`ESTTA624336
`ESTTA Tracking number:
`08/29/2014
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`Petition for Cancellation
`
`Notice is hereby given that the following party requests to cancel indicated registration.
`Petitioner Information
`
`Name
`Entity
`Address
`
`BBK Holdings, LLC
`Limited Liability Company
`117 Kendrick Street Suite 600
`Needham, MA 02494
`UNITED STATES
`
`Citizenship
`
`Massachusetts
`
`Attorney informa-
`tion
`
`Sheri S. Mason
`Morse, Barnes-Brown & Pendleton, P.C>
`230 Third Avenue, 4th Floor CityPoint
`Waltham, MA 02451
`UNITED STATES
`ttab@mbbp.com, tdunn@mbbp.com, smason@mbbp.com Phone:781 622 5930
`Registration Subject to Cancellation
`
`Registration No
`Registrant
`
`4133304
`Epernicus, LLC
`35 Highland Circle, Suite 300
`Needham, MA 02494
`UNITED STATES
`Goods/Services Subject to Cancellation
`
`Registration date
`
`04/24/2012
`
`Class 042. First Use: 2011/04/01 First Use In Commerce: 2011/04/01
`All goods and services in the class are cancelled, namely: Computer services, namely, providing on-
`line communities for members of medicalresearch project teams to share information, collaborate,
`participate in discussions, receive information through emailand search for relevant content; Software
`as a service (SAAS) services, namely,hosting software for use by others for managing and exchan-
`ging medical information, content and documents; Providing a resource website featuring searchable
`databases and document libraries featuringinformation in the field of medical research in the field of
`clinical trials
`Class 044. First Use: 2011/04/01 First Use In Commerce: 2011/04/01
`All goods and services in the class are cancelled, namely: Providing a resource website featuring
`searchable databases and document libraries featuring information in the field of medicine
`
`Grounds for Cancellation
`
`Genericness
`
`Related Proceed-
`ings
`
`Trademark Act section 23
`
`TCN Technologies, LLC and BBK Holdings, LLC v. Epernicus, LLC, d/b/a Trial-
`Networks and DrugDev, Inc., Massachusetts District Court, Civil Action No.
`1:14-cv-12057-RBC
`
`Attachments
`
`Petition to Cancel - Generic (BBKHTM-ADV003) (M0679773).PDF(113574
`
`
`
`bytes )
`Part 1 (M0679786).PDF(670068 bytes )
`Part 2 (M0679787).PDF(1124698 bytes )
`Part 3 (M0679788).PDF(1366287 bytes )
`Part 4 (M0679789).PDF(3351609 bytes )
`Part 5 (M0679033).PDF(4933164 bytes )
`
`Certificate of Service
`
`The undersigned hereby certifies that a copy of this paper has been served upon all parties, at their address
`record by First Class Mail on this date.
`
`Signature
`Name
`Date
`
`/Sheri S. Mason/
`Sheri S. Mason
`08/29/2014
`
`
`
`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`____________________________________
`
`
`
`
`
`)
`TCN Technologies, LLC,
`
`
`)
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`
`)
`Petitioner,
`
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`)
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`)
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`v.
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`)
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`Epernicus, LLC
`)
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`
`
`)
`
`
`
`Registrant.
`____________________________________)
`
`
`In re Reg No.
`
`4,133,304
`
`
`
`Mark:
`
`Filing Date:
`
`Reg. Date:
`
`
`Cancellation No.:
`
`
`
`“TrialNetworks”
`
`January 18, 2011
`
`April 24, 2012
`
`_______________
`
`
`PETITION FOR CANCELLATION
`
`
`
`TCN Technologies, LLC (“Petitioner”) believes that it is damaged by the continued
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`registration of “TrialNetworks”, shown in U.S. Registration No. 4,133,304, (hereinafter
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`“Registration”), registered on April 24, 2012 by Epernicus, LLC, d/b/a “TrialNetworks”
`
`(“Registrant”). Petitioner hereby petitions to cancel the Registration pursuant to Section 14 of
`
`the Lanham Act, 15 U.S.C. §1064.
