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Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 1 of 30 PageID #: 23768
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 18-924-CFC
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`GENENTECH, INC. and CITY OF HOPE,
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`
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`v.
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`AMGEN, INC.,
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`
`
`
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`
`
`
`
`
`Plaintiffs,
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`Defendant.
`
`
`
`DECLARATION OF NORA Q.E. PASSAMANECK IN SUPPORT OF
`PLAINTIFFS’ EMERGENCY MOTION FOR A TEMPORARY RESTRAINING ORDER
`AND A PRELIMINARY INJUNCTION
`
`
`
`I, Nora Q.E. Passamaneck, declare and state as follows:
`
`1.
`
`I am an attorney at Wilmer Cutler Pickering Hale and Dorr LLP, counsel for
`
`Genentech, Inc. (“Genentech”) in Case No. 18-cv-00924-GMS (D. Del.). I am familiar with the
`
`facts set forth herein, and if called as a witness, I could and would testify competently to those
`
`facts under oath.
`
`2.
`
`Attached hereto as Exhibit 1 is a true and correct copy of an excerpted version of
`
`Unites States Patent No. 6,627,196.
`
`3.
`
`Attached hereto as Exhibit 2 is a true and correct copy of an excerpted version of
`
`Unites States Patent No. 7,371,379.
`
`4.
`
`Attached hereto as Exhibit 3 is a true and correct copy of an excerpted version of
`
`Unites States Patent No. 10,160,811.
`
`5.
`
`Attached hereto as Exhibit 4 is a true and correct copy of the Kanjinti Label, dated
`
`June 2019. This exhibit is marked Confidential.
`
`
`
`1
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`PUBLIC VERSION FILED:
`
`July 19, 2019
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`

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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 2 of 30 PageID #: 23769
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`6.
`
`Attached hereto as Exhibit 5 is a true and correct copy of
`
` This exhibit is marked
`
`Confidential.
`
`7.
`
`Attached hereto as Exhibit 6 is a true and correct copy of
`
`
`
`
`
`. This exhibit is marked
`
`Confidential.
`
`8.
`
`Attached hereto as Exhibit 7 is a true and correct copy of an excerpted version of
`
`the Herceptin Label, dated November 2018.
`
`9.
`
`Attached hereto as Exhibit 8 is a true and correct copy of an excerpted version of
`
`an Amgen Press Release, titled “FDA Approves Amgen And Allergan’s KANJINTI™
`
`(trastuzumab-anns), A Biosimilar to Herceptin® (trastuzumab).”
`
`10.
`
`Attached hereto as Exhibit 9 is a true and correct copy of
`
`
`
` This exhibit is
`
`marked Confidential.
`
`11.
`
`Attached hereto as Exhibit 10 is a true and correct copy of
`
` This exhibit is marked Confidential.
`
`12.
`
`Attached hereto as Exhibit 11 is a true and correct copy of
`
` This exhibit is marked
`
`Confidential.
`
`13.
`
`Attached hereto as Exhibit 12 is a true and correct copy of
`
`
`
`
`
`
`
`. This
`
`exhibit is marked Confidential.
`
`
`
`2
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`

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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 3 of 30 PageID #: 23770
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`14.
`
`Attached hereto as Exhibit 13 is a true and correct copy of an excerpted version of
`
`the Robert Jacobson Deposition Transcript, dated May 20, 2019. This exhibit is marked
`
`Confidential.
`
`15.
`
`Attached hereto as Exhibit 14 is a true and correct copy of Defendant Amgen
`
`Inc’s Second Supplemental Objections and Responses to Plaintiffs’ First Set of Interrogatories
`
`(Nos. 2, 3), dated September 4, 2018. This exhibit is marked Confidential.
`
`16.
`
`Attached hereto as Exhibit 15A is a true and correct copy of Genentech’s 3A
`
`disclosure letter, from Emily Whelan to Michelle Rhyu, Ph. D., dated December 15, 2017.
`
`17.
`
`Attached hereto as Exhibit 15B is a true and correct copy of Genentech’s 3A
`
`disclosure letter, from Nora Passamaneck to Counsel, dated December 26, 2018.
`
`18.
`
`Attached hereto as Exhibit 16 is a true and correct copy of an email chain that
`
`begins with
`
`marked Confidential.
`
`. This exhibit is
`
`19.
`
`Attached hereto as Exhibit 17 is a true and correct copy of a document titled,
`
` This exhibit is marked Confidential.
`
`20.
`
`Attached hereto as Exhibit 18 is a true and correct copy of an excerpted version of
`
`a document titled,
`
` This exhibit is marked Confidential.
`
`
`
`21.
`
`Attached hereto as Exhibit 19 is a true and correct copy of an excerpted version of
`
`a document titled,
`
`marked Confidential.
`
` This exhibit is
`
`22.
`
`Attached hereto as Exhibit 20 is a true and correct copy of a document titled,
`
` This exhibit is marked Confidential.
`
`
`
`3
`
`

