Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA1058468
`05/28/2020
`
`ESTTA Tracking number:
`
`Filing date:
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Notice of Opposition
`
`Notice is hereby given that the following party opposes registration of the indicated application.
`
`Opposer Information
`
`Name
`
`Entity
`
`Address
`
`Attorney informa-
`tion
`
`Gilead Sciences Ireland UC
`
`Unlimited Company
`
`Citizenship
`
`Ireland
`
`IDA Business & Technology Park
`CARRIGTOHILL, CO. CORK, 0
`IRELAND
`
`Jack Wessel
`333 Lakeside Drive
`Gilead Sciences, Inc.
`Foster City, CA 94404
`UNITED STATES
`trademarks@gilead.com, jack.wessel@gilead.com
`no phone number provided
`
`Applicant Information
`
`Application No
`
`88693644
`
`Publication date
`
`04/07/2020
`
`Opposition Filing
`Date
`
`Applicant
`
`05/28/2020
`
`Opposition Peri-
`od Ends
`
`05/07/2020
`
`Vital Legal Nurse Consulting
`11618 Highbury Way
`Tampa, FL 33626
`UNITED STATES
`
`Goods/Services Affected by Opposition
`
`Class 005. First Use: 2019/04/15 First Use In Commerce: 2019/04/15
`All goods and services in the class are opposed, namely: Dietary supplements
`
`Grounds for Opposition
`
`Priority and likelihood of confusion
`
`Trademark Act Section 2(d)
`
`No use of mark in commerce before application
`or amendment to allege use was filed
`
`Applicant not rightful owner of mark for identified
`goods or services
`
`Trademark Act Sections 1(a) and (c)
`
`Trademark Act Section 1
`
`Mark Cited by Opposer as Basis for Opposition
`
`U.S. Registration
`No.
`
`4797730
`
`Application Date
`
`01/20/2014
`
`Registration Date
`
`08/25/2015
`
`Foreign Priority
`
`11/01/2013
`
`

`

`Word Mark
`
`Design Mark
`
`GENVOYA
`
`Date
`
`Description of
`Mark
`
`Goods/Services
`
`NONE
`
`Class 005. First use: First Use: 0 First Use In Commerce: 0
`Pharmaceutical preparations for the prevention and treatment of hepatitis and
`HIV infection; antivirals; anti-inflammatories; antifungal preparations; pharma-
`ceutical preparations for use in the treatment of infectious diseases, liver dis-
`eases and disorders, respiratory diseases and disorders, oncological diseases
`and disorders, and cardiovascular diseases and disorders
`
`Attachments
`
`86170336#TMSN.png( bytes )
`ZENVOYA NUTRITION - Notice of Opposition.pdf(423293 bytes )
`ZENVOYA NUTRITION - Exhibits.pdf(974769 bytes )
`
`Signature
`
`Name
`
`Date
`
`/jack wessel/
`
`Jack Wessel
`
`05/28/2020
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Opposition No.
`
`) )
`
`) )
`
`) )
`
`) )
`
`) )
`
`In the matter of Application Ser. No. 88/693,644
`For the Trademark ZENVOYA NUTRITION
`
`Published in the Official Gazette on April 7, 2020
`
`GILEAD SCIENCES IRELAND UC,
`
`Opposer,
`
`V.
`
`VITAL LEGAL NURSE CONSULTING
`
`Applicant.
`
`NOTICE OF OPPOSITION
`
`Opposer Gilead Sciences Ireland UC (“Gilead” or “‘Opponent”), an Ireland unlimited
`
`company having its principal place ofbusiness at IDA Business and Technology Park, Carrigtohill,
`
`Co. Cork, Ireland, believes that it will be damaged by the issuance of a registration for the
`
`ZENVOYA NUTRITION mark (“Applicant’s Mark”), as represented in Application Serial No.
`
`88/693,644 (the “Subject Application”) filed on November 15, 2019 by Vital Nurse Consulting
`
`(“Applicant”), a Florida limited liability company having its address of record at 11618 Highbury
`
`Way, Tampa, Florida 33626. Pursuant to 15 U.S.C. § 1063, Gilead hereby opposes the registration
`
`of the Subject Application. As grounds for opposition, Gilead alleges the following.
`
`GILEAD AND THE GENVOYA MARK
`
`1.
`
`Gilead is the wholly owned subsidiary of Gilead Sciences, Inc., one of the world’s
`
`largest biopharmaceutical companies, dedicated to discovering, developing, and commercializing
`
`innovative therapeutics in areas of unmet medical need.
`
`

