EFiled: Jun 01 2015 07:22P
`Transaction ID 57319242
`Case No. 11076-VCL
`IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE
`
`
`
`BRISTOL-MYERS SQUIBB CO.,—:
`
`Plaintiff,
`
`V.
`
`DAVID BERMAN,
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`Defendant.
`
`Civil Action No. 11076-VCL
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`AFFIDAVIT OF DAVID BERMAN
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`l.
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`I am the defendant in the above-captioned matter and a former
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`employee of Bristol-Myers Squibb Co. (“BMS”).
`
`2.
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`This Affidavit is based upon mypersonal knowledge.
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`I am giving this
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`Affidavit in opposition to BMS’s Motion for a Temporary Restraining Order.
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`5.
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`I have reviewedthe Verified Complaint for Injunctive Relief
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`(“Complaint”) and other papers that BMShasfiled against me.
`
`I believe that they
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`contain numerous factual inaccuracies, which | will attempt to address below. In
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`addition, I will provide some information to the Court that I believe is necessary
`
`context for deciding this dispute.
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`118207123_5
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`EFiled: Jun 01 2015 07:22PM EDT
`Transaction ID 57319242
`Case No. 11076-VCL
`
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`My Educational and Employment Background
`
`For my entire career, I have workedin the field of oncology research.
`
`In terms of my educational background, I graduated from the
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`4.
`
`5,
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`Massachusetts Institute of Technology in 1992 with an undergraduate degree in
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`Biology, and from the University of Texas Southwestern Medical Centerat Dallas
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`in 1999 with both an M.D. and a Ph.D. From 1999 through 2002, I performed my
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`residency at the National CancerInstitute in the field of Anatomic Pathology, and
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`over the next year participated in a Fellowship at Johns Hopkins Hospital.
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`6.
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`In terms of my employment background, I worked as an Anatomical
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`Pathologist at the National CancerInstitute from 1999 through 2005.
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`‘Z
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`8.
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`I joined BMSin Mayof 2005.
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`On May 26, 2015, I resigned from BMSto join MedImmune, LLC
`
`(“MedImmune”), the biologics research and development arm of AstraZeneca
`
`Pharmaceuticals LP (“AZ”).
`
`My Agreements to Protect BMS’s Confidential Information
`and Limit the Scope of My Post-EmploymentActivities
`
`7.
`
`WhenI joined BMS, I signed a documenttitled Employee Agreement
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`Relating to Inventions, Patents, Copyright and Confidential Information
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`(“Confidentiality Agreement”), a copy of which is attached as Exhibit “A” to the
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`Complaint filed by BMS.
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`10.
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`Consistent with my obligations under the Confidentiality Agreement,
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`I have not disclosed any confidential BMS information to anyone, including
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`anyoneaffiliated with MedImmuneor AZ, and I have no intention of doing so in
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`the future.
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`11.
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`Indeed, MedImmunehas not asked meto use or disclose any of
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`BMS’s confidential information. To the contrary, MedImmunehas repeatedly
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`advised me to make sure I do not use or disclose any confidential BMS
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`information.
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`12.
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`Idonot believe that my job responsibilities at MedImmune will
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`require meto use or disclose any confidential BMS information.
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`13. During my tenure at BMS, I participated in a stock incentive plan (the
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`‘‘Plan’’), pursuant to which I waseligible to receive stock units subject to certain
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`restrictions and vesting schedules.
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`14.
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`As part of that Plan, I agreed to be subject to certain non-competition
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`and non-solicitation covenantsthat are set forth in identical language in Exhibit
`
`“B”(pages 6-10) and Exhibit “C” (pages 8-11) to BMS’s Complaint(collectively,
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`the “Non-Compete Covenant”).
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`15.
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`Iam oneof hundreds of BMS employees worldwide to participate in
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`the Plan and be subject to the Non-Compete Covenant.
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`16.
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`I did not have the ability to negotiate the terms of the Non-Compete
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`Covenant.
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`17.
