UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS CORP.
`
`Patent Owner
`
`Patent No. 9,358,240
`
`Issue Date: June 7, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`
`Inter Parles Review No. 2017-01621
`
`
`DECLARATION OF AARON TRIPPE
`
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01621
`
`UNITED THERAPEUTICS, EX. 2106
`
`Page 1 of 19
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS CORP.
`
`Patent Owner
`
`Patent No. 9,358,240
`
`Issue Date: June 7, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`
`Inter Parles Review No. 2017-01621
`
`
`DECLARATION OF AARON TRIPPE
`
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01621
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`UNITED THERAPEUTICS, EX. 2106
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`Page 1 of 19
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`IPR2017—01621
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`Declaration of Aaron Trippe
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`I, Aaron Trippe, hereby declare as follows:
`
`1.
`
`I graduated with an AB. in Computer Science and a certificate in
`
`Neuroscience from Princeton University in 2012. Upon graduation I was elected as
`
`a member of Sigma Xi, the Scientific Research Society. While attending Princeton,
`
`I worked in the lab of Dr. Naomi Leonard developing a multi-camera motion
`
`tracking system and conducted research on artificial neural networks under Dr.
`
`Ken Norman. From 2012 to 2015, I was employed by Elysium Digital, LLC, a
`
`technical litigation consulting company specializing in providing computer science
`
`and electrical engineering expertise in legal disputes involving intellectual
`
`property, computer forensics, and other high—tech subject matter. In 2015, Elysium
`
`Digital was acquired by the risk management company Stroz Friedberg, LLC. 1 am
`
`currently employed as a Manager in the Intellectual Property division of Stroz
`
`Friedberg, LLC. During my time at Elysium Digital and Stroz Friedberg, I have
`
`worked on over 100 technical matters involving computer forensics, computer
`
`networks, mobile applications, microprocessor technology, and other diverse fields
`
`within computer science- My CV and Biography are provided as Ex. 2107-
`
`2.
`
`I am a paid consultant for United Therapeutics Corporation (“United
`
`Therapeutics”), the assignee of US. Patent No. 9,358,240 (“the “240 patent”), in
`
`connection with IPR2017—01621. My compensation does not depend on the
`
`content of my opinions or the disposition of this proceeding.
`
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`3.
`
`At the request of United Therapeutics, 1 reviewed various archived
`
`Internet web pages available through the Wayback Machine, a tool provided by the
`
`Internet Archive. The statements in this declaration are made based on my review
`
`of those archived pages, my training and experience, and other materials I
`
`reviewed in connection with this matter. Specifically, I reviewed the Ex. 1014
`
`(“Butler Affidavit”), Ex. 1009 (“Ventavis label”), Ex. 1042 (“Commission
`
`Decision”), Ex. 1043 (“EU Community Register”), Ex. 1044 (“Summary of
`
`Decisions”), Ex. 1051 (“European Commission — Homepage”), Ex. 1053
`
`(“European Commission Exhibit”), and paragraphs 99 and 100 of Ex. 1002
`
`(“Donovan Declaration”), all submitted in this matter by Watson Laboratories, Inc.
`
`(“Watson”). In addition, I reviewed public materials on the lntemet Archive (such
`
`as the Internet Archive FAQ page at http://archive.org/about/fagsphp), Alexa
`
`Internet, and other relevant topics-
`
`I. BACKGROUND: CRAWLING, INDEXING, AND SEARCH
`
`4.
`
`The following paragraphs regarding crawling, indexing, and searching
`
`on the intemet are applicable to the 2002-2006 timeframe, which I am advised is
`
`the relevant timeframe for the documents and webpages Watson has identified for
`
`this proceeding, even though some information may be presented in the present
`
`tense.
`
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`5.
