Loading...
CR Documents 06/14/2022 R c 'J Ce 'CJ < c0 = z_ n W w >- _ > --I maz F- o - ct 41 14 p z zo Q w >- < < < Z CD = 0 m o U z > F2 = 0 W O_ w a A cn F- O c.%) O � z0 0 � o CD Q W Q O cn � w LU �a .< W a. ` 1Qcn W � m -J .c O ui Ce F- J I O o 0 Q z § Q o Z W_ I Q OU O o J Q U O u- N0 °� Z mfy O 2 W w a LI- Q co I- i z w J O cn oz F= w W O CL5Q � o = F— = _j ono I- E g -' mz = =O � 0 0 oE Li] o � = m �. U s N Q _ w LL. O p 1a- c,- C -± ~ CL z H < Z F- = O - Z � M 5- 2 Z tL }� c u O V/ Noo i- M W F_ 2 Q o -1 cr j O O ce Z W F- 0- Q U < ccnn W oQ LP- ,--_,... Zz3 W in C z z - = w im H C5 u� r- z W J 1 W\ o0w O I- - a z W 0 - z w O J Wcn cnZ U Z W ;, � o .- F- zm v W o - w CD 0 a) U Q s ✓ C (= Q CT) co asc .a c -� O C �- N C) c L CM '411a E ct. < C Z Ce Ce Q 0 `4 = z >-- 0 r z W w >- o T mww >- Qo O J z W Job Z ww J Q O = C.)I QQ Q I- F- jQ 0co z Zi mw WwQn ry 0 1-1-1 u) I-A 3 wzo = o c cocC Q wY aIcw ww0 O Ycn J ni. :ic a5 i ( Qw w °) m { % 0 O Q z J I O NF- z w - Q ,., J oo - 0 Ez o in s Q U O _ CD 1- mmpI- 0 O Z O LUMW [L u I- CJ t� m F- w W .� Q Q Q O w --I Om N.,... . oz0 O F= u._ W O v 050 O H a) z m O O I-- E o =F- w w CI) w W V z W 0) W m c� wE O � E Q to ¢ ? W V- Ow 0 F- "0 a P. QQU W O = I- -0 � zm Oz z Q mI_ Z v Oo ¢ 114 (\\ . 0zrw o0_ O U ¢ � W oQ LL zz0 W wz 0 \ ce oO W .•• z0 � zU c---\ E z___ --:: i_... 1-- rY w �1 a � zz I— O � n . I zw0 0 zw 0 � wC W Wz O Z I L Oo � I- z � w E _ U J o = a) 1, +' p � W 0 I- CID U Cm!) El- Q J = = m J _ F+_ 0 ^ o N >- c a) 11...) a E 0- Q n z et Ce Q 0 = z r C.) Z5 c = W w >- CCI u_ w ›- ° 0n J za W CC � Z2J_1 0 0 C..C...)a fl i O z ¢mo in Z W o aU '- = o _Int- r _ � � cz-nw Q � a Q � 1.11 wY W o O Ycn J moo ¢ H- wa d cJecn LLJ � m I N o Now Q wJ a Ili ooz 0 2 0 ova U0 I-- No °w° Z ? 0E. O zmQ zw W a• a O cn J � o S ZC70 O O " � zQ C# 00 = o ~ 1� >- JC° = rt2 O E E 0oz_2 O � O 0 00) O �' w � J - o o 0 w � � 0 u) 2 m as - � 1 U) Q > w O O o I-- o La ¢ aw W � 0 = M0 = I- CC CD I-- < .� "' z = Z OY Z J om � Q - O 0J M o0 O z >- W �. I__ O_ v 0 < w W aQ u. c zzc5 W oz 0 zz � = w � FW- E5 C� L._ Z 2 �� J> o <cw O 1. a. N Ul r_ wo 1- 0M M 'N' w u5 W cn z C.) Z Nt as � � n ~ zm C.) U J nw J CI- a) ► Jp � W o 1 �- � U = U cCa n Q co • °' O a- C o C >- a) N a ap ID_ < m E re C4 a = Z >-- U cr' 1— 1= ~ D w1 = >-Hil I...z W W < Z-I 0 0 = U I— OW CO z > z q) m _ � w ww coma OC Oz _, it LU ? Zo CI cno CO cn a 1 w Q O � � wY W • aQ O w ¢ a H r, O O ? Ce act z --A0 N 1- 3 W § Q 13 z ILI Z CI Z W S 2 c O O = 9 JQ i UO 1-- 40 0 1- O E- = o0C° Z mo 0 w F- 1=- W a lL �V zm1- 5 zw W Q Q Q 0 OW Qo zc5o O f= LL w Q N ♦ CL 6 Q U 00 = ODO Ce cn 1- ~ >— a c[ O EE - Z = O O E" E � � F- >" J � W CD V •' Z w O w w co CC "ig W C) Q H Lim OL O F- 73 a La QQv W O = C LL -a •S LozF OZ z Q J om =_ z ¢ F, O Q c0 5 WE 5 OJcc M OO O �� Z >- W � W o < cw W c U- N. ¢ z = ZO W ,. • z CD LOG w cn E- 1 \4 k.) oQ "' ~ z � LU • z � O, OELL' en w u5 W cnZ CaZ � M a � _ = zm s U U-I E , , O J JwU w rz OzQ+ , 4 Ow I- 9 U Q CL c=/) Q V o% \� u) c a) m a E Q- Q M z z 0. Ce Q (9 = z_ >- C.) E5 n u) D = w '- mOLLw › z0 Q L Job J — w W � Ct Z cw7 = U O �., \� m wC ) zw Z¢ o � > _ F- wn W• = cti— == Ja = c 0 0 0 w � ( w �Q0Q co CC wLil } 1111 = wo O < ci) J N < W Id upm N.- wUo N �z Ce Qw CO J 0 co O 0 1- U o071- m Z m171 ct O wz = W wa .� Q t Q m Q Z. J 0.0 Zoo O i= u_ w 0 v p Q V 0 O = OD0 m I— ~ >- -1m D (YII O E 1 v �. oz = O 40 I— E- e- J U W \ z E 0w mw =w F- QU0 N > � LL O p '� a �" ¢ ¢ v Liu p = c LL N V co (7 = I- p 1� < _j MOH oZ Z 0) \ c o w E n Qzz >- w � � ix 0 (i U <2 W Z zzW = wcn F— l '..‘ c U a ~ z w J tJ >- z z 0 c in ,i ` zw0 p zw O 0 \ � w �n cnz 0 cn W Z L 0U0 � H zm 1-1-1LL EO w m PI2 � � Q .j U J El] J G) \ .... '+r Jp W 8 F a IMIM I �) a U 01 c= Q U J CU C = m -a o c 0 0 co cu E r Q Q C Z Ce W Q 0 = z_ >-- U cn u) z W w >- _ > = J m (Dz ~ ce L. w >- 0 J Z as W � � z 0 0i U Qmoz >co Z ~ = o W o � a u) 1- w c _ � 0o i F2 w � zw p co to �of wz 0 ry ¢ Q J moo ¢ F- ww 0.. a) , < u) W � m �- w O R'I L2 n Q ,zi, Q o o - CI � z CI¢ h- 0 Z 0o W ¢ O — J I- 1 No Vm Zo O w UUi a v znwL < o. Q < 0- , zc7o O f= u_ w O N acoQ 2w = c E 0° z = O w o F- w �~ > - W 0 zzw � 1.1 cn w COA� U _r > F- U) ¢ w IJ.. O O V a ¢ ¢ " W 0 _ o o I— CC F- ="CS oZ Q = ZU Oom ¢ Nd �o mQ Zrw p \ so ♦ z ¢ ~ 'caw u- vnW Z z CD W zzwoc � � � = o z C wwLU I-- z LLI � z CD ~z o � M zzwcmw O O ow cL c W � z U Z ' a) 0 0 ~ z m U w E oo wmo r Q 4ye. 0 J = a p - w 8 ,I .�� ` U co= Q Ce m as a dclIS �+ O C 0 a) > N C CD L) m E Q- Q 2 z ce / i ✓ z_ in • O H z C� O re J 0w a z W J 1� U V I w W r Q O = _ w >- `n w = H oD __I ce m ~ > ¢ O Q cA J J z la_ W Z W W J F W O 0w 1- .2. c~i) � U zj Z rW W wLijQ § J O 0 - O W O_ < w L W a) 1 W W � m I W 0 ,. z J _ z � Z � w O 0 j Q 00 W 000 Z m � Q V `'' off M a � U- .. - Q zoo zw W ¢ mz 0co J 0 W up 0 O O W r (-sO w 0co O eL O 01- w♦ ? -- zW _ wtx W Vim/ zfxce (X N W -I J — o y 000 O (6I- Q CQm u" 00 F- 0e_s-W c W giml:: a � m0 � F-ma ft0 II--.o a • O � Q Z oZ Z av —Z 0 O z _1 < — Q - w � ¢ � w � M . < 0 00 U u) 0z Oa O 19 V-- 0a 9 0 W s oz 1- W p Np ZW J O1 0 - 2 a . \, z v I- o u zZ W u) z OU Z L Q I_ 1-LT, v) w �cr, W 47. 0f- 0 J 2w J W < W ore 0 I a --EhZ Q J co 0 co 72 0 a) w= O >- W c __IN d J } Q / Ce a = Z i— z w cC co- 0 Z Q O m2u_ w Q O w Z 0 w e' � 0 � Z ww w ca co �¢ o = w j Z wCO ~ � w Ce o __ILL' a O I 0 o o w v cz00 — c0to � 1woY J � 0 ¢ 1-- wQ a. ✓ `J o ¢ � w � J cn O gl O D Q Z J �, DDZ o w - a J Zw � Z z CI 1 S - Q 8o o f— m I-- = o u. c.izw Z CO O V 0 ( < U = � . ALL U- ■Qo QmQ M CD- J zU0 cn 0 n V CC p Q U 0 0 = O lJ S m0w 0 wct O o (- 0 �H O a_ O I- .