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.


		2.4	Norman
                                         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


		3.1	Antigen
                                         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. 



		3.2	The
                                         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”). 



 


		3.3	Antigen
                                         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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		3.4	NSABP
                                         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.



		3.5	Antigen
                                         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


		4.1	In
                                         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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		4.1.1	The
                                         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.



		4.1.2	Antigen
                                         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.



		4.2	If
                                         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.



		4.3	The
                                         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.



		4.4	It
                                         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


		5.1	Study
                                         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.



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



		5.1.3	Antigen
                                         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. 



		5.1.4	NSABP
                                         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.



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



		5.1.6	In
                                         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.



		5.2	Study
                                         Drug Distribution. 



		5.2.1	Antigen
                                         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. 



		5.3	Disposition
                                         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. 



		5.4	Continued
                                         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


		8.1	At
                                         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.



		8.2	Antigen
                                         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.



 


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



 


		8.4	The
                                         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


		9.1	NSABP,
                                         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.



		9.2	Each
                                         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.



		9.3	Adverse
                                         Reactions and SAEs.



		9.3.1	Antigen
                                         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.



		9.3.2	As
                                         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.



		9.3.3	As
                                         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).



		9.4	NSABP
                                         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.



		9.5	NSABP
                                         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.






    	 	11	 



     


    

 


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.



		11.2	The
                                         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.



		11.3	In
                                         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.




    	 	12	 



     


    
		11.4	Confidential
                                         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.



		11.5	Receiving
                                         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.



		11.6	Permitted
                                         Disclosures. 



		11.6.1	Receiving
                                         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.




    	 	13	 



     


    
		11.6.2	Notwithstanding
                                         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.



		11.6.3	A
                                         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. 



		11.7	The
                                         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


		12.1	Notwithstanding
                                         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.




    	 	14	 



     


    
		12.2	Notwithstanding
                                         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.



		12.3	Neither
                                         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


		13.1	NSABP
                                         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. 



		13.2	NSABP
                                         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. 




    	 	15	 



     


    
		13.3	All
                                         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.



		13.4	With
                                         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.



		13.5	NSABP
                                         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. 



		13.6	Antigen
                                         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.



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



		13.7.1	a
                                         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




    	 	16	 



     


    
		13.7.2	an
                                         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


		15.1	Antigen
                                         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.



		15.2	Merck
                                         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.



    	 	18	 



     


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



		15.4	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 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.



		15.5	The
                                         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.



		15.6	Selected
                                         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.



		15.7	Antigen
                                         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.



		15.8	Each
                                         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.



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



		15.9.1	FOR
                                         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




    	 	19	 



     


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



ARTICLE
XVI


HUMAN
SUBJECTS


		16.1	Informed
                                         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.



		16.2	If
                                         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.


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



		17.2.1	Immediately
                                         upon written notice to the other Party:



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



		17.2.1.2	if
                                         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;



		17.2.1.3	if
                                         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;




    	 	20	 



     


    
		17.2.1.4	If
                                         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.



		17.2.2	Either
                                         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.



		17.3	NSABP
                                         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 



		17.4	Obligations
                                         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. 



		17.5	Survival.
                                         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.






    	 	21	 



     


    

 


ARTICLE
XX


INTEGRATION


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


ARTICLE
XXI


ASSIGNMENT


		21.1	Neither
                                         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.



		21.2	This
                                         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	 



     


    

 


 


 


 


 


 






    	 	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.:


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		Name	



		__________________________________	



		Title	



		__________________________________	



		Signature	







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