1/7/2021
`
`History of Changes for Study: NCT00509795
`
`History of Changes for Study: NCT00509795
`
`Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related
`Macular Degeneration(AMD) (VIEW1)
`
`Latest version (submitted December 20, 2012) on ClinicalTrials.gov
`
`A study version is represented by a row in the table.
`
`Select two study versions to compare. One each from columns A and B.
`
`Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only
`applies to the Protocol section of the study.
`
`Click "Compare" to do the comparison and show the differences.
`
`Select a version's Submitted Date link to see a rendering of the study for that version.
`
`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
`
`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
`
`Study edits or deletions are displayed in red.
`
`Study additions are displayed in green .
`
`Study Record Versions
`
`Version
`
`A
`
`B
`
`Submitted Date
`
`Changes
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`1
`
`2
`
`July 31, 2007 None (earliest Version on record)
`
`August 17, 2007 Recruitment Status, Study Status and Contacts/Locations
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`1/27
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`Mylan v. Regeneron, IPR2021-00881
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`1/7/2021
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`Version
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`A
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`B
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`Submitted Date
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`History of Changes for Study: NCT00509795
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`Changes
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`3
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`4
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`5
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`14
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`November 14, 2007 Contacts/Locations and Study Status
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`December 4, 2007 Study Status and Contacts/Locations
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`March 13, 2008 Study Status and Eligibility
`
`June 26, 2008 Contacts/Locations, Arms and Interventions, Study Design, Study Status, Outcome Measures and Study
`Identification
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`January 22, 2009 Contacts/Locations, Study Status, Arms and Interventions, Outcome Measures, Eligibility and
`Sponsor/Collaborators
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`March 3, 2009 Study Status and Contacts/Locations
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`April 28, 2009 Outcome Measures, Arms and Interventions, Study Status, Eligibility, Conditions and Study Identification
`
`September 12, 2009 Recruitment Status, Study Status and Contacts/Locations
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`December 1, 2009 Study Status, Contacts/Locations and Sponsor/Collaborators
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`January 5, 2011 Study Status
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`April 18, 2011 Study Status and Study Design
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`May 4, 2011 Study Status
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`December 1, 2011 Recruitment Status, Study Status and Sponsor/Collaborators
`
`April 13, 2012 Arms and Interventions, Outcome Measures, Study Status, More Information, Reported Adverse Events,
`Baseline Characteristics, Participant Flow, Eligibility, Study Description and Study Identification
`
`December 17, 2012 Reported Adverse Events, Outcome Measures, Baseline Characteristics, Participant Flow and Study Status
`
`December 20, 2012 Outcome Measures, References and Study Status
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`2/27
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`Mylan v. Regeneron, IPR2021-00881
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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`Compare
`
` Comparison Format:
`
` Merged
` Side-by-Side
`
`Compare v7 to v8
`
`Scroll up to access the controls
`
`Changes (Merged) for Study: NCT00509795
`March 3, 2009 (v8) -- April 28, 2009 (v9)
`
`Compare v9 to v10
`
`Changes in: Outcome Measures, Arms and Interventions, Study Status, Eligibility, Conditions and Study Identification
`
` Show only changed modules
`
`Study Identification
`Unique Protocol ID: VGFT-OD-0605
`Brief Title: Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW
`1) (VIEW1) Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in
`Wet Age-Related Macular Degeneration(AMD) (VIEW1)
`Official Title: A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and
`Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related
`Macular Degeneration
`
`Secondary IDs:
`
`Study Status
`
`Record Verification: March 2009 April 2009
`Overall Status: Recruiting
`Study Start: August 2007
`Primary Completion: October 2010 December 2011 [Anticipated]
`Study Completion: January 2012 December 2011 [Anticipated]
`
`First Submitted: July 31, 2007
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`3/27
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`Mylan v. Regeneron, IPR2021-00881
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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`July 31, 2007
`
`First Submitted that
`Met QC Criteria:
`First Posted: August 1, 2007 [Estimate]
`
`March 3, 2009 April 28, 2009
`
`Last Update Submitted that
`Met QC Criteria:
`Last Update Posted: March 5 April 29 , 2009 [Estimate]
`Sponsor/Collaborators
`
`Sponsor: Regeneron Pharmaceuticals
`Responsible Party:
`Collaborators: Bayer
`
`Oversight
`U.S. FDA-regulated Drug:
`U.S. FDA-regulated Device:
`Data Monitoring: Yes
`Study Description
`Brief Summary: This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-
`Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will
`be randomized in the US and Canada.
