either Party, except to the extent expressly set forth herein.

ARTICLE XXIV

CONFORMANCE WITH LAW AND ACCEPTED PRACTICE

In performing their respective obligations hereunder, the Parties shall comply,
as applicable, with generally accepted standards of clinical practice, with the
Protocol, and with all Applicable Law governing the performance of clinical
investigations as applicable to the Study.

ARTICLE XXV

WAIVER

No waiver of any term, provision, or condition of this Agreement whether by
conduct or otherwise in any one or more instances shall be deemed to be or
construed as a further or continuing waiver of any such term, provision or
condition, or of any other term, provision or condition of this Agreement.

 22 

 

 

ARTICLE XXVI

FORCE MAJEURE

Neither Party shall be liable for any failure to perform as required by this
Agreement, to the extent such failure to perform is due to circumstances
reasonably beyond either Party's control, such as labor disturbances or labor
disputes of any kind, accidents, failure of utilities, mechanical breakdowns,
material shortages, hurricanes, tornadoes, blizzards, electrical outages,
disease, or other such occurrences.

ARTICLE XXVII

DEBARMENT

NSABP certifies that as of the Effective Date, neither NSABP nor any person
engaged or employed thereby directly in the performance of or providing services
for the Study is (i) currently debarred under Section 306(a) or (b) of the
Federal Food, Drug and Cosmetic Act; or (ii) disqualified. NSABP shall obligate
its Research Collaborators to certify that (i) none of its Investigators or
Participating Sites, nor any of their respective Study Personnel, are currently
debarred; or disqualified; and (ii) will notify NSABP immediately of any such
occurrence. If at any time after execution of this Agreement, NSABP becomes
aware of any such debarment or disqualification, NSABP hereby certifies that
NSABP will promptly notify Antigen Express.

ARTICLE XXVIII

GOVERNING LAW

 

This Agreement and the rights and obligations of the Parties hereunder shall be
governed by and construed under the laws of the Commonwealth of Pennsylvania
without reference to principles of conflicts of laws. The Parties hereby agree
that any and all disputes or controversies arising out of or related to this
Agreement shall be subject to venue and jurisdiction in the state and federal
courts situated in Pittsburgh, Allegheny County, Pennsylvania. Notwithstanding
the foregoing, this Article XXIX shall not apply to Participating Sites that are
state universities or institutions, and contracts with such Research
Collaborators will be silent on choice of law.

 

ARTICLE XXX

ENTIRE AGREEMENT

This Agreement and the Appendices hereto, represent the entire understanding and
agreement of the Parties with respect to the subject matter herein, and
supersedes all prior discussions, agreements, and understanding entered into
orally or otherwise between the Parties in connection with the subject matter
herein. Each Party confirms that it is not relying on any representations or
warranties of any other Party except as specifically set forth in this
Agreement. To the extent of any conflict or inconsistency between the terms of
this Agreement, Appendices or the Protocol, the terms of this Agreement will
control, except that the terms of the Protocol will nonetheless control with
respect to scientific and medical issues in connection with any such conflict or
inconsistency. This Agreement may only be modified by a writing duly executed by
both Parties.

ARTICLE XXXI

COUNTERPARTS

This Agreement and any amendments may be executed in any number of counterparts,
each of which shall be an original and all of which together shall constitute
one and the same document, binding on all Parties notwithstanding that each of
the Parties may have signed different counterparts. Facsimiles or scanned copies
of signatures or electronic images of signatures shall be considered original
signatures unless prohibited by Applicable Law.

 

[The remainder of this page intentionally left blank.]

 

 23 

 

 

BINDING EXECUTION

 

IN WITNESS WHEREOF, the Parties hereto have executed this Agreement in duplicate
by the proper persons thereunto duly authorized.

 

NSABP FOUNDATION, INC. ANTIGEN EXPRESS, INC.

 

 

By:

 

 

By:

     

 

Joan Beyer Goldberg, MPH

 

 

 

Printed Name   Printed Name

 

Chief Executive Officer

 

 

 

Title   Title

 

 

    Date   Date

 

 24 

 

 

Appendix A

 

PROTOCOL

 

 

A Phase II Clinical Trial of Pembrolizumab in Combination with the AE37 Peptide
Vaccine in Patients with Metastatic Triple Negative Breast Cancer (FB-14)

 

[Appendix A is set out on the following pages]

 

 A-1 

 

 

Appendix B

 

BUDGET, PAYMENT SCHEDULE, AND TASK LIST

 

 

1.Antigen Express agrees to pay NSABP an amount not to exceed $2,118,461 as set
forth in this Appendix B to perform the work under the terms of this Agreement.
Such payments assumes (a) an actual enrollment of twenty-nine (29) evaluable
patients, (b) five (5) sites, (c) twelve (12) months accrual, (d) six (6) months
average treatment, and (d) at least one (1) patient receives treatment for 24
months.