`
`As grounds for the cancellation of the Registration are as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`Petitioner is a limited liability company organized and existing under the laws of
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`the Commonwealth of Massachusetts, with a business address of 117 Kendrick Street Suite 600,
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`Needham, Massachusetts, 02494.
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`2.
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`On information and belief, Registrant is a limited liability company organized and
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`existing under the laws of Delaware and has a business address of 383 Elliot Street, Suite G,
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`Newton, Massachusetts, 02464.
`
`
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`{M0677433.1 }
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`1
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`3.
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`Petitioner’s mission is to accelerate time-to-market for new and improved
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`medicines and treatments by streamlining the clinical trial enrollment process through innovative
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`strategies, programs, and technologies.
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`4.
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`Petitioner is a well-known provider of various technologies and related services in
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`the field of clinical trials, including but not limited to TRIALCENTRALNET, a non-
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`downloadable web application for management of multiple elements of clinical research study
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`operations inclusive of patient recruitment and retention programs, tools, and processes; a web-
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`based software application for identifying, recruiting and managing the participation of patients
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`in clinical trials; and software as a service (SAAS) services featuring software for identifying,
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`recruiting and managing the participation of patients in clinical trials, managing and monitoring
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`activities and performance of various members of clinical study teams, and providing metrics
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`and reporting on each of these activities. Petitioner is a holding company and the sole owner of
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`TCN Technologies, LLC. Petitioner also is the parent company of BBK Worldwide, LLC, a full-
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`service marketing consultancy specializing in patient recruitment and engagement in the
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`biopharmaceutical and medical device industry. BBK Worldwide often incorporates
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`TRIALCENTRALNET software in its service offerings to its customers. BBK Worldwide was
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`founded in 1983 as BB&K Communications, Inc.Petitioner provides a clinical trial optimization
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`and management solution on its website, www.trialcentralnet.com.
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`5.
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`Petitioner has offered clinical trial goods and services in interstate commerce
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`since at least as early as 2003.
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`II.
`
`THE REGISTRATION
`
`
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`{M0677433.1 }
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`2
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`6.
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`On January 18, 2011, Registrant filed an application to register “TrialNetworks”
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`(as a standard character mark) on the Principal Register under Section 1(b) of the Lanham Act,
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`15 U.S.C. § 1051(a).
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`7.
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`On March 2, 2012, the Registrant amended its application to register
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`“TrialNetworks” on the Supplemental Register.
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`8.
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`On March 2, 2012, Registrant filed an Allegation of Use, alleging the date of first
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`use for “TrialNetworks” is April 1, 2011.
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`9.
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`On April 24, 2012, “TrialNetworks” was registered for use in connection with
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`“Computer services, namely, providing on-line communities for members of medical research
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`project teams to share information, collaborate, participate in discussions, receive information
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`through email and search for relevant content; Software as a service (SAAS) services, namely,
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`hosting software for use by others for managing and exchanging medical information, content
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`and documents; Providing a resource website featuring searchable databases and document
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`libraries featuring information in the field of medical research in the field of clinical trials” in
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`International Class 42 and “Providing a resource website featuring searchable databases and
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`document libraries featuring information in the field of medicine” in International Class 44 (the
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`“Services”), see Exhibit A.
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`III. TRIALNETWORKS IS GENERIC
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`10.
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`“Trial” is defined as “a tryout or experiment to test quality, value, or usefulness.”
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`In the medical industry, a “trial” is interpreted to mean “clinical trial,” see Exhibit B.
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`11.
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`Registrant’s Services are used “in the field of medical research in the field of
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`clinical trials” (emphasis added), see Exhibit C.
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`
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`{M0677433.1 }
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`3
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`12.
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` “Network” is defined as “a group of people or organizations that are closely
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`connected and that work with each other,” see Exhibit D.
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`13.