�..r z Oi- cl' w m Y O , _ _ < F w u- 0 o < i Q 0 U W p w 'Croi op ri C� =u-I I- co I- CD Q L9 } F-- 0 Oz Z oO m L¢ � m aOJ � 0Q J wz � O v ¢ c/) w DJ V- zzC� w wz 0 Z W0z _ = c¢ 1- z O E I- = w z z02 M zwo 0 zW O Z OCCU w 2z 0 . d-2 U OJ Z D w uw_ 2 M wm U vpw- m UJL_ QwQ) a000 w O 0- = Q U0 I- CU co N m C co O S CA C m m CO fi) as a) Q H Z Ce BEFORE THE GOVERNING BOARD OF THE SOUTH FLORIDA WATER MANAGEMENT DISTRICT RECEIVED DISTRICT CLERK'S OFFICE SOUTH FLORIDA WATER 4:07 pm Jun 8, 2022 MANAGEMENT DISTRICT, SOUTH FLORIDA WATER MANAGEMENT DISTRI T Complainant, v. SFWMD No. 2022-029-CO-ERP HIGHLAND PROPERTIES OF LEE AND COLLIER, LIMITED Respondent CONSENT ORDER This Consent Order is entered into between Complainant, South Florida Water Management District ("District"), and Respondent, Highland Properties of Lee and Collier, Limited ("Respondent"), by mutual consent who agree as follows: FINDINGS OF FACT 1. The District, a government entity created under Chapter 373, Florida Statutes, is a multipurpose water management district with its principal office located at 3301 Gun Club Road, West Palm Beach, Florida 33406. 2. Respondent is a person within the meaning of Section 373.019(15), Florida Statutes. Respondent's mailing address is 6980 Sandalwood Lane, Naples, FL 34109. The Respondent requests that correspondence also be sent to Harrison Hubschman, 525 Sol Street, Naples, FL 34109. 3. The following exhibits are attached and incorporated into this Consent Order for reference purposes: Exhibit A— Location Map; Exhibit B — Recorded Conservation Easement; Exhibit C — Draft 2020 Consent Order (excluding exhibits); Exhibit D — Pre-Application Meeting Request Form; Exhibit E — Notice of Rights; and Exhibit F — Notice of Consent Order 4. Respondent owns property with Parcel Identification Numbers 00407360000, 00407320008, 00408160005, 00408400008, 00408440000, and 00406720007; located in Section 9, Township 50 South; Range 26 East; Collier County, Florida ("Property"). The Property is shown on the location map attached as Exhibit A. 5. The District has jurisdiction over the Respondent, the Property, any stormwater management system, wetlands, wetland impacts, all works, and maintenance activities conducted on the Property as provided in Chapter 373, Florida Statutes. 6. On September 13, 2010, the District issued Respondent Environmental Resource Permit No. 11-03160-P to construct and operate a stormwater management system for an 82.51-acre residential and commercial development known as Taormina Reserve ("Permit"). 7. On February 22, 2018, a Conservation Easement was recorded in the Collier County Official Records, as required by the Permit ("Recorded Conservation Easement"). The Recorded Conservation Easement is attached as Exhibit B. 2 8. On July 31, 2019, the District issued Respondent a Notice of Violation for the unauthorized filling and dredging of wetlands encumbered by the Recorded Conservation Easement, and for the removal of native vegetation from within the Recorded Conservation Easement ("2019 NOV"). 9. On March 20, 2020, the District sent a Draft Consent Order to Respondent to resolve the noncompliance identified in the 2019 NOV ("Draft 2020 Consent Order"). Respondent never signed nor returned the Draft 2020 Consent Order to the District for execution. Thus, the violations identified in the 2019 NOV remained unresolved. The Draft 2020 Consent Order, excluding exhibits, is attached as Exhibit C. 10. District staff inspected the Property again and observed that the project was not in compliance with the following Special and General Conditions of the Permit: a. Special Condition 28: conservation areas must not exceed 5% total cover of exotic and nuisance plant species. b. General Condition 3 and Paragraph 3 of the Conservation Easement: Respondent must implement best management practices, and is prohibited from placing material such as fill, trash, or waste within the conservation area. In addition, no trails are authorized within the conservation area. c. Special Condition 29: permanent physical markers, i.e. preserve signs, are required. 11. Additionally, the berm adjacent to the conservation area was not constructed in accordance with Exhibit 2.0 of the Permit. 12. The District issued Respondent a Notice of Noncompliance for the violations identified above in Paragraphs 10 and 11. The violations remained 3 Ulb l'RU9.I unresolved, so the District issued a Final Notice of Noncompliance on December 7, 2020. 13. On September 8, 2021, the District issued Respondent a Notice of Violation for the violations identified above in Paragraphs 10 and 11 ("2021 NOV"). The 2021 NOV stated that staff costs and penalties would be reassessed because that the Draft 2020 Consent Order remained unsigned, leaving the initial violations unresolved. 14. District staff conducted eight site inspections between the issuance of the Draft 2020 Consent Order and the 2021 NOV. The inspections revealed that Respondent had not resolved the previous violations and that the project remained out of compliance with the Permit. 15. Respondent has now resolved the violations identified in the 2019 NOV and 2021 NOV to the District's satisfaction. 16. By entering into this Consent Order, Respondent provided the District with reasonable assurances of good faith and the District agrees not to initiate an enforcement action for the violations described above. Respondent agrees that all factual and legal claims providing the basis for this Consent Order, including all terms, provisions, and matters referred to in the Findings of Fact and Conclusions of Law, shall not be contested in any subsequent legal proceeding, which may be brought to enforce the terms of this Consent Order. CONCLUSIONS OF LAW 17. As provided in Rule 62-330.020, Florida Administrative Code, and Sections 373.413 and 373.416, Florida Statutes, the District requires permits to construct, alter, operate, or maintain stormwater management systems or works 4 016390 3,1 including activities that impact wetlands. The activity must not harm the District's water resources. 