`
`Detailed Description:
`
`Conditions
`
`Study Design
`
`Conditions: Neovascular Age-Related Macular Degeneration
`Keywords:
`
`Study Type: Interventional
`Primary Purpose: Treatment
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`4/27
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`Mylan v. Regeneron, IPR2021-00881
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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`Study Phase: Phase 3
`Interventional Study Model: Parallel Assignment
`Number of Arms: 4
`Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`Allocation: Randomized
`Enrollment: 1200 [Anticipated]
`Arms and Interventions
`
`Arms
`
`Assigned Interventions
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`5/27
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`Mylan v. Regeneron, IPR2021-00881
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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`Experimental: 1
`
`Arms
`
`Assigned Interventions
`Drug: VEGF Trap-Eye
`0.5 mg VEGF Trap-Eye administered every 4 weeks during
`the first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
`every 12 weeks.
`Drug: VEGF Trap-Eye
`VGFT-OD-0605 is a double-masked, randomized, Phase III
`study. Subjects will be rand. assigned in a 1:1:1:1 ratio to 1
`of 4 dosing regimens:1)2mg VEGF Trap-Eye adm. every 4
`wks (2Q4), 2) 0.5mg VEGF Trap-Eye adm. every 4 wks
`(0.5Q4), 3) 2mg VEGF Trap-Eye adm. every 8 wks (2Q8),
`and 4) 0.5mg ranibizumab adm. every 4 wks (RQ4); subj.
`assigned to (2Q8) will receive the 2mg injection every 4 wks
`to wk 8 & then a sham inject at interim 4-wk visits (when
`study drug is not to be adm) during the first 52 wks of the
`study. VEGF Trap-Eye will be supplied in sealed 3mL single
`use vials each with a "withdrawable" vol. of approx. 0.5 mL at
`a concentration of 10mg/mL or 40 mg/mL.VEGF Trap-Eye
`will be withdrawn using aseptic technique through an 18
`"gauge" needle attached to a 1 mL syringe. The syringe
`needle will then be removed and replaced with a 30 gauge
`needle to be used for the ITV inject. The inject. vol. will be
`50µL (0.05 mL) for the 0.5mg & 2mg doses of VEGF Trap-
`Eye and 0.5 mg ranibizumab
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`6/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 6
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`Joining Petitioner: Apotex
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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`Experimental: 2
`
`Arms
`
`Assigned Interventions
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 4 weeks during
`the first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
`every 12 weeks.
`Drug: VEGF Trap-Eye
`VGFT-OD-0605 is a double-masked, randomized, Phase III
`study. Subjects will be rand. assigned in a 1:1:1:1 ratio to 1
`of 4 dosing regimens:1)2mg VEGF Trap-Eye adm. every 4
`wks (2Q4), 2) 0.5mg VEGF Trap-Eye adm. every 4 wks
`(0.5Q4), 3) 2mg VEGF Trap-Eye adm. every 8 wks (2Q8),
`and 4) 0.5mg ranibizumab adm. every 4 wks (RQ4); subj.
`assigned to (2Q8) will receive the 2mg injection every 4 wks
`to wk 8 & then a sham inject at interim 4-wk visits (when
`study drug is not to be adm) during the first 52 wks of the
`study. VEGF Trap-Eye will be supplied in sealed 3mL single
`use vials each with a "withdrawable" vol. of approx. 0.5 mL at
`a concentration of 10mg/mL or 40 mg/mL.VEGF Trap-Eye
`will be withdrawn using aseptic technique through an 18
`"gauge" needle attached to a 1 mL syringe. The syringe
`needle will then be removed and replaced with a 30 gauge
`needle to be used for the ITV inject. The inject. vol. will be
`50µL (0.05 mL) for the 0.5mg & 2mg doses of VEGF Trap-
`Eye and 0.5 mg ranibizumab
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`7/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 7
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`Joining Petitioner: Apotex
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`

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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`Experimental: 3
`
`Arms
`
`Active Comparator: 4
`
`Assigned Interventions
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 8 weeks
`(including one additional 2.0 mg dose at week 4) during the
`first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
`every 12 weeks.