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`“Clinical trial network” (or “trial network”) is defined as a “formalized
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`consortium, collective, cooperative or collaborative research group established for the purpose of
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`facilitating the conduct of clinical trial research,” see Exhibit E.
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`14.
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`Defendant uses the term “trial networks” is used generically on Registrant’s
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`website, which is or has been made available by Registrant as an example of the clinical trial
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`networks functionality of its “Trial Network” services, see Exhibit F.
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`15.
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`In the medical industry, a “network” is a generic term for members of medical
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`research project teams, see Exhibit G.
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`16.
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`Registrant’s Services are for “members of medical research project teams” and
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`are used “for managing and exchanging medical information, content and documents,” see
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`Exhibit H.
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`17.
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`The terms “trial” and “network” are widely used in combination with each other
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`as a generic phrase for a group of medical researchers or other healthcare professionals in a
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`network intended to provide research for clinical trials, see Exhibit I.
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`18.
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`“Trial” and “network” are also widely used in combination with each other to
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`refer to research conducted in industries (including the technology industry) by a group of
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`researchers or other professionals, see Exhibit J.
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`19.
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`“TrialNetworks” combines the two generic terms “trial” and “network” into a
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`compound work, “TrialNetworks.”
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`
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`{M0677433.1 }
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`4
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`20.
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`Taken as a whole, “TrialNetworks” is a generic phrase for a group of medical
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`researchers or other professionals in a network proving research for clinical trials, or a “trial
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`network.”
`
`21.
`
`Registrant’s Services provide a network of medical researchers or other healthcare
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`professionals conducting clinical trial research the ability: (i) to share information, collaborate,
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`participate in discussions, receive information for a clinical trial for research purposes; (ii) to
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`manage and exchange information, content and documents; and (iii) to conduct research
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`information in the medical industry.
`
`22.
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`The term “trial networks” is generic in that the primary meaning of the term to the
`
`relevant public is the same as the name for a network of medical researchers or other healthcare
`
`professionals conducting clinical trial research.
`
`23.
`
`24.
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`“TrialNetworks” is generic for Registrant’s Services.
`
`Because “TrialNetworks” is generic, Petitioner is damaged by the continued
`
`registration of the “TrialNetworks.”
`
`WHEREFORE, Petitioner respectfully requests that this Petition to Cancel be sustained
`
`and the Registration be canceled.
`
`Respectfully submitted by:
`
`
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`TCN Technologies, LLC
`
`By its attorneys
`
`MORSE, BARNES-BROWN & PENDLETON,
`P.C.
`
`By:
`
`
`/s/ Sheri S. Mason___________________________
`Sheri S. Mason, Esq.
`
`{M0677433.1 }
`
`5
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`Date: August 29, 2014
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`Thomas Dunn, Esq.
`230 Third Avenue, 4th Floor
`Waltham, MA 02451
`Tel:
`(781) 622-5930
`Fax:
`(781) 622 5933
`Email: ttab@mbbp.com
`
`{M0677433.1 }
`
`6
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`CERTIFICATE OF SERVICE
`
`
`I, Sheri S. Mason, certify that a copy of the foregoing Petition to Cancel was served on:
`
`
`Robert D. Carroll, Esq.
`Goodwin Procter LLP
`Exchange Place, 53 State Street
`Boston, MA 02109
`
`by placing same with the U.S. Postal Service, Priority Mail, postage pre-paid, this 29th day of
`August, 2014.