`

`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 4 of 30 PageID #: 23771
`
`23.
`
`Attached hereto as Exhibit 21 is a true and correct copy of an excerpted version of
`
`“Final Written Decision” for IPR2017-01139 for patent 6,627,196, dated October 3, 2018.
`
`24.
`
`Attached hereto as Exhibit 22 is a true and correct copy of an excerpted version of
`
`“Final Written Decision” for IPR2017-00804 for patent 6,627,196, dated October 3, 2018.
`
`25.
`
`Attached hereto as Exhibit 23 is a true and correct copy of an excerpted version of
`
`“Final Written Decision” for IPR2017-00805 for patent 7,371,379 B2, dated October 3, 2018.
`
`26.
`
`Attached hereto as Exhibit 24 is a true and correct copy of an excerpted version of
`
`“Final Written Decision” for IPR2017-00140 for patent 7,371,379 B2, dated October 3, 2018.
`
`27.
`
`Attached hereto as Exhibit 26 is a true and correct copy of an excerpted version of
`
`Amgen’s Opening Brief in Support of Motion for Permanent Injunctive Relief, in Amgen Inc. et
`
`al. v. Sanofi et al., No. 14-cv-1317-SLR (D. Del. April 27, 2016), ECF No. 340.
`
`28.
`
`Attached hereto as Exhibit 27 is a true and correct copy of an excerpted version of
`
`a website article titled, “Marketing Director and Launch Lead, US Biosimilar Trastuzumab.”
`
`29.
`
`Attached hereto as Exhibit 28 is a true and correct copy of Amgen’s Opening
`
`Brief in Support of its May 26, 2017 Motion for a Preliminary Injunction, in Amgen Inc. et al. v.
`
`Hospira, Inc., No. 1:15-cv-839-RGA (D. Del. June 5, 2017), ECF No. 230.
`
`30.
`
`Attached hereto as Exhibit 29 is a true and correct copy of an excerpted version of
`
`a website article titled, “Celltrion CEO aims to sell Truxima in US This Year” dated March 26,
`
`2019.
`
`31.
`
`Attached hereto as Exhibit 30 is a true and correct copy of an excerpted version of
`
`Amgen’s Opening Brief in Support of its Motion for an Emergency Injunction Pending Appeal,
`
`in Amgen Inc. v. Amneal Pharms. LLC, et al., No. 1:16-cv-853-MSG, (D. Del. Mar. 26, 2019),
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`ECF No. 440.
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`
`
`4
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`

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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 5 of 30 PageID #: 23772
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`32.
`
`Attached hereto as Exhibit 31 is a true and correct copy of Exhibit 239 of the
`
`Molly Benson deposition, dated June 27, 2019. This exhibit is marked Confidential.
`
`33.
`
`Attached hereto as Exhibit 32 is a true and correct copy of an excerpted version of
`
`an Amgen presentation titled,
`
` dated March 2019. This exhibit is
`
`marked Confidential.
`
`34.
`
`Attached hereto as Exhibit 33 is a true and correct copy of a website article titled,
`
`“Perseverance, The Inside Story of a Breast Cancer Breakthrough, 30 Years in the Making.”
`
`35.
`
`Attached hereto as Exhibit 34 is a true and correct copy of a Genentech Press
`
`Release titled, “Herceptin Plus Chemotherapy Improved Disease-Free Survival and Overall
`
`Survival in Adjuvant Setting for Early-Stage Her2- Positive Breast Cancer Patients,” dated May
`
`13, 2005.
`
`36.
`
`Attached hereto as Exhibit 35 is a true and correct copy of an excerpted version of
`
`a presentation titled,”
`
`
`
`. This exhibit is marked Confidential.
`
`37.
`
`Attached hereto as Exhibit 36 is a true and correct copy of an excerpted version of
`
`a presentation titled,
`
`Confidential.
`
`” This exhibit is marked
`
`38.
`
`Attached hereto as Exhibit 37 is a true and correct copy of an excerpted version of
`
`. This exhibit is marked Confidential.
`
`39.
`
`Attached hereto as Exhibit 38 is a true and correct copy of an excerpted version of
`
`40.
`
`Attached hereto as Exhibit 39 is a true and correct copy of document titled
`
`. This exhibit is marked Confidential.
`
` This exhibit is marked Confidential.
`
`
`
`5
`
`