`
`The Internet consists of a vast amount of unstructured data- Unlike a
`
`library, where documents are centrally sorted and indexed to facilitate searching,
`
`web pages are hosted by a wide variety of third parties and there is no universal
`
`way of organizing them. Search engines, such as Google, have attempted to solve
`
`this problem by locating Internet content and structuring it to allow for retrieval in
`
`response to user queries. Since at least the early 20005, keyword search engines
`
`have been one of the main ways users locate information on the Internet, so much
`
`so that the verb “Google” has entered the English lexicon.
`
`6.
`
`At a high level, most keyword search engines use a crawler-indexer
`
`architecture. A web crawler navigates from website to website by following
`
`hyperlinks, a process called crawling or spidering. It feeds information (e.g. textual
`
`content) about each identified site to an indexer, which builds an index. The index
`
`is an organized representation of the crawled content (or a subset of the crawled
`
`content) that facilitates fast identification of websites for keyword queries. Search
`
`engines also employ ranking algorithms, which rank the responses to a query based
`
`on various indicators, such as number of keyword hits, indicators of website
`
`popularity (such as the number of incoming links), word relevance rankings, etc.
`
`7.
`
`Web crawlers can be operated independently of indexers, and thus
`
`used for other purposes than user-facing search engines. One example of this is the
`
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`crawler operated by the Internet Archive’s Wayback Machine, which uses it for
`
`locating and saving website content in order to create an archive of websites as
`
`they existed at a particular point in time. Alexa Internet operated a crawler starting
`
`in the 1990s that performed a similar function as the Wayback Machine crawler,
`
`and in some instances the information archived by Alexa lntemet is provided to the
`
`Internet Archive for storage in its archive of website content.‘ 2 The archiving of a
`
`web page does not require or imply the indexing of a page for search by a search
`
`engine. Archived pages can simply be maintained in connection with a given URL
`
`and any relevant metadata, such as the date the page was archived, such as in the
`
`case of the Wayback Machine of the Internet Archive. As a result, while words or
`
`phrases may be present throughout a website that has been crawled by the Internet
`
`Archive or Alexa Internet, that does not mean such words or phrases are searchable
`
`1 Ex. 21 18 is a true and correct copy of Kalev Leetaru, “The Internet Archive
`
`Turns 20: A Behind The Scenes Look At Archiving The Web,” retrieved from
`
`https://www.forbes.com/Sites/kalevleetaru/ZO1 6/01/1 8/the-internet-archive-tums-
`
`20-a-behind-the-scenes-look-at-archiving-the—web/#l a67d0f082e0, accessed on
`
`June 19. 2018.
`
`2 Ex. 2119 is a true and correct copy of the webpage “Alexa Crawls,” retrieved
`
`from htmszflarchiveorg/details/alexacrawls, accessed on June 19, 2018.
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`through any public, contemporary search engine as related to the website or even
`
`that links on the parent website would lead a person to individual archived content.
`
`The result is that the website and any of its individual webpages would not
`
`necessarily be searchable and thus identifiable using a public, contemporary search
`
`engine.
`
`8.
`
`Furthermore, while a given party might operate several crawling
`
`programs in parallel to speed up their collection of information, web crawlers from
`
`different parties typically operate independently of each other. The set of web
`
`pages crawled and indexed by search provider A typically differs from the set
`
`crawled and indexed by search provider B (though the sets may overlap). This also
`
`means that pages may be crawled by third parties such as the lntemet Archive or
`
`Alexa Internet, yet still not crawled or indexed by one or more search providers
`
`and thus not readily available through a keyword search.
`
`[1.
`
`REVIEW OF ARCHIVED PAGES
`
`a.
`
`OptiNeb-ir Manual
`
`9.
`
`I was asked to navigate to the URL
`
`
`https://web.archive.org/web/200407 l 81 12852/http ://www.nebu-
`
`tec.de:80/PDF/GA B depdf and provide my opinion regarding the manner in
`
`which it was archived.
`
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`10.