`
`
`
`/s/ Sheri S. Mason_____________________
`Sheri S. Mason
`TCN Technologies, LLC
`
`{M0677433.1 }
`
`7
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`EXHIBIT A
`
`
`
`qgguitkb%Im'tetI £tatn2s< ilfiatent ant: fltrahemark ®ffice
`
`TRIALNETWORKS
`
`EPERNICUS, LLC (DELAWARE LIMITED LIABILITY COMPANY)
`35 HIGHLAND CIRCLE, SUITE 300
`NEEDHAM, MA 02494
`
`FOR: COMPUTER SERVICES, NAMELY, PROVIDING ON-LINE COMMITNITIES FOR
`MEMBERS OF MEDICAL RESEARCH PROJECT TEAMS TO SHARE INFORMATION,
`COLLABORATE, PARTICIPATE IN DISCUSSIONS, RECEIVE INFORMATION THROUGH
`EMAIL AND SEARCH FOR RELEVANT CONTENT; SOFTWARE AS A SERVICE (SAAS)
`SERVICES, NAMELY, HOSTING SOFTWARE FOR USE BY OTHERS FOR MANAGING
`AND EXCHANGING MEDICAL INFORMATION, CONTENT AND DOCUMENTS;
`PROVIDING A RESOURCE WEBSITE FEATURING SEARCHABLE DATABASES AND
`DOCUMENT LIBRARIES FEATURING INFORMATION IN THE FIELD OF MEDICAL RE-
`SEARCII IN THE FIELD OF CLINICAL TRIALS, IN CLASS 42 (US CLS. 100 AND 101),
`
`FIRST USE 4-I-2011; IN COMMERCE 4-I-2011.
`
`FOR: PROVIDING A RESOURCE WEBSITE FEATURING SEARCHABLE DATABASES AND
`DOCUMENT LIBRARIES FEATURING INFORMATION IN THE FIELD OF MEDICINE, IN
`CLASS 44 (US. CLS. IOOAND 101).
`
`FIRST USE 4-1-2011; IN COMMERCE 4-1-2011.
`
`THE MARK CONSISTS OF STANDARD CHARACTERS WITHOUT CLAIM TO ANY PAR-
`TICULAR FONT, STYLE, SIZE, OR COLOR.
`
`SER. NO. 85—220,267, FILED P.R I-18-201 I; AM, S.R 3-2-2012.
`
`MARIA-VICTORIA SUAREZ, EXAMINING ATTORNEY
`
`Reg. No. 4,133,304
`
`Registered Apr. 24, 2012
`
`Int. Cls.: 42 and 44
`
`SERVICE MARK
`
`SUPPLEMENTAL REGISTER
`
`
`
`))irecluruI'1Im United Slums Palcm und 'J‘uuIe1nurk ()IT1ue
`
`
`
`EXHIBIT B
`
`
`
`Trial — Definition and More from the Free Merriam-Webster Dictionary
`
`Page 2 of 3
`
`Synonyms
`cross, crucible, fire, gauntlet (also gantiet), ordeal,
`baptism of fire
`; more
`
`atrial arijecriive
`: relating to or used in a test that is done for a period of
`time to see if something is worth buying, using, etc,
`
`H11! iffietirrition of ‘l’R'iifi.i,,,
`
`1 : of, relating to, or used in a trial
`2 : made or done as a test or experiment
`
`3 : used or tried out in a test or experiment
`
`:2? See trial defined for English-language learners >>
`
`iixarrspleez of Wéifiafim
`
`trial use of the product
`
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`Medical tisefiniriryn C}? W121!/Si,
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`
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`usefulness—see CLINICAL 'l"R;AL
`2 : one of a number of repetitions of an experiment
`
`
`
`Q
`
`trial mean
`
`(Crmcise Eneyciopeciia)
`
`In law, a judicial examination of issues of fact or law for the
`purpose of determining the rights of the parties involved.
`Attorneys for the plaintiff and the defendant make opening
`statements to a judge or jury, then the attorney for the
`plaintiff makes his case by calling witnesses, whom the
`defense attorney may cross—examine. Unless the case is then
`dismissed for lack of sufficient evidence, the defense attorney
`next takes a turn calling witnesses, whom the plaintiff's
`attorney cross—exam|nes. Both sides make closing arguments.
`In a trial before a jury, the judge instructs the jury on the
`applicable laws, and the jury retires to reach a verdict, If the
`defendant is found guilty, the judge then hands down a
`sentence.