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`The Non-Compete Covenantstates, in relevant part, the following:
`
`Given the extent and nature of the confidential information you have
`obtained or will obtain during the course of your employment with the
`Companyora subsidiary of the Company, it would be inevitable or, at
`the least, substantially probable that such confidential
`information
`would be disclosed or utilized by you should you obtain employment
`from, or otherwise becomeassociated with, an entity or person thatis
`engaged in a business or enterprise that directly competes with the
`Company. Even if not
`inevitable,
`it would be
`impossible or
`impracticable for the Company to monitor yourstrict compliance with
`your confidentiality obligations. Consequently, you agree that you
`will not, directly or indirectly:
`
`OOK OK
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`OR
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`OOK
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`GE
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`OK
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`Gk
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`Ok
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`during the Non-Competition and Non-Solicitation Period,
`(ii)
`whether or not for compensation, either on your own behalf or as an
`employee, officer, agent, consultant, director, owner, partner, joint
`venturer, shareholder, investor, or in any other capacity, be actively
`connected with a Competitive Business or otherwise advise orassist a
`Competitive Business with regard to any product,
`investigational
`compound,
`technology,
`service,
`line of business, department or
`business unit that competes with any product, technology, service, line
`of business, department or business unit with which you worked or
`about which you became familiar as a result of your employment with
`the Companyor a subsidiary of the Company. Notwithstanding the
`foregoing, after your employment with the Company or a
`subsidiary of the Companyterminates for any reason, you may be
`affiliated with a Competitive Business provided that your
`affiliation
`does
`not
`involve
`any
`product,
`investigational
`compound, technologyor service, that competes with any product,
`investigational compound, technology or service with which you
`were involved within the last twelve months of your employment
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`with the Companyora subsidiary of the Company,including any
`product, investigational compound, technology or service which
`the Companyis developing and of which you had knowledge, and
`you and the Competing Business provide the Company written
`assurancesof this fact prior to your commencing suchaffiliation;
`
`See Exhibit “B”at p.7 and Exhibit “C” at p. 8 (emphasis added).
`
`18.
`
`I have added emphasis to certain quoted language in the foregoing
`
`paragraph above, which I will refer to as the “Competitor Allowance,” for two
`
`reasons. First, the Competitor Allowance language reflects the portion of the Non-
`
`Compete Covenant that I believe allows me to work for a company that competes
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`with BMS during the Non-Competition Period, so long as my work does not
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`involve any drugs that compete (7.e., have the same mechanism ofaction) with the
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`drugs with which I was“involved” during my last twelve months at BMS.
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`19.
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`Second, for reasons unknownto me, BMSdid not quote the
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`Competitor Allowance languagein its Complaint or in any of the other papersit
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`filed against me.
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`In fact, BMS’s papersentirely omit the Competitor Allowance
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`from the language it quotes to describe my Non-Compete Covenant.
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`I believe this
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`gives the impression that the Competitor Allowance was not part of my Non-
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`Compete Covenant, whichis false.
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`20. Without the Competitor Allowance forming part of the Non-Compete
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`Covenant to which I agreed, I could not work in my field of expertise for up to one
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`year if I left BMS. This would imposea significant hardship on me and my
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`family.
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`21.
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`It is my understanding that, based on the Competitor Allowance
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`language, my duties of employment with MedImmunecannot, prior to May 26,
`
`2016, require me to be involved with any drug that has the same mechanism (i.e.
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`competes with) any drug with which I was involved during the last twelve months
`
`of my employment with BMS(hereafter the “BMSRestricted Drugs’).
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`22.
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`I fully intend to comply with that restriction, and MedImmunealso
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`insists that I comply with thatrestriction.
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`23.
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`Lonly accepted the MedImmuneposition onceI realized that there
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`were a sufficient number of MedImmunedrugs under development which did not
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`compete with any of the BMS Restricted Drugs.
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`Safeguards to Protect Confidential Information
`About the BMSRestricted Drugs
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`24. During the twelve monthsprior to my resignation from BMS, I was
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`involvedin the early stage developmentof certain Immuno-Oncology drugs. Four
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`of the BMS Restricted Drugs are publicly known, each of which targets a unique,
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`specific protein. The remainder of the BMSRestricted Drugs with which I was
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`involved are in the pre-clinical stage. Since these pre-clinical drugs are not
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`publically known, I will not specify them furtherin this Affidavit.
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`25.
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`Regarding the publicly-known BMSRestricted Drugs, MedImmune
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`currently does not have any competing drugs in development. To the extent that
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`AZ has competing drugs under development,I will have no participation in the
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`development of such drugs during my twelve-month Non-Competition Period. If]
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`am requested to participate in the developmentof such drugs in any manner, I will
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`refuse to do so.
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`26.