`Drug: VEGF Trap-Eye
`VGFT-OD-0605 is a double-masked, randomized, Phase III
`study. Subjects will be rand. assigned in a 1:1:1:1 ratio to 1
`of 4 dosing regimens:1)2mg VEGF Trap-Eye adm. every 4
`wks (2Q4), 2) 0.5mg VEGF Trap-Eye adm. every 4 wks
`(0.5Q4), 3) 2mg VEGF Trap-Eye adm. every 8 wks (2Q8),
`and 4) 0.5mg ranibizumab adm. every 4 wks (RQ4); subj.
`assigned to (2Q8) will receive the 2mg injection every 4 wks
`to wk 8 & then a sham inject at interim 4-wk visits (when
`study drug is not to be adm) during the first 52 wks of the
`study. VEGF Trap-Eye will be supplied in sealed 3mL single
`use vials each with a "withdrawable" vol. of approx. 0.5 mL at
`a concentration of 10mg/mL or 40 mg/mL.VEGF Trap-Eye
`will be withdrawn using aseptic technique through an 18
`"gauge" needle attached to a 1 mL syringe. The syringe
`needle will then be removed and replaced with a 30 gauge
`needle to be used for the ITV inject. The inject. vol. will be
`50µL (0.05 mL) for the 0.5mg & 2mg doses of VEGF Trap-
`Eye and 0.5 mg ranibizumab
`
`Drug: Comparator Drug: ranibizumab
`0.5 mg ranibizumab adm. every 4 wks (RQ4); 0.5 mg
`administered every 4 weeks during the first year. Thereafter
`a dose may be administered as frequently as every 4 weeks,
`but no less frequently than every 12 weeks.
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`8/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 8
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`History of Changes for Study: NCT00509795
`
`1/7/2021
`Outcome Measures
`Primary Outcome Measures:
`1. Primary measure will be visual acuity changes compared to baseline. The proportion of subjects who maintain vision at Week
`52, where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS chart compared
`to baseline (i.e. prevention of moderate vision loss)
`Monthly Week 52
`Secondary Outcome Measures:
`2. Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52
`Week 52
`3. The proportion of subjects who gain at least 15 letters of vision at Week 52
`Week 52
`4. Mean change from baseline in total NEI VFQ-25 score at Week 52
`Week 52
`5. Secondary measures will be angiographic and anatomical changes compared to baseline. Mean change from baseline in CNV
`area at Week 52
`as dictated by protocol Week 52
`
`Eligibility
`
`Minimum Age: 50 Years
`Maximum Age:
`Sex: All
`Gender Based:
`Accepts Healthy Volunteers: Yes No
`Criteria: Key Inclusion Criteria:
`
`1. Signed Informed Consent.
`2. Men and women ≥ 50 years of age.
`3. Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal
`lesions that affect the fovea as evidenced by FA in the study eye.
`4. CNV must be at least 50% of total lesion size.
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
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`History of Changes for Study: NCT00509795
`5. ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
`6. Willing, committed, and able to return for ALL clinic visits and complete all study-related
`procedures.
`7. Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person
`administering the informed consent or a family member. See Appendix J.4) understand and
`willing to sign the informed consent form.
`
`Key Exclusion Criteria:
`
`1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except
`dietary supplements or vitamins.
`2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in
`the study eye, except dietary supplements or vitamins.
`3. Any prior treatment with anti-VEGF agents in the study eye.
`4. Prior treatment with anti-VEGF agents as follows:
`Prior treatment with anti-VEGF therapy in the study eye is not allowed.
`Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not
`FDA approved, e.g. bevacizumab) is allowed up to 3 months prior to first dose in the study,
`and such treatment will not be allowed during the study. Prior treatment with an FDA/Health
`Canada approved anti-VEGF therapy in the fellow eye is allowed.