`

`NOTICE OF OPPOSITION
`
`APP. SER. No. 88/693,644
`
`2.
`
`On January 20, 2014, Gilead filed an application to register the mark GENVOYA
`
`covering the following goods in International Class 5: “Pharmaceutical preparations for the
`
`prevention and treatment of hepatitis and HIV infection; antivirals; anti-inflammatories;
`
`antifungal preparations; pharmaceutical preparations for use in the treatment of infectious
`
`diseases, liver diseases and disorders, respiratory diseases and disorders, oncological diseases
`
`and disorders, and cardiovascular diseases and disorders,” which was granted registration on
`
`August 25, 2015 (US. Reg. No. 4,797,730, the “GENVOYA Registration”). A true and correct
`
`copy of the Certificate of Registration for GENVOYA is set forth as Exhibit A.
`
`3.
`
`4.
`
`The GENVOYA mark is a coined word and inherently distinctive.
`
`On November 5, 2015 the US Food and Drug Administration (“FDA”) approved
`
`GENVOYA®, a 150/150/200/ 10 mg fixed-dose combination tablet of elvitegravir, cobicistat,
`
`emtricitabine and tenofovir alafenamide, for treatment of HIV-1 infection in specific populations
`
`of adults and pediatric patients 12 years of age or Older. A true and correct copy of the Approval
`
`Letter issued by the FDA to Gilead Sciences, Inc. is attached in Exhibit B.
`
`5.
`
`The GENVOYAtrademark has garnered substantial recognition in part due to the
`
`widespread sales of the product by Opposer and its related companies, totaling USD $3 .931 billion,
`
`$4.624 billion, and $3 .674 billion in 2019, 2018, and 2017, respectively across the world, including
`
`$2984 in 2019 in the United States
`
`APPLICANT AND THE SUBJECT APPLICATION
`
`6.
`
`On November 15, 2019, Applicant filed the Subject Application on an in—use basis,
`
`pursuant to Section 1(a) Of the Trademark Act,
`
`in connection with the following goods in
`
`International Class 5: “dietary supplements.”
`
`

`

`NOTICE OF OPPOSITION
`
`APP. SER. NO. 88/693,644
`
`7.
`
`The Subject Application was filed in the name of “Vital Legal Nurse Consulting, a
`
`limited liability company legally organized under the laws ofFlorida” (“Vital”) and the Subject
`
`Application was signed by a Mr. Todd Blackwell, CFO.
`
`8.
`
`At the time of filing the Subject Application, Vital was not a valid, existing legal
`
`entity with the Florida Division of Corporations. True and correct copies of the Division of
`
`Corporations search page and entity listing showing the company as inactive effective as of
`
`September 22, 2017 are attached in Exhibits C and D.
`
`9.
`
`Articles of Organization for the lapsed company, Vital,
`
`list only Elizabeth
`
`Blackwell, Mgr, as a “person(s) authorized to manage [the] LLC.” A true and correct copy of the
`
`Articles of Organization are attached in Exhibit E.
`
`10.
`
`Applicant submitted a specimen alleging use of the mark on www.2envoya.com
`
`(“Website”), purportedly on a website currently used in commerce, with a page header stating
`
`“Zenvoya Organic Nutraceuticals” and what appears to be a mockup of a carton and vial named
`
`“Zenvoya Nutrition BIOTIN” (“Package,” and as-filed “‘Specimen”).
`
`11.
`
`The Specimen of record contains an image of a vial and carton that appear
`
`completely flat and two dimensional, not of an image of a three dimensional good on which the
`
`Subject Mark is applied.
`
`12.
`
`On April 7, 2020, the PTO published the Subject Application in the Oflicial
`
`Gazette. Gilead timely requested and obtained an extension of time to Oppose the Subject
`
`Application on April 22, 2020.
`
`13.
`
`On April 24, 2020, Applicant contacted Opponent about the extension of time and
`
`claimed to be a “supplement company that Operates primarily on Amazon.” Opponent responded
`
`on the same day requesting that Applicant voluntarily withdraw the Subject Application.
`
`-3-
`
`