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`Regarding the BMS Restricted Drugsthat are not publicly known, if
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`MedImmunehas any competing drugs under development, I will have no
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`participation in the development of such drugs during my twelve-month Non-
`
`Competition Period. If I am requested to participate in the development of such
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`drugs in any manner,I will refuse to doso.
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`27. Moreover, MedImmunehasadvised methat it does not want me to do
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`anything that would violate my post-employmentobligations to BMS.
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`28. Accordingly, if I am presented with any situation that would require a
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`violation of either my Confidentiality Agreement or Non-Compete Covenant, I will
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`immediately inform MedImmuneofthat conflict and myrefusal to participate with
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`the developmentofthe conflicting drug during the Non-Competition Period.
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`29.
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`To safeguard against any potential violation of my post-employment
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`obligations to BMS, MedImmuneisaltering the original requirements of the
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`position for which I washired andis creating a job description that specifically
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`takes into account my obligations to BMS. To that end, MedJmmunewill have
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`another senior oncology executive be involved in my stead with respect to any
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`drugs that compete with the BMSRestricted Drugs during the Non-Competition
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`Period.
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`30.
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`Because these safeguards have been putin place, I do not believe my
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`employment at MedImmunewill in any way require meto violate my
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`Confidentiality Agreement or Non-Compete Covenant.
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`BMS’s Analysis of the Non-Compete Covenant
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`31. When I advised BMS on May21, 2015, of my intent to resign and
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`join MedImmune, BMStold methat I was prohibited from working for
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`MedImmunefor one year because it was a competitor of BMS.
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`32.
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`BMS further threatened methat if I went to work for MedImmune,I
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`would be sued.
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`33.
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`[told BMSthat it was my understanding that I could workfor a
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`competitor so long as I complied with the terms of the Competitor Allowance,
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`which I believed applies to my new position at MedImmune.
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`34.
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`BMS’s response wasthat the Competitor Allowance language in the
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`Non-Compete Covenant did not apply to mysituation.
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`35.
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`BMSdid not explain whyit believed that the Competitor Allowance
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`did not apply to my situation.
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`36.
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`On May 26, 2015, BMSrepeatedits threat to sue me if I joined
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`MedImmune,at which time I decided to resign immediately.
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`37.
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`BMSfiled its lawsuit against me two dayslater.
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`Many of BMS’s Allegations Are Not True
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`38.
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`In addition to omitting a critical part of the Non-Compete Covenant
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`from its papers that would allow me to work for MedImmune, BMS hasasserted
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`that I should be barred from working in any capacity in the entire Immuno-
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`Oncology(“I-O”) field for the next year based on a numberof incorrect factual
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`assertions about my employment at BMS and my new employment with
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`MedImmune.
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`39.
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`For example, BMSincorrectly alleges in Paragraph 10 of the
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`Complaint that I have accepted employment with AZ and am responsible for
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`research and development for AZ’s portfolio of I-O products (which includes two
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`drugs that compete with BMS’s Yervoy and Opdivo products). This is false. As
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`stated above, I am working for MedImmune, not AZ. Further, my responsibilities
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`at MedImmuneare being specifically tailored so that I will be able to comply with
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`my commitments to BMSpursuant to the Competitor Allowance language in my
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`Non-Compete Covenant, which meansthat I will not work on any drugsthat
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`compete with the BMSRestricted Drugs over the next twelve months.
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`40.
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`The Complaint also implies that BMS and MedImmuneare essentially
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`developing the same products. Thatis not true either. Currently, BMS has a
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`predominant focus on developing monoclonal antibodies that target specific
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`proteins. While MedImmuneis also developing monoclonalantibodies, publicly
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`available data showsthat many of proteinsit is targeting are different from those
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`targeted by BMS.
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`In addition, MedImmuneis developing I-O therapies beyond
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`monoclonal antibodies (such as vaccines), with which I was not involved at BMS.
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`41.
`
`Contrary to the allegations in Paragraphs 14 and 44 of the Complaint,
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`I was not responsible for evaluation and developmentof new I-O targets, was not
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`closely connectedto the entire J-O portfolio and wascertainly not responsible for
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`BMS’s entire worldwide I-O portfolio. My role at BMS wassignificantly
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`narrower than BMSclaims. For more than the past twelve months, my focus has
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`been exclusively on the Early Clinical development phase. As such, I was not a
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`memberof the senior managementteam that had oversight over the I-O portfolio
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`and was responsible for major decisions for these products.