18. The District finds that Respondent violated Chapter 373, Florida Statutes, and its corresponding rules, by not complying with the Special and General Conditions of the Permit. 19. The District may initiate and maintain legal action to enforce its rules, permits, and orders, or to protect and preserve the state's water resources as provided in Section 373.129, Florida Statutes. The District may recover a civil penalty for each offense in an amount not to exceed $15,000.00 per offense. Each additional day in which a violation occurs will constitute a separate offense. The District may further recover investigative costs, court costs, and reasonable attorney's fees. THEREFORE, having reached resolution of this matter, it is ORDERED: ORDER 20. Within 15 days of the effective date of this Consent Order, Respondent shall voluntarily dismiss without prejudice its Petition for Formal Administrative Hearing challenging the District's decision to deny a permit extension under Section 252.363, Florida Statutes. If Respondent obtains an ERP, as required under this Consent Order, and if such ERP is challenged by a third party, the Respondent may properly refile an identical or substantially similar Petition for Formal Administrative Hearing challenging the District's decision to deny a permit extension under Section 252.363, Florida Statutes, and the District agrees that it will not dismiss the petition on the grounds of timeliness and will not otherwise challenge the timeliness of the petition. 21. Pursuant to the terms of this Consent Order, Respondent must pay the District a total of$29,550.00 in civil penalties and costs for settlement of 5 the violations identified in this Consent Order. This amount includes $27,050.00 in civil penalties and $2,500.00 for the District's costs and attorney's fees incurred during the investigation of this matter and for preparing and tracking this Consent Order. Respondent shall pay $2,462.50 every month for twelve (12) consecutive months. The First payment shall be made within ten (10) days of the effective date of this Consent Order, the second payment shall be made by the third day of the month following the month of the first payment, and each payment thereafter shall be paid by the third day of each following month. For example, if the first payment is made on November 5th, the second payment is due by December 3rd, the third payment is due by January S'd etc. Payment shall be made by cashier's check or money order. The instrument must be made payable to the "South Florida Water Management District" and must be delivered via U.S. Mail or hand delivery at the following address: South Florida Water Management District, MSC 9210, Environmental Resource Bureau, 3301 Gun Club Road, West Palm Beach, Florida 33406. Respondent agrees that these amounts are reasonable and shall not contest them in any subsequent action regarding this Consent Order. 22. Within 30 days of the effective date of this Consent Order, Respondent must request a pre-application meeting. The pre-application meeting must be requested by submitting a Pre-Application Meeting Request Form via email to erpreappsfwmd.qov. The Pre-Application Meeting Request Form is attached as Exhibit D. 23. Prior to conducting any construction activities Respondent must obtain a new ERP for the project, which shall include a revised mitigation and monitoring work schedule. 6 mom,' 24. Within 90 days of the effective date of this Consent Order, Respondent must submit a complete ERP application. This application must be substantially complete upon submittal. If a Request for Additional Information ("RAI") is necessary, a complete written response to the District is required within 30 days of the RAI. Respondent shall obtain an ERP within 365 days of the effective date of the Consent Order. 25. Once an ERP has been obtained and prior to construction, Respondent shall request a pre-construction meeting with District staff. District staff will verify that all noncompliance items detailed in the 2019 NOV and 2021 NOV remain corrected, including installing the necessary best management practices and preserve signs, and removing trash and debris from the Recorded Conservation Easement. Construction shall not commence until the District has verified that all noncompliance items are corrected to the District's satisfaction. 26. Respondent agrees to pay the District stipulated penalties in the amount of $100.00 per day for each day Respondent fails to timely comply with any of the requirements of this Consent Order. A separate stipulated penalty shall be assessed for each violation of this Consent Order. Within 30 days of the District's written demand, Respondent must make payment of the stipulated penalties to the "South Florida Water Management District" by cashier's check or money order. The District may make demand for payment at any time after a failure to comply occurs. Nothing in this paragraph shall prevent the District from filing suit to specifically enforce any of the terms of this Consent Order. Any stipulated penalties assessed under this paragraph shall be in addition to the settlement sum agreed to in Paragraph 21 of this Consent Order. If the District is required to file a lawsuit to recover stipulated penalties under this 7 paragraph or to enforce this Consent Order, the provisions pertaining to stipulated penalties are waived and the District is not foreclosed from seeking civil penalties of up to $15,000.00 per offense per day, costs, and attorney's fees for violations of this Consent Order. Should Respondent not obtain an ERP within the timeframes under Paragraphs 22-24 due to the District's delay in processing the application, such delay shall not constitute a failure to timely comply with any of the requirements of this Consent Order. GENERAL PROVISIONS 27. District representatives may enter the Property at reasonable times to verify compliance with this Consent Order. Respondent's failure to comply with this Consent Order shall constitute a violation of Chapter 373, Florida Statutes. 