 

2.Antigen Express will make payments to NSABP in the increments and at the times
indicated on the Payment Schedule in this Appendix B. Payments to NSABP shall be
made in four phases as follows – Start-Up Activities, Accrual and Treatment
Period, Follow-Up Period and Primary Endpoint. Antigen Express shall pay NSABP
invoices not later than thirty (30) days after receipt of an invoice.

 

3.Start-Up Activities – $340,000 – Within thirty days after receipt of a fully
executed Agreement, Antigen Express will make an initial payment (“Initial
Payment”) to NSABP in the amount of $340,000. The Initial Payment shall become
nonrefundable upon execution of this Agreement to the extent it has been
expended for costs actually reasonably incurred or committed pursuant to this
Agreement. The Initial Payment supports: pre-study activities, site start-up
costs, drug distributor, central lab, and database start-up costs, and other
initiation and administration functions, and protocol education and awareness
building.

 

4.Accrual and Treatment Period – $1,458,461 – Antigen Express will pay NSABP
$1,458,461 during the Accrual and Treatment Period commencing with the
enrollment of the first (1) Subject randomized to FB-14 and in increments as
indicated on the Payment Schedule contained in this Appendix B. These payments
support the costs of regulatory, administrative, and other services as
anticipated in the performance of FB-14. In addition, payments include support
for activities performed and costs incurred at Participating Sites, such as:
patient screening, eligibility assessment and recruitment activities, patient
instruction, incidental supplies and materials, tissue acquisition and storage,
other unfunded costs related to the study, and the cost of patient care
procedures that are considered non-routine care.

 

5.Follow-Up Period - $240,000 – Antigen Express shall pay an amount up to
$240,000 in three (3) annual payments of $80,000 each. Invoices for annual
payments will be submitted at the beginning of the calendar years for which the
payments are related.

 

6.Primary Endpoint - $80,000 – Antigen Express will make a final payment of
$80,000 upon completion of the primary endpoint analysis and submission of the
primary endpoint manuscript to Antigen Express.

 

7.Antigen Express shall not be obligated to make any payments to NSABP in excess
of the amounts provided herein, unless such excess amounts have been agreed upon
in advance and in writing by NSABP and Antigen Express.

 

8.In the event Antigen Express disputes any portion of an invoice, Antigen
Express shall pay NSABP the undisputed amount of the invoice within thirty (30)
days after Antigen Express' receipt of the invoice and notify NSABP in writing
within fifteen (15) days after Antigen Express' receipt of the invoice of the
amount of the invoice that is disputed and the reason for the dispute, after
which each of Antigen Express and NSABP shall endeavor to resolve the disputed
portion of the invoice.

 B-1 

 

 

 

9.If, for any reason, FB-14 is terminated, or FB-14 is closed to accrual prior
to completion, or FB-14 is not completed with final analysis, in accordance with
Article XVIII herein, Antigen Express agrees to pay NSABP for services rendered
and commitments for services rendered through the termination date. Payment of
the outstanding amount due determined by the final accounting analysis and will
be made by Antigen Express after Antigen Express has received a final report and
accounting for the FB-14 and all queries are resolved.

 

10.NSABP shall invoice Antigen Express referring to this Agreement and any
appropriate invoice number provided by Antigen Express. Invoices shall be
payable by Antigen Express forty-five (45) days from Antigen Express’s receipt
of invoice.

 

 

Generex Biotechnology Corporation

4145 North Service Road, Suite 200

Burlington, Ontario, Canada L7L 6A3

Attention: Mark Fletcher, Executive Vice-President & General Counsel

mfletcher@generex.com

416-364-2551, ext 235

 

11.Checks shall be made payable to “NSABP Foundation, Inc.”, (Tax Identification
Number 25-1781357) and sent to:

 

Accounts Receivables

NSABP Foundation, Inc.

Nova Tower 2

Two Allegheny Center, Suite 1200

Pittsburgh, PA 15212

 

 B-2 

 

 

 

[image_001.gif] 

 

 

 

 B-3 

 

 

Appendix B

FB-14

Task List

 

Compound: Pembrolizumab and AE37 Peptide Vaccine  (collectively, "Study Drugs")
Protocol: FB-14 SOP Accountability: NSABP IND Holder: Antigen Express Version
Date: 02/06/2018

 

Key:
E = Execute; R = Review; S = Support
A = Approve; AC = Accept

 

Antigen express

 

