Document:

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.:

__________________________________

		Name	

		__________________________________	

		Title	

		__________________________________	

		Signature	

    	 	D-2Exhibit 10.1

 

SUPPORT AGREEMENT

This Support Agreement, dated November 26, 2018 (this “Agreement”), is by and among the persons and entities listed on Schedule A hereto (collectively, “Third Point”, and each individually, a “member” of Third Point), Campbell Soup Company (the “Company”), and The Revocable Trust of George Strawbridge, Jr., dated January 21, 1991 (the “Strawbridge Trust”), solely for purposes of Sections 1(a)(viii)-(ix), Section 17 and Section 18.

WHEREAS, Third Point has (i) given notice to the Company that they intend to nominate Sarah Hofstetter, Munib Islam, Bozoma Saint John, Kurt Schmidt and William Toler (the “Third Point Nominees”) for election as directors of the Company at the Company’s 2018 Annual Meeting of Shareholders (the “2018 Annual Meeting”) and (ii) filed a definitive proxy statement with the Securities and Exchange Commission (the “SEC”) relating to the solicitation of proxies for the 2018 Annual Meeting;

WHEREAS, Third Point and its Affiliates (as defined herein) beneficially own 21,000,000 shares of common stock of the Company, par value $0.0375 (the “Common Stock”), of the Common Stock issued and outstanding on the date hereof;

WHEREAS, by letters dated September 12, 2018, Cede & Co., on behalf of certain Affiliates of Third Point, made demands to inspect and copy certain stocklist materials of the Company as set forth more fully therein, pursuant to §14A:5-28 of the New Jersey Revised Statutes and applicable common law (the “Stocklist Demand”);

WHEREAS, by letters dated October 3, 2018, Cede & Co., on behalf of certain Affiliates of Third Point, made demands to inspect and copy certain books and records of the Company as set forth more fully therein, pursuant to §14A:5-28 of the New Jersey Revised Statutes and applicable common law (the “Books and Records Demand”);

WHEREAS, by letter dated October 4, 2018, the Strawbridge Trust joined the Books and Records Demand;

WHEREAS, on October 25, 2018, certain members of Third Point and the Strawbridge Trust filed an action in the Superior Court of New Jersey Chancery Division – Camden County (the “Court”), captioned Third Point, LLC, et al. v. Campbell Soup Company, et al., Docket No. CAM-C-102-18 (the “Proxy Action”) asserting claims for breach of fiduciary duty against the Board and a claim for aiding and abetting against the Company; and

WHEREAS, the Company has determined that it is in the best interests of the Company and its shareholders and Third Point has determined that it is in its best interests to come to an agreement with respect to the election of members of the Company’s Board of Directors (the “Board”) at the Company’s 2018 Annual Meeting and certain other matters, as provided in this Agreement, and to terminate the pending proxy contest for election of directors at the 2018 Annual Meeting.

NOW, THEREFORE, in consideration of and reliance upon the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows:

1. Board Representation and Board Matters.

(a) The Company and Third Point agree as follows:

(i) the Company and the Board shall take all action necessary (A) to increase the size of the Board by two directors to 14 directors, effective at the close of business on November 29, 2018, and (B) subject to completion of the Company’s standard Director and Officer questionnaire and director background check, which is intended to be completed no later than November 29, 2018, to appoint each of Sarah Hofstetter and Kurt Schmidt (collectively, the “Designees”) to fill the vacancies created thereby and serve as directors of the Company, effective at the close of business on November 29, 2018, until the later of (1) the conclusion of the Company’s 2019 Annual Meeting of Shareholders (the “2019 Annual Meeting”) and (2) the date that their successors are duly elected and qualified, subject to the terms of this Agreement;

 

 

(ii) the Company agrees that (A) it shall add an additional independent member of the Board by no later than the meeting of the Board to be held in May 2019 and (B) it shall consult with Third Point and solicit the views and opinions of Third Point with respect to such additional independent Board member, it being agreed that the two individuals identified by Third Point to the Company prior to the date hereof shall be included in the pool of individuals being considered for such Board seat by the Company;

(iii) the Company’s slate of nominees for election as directors of the Company at the 2018 Annual Meeting shall be: Fabiola R. Arredondo; Howard M. Averill; Bennett Dorrance; Maria Teresa Hilado; Randall W. Larrimore; Marc B. Lautenbach; Mary Alice D. Malone; Sara Mathew; Keith R. McLoughlin; Nick Shreiber; Archbold D. van Beuren; and Les C. Vinney;

(iv) that no later than the date of this Agreement, Third Point will provide to the Company an executed letter in the form attached hereto as Exhibit A, which includes a consent from each Designee to serve as a director of the Company effective at the close of business on November 29, 2018 (the “Nominee Letter”);

(v) the Board, based on information provided by Third Point and the Designees, has determined that the Designees would be independent directors of the Board of the Company under the applicable New York Stock Exchange rules;

(vi) that Third Point irrevocably withdraws (A) its letter dated September 7, 2018 providing notice to the Company of its intention to nominate certain individuals for election as directors of the Company at the 2018 Annual Meeting (the “Third Point Shareholder Nomination”) and (B) its letter dated November 9, 2018 providing an update to the Third Point Shareholder Nomination and reducing the number of individuals it intends to nominate for election as directors of the Company at the 2018 Annual Meeting (the “Update to Third Point Shareholder Nomination”);

(vii) that each member of Third Point shall immediately cease all efforts, direct or indirect, in furtherance of the Third Point Shareholder Nomination and the Update to Third Point Shareholder Nomination and any related solicitation in connection with the Third Point Shareholder Nomination and the Update to Third Point Shareholder Nomination, including any negative solicitation efforts relating to the 2018 Annual Meeting concerning the Company and members of the slate of nominees proposed by the Company, and terminate Third Point’s proxy solicitation website, https://www.refreshcampbells.com. At the same time, the Company shall immediately cease all direct or indirect negative solicitation efforts relating to the 2018 Annual Meeting concerning Third Point and members of the slate of nominees proposed by Third Point;

(viii) Third Point and the Strawbridge Trust each irrevocably withdraws the Stocklist Demand and Books and Records Demand;

(ix) the Company, the Board, Third Point, and the Strawbridge Trust shall promptly, but no later than the close of business on November 27, 2018, cause a voluntary stipulation of dismissal with prejudice to be signed and filed in the Proxy Action;

(x) if the Company reasonably determines, based on the standard director nominee background check, that any Designee is unable to be appointed to and serve as a member of the Board, or if any Designee does not become a member of the Board for any other reason by the close of business on November 29, 2018 as contemplated hereby, Third Point shall be entitled to designate a replacement for such Designee from the list of Third Point’s initial director nominees for the 2018 Annual Meeting (provided that such replacement is not a Third Point employee or Affiliate) that is reasonably consented to by the Board and shall have the right to continue to do so until such person is consented to by the Board (such consent not to be unreasonably withheld) (a “Replacement”), and the Company shall take all necessary action to implement the foregoing as promptly as practicable.     If any Designee becomes a member of the Board by the close of business on November 29, 2018 as contemplated hereby, but thereafter ceases to be a member of the Board for any reason prior to the conclusion of the 2019 Annual Meeting of Shareholders, the Company shall consult with Third Point and solicit the views and opinions of Third Point with respect to a replacement for such Designee and shall consider in good faith offering such Board seat to the individual recommended by Third Point (provided that such individual is not a Third Point employee or Affiliate), and if such individual becomes a member of the Board such individual shall be deemed a Replacement hereunder.  Any person that becomes a Replacement shall be deemed to be a Designee for all purposes under this Agreement, and prior to his or her appointment to the Board, shall be required to provide to the Company such information and documentation as is typically required of prospective members of the Board in connection with the customary onboarding process thereof;

 