`
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`§§,13ritannica.com: Encyclopedia article about "trial"
`
`Browse
`
`http://wwwmerriarn-Webster.com/dictionary/trial
`
`8/27/2014
`
`
`
`EXHIBIT C
`
`
`
`étatnzz of amen,”
`r®xx'\t\ZIJIlléiniteh Qtatnzszé ilfiatent anti Ulrahemark ®ff1'z2
`
`TRIALNETWORKS
`
`EPERNTCUS, LLC (DELAWARE LIMITED LIABILITY COMPANY)
`35 HIGHLAND CIRCLE, SUITE 300
`NEEDHAM, MA 02494
`
`FOR: COMPUTER SERVICES, NAMELY, PROVIDING ON—I.INE COMMUNITIES FOR
`MEMBERS OF MEDICAL RESEARCH PROJECT TEAMS TO SHARE INFORMATION,
`COLLABORATE, PARTICIPATE IN DISCUSSIONS, RECEIVE INFORMATION THROUGH
`EMAIL AND SEARCH FOR RELEVANT CONTENT; SOFTWARE AS A SERVICE (SAAS)
`SERVICES, NAMELY, HOSTING SOFTWARE FOR USE BY OTHERS FOR MANAGING
`AND EXCHANGING MEDICAL INFORMATION, CONTENT AND DOCUMENTS;
`PROVIDING’ A RESOURCE WEBSITE FEATURING SEARCHABLE DATABASES AND
`DOCUMENT LIBRARIES FEATURING INFORMATIONOF MEDICAL RE-
`
`S__E_ARCII IN THE FIELD OF CLINICAL TRIALS, IN CLASS 42 (U.S. CLS. 100 AND 101).
`
`FIRST USE 4-1-2011; IN COMMERCE 4-1-2011.
`
`FOR: PROVIDING A RESOURCE WEBSITE FEATURING SEA RCIIABLE DATABASES AND
`DOCUMENT LIBRARIES FEATURING INFOR\/IATION IN THE FIELD OF MEDICINE, IN
`CLASS 44 (US. CLS. I00 AND 101).
`
`FIRST USE 4—I—20I I; IN COMMERCE 4-]-2011.
`
`THE MARK CONSISTS OF STANDARD CHARACTERS WITHOUT CLAIM TO ANY PAR-
`TICULAR FONT, STYLE, SIZE, OR COLOR.
`
`SER NO. 85-220,267, FILED P.R. 1-18-201 1;AM. S.R. 3-2-2012.
`
`MA RIA-VICTORIA SUA REZ, EXAMINING ATTORNEY
`
`Reg. No. 4,133,304
`
`Registered Apr. 24, 2012
`
`Int. Cls.: 42 and 44
`
`SERVICE MARK
`
`SUPPLEMENTAL REGISTER
`
`
`
`Director ofllw United Slants Palem and ’I‘m(IcmuI'k ()fTu:::
`
`
`
`EXHIBIT D
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`especially for business opportixnities or advice
`
`
`
`EXHIBIT E
`
`
`
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`I C-Qnsurner’ guide to
`V clinical trials
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`
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`Hume, » ‘wit? xi rm. n . e.,
`
`Find a clinical trial website
`
`Clinical trial sites, clinical s, clinical trial resource organisations and
`clisease/condition~speclfic s"'upp0rt groups
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`(illnicnl rrlal site «- r'lzel‘lnt>,d as a l’lC.lll--CI(}lTll'l’ll‘3l'Cl8l entlty leg a lrosplral or research Institute) that (;Oll(.'llJ(Ll§ clmlcal trial researclr or r,lrltlr.>,r whose
`a clmlcal trial ls ccmrlucrcd.
`
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`clolrrxrrd as armrganlstttron that l'Jf0\Ill,l(*,S rnfommtlnn, gtrldmlce, rtzscourclés or other SEl'VlC(l.S to the ptmllr.
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`related to umlrsrstancllng £3l'()éll{l(1l§I)8llllg an clrnlcal trial litfil-,‘al’(’ll.
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`s2:mcll‘rr.: Cli5€ElSl3. condition or set of rlisaases or conditions via advocacy, promotion or networlmg.