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`42.
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`The Complaint further incorrectly contends that I was one of a few
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`senior employees involved in crafting BMS’s long-term strategic plan. Thatis
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`simply not correct.
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`43.
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`The Complaint also incorrectly states or implies that I had significant
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`involvementin the two I-O drugs that BMSis currently marketing (Yervoy and
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`Opdivo) up to the date of my departure. That also is not correct, as my
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`involvement with those drugs ended by October 2013.
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`44.
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`In short, BMS’s characterization of my role with that company,the
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`information I possessasa result of that role, and, most importantly, the value of
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`that information if provided to a competitor, is incorrect and distorted.
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`45.
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`As described above, BMShas also mischaracterized and
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`misrepresented my future role at MedImmune.
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`The Field of Immuno-Oncology
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`46.
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`In orderto facilitate the Court’s understanding as to why I believe the
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`impressions created by the Complaint are false, and why the requestedrelief is
`
`inappropriate, what follows is an overview ofthe I-O field and the I-O drug
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`developmentprocess.
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`47.
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`Oncologyis a branch of medicine that deals with tumors and cancer.
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`The four major categories of oncology are surgery, radiation, chemotherapy andI-
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`er
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`48.
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`J-Orefers to any medical therapy that uses the body’s immune system
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`to combat cancer.
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`I-O therapies target pathways that cancer uses to evade immune
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`recognition and destruction. Certain types of radiation and chemotherapy
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`treatments target these pathwaysand, thus, are considered to overlap with the I-O
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`therapies.
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`49.
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`Atpresent, I-O is generally thought to encompass roughly five
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`categories of approaches for impacting the immune system. Within thosefive
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`categories are numerous sub-categories, each of which involvesa different
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`approach to impact the immune system.
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`50. Attached as Exhibit 1 to this Affidavit is a flow chart, adapted from a
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`recent and widely-cited review article, identifying five major categories of I-O,
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`along with examples of 21 sub-categories in which I-O research and development
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`is currently being conducted. This flow chart highlights the immensebreadth of
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`the field of I-O.
`
`51.
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`Someof these sub-categories involve the development of whatare
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`historically considered oncology drugs (such as tumortargeted antibodies). Other
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`therapies are completely novel to the field of oncology (such as vaccines, oncolytic
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`viral therapy or engineered T cells).
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`52. Among those sub-categories that fall under the category oftraditional
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`oncology drugs, some involve the development of drugs whichtarget a specific
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`protein foundin or on the cell (such as the NK-cell therapy or checkpoint receptor
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`therapy), and some involve the development of drugs which do nottarget specific
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`proteins (such as vaccines and oncolytic viral therapy).
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`53. With respect to the developmentof drugs that target a specific cell
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`protein, there are currently dozens ofpotential protein targets in many different
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`cell types, ranging from tumorcells to immunecells to blood vessels.
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`54.
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`The twopreviously cited protein targets on T cells — PD1 protein
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`(which Opdivo was developed to target) and CTLA4 protein (which Yervoy was
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`developed to target) — are just two of the many potential protein targets on T cells
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`alone,let alone othercell types, currently being explored. Therefore, those two
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`protein targets are just the tip of the proverbial iceberg of potential therapies.
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`55.
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`There is a vast amountofscientific research and developmentI can
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`perform in the I-O field that has nothing to do with targeting the BMS Restricted
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`Drugsor even the twospecific T cell proteins targeted by Opdivo and Yervoy.
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`56.
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`As evidenced by the attached chart,the I-O field is vast in its many
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`approaches, therapies and potential targets. Product-specific information I may
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`have obtained in the development of Yervoy and Opdivo will have no application
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`to the rest of the universe of I-O therapies.
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`57. Asaresult, BMS’s claim that my experience in developing a limited
`
`numberofclinical stage therapies is translatable to the entire I-O field — and
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`therefore should prevent me from working in myfield of expertise — is completely
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`false and unsupported byscience.
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`Research From the Development of a Specific I-O Drug
`HasLittle to No Value to the Development of Another I-O Drug
`Unless Both Drugs Use the Identical Approach
`and Target the Identical Protein
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`58.
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`Because of the different function of each targeted protein, the
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`different cells that express the proteins, and the different modalities of I-O therapy
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`(such as antibodies or small molecular weight drugsor viruses), research from the
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`developmentof one drug in one sub-category would havelittle to no value to the
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`developmentof another drug in a different sub-category.