`Prior systemic anti-VEGF therapy, investigational or FDA/Health Canada approved, is only
`allowed up to 3 months prior to first dose, and will not be allowed during the study
`5. Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as
`assessed by FA in the study eye.
`6. Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under
`the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea,
`then the fovea must be surrounded 270 degrees by visible CNV.)
`7. Scar or fibrosis, making up > 50% of total lesion in the study eye.
`8. Scar, fibrosis, or atrophy involving the center of the fovea.
`9. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
`10. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
`11. Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8
`diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome,
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`10/27
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`Mylan v. Regeneron, IPR2021-00881
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`History of Changes for Study: NCT00509795
`angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye. Presence of other
`causes of CNV in the study eye.
`12. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular
`disease affecting the retina,other than AMD, in either eye.
`13. Prior vitrectomy in the study eye.
`14. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
`15. Any history of macular hole of stage 2 and above in the study eye.
`16. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid
`surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to
`interfere with the injection.
`
`Contacts/Locations
`Central Contact: Regeneron
`Telephone: 866-549-8439
`Email: VIEW1study@rtp.ppdi.com
`Study Officials: Avner Ingerman, MD
`Study Director
`Regeneron Pharmaceuticals
`Locations: United States, Alabama
`[Recruiting]
`Birmingham, Alabama, United States, 35205
`[Recruiting]
`Birmingham, Alabama, United States, 35223
`United States, Arizona
`[Recruiting]
`Phoenix, Arizona, United States, 85014
`[Recruiting]
`Phoenix, Arizona, United States, 85020
`[Recruiting]
`Tucson, Arizona, United States, 85704
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`11/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 11
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`Joining Petitioner: Apotex
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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Tucson, Arizona, United States, 85710
`United States, California
`[Recruiting]
`Beverly Hills, California, United States, 90211
`[Recruiting]
`Campbell, California, United States, 95008
`[Recruiting]
`Fullerton, California, United States, 92835
`[Terminated]
`Glendale, California, United States, 91203
`[Recruiting]
`Irvine, California, United States, 92697
`[Recruiting]
`La Jolla, California, United States, 92037
`[Recruiting]
`Loma Linda, California, United States, 92354
`[Withdrawn]
`Los Angeles, California, United States, 90033
`[Recruiting]
`Los Angeles, California, United States, 90048
`[Recruiting]
`Menlo Park, California, United States, 94025
`[Recruiting]
`Mountain View, California, United States, 94040
`[Recruiting]
`Oakland, California, United States, 94609
`[Recruiting]
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`12/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 12
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`1/7/2021
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`History of Changes for Study: NCT00509795
`Palm Springs, California, United States, 92262
`[Recruiting]
`Pasadena, California, United States, 91105
`[Withdrawn]
`Poway, California, United States, 92064
`[Recruiting]
`Sacramento, California, United States, 95819
`[Active, not recruiting]
`San Diego, California, United States, 92120
`[Terminated]
`San Francisco, California, United States, 94107
`[Recruiting]
`Santa Ana, California, United States, 92705
`[Recruiting]
`Torrance, California, United States, 90503
`[Withdrawn]
`Ventura, California, United States, 93003
`[Recruiting]
`Westlake Village, California, United States, 91361
`[Recruiting]
`Yorba Linda, California, United States, 92887
`United States, Colorado
`[Terminated]
`Aurora, Colorado, United States, 80045
`[Recruiting]
`Denver, Colorado, United States, 80205
`[Withdrawn]
`Denver, Colorado, United States, 80205