`
`After navigating to said URL, I then clicked “About this capture” in
`
`the lower right-hand corner of the top bar. This displays information about the
`
`archived page, including which organization captured it, the collection to which it
`
`belongs, and the timestamps of any sub—resources (such as external images or
`
`scripts). I noted that the organization that captured the page is called “Alexa
`
`Crawls,” and the crawl is in the collection “Alexa Crawl DX.” The descriptions
`
`underneath the organization and collection indicate both “Alexa Crawls” and
`
`“Alexa Crawl DX” are connected to Alexa Internet, and that Alexa Internet
`
`donates their crawl data to the Internet Archive. An image of the “About this
`
`capture” information for this particular .pdf is provided in Ex. 2120.3
`
`b.
`
`European Community Register website
`
`11.
`
`I was asked to navigate to a series of identified URLs on the
`
`“ec.europa.eu” domain and provide my opinion regarding the earliest available
`
`archived version of those websites through the Internet Archive’s Wayback
`
`Machine.
`
`3 Ex. 2120 is a true and correct copy of the “About this capture” information for
`
`
`the .pdf located at https://web.archiveorg/web/200407l8l 12852/http://www.nebu-
`
`tec.de:80/PDF/GA B depdf.
`
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`12.
`
`I navigated to the Internet Archive’s Wayback Machine, which is
`
`available at the URL https://web.archive.org. I entered the URL
`
`http://ec.europaeu/health/documents/community-register/ into the search bar,
`
`which resulted in a display of the dates of all archived versions of this page
`
`available through the Wayback Machine.4 According to the results page, the
`
`earliest available archived version of the web site at this URL is dated October 12,
`
`2013.5
`
`13.
`
`I then entered the URL
`
`http:l/ec.europa.eu/health/documents/communifl-register/html/h255.htm into the
`
`Wayback Machine. According to the results page, the earliest available archived
`
`4 Ex. 2121 is a true and correct copy of the webpage at
`
`https://web.archive_org[web/20130801000000*/http://ec.europa.eu/health/documen
`
`ts/community-registerl.
`
`5 Ex. 2122 is a true and correct copy of the webpage at
`
`
`https://web.archive.org/web/20l31012l4092S/http://ec.europa.eu/health/document
`
`s/community-registerI.
`
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`version is dated August 18, 2010.6 l I navigated to the earliest archived version of
`
`this page, which lists a procedure with the EMEA number EMEA/H/C/474/Il/5
`
`and a “close date procedure” of 8/09/2005. For this procedure, I attempted to locate
`
`the associated documents via the “summary publ,” “decision docs,” and “annex”
`
`dropdown menus.
`
`14.
`
`I noted that upon selection of each “summary publ” language option, a
`
`popup window appeared indicating the request could not be processed.8 I then
`
`entered the URL of each popup window into the Wayback Machine that resulted
`
`5 Ex. 2123 is a true and correct copy of the webpage at
`
`https://web.archive.0rg/web/20l00815000000*/http://ec.europa.eu/health/d0cumen
`
`ts/community-register/html/h255.htm.
`
`7 Ex. 2124 is a true and correct copy of the webpage at
`
`https://web.archive.0rg/web/20l 0081 81 8143 5/http://ec.europa.eu/health/document
`
`s/community—register/html/h255.htm.
`
`8 Ex. 2125 is a true and correct copy of the popup window resulting from the
`
`selection of the “EN” option in the “summary publ” menu
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`from each selected language option. None of the URLs had available archived
`
`-
`verswns.
`
`9
`
`15.
`
`Upon selection of each “decision docs” and “annex” option, a popup
`
`window appeared, attempting to show an archived version of the associated PDF
`
`file. I observed that for each language option, the URL for the PDF was always of
`
`the same format, namely the sub—URL
`
`http://ec.europa.eu/health/documents/community—register/2005/2005090510259/
`
`followed by the name of the PDF file (ag. dec_10259_en.pdf or
`
`anx_10259_en.pdf). I found that for each language option, the popup window
`
`indicated there was no available archived version of the associated PDF file. 10 I
`
`then checked whether any archived pages existed under aforementioned sub—URL
`
`by navigating to
`
`9 Ex. 2126 is a true and correct copy of the Wayback Machine results for the
`
`webpage at the popup window resulting from the selection of the “EN” option in
`
`the “summary publ” menu.