`
`Australian clinirral trials wetsslte external wellslte ellglbillty r‘equlrerrIen1‘s,
`Furtlrer mlormation on external webslres mclucled In the clinical malwelnsltes searclr.
`
`Search
`
`Dlseage orcczntlltlorrz
`<Any>
`
`or sort lily Organlsatlon name A--Z
`
`Keywords:
`01'
`
`
`5191115!
`
`ArB(:DEFCsH‘JKLMNC)PQR.S1_UV\NXYZ($hOWa.”)
`
`Addiction Neuroszcletntze Network Australia
`
`Aclrilttzlwrz l\3x2urosc,rerrlct=, hl2et'w<>rl< All$('l'zillél is at networl; of arlrlrction ¥l+‘,l.ll()$ClQllll$'[iS ézéllklbllsllétl to facllstare re;sea‘rcl*r collanoratlons
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`Alzheimer’s Australia Research Limited
`
`.x\lz.lw,srnm’s Atrsmtlra Research l..lrr\§te,<3 movlrles lrllorrrralion, supnort, tmrrrsallllrg, tralnlng and é?£lllC<'ll'll3l'l. at: well as national prnllrrv and
`advocacy, for people wlth dementla.
`
`
`ANZAC Research lnstltute
`
`ANZAC Research Institute undertakes and collaborates in basic, clinical and epidemiological research, with a particular focus on ageing.
`
`
`
`Applied Science & Nutrition (ASN)
`Arlpllaérl fZ>rle.llc.e 6; Nutrltlon (ASND is a l3rlsl>ae1r:~llas,<ad mnmarlv that movlrles mnsultmg ser'vrt.e5 to thra nutr‘acel1:l<:a| and rmrlplemenrzrry
`rnedlt‘lm.= mtlrrstry, and (,()lldlll,‘l‘.s <:llnrt:al trials 10 assess the el‘l’et'ti of natural ll€al1‘lllJlOl.ll.l('lS.
`
`
`
`Arthritis Australia
`
`Arthritis Australia is a support and advocacy organrlsatlon for people with arthritis, and both funds researtll projects and provides details of
`current research and clinical trials,
`
`
`
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`Asthma Foundation provides asthma inforrnatlon, etlucarlon, tralnlng and advocacy; prumotes asthma research; and provldes details on current
`research and trlals.
`
`
`
`
`
`EXHIBIT F
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`F-‘l1.L).. ln?ecticLIs Dieeatselimmunekagy , Texas A&%‘~/I Univeiséty
`(Coliego Statics», TX)
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`TX)
`B.f:‘.y E33cz1ogy1T»!rm-vasimw Piemts, University of 'I'rsxa5» ai Ausiin
`(Austin, TX)
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`Robb Akridge, PI1.D.
`
`
`
`EXHIBIT G
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`
`
`{HS establishes new network to perform clinical studies
`
`http://www.hhs.gov/news/press/20l4pres/O3/201403 l lb.html
`
`HHS.gov
`
`U.S. Department of Health & Human Services
`
`
`
`FOR IMMEDIATE RELEASE
`
`March 11, 2014
`
`HHS establishes new network tg Cal stud'es
`
`
`
`__,,...a.«»dfi"'-“"““"‘“’””
`
`ma
`
`Contact: HHS Press Office
`
`202~690—6343
`
`Network can prepare, conduct clinical studies for drugs to protect health in emergencies
`
`HHS today established a network of five clinical research Vowrggamnj_zati,ons that will design and
`conduct clinical studies"r’f§eded to develop medical countermem5§UF"€s
`— drugs, vaccines, and
`
`
`
`diagnostic tests that help protect health against bioterrorism, pandemic influenza, and other
`
`public health emergencies.
`
`The new clinical studies network will provide a full range of services required to plan, perform,
`
`monitor, and interpret clinical studies. The services include performing clinical studies that are
`
`required by the U.S. Food and Drug Administration for the approval of a product for human use,
`comparing the properties of multiple products, or evaluating the potency of products stored in
`
`U.S. government stockpiles.