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(xi) the Company agrees that during the Standstill Period (as defined below) for so long as (A) Kurt Schmidt (or any Replacement therefor) serves on the Board, such Designee (or such Replacement) shall be offered the opportunity to become a member of the Governance Committee of the Board and, if applicable, any other committee of the Board that is charged with overseeing the process for the selection of the next Chief Executive Officer of the Company (the “CEO Search Process”), and (B) without limitation of clause (A), during the Standstill Period (as defined below), for so long as any Designee (or any Replacement therefor), including Kurt Schmidt, serves on the Board, such Designee (including any Replacement therefor) shall be offered the opportunity to become a member of such committees of the Board selected by the Board promptly following such Designees appointment to the Board (it being agreed that each Designee shall serve on at least one committee of the Board), provided that the Designees (including any Replacements) may serve on the applicable committee of the Board only if he or she meets any independence or other requirements under applicable law and the rules and regulation of the New York Stock Exchange (or other securities exchange on which the Company’s securities may then be traded) for service on such committee. At all times during the Standstill Period (as defined below) any Designee (or Replacement), regardless of whether a member of such committee, shall be entitled, consistent with existing company policies, to attend any meeting of any committee of the Board and participate as a non-voting member (if not a committee member) and shall be entitled to receive any materials distributed to any committee members, so long as such activities do not contravene the independence or other requirements applicable to such committees under applicable law and the rules and regulation of the New York Stock Exchange (or other securities exchange on which the Company’s securities may then be traded);

(xii) the Company agrees that for so long as any Designee is on the Board the Company shall notify Third Point in writing (a “Slate Notice”), no later than 30 days prior to the advance notice deadline for making director nominations under the Company’s bylaws at the 2019 Annual Meeting, whether each of the Designees will be included on the Company’s slate of nominees for the 2019 Annual Meeting and whether all members of the Board have confirmed to the Company in writing their agreement to vote in favor of the Company’s proposed slate of directors at such annual meeting, provided that if for any reason the Company fails to include each of the Designees on the Company’s slate of nominees at any annual meeting the Company shall inform Third Point thereof in writing and the Company shall thereafter take such action (including extending the director nomination deadline) to ensure that Third Point has at least 45 days from the date that the Company informs Third Point in writing that any of the Designees shall not be on such slate to submit director nominations for such annual meeting in accordance with the bylaws of the Company, and the Company shall not hold any such annual meeting for at least 75 days from the date that the Company so informs Third Point thereof.  The Company further agrees that for the 2019 Annual Meeting to the extent any Designee is nominated by the Company and agrees to serve, the Company shall use commercially reasonable efforts to cause the election of such Designee so nominated by the Company (including recommending that the Company’s shareholders vote in favor of the election of such Designee, including such Designee in the Company’s proxy statement for such annual meeting and otherwise supporting such Designee for election in a manner no less rigorous and favorable than the manner in which the Company supports its other nominees in the aggregate); and

(xiii) the Company agrees that, until the 1-year anniversary of the date of this Agreement, it shall provide Third Point the opportunity to meet with the Board for no less than 60 minutes at least twice in the next twelve-month period and with the Company’s Chief Executive Officer for no less than 60 minutes at least twice in the next twelve-month period, in each case to enable Third Point to provide its thoughts and views to the Board and the Chief Executive Officer with respect to Company performance, strategy and other matters that Third Point determines to be relevant, and the Company shall consider in good faith the views and thoughts provided by Third Point and shall provide substantive responses to Third Point with respect thereto.

(b) Third Point acknowledges that, at all times while serving as a member of the Board, the Designees are required to comply with all policies, procedures, processes, codes, rules, standards and guidelines generally applicable to Board members, including the Company’s code of business conduct and ethics, securities trading policies, anti-hedging policies, Regulation FD-related policies, director confidentiality policies and corporate governance standards, in each case that have been identified to the Designees, and preserve the confidentiality of Company business and information, including discussions or matters considered in meetings of the Board or Board committees.  Third Point further acknowledges that following their appointment to the Board, Third Point will not communicate with the Designees regarding the Company without the prior written consent of the Company (but the foregoing shall in no way limit any communications with the Company and the full Board or with any full committee thereof) and that Third Point shall not compensate the Designees in any way, including, without limitation, reimbursing expenses, provided that Third Point can fulfill any obligations owed to such Designees pursuant to agreements disclosed to the Company prior to the date hereof.

 

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2. Other Agreements.  The Company agrees during the Standstill Period (as defined below) to consult in good faith with Third Point with respect to the selection of a permanent Chief Executive Officer pursuant to the CEO Search Process.  In connection with such consultation, the Company agrees, among other things, to (a) discuss with Third Point the qualifications, background and experience of potential Chief Executive Officer candidates and share with Third Point a list of candidates of potential Chief Executive Officer candidates that the Board or any committee thereof has considered, currently is considering and may in the future consider for the Chief Executive Officer, (b) keep Third Point reasonably informed regarding the CEO Search Process so that they can provide input and feedback to the Board or applicable committee thereof, (c) provide Third Point with an opportunity to meet any Chief Executive Officer candidate who the Board believes is reasonably likely to be the finalist for the position a reasonable amount of time before the Board votes with respect to such person’s candidacy (such period of time to be at least sufficient to enable Third Point to provide feedback to the Board or applicable committee thereof pursuant to the immediately following clause (d)), and (d) provide Third Point with an opportunity to present its views to the Board or the applicable committee thereof in respect of the CEO Search Process and the candidates being considered or the candidate selected in connection therewith.  The Company and Third Point agree that all information provided to Third Point in connection with the foregoing sentence shall be subject to and solely in accordance with the terms of the confidentiality agreement in the form attached hereto as Exhibit B (the “Confidentiality Agreement”), which Third Point agrees to execute and deliver to the Company simultaneously with Third Point’s execution and delivery of this Agreement.

3. Standstill.

(a) Until the earliest to occur of (i) 12:01 a.m. on November 27, 2019, (ii) the Company’s failure to take such action to appoint each of the Designees (or a Replacement) to serve as a director of the Company effective at the close of business on November 29, 2018, (iii) the delivery of a Slate Notice that does not state that each of  the Designees will be included on the Company’s slate of nominees for the 2019 Annual Meeting and that all members of the Board have confirmed to the Company their agreement to vote in favor of the Company’s proposed slate of directors at the 2019 Annual Meeting, (iv) the Company’s failure to deliver the Slate Notice on or prior to the date that is 30 days prior to the advance notice deadline for making director nominations under the Company’s bylaws at the 2019 Annual Meeting, and (v) the Company’s failure to include each of the Designees on the Company’s slate of nominees for the 2019 Annual Meeting (the “Standstill Period”), no member of Third Point shall, directly or indirectly, and each member of Third Point shall cause each Third Point Affiliate it controls not to, directly or indirectly:

(i) solicit proxies or written consents of shareholders or conduct any other type of referendum (binding or non-binding) with respect to, or from the holders of, the Voting Securities (as defined below), or become a “participant” (as such term is defined in Instruction 3 to Item 4 of Schedule 14A promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) in or knowingly assist any person or entity not a party to this agreement (a “Third Party”) in any “solicitation” of any proxy, consent or other authority (as such terms are defined under the Exchange Act) to vote any shares of the Voting Securities (other than such encouragement, advice or influence that is consistent with Company management’s recommendation in connection with such matter);

(ii) knowingly encourage, advise or influence any other person or assist any Third Party in so encouraging, assisting or influencing any person with respect to the giving or withholding of any proxy, consent or other authority to vote or in conducting any type of referendum (other than such encouragement, advice or influence that is consistent with Company management’s recommendation in connection with such matter);

(iii) form or join in a partnership, limited partnership, syndicate or other group, including a “group” as defined under Section 13(d) of the Exchange Act, with respect to the Voting Securities (for the avoidance of doubt, excluding any group composed solely of Third Point and the Third Point Affiliates) or otherwise support or participate in any effort by a Third Party with respect to the matters set forth in clauses (i), (vii) or (ix) herein;

(iv) present at any annual meeting or any special meeting of the Company’s shareholders any proposal for consideration for action by shareholders or seek the removal of any member of the Board or, except as otherwise expressly contemplated by this Agreement, propose any nominee for election to the Board or seek representation on the Board;

 

4

 

(v) other than in market transactions where the identity of the ultimate purchaser is not known and in underwritten widely dispersed public offerings, sell, offer or agree to sell directly or indirectly, through swap or hedging transactions or otherwise, the securities of the Company or any rights decoupled from the underlying securities held by Third Point to any Third Party unless such sale, offer, or agreement to sell would not knowingly result in such Third Party, together with its Affiliates, owning, controlling or otherwise having any beneficial or other ownership interest in the aggregate of 5% or more of the shares of Common Stock outstanding at such time or would increase the beneficial or other ownership interest of any Third Party who, together with its Affiliates, has a beneficial or other ownership interest in the aggregate of 5% or more of the shares of Common Stock outstanding at such time, except in each case in a transaction approved by the Board;