`
`1" Ex. 2127 is a true and correct copy of the popup window resulting from the
`
`selection of the “EN” option in the “decision docs” menu, and a true and correct
`
`copy of the popup window resulting from selection of the “EN” option in the
`
`“annex” menu.
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`
`htt s://web.archive.or /web/*/htt
`://ec.euro a.eu/healfli/documents/communit —
`
`register/20050005090510259/*. N0 URLs were archived under this sub-URL.ll
`
`16.
`
`Finally, 1 navigated t0 the current hosted version of the page at the
`
`URL http://ec.europaeu/health/documents/community—register/html/h255.htm,
`
`which also lists a procedure with the EMEA number EMEA/H/C/474/11/5, a “close
`
`date procedure” of 8/09/2005, and three drop down menus (“summary publ,”
`
`“decision docs,” and “annex”) with different language options. 12 Upon selection,
`
`the “decision docs” and “annex” options (all languages) each open a new tab with
`
`a PDF file located under the sub-U RL
`
`http://ec.europa.eu/health/documents/community—register/2005/2005090510259/
`
`(the same sub—URL triggered by selection of the analogous menus in the archived
`
`” Ex. 2128 is a true and correct copy of the webpage at
`
`https : //web . archive . org/web/*/http : //ec .europa. eu/health/documents/commun ity—
`
`register/20050005090510259/*.
`
`12 Ex. 2129 is a true and correct copy of the webpage at
`
`http://eceuropa.eu/health/documents/community-register/html/h255.htm as
`
`accessed on June 29, 2018.
`
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`page version mentioned above in paragraph 15).13 Upon selection of each
`
`“summary publ” menu option (i.e., all languages), a new tab opened showing
`
`content from a different URL than that triggered by selection of the analogous
`
`menu option in the archived page (tie. the URLs of the popup windows discussed
`
`in paragraph 14).14 I entered each of the URLs triggered by selection of the
`
`“summary publ” menu options into the Wayback Machine and observed that none
`
`of them had available archived versions]5
`
`c.
`
`European Commission: Document Search Page
`
`17.
`
`I navigated to the Internet Archive’s Wayback Machine, which is
`
`available at the URL https://web.archive.org. I entered the URL
`
`https://ec.europa.eu/transparency/regdoc/index.cfm?fuseaction=home into the
`
`13 EX. 2130 is a true and correct copy of the new tab resulting from the selection of
`
`the “ENG” option in the “decision docs” menu and a true and correct copy of the
`
`new tab resulting from selection of the “ENG” option in the “annex” menu.
`
`1" Ex. 2131 is a true and correct copy of the new tab resulting from the selection of
`
`the “ENG” option in the “summary publ” menu.
`
`15 Ex. 2132 is a true and correct copy of the Wayback Machine results for the
`
`webpage at new tab resulting from the selection of the “ENG” option in the
`
`“summary publ” menu.
`
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`search bar, which resulted in a display of the dates of all archived versions of this
`
`page available through the Wayback Machine. According to the results page, the
`
`earliest available archived version of the web site at this URL is dated January 1,
`
`2014-1617
`
`18.
`
`1 then entered the top level domain of the web site
`
`(https://ec.europa.eu) into the Wayback Machine and navigated to the earliest
`
`archived version.18 I clicked “Welcome to the European Commission!”, which
`
`loaded an archived version of the European Commission’s English language main
`
`1“ Ex. 2133 is a true and correct copy of the webpage available at
`
`
`https://web.archive_org/web/201401 1 5000000 */https://ec.europa.eu/transparency/r
`
`egdoc/index.cfm?fuseaction=home.