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`13/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 13
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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`[Withdrawn]
`Denver, Colorado, United States, 80230
`United States, Connecticut
`[Recruiting]
`Bridgeport, Connecticut, United States, 06606
`[Withdrawn]
`Hamden, Connecticut, United States, 06518
`[Active, not recruiting]
`New Haven, Connecticut, United States, 06510
`[Recruiting]
`New London, Connecticut, United States, 06320
`United States, Florida
`[Recruiting]
`Altamonte Springs, Florida, United States, 32701
`[Recruiting]
`Boynton Beach, Florida, United States, 33426
`[Recruiting]
`Fort Myers, Florida, United States, 33907
`[Withdrawn]
`Ft. Lauderdale, Florida, United States, 33351
`[Recruiting]
`Ft. Myers, Florida, United States, 33912
`[Withdrawn]
`Gainesville, Florida, United States, 32610
`[Recruiting]
`Jacksonville, Florida, United States, 32224
`[Withdrawn]
`Miami, Florida, United States, 33136
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`14/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 14
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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Miami, Florida, United States, 33143
`[Terminated]
`Mount Dora, Florida, United States, 32757
`[Recruiting]
`Orlando, Florida, United States, 32803
`[Recruiting]
`Orlando, Florida, United States, 32806
`[Recruiting]
`Oscala, Florida, United States, 34472
`[Recruiting]
`Palm Beach Gardens, Florida, United States, 33410
`[Recruiting]
`Pensacola, Florida, United States, 32503
`[Withdrawn]
`Sarasota, Florida, United States
`[Recruiting]
`Stuart, Florida, United States, 34994
`[Recruiting]
`Tampa, Florida, United States, 33612
`[Recruiting]
`Winter Haven, Florida, United States, 33880
`United States, Georgia
`[Recruiting]
`Augusta, Georgia, United States, 30909
`United States, Hawaii
`[Recruiting]
`Aiea, Hawaii, United States, 96701
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`15/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 15
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`

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`1/7/2021
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`History of Changes for Study: NCT00509795
`
`[Withdrawn]
`Honolulu, Hawaii, United States, 96813
`United States, Illinois
`[Recruiting]
`Oak Brook, Illinois, United States, 60523
`United States, Indiana
`[Recruiting]
`Fort Wayne, Indiana, United States, 46804
`[Recruiting]
`Indianapolis, Indiana, United States, 46202
`[Terminated]
`Indianapolis, Indiana, United States, 46260
`[Recruiting]
`Indianapolis, Indiana, United States, 46280
`[Recruiting]
`New Albany, Indiana, United States, 47150
`United States, Iowa
`[Recruiting]
`Iowa City, Iowa, United States, 52242-1091
`United States, Kansas
`[Recruiting]
`Wichita, Kansas, United States, 67214
`United States, Kentucky
`[Recruiting]
`Louisville, Kentucky, United States, 40202
`[Recruiting]
`Louisville, Kentucky, United States, 40207
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`16/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 16
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Terminated]
`Paducah, Kentucky, United States, 42001
`United States, Louisiana
`[Recruiting]
`New Orleans, Louisiana, United States, 70115
`[Recruiting]
`New Orleans, Louisiana, United States, 70121
`[Terminated]
`Shreveport, Louisiana, United States, 71105
`United States, Maine
`[Recruiting]
`Bangor, Maine, United States, 04401
`[Recruiting]
`Portland, Maine, United States, 04102
`United States, Maryland
`[Recruiting]
`Baltimore, Maryland, United States, 21209
`[Recruiting]
`Baltimore, Maryland, United States, 21287
`[Recruiting]
`Chevy Chase, Maryland, United States, 20815
`[Recruiting]
`Hagerstown, Maryland, United States, 21740
`[Recruiting]
`Towson, Maryland, United States, 21204
`United States, Massachusetts
`[Withdrawn]
`Boston, Massachusetts, United States, 02111
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`17/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 17
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Boston, Massachusetts, United States, 02114
`[Recruiting]
`Boston, Massachusetts, United States, 02215
`[Withdrawn]
`Boston, Massachusetts, United States