28. Should Respondent fail to meet the requirements set forth in this Consent Order, the District reserves the right to petition for judicial or administrative enforcement of its terms. In such event, Respondent shall not contest or deny any fact, legal conclusion, or any other matter or fact set forth in this Consent Order, including the Findings of Fact and Conclusions of Law, penalties, fees, and costs. However, Respondent reserves the right to contest any allegation of such failure to meet the requirements set forth in this Consent Order. In exchange for the District not initiating legal proceedings and by signing below, Respondent waives all rights set forth in the Notice of Rights, attached as Exhibit E. 29. If the District successfully petitions or sues for enforcement of this Consent Order, Respondent agrees to and must pay the District's attorneys' fees, including, but not limited to, the fair market value of in-house counsel fees as if performed by outside or private counsel, court costs, and any other damages. 8 0tb39039-I 30. The District expressly reserves the right to initiate appropriate legal action to prevent or prohibit the future violation of applicable statutes or the corresponding rules, or to alleviate an immediate serious danger to the public health, safety, or welfare. If Respondent's non-compliance with this Consent Order leads to the District bringing an enforcement action, Respondent consents to receive service of process by registered mail with no signature required, delivered to Respondent's address. 31. This Consent Order shall take effect after the Respondent and the District's (collectively, "Parties") execution, and shall remain in full force and effect until its terms and conditions are completed to the District's satisfaction. 32. In addition, prior to any sale, transfer, conveyance or lease of the Property, Respondent must provide a copy of this Consent Order to any prospective purchaser or successor in interest. Respondent shall provide notification to the District of the sale, transfer, or conveyance of the Property within 30 days. 33. Respondent, as the Property owner, consents to the District recording notice of this Consent Order in the Collier County official records utilizing Form 62- 330.090(1), Florida Administrative Code, attached as Exhibit F. The terms, conditions, covenants, and provisions of this Consent Order encumber the Property, run with the Property, and are binding upon and inure to the benefit of the Parties, their heirs, successors, and assigns, and all subsequent Property owners of the Property. 34. Entry of this Consent Order does not relieve Respondent of the need to comply with all applicable federal, state, and local laws, regulations, or ordinances, including District permitting requirements. This Consent Order does not give Respondent the authority to conduct any activities on the Property that are under the District's jurisdiction without first obtaining District authorization. 9 U I fiy➢ll 9.l 35. If any event causes delay, or reasonable likelihood of delay, in complying with the requirements or deadlines of this Consent Order, Respondent must prove that the delay was or will be caused by circumstances beyond Respondent's control. The failure of a contractor, subcontractor, materialman, or other agent who Respondent delegates to meet contractually imposed deadlines shall not be considered a cause beyond the Respondent's control. 36. Upon an event causing delay, or upon becoming aware of a potential for delay, Respondent must notify the District verbally within 24 hours, or by the next working day. Within 7 days of verbal notification, Respondent must notify the District in writing of the anticipated length and cause of the delay, the measures taken or to be taken to prevent or minimize the delay, and the timetable to implement these measures. If the District agrees that the delay or anticipated delay has been or will be caused by circumstances beyond Respondent's reasonable control, the time for performance may be extended for a period equal to the agreed delay. Such agreement shall be set forth in writing and include all reasonable measures necessary to avoid or minimize delay. The Respondent's failure to comply with the notice requirements in a timely manner shall constitute a waiver of Respondent's right to request an extension of time for compliance with the requirements or deadlines in this Consent Order. In the event it is necessary for the District to initiate legal action regarding this Consent Order, such action may be initiated in the Fifteenth Judicial Circuit in Palm Beach County, Florida. The District also reserves the right to seek administrative enforcement by issuing an Administrative Complaint and Order for Corrective Action. If the District pursues 10 016 i901')-I administrative enforcement, any final hearing shall be located at the closest District facility to the