`
`17 Ex. 2134 is a true and correct copy of the webpage available at
`
`htt s://web.archive_or7web/20140101160453/htt
`
`://ec.euro a.eu/trans arenc
`
`
`
`
`
`doc/index.cfm?fuseacti0n=home.
`
`18 Ex. 2135 is a true and correct copy of the webpage available at
`
`
`https://web.archiveorg/web/200605 l3232957/http://ec.europa.eu/ (dated May 13,
`
`2006)
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`page. 19 20 I clicked “Documents” in the Quick Links on the bottom right of the
`
`page.21 From here I clicked “Register of COM, SEC and C documents” which
`
`
`
`'9 Ex. 2136 is a true and correct copy of the webpage available at
`
`https://web.archive.0rg/web/200605 l 4064044/https://ec.europa.eu/index en.htm
`
`(dated May 14, 2006).
`
`20 In some cases, clicking on said link navigated to the URL
`
`https://web.archive.0rg/web/200605 l 3232957/https://index en.htm, which has not
`
`been archived. I was able to navigate to the archived version of the European
`
`Commission’s English language main page in these cases by entering
`
`https://ec.europa.eu/index en.htm into the Wayback Machine
`
`21 Ex. 2137 is a true and correct copy of the webpage available at
`
`
`https://web.archiveorg/web/ZOOéOé l 3 l 14419/http://europa.eu:80/documents/com
`
`m/index en.htm (dated June 13, 2006).
`
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`redirected me to a French language page.22 After selecting the option for English,23
`
`I observed that this was an archived version of the top level page for the European
`
`Commission document register, and that it is intended to provide access to COM,
`
`C, and SEC documents as well as “other categories such as the agendas and
`
`minutes of Commission meetings.” Based on the content, the page is an early
`
`version of the web page shown in the “European Commission — Homepage”
`
`exhibit (Exhibit 1051).
`
`19.
`
`I then clicked “Document Search-” This took me to an archive of the
`
`URL http://ec.europa.eu/comm/secretariat general/regdoc/recherche.cfm?CL=en.
`
`According to the top bar of Wayback Machine information, the earliest archived
`
`22 Ex. 2138 is a true and correct copy of the webpage available at
`
`https://web.archive_org[web/200606l 5094022/http://ec.europa.eu: 80/comm/secreta
`
`riat general/regdoc/registre.cfm (dated June 15, 2006).
`
`23 Ex. 2139 is a true and correct copy of the webpage available at
`
`
`https://web.archiveorg/web/200609201 1 1254/http://ec.europa.eu/comm/secretariat
`
`general/regdoc/registre.cfm?CL=en (dated September 20, 2006).
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`version of this page is dated June 15, 2006.24 The page provides an interface for
`
`searching documents.
`
`20.
`
`I entered “ventavis” in the “Word(s) in the title or subject” field and
`
`clicked search. This resulted in a page indicating the Wayback Machine did not
`
`have the resulting URL archived.25 I also reviewed the archived materials under the
`
`URL http://ec_europaeu:80/comm/secretariat general/regdoc/.26 In this set, there
`
`24 Ex. 2140 is a true and correct copy of the webpage located at
`
`
`https://web.archive_org/web/20060615 002523/http://ec.europa.eu/c-omrn/secretariat
`
`general/regdoc/recherche.cfm?CL=en.
`
`1‘ Ex. 2141 is a true and correct copy of the webpage located at
`
`
`htt s://web.archive_orrweb/20060615002523/htt
`://ec.euro a.eu:80/comrr1/secreta
`
`riat general/regdoc/liste.cfm?CL=en resulting from a search for “ventavis.”
`
`26 Ex. 2142 is a true and correct copy of the webpage located at
`
`
`https://web.archive.org/web/*/http://ec.europa.eu:80/comrn/secretariat_genera1/reg
`
`
`doc/*
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`was one item with the MIME type application/pdf, with a single archived version
`
`dated September 20, 2006, which is not Ex. 1009.27
`
`21.