(vi) grant any proxy, consent or other authority to vote any Voting Securities of the Company with respect to any matters (other than to the named proxies included in the Company’s proxy card for any annual meeting or special meeting of shareholders) or deposit any Voting Securities of the Company in a voting trust or subject them to a voting agreement or other arrangement of similar effect with respect to any annual meeting except as provided in Section 3(b) below, special meeting of shareholders or action by written consent (excluding customary brokerage accounts, margin accounts, prime brokerage accounts and the like);

(vii) make any request for stocklist materials or other books and records of the Company under Section 14A:5-28 of the New Jersey Revised Statutes or otherwise;

(viii) make, or cause to be made, any statement or announcement that relates to and constitutes an ad hominem attack on, or relates to and otherwise criticizes or disparages, the Company or its business, operations or financial performance, its officers or its directors or any person who has served as an officer or director of the Company in the past, or who serves on or following the date of this Agreement as an officer, director or agent of the Company, including without limitation, (A) in any document or report filed with or furnished to the SEC or any other governmental agency, (B) in any press release or other publicly available format, or (C) to any shareholder, analyst, journalist or member of the media (including without limitation, in a television, radio, internet, newspaper or magazine interview) (and the Company agrees that this Section 3(a)(viii) shall apply mutatis mutandis to the Company, its subsidiaries and their respective directors and officers with respect to Third Point and its Affiliates), but nothing herein shall limit or preclude Third Point from exercising any rights under this Agreement or conveying its opinion and views to any members of the Board privately and in a manner that does not require public disclosure by the Company or Third Point;

(ix) institute, solicit or join, as a party, any litigation, arbitration or other proceeding against the Company or any of its current or former directors or officers in their capacities as such (including derivative actions), other than (A) litigation by Third Point to enforce the provisions of this Agreement, (B) counterclaims with respect to any proceeding initiated by, or on behalf of, the Company or its Affiliates against Third Point or a Designee, and (C) the exercise of statutory appraisal rights; provided that the foregoing shall not prevent any member of Third Point from responding to or complying with a validly issued legal process  (and the Company agrees that this Section 3(a)(ix) shall apply mutatis mutandis to the Company, its subsidiaries and their respective directors and officers with respect to Third Point and its Affiliates);

(x) without the prior written approval of the Board, separately or in conjunction with any other person or entity in which it is or proposes to be either a principal, partner or financing source or is acting or proposes to act as broker or agent for compensation, propose (publicly, privately or to the Company) or effect any tender offer or exchange offer, merger, acquisition, reorganization, restructuring, recapitalization or other business combination involving the Company or a material amount of the assets or businesses of the Company (an “Extraordinary Transaction”) or actively encourage, initiate or support any other Third Party in any such activity, but nothing shall preclude Third Point from tendering its securities of the Company into any tender or exchange offer or otherwise voting any of its Voting Securities in any manner it determines in connection with an Extraordinary Transaction;

(xi) purchase or cause to be purchased or otherwise acquire or agree to acquire Beneficial Ownership of any Voting Securities if in any such case, immediately after the taking of such action, Third Point would, in the aggregate, collectively beneficially own, or have an economic interest in, an amount that would exceed 9% of the then outstanding shares of Common Stock;

(xii) enter into any negotiations, agreements, arrangements or understandings with any Third Party with respect to the matters set forth in this Section 3; or

 

5

 

(xiii) request, directly or indirectly, any amendment or waiver of the foregoing in a manner that would be reasonably likely to require public disclosure by Third Point (or any Third Point Affiliates) or the Company.

As used in this Agreement, the term “Voting Securities” shall mean the Common Stock, and any other securities of the Company entitled to vote in the election of directors, or securities convertible into, or exercisable or exchangeable for Common Stock or such other securities, whether or not subject to the passage of time or other contingencies.

As used in this Agreement, the term “Beneficial Ownership” of “Voting Securities” means ownership of:  (i) Voting Securities and (ii) rights or options to own or acquire any Voting Securities (whether such right or option is exercisable immediately or only after the passage of time or upon the satisfaction of one or more conditions (whether or not within the control of such person), compliance with regulatory requirements or otherwise).  For purposes of this Section 3, no Person shall be, or be deemed to be, the “Beneficial Owner” of, or to “beneficially own,” any securities beneficially owned by any director of the Company to the extent such securities were acquired directly from the Company by such director as or pursuant to director compensation for serving as a director of the Company.

As used in this Agreement, the term “Affiliate” shall have the meaning set forth in Rule 12b-2 promulgated by the SEC under the Exchange Act.

(b) Until the end of the Standstill Period, Third Point together with all controlled Affiliates of the members of Third Point (such controlled Affiliates, collectively and individually, the “Third Point Affiliates”) shall cause all Voting Securities owned by them directly or indirectly, whether owned of record or Beneficially Owned, as of the record date for any annual or special meeting of shareholders or in connection with any solicitation of shareholder action by written consent (each a “Shareholders Meeting”) within the Standstill Period, in each case that are entitled to vote at any such Shareholders Meeting, to be present for quorum purposes and to be voted, at all such Shareholders Meetings or at any adjournments or postponements thereof, (i) for all directors nominated by the Board for election at such Shareholders Meeting and (ii) in accordance with the recommendation of the Board on any precatory or non-binding proposals and any non-transaction-related proposals that come before any Shareholders Meeting.

4. Public Announcements.  Promptly following the execution of this Agreement, the Company and Third Point shall announce this Agreement by means of a jointly issued press release in the form attached hereto as Exhibit C (the “Press Release”).  Neither the Company (and the Company shall cause each of its Affiliates, directors and officers not to) nor Third Point or any Third Point Affiliate shall make or cause to be made any public announcement or statement with respect to the subject of this Agreement that is in any way inconsistent with the statements made in the Press Release, except as required by law or the rules of any stock exchange, in connection with the enforcement of this Agreement, or with the prior written consent of the other party. The Company acknowledges that Third Point intends to file this Agreement and the Press Release as exhibits to its Schedule 13D pursuant to an amendment. The Company shall have reasonable advance review and consultation rights upon any Schedule 13D filing (or amendment thereto) made by Third Point with respect to this Agreement. Third Point acknowledges and agrees that the Company intends to (i) file this Agreement and file or furnish the Press Release with the SEC as exhibits to a Current Report on Form 8-K and to file this Agreement as an exhibit to future filings with the SEC and (ii) file a Current Report on Form 8-K announcing appointment of the Designees once appointed and may issue a press release (and file or furnish such press release as an exhibit to such 8-K) in connection with such appointment, and Third Point shall have reasonable advance review and consultation rights upon any such Form 8-K filing (or amendment thereto) made by the Company with respect to this Agreement.

5. Representations and Warranties of All Parties.  Each of the parties represents and warrants to the other party that: (a) such party has all requisite power and authority to execute and deliver this Agreement and to perform its obligations hereunder; (b) this Agreement has been duly and validly authorized, executed and delivered by it and is a valid and binding obligation of such party, enforceable against such party in accordance with its terms; and (c) this Agreement will not result in a violation of any terms or conditions of any agreements to which such person is a party or by which such party may otherwise be bound or of any law, rule, license, regulation, judgment, order or decree governing or affecting such party.

 

6

 

6. Representations and Warranties of Third Point.  Each member of Third Point severally represents and warrants that, as of the date of this Agreement: (a) Third Point, together with all of the Third Point Affiliates, collectively Beneficially Own, an aggregate of 21,000,000 shares of Common Stock; (b) except for such ownership, no member of Third Point, individually or in the aggregate with all other members of Third Point  and the Third Point Affiliates, has any other Beneficial Ownership of any Voting Securities; and (c) Third Point, collectively with the Third Point Affiliates, have a Net Long Position of 21,000,000 shares of Common Stock.  The term “Net Long Position” shall mean:  such shares of Common Stock Beneficially Owned, directly or indirectly, that constitute such person’s net long position as defined in Rule 14e-4 under the Exchange Act mutatis mutandis, provided that “Net Long Position” shall not include any shares as to which such person does not have the right to vote or direct the vote; and the terms “person” or “persons” shall mean any individual, corporation (including not-for-profit), general or limited partnership, limited liability or unlimited liability company, joint venture, estate, trust, association, organization or other entity of any kind or nature.