`

`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 6 of 30 PageID #: 23773
`
`41.
`
`Attached hereto as Exhibit 40 is a true and correct copy of a website article titled,
`
`FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2- Positive Breast
`
`Cancers,” dated February 28, 2019.
`
`42.
`
`Attached hereto as Exhibit 41 is a true and correct copy of the Perjeta Label,
`
`revised December 2018. This exhibit is marked Confidential.
`
`43.
`
`Attached hereto as Exhibit 42 is a true and correct copy of titled
`
`This exhibit is marked Confidential.
`
`44.
`
`Attached hereto as Exhibit 43 is a true and correct copy of
`
`
`
`
`
`. This exhibit is marked Confidential.
`
`45.
`
`Attached hereto as Exhibit 44 is a true and correct copy of a Genentech press
`
`release titled, FDA Approves Genentech's Kadcyla for Adjuvant Treatment of People with
`
`HER2- Positive Early Breast Cancer with Residual Invasive Disease After Neoadjuvant
`
`Treatment, dated May 3, 2019.
`
`46.
`
`Attached hereto as Exhibit 45 is a true and correct copy of a document titled
`
` This exhibit is marked Confidential.
`
`47.
`
`Attached hereto as Exhibit 46 is a true and correct copy of
`
`dated April 2015. This exhibit is marked Confidential.
`
`48.
`
`Attached hereto as Exhibit 47 is a true and correct copy
`
`
`
`
`
`. This exhibit is marked Confidential.
`
`49.
`
`Attached hereto as Exhibit 48 is a true and correct copy of Rituxan Hycela
`
`Prescribing Information, revised June 2017.
`
`50.
`
`Attached hereto as Exhibit 49 is a true and correct copy of
`
`
`
` This exhibit is marked Confidential.
`
`
`
`6
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`

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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 7 of 30 PageID #: 23774
`
`51.
`
`Attached hereto as Exhibit 50 is a true and correct copy of
`
`
`
` This exhibit is marked Confidential.
`
`52.
`
`Attached hereto as Exhibit 51 is a true and correct copy of an excerpted version of
`
`a document titled,
`
`
`
`This exhibit is marked Confidential.
`
`53.
`
`Attached hereto as Exhibit 52 is a true and correct copy of an excerpted version of
`
`a document titled,
`
`This exhibit is marked Confidential.
`
`
`
`54.
`
`Attached hereto as Exhibit 53 is a true and correct copy of an excerpted version of
`
`a document titled,
`
` This exhibit is marked Confidential.
`
`
`
`55.
`
`Attached hereto as Exhibit 54 is a true and correct copy of an excerpted version of
`
`a document titled,
`
`marked Confidential.
`
`This exhibit is
`
`56.
`
`Attached hereto as Exhibit 55 is a true and correct copy of a document produced
`
`in native format. This exhibit is marked Confidential.
`
`57.
`
`Attached hereto as Exhibit 56 is a true and correct copy of Defendant Amgen’s
`
`First Supplemental Objections and Responses to Plaintiffs’ First Set of Interrogatories, dated
`
`April 5, 2019. This exhibit is marked Confidential.
`
`58.
`
`Attached hereto as Exhibit 57 is a true and correct copy of a document titled, “List
`
`of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools).”
`
`59.
`
`Attached hereto as Exhibit 58 is a true and correct copy of an excerpted version
`
`of, HercepTest, Code K5204.
`
`
`
`7
`
`