`

`NOTICE OF OPPOSITION
`
`APP. SER. NO. 88/693,644
`
`14.
`
`On April 24, 2020, and again on May 19, 2020, Opponent attempted to navigate to
`
`Website, but there was no content on the site on either occasion where the Specimen supposedly
`
`originated from. True and correct copies of the www.zenvoya.com website content with date
`
`stamps are attached in Exhibit F and G
`
`15.
`
`On May
`
`19, 2020, Opponent
`
`attempted to
`
`search for
`
`“Zenvoya” on
`
`www.amazon.com, but there were no results returned for products sold under that name. A true
`
`and correct copy of the www.amazon.com search result from May 19, 2020 is attached in Exhibit
`
`H.
`
`GROUND FOR OPPOSITION
`
`LIKELIHOOD 0F CONFUSION
`
`16.
`
`Gilead incorporates by reference paragraphs 1 through 15 above, inclusive, as if
`
`fully set forth here.
`
`17.
`
`Gilead’s priority date in and use Of the GENVOYA mark predates Applicant’s
`
`filing of the Subject Application and, on information and belief, any actual use of Applicant’s
`
`Mark by Applicant.
`
`18.
`
`The distinctive portion of Applicant’s Mark, ZENVOYA, is substantially similar
`
`in appearance, sound, and overall commercial impression to the GENVOYA mark, with the marks
`
`sharing 7 of 8 identical letters, in identical order, with an identical three—syllable cadence and
`
`identical vowel sounds.
`
`jen-VOY-uh
`zen-VOY—uh
`
`19.
`
`Similarity Of the respective marks is highlighted when using the FDA’s Phonetic
`
`Orthographic Computer Analysis (“POCA”) algorithm, which computes the similarity of drug
`
`

`

`NOTICE OF OPPOSITION
`
`APP. SER. NO. 88/693,644
`
`names, the similarity scores for GENVOYA and ZENVOYA were 90 (combined), 95 (phonetic),
`
`and 86 (orthographic). A true and correct copy of the POCA scores are attached in Exhibit I. The
`
`FDA considers such a score, and any combined scores over 70 to indicate a “Highly Similar Pair”
`
`representing a risk for confusion that often cannot be mitigated by product differences. A true and
`
`correct excerpted copy of the FDA’s guidance is attached in Exhibit J.
`
`20. When considered in light of the similarity of the marks, the goods in the Subject
`
`Application are sufficiently similar and related to the goods in the GENVOYA registration to make
`
`confusion likely, particularly considering that certain institutional pharmacies dispense to patients
`
`both pharmaceutical preparations for treatment of HIV and non-prescription dietary supplements.
`
`21.
`
`The Subject Application identifies no restrictions on channels Of trade and,
`
`therefore, the identified goods must be presumed to travel in all ordinary channels of trade, thus
`
`Applicant’s dietary supplements are likely to be sold in or dispensed by the same pharmacies
`
`Opposer’s medicines are sold.
`
`22.
`
`On information and belief, Applicant knew or should have known about Gilead’s
`
`GENVOYA mark when Applicant selected Applicant’s Mark or, at the very least, should have
`
`abandoned its plans to use the GENVOYA mark after receipt of Gilead’s demand letter.
`
`23.
`
`Gilead is not affiliated or connected with Applicant or its goods, nor has Gilead
`
`endorsed or sponsored Applicant or its goods.
`
`24.
`
`Gilead has no control over the nature and quality of the goods that will be Offered
`
`by Applicant under Applicant’s Mark.
`
`25.
`
`Because of the likelihood of confusion between Applicant’s Mark and the
`
`GENVOYA mark, any defects, improprieties, or faults found with Applicant’s goods would
`
`