7. Miscellaneous.  The parties hereto recognize and agree that if for any reason any of the provisions of this Agreement are not performed in accordance with their specific terms or are otherwise breached, immediate and irreparable harm or injury would be caused for which money damages would not be an adequate remedy.  Accordingly, each party agrees that in addition to other remedies the other party or parties shall be entitled to at law or equity, the other party or parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement exclusively in the Chancery Division of the New Jersey Superior Court (provided that, in the event that subject matter jurisdiction is unavailable in that court, then all such claims shall be brought, heard and determined exclusively in any other state or federal court sitting in the State of New Jersey).  Furthermore, each of the parties hereto (a) consents to submit itself to the personal jurisdiction of the Chancery Division of the New Jersey Superior Court or other federal or state courts of the State of New Jersey in the event any dispute arises out of this Agreement or the transactions contemplated by this Agreement, (b) agrees that it shall not attempt to deny or defeat such personal jurisdiction by motion or other request for leave from any such court, (c) agrees that it shall not bring any action relating to this Agreement or the transactions contemplated by this Agreement in any court other than the Chancery Division of the New Jersey Superior Court or other federal or state courts of the State of New Jersey, and each of the parties irrevocably waives the right to trial by jury and (d) irrevocably consents to service of process by a reputable overnight mail delivery service, signature requested, to the address of such party’s principal place of business or as otherwise provided by applicable law.  THIS AGREEMENT SHALL BE GOVERNED IN ALL RESPECTS, INCLUDING VALIDITY, INTERPRETATION AND EFFECT, BY THE LAWS OF THE STATE OF NEW JERSEY APPLICABLE TO CONTRACTS EXECUTED AND TO BE PERFORMED WHOLLY WITHIN SUCH STATE WITHOUT GIVING EFFECT TO THE CHOICE OF LAW PRINCIPLES OF SUCH STATE.

8. No Waiver.  Any waiver by any party of a breach of any provision of this Agreement shall not operate as or be construed to be a waiver of any other breach of such provision or of any breach of any other provision of this Agreement.  The failure of a party to insist upon strict adherence to any term of this Agreement on one or more occasions shall not be considered a waiver or deprive that party of the right thereafter to insist upon strict adherence to that term or any other term of this Agreement.

9. Entire Agreement.  This Agreement and the Confidentiality Agreement contain the entire understanding of the parties with respect to the subject matter hereof and may be amended only by an agreement in writing executed by the parties hereto.

10. Notices.  All notices, consents, requests, instructions, approvals and other communications provided for herein and all legal process in regard hereto shall be in writing and shall be deemed validly given, made or served, if (a) given by email, when such email is sent to the email address set forth below during normal business hours and the appropriate confirmation is received or (b) if given by any other means, when actually received during normal business hours at the address specified in this subsection:

 

	
if to the Company:

	
Campbell Soup Company

	 	
1 Campbell Place

	 	
Camden, New Jersey  08103

	 	
Attention:

	
Adam Ciongoli, General Counsel and 

Senior Vice President

	 	
Email:

	
adam_ciongoli@campbellsoup.com

	 
	

 

 

 

 

 

 

 

 

 

 

7

 

 

	
With a copy to (which shall not constitute notice):

	 	 	 
	 	
Weil, Gotshal & Manges LLP

	 	
767 Fifth Avenue

	 	
New York, New York  10153

	 	
Attention:

	
Michael J. Aiello

	 	
Email:

	
michael.aiello@weil.com

	 	 	 
	
if to Third Point:

	
c/o Third Point LLC

	 	
390 Park Avenue, 18th Floor

	 	
New York, New York  10022

	 	
Attention:

	
Josh Targoff, Chief Operating Officer and

General Counsel

	 	
Email:

	
jtargoff@thirdpoint.com

	 	 	 
	
With a copy to (which shall not constitute notice):

	 	 	 
	 	
Willkie Farr & Gallagher LLP

	 	
787 Seventh Avenue

	 	
New York, New York  10019

	 	
Attention:

	
Steven Gartner and Russell Leaf

	 	
Email:

	
sgartner@willkie.com and rleaf@willkie.com

 

11. Severability.  If at any time subsequent to the date hereof, any provision of this Agreement shall be held by any court of competent jurisdiction to be illegal, void or unenforceable, such provision shall be of no force and effect, but the illegality or unenforceability of such provision shall have no effect upon the legality or enforceability of any other provision of this Agreement.

12. Counterparts.  This Agreement may be executed in two or more counterparts which together shall constitute a single agreement.

13. Successors and Assigns.  This Agreement shall not be assignable by any of the parties to this Agreement.  This Agreement, however, shall be binding on successors of the parties hereto.

14. No Third Party Beneficiaries.  This Agreement is solely for the benefit of the parties hereto and is not enforceable by any other persons.

 

8

 

15. Fees and Expenses.  Each party to this Agreement shall bear and pay all fees, costs and expenses that have been incurred or that are incurred in the future by such party in connection with, relating to or resulting from such party’s efforts and actions, and any preparations therefor, prior to the execution and delivery of this Agreement, including, without limitation, communications between Third Point, on the one hand, and the Board and the Company’s management, on the other hand, Third Point’s Schedule 14A and Hart-Scott-Rodino filings, the Stocklist Demand, the Books and Records Demand, the Proxy Action and such party’s preparation of soliciting materials and this Agreement.

16. Interpretation and Construction.  Each of the parties hereto acknowledges that it has been represented by counsel of its choice throughout all negotiations that have preceded the execution of this Agreement, and that it has executed the same with the advice of said independent counsel.  Each party and its counsel cooperated and participated in the drafting and preparation of this Agreement and the documents referred to herein, and any and all drafts relating thereto exchanged among the parties shall be deemed the work product of all of the parties and may not be construed against any party by reason of its drafting or preparation.  Accordingly, any rule of law or any legal decision that would require interpretation of any ambiguities in this Agreement against any party that drafted or prepared it is of no application and is hereby expressly waived by each of the parties hereto, and any controversy over interpretations of this Agreement shall be decided without regards to events of drafting or preparation.  The section headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.  The term “including” shall be deemed to mean “including without limitation” in all instances.

17. Mutual Release.

(a) The Company, on the one hand, and Third Point and the Strawbridge Trust, on the other hand, on behalf of themselves and for all of their past and present affiliated, associated, related, parent and subsidiary entities, joint ventures and partnerships, successors, assigns, and the respective owners, officers, directors, partners, limited partners, members, managers, principals, parents, subsidiaries, predecessor entities, agents, representatives, employees, shareholders, advisors, consultants, attorneys, heirs, executors, administrators, successors and assigns of any said person or entity, security holders of any said person or entity, and any other person claiming (now or in the future) through or on behalf of any of said persons or entities (collectively “Released Persons”), irrevocably and unconditionally release, settle, acquit and forever discharge the other and all of their Released Persons, from any and all causes of action, claims, actions, rights, judgments, obligations, damages, amounts, demands, losses, controversies, contentions, complaints, promises, accountings, bonds, bills, debts, dues, sums of money, expenses, specialties and fees and costs (whether direct, indirect or consequential, incidental or otherwise including, without limitation, attorney’s fees or court costs, of whatever nature) incurred in connection therewith of any kind whatsoever, whether known or unknown, suspected or unsuspected, in their own right, representatively, derivatively or in any other capacity, in law or in equity or liabilities of whatever kind or character, arising under federal, state, foreign, or common law or the laws of any other relevant jurisdiction (the “Claims”), which have arisen, could have arisen, arise now, or hereafter may arise out of or relate in any manner to the allegations, facts, events, transactions, acts, occurrences, statements, representations, misrepresentations, omissions or any other matter, thing, or cause whatsoever, or any series thereof, embraced, involved, arising out of, set forth in, or otherwise related in any way to the Stocklist Demand, the Books and Records Demand, the Proxy Action, the Third Point Shareholder Nomination, the Update to Third Point Shareholder Nomination, the Third Point proxy contest at the 2018 Annual Meeting, and the Company’s nomination of directors for election at the 2018 Annual Meeting (collectively, the “Released Claims”); provided, however, this release and waiver of Claims shall not include claims to enforce the terms of this Agreement.