`

`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 8 of 30 PageID #: 23775
`
`60.
`
`Attached hereto as Exhibit 59 is a true and correct copy of an excerpted version of
`
`“Bond™ Oracle™ HER2 IHC System for Leica BOND-MAX System Instructions For Use.”
`
`61.
`
` Attached hereto as Exhibit 60 is a true and correct copy of an excerpted version
`
`of “PATHWAY anti-HER-2/neu (485) Rabbit Monoclonal Primary Antibody, dated March 16,
`
`2012.
`
`62.
`
`Attached hereto as Exhibit 61 is a true and correct copy of a document titled,
`
`“HER2 IQF1SH pharmDx, Code K5731.”
`
`63.
`
`Attached hereto as Exhibit 62 is a true and correct copy of a document titled,
`
`“PathVysion, HER-2 DNA Probe Kit.”
`
`64.
`
`Attached hereto as Exhibit 63 is a true and correct copy of an excerpted version of
`
`a document titled, “The Amgen Experience You Can Trust.” This exhibit is marked Confidential.
`
`65.
`
`Attached hereto as Exhibit 64 is a true and correct copy of an excerpted version of
`
`a document titled,
`
`
`
`66.
`
`Attached hereto as Exhibit 66 is a true and correct copy of an excerpted version of
`
` This exhibit is marked Confidential.
`
`a document titled,
`
`Confidential.
`
` This exhibit is marked
`
`67.
`
`Attached hereto as Exhibit 67 is a true and correct copy of an article titled,
`
`“Efficacy and Safety of ABP 980 Compared with Reference Trastuzumab in Women with
`
`HER2-positive Early Breast Cancer (LILAC study): a Randomised, Double-blind, Phase 3
`
`Trial,” by Minkwitz, et al.
`
`68.
`
`Attached hereto as Exhibit 69 is a true and correct copy of a document titled,
`
` This exhibit is marked Confidential.
`
`
`
`8
`
`

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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 9 of 30 PageID #: 23776
`
`69.
`
`Attached hereto as Exhibit 70 is a true and correct copy of a document titled,
`
` This exhibit is marked Confidential.
`
`70.
`
`Attached hereto as Exhibit 71 is a true and correct copy of a document titled,
`
`
`
` This exhibit is marked Confidential.
`
`71.
`
`Attached hereto as Exhibit 72 is a true and correct copy of a document titled,
`
`
`
` This exhibit is marked Confidential.
`
`72.
`
`Attached hereto as Exhibit 73 is a true and correct copy of an excerpted version of
`
`a document titled,
`
`
`
` This exhibit is marked Confidential.
`
`73.
`
`Attached hereto as Exhibit 74 is a true and correct copy of an excerpted version of
`
`a document titled,
`
`
`
`
`
` This exhibit is marked Confidential.
`
`74.
`
`Attached hereto as Exhibit 76 is a true and correct copy of an excerpted version of
`
`Notice of Motion and Motion by Amgen for a Preliminary Injunction, in Amgen Inc. et al. v.
`
`Sandoz Inc., No. 3:14-cv-04741-RS (N.D. Cal. Feb. 5, 2015), ECF No. 56.
`
`75.
`
`Attached hereto as Exhibit 77 is a true and correct copy of an excerpted version of
`
`a document titled,
`
` This exhibit is marked Confidential.
`
`76.
`
`Attached hereto as Exhibit 78 is a true and correct copy of the document titled
`
`“What Are ‘Biologics’ Questions and Answers.”
`
`
`
`9
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`

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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 10 of 30 PageID #: 23777
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`77.
`
`Attached hereto as Exhibit 79 is a true and correct copy of the website titled
`
`“Biosimilar and Interchangeable Products,” available at
`
`https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#diffbiochange.
`
`78.
`
`Attached hereto as Exhibit 80 is a true and correct copy of the document titled,
`
`“Implementation of the Biosimilar Pathway: Economic and Policy Issues,” dated April 19, 2011.
`
`79.
`
`Attached hereto as Exhibit 81 is a true and correct copy of the website titled
`
`“FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar
`
`Products in the U.S.,” available at www.fda.gov/files/drugs/published/FDA’s-Overview-of-the-
`
`Regulatory-Guidance-for-the-Development-and-Approval-of-Biosimilar-Products-in-the-US.pdf.
`
`80.
`
`Attached hereto as Exhibit 82 is a true and correct copy of the document titled
`
`“Biosimilars: Considerations for Payers,” dated 2019.
`
`81.
`
`Attached hereto as Exhibit 83 is a true and correct copy of the website titled
`
`“Biosimilar Development,” available at https://www.pfizerbiosimilars.com/biosimilars-
`
`development.
`
`82.
`
`Attached hereto as Exhibit 84 is a true and correct copy of the document titled
`
`“American Society of Clinical Oncology Statement: Biosimilars in Oncology,” Journal of
`
`Clinical Oncology, dated April 20, 2018.
`
`83.
`
`Attached hereto as Exhibit 85 is a true and correct copy of the document titled
`
`“Opportunities and Challenges in Biosimilar Uptake in Oncology.”
`
`84.
`
`Attached hereto as Exhibit 86 is a true and correct copy of the document titled
`
`“Follow the Pill: Understanding the U.S. Commercial Pharmaceutical Supply Chain,” dated
`
`March 2005.
`
`
`
`10
`
`