subject Property, unless the District agrees otherwise. DONE AND SO ORDERED in West Palm Beach, Palm Beach County, Florida, this 8th day of June 2022. SOUTH FLORIDA WATER MANAGEMENT DISTRICT Regu ' n Division dill--s: eec Da STATE OF FLORIDA ) COUNTY OF PALM BEACH ) The foregoing instrument was acknowledgedpefore me by means of Q physical presence or ❑ online notarization, this An day of ow_ , 2022 by Jill S. Creech. � = 1aoa� v /'/ - Sj ature of Notary Public— State of Florida Print, Type, or Stamp Commissioned Name of Notary Public t/ .:,,,,,'-. JUANITABOZEMAN Personally Known " OR Produced Identification „: °= CommissionHHO85lsa �4 ;; Expires February 5,2025 Type of Identification Produced 'E.2!,.rN°. Bonded fin Frey Fain Insurance 600-385.7019 G ral Couns Concurrence 51 k1aa, J is Lomonico, Interim General Counsel Date 11 01G39039-I RESPONDENT — HIGHLAND PROPERTIES OF LEE AND COLLIER COUNTY, LIMITED BY: � , 'f-"- �� '5/0/2 z__._ Signature Date PRINT NAME: /IA-?/2 i'J b/p/53cL/71/1AalA TITLE: (;)wtA el;/C,-,,,t- z_L_ Av°7---;i ev^ STATE OF FLORIDA ) COUNTY OF83///?/- ) The foregoing instrument was acknowledged be/fpre me by mans of" physical presence or ❑ online notarization, this /1i f) day of , 2022 by Signs ure of N tary P i 6 S e of lorida Print, Type, or Stamp Commissioned Name of Notary Public IT' ., r :'«n`'gig;,„ MAYRA L.CESPEDES .,2` `c*; MY COMMISSION N GG 336326 Personallyknown OR Produced Identification -,; '' Exf'IRES:August 7,2023 'F ° Bonded Th Public Underwriters o, r Type of Identification roduced 'o:r"" :.._— ru Notary - - f--IAk r sok.; //C13Sc_t-If-(/ r-J , ( G-u 114. iJC2_ (name of acknowledging partner or agent) Highland Properties of Lee and Collier Limited, a Florida Limited Partnership, on behalf of a partnership. 12 ti1 aet/IV 1ld '+ r 4.: bII. t lv tt• ,\'` , 4' „ ) s� sill4p,\ 'e✓ ' *� ( i e r + .1 + ,y ti '. d��v .'. 1 !' a , w " e I'.e, -_n rrc.. a . ;~1 :S! ♦i ♦ e.} i eta+1,1. ��! f • -. ! 'f t '•'; / r 1 •�' rt' Zf Y o.i t� ,tit «V i OPJ^ `'. r ��f.' + i I ,+ r fit r 1-12 . stok, il ` -. ,/ K ../,. + -4, _+r r i + e S '�ye�' t •Y t i .'7x -+�,.. :• ` f ' 'F.'k. * .. '41'.....a.ad ' ''' —. .• 7 il I 4 , , i • ,,,,,,,- . , .. .. . ,. .,„ %r-- • I ' — •, t. + + •..S,ti'^. - .r' 3 i i Yam, _1* . 0• : . „,In '? 'Aciiii:iti.E4 44_ t _ Fr3L f )1 Tit fi it " c •'t'_ •S I 'j e• b 4 .`' y � + - r,irtlV '�- 'y� �. �+ .• •'� �i MARTINS F •.. '" 1 ..,,.,,.++ O : y �y s :.t• :. fj�.� <.• as a _ R tr ♦. ter'. V+. ,!.a a J .tBAYOU '`� • EWIN,yG�qLN s C. '/ M*414'7 �r;1 liCt%J v rt' +l in. :) `: .ri f, 'a'1 4. ,4 I I c F (. (`J\ c. s l ''' COP LN ' - I COPEfI LN { • l� • itr.. I e ; � z ANJ. ; ' .-, 4 • 4 iam• `k Y Z " i..:;y tip ' t COUNT D !!! r .✓ r,,. 1 --- _ — T �¢ a f X ,,;. N,. M ? C35, off;^ :�s. o. x I`WEFNDYL•i_,•, ` , rn a ° lir k , ^- '• s4 R �VVHITAKER RD. Z 11VHITAK- .'�• x I ti 3 DP N� � Rr ,f, ri o J lS < i, Q4 J , it r";"F'{`jy-y� k)ea W'.yti , •,O \\ /GI.� ,' `rye i ,u'I e7 i �)'��f M� t►`j�i Y. A'T ' r O _, IP" ,�+�' ,:�, II • y��� { � I L l , fir a. r: OQ• N1i`. a] Y , e ALLY A ROW AVE 4 e rWi MD G-d'Spatia�lh-;iiv � ' Exhibit Created On:Exhibit A 2017-07-21 COLLIER COUNTY, FL TAORMINA RESERVE REGULATION DIVISION Cost Code 11252 TAORMINA RESERVE & SEYCHELLES G IA.-MI ems, N A ....•11.4l 0 1,400 2,800 `� South Florida Water Management District Feet ,...,C+, INSTR 5514665 OR 5480 PG 330 RECORDED 2/22/2018 2:08 PM PAGES 8 RE-RECORD DWIGHT E. BROCK, CLERK OF THE CIRCUIT COURT, COLLIER COUNTY FLORIDA DOC@.70 $0.70 REC $69.50 ''conservation Easement not to be recorded until the issuance of permit for Application No.070405-4 and Zoning" SOUTH FLORIDA WATER MANAGEMENT DISTRICT DEED OF CONSERVATION EASEMENT Return recorded document to: South Florida Water Management District 3301 Gun Club Road,MSC 4210 West Palm Beach,FL 33406 THIS DEED OF CONSERVATION EASEMENT is given this day of September , 20 09 , by Highland Properties of Lee and Collier,Ltd. 6980 Sandalwood Lane,Naples,FL 34109 , ("fir; , ("Grantor") . whose mailing'�0� address• is /t'�!r to the South Florida Water'Management District("Grante ' ! As used herein, the term "Grantor" shall include any and,all heirs,,successors or assignp.of'the Grantor, and all subsequent owners of the.,"Property" (as hereinafter defned)' the term "Grantee" shall include any successor or assignee of Grantee. ! / \ ,\ JTNESSETH L.) WHEREAS, the Grantor 'Is- tt+il F owner of certain lands situated in Collier -County, Florida, and more specifically described in Exhibit"A"attached hereto and incorporated herein ("Property"); and WHEREAS, the Grantor desires to construct Taormina Reserve ("Project") at a site in Collier County, which is subject to the regulatory jurisdiction of South Florida Water Management District("District"); and WHEREAS, District Permit No. Application No.070405-4 ("Permit") authorizes certain activities which affect surface waters in or of the State of Florida; and INSTR 5512452 OR 5478 PG 2449 RECORDED 2/19/2018 12:43 PM PAGES 8 DWIGHT E.BROCK, CLERK OF THE CIRCUIT COURT COLLIER COUNTY FLORIDA DOC@.70$0.70 REC$69.50 ..rSeniand.9 Form 1191 (01/2007) Deed of Conservation Easement-Standard Passive Recreational Page 1 of 9 Exhibit 3.6 Application No. 070405-4 1 of 6 EXHIBIT B Page 1 of 8 OR 5480 PG 331 WHEREAS, this Permit requires that the Grantor preserve, enhance, restore and/or mitigate wetlands and/or uplands under the District's jurisdiction; and WHEREAS, the Grantor has developed and proposed as part of the Permit conditions a conservation tract and maintenance buffer involving preservation of certain wetland and/or upland systems on the Property; and WHEREAS,the Grantor, In consideration of