NSABP

 

merck

1.       Protocol Preparation       Approve / Accept final Study proposal AC E
AC Write draft Protocol (consultants, literature review, background research)  
E   Review draft Protocol R   R Write final Protocol A E AC Write Protocol
amendments A E AC Provide copies of Protocol   E   2.       Informed Consent
Document Preparation       Prepare informed consent template   E   Assist sites
with informed consent modification(s)   E   Prepare and review translations   E
  3.       eCRF Development & eCRF Completion Guide       Design eCRF   E  
Write eCRF Completion Guidelines   E   eCRF Distribution   E   4.       Design
Systems Required for Data Management       IT Set-Up, System Administration and
Maintenance   E   5.       Design & Implement Patient Registration       Develop
registration mechanism   E   6.       Database Design & Implementation      
Design clinical database   E   Programming and mapping of SAS datasets   E  
7.       Distribution of Study Documents       Distribute Protocol to Sites   E
  Distribute amendments to Sites   E   Distribution of IB to NSABP E   E
Distribution of IB to Sites   E   8.       Site Qualifications       Develop
list of Sites for qualification R, A E   Site qualification   E   Site selection
R, A E   9.       Investigator Site Contracts & Budgets       Negotiate and
finalize Site-specific CDAs   E   Negotiate and finalize Site-specific Study
Agreements   E   10.   Site Regulatory Documents       Collect the following
regulatory documents for Sites:       Ø  FDA Form 1572   E   Ø  CVs for
Investigators and Subinvestigators   E   Ø  Medical licenses for Investigators
and Subinvestigators   E   Ø  Financial Disclosure for Investigators and
Subinvestigators   E   Ø  Protocol Signature Page signed by Investigator   E  
Ø  IB Acknowledgement Page signed by Investigator   E   Ø  IRB-approved
Institution Informed Consent Form   E   Ø  IRB approval documents   E   Ø  OHRP
IRB registration   E   11.   Agency Regulatory Documents       IND-related
filings with the FDA S/A E S clinicaltrials.gov registration   E   12.   Study
Initiation Visits (SIV)       Plan, organize, manage webcast SIV   E   Record
and post SIV content   E   Present Science / Protocol / Safety Profile   E  
Present regulatory topics   E   Present AE / SAE reporting   E   Present
monitoring information   E   Present eCRFs   E   Present Biologic Repository lab
procedures / information E E E Present Study Drugs Ordering Process to Sites   E
  13.   Site Monitoring       Develop and Implement monitoring plan   E  
Conduct monitoring (Source document verification, drug accountability,
regulatory document review, eCRF review, supply inventory, etc.)   E   Identify
and report non-compliance   E   Provide written monitoring reports   E   Conduct
Site close-out procedure (final source document verification, drug
accountability, regulatory document review, eCRF review, study supply
disposition, etc.)   E   14.   Quality Control & Quality Assurance Audits      
Develop Protocol-specific Audit Plan   E   Perform QC review of Study Data and
TMF   E   Perform QA audits according to Audit Plan   E   Perform audits of
vendors   E   15.   Operational Issues       Provide on-going Site support   E  
16.   Serious Adverse Event Management       Receive SAE report from Sites and
review   E   Write Protocol-specific SAE Reporting Work Instruction   E  
Maintain a tracking log of all SAE reports from Sites   E   Write SAE Narrative
  E   SAE follow-up and resolution   E   SAE reporting to FDA R/A E   SAE
reporting to Antigen Express/Merck (as applicable)   E   Distribution of IND
Safety Reports (expedited reports) to Investigators   E   SAE reconciliation   E
  Global SUSARS reporting S E S 17.   Sample Management       Tumor Samples   E
  Blood Samples   E   18.   Project Management       Process and provide
payments to Sites   E   Organize and participate in periodic conference calls
with Antigen Express/Merck (agenda, logistics, etc.) S E S Prepare meeting and
conference call minutes following meeting/call completion and distribute to
project team   E   Manage project management issues   E   19.   Management of
Study Kits       Supply Study Kits   E   Process Study Kit orders and reorders  
E   Distribute Study Kits to Sites   E   Coordinate post-Study disposition of
Study Kits   E   Manage general Study Kit issues   E   20.   Management of Study
Drugs       Manufacture of the Study Drugs E   E Labeling (investigational use)
E (both study drugs)   E Distribute to the designated NSABP drug distributor E  
  Receipt of the Study Drugs from the manufacturer     E   Process Site Study
orders and reorders   E   Coordinate post-Study disposition of Study Drugs   E  
Provide post-Study accountability of Study Drugs   E   Manage general Study
Drugs issues   E   21.   Data Management       Write data validation plan   E  
Write data management plan   E   Write statistical analysis plan R E   Provide
Electronic Data Capture System   E   Validate EDC System   E   Resolve queries  
E   Perform QC review of eCRFs   E   Code terms   E   Approve coding   E   22.  
Tables, Listings & Figurines       Define safety listings and tables   E  
Define efficacy listings and tables   E   Produce safety listings and tables   E
  Produce efficacy listings and tables   E   Validate safety listings and tables
  E   Validate efficacy listings and tables   E   23.   Study Reports      
Provide final statistical report R/AC E   Prepare primary publication R E  
Prepare subsequent publications / abstracts R E  