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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 11 of 30 PageID #: 23778
`
`85.
`
`Attached hereto as Exhibit 87 is a true and correct copy of the website titled
`
`“Herceptin Distribution: Authorized Distributors and Specialty Pharmacies,” available at
`
`https://www.genentech-access.com/hcp/brands/herceptin/learn-about-our-services/product-
`
`distribution.html.
`
`86.
`
`Attached hereto as Exhibit 88 is a true and correct copy of the website titled
`
`“Follow the Vial: The Buy-and-Bill System for Distribution and Reimbursement of Provider-
`
`Administered Outpatient Drugs,” available at https://www.drugchannels.net/2016/10/follow-vial-
`
`buy-and-bill-system-for.html.
`
`87.
`
`Attached hereto as Exhibit 89 is a true and correct copy of the website titled “42
`
`C.F.R. § 1001.952 (j), available at www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-
`
`2011-title42-vol5-sec1001-952.pdf.
`
`88.
`
`Attached hereto as Exhibit 90 is a true and correct copy of the website titled
`
`“PBGs vs. GPOs: What’s the Difference?” available at www.nationalpurchasinggroup.com/pbg-
`
`vs-gpo/.
`
`89.
`
`Attached hereto as Exhibit 91 is a true and correct copy an excerpted version of
`
`the document titled “Group Purchasing Organizations: Funding Structure Has Potential
`
`Implications for Medicare Costs,” dated October 2014.
`
`90.
`
`Attached hereto as Exhibit 92 is a true and correct copy an excerpted version of
`
`the document titled
`
` produced at GNE-HER_001378593, dated
`
`November 2018. This exhibit is marked Confidential.
`
`91.
`
`Attached hereto as Exhibit 93 is a true and correct copy an excerpted version of
`
`
`
`This exhibit is marked Confidential.
`
`
`
`11
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`