`

`NOTICE OF OPPOSITION
`
`APP. SER. NO. 88/693,644
`
`negatively reflect upon and injure the reputation for Gilead’ S goods Offered in connection with the
`
`GENVOYA mark.
`
`26.
`
`Registration of Applicant’s Mark would damage Gilead and the value of the
`
`GENVOYA mark because Applicant’s Mark, when used on or in connection with the applied-for
`
`goods, is likely to cause confusion, mistake, or deception as to the affiliation, connection, or
`
`association of Applicant with Gilead, or as to the origin, sponsorship, or approval of Applicant’s
`
`goods and commercial activities by Gilead. Thus, Applicant’s Mark is unregisterable under 15
`
`use § 1052(d).
`
`GROUND FOR OPPOSITION
`
`VOID AB INITIO FOR LACK OF OWNER
`
`27.
`
`Gilead incorporates by reference paragraphs 1 through 26 above, inclusive, as if
`
`fully set forth here.
`
`28.
`
`Upon information and belief Applicant, Vital, was not a valid, legally existing
`
`corporation on the date the Subject Application was filed.
`
`29.
`
`Thus, because the Subject Application was filed in the name of an entity which was
`
`not in legal existence, the Applicant is not the owner of the applied-for-mark and the Subject
`
`Application is void ab initio under 15 U.S.C. § 1051.
`
`GROUND FOR OPPOSITION
`
`LACK OF USE AT THE TIME OF FILING
`
`30.
`
`Gilead incorporates by reference paragraphs 1 through 30 above, inclusive, as if
`
`fully set forth here.
`
`

`

`NOTICE OF OPPOSITION
`
`APP. SER. NO. 88/693,644
`
`31.
`
`Upon information and belief,
`
`the Specimen appears fabricated and does not
`
`demonstrate that any mark has been applied to goods at the time of the filing, nor has Opposer
`
`found any current use of the Applicant’s Mark on the applied for goods.
`
`32.
`
`Upon information and belief, because the Subject Application was filed on a use
`
`basis, when no use was made before or at the time of filing, the application is void ab initio under
`
`15 U.S.C. § 1051(a).
`
`***
`
`Wherefore, Gilead prays that
`
`this Opposition be sustained, and that registration of
`
`Application Serial No. 88/693,644 be refused.
`
`Date: May 28, 2020
`
`By:
`
`flack wessel/
`Jack Wessel
`
`Respectfully submitted,
`
`Gilead Sciences, Inc.
`333 Lakeside Drive
`
`Foster City, California 94404
`Tel: (650) 425-8540
`Emails: trademarks@gilead.com,
`j ack.wessel@gilead.com
`
`

`

`NOTICE OF OPPOSITION
`
`APP. SER. NO. 88/693,644
`
`CERTIFICATE OF SERVICE
`
`The Undersigned hereby certifies that on May 28, 2020, a true and complete copy of the
`
`foregoing document was forwarded via US Mail to the Applicant at the following address of
`
`record, in addition to a copy sent Via electronic mail to address:
`
`Vital Legal Nurse Consulting
`1 1618 Highbury Way
`Tampa, Florida 33626
`artner
`
`amazonti er.com
`
`David Castro, May 28, 2020
`
`