`
`Finally, I selected each of the different language options from the
`
`menu in the top right of the document search page and, if any archived versions
`
`were available, observed the date of the earliest archived version as provided by
`
`the Internet Archive- I attempted to search “ventavis” from the earliest archived
`
`version and recorded the result. This information is shown in the table below.
`
`Lan
`
`Date of Earliest Archived
`a e C0de*
`Version
`gu g
`_ June 17 2006
`
`_JJune 15, 2006
`
`Result of Search
`
`27 Ex. 2143 is a true and correct copy of the .pdf located at
`
`https://web.archive_org/web/20060920103 705/http://ec.europa.eu/c-omrn/secretariat
`
`general/regdoc/rep/2/2006/EN/2-2006-73 7-EN-1-0Pdf
`
`35‘ Ex. 2144 is a true and correct copy of the webpage located at
`
`
`
`htt s://web.archive_orrweb/20060617112044/htt ://ec.euro a.eu:80/comm/secreta
`
`riat general/regdoc/recherche.cfm?CL=fr
`
`39 Ex. 2145 is a true and correct copy of the webpage located at
`
`https://web.archiveorg/web/200606 l 5002523/http://ec.europa.eu:80/comrn/secreta
`
`riat general/regdoc/liste.cfm?CL=en
`
`UNITED THERAPEUTICS, EX. 2106
`WATSON LABORATORIEyv. UNITED THERAPEUTICS, |PR2017-01621
`Page 17 of 19
`
`
`
`IPR2017-0162l
`
`Declaration of Aaron Trippe
`
`Lan
`
`Result of Search
`
`Date of Earliest Archived
`a e C0de*
`Version
`gu g
`
`N/A (not archived)
`N/A
`
`N/A (not archivem)
`N/A
`
`da
`August 27 2006
`Page not archived
`el
`N/A not archived
`N/A
`
`- N/A (redirects to different N/A
`
`ua;e
`
`N/A
`N/A not archived
`N/A
`_ N/A not archived
`N/A
`_ N/A not archived
`
`
`
`
`
`_ August 27 2006
`
`N/A not archived
`_ N/A not archived
`
`Page not archived
`
`N/A
`N/A
`
`_ N/A (not archived)
`
`N/A not archived
`_ N/A not archived
`N/A not archived
`
`N/A (not archived)
`
`N/A
`
`N/A
`N/A
`N/A
`
`N/A
`
`“‘ Ex. 2146 is a true and correct copy of the webpage located at
`
`
`htt s://web.archive_or7web/20060827110233/htt
`://ec.euro a.eu/comm/secretariat
`
`general/regdoc/recherche.cfm?CL=da
`
`3' Ex. 2147 is a true and correct copy of the webpage located at
`
`
`https://web.archiveorg/web/20060827l l2249/http://ec.europa.eu/comm/secretariat
`
`general/regdoc/recherche.cfm?CL=it
`
`UNITED THERAPEUTICS, EX. 2106
`WATSON LABORATORIEé8v. UNITED THERAPEUTICS, |PR2017-01621
`Page 18 of 19
`
`
`
`IPR2017-01621
`
`Declaration of Aaron Trippe
`
`Language Code*
`
`Date of Earliest Archived
`V .ersron
`
`Result of Search
`
`
`
`NA (not archived
`NA not archived
`
`* The URL for
`
`the listed page is
`
`the language code appended to
`
`http://ec.europa-eu:80/comm/secretariat_general/regdoc/recherche.cfm?CL=
`
`22.
`
`I hereby declare that all statements made herein of my knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and fiirther that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both
`
`under Section 1001 of Title 18 of the United States Code.
`
`Date: July 11,2018 W
`
`
`
`Aaron Trippe
`
`UNITED THERAPEUTICS, EX. 2106
`9
`WATSON LABORATORIEé v. UNITED THERAPEUTICS, |PR2017-01621
`Page 19 of 19
`
`
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