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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 12 of 30 PageID #: 23779
`
`92.
`
`Attached hereto as Exhibit 94 is a true and correct copy of the website titled
`
`“340B Drug Pricing Program,” available at www.hrsa.gov/opa/faqs/index.html.
`
`93.
`
`Attached hereto as Exhibit 95 is a true and correct copy of the document titled
`
`“Does A ‘One-Size-Fits-All’ Formulary Policy Make Sense?” dated June 2, 2016.
`
`94.
`
`Attached hereto as Exhibit 96 is a true and correct copy an excerpted version of
`
`the document titled “Prescription Drug Prices: Why Do Some Pay More Than Others Do?” dated
`
`2001.
`
`95.
`
`Attached hereto as Exhibit 97 is a true and correct copy of the website titled
`
`“Inside the Secret World of Drug Company Rebates,” available at
`
`www.forbes.com/sites/matthewherper/2012/05/10/why-astrazeneca-gives-insurers-60-discounts-
`
`on-nexiums-list-price/#a3b52532b25c.
`
`96.
`
`Attached hereto as Exhibit 98 is a true and correct copy an excerpted version of
`
`an excerpted version of the document titled
`
`marked Confidential.
`
`
`
`. This exhibit is
`
`97.
`
`Attached hereto as Exhibit 99 is a true and correct copy an excerpted version of
`
`the document titled "The Effects and Role of Direct-to-Physician Marketing in the
`
`Pharmaceutical Industry: An Integrative Review,” dated 2005.
`
`98.
`
`Attached hereto as Exhibit 100 is a true and correct copy an excerpted version of
`
`the document titled “Addressing the Trust Issue: From Share of Voice to Share of Care,” dated
`
`May 31, 2007.
`
`99.
`
`Attached hereto as Exhibit 101 is a true and correct copy of the website titled
`
`“About Us,” available at www.gene.com/about-us.
`
`
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`12
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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 13 of 30 PageID #: 23780
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`100. Attached hereto as Exhibit 102 is a true and correct copy of the website titled
`
`“Roche Completes Acquisition of Genentech,” available at www.gene.com/media/press-
`
`releases/12007/2009-03-26/roche-completes-acquisition-of-genentech.
`
`101. Attached hereto as Exhibit 103 is a true and correct copy an excerpted version of
`
`the website titled "Annual Report 2018," available at
`
`https://www.roche.com/investors/annualreport18.htm#more.
`
`102. Attached hereto as Exhibit 104 is a true and correct copy of the website titled
`
`“Finance Report - 2018,” available at https://www.roche.com/dam/jcr:933329c4-4564-4b17-
`
`a29b-246ac7e617d5/en/fb18e.pdf.
`
`103. Attached hereto as Exhibit 105 is a true and correct copy of the website titled
`
`“Foreign Exchange Rates - H.10,” available at
`
`www.federalreserve.gov/releases/h10/hist/dat00_sz.htm.
`
`104. Attached hereto as Exhibit 106 is a true and correct copy an excerpted version of
`
`the document titled
`
`marked Confidential.
`
` This exhibit is
`
`105. Attached hereto as Exhibit 107 is a true and correct copy of the website titled
`
`“The Amgen Story,” available at https://www.amgenhistory.com/~/media/amgen/full/www-
`
`amgenhistory-com/pdfs/amgen_timeline_february-2016.ashx.
`
`106. Attached hereto as Exhibit 108 is a true and correct copy of the website titled
`
`“About Amgen,” available at https://www.amgen.com/~/media/amgen/full/www-amgen-
`
`com/downloads/fact-sheets/fact_sheet_amgen.ashx.
`
`107. Attached hereto as Exhibit 109 is a true and correct copy of the website titled
`
`“Products,” available at https://www.amgen.com/products/.
`
`
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`13
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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 14 of 30 PageID #: 23781
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`108. Attached hereto as Exhibit 110 is a true and correct copy of the website titled
`
`“FDA-Approved Biosimilar Products,” available at
`
`https://www.amgenbiosimilars.com/products/approved-products/.
`
`109. Attached hereto as Exhibit 111 is a true and correct copy of the website titled
`
`“FDA Approves Amgen and Allergan's KANJINTI™ (trastuzumab-anns), A Biosimilar To
`
`Herceptin® (trastuzumab),” available at https://www.amgen.com/media/news-
`
`releases/2019/06/fda-approves-amgen-and-allergans-kanjinti-trastuzumabanns-a-biosimilar-to-
`
`herceptin-trastuzumab/.
`
`110. Attached hereto as Exhibit 112 is a true and correct copy of the website titled
`
`“Our Pipeline,” available at https://www.amgenbiosimilars.com/products/our-pipeline/.
`
`111. Attached hereto as Exhibit 113 is a true and correct copy an excerpted version of
`
`the document titled
`
`
`
` This exhibit is marked Confidential.
`
`112. Attached hereto as Exhibit 114 is a true and correct copy an excerpted version of
`
`an excerpted version of the Molly Benson Deposition Transcript, dated June 27, 2019. This
`
`exhibit is marked Confidential. This exhibit is marked Confidential.
`
`113. Attached hereto as Exhibit 115 is a true and correct copy of the website titled
`
`“Herceptin,” available at https://www.breastcancer.org/treatment/targeted_therapies/herceptin.
`
`114. Attached hereto as Exhibit 116 is a true and correct copy of the website titled
`
`“Proposed Mechanism of Action,” available at https://www.herceptin.com/hcp/treatment/moa.
`
`115. Attached hereto as Exhibit 117 is a true and correct copy of the website titled
`
`“Herceptin: Homepage,” available at www.herceptin.com.
`
`
`
`14
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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 15 of 30 PageID #: 23782
