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`www jirchivf.org
`415.561.6767
`415.S40-0391 r fax
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`IntcmcJ Atchivi-
`300 Funston Avcrnu-
`San FranaKO.CA 'Ml 18
`
`AFFIDAVIT OF CHRISTOPHER BUTLER
`
`!. 1 am the Office Manager at the Internet Archive, located in San Francisco.
`California, I make this declaration of my own personal knowledge.
`2. The Internet Archive is a website that provides access to a digital library of
`Internet sites and other cultural artifacts in digital form. Like a paper library. we provide
`free access to researchers, historians, scholars, and the general public. I he Internet
`Archive has pannered wit h and receives support from various institutions, including the
`Library of Congress.
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to surf more than 450 billion pages stored in the
`Internet Archive's web archive. Visitors to the Wayback Machine can search archives
`by URL (i.e.. a website address), if archived records for a URL are available, the visitor
`will be presented with a list of available dates. The visitor may select one of those
`dates, and then begin surfing on an archived version of the Web. The links on the
`archived files, when served by the Wayback Machine, point to other archived files
`(whether HTML pages or images). If a visitor clicks on a link on an archived page, the
`Wayback Machine will serve the archived file with the closest available date to the page
`upon which the link appeared and was clicked.
`4. The archived data made viewable and browseable by the Wayback Machine is
`compiled using software programs known as crawlers, which surf the Web and
`automatically store copies of web files, preserv ing these files as they exist at the point of
`lime of capture.
`5. The Internet Archive assigns a URL on its site to the archived flies in the format
`hllp://web.archive.org/web/|Year in yyyy||Monih in mml[Day in dd||Time code in
`hh:mm:ssl/[Archived URL). Thus, the Internet Archive URL
`http://web.archlve.Org/web/l9970l26045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http;//www.archive.org/) archived on January 26. 1997 at 4:58 a.m. and 28 seconds
`(1997/01/26 at 04:58:28), A web browser may be set such that a printout from it will
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`Likewise, if a website is designed with "frames." the dale assigned by the Intemel
`Archive applies to the frameset as a whole, and not the individual pages within each
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`6. Attached hereto as Exhibit A are true and accurate copies of printouts of the
`Internet Archive's records of the HTML files for the URLs and the dates specified in the
`footer of lhe printout.
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`DATE:
`
`L/juJlk
`
`1
`
`Christopher Butler
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`00001
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`MYLAN - EXHIBIT 1026
`
`

`
`CALIFORNIA JURAT
`
`See Anached Document.
`
`Stale of California
`County of San Francisco
`
`A notary public or other officer completing this
`certificate verifies only the identity of the
`individual who signed ihe document to which this
`certificate is alached. and not ihe truthfulness,
`accuracy, or validity of that document.
`
`Subscribed and sworn to (or affirmed) before me on
`this
`
`2&_f±da> of- ) a n
`
`X,
`
`- t o i u . by
`
`Christopher Butler.
`
`proved to me on the basis of satisfactory evidence to be
`the person who appeared before mc.
`
`Signature:
`
`L
`imOK^OUG
`Commission # 2086421 |
`Mouiy PuWic • C»iiiorroa
`z
`Sin francisco County
`s
`Coffirn.
`
`i
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`00002
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`

`
`Exhibit A
`Exhibit A
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`00003
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`00003
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`

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`XRP6258 Plus Prednisone Compared 10 Miloxanirone Plus Prcdni...
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`I of 3
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`ClinicalTnals.gov
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`A Mono* of tf* U S
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`tnaUMM ol
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`Full Text View
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`Tabular Ytg» ^ Contacts and Locations
`
`Home Search Study Topics Gloetary
`
`Search
`
`Related Studies
`
`XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone
`Refractory Metastatic Prostate Cancer (TROPIC)
`
`This study Is currently recruiting participants.
`Verified by Sanoti-Aventis. August 2008
`
`Sponsored by: Sanofi-Aventis
`
`Information provided by:
`
`Sanoll-Aventis
`
`CllnlcalTrlals.gov Identifier:
`
`NCT00417079
`
`• Purpose
`
`I his is a randomized, open-label, multi-contor study comparing the safety and efficacy of XRP6258 plus prednisone to
`mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a
`Taxotere-containing regimen, The primary objective is overall survival Secondary objectives Include progression free
`survival overall response rate prostate-specific antigen (PSA) response/progression, pain response/progression, overall
`safety and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a
`maximum of 10 cycles Patients will have long-term follow-up for a maximum of up to 2 years
`
`Condition
`
`Neoplasms
`Prostatic Neoplasms
`
`Intervention
`
`Drug XRP6258 (RPR116258)
`Drug: mitoxantrone
`Drug prednisone
`
`Phase
`
`Phase III
`
`MeOhnePiUS related topics: Cancer Prostate Cancor
`
`: Doge^xpl Mitoxantrone hydrochloride MUpxpn^n^ Pr^ni^pne
`
`Study Type:
`Interventional
`Study Design: Treatment. Randomized. Open Label. Active Control, Parallel Assignment. Efficacy Study
`
`Official Title: A Randomized. Open Label Multi-Center Study of XRP6258 m Combination With Predmsooe Every 3
`Weeks Compared to Mitoxantrone m Combination With Prednisone For The Treatment of Hormone
`Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere'-Contaming Regimen
`
`Further study details as provided by Sanofi-Aventis:
`
`Primary Outcome Measures
`• overall survival defined as the time interval from the date of randomization to the date of death due
`to any cause. ( Time Frame: study period ) ( Designated as safety issue: No ]
`
`Secondary Outcome Measures
`• PSA levels {Time Frame at screening, day 1 of every treatment cycle end of study treatment, and
`m follow-up until documented progression j [ Designated as safety issue No)
`• Anti-tumor activity via Computerized Tomography / Magnetic Resonance Imaging (and bone scans,
`as indicated) [ Time Frame study period J [ Designated as safety issue No)
`• Pam via an analgesic consumption score and the Present Pain Index over a one-week period
`( T i m e F r a m e s t u d y p e r i o d ] ( D e s i g n a t e d a s s a f e t y i s s u e N o )
`• Adverse events: laboratory abnormalities vital signs [ Time Frame Study period ]
`
`hiips://\vcb.archivc.org/\vcb/20081023121613/hiip://clinicallrials.gov7ct2/show/NC I (KM 17079
`
`00004
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`