(b) The parties acknowledge and agree that they may be unaware of or may discover facts in addition to or different from those which they now know, anticipate or believe to be true related to or concerning the Released Claims. The parties know that such presently unknown or unappreciated facts could materially affect the claims or defenses of a party or parties. It is nonetheless the intent of the parties to give a full, complete and final release and discharge of the Released Claims. In furtherance of this intention, the releases herein given shall be and remain in effect as full and complete releases with regard to the Released Claims notwithstanding the discovery or existence of any such additional or different claim or fact. To that end, with respect to the Released Claims only, the parties expressly waive and relinquish any and all provisions, rights and benefits conferred by any law of the United States or of any state or territory of the United States or of any other relevant jurisdiction, or principle of common law, under which a general release does not extend to claims which the parties do not know or suspect to exist in their favor at the time of executing the release, which if known by the parties might have affected the Parties’ settlement. The parties acknowledge and agree that the inclusion of this Section 17 was separately bargained for and is a material term of this Agreement.

 

9

 

18. Liability Several and Not Joint; Exercise of Third Point Rights.  Notwithstanding anything contained herein to the contrary, the obligations of the members of Third Point hereunder are several and not joint or collective.  Without limiting the foregoing, for the avoidance of doubt, none of the persons or entities listed on Schedule A shall have any liability or obligation with respect to any covenants, agreements, representations or warranties made by, or actions taken or not taken by the Strawbridge Trust, and the Strawbridge Trust shall not have any liability or obligations in respect of any covenants, agreements, representations or warranties made by, or actions taken or not taken by any of the persons or entities listed on Schedule A.  In addition, any references in this Agreement that provide any rights or remedies to Third Point shall, solely for purposes of exercising such rights or remedies, be deemed references to Third Point LLC.

[Signature Pages Follow]

 

10

 

IN WITNESS WHEREOF, each of the parties hereto has executed this Agreement, or caused the same to be executed by its duly authorized representative as of the date first above written.

	 	
CAMPBELL SOUP COMPANY

	 	 
	 	
By:

	
/s/ Charles A. Brawley, III

	 	 	
Name:

	
Charles A. Brawley, III

	 	 	
Title:

	
Vice President, Deputy General

Counsel and Secretary

	 	 
	 	 
	 	
THIRD POINT LLC

	 	 	 	 
	 	
By:

	
/s/ Josh Targoff

	 	 	
Name:

	
Josh Targoff,

	 	 	
Title:

	
Chief Operating Officer and

General Counsel

	 	 	 	 
	 	 	 	 
	 	
THIRD POINT PARTNERS QUALIFIED L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 	 
	 	
By:

	
/s/ Josh Targoff

	 	 	
Name:

	
Josh Targoff,

	 	 	
Title:

	
Chief Operating Officer and

General Counsel

	 	 	 	 
	 	 	 	 
	 	
THIRD POINT PARTNERS L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 	 
	 	
By:

	
/s/ Josh Targoff

	 	 	
Name:

	
Josh Targoff,

	 	 	
Title:

	
Chief Operating Officer and

General Counsel

 

 

SIGNATURE PAGE TO SUPPORT AGREEMENT

	 	
THIRD POINT OFFSHORE MASTER FUND L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 
	 	
By:

	
/s/ Josh Targoff

	 	 	
Name:

	
Josh Targoff,

	 	 	
Title:

	
Chief Operating Officer and

General Counsel

	 	 	 	 
	 	 	 	 
	 	
THIRD POINT ULTRA MASTER FUND L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 	 
	 	
By:

	
/s/ Josh Targoff

	 	 	
Name:

	
Josh Targoff,

	 	 	
Title:

	
Chief Operating Officer and

General Counsel

	 	 	 	 
	 	 	 	 
	 	
THIRD POINT ENHANCED L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 
	 	
By:

	
/s/ Josh Targoff

	 	 	
Name:

	
Josh Targoff,

	 	 	
Title:

	
Chief Operating Officer and

General Counsel

	 	 	 	 
	 	
THIRD POINT ADVISORS LLC

	 	 	 	 
	 	
By:

	
/s/ Josh Targoff

	 	 	
Name:

	
Josh Targoff,

	 	 	
Title:

	
Chief Operating Officer and

General Counsel

	 	 	 	 
	 	
THIRD POINT ADVISORS II LLC

	 	 	 	 
	 	
By:

	
/s/ Josh Targoff

	 	 	
Name:

	
Josh Targoff,

	 	 	
Title:

	
Chief Operating Officer and

General Counsel

	
 

 

	 	 	 

 

SIGNATURE PAGE TO SUPPORT AGREEMENT

	 	
REVOCABLE TRUST OF GEORGE STRAWBRIDGE, JR. DATED JANUARY 21, 1991

	 	 	 
	 	
TRUSTEES:

	 
	 	 	 
	 	
By:

	/s/ George Strawbridge, Jr. 
	 	 	
Name:

	
George Strawbridge, Jr.

	 	 	 	 
	 	
By:

	/s/ Barton Winokur
	 	 	
Name:

	
Barton Winokur

 

 

SIGNATURE PAGE TO SUPPORT AGREEMENT

 

SCHEDULE A

Third Point LLC

Third Point Partners Qualified L.P.

Third Point Partners L.P.

Third Point Offshore Master Fund L.P.

Third Point Ultra Master Fund L.P.

Third Point Enhanced L.P.

Third Point Advisors LLC

Third Point Advisors II LLC

 

 

 

EXHIBIT A

 FORM OF NOMINEE LETTER

November 26, 2018

Attention:  Board of Directors

Campbell Soup Company

1 Campbell Place

 Camden, NJ  08103

Re: Nominee Consent

Ladies and Gentlemen:

This letter is delivered pursuant to Section 1(a)(ii) of the Support Agreement, dated as of November 26, 2018 (the “Agreement”), by and among Campbell Soup Company and Third Point (as defined therein).  Capitalized terms used herein but not defined shall have the meaning set forth in the Agreement.

In connection with the Agreement, I hereby consent to serve as a director of the Company effective at the close of business on November 29, 2018.  I also agree that, after the date hereof, I will provide to the Company, as requested by the Company from time to time, such information as the Company is entitled to reasonably receive from other members of the Board and as is required to be disclosed in proxy statements under applicable law.

At all times while serving as a member of the Board, I agree to comply with all policies, procedures, processes, codes, rules, standards and guidelines generally applicable to Board members, including the Company’s code of business conduct and ethics, securities trading policies, anti-hedging policies, Regulation FD-related policies, director confidentiality policies, related party transaction policy and corporate governance standards, in each case that have been identified to me, and preserve the confidentiality of Company business and information, including discussions or matters considered in meetings of the Board or Board committees.

	 	
Sincerely,

	 	 
	 	 
	 	
Name:

 

 

 

 

EXHIBIT B

 FORM OF CONFIDENTIALITY AGREEMENT

Confidentiality Agreement

CAMPBELL SOUP COMPANY

1 Campbell Place

 Camden, NJ 08103

November 26, 2018

	To:	
Each of the persons or entities listed on Schedule A hereto (collectively, “Third Point” or “you” and each individually, a “member” of Third Point)

Ladies and Gentlemen:

This letter agreement shall become effective upon the date hereof.  Capitalized terms used but not otherwise defined herein shall have the meanings given to such terms in the Support Agreement (the “Support Agreement”), dated as of November 26, 2018, among Campbell Soup Company (the “Company”) and Third Point.  The Company understands and agrees that, subject to the terms of, and in accordance with, this letter agreement, the Company may confidentially disclose to you and the Specified Third Point Personnel (as hereinafter defined) certain non-public information regarding the Company’s Chief Executive Officer (“CEO”) search process. You acknowledge that this information is confidential and may include business information the disclosure of which could harm the Company and the CEO search process, and the Company acknowledges that the information disclosed to you hereunder shall be limited to information relating to the CEO search process and that prior to disclosing any material non-public information to you the Company will advise you of its intention to do so and you may elect to decline to receive such information.  In consideration for, and as a condition of, the information being furnished to you and, subject to the restrictions in paragraph 2, any other employees of Third Point LLC and any counsel or advisor to Third Point LLC (collectively, the “Specified Third Point Personnel”), you agree to treat any and all information concerning or relating to the Company’s CEO search that is furnished to you or the Specified Third Point Personnel (regardless of the manner in which it is furnished, including in written or electronic format or orally, gathered by visual inspection or otherwise) by or on behalf of the Company or any Company Representatives, together with the relevant portion of any notes, analyses, reports, compilations, studies, interpretations, documents, records or extracts thereof to the extent containing, referring, relating to, based upon or derived from such information, in whole or in part (collectively, “Confidential Information”), in accordance with the provisions of this letter agreement, and to take or abstain from taking the other actions hereinafter set forth.