the consent granted by the Permit, is agreeable to granting and securing to the Grantee a perpetual Conservation Easement defined in Section 704.06, Florida Statutes, over the area described on Exhibit "B" ("Conservation Easement"). NOW, THEREFORE, in consideration of the issuance of the Permit to construct and operate the permitted activity, and as an inducement to Grantee in issuing the Permit, together with other good and valuable consideration, the adequacy and receipt of which are hereby acknowledged, Grantor hereby grants, creates, and establishes a perpetual Conservation Easement for ands'.;farr-:of.t�he Grantee upon the property described on Exhibit"B"which shag,ri rr,vy t._1a. dir `;be binding upon the Grantor, and shall remain in full force and e tforev .. '.;6 er. ` `{ . \ The scope, nature, and";iraicter of this Conserva't;ton Easement shall be as follows: j� /f ),z—a. ._.. _ ` 1 1. Recitals, Thei'rec ein-gifdx#`_- 7*-r 4serhent ue And correct and are hereby Incorporated into anti mr ia pert Of t)is o ei'v icl . 2. Purpose. It is>!ne urpose of this ConsWVatiot Ea's' rrlent to retain land or water areas in their natural, v g tative, hydrologic, s i�c,pp .;*ricultural or wooded condition and to retain such are .`as suitable habitat for.-fli plants or wildlife. Those wetland and/or upland areas in'efuded.,in the Conservatio •Easement which are to be enhanced or created pursuant to`We,P`firrnit-shall-beiretOirted and maintained in the enhanced or created conditions required* Q i eftiiit ::--' To carry out this purpose, the following rights are conveyed to Grantee by this easement: a. To enter upon the Property at reasonable times with any necessary equipment or vehicles to enforce the rights herein granted in a manner that will not unreasonably interfere with the use and quiet enjoyment of the Property by Grantor at the time of such entry; and b. To enjoin any activity on or use of the Property that is inconsistent with this Conservation Easement and to enforce the restoration of such areas or features of the Conservation Easement that may be damaged by any inconsistent activity or use. 3. Prohibited Uses. Except for restoration, creation, enhancement, maintenance and monitoring activities, or surface water management improvements, or Form 1191 (01/2007) Deed of Conservation Easement-Standard Passive Recreational Page 2 of 9 Exhibit 3.6 Application No. 070405-EXHIBIT B 2 of 6 page 2 of 8 OR 5480 PG 332 • • other activities described herein that are permitted or required by the Permit, the following activities are prohibited in or on the Conservation.Easement: a. Construction or placing of buildings, roads, signs, billboards or other advertising, utilities, or other structures on or above the ground; b. Dumping or placing of soil or other substance or material as landfill, or dumping or placing of trash, waste, or unsightly or offensive materials; c. Removal or destruction of trees, shrubs, or other vegetation, except for the removal of exotic or nuisance vegetation in accordance with a District approved maintenance plan; d. Excavation, dredging, or removal of loam, peat, gravel, soil, rock, or other material substance in such manner as to affect the surface; e. Surface use except ter purposes that permit the land or water area to remain in its natural or enhanced conditieW, r;.x`f` t4� f. Activities.detritrfental to drainage, flood'control, water conservation, erosion control, soil conservation,gr fish and wildlife habitat,preservation including, but not limited to, ditching, diking and fencing; .,.� g. Acts or uses!detrim ntal td such afoteiiientio`ned retention of land or water areas; ,t\ r N. )'... `,.. ..4 , 1 , h. Acts at, uses which are detrimental to the preservation of the structural integrity or physical appearance of site, or Rebottles having historical, archaeological, or cultural significance. 4. Passive Recreational'Facilities. .Grantor reserves all rights as owner of the Property, including the right to engage in use's.of-the Property that are not prohibited herein and that are not inconsistent with any District rule, criteria, the Permit and the intent and purposes of this Conservation Easement. Passive recreational uses that are not contrary to the purpose of this Conservation Easement may be permitted upon written approval by the District. a. The Grantor may conduct limited land clearing for the purpose of constructing such pervious facilities as docks, boardwalks or mulched walking trails. b. The construction and use of the approved passive recreational facilities shall be subject to the following conditions: i. Grantor shall minimize and avoid, to the fullest extent possible, impact to any wetland or upland buffer areas within the Conservation Easement Area and shall avoid materially diverting the direction of the natural surface water flow in such area; Form 1191 (01/2007) Deed of Conservation Easement-Standard Passive Recreational Page 3 of 9 Exhibit 3.6 Application No. 070405-4 3 of 6 EXHIBIT B Page 3 of 8 OR 5480 PG 333 ii. Such facilities and improvements shall be constructed and maintained utilizing Best Management Practices; iii. Adequate containers for litter disposal shall be situated adjacent to such facilities and improvements and periodic inspections shall be instituted by the maintenance entity, to clean any litter from the area surrounding the facilities and • improvements; iv. This Conservation Easement shall not constitute permit authorization for the construction and operation of the passive recreational facilities. Any such work shall be subject to all applicable federal, state, District or local permitting requirements. 