`
`XRP6258 Plus Prednisone Compared lo Miloxunirone Plus Predni...
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`2 of 3
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`[ Designated as safety issue. Yes ]
`
`720
`Estimated Enrollment
`December 200(3
`Study Start Date
`May 2010
`Estimated Study Completion Date:
`Estimated Primary Completion Date: May 2010 (Final data collection date lor pnmary outcome measure)
`
`Arms
`
`Arm A; Active Comparator
`
`Arm B: Experimental
`
`Anlgnad Intervention*
`
`Drug mitoxantrone
`administered Dy IV route
`Drug prednisone
`administered Dy oral route
`
`Drug XRP6258 (RPR116258)
`administered by IV route
`Drug prednisone
`administered by oral route
`
`> Eligibility
`
`18 Years and older
`Ages Eligible for Study
`Genders Eligible for Study Male
`Accepts Healthy Volunteers; No
`
`Criteria
`
`Inclusion Criteria
`1. Histologically or cytdogically confirmed adenocarcinoma of the prostate
`2 Documented progression of disease (Oemonsiraimg at least one visceral or soft tissue metasiatvc
`lesion, including a new lesion) Patients with non-measurabte disease must have documented
`nsmg PSA levels or appearance of new lesion
`3 Surgcai or hormooemduced castration
`4. Life expectancy > 2 months
`5 Eastern Cooperative Oncology Group (ECOG) performance status 0 • 2
`
`Exclusion crtena
`1 Previous treatment with mitoxantrone
`2 Poor radiotherapy lo a 40S o* bone marrow
`3 Surgery raOaton chemocherapy or other ant-cancer therapy wttfrr 4 weeks pnor to enroumem <r
`the study
`4 Other pnor malignancy except tor adequatety treated superficial basal eel skin cancer or any
`other cancer from which the patient has been Oisease-tree tor less than 5 years
`5 Known bram or leptomenngeal involvement
`6 Other concurrent senous illness or medical conditions
`7 Inadequate organ function evxJenced by unacceptable laboratory results
`
`The investigator will evaluate whether there are ocher reasons why a patient may not participate
`
`• Contacts and Locations
`
`refer to this study by US OmcalTnals gov identifier NCT00417079
`
`Contacts
`
`Contact Public Registry CD
`
`Sponsors and Collaborators
`
`hups
`
`\\cb archi\c.OTg/\vcb/2008102312161 .Vhtlp://clinicaltrials.gov7ct2/show/NCT()0417079
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`00005
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`
`XRP6258 Plus Prednisone Compared 10 Miioxanirone Plus Predni...
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`3 of 3
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`Sanofi-Aventis
`
`Investigators
`
`Study Director C D Sancrfi-Aveniis
`
`• More Information
`
`Rglatgfl Info "u
`
`Responsible Party;
`sanofi-aventis (ICD Study Director)
`Study ID Numbers
`EFC6193, XRP6258
`First Received
`December 281 2006
`Last Updated
`August 29. 2008
`ClimcalTrlals gov Identifier NCT00417079
`United Slates: Food and Drug Administration; United Kingdom Medicines and Healthcare
`Health Authority
`Products Regulatory Agency, Canada: Health Canada
`
`Keywords provided by Sanofi-Aventis:
`Cancer
`Prostate
`
`Study placed in the following toptc categories
`Docetaxel
`Prednisone
`Prostatic Diseases
`Genital Neoplasms. Male
`
`Urogenital Neoplasms
`Mitoxantrone
`Genital Diseases Male
`Prostatic Neoplasms
`
`Additional relevant MeSH terms:
`Anti-Inflammatory Agents
`Neoplasms
`Antineoplastic Agents, Hormonal
`Neoplasms by Site
`Antineoplastic Agents
`Sensory System Agents
`Physiological Effects of Drugs
`Therapeutic Uses
`Hormones. Hormone Substitutes and Hormone AntagomstsAnalgesics
`Glucocorticoids
`Peripheral Nervous System Agents
`Hormones
`Central Nervous System Agents
`Pharmacologic Actions
`
`ClimcalTnals gov processed this record on October 22. 2008
`
`u.s
`
`Lir*$ lo an Sludw - pinwly l y pawi^
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`hltps://ueb.archivc.org/weh/2()0X l023l216l3/htlp://clinicaltrials.gov/ci2/show/N(T004l7079
`
`00006