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`In fact, the inability to
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`fully extrapolate from one therapy to another is why pharmaceutical companies
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`repeat the same sequenceoftesting (phase 1, phase2, phase 3) for every new I-O
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`therapy.
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`59.
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`For example, the safety and activity profile of Yervoy (CTLA4)is
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`significantly different from that of Opdivo (PD1), even though bothtarget
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`checkpoint receptors on T cells. Indeed, since they each target a distinct protein,
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`the research from the development of Yervoy wasoflimited benefit to and did not
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`predict the development of Opdivo.
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`60.
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`The only scenario in which there may be a potential benefit in
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`knowingprior researchis if both drugs are being developed under the same sub-
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`category approach andare targeting the same identical protein. However, even in
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`that situation, somescientists (including scientists at BMS) believe that prior
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`research may not be informative to the competing drug if the two drugs have
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`differences in important structural properties.
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`61.
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`In my last twelve months at BMS, I was only involvedin a limited
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`numberofI-O drugs in the Early Clinical development phase. Thus, BMS’s
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`portrayal that this experience provides me, and by extension MedImmune, with a
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`treasure trove of proprietary information applicable to all other I-O therapies is
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`simply not scientifically accurate.
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`The I-O Drug Development Process and My Role at BMS
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`62.
`
`The typical process in developing an I-O drug involves pre-clinical
`
`and clinical work.
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`63.
`
`The clinicaltrials typically follow three phases. Phase1 clinicaltrials
`
`test the drug for safety. Phase 2A and 2Bclinical trials test the drug for efficacy.
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`Phase3 clinicaltrials are large scale studies conducted for regulatory approval.
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`64.
`
`At BMS, responsibilities for the -O development process were
`
`typically divided into three categories: Discovery (the pre-clinical stage); Early
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`Clinical (Phases 1 & 2A); and Late Stage Clinical (Phases 2B and 3). A separate
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`group is then responsible for marketing the drug.
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`65.
`
`Inthe past twelve months at BMS, I was responsible only for, and
`
`involved only in, the Early Clinical development phase.
`
`The Results of the Clinical Trials Are Required
`to be Released to the Public Throughout the Development Process
`
`66.
`
`Throughout the drug developmentprocess, the results of each clinical
`
`phase are required to be publicly released within a reasonable timeafter
`
`completion of that phase (whichis typically within twelve months from the
`
`analysis of the key results). Therefore, clinical information which may be
`
`proprietary at one momentin time inevitably becomes public in the normal course
`
`of the drug developmentprocess.
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`67.
`
`For example, as discussed below, I had some involvement with the
`
`Late Stage Clinical development of Yervoy, and much more limited involvement
`
`with the Late Stage Clinical development of Opdivo. My involvementwith each
`
`drug pre-dates the last twelve months of my employment at BMS.
`
`I have had no
`
`involvement with developmentof either drug since October 2013.
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`68.
`
`During the course of my role in Early Clinical development, I was
`
`granted access to certain non-publicclinical trial results for these two drugs.
`
`However, any valuable clinical knowledge I had regarding either of these drugs
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`becamepublicly available when BMSpresentedthe results of the key clinical trials
`
`in April 2015 at the meeting of the American Association of Cancer Researchers,
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`and more recently at the meeting of the American Society of Clinical Oncology
`
`(ASCO)that started this past weekend (May 29-June 2, 2015).
`
`69.
`
`Therefore, it is entirely incorrect to assert or imply that by virtue of
`
`working at BMS I becameprivy to a vast amountof research that is not known
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`publicly and/oris of significant value to any company which competes with BMS.
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`70.
`
`It is also incorrect to state that I was involved in overseeing BMS’s
`
`entire I-O portfolio. Of the three stages of development, I was a team leaderfor
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`only the Early Clinical development team. Furthermore, at BMS, team leaders do
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`not makefinal strategic decisions and must report to an executive oversight
`
`committee, which is charged with making final decisions.
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`71.
`
`I was also not a memberof the Late Stage development teams for
`
`Yervoy or Opdivo in mylast twelve months at BMS, nor was I a memberof their
`
`senior executive oversight committees.
`
`I, therefore, clearly could not have
`
`overseen Late Stage developmentofthese drugs.