`

`EXHIBITS
`
`

`

`Exhibit A
`
`

`

`(09mm:
`mutter! évtatm iBatent arm flhahemark @ffilze
`
`r I
`It}?
`
`GENVOYA
`
`Reg. No. 4,797,730
`
`Registered Aug. 25, 2015
`
`GILEAD SCIENCES IRELAND UC (IRELAND UNLIMITED COMPANY), DBA/AKA/TA.
`DBA GILEAD SCIENCES IRELAND UC
`IDA BUSINESS AND TECHNOLOGY PARK
`CARRIGTOI-IILL, CO. CORK, IRELAND
`
`FOR: PHARMACEUTICAL PREPARATIONS FOR THE PREVENTION AND TREATMENT
`OF HEPATITIS AND HIV INFECTION; ANTIVIRALS; ANTI-INFLAMNIATORIES; ANTI-
`FUNGAL PREPARATIONS; PHARMACEUTICAL PREPARATIONS FOR USE IN THE
`TREATMENT OF INFECTIOUS DISEASES, LIVER DISEASES AND DISORDERS, RESPIR-
`ATORY DISEASES AND DISORDERS, ONCOLOGICAL DISEASES AND DISORDERS, AND
`CARDIOVASCULAR DISEASES AND DISORDERS, IN CLASS 5 (US. CLS, 6, 18, 44,46, 51
`AND 52).
`
`THE MARK CONSISTS OF STANDARD CHARACTERS WITHOUT CLAIM TO ANY PAR-
`TICULAR FONT, STYLE, SIZE, OR COLOR,
`
`PRIORITY CLAIMED UNDER SEC. 44(D) ON ERPN CMNTY TM OFCAPPLICATION NO.
`2013/02007, FILED 11-1-2013, REG. N0. 12520607, DATED 6-17-2014, EXPIRES 3—10—2024.
`
`SER. NO. 86-170,336, FILED 1-20-2014.
`
`JAMES A. RAU'EN, EXAMINING ATTORNEY
`
`Int. CL: 5
`
`TRADEMARK
`
`PRINCIPAL REGISTER
`
`
`
`Director of the United States
`Patent and Trademark Office
`
`

`

`REQUIREMENTS TO MAINTAIN YOUR FEDERAL
`TRADEMARK REGISTRATION
`
`DOCUNIENTS BELOW DURING THE SPECIFIED TIME PERIODS.
`
`WARNING: YOUR REGISTRATION WILL BE CANCELLED IF YOU DO NOT FILE THE
`
`Requirements in the First Ten Years“
`What and When to File:
`
`First Filing Deadline: You must file a Declaration of Use (or Excusablc Nonuse) between the
`5th and 6th years after the registration date. See 15 U.S.C. §§1058, 1141k.
`If the declaration is
`accepted, the registration will continue in force for the remainder ofthe ten—year period, calculated
`from the registration date, unless cancelled by an order of the Commissioner for Trademarks or a
`federal court.
`
`Second Filing Deadline: You must file a Declaration of Use (or Excusablc Nonusc) and an
`Application for Renewal between the 9th and 10th years after the registration date.*
`See 15 U.S.C. §1059.
`
`Requirements in Successive Ten—Year Periods”
`What and When to File:
`
`You must file a Declaration ofUse (or Excusablc Nonuse) and an Application for Renewal between
`every 9th and lOth-year period, calculated from the registration date.*
`
`Grace Period Filings*
`
`The above documents will be accepted as timely if filed within six months after the deadlines listed above
`with the payment of an additional fee.
`
`*ATTENTION MADRID PROTOCOL REGISTRANTS: The holder ot'an international registration with
`an extension of protection to the United States under the Madrid Protocol must timely file the Declarations
`of Use (or Excusablc Nonuse) referenced above directly with the United States Patent and Trademark Ofiice
`(U SPTO). The time periods for filing are based on the U.S. registration date (not the international registration
`date). The deadlines and grace periods for the Declarations of Use (or Excusablc Nonuse) are identical to
`those for nationally issued registrations.
`See 15 U.S.C. §§1058, ll41k. However, owners of international
`registrations do not file renewal applications at the USPTO. instead, the holder must file a renewal of the
`underlying international registration at the Intemational Bureau of the World Intellectual Property Organization,
`under Article 7 of the Madrid Protocol, before the expiration of each ten-year term of protection, calculated
`from the date of the international registration. See 15 U.S.C. §114lj. For more infomtation and renewal
`forms for the international registration, see http://www.wipo.int/inadrid/eifl.
`
`NOTE: Fees and requirements for maintaining registrations are subject to change. Please check the
`USPTO website for further information. With the exception of renewal applications for registered
`extensions of protection, y0u can file the registration maintenance documents referenced above online
`at http://wwwusptogov.
`
`NOTE: A courtesy c—mail reminder of USPTO maintenance tiling deadlines will be sent to trademark
`owners/holders who authorize e—mail communication and maintain a current e-mail address with the
`USPTO. To ensure that e-mail is authorized and your address is current, please use the Trademark
`Electronic Application System (TEAS) CorrespondenceAddress and Change of Owner Address Forms
`available at http://www.uspto .gov.
`
`Page: 2 /RN # 4,797,730
`
`