`[Recruiting]
`Peabody, Massachusetts, United States, 01960
`United States, Michigan
`[Recruiting]
`Ann Arbor, Michigan, United States, 48105
`[Recruiting]
`Battle Creek, Michigan, United States, 49015
`[Active, not recruiting]
`Detroit, Michigan, United States, 48202
`[Recruiting]
`Grand Rapids, Michigan, United States, 49525
`[Recruiting]
`Jackson, Michigan, United States, 49201
`[Recruiting]
`Royal Oak, Michigan, United States, 48073
`[Recruiting]
`Southfield, Michigan, United States, 48034
`[Withdrawn]
`West Bloomfield, Michigan, United States, 48322
`United States, Minnesota
`[Withdrawn]
`Edina, Minnesota, United States, 55435
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`18/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 18
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Minneapolis, Minnesota, United States, 55404
`[Recruiting]
`Rochester, Minnesota, United States, 55905
`United States, Missouri
`[Recruiting]
`Florissant, Missouri, United States, 63031
`[Recruiting]
`Kansas City, Missouri, United States, 64108
`[Withdrawn]
`Kansas City, Missouri, United States, 64111
`[Recruiting]
`Springfield, Missouri, United States, 65804
`[Recruiting]
`St. Louis, Missouri, United States, 63110
`United States, Montana
`[Recruiting]
`Missoula, Montana, United States, 59801
`United States, Nebraska
`[Recruiting]
`Lincoln, Nebraska, United States, 68506
`[Withdrawn]
`Omaha, Nebraska, United States, 68131
`United States, Nevada
`[Recruiting]
`Las Vegas, Nevada, United States, 89144
`United States, New Jersey
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`19/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 19
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Lawrenceville, New Jersey, United States, 08648
`[Terminated]
`New Brunswick, New Jersey, United States, 08901
`[Recruiting]
`Northfield, New Jersey, United States, 08225
`[Withdrawn]
`Teaneck, New Jersey, United States, 07666
`[Recruiting]
`Toms River, New Jersey, United States, 08753
`United States, New Mexico
`[Recruiting]
`Albuquerque, New Mexico, United States, 87106
`United States, New York
`[Recruiting]
`Albany, New York, United States, 12206
`[Recruiting]
`Brooklyn, New York, United States, 11223
`[Recruiting]
`Lynbrook, New York, United States, 11563
`[Recruiting]
`New York, New York, United States, 10003
`[Recruiting]
`New York, New York, United States, 10021
`[Recruiting]
`New York, New York, United States, 10032
`[Terminated]
`Poughkeepsie, New York, United States, 12601
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`20/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 20
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Rochester, New York, United States, 14620
`[Recruiting]
`Rochester, New York, United States, 14642
`[Recruiting]
`Slingerlands, New York, United States, 12159
`[Recruiting]
`Syracuse, New York, United States, 13224
`United States, North Carolina
`[Recruiting]
`Asheville, North Carolina, United States, 28803
`[Recruiting]
`Charlotte, North Carolina, United States, 28210
`[Recruiting]
`Raleigh, North Carolina, United States, 27607
`[Terminated]
`Southern Pines, North Carolina, United States, 28387
`[Recruiting]
`Winston-Salem, North Carolina, United States, 27157
`United States, Ohio
`[Withdrawn]
`Cincinnati, Ohio, United States, 45202
`[Recruiting]
`Cincinnati, Ohio, United States, 45242
`[Terminated]
`Columbus, Ohio, United States, 43215
`[Terminated]
`Toledo, Ohio, United States, 43608
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`21/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 21
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`United States, Oklahoma
`[Recruiting]
`Oklahoma City, Oklahoma, United States, 73104
`United States, Oregon
`[Recruiting]
`Ashland, Oregon, United States, 97520
`[Recruiting]
`Portland, Oregon, United States, 97210
`[Recruiting]
`Portland, Oregon, United States, 97227
`[Recruiting]
`Salem, Oregon, United States, 97302
`United States, Pennsylvania
`[Recruiting]
`Kingston, Pennsylvania, United States, 18704
`[Active, not recruiting]
`Philadelphia, Pennsylvania, United States, 19104
`[Recruiting]
`Philadelphia, Pennsylvania, United States, 19107
`[Recruiting]
`Philadelphia, Pennsylvania, United States, 19124
`[Recruiting]
`Pittsberg, Pennsylvania, United States, 15231
`[Recruiting]