1. The term “Confidential Information” does not include information that (i) is or has become generally available to the public other than as a result of a direct or indirect disclosure by you or the Specified Third Point Personnel in violation of this letter agreement, (ii) was within your or any of the Specified Third Point Personnel’s possession on a non-confidential basis prior to its being furnished to you by or on behalf of the Company or its agents, representatives, attorneys, advisors, directors, officers or employees (collectively, the “Company Representatives”), (iii) is received from a source other than the Company or any of the Company Representatives; provided, that in the case of (ii) or (iii) above, the source of such information was not believed by you, after reasonable inquiry of the disclosing person, to be bound by a confidentiality agreement with or other contractual, legal or fiduciary obligation of confidentiality to the Company or any other person with respect to such information at the time the information was disclosed to you or (iv) is independently developed by you or the Specified Third Point Personnel without reliance upon the Confidential Information.

 

B-1

 

2. You will, and you will cause the Specified Third Point Personnel to, (a) keep the Confidential Information strictly confidential and (b) subject to paragraph 3, not disclose any of the Confidential Information in any manner whatsoever without the prior written consent of the Company; provided, however, that you may privately and confidentially disclose any of such information to the Specified Third Point Personnel (i) who need to know such information for the sole purpose of advising you with respect to the Company’s CEO search and (ii) who are informed by you of the confidential nature of such information; provided, further, that you will be responsible for any violation of this letter agreement by the Specified Third Point Personnel to whom you have disclosed Confidential Information as if they were parties hereto.  It is understood and agreed that the Company shall have no obligation to disclose to you or the Specified Third Point Personnel any Legal Advice (as defined below) that may be included in the Confidential Information with respect to which the Company determines that such disclosure would, in the Company’s sole discretion, constitute waiver of the Company’s attorney-client privilege or attorney work product privilege.  “Legal Advice” as used herein shall be solely and exclusively limited to the advice provided by legal counsel and shall not include any factual information or the formulation or analysis of business strategy that is not protected by the attorney-client or attorney work product privilege.

3. In the event that you or any of the Specified Third Point Personnel are required or requested by applicable law, rule, regulation, legal process, interrogatory, subpoena or any similar process relating to any legal proceeding, investigation, hearing or otherwise to disclose any of the Confidential Information, you will promptly notify (except where such notice would be legally prohibited) the Company in writing (electronic mail shall be sufficient) so that the Company may seek a protective order or other appropriate remedy (and if the Company seeks such an order, you will provide such cooperation as the Company shall reasonably request), at its sole cost and expense.  Nothing herein shall be deemed to prevent you or the Specified Third Point Personnel, as the case may be, from honoring a subpoena, legal process or other legal or regulatory requirement that requires or requests discovery, disclosure or production of the Confidential Information if (a) you produce or disclose only that portion of the Confidential Information which your legal counsel (internal or external) advises you is legally required or requested to be so produced or disclosed and you inform the recipient of such Confidential Information of the confidential nature of such Confidential Information; or (b) the Company consents in writing to having the Confidential Information produced or disclosed pursuant to the subpoena, legal process or other legal requirement or request.  In no event will you or any of the Specified Third Point Personnel oppose action by the Company to obtain a protective order or other relief, at its sole expense, to prevent the disclosure of the Confidential Information or to obtain reliable assurance that confidential treatment will be afforded the Confidential Information.  For the avoidance of doubt, it is understood that there shall be no “legal requirement” requiring you to disclose any Confidential Information solely by virtue of the fact that, absent such disclosure, you would be prohibited from purchasing, selling, or engaging in derivative or other voluntary transactions with respect to the Common Stock of the Company or otherwise proposing or making an offer to do any of the foregoing, or you would be unable to file any proxy materials in compliance with Section 14(a) of the Exchange Act or the rules promulgated thereunder.  The foregoing obligations and requirements in this paragraph shall not be required or apply in connection with disclosures made to the extent required by law to, or requested by, a federal or state regulatory agency, self-regulatory organization or supervisory authority in the course of such authority’s examinations or supervisory inspections not specifically related to the Company.

4. You acknowledge that (a) none of the Company or any of the Company Representatives makes any representation or warranty, express or implied, as to the accuracy or completeness of any Confidential Information, and (b) none of the Company or any of the Company Representatives shall have any liability to you or to any of the Specified Third Point Personnel relating to or resulting from the use of the Confidential Information or any errors therein or omissions therefrom, except in the case of fraud.  You and the Specified Third Point Personnel (or anyone acting on your or their behalf) shall not directly or indirectly initiate contact or communication with any executive or employee of the Company other than the Chief Executive Officer and General Counsel, and/or such other persons approved in writing by the foregoing or the Board, concerning the CEO search process, or to seek any information in connection therewith from any such person other than the foregoing, without the prior consent of the Company.

 

B-2

 

5. All Confidential Information shall remain the property of the Company.  Neither you nor any of the Specified Third Point Personnel shall by virtue of any disclosure of and/or your use of any Confidential Information acquire any rights with respect thereto, all of which rights shall remain exclusively with the Company.  At any time after the expiration of this letter agreement in accordance with Section 15 hereof, upon the written request of the Company for any reason, you will promptly return to the Company or destroy, at your election, all hard copies of the Confidential Information and use commercially reasonable efforts to permanently erase or delete all electronic copies of the Confidential Information in your or any of the Specified Third Point Personnel’s possession or control (and, upon the written request of the Company, shall promptly certify to the Company that such Confidential Information has been erased or deleted, as the case may be); provided, however, that you may retain (and the Specified Third Point Personnel may retain) such copies of Confidential Information as may be required to be retained by you (or such Specified Third Point Personnel) pursuant to applicable law, rule regulation, legal process or as part of your (or their) bona fide information technology system back-ups or your (or their) internal compliance policies.

6. You acknowledge, and will advise the Specified Third Point Personnel, that the Confidential Information may constitute material non-public information under applicable federal and state securities laws, and that the United States securities laws prohibit any person who has received from an issuer any such material, non-public information from purchasing or selling securities of such issuer or from communicating such information to any other person under circumstances in which it is reasonably foreseeable that such person is likely to purchase or sell such securities.

7. You hereby represent and warrant to the Company that (i) you have all requisite power and authority to execute and deliver this letter agreement and to perform your obligations hereunder, (ii) this letter agreement has been duly authorized, executed and delivered by you, and is a valid and binding obligation, enforceable against you in accordance with its terms, (iii) this letter agreement will not result in a violation of any terms or conditions of any agreements to which you are a party or by which you may otherwise be bound or of any law, rule, license, regulation, judgment, order or decree governing or affecting you, and (iv) your entry into this letter agreement does not require approval by any owners or holders of any equity or other interest in you (except as has already been obtained).

8. Any waiver by the Company of a breach of any provision of this letter agreement shall not operate as or be construed to be a waiver of any other breach of such provision or of any breach of any other provision of this letter agreement.  The failure of the Company to insist upon strict adherence to any term of this letter agreement on one or more occasions shall not be considered a waiver or deprive the Company of the right thereafter to insist upon strict adherence to that term or any other term of this letter agreement.

9. You acknowledge and agree that the value of the Confidential Information to the Company is unique and substantial, but may be impractical or difficult to assess in monetary terms.  You further acknowledge and agree that in the event of an actual or threatened violation of this letter agreement, immediate and irreparable harm or injury would be caused for which money damages would not be an adequate remedy.  Accordingly, you acknowledge and agree that, in addition to any and all other remedies which may be available to the Company at law or equity, the Company shall be entitled to an injunction or injunctions to prevent breaches of this letter agreement and to enforce specifically the terms and provisions of this letter agreement exclusively in the Chancery Division of the New Jersey Superior Court or other federal or state courts of the State of New Jersey. In the event that any action shall be brought in equity to enforce the provisions of this letter agreement, you shall not allege, and you hereby waive the defense, that there is an adequate remedy at law.