`

`Exhibit B
`
`

`

`fum,‘
`
`g gDEPARTMENTOFHEALTHANDHUMANSERVICES
`
`km
`
`NDA 207561
`
`Gilead Sciences, Inc.
`Attention: Erik Berglund, M.D., Ph.D., RAC
`Associate Director, Regulatory Affairs
`333 Lakeside Drive
`
`Foster City, CA 94404
`
`Dear Dr. Berglund:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`Please refer to your New Drug Application (NDA) dated and received November 5, 2014, submitted
`under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for GENVOYA®
`(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), 150/150/200/10 mg fixed-dose
`combination tablet.
`
`We acknowledge receipt of your amendments dated:
`
`November 10, 2014
`November 25, 2014
`December 5, 2014
`January 26, 2015
`February 6, 2015
`February 17, 2015
`February 19, 2015
`February 24, 2015
`March 10, 2015
`March 13, 2015
`
`April 6, 2015
`April 13, 2015
`April 17, 2015
`April 27, 2015
`May 7, 2015
`May 12, 2015
`May 20, 2015
`May 22, 2015
`May 29, 2015
`June 5, 2015
`
`June 8, 2015
`June 12, 2015
`June 17, 2015
`July 2, 2015
`July 7, 2015
`July 8, 2015
`July 22, 2015
`August 4, 2015
`August 7, 2015
`August 12, 2015
`
`August 14, 2015
`September 3, 2015
`September 17, 2015
`September 30, 2015
`October 7, 2015
`October 9, 2015
`October 16, 2015
`October 19, 2015
`October 23, 2015
`November 2, 2015 (x3)
`
`We also acknowledge receipt of information related to GENVOYA® (elvitegravir, cobicistat,
`emtricitabine, and tenofovir alafenamide), 150/150/200/10 mg fixed-dose combination tablet
`for your Gilead Access Program that was reviewed as part of this application.
`
`This new drug application provides for the use of GENVOYA® (elvitegravir, cobicistat,
`emtricitabine, and tenofovir alafenamide), 150/150/200/10 mg fixed—dose combination tablet for
`treatment of HIV-1 infection in adults and pediatric patients 12 years of age or older who have
`no antiretroviral treatment history or to replace the current antiretroviral regimen in those who
`are Virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral
`regimen for at least 6 months with no history of treatment failure and no known substitutions
`associated with resistance to the individual components of GENVOYA®.
`
`Reference ID: 3843048
`
`

`

`NDA 207561
`
`Page 2
`
`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed—upon labeling text.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 3 1450(1)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://wwwfda.gov/Forlndusth/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert and patient
`package insert). Information on submitting SPL files using eLIST may be found in the guidance
`for industry SPL Standardfor Content ofLabeling Technical Qs and As, available at
`http://wwwfda. gov/downloads/Drugs/GuidanceComplianceRegglatorylnformation/Guidances/U
`CMO72392pdf.
`
`The SPL will be accessible via publicly available labeling repositories.
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed immediate container label that is identical to the enclosed immediate
`container label, as soon as they are available, but no more than 30 days after they are printed.
`Please submit this label electronically according to the guidance for industry Providing
`Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications
`and Related Submissions Using the eCTD Specifications (June 2008). Alternatively, you may
`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
`similar material. For administrative purposes, designate this submission “Final Printed
`Container Label for approved NDA 207561.” Approval of this submission by FDA is not
`required before the labeling is used.
`
`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
`
`ADVISORY COMlVIITTEE
`
`Your application for GENVOYA was not referred to an FDA advisory committee because
`during the review process no substantive issues were encountered that would benefit from
`Advisory Committee discussion; three of the component drugs were previously approved and
`tenofovir alafenamide (the only New Molecular Entity) represents a second prodrug of a well-
`characterized antiretroviral.
`
`Reference ID: 3843048
`
`