`
`If needed, the network will also be able to supplement National Institute of Health capabilities
`by conducting clinical studies during public health emergencies such as a pandemic. This
`capability will enhance the nation's science preparedness by ensuring that clinical studies that
`address critical research questions for emergency response and recovery can be performed in a
`
`timely manner.
`
`“Recent disasters, such as Hurricane Sandy, the Deepwater Horizon oil spill, the 2009-H 1N1
`pandemic, underscored the importance of developing a capability to perform rigorous scientific
`
`studies in real time, potentially to shape the response to an unfolding crisis and to support
`recovery,” explained Robin Robinson, Ph.D., director of the Biomedical Advanced Research and
`Development Authority (BARDA). BARDA is part of the HHS Office of the Assistant Secretary for
`
`Preparedness and Response and will manage the clinical studies network.
`
`In an emergency, the BARDA clinical studies network may use local institutional review boards
`or the national Public Health Emergency Research Review Board, a central institutional review
`
`board administered by the National Institutes of Health to review multi—site research studies on
`
`health problems arising in the context of a public health emergency. Both types of boards assure
`
`that appropriate steps are taken to protect the rights and welfare of people participating as
`_ .9.
`ELL
`(fl
`n tne research.
`subL.-
`
`The clinical studies network will support BARDA=funded medical countermeasure developers and
`
`conduct clinical studies on behalf of BARDA. The activities of BARDA’s clinical studies network
`
`lof3
`
`8/27/2014 1:50 PM
`
`
`
`'-[HS establishes new network to perform clinical studies
`
`http://www.hhs.gov/news/press/2014pres/03/20140311b.html
`
`will be coordinated with those of HHS interagency and industry partners, including the National
`
`Institute of Allergy and Infectious Diseases (NIAID).
`
`ASPR awarded contracts to five U.S. companies that will make up the network's clinical studies.
`
`Today's contracts are with EMMES Corporation of Rockville, Md.; PPD Development LLC of
`
`Wilmington, N.C.; Technical Resources International Inc. of Bethesda, Md.; Clinical Research
`
`Management, Inc. of Hinckley, Ohio, and Rho Federal Systems Division Inc. of Chapel Hill, N.C.
`
`M Each contract includes a minimum guarantee of $400,000 over the initial two years for access to
`the clinical research organization's services. Each contract can be extended for up to a total of
`
`five years and a maximum of a $100 million. Clinical studies will be performed through the
`
`network based on proposals provided by the network members in response to specific BARDA
`
`requests.
`
`The new clinical studies network expands the core service assistance programs through BARDA
`
`to aid medical countermeasure development. In addition to the clinical studies network, BARDA
`
`oversees a nonclinical development network, Centers of Innovation in Advanced Development
`
`and Manufacturing (CIADM§), and a fill finish manufacturing network.
`
`The nonclinical development network supports preclinical testing of medical countermeasures
`
`while the CIADMS provide an array of manufacturing services and influenza vaccine surge
`
`manufacturing capacity. The fill finish manufacturing network covers the final steps in the
`
`vaccine manufacturing process and supplements the filling capacity of current influenza vaccine
`manufacturers.
`
`BARDA provides a comprehensive integrated portfolio approach to the advanced research and
`
`development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics,
`
`diagnostic tools, and non—pharmaceutica| products for public health emergency threats. These
`
`threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic
`
`influenza, and emerging infectious diseases.
`
`ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of
`I
`um
`hstand adversity, strengthening health and
`
`emergencies, supporting communities’ ability to wit
`
`response systems, and enhancing national health security. To learn more about ASPR and
`
`preparedness, response and recovery from the health impacts of disasters, visit the HHS public
`
`health and medical emergency website, www.phe.gov.
`
`HHS is the principal federal agency for protecting the health of all Americans and providing
`
`essential human services, especially for those who are least able to help themselves. To learn
`
`more about HHS, visit www.hhs.gov.