5. No Dedication. No right of access by the general public to any portion of the Property is conveyed by this Conservation Easement. 6. Grantee's Liability. Grantee:.0'1 701 be responsible for any costs or liabilities related to the operation,,upkeep'or mainteftanc of the Property. 7. Property Taxes. Grantor shall keep the payment of taxes and assessments on the Easement Parcel current and, shall not allow any lien on the Easement Parcel superior to this Easement, Irt the event Grntor, fails to extinguish or obtain a subordination of suc ,lien, inoaddition ko nyx tliel emedy, the Grantee may, but shall not be obligated to, ect to pay the lisni,6n'Oehal'f ofithe Grantor and Grantor ,Grantee shall reimburse Grantee for ,t " amount paid by Grantee, with Grantee's reasonable attorney's fees\a1~ \costs, with interest'at the maximum rate allowed by law, no later than thirty days ' s such payment. 1h1.the event.Grantor does not so ,s reimburse the Grantee, the` bt owed to Grantee hall constitute a lien against the Easement Parcel which shalt:automatically relate back to the recording date of this Easement. Grantee may foreclose this lien on.the.,Easement Parcel in the manner provided for mortgages on real property'if:. ( j\Z( 8. Enforcement. Enforcement of the terms, provisions and restrictions of this Conservation Easement shall be at the reasonable discretion of Grantee, and any forbearance on behalf of Grantee to exercise its rights hereunder in the event of any breach hereof by Grantor, shall not be deemed or construed to be a waiver of Grantee's rights hereunder. 9. Assignment. Grantee will hold this Conservation Easement exclusively for conservation purposes. Grantee will not assign its rights and obligations under this Conservation Easement except to another organization or entity qualified to hold such interests under the applicable state laws. 10. Severability. If any provision of this Conservation Easement or the application thereof to any person or circumstances is found to be invalid, the remainder of the provisions of this Conservation Easement shall not be affected thereby, as tong as the purpose of the Conservation Easement is preserved. Form 1191 (0112007) Deed of Conservation Easement-Standard Passive Recreational Page 4 of 9 Exhibit 3.6 Application No. 070405-4 4 of 6 EXHIBIT B Page 4 of 8 OR 5480 PG 334 11. Terms, Conditions, Restrictions, Purpose. The terms, conditions, restrictions and purpose of this Conservation Easement shall be inserted by Grantor in any subsequent deed or other legal instrument by which Grantor divests itself of any interest in the Conservation Easement. Any future holder of the Grantor's interest in the Property shall be notified in writing by Grantor of this Conservation Easement. 12. Written Notice. All notices, consents, approvals or other communications hereunder shall be in writing and shall be deemed properly given if sent by United States certified mail, return receipt requested, addressed to the appropriate party or successor-in-interest. 13. Modifications. This Conservation Easement may be amended, altered, released or revoked only by written agreement between the parties hereto or their heirs, assigns or successors-in-interest, which shall be filed in the public records in Collier County. TO HAVE AND TO HOLD unto. it ritee: forever. The covenants, terms, conditions, restrictions and purposes imposed with,this=,Conservation Easement shall be binding upon Grantor, and shalt"continue as a servitude.rtinning in perpetuity with the Property. Grantor hereby covenant_with said Grantee that Grantor is lawfully seized of said Property in fee simple;;Fiat Ilie Conservation rasem nt is free and clear of all encumbrances that are incor%4istent With the terms of this,Conservation Easement; and all mortgages and liens on'the;.Consetvatior '.Easement area, if any, have been subordinated to this Conservation Easement; and that Grantor has good right and lawful authority to convey this Conservation Easement; and that It hereby fully warrants and defends the title to the Conservation Easement hereby;conveyed against the lawful claims of all persons whomsoever. • IN WITNESS WHEREOF, Samuel Hubschman (Grantor) has hereunto set its authorized hand this day of ,S er�'e_,61-,n y , 201.I" . a Florida corp•ration By: f •i (Signature) • Samuel Hubschman now »«a7 Name: (Pent) Title: Owner Form 1191 (01/2007) Deed of Conservation Easement-Standard Passive Recreational Page 5 of 9 Exhibit 3.6 Application No. 070405-4 5of6 EXHIBIT B Page 5 of 8 OR 5480 PG 335 Signed, sealed nd de'vexed in our presence as witnesse • By: By: (signature) • &ID .c— Name: SRmtipi_ Jfcceivttrit, ,/ _ Name --- '(or nt) Pant STATE OF FLORIDA ss: COUNTY OF collier On this )(v{4` e day of rr Pel>rmai, 2 10 _ before me, the undersigned notary public, personally appeared ,�l�m it e-1 NrLb9r_i��►rya i� , the person who subscribed to the foregoing instrument, as the President"-; (title), of _Highland Properties of Lee and GolLier,_i;TD` :(corporation), a Florida corporation, and acknowledged".that he/she executed the same on behalf of said corporation and that he/she was duly authorized to do so. .He/She is personally known .to me. or has produced a (state) driver's license as identification. IN WITNESS WHEREOF, I hereunto set my hand and official`seal,,.i - .._... • C ._ . �/ NOTARY PUBLIC, STATE OF fLORIDA r -1'6 � Sgatue . Na —7�e,/:r � l --� , /' -,l i 4=tr . - (Print) •. - - My Commission Expires: R -S a2 "s' GLENNA S.TOLSON • ‘A, MYCOMMISSION a#GG 148792 �.