 

B-3

 

10. Each of the parties hereto (a) consents to submit itself to the personal jurisdiction of the Chancery Division of the New Jersey Superior Court or other federal or state courts of the State of New Jersey in the event any dispute arises out of this letter agreement or the transactions contemplated by this letter agreement, (b) agrees that it shall not attempt to deny or defeat such personal jurisdiction by motion or other request for leave from any such court, (c) agrees that it shall not bring any action relating to this letter agreement or the transactions contemplated by this letter agreement in any court other than the Chancery Division of the New Jersey Superior Court or other federal or state courts of the State of New Jersey, and each of the parties irrevocably waives the right to trial by jury, and (d) irrevocably consents to service of process by a reputable overnight delivery service, signature requested, to the address of such party’s principal place of business or as otherwise provided by applicable law.  THIS LETTER AGREEMENT SHALL BE GOVERNED IN ALL RESPECTS, INCLUDING VALIDITY, INTERPRETATION AND EFFECT, BY THE LAWS OF THE STATE OF NEW JERSEY APPLICABLE TO CONTRACTS EXECUTED AND TO BE PERFORMED WHOLLY WITHIN SUCH STATE WITHOUT GIVING EFFECT TO THE CHOICE OF LAW PRINCIPLES OF SUCH STATE.

11. This letter agreement and the Support Agreement contain the entire understanding of the parties with respect to the subject matter hereof and thereof and supersedes all prior or contemporaneous agreements or understandings, whether written or oral.  This letter agreement may be amended only by an agreement in writing executed by the parties hereto.

12. All notices, consents, requests, instructions, approvals and other communications provided for herein and all legal process in regard hereto shall be in writing and shall be deemed validly given, made or served, if (a) given by email, when such email is sent to the email address set forth below and the appropriate confirmation is received or (b) if given by any other means, when actually received during normal business hours at the address specified in this subsection:

	
if to the Company:

	
Campbell Soup Company

	 	
1 Campbell Place

	 	
Camden, New Jersey 08103

	 	
Attention:

	
Adam Ciongoli, General Counsel and

Senior Vice President

	 	
Email:

	
adam_ciongoli@campbellsoup.com

	
With a copy to (which shall not constitute notice):

	 	 	 
	 	
Weil, Gotshal & Manges LLP

	 	
767 Fifth Avenue

	 	
New York, New York 10153

	 	
Attention:

	
Michael J. Aiello

	 	
Email:

	
michael.aiello@weil.com

	
if to Third Point:

	
c/o Third Point LLC

	 	
390 Park Avenue, 18th Floor

	 	
New York, New York 10022

	 	
Attention

	
Josh Targoff, Partner, Chief Operating Officer and

General Counsel

	 	
Email:

	
jtargoff@thirdpoint.com

	 	 	 
	
With a copy to (which shall not constitute notice):

	 	 	 
	 	
Willkie Farr & Gallagher LLP

	 	
787 Seventh Avenue

	 	
New York, New York 10019

	 	
Attention:

	
Steven Gartner and Russell Leaf

	 	
Email:

	
sgartner@willkie.com and rleaf@willkie.com

	 	 	 

 

 

 

B-4

13. If at any time subsequent to the date hereof, any provision of this letter agreement shall be held by any court of competent jurisdiction to be illegal, void or unenforceable, such provision shall be of no force and effect, but the illegality or unenforceability of such provision shall have no effect upon the legality or enforceability of any other provision of this letter agreement.

14. This letter agreement may be executed (including by facsimile or PDF) in two or more counterparts which together shall constitute a single agreement.

15. This letter agreement and the rights and obligations herein may not be assigned or otherwise transferred, in whole or in part, by you without the express written consent of the Company.  This letter agreement, however, shall be binding on successors of the parties hereto.

16. This letter agreement shall expire on the earlier to occur of (i) one (1) year from the date that Confidential Information is first provided to Third Point, and (ii) the public announcement by the Company of the hiring of a new CEO, provided that following such expiration and until the time period in clause (i) has elapsed, Third Point shall continue to abide by the terms hereof in respect of the identity of any other CEO candidates that were under consideration by the Company and that were disclosed to Third Point hereunder.

17. No licenses or rights under any patent, copyright, trademark, or trade secret are granted or are to be implied by this letter agreement.

18. Each of the parties hereto acknowledges that it has been represented by counsel of its choice throughout all negotiations that have preceded the execution of this letter agreement, and that it has executed the same with the advice of said counsel.  Each party and its counsel cooperated and participated in the drafting and preparation of this letter agreement and the documents referred to herein, and any and all drafts relating thereto exchanged among the parties shall be deemed the work product of all of the parties and may not be construed against any party by reason of its drafting or preparation.  Accordingly, any rule of law or any legal decision that would require interpretation of any ambiguities in this letter agreement against any party that drafted or prepared it is of no application and is hereby expressly waived by each of the parties hereto, and any controversy over interpretations of this letter agreement shall be decided without regards to events of drafting or preparation.  The term “including” shall in all instances be deemed to mean “including without limitation.”

 [Signature Pages Follow]

 

B-5

 

Please confirm your agreement with the foregoing by signing and returning one copy of this letter agreement to the undersigned, whereupon this letter agreement shall become a binding agreement between you and the Company.

	 	
Very truly yours,

	 	 	 
	 	
CAMPBELL SOUP COMPANY

	 	 	 
	 	 	 
	 	
By:

	
	 	 	
Name:

	 	 	
Title:

 

 

SIGNATURE PAGE TO SUPPORT AGREEMENT

 

	 	
Accepted and agreed as of the date first written above:

	 	 	 	 
	 	
THIRD POINT LLC

	 	 
	 	
By:

	 
	 	 	
Name:

	 
	 	 	
Title:

	 
	 	 	 	 
	 	
THIRD POINT PARTNERS QUALIFIED L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 	 
	 	
By:

	 
	 	 	
Name:

	 
	 	 	
Title:

	 
	 	 	 	 
	 	
THIRD POINT PARTNERS L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 	 
	 	
By:

	 
	 	 	
Name:

	 
	 	 	
Title:

	 
	 	 
	 	
THIRD POINT OFFSHORE MASTER FUND L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 
	 	
By:

	 
	 	 	
Name:

	 
	 	 	
Title:

	 
	 	 	 	 
	 	
THIRD POINT ULTRA MASTER FUND L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 	 
	 	
By:

	 
	 	 	
Name:

	 
	 	 	
Title:

	 

 

SIGNATURE PAGE TO SUPPORT AGREEMENT

 

	 	
THIRD POINT ENHANCED L.P.

	 	
By:

	
Third Point LLC, its investment manager

	 	 	 	 
	 	
By:

	 
	 	 	
Name:

	 
	 	 	
Title:

	 
	 	 
	 	
THIRD POINT ADVISORS LLC

	 	 	 	 
	 	
By:

	 
	 	 	
Name:

	 
	 	 	
Title:

	 
	 	 	 	 
	 	
THIRD POINT ADVISORS II LLC

	 	 	 	 
	 	
By:

	 
	 	 	
Name:

	 
	 	 	
Title:

	 

 

 

SIGNATURE PAGE TO SUPPORT AGREEMENT

 

SCHEDULE A

Third Point LLC

Third Point Partners Qualified L.P.

Third Point Partners L.P.

Third Point Offshore Master Fund L.P.

Third Point Ultra Master Fund L.P.

Third Point Enhanced L.P.

Third Point Advisors LLC

Third Point Advisors II LLC

 

 

EXHIBIT C

PRESS RELEASE

FOR IMMEDIATE RELEASE

	 	 
	
CAMPBELL INVESTOR CONTACT:

	
CAMPBELL MEDIA CONTACT:

	
Ken Gosnell

	
Thomas Hushen

	
(856) 342-6081

	
(856) 342-5227

	
ken_gosnell@campbellsoup.com

	
thomas_hushen@campbellsoup.com

	 	 
	 	
THIRD POINT MEDIA CONTACT:

	 	
Elissa Doyle

	 	
(212) 715-4907

	 	
edoyle@thirdpoint.com

 

CAMPBELL AND THIRD POINT REACH AGREEMENT

CAMDEN, N.J., and NEW YORK, Nov. 26, 2018 - Campbell Soup Company (NYSE: CPB) and Third Point (NYSE: TPRE) announced today that they have reached an agreement with respect to the election of directors at Campbell’s 2018 Annual Meeting of Shareholders and certain other matters. Under the terms of the agreement, following its Nov. 29, 2018 Annual Meeting, Campbell will increase the size of its Board from 12 to 14 members and add two new, independent directors from Third Point’s proposed slate: Sarah Hofstetter, President of Comscore, and Kurt Schmidt, former Director and CEO of Blue Buffalo Company, Ltd. In connection with this settlement, Third Point has agreed to a 12-month standstill and certain support commitments.