`
`###
`
`Note: All HHS press releases, fact sheets and other news materials are available at
`
`’.of3
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`8/27/2014 1:50 PM
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`
`
`Jung-MAP Launches: First Precision Medicine Trial From National C...
`
`http://www.cancer.gov/newscenter/newsfromnci/2014/LungMAPlaunch
`
`News
`
`Contact the NCI Office of Media Relations | RSS Feed
`
`In English
`Posted: 06/16/2014
`
`NCI Press Release
`
`Lung—MAP Launches: First Precision Medicine Trial From
`National Clinical Trials Network
`
`
`
`A abQLat flg .
`WWW“
`.
`.
`..-. cr nstitute V,
`.
` rt e Natiopal
`Institutes of Health, SWOCG Cancer Research, Friends of Cancer Research, the Foundation_fiQ_;_the
`National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentbe_g_h,,,Efi_ger,
`,..,....,._............,v
`'5 AstraZeneca, and AstraZeneca’s global biologics R&D arm, Medlmmune), and Foundati0nW1\”/lflegoicine
`today announced the initiation of the Lung Cancer Master l’_f5to"dolm(Lung—MAP) trial.
`......—-we.-.....,._............._......««
`...u.a1_s...¢...M....=.
`
`
`
`I Lung—MAP is a multi—drug, mu1ti—arm, biomarl<er—driven clinical trial for patients with advanced
`squamous cell lung cancer. Squamous cell carcinoma represents about a quarter of all lung cancer
`diagnoses, but there are currently few treatment options beyond surgery for the disease. The trial will use
`genomic profiling to match patients to one of several different investigational treatments that are
`designed to target the genomic alterations found to be driving the growth of their cancer. This innovative
`approach to clinical testing should both improve access to promising drugs for patients and ease the
`significant recruitment and infrastructure burdens on researchers involved in traditional clinical trials.
`
`
`
`w__d______.........._...................__
` -mu
`—.........._l.__m...&w.
`“This diverse, collaborative approach, with s mdmg lun cancer advocac 0rg§.I.1,LZaIions,
` mWWmWfli.
`,
`t
`helps to ensure that he needs of patients, clinicians, developers, and regulators are all considered in the
`desi
`n
`of the trial,” said Dr. Ellen Sigal, Chair & Founder of Friends of Cancer Research.
`rm 2 d operatm
`
`The trial will initially test five experimental drugs——four targeted therapies and an anti—PD—L1
`imrnunotherapy. It is anticipated that between 500 and 1000 patients will be screened per year for over
`200 cancer—related genes for genomic alterations. The results of this test will be used to assign each
`patient to the trial arm that is best matched to their tumor’s genomic profile.
`
`
`dri tret .,
`@ “ ung—MAP re resentsthefirstofseveral plannedlarge, gen0micay—
`con am1mangmNmN), sid Jeff Abrams, M.D.,
`Xssbciate Director of NCI’s Cancer Therapy Evaluation Program. “The restructuring and consolidation of
`NCI’s large trial treatment program, resulting in the formation of the NCI“N, is quite timely, as it now can
`offer an ideal platform for bringing the benefits of more precise molecular diagnostics to cancer patients
`
`
`
`in communities large and small.”
`
`"Squamous cell lung cancer, like many other neoplasms, is increasingly recognized as consisting of a
`of relatively rare genomic subsets, each of which may require treatment with a different targeted drug,
`
`-st
`
`1 of2
`
`8/27/20l4 1:50 PM
`
`
`
`iung—MAP Launches: First Precision Medicine Trial From National C...
`
`http://wwwcancer. gov/newscenter/newsfromnci/2014/LungMAP1aunch
`
`said Dr. Charles Blanke, Chair of SWOG Cancer Research. “The Lung—MAP S1400 trial models a way to
`efficiently study a large number of these rare squamous cell subsets under one master protocol."
`
`Lung—MAP aims to establish a model of clinical testing that more effici