`

`NDA 207561
`
`Page 3
`
`RE UIRED PEDIATRIC ASSESSNIENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 3550), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`We are waiving the pediatric study requirement for ages 0 to less than 6 years of age because:
`
`0
`
`0
`
`In patients from birth up to 28 days of age, necessary studies are impossible or highly
`impracticable because the number of patients in this age group is too small and
`geographically dispersed to allow studies.
`
`In patients 29 days up to 6 years of age, the product fails to represent a meaningful
`therapeutic benefit over existing therapies for pediatric patients m is unlikely to be used
`in a substantial number of pediatric patients in this age group. In this age group, use of
`the individual component drugs or other antiretroviral formulations allows more accurate
`dosing across weights of rapidly growing children.
`
`We are deferring submission of your pediatric study for ages 6 to less than 12 years for this
`application because this product is ready for approval for use in adults and the pediatric study has
`not been completed.
`
`Your deferred pediatric study required by section 505B(a) of the FDCA are required
`postmarketing study. The status of this postmarketing study must be reported annually according
`to 21 CFR 314.81 and section 505B(a)(3)(B) of the FDCA. This required study is listed below.
`
`2971-1
`
`Conduct your deferred pediatric study in HIV-infected patients 6 years to less
`than 12 years to assess the pharmacokinetics, safety and tolerability, and antiviral
`activity of age—appropriate doses of elvitegravir, cobicistat, emtricitabine, and
`tenofovir alafenamide given in combination. At least some of the safety data
`must be derived from dosing as the GENVOYA® fixed dose combination
`(duration and number of subjects on GENVOYA® to be agreed upon with the
`Agency).
`
`Protocol Submission:
`Study Completion:
`Final Report Submission:
`
`January 15, 2015 (completed)
`September 2017
`March 2018
`
`Reports of this required pediatric postmarketing study must be submitted as a new drug
`application (NDA) or as a supplement to your approved NDA with the proposed labeling
`changes you believe are warranted based on the data derived from this study. When submitting
`the reports, please clearly mark your submission "SUBMISSION OF REQUIRED
`PEDIATRIC ASSESSMENTS" in large font, bolded type at the beginning of the cover letter of
`the submission.
`
`Reference ID: 3843048
`
`

`

`N'DA 207561
`
`Page 4
`
`This product is appropriately labeled for use in ages 12 to less than 18 years for this indication.
`Therefore, no additional studies are needed in this pediatric age group for PREA purposes.
`
`POSTMARKETING COMIVIITMENTS SUBJECT TO REPORTING REQUIREMENTS
`UNDER SECTION 506B
`
`We remind you of your postmarketing commitment:
`
`2971-2
`
`Submit the long—term safety and antiviral activity data for Study GS-US-292-
`0106. Include data and analyses for the entire study population through Week 48
`and for all subjects enrolled in the extension phase through 96 weeks of
`GENVOYA® dosing.
`
`The timetable you submitted on October 16, 2015, states that you will conduct this study
`according to the following schedule:
`
`Final Protocol Submission:
`Study Completion:
`Final Report Submission:
`
`February 2013 (completed)
`September 2018
`March 2019
`
`Under 21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii) you should include a status summary of
`each commitment in your annual report to this NDA. The status summary should include
`expected study completion and final report submission dates, any changes in plans since the last
`annual report, and, for clinical studies, number of patients entered into each study. All
`submissions, including supplements, relating to this postrnarketing commitment should be
`prominently labeled “Postmarketing Commitment Protocol,” “Postmarketing Commitment
`Final Report,” or “Postmarketing Commitment Correspondence.”
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert,
`and patient PI (as applicable) to:
`
`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`
`Beltsville, MD 20705-1266
`
`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`
`Reference ID: 3843048
`
`