The two parties have also agreed that Third Point will provide input into Campbell’s ongoing CEO search process. The final decision regarding the Company’s permanent CEO will be made by the Campbell Board of Directors – including Ms. Hofstetter and Mr. Schmidt. Underscoring the open channels of communication between the parties, Campbell has invited Third Point to present its views at two meetings of the Board and two meetings with Campbell’s CEO within the next 12 months.

 

 

As a result of today’s announcement, Third Point has agreed to immediately withdraw its slate of director nominees and support the Company’s slate of directors at the upcoming Annual Meeting. Third Point also will dismiss its litigation against Campbell and withdraw its books and records request.

Additionally, Campbell and Third Point have agreed that the Company will add a third director by the meeting of the Board to be held in May 2019 and will consult with Third Point with respect to the appointment of this additional director.

“We are pleased to have reached an agreement with Third Point that is in the best interests of Campbell shareholders, and we look forward to welcoming both Sarah and Kurt to our Board of Directors,” said Keith McLoughlin, interim President and CEO of Campbell. “We will continue to maintain an active and productive dialogue with all of our shareholders, including Third Point, as we execute our strategic plan and build a stronger and more focused company that creates long-term value for shareholders.”

“Third Point looks forward to working collaboratively with Campbell to improve value for all shareholders at this important time for the Company,” said Daniel S. Loeb, CEO of Third Point. “We are confident that Campbell will find a world-class CEO who is given the necessary support to execute on the strategy to strengthen the Company, and that Sarah and Kurt will provide valuable perspectives to the Campbell Board.”

The complete agreement between Campbell and Third Point will be included as an exhibit to a Current Report on Form 8-K, which will be filed with the Securities and Exchange Commission.

Sarah Hofstetter

President of Comscore

Ms. Sarah Hofstetter is the President of Comscore, a global information and analytics company that measures consumer audiences and advertising across media platforms. From April to October 2018, Ms. Hofstetter served as Chairwoman of 360i, a U.S. advertising arm of Dentsu, Inc., a Japanese advertising and public relations company, that has helped its clients capitalize on industry changes. From 2013 until April 2018, Ms. Hofstetter served as Chief Executive Officer of 360i, and from 2006 to 2010 as Senior Vice President, Emerging Media & Brand Strategy. Under Ms. Hofstetter’s stewardship, 360i was named Adweek’s Breakthrough Media Agency of the Year in 2018 and featured in Ad Age’s coveted A-List issue for eight consecutive years from 2011 to 2018. Ms. Hofstetter currently sits on the Board of Directors of American Association of Advertising Agencies (“4A”) and was named to both the 2014 American Advertising Federation Hall of Achievement and the 4A’s list of 100 People Who Make Advertising Great in 2017. Prior to joining 360i, Ms. Hofstetter founded Kayak Communications, a marketing agency focused on developing brand strategy and communications plans for new media brands, where she also served as President from 2004 to 2006. Before starting her own agency, Ms. Hofstetter served in a series of senior leadership positions at Net2Phone, a subsidiary of IDT Corporation, from 1998 to 2004 and at IDT Corporation, a telecommunications company, from 1996 to 1998. Ms. Hofstetter graduated from Queens College, City University of New York with a B.A. in Sociology and Journalism.

 

 

Kurt T. Schmidt

Former Director and Chief Executive Officer of Blue Buffalo Company

Mr. Kurt Schmidt is currently retired and formerly served as a director and the Chief Executive Officer of Blue Buffalo Company, Ltd. (“Blue Buffalo”), a pet food company, from 2012 to December 31, 2016. Prior to joining Blue Buffalo, from 2011 to 2012, Mr. Schmidt served as a Deputy Executive Vice President at Nestlé Nutrition at Nestlé S.A. (“Nestlé”), a multinational food and beverage company. At Nestlé, Mr. Schmidt was responsible for the $8 billion global Health & Wellness Division, and he was a member of Nestlé’s Executive Committee. Mr. Schmidt joined Nestlé in 2007 as part of its acquisition of Gerber Products from Novartis, where he was the President and Chief Executive Officer of Gerber Products Company, a baby food and baby products manufacturer, from 2004 to 2007. Mr. Schmidt received a B.S. in Chemistry from the United States Naval Academy and an MBA from the University of Chicago.

About Campbell Soup Company

Campbell (NYSE: CPB) is driven and inspired by our Purpose, “Real food that matters for life’s moments.” For generations, people have trusted Campbell to provide authentic, flavorful and affordable snacks, soups and simple meals, and beverages. Founded in 1869, Campbell has a heritage of giving back and acting as a good steward of the planet’s natural resources. The company is a member of the Standard and Poor’s 500 and the Dow Jones Sustainability Indexes. For more information, visit www.campbellsoupcompany.com or follow company news on Twitter via @CampbellSoupCo. To learn more about how we make our food and the choices behind the ingredients we use, visit www.whatsinmyfood.com.

About Third Point LLC

Third Point LLC is an alternative investment firm managing $17B in assets for public institutions, private entities and qualified individual clients. The firm was founded in 1995 by Daniel S. Loeb, who serves as Chief Executive Officer and oversees its investment activity. Third Point employs an opportunistic approach to invest globally in equity and credit securities.

 

 

Forward-Looking Statements

This release contains “forward-looking statements” that reflect the company’s current expectations about the impact of its future plans and performance on the company’s business or financial results. These forward-looking statements rely on a number of assumptions and estimates that could be inaccurate and which are subject to risks and uncertainties. The factors that could cause the company’s actual results to vary materially from those anticipated or expressed in any forward-looking statement include: (1) the company’s ability to execute on and realize the expected benefits from the actions it intends to take as a result of its recent strategy and portfolio review, (2) the ability to differentiate its products and protect its category leading positions, especially in soup; (3) the ability to complete and to realize the projected benefits of planned divestitures and other business portfolio changes; (4) the ability to realize the projected benefits, including cost synergies, from the recent acquisitions of Snyder’s-Lance and Pacific Foods; (5) the ability to realize projected cost savings and benefits from its efficiency and/or restructuring initiatives; (6) the company’s indebtedness and ability to pay such indebtedness; (7) disruptions to the company’s supply chain, including fluctuations in the supply of and inflation in energy and raw and packaging materials cost; (8) the company’s ability to manage changes to its organizational structure and/or business processes, including selling, distribution, manufacturing and information management systems or processes; (9) the impact of strong competitive responses to the company’s efforts to leverage its brand power with product innovation, promotional programs and new advertising; (10) the risks associated with trade and consumer acceptance of product improvements, shelving initiatives, new products and pricing and promotional strategies; (11) changes in consumer demand for the company’s products and favorable perception of the company’s brands; (12) changing inventory management practices by certain of the company’s key customers; (13) a changing customer landscape, with value and e-commerce retailers expanding their market presence, while certain of the company’s key customers maintain significance to the company’s business; (14) product quality and safety issues, including recalls and product liabilities; (15) the costs, disruption and diversion of management’s attention associated with campaigns commenced by activist investors; (16) the uncertainties of litigation and regulatory actions against the company; (17) the possible disruption to the independent contractor distribution models used by certain of the company’s businesses, including as a result of litigation or regulatory actions affecting their independent contractor classification; (18) the impact of non-U.S. operations, including trade restrictions, public corruption and compliance with foreign laws and regulations; (19) impairment to goodwill or other intangible assets; (20) the company’s ability to protect its intellectual property rights; (21) increased liabilities and costs related to the company’s defined benefit pension plans; (22) a material failure in or breach of the company’s information technology systems; (23) the company’s ability to attract and retain key talent; (24) changes in currency exchange rates, tax rates, interest rates, debt and equity markets, inflation rates, economic conditions, law, regulation and other external factors; (25) unforeseen business disruptions in one or more of the company’s markets due to political instability, civil disobedience, terrorism, armed hostilities, extreme weather conditions, natural disasters or other calamities; and (26) other factors described in the company’s most recent Form 10-K and subsequent Securities and Exchange Commission filings. The company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.

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