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`116. Attached hereto as Exhibit 118 is a true and correct copy of the document titled
`
`“Breast Cancer: Version 1.2019,” dated April 26, 2019.
`
`117. Attached hereto as Exhibit 119 is a true and correct copy of the document titled
`
`“Gastric Cancer: Version 1.2019,” dated April 16, 2019.
`
`118. Attached hereto as Exhibit 120 is a true and correct copy of the website titled
`
`“U.S. Breast Cancer Statistics,” available at
`
`www.breastcancer.org/symptoms/understand_bc/statistics.
`
`119. Attached hereto as Exhibit 121 is a true and correct copy of the document titled
`
`Fletcher, Jenna, “What's to know about HER2-positive breast cancer?” dated January 21, 2019.
`
`120. Attached hereto as Exhibit 122 is a true and correct copy of the website titled
`
`“Cancer Stat Facts: Stomach Cancer,” available at
`
`www.seer.cancer.gov/statfacts/html/stomach.html.
`
`121. Attached hereto as Exhibit 123 is a true and correct copy of the website titled
`
`“Key Statistics for Stomach Cancer,” available at
`
`www.cancer.org/cancer/stomachcancer/detailedguide/stomach-cancer-key-statistics.
`
`122. Attached hereto as Exhibit 124 is a true and correct copy of the website titled
`
`“Targeted Therapies for Stomach Cancer,” available at https://www.cancer.org/cancer/stomach-
`
`cancer/treating/targeted-therapies.html.
`
`123. Attached hereto as Exhibit 125 is a true and correct copy of the website titled
`
`“Genentech Reports 1999 Year-End Results,” available at www.gene.com/media/press-
`
`releases/4601/2000-01-20/genentech-reports-1999-year-end-results.
`
`124. Attached hereto as Exhibit 126 is a true and correct copy of the website titled U.S.
`
`National Library of Medicine Clinical Trials, available at www.clinicaltrials.gov.
`
`
`
`15
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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 16 of 30 PageID #: 23783
`
`125. Attached hereto as Exhibit 127 is a true and correct copy of the website titled
`
`“FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast
`
`Cancers,” available at www.roche.com/media/releases/med-cor-2019-02-28.htm.
`
`126. Attached hereto as Exhibit 128 is a true and correct copy of the website titled
`
`“Biologics License Application Approval: Kanjinti,” available at
`
`https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761073Orig1s000ltr.pdf.
`
`127. Attached hereto as Exhibit 129 is a true and correct copy of the website titled
`
`“Amgen And Allergan Present Phase 3 Data On Biosimilar Trastuzumab Candidate ABP 980 At
`
`The European Society For Medical Oncology 2017 Congress,” available at
`
`www.amgen.com/media/news-releases/2017/09/amgen-and-allergan-present-phase-3-data-on-
`
`biosimilar-trastuzumab-candidate-abp-980-at-the-european-society-for-medical-oncology-2017-
`
`congress/.
`
`128. Attached hereto as Exhibit 130 is a true and correct copy of the website titled
`
`“FDA Approves Genentech's Kadcyla (Ado-Trastuzumab Emtansine), the First Antibody-Drug
`
`Conjugate for Treating HER2-Positive Metastatic Breast Cancer,” available at
`
`https://www.gene.com/media/press-releases/14347/2013-02-22/fda-approves-genentechs-
`
`kadcyla-ado-tras.
`
`129. Attached hereto as Exhibit 131 is a true and correct copy of the document titled
`
`“Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer,” dated December
`
`5, 2018.
`
`130. Attached hereto as Exhibit 132 is a true and correct copy of the website titled
`
`“FDA Approves Genentech’s Kadcyla for Adjuvant Treatment of People with HER2-Positive
`
`Early Breast Cancer with Residual Invasive Disease after Neoadjuvant Treatment,” available at
`
`
`
`16
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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 17 of 30 PageID #: 23784
`
`https://www.gene.com/media/press-releases/14785/2019-05-03/fda-approves-genentechs-
`
`kadcyla-for-adju.
`
`131. Attached hereto as Exhibit 133 is a true and correct copy of the website titled
`
`“Finance Report - 2014,” available at https://www.roche.com/dam/jcr:392d8bee-11de-485c-
`
`a8e0-b3beba9957dc/en/fb14e.pdf.
`
`132. Attached hereto as Exhibit 134 is a true and correct copy of the website titled
`
`“Learn More about HER2+ Breast Cancer,” available at https://www.perjeta.com/patient/breast-
`
`cancer/about/HER2-positive-breast-cancer.html.
`
`133. Attached hereto as Exhibit 135 is a true and correct copy of the website titled
`
`“FDA Approves Perjeta (Pertuzumab) for People with HER2-Positive Metastatic Breast
`
`Cancer,” available at https://www.gene.com/media/press-releases/14007/2012-06-08/fda-
`
`approves-perjeta-pertuzumab-for-peop.
`
`134. Attached hereto as Exhibit 136 is a true and correct copy of the website titled
`
`“FDA Grants Genentech’s Perjeta Accelerated Approval for Use before Surgery in People with
`
`HER2-Positive Early Stage Breast Cancer,” available at https://www.gene.com/media/press-
`
`releases/14548/2013-09-30/fda-grants-genentechs-perjeta-accelerate.
`
`135. Attached hereto as Exhibit 137 is a true and correct copy of the website titled
`
`“FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of
`
`Early Breast Cancer,” available at https://www.gene.com/media/press-releases/14703/2017-12-
`
`20/fda-approves-genentechs-perjeta-pertuzum.
`
`136. Attached hereto as Exhibit 138 is a true and correct copy of the document titled
`
`“Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer,” dated July 13,
`
`2017.
`
`
`
`17
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`