`

`NDA 207561
`
`Page 5
`
`http://wwwfda. gov/downloads/Drugs/GuidanceC omplianceRegglatorylnformation/Guidances/U
`CM443702pdf ).
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. Form FDA 2253 is available at
`
`http://wwwfda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCMO83570.pdf.
`Information and Instructions for completing the form can be found at
`ht_tp://www.fda. gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM3 75154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://wwwfda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`MEDWATCH-TO-MANUFACTURER PROGRAM
`
`The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse
`event reports that are received directly by the FDA. New molecular entities and important new
`biologics qualify for inclusion for three years after approval. Your firm is eligible to receive
`copies of reports for this product. To participate in the program, please see the enrollment
`instructions and program description details at
`http://wwwfda. gov/S afety/MedWatch/HowToReport/ucm1 66910.htm.
`
`POST APPROVAL FEEDBACK MEETING
`
`New molecular entities and new biologics qualify for a post approval feedback meeting. Such
`meetings are used to discuss the quality of the application and to evaluate the communication
`process during drug development and marketing application review. The purpose is to learn
`from successful aspects of the review process and to identify areas that could benefit from
`improvement. If you would like to have such a meeting with us, call the Regulatory Project
`Manager for this application.
`
`PDUFA V APPLICANT INTERVIEW
`
`FDA has contracted with Eastern Research Group, Inc. (ERG) to conduct an independent interim
`and final assessment of the Program for Enhanced Review Transparency and Communication for
`NME NDAs and Original BLAs under PDUFA V (‘the Program”). The PDUFA V Commitment
`Letter states that these assessments will include interviews with applicants following FDA action
`on applications reviewed in the Program. For this purpose, first-cycle actions include approvals,
`complete responses, and Withdrawals after filing. The purpose of the interview is to better
`understand applicant experiences with the Program and its ability to improve transparency and
`communication during FDA review.
`
`Reference ID: 3843048
`
`

`

`NDA 207561
`
`Page 6
`
`ERG will contact you to schedule a PDUFA V applicant interview and provide specifics about
`the interview process. Your responses during the interview will be confidential with respect to
`the FDA review team. ERG has signed a non-disclosure agreement and will not disclose any
`identifying information to anyone outside their project team. They will report only anonymized
`results and findings in the interim and final assessments. Members of the FDA review team will
`be interviewed by ERG separately. While your participation in the interview is voluntary, your
`feedback will be helpful to these assessments.
`
`If you have any questions, call Myung-Joo Patricia Hong, M.S., Senior Regulatory Project
`Manager, at (301) 796-0806.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`John Farley, M.D., M.P.H.
`Deputy Director
`Office of Antimicrobial Products
`
`Center for Drug Evaluation and Research
`
`Enclosures:
`
`Content of Labeling
`Container Labeling
`
`Reference ID: 3843048
`
`

`

`Exhibit C
`
`

`

`5/19/2020
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`VITAL LEGAL NURSE CONSULTING LLC
`VITALLEN LLC
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`L20000082359
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`VITALLEO LLC
`VITAL LIFE
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`VITAL LIFE CARE LLC
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`VITALLIFE ENTERPRISES INTERNATIONAL LLC L08000116459
`VITAL L|FE GROUP INC.
`P11000052104
`VITAL LIFE HEALTHCARE INC.
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`P97000055406
`VIIAL LIFE HEALTHCARE PRODUCTS INC.
`L12000096223
`VITAL L|FE INSTITUTE,__L_|&
`VITAL L|FE MEAL PREP AND DELIVERY,LC L16000131948
`VITAL L|FE PHARMACY LLC
`L14000066099
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`VITALLIFESENIOR.COM,%
`VITAL L|FE SERVICES, LLC
`VITAL L|FE TECHNOLOGIES, INC.
`VITAL L|FE USA L L.C
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`L130001295o3
`L19000016128
`P06000112655
`L14000112422
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`

`

`Exhibit D
`
`

`

`5119/2020
`
`Detail by En