`Pittsburgh, Pennsylvania, United States, 15212
`[Recruiting]
`Pittsburgh, Pennsylvania, United States, 15213
`[Recruiting]
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`22/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 22
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`West Mifflin, Pennsylvania, United States, 15122
`[Withdrawn]
`Wyomissing, Pennsylvania, United States, 19610
`United States, Rhode Island
`[Recruiting]
`Providence, Rhode Island, United States, 02903-4928
`United States, South Carolina
`[Recruiting]
`Charleston, South Carolina, United States, 29414
`[Recruiting]
`Columbia, South Carolina, United States, 29223
`[Recruiting]
`Greenville, South Carolina, United States, 29605
`[Recruiting]
`West Columbia, South Carolina, United States, 29169
`United States, South Dakota
`[Recruiting]
`Rapid City, South Dakota, United States, 57701
`United States, Tennessee
`[Terminated]
`Memphis, Tennessee, United States, 38119
`[Terminated]
`Memphis, Tennessee, United States, 38120
`[Recruiting]
`Nashville, Tennessee, United States, 37203
`United States, Texas
`[Recruiting]
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`23/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 23
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`Abilene, Texas, United States, 79606
`[Recruiting]
`Austin, Texas, United States, 78705
`[Active, not recruiting]
`Corpus Cristi, Texas, United States, 78413
`[Recruiting]
`Dallas, Texas, United States, 75390
`[Terminated]
`DeSoto, Texas, United States, 75115
`[Recruiting]
`Ft. Worth, Texas, United States, 76102
`[Recruiting]
`Ft. Worth, Texas, United States, 76104
`[Withdrawn]
`Galveston, Texas, United States, 77555
`[Recruiting]
`Houston, Texas, United States, 77030
`[Withdrawn]
`Houston, Texas, United States, 77030
`[Terminated]
`Houston, Texas, United States, 77030
`[Recruiting]
`McAllen, Texas, United States, 78503
`[Recruiting]
`Odessa, Texas, United States, 79761
`[Recruiting]
`San Antonio, Texas, United States, 78240
`United States, Utah
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`24/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 24
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Salt Lake City, Utah, United States, 84107
`[Recruiting]
`Salt Lake City, Utah, United States, 84132
`United States, Vermont
`[Recruiting]
`Burlington, Vermont, United States, 05401
`United States, Virginia
`[Recruiting]
`Charlottesville, Virginia, United States, 22908
`[Recruiting]
`Fairfax, Virginia, United States, 22031
`[Recruiting]
`Richmond, Virginia, United States, 23221
`United States, Washington
`[Recruiting]
`Seattle, Washington, United States, 98104
`[Recruiting]
`Silverdale, Washington, United States, 98383
`United States, Wisconsin
`[Recruiting]
`Madison, Wisconsin, United States, 53715
`[Recruiting]
`Madison, Wisconsin, United States, 58705
`[Recruiting]
`Milwaukee, Wisconsin, United States, 53226
`Canada, Alberta
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`25/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 25
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Calgary, Alberta, Canada, T3E 7MB
`Canada, British Columbia
`[Recruiting]
`Vancouver, British Columbia, Canada, V5Z 3N9
`[Recruiting]
`Victoria, British Columbia, Canada, V8V 1B3
`Canada, Nova Scotia
`[Recruiting]
`Halifax, Nova Scotia, Canada, B3H 2Y9
`Canada, Ontario
`[Recruiting]
`London, Ontario, Canada, N6A 4G5
`[Recruiting]
`Mississauga, Ontario, Canada, L4W 1W9
`[Recruiting]
`Ottawa, Ontario, Canada, K1H8L6
`[Recruiting]
`Toronto, Ontario, Canada, M4N3M5
`[Active, not recruiting]
`Toronto, Ontario, Canada, M5C 2T2
`Canada, Quebec
`[Recruiting]
`Montreal, Quebec, Canada, H1T 2M4
`[Recruiting]
`Montreal, Quebec, Canada, H3A 1A1
`Canada, Saskatchewan
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`26/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 26
`
`Joining Petitioner: Apotex
`
`

`

`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Regina, Saskatchewan, Canada, S4T 1A5
`
`IPDSharing
`
`References
`
`Plan to Share IPD:
`
`Citations:
`
`Links:
`Available IPD/Information:
`
`Scroll up to access the controls
`
`Scroll to the Study top
`
`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`27/27
`
`Mylan Exhibit 1014
`Mylan v. Regeneron, IPR2021-00881
`Page 27
`
`Joining Petitioner: Apotex
`
`