 

 B-4 

 

 

Appendix C

 

NSABP’s Ownership of Data and Materials Ownership Policy

 

[Appendix C is set out on the following pages]

 

 C-1 

 

 

 

Appendix D

 

SELECTED TERMS OF AGREEMENT FOR DISCLOSURE TO SITES

 

Indemnification

 

This is to confirm that Antigen Express and NSABP have agreed to the following
for the FB-14 trial:

 

1.Antigen Express (Indemnitor) shall defend, indemnify, and hold harmless the
NSABP Principal Investigator, NSABP, Participating Sites, and their respective
officers, employees, IRBs, contractors, and agents (collectively the “NSABP
Indemnitees”), from any and all liabilities, expenses including attorneys' fees,
claims, actions, or suits, including (without limitation) those for personal
injury or death (the “Claims”):

 

(a)related to the use of the Antigen Express Study Drug used in accordance with
the Study and written instructions/information provided by Antigen Express to
NSABP or through NSABP to any third party including participants in connection
with the Study;

 

(b)related to the use of the Antigen Express Study Drug in accordance with the
Protocol and/or written instructions/information supplied or distributed to
third parties (including the general public) by Antigen Express in connection
with the Antigen Express Study Drug;

 

(c)related to any claimed design defect, manufacturing defect, contamination or
adulteration, or failure to warn relating to the Antigen Express Study Drug.

REGARDLESS OF WHETHER THE SAME ARE CAUSED, IN WHOLE OR IN PART, BY THE
CONCURRENT NEGILGENCE OF THE INDEMNITEES; PROVIDED, HOWEVER:

(i)that NSABP Indemnitees conduct the Study in accordance with Protocol
requirements and written instructions delivered by Antigen Express concerning
administration of the Antigen Express Study Drug and applicable ICH GCP
guidelines;

(ii)that such loss does not arise out of, in the case of NSABP, the breach of
the Clinical Trial Agreement by NSABP or, in the case of the Participating Site
Indemnitees, the negligence or willful malfeasance of any Indemnitees;

(iii)that Antigen Express is promptly notified in writing of any written
complaint or claim, or any serious injury relating to any loss subject to this
indemnification; and,

(iv)that Antigen Express shall have the right to select defense counsel and to
direct the defense or settlement of any such claim or suit. Notwithstanding the
foregoing, this Section 15.1(iv) shall apply to state universities or
institutions only to the extent allowed under applicable state law.

 

 D-1 

 

2.Antigen Express represents and warrants that under the terms of the agreement
between Merck and Antigen Express, Merck ("Indemnitor") has agreed to defend,
indemnify and hold harmless Antigen Express, its affiliates, and its and their
employees, directors, subcontractors and agents from and against any liability
to the extent such liability was directly caused by:

(a)negligence or willful misconduct on the part of Merck (or any of its
affiliates, or its and their employees, directors, subcontractors or agents;

(b)a breach on the part of Merck of any of its representations and warranties or
any other covenants or obligations of Merck under this Agreement; or

(c)a breach of Applicable Law by Merck.

3.Indemnitor(s) shall provide diligent defense against or settlement of any
Claims, whether such Claims are rightfully or wrongfully brought or filed.

3.Any Claim, to the extent found by a court of competent jurisdiction to have
resulted from the negligence or willful malfeasance of an Indemnitee, is
excluded from the Indemnitor(s)' indemnity obligations under this Agreement to
such extent. Deviations, defined as single event variations from the terms of
Protocol which would not have a significant deleterious effect on the research
or on the participant that may arise out of necessity, do not constitute
negligence or willful malfeasance or a violation of the requirements of Section
15.1(i) and/or Section 15.1(ii) above.

4.The NSABP Indemnitee(s) shall reasonably cooperate with Indemnitor(s) and its
legal representatives in the investigation and defense of any Claim covered
under this Agreement. In the event a Claim is or may be asserted, NSABP shall
have the right to select and to obtain representation by separate legal counsel.
Legal counsel selected by NSABP may participate in any settlement negotiations
or legal proceedings subject to Article XV, but Antigen Express shall retain the
right to direct the settlement or defense of any Claim, subject to the NSABP
Indemnitee’s consent and to the extent allowed under state law for Participating
Sites that are state universities and institutions, which consent shall not be
unreasonably withheld or delayed. If NSABP, or Participating Sites that are
state universities and institutions, exercises such right, all costs and
expenses incurred by NSABP, or such Participating Sites, for such separate
counsel shall be borne by NSABP, or such Participating Site.

Antigen Express, Inc.:

__________________________________

Name

__________________________________

Title

__________________________________

Signature

 D-2