`
`72.
`
`The pre-clinical stage (Discovery) is also under the supervision of a
`
`different department with its own leader and a separate senior executive
`
`committee.
`
`I was just one of dozens of employeesofall grade levels from many
`
`different departments who saw the samelevel of detail for pre-clinical work, and
`
`certainly did not oversee this group.
`
`73.
`
`Myrole in mylast year at BMS was limited to the developmentof a
`
`finite numberof Early Stage drugs. As I have already stated, if I am presented
`
`with any developmentprojects at MedImmunethat involve drugs that compete
`
`with any of them, I will not participate in such projects for the duration of the Non-
`
`Competition Period. MedImmune has more than a sufficient number of non-
`
`competing drugs for me to work on over the next year and allow me to comply
`
`with the terms of the Competitor Allowance.
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`Yervoy and Opdivo
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`74.
`
`From the allegations in the Complaint, it appears that BMS’s main
`
`concern arises from my earlier involvement with the development of Yervoy and
`
`Opdivo, and that the knowledge I gained from those projects will somehow benefit
`
`MedImmune.
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`75.
`
`Since I have not been involved in the developmentof these projects
`
`since October 2013, it is my understanding that they would not be considered BMS
`
`Restricted Drugs under the Non-Compete Covenant.
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`76. Nevertheless, since the Complaint is focused on those two drugs,I
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`will provide the Court with facts regarding my involvementwith their
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`development.
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`77.
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`Iwasa lead for the Yervoyclinical sub-team from December2011
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`until October 2013. In that capacity, I wasprivy to the clinicaltrials that took
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`place during that time period and anyresults from suchtrials that were obtained
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`during that time period.
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`It is my understandingthatall of the clinical results from
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`that time period have already been publicly announced by BMS.
`
`78.
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`Since October 2013, I have had no involvementwith the Yervoy
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`developmentor marketing teams.
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`118207123.5
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`79.
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`Regarding Opdivo, I was a memberof the developmentteam for a
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`brief period of time, from June 2013 to October 2013. During that time I was
`
`involved in oneclinicaltrial. I left the team before results were available.
`
`80.
`
`To the best of my knowledge, since the end of 2013, I have never
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`participated in any Yervoy or Opdivo development team meetings, protocol design
`
`meetings, day-to-day operations,final results meetings, health authority/regulatory
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`meetings or marketing meetings.
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`81.
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`Executive oversight of Opdivo or Yervoy is managed by two
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`committees at BMS: an Oncology Development Committee and a Portfolio Wide
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`Committee. These are the committees to which the Yervoy and Opdivo
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`development teams report. These committees have the mandate to endorse
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`strategy, future trials and tumors, dosing regimens for high value studies, review
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`high-level trial results from majorclinical trials and integrate with the rest of the
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`BMSoncology portfolio. I was not a memberof these committees.
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`118207123_5
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`20
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`2015 Long Term I-O Strategy Planning
`
`82.
`
`Prior to 2015, I was neverinvolved in any I-O long-term strategy
`
`planning at BMS.
`
`83.
`
`In 2015, I was one of dozens of BMSexecutivesto participate in a
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`long term I-O strategy workshop. There were several different work streams at
`
`this workshop. My work stream waslimited to drugs in the Early Clinical stage of
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`development. All of the work streamspresented their options to a room consisting
`
`of dozens of executives. All subsequent work, including the final strategic plan,
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`was developed by a team of senior BMSexecutivesin private. I was not a member
`
`of that team.
`
`84.
`
`Myonlyrole at this meeting was to present my optionsfor the Early
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`Clinical drugs with which I was involved. To this day, I have no idea if my
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`recommendations were adopted, modified or rejected.
`
`85.
`
`To this day, I have no knowledge of the final BMS I-O strategy for
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`2015,
`
`86.
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`I swear under penalty of perjury that the foregoing is true and correct.
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`a1
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`=
`taMa
`. ~ e
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`1
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`
`ar6ll—
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`DAVID BERMAN, M.D., Ph.D.
`
`Sworn to and subscribed before methis
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`day of su NO
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`, 2015.
`
`LuLioxi
`
`
`NOTARY PUBLIC
`
`My Commission Expires: Sept 05,2019
`
`ROSA M HERRERA
`Notary Public
`State of New Jersey
`My Commission Expires Sept. 05, 2019
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`__1.D.# 2449714
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`