`

`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 18 of 30 PageID #: 23785
`
`137. Attached hereto as Exhibit 139 is a true and correct copy of the document titled
`
`“Finance Report - 2013,” available at https://www.roche.com/dam/jcr:17d47300-2921-45bd-
`
`bf9c-89a94b3562b6/en/fb13e.pdf.
`
`138. Attached hereto as Exhibit 140 is a true and correct copy of an excerpted version
`
`of the Biddle Deposition Transcript.
`
`139. Attached hereto as Exhibit 141 is a true and correct copy of the website titled
`
`“FDA approves new formulation of Herceptin for subcutaneous use,” available at
`
`https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-formulation-
`
`herceptin-subcutaneous-use.
`
`140. Attached hereto as Exhibit 142 is a true and correct copy of the document titled
`
`“Patients’ Preferences for Subcutaneous Trastuzumab Versus Conventional Intravenous Infusion
`
`for the Adjuvant Treatment of HER2-positive Early Breast Cancer: Final Analysis of 488
`
`Patients in the International, Randomized, Two-cohort PrefHer Study,” dated October 2014.
`
`141. Attached hereto as Exhibit 143 is a true and correct copy of the website titled
`
`“2018 Results,” available at www.roche.com/dam/jcr:0314a05b-369f-4941-8660-
`
`5c0a7688aab5/en/irp190131.pdf.
`
`142. Attached hereto as Exhibit 144 is a true and correct copy of the website titled
`
`“Implementation of the Biologics Price Competition and Innovation Act of 2009,” available at
`
`https://www.fda.gov/drugs/guidance-compliance-regulatory-information/implementation-
`
`biologics-price-competition-and-innovation-act-2009.
`
`143. Attached hereto as Exhibit 145 is a true and correct copy of the website titled
`
`“Biologics License Application Approval: Granix,” available
`
`at www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125294Orig1s000ltr.pdf.
`
`
`
`18
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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 19 of 30 PageID #: 23786
`
`144. Attached hereto as Exhibit 146 is a true and correct copy of the document titled
`
`Granix [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc., dated March 2019.
`
`145. Attached hereto as Exhibit 147 is a true and correct copy of the document titled
`
`Neupogen [package insert]. Thousand Oaks, CA: Amgen, Inc., dated June 2018.
`
`146. Attached hereto as Exhibit 148 is a true and correct copy of the website titled
`
`Chen, Ying, et al., “Five things to know about biosimilars right now,” available at
`
`www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/five-things-
`
`to-know-about-biosimilars-right-now.
`
`147. Attached hereto as Exhibit 149 is a true and correct copy of an excerpted version
`
`of the document titled
`
`
`
`, dated May 21, 2018.
`
`148. Attached hereto as Exhibit 150 is a true and correct copy of the document titled
`
`“Biosimilar Cost Savings in the United States,” dated March 30, 2018.
`
`149. Attached hereto as Exhibit 151 is a true and correct copy of the document titled
`
`“OHE Briefing: The Market for Biosimilars: Evolution and Policy Options,” dated October
`
`2008.
`
`150. Attached hereto as Exhibit 152 is a true and correct copy of an excerpted version
`
`of the document titled
`
` This exhibit is marked Confidential.
`
`151. Attached hereto as Exhibit 153 is a true and correct copy of an excerpted version
`
`of the website titled “2018 Letter to Shareholders,” available at
`
`http://investors.amgen.com/static-files/e3bd5ffc-957d-4dac-a8b4-5ed9a9a34e94.
`
`
`
`19
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`Case 1:18-cv-00924-CFC Document 312 Filed 07/19/19 Page 20 of 30 PageID #: 23787
`
`152. Attached hereto as Exhibit 154 is a true and correct copy of an excerpted version
`
`of the document titled Glasgow Deposition Transcript. This exhibit is marked Confidential.
`
`153. Attached hereto as Exhibit 155 is a true and correct copy of the website titled
`
`“FDA approves Lonsurf for recurrent, metastatic gastric and gastroesophageal junction
`
`adenocarcinoma,” available at https://www.fda.gov/drugs/drug-approvals-and-databases/fda-
`
`approves-lonsurf-recurrent-metastatic-gastric-and-gastroesophageal-junction-adenocarcinoma.
`
`154. Attached hereto as Exhibit 156 is a true and correct copy of the document titled
`
`"Loss Aversion in Riskless Choice: A Reference -Dependent Model,” dated 1991.
`
`155. Attached hereto as Exhibit 157 is a true and correct copy of the document titled
`
`"Misbehaving: The Making of Behavioral Economics," dated 2015.
`
`156. Attached hereto as Exhibit 158 is a true and correct copy of an excerpted version
`
`of the document titled
`
`
`
` This exhibit is marked Confidential.
`
`157. Attached hereto as Exhibit 159 is a true and correct copy of the document titled
`
`“Size and Dynamics of Order-of-Entry Effects in Pharmaceutical Markets,” dated 2018.
`
`158. Attached hereto as Exhibit

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