•a:` EXPIRES:February 5,2022 .F°f,i: Board rnru Notary Punic Uoderw,xers sa1011122glaa v Form 1191 (01/2007) Deed of Conservation Easement-Standard Passive Recreational Page 6 of 9 Exhibit 3.6 Application No. 0704E1611BIT B 6 of 6 Page 6 of 8 OR 5480 PG 336 • wor•wrt•ntiC:rKtwuppror:l vett s . 444 ]" _ e& p I F - 1 rlx'1� (1.i Irk T1.I a , I. In� I I �'k• '�) `a I , �'' K�t�S rIi II ;} �l I♦' in I,,. uP.il I ,fiiiii lk L IIrI . I fxp .'�:.•'�:I II�' .!..4:.M:':...1 7' �� +�.q'4rr� 'I k l llCl�k O;Il��i Jr '`c ia�it"< t' �1��1j�'TRT .(I�I.Y,ri FrLLft ii ri 1-. g W ;sISr Spa:t _..._ L° S 00'43$0'E311.133' •'L11 ..1. , i ' L• r `} -- e1 (-) • OF F Q& i i t, ,1 z i��:• t'�• .-\ l ,F^ -i .T . ' 4Y S W g Provovoo:rj 1 2 ' -.--.‘:'::-,) ,--;:.--.1.-,...,7---:,-.:,', ,h. .. �tb•0i I' �1 J1)') cff.. 4t • 1 A 1 i' 'ilk I •.,-1r, \k ••K; a h / J p . r 1 -� ,.. ...A ,,o p 1gef11za'w 3S?.12 , w.:It; 1 11 -, Va 'a J I L4 I e 71 v, w . 15 J e EXHIBIT B Exhibit 3.7 Page 7 of 8 Application No. 070405-4 2 of 2 Best Available Image *** OR 5480 PG 337 ,>x* :'rr-srcr c;sra,cla+otMIN1r'tatl ji'''•y�e'r ;y2 F r 0,*. .r r S p . IN }±u S w b 1a gl 4 W w r ¢� p $ ,t a Ig�:6 2j$ fi1N 1Fk ‘` ly� �8i y .lC fl�T. wr 4 £ ��LL !Wn pp, td. f.. isle • ,� 5§ it '� �i �� N Ana ~ qU a< g � by ~R 4Sx ha ti7 c'C ikW:*"" b �6 ea '��r4j a, to � yaqhVK � 2G h ' '''IiE4yy "A hh".0 die ,It ',. h • /A, Ei gam' of }+-��� S". i V Z f $, J eWy K, *s0 � a 110 0.F7�Za ALI,!Q3 2C!Sc za,.'.b�Yu� .3�n, $a c. 4 WiiM.4*An!'44AO'ak4.A.-0 '',!4w i iii ar ax '`kh- ,v. Fi n t'O.. K-iz; e 9J E r:§ 4; Gon.. xi?y Cu 1„ _, a ,a fig. `•� d E h' �`� kn� ych,i _are"A""" ' A§ Ott4,, F4:, st=misfa% ke y5 ' hc'•Si L, y & Exhibit 3.7 EXHIBIT B Apopli ation No. 070405-4 Page 8 of 8 ialit SOUTH FLORIDA WATER MANAGEMENT DISTRICT Cost Code 11252 March 20, 2020 Mr. Samuel Hubschman Highland Properties of Lee and Collier LTD 6980 Sandlewood Lane Naples, FL 34109 Subject: Taormina Reserve Consent Order Collier County PCN: 00407360000 Dear Mr. Hubschman: As discussed with South Florida Water Management District (District) staff and Andy Woodruff on March 20, 2020, a Consent Order (Order) settling the outstanding enforcement issues regarding the above-referenced violation is enclosed. Please read the entire document and have your authorized representative sign and print their name on the signature page, have a witness or notary attest the signature of the representative as indicated, and return the entire document to this office before April 30, 2020. Final agency action regarding this matter will then be presented to the Division Director of Regulation for finalization. A complete, executed copy will be provided for you upon execution of the Order by the District. Thank you for your cooperation in this matter. If you have any questions or require additional information, please contact the undersigned at (239) 338-2929 ext. 7713, or via e-mail at jbrosiou@sfwmd.gov, in the Fort Myers Service Center. Sincerely, dfl1 — Matt Brosious, PWS, Environmental Analyst Environmental Resource Bureau Enclosure: Consent Order c: Andy Woodruff, Passarella & Associates, Inc. (via Email) EXHBIT C PAGE 1 OF 9 111!I( un(ho,Road,11'1,1 Palm Rea,h,I6,rida 11406•(ia,IIbM,-FWM)• I-hIHl4' 'Mi•,,,,,,sh,md.go‘ -..._. BEFORE THE GOVERNING BOARD OF THE SOUTH FLORIDA WATER MANAGEMENT DISTRICT SOUTH FLORIDA WATER MANAGEMENT DISTRICT, Complainant, v. SFWMD No. 202 - -CO-ERP HIGHLAND PROPERTIES OF LEE AND COLLIER, LIMITED, Respondent. CONSENT ORDER This Consent Order is entered into between Complainant, South Florida Water Management District("District"), and Respondent, Highland Properties of Lee and Collier Limited ("Respondent") by mutual consent, who agree as follows: FINDINGS OF FACT 1. The District, a government entity created under Chapter 373, Florida Statutes, is a multipurpose water management district with its principal office located at 3301 Gun Club Road, West Palm Beach, Florida 33406. 2. Respondent is a person within the meaning of Section 373.019(15), Florida Statutes. Respondent's mailing address is 6980 Sandlewood Lane, Naples, FL 34109. 3. The following exhibits are attached and incorporated into this Consent Order: Exhibit A— Location Map March 20, 2020 Page 1 of 8—COST CODE 11252 Short Form Consent Order(08/19/19) EXHBIT C PAGE 2 OF 9 Exhibit B — Deed of Conservation Easement Exhibit C — Notice of Rights 4. Respondent owns property with Parcel Identification Number 00407360000, located in Section 9, Township 50, Range 26; Collier County, Florida ("Property"). The Property is shown on the location map attached as Exhibit A. 5. The District has jurisdiction over the Respondent, the Property, any stormwater management system, wetlands, wetland impacts, and all works, and maintenance activities conducted on the property as provided in Chapter 373, Florida Statutes. 6. On September 13, 2010, the District issued Environmental Resource Permit No. 11-03160-P to the Respondent to construct and operate a stormwater management system for an 82.51-acre residential and commercial development known as Taormina Reserve ("Permit"). 7. On December 21, 2018, the District inspected the Property and discovered impacts to wetlands from depositing fill material and dredging. Staff also observed that native vegetation was removed from the preserve area, prohibited by Paragraph 3(c) of the recorded conservation easement. 8. On July 31, 2019, the District issued a Notice of Violation ("NOV') to the Respondent for the activities described in Paragraph 7. 9. The Respondent restored the violation to the District's satisfaction. 10. By entering into this Consent Order, Respondent provided the District with reasonable assurances of good faith and the District agrees not to initiate an enforcement March 20, 2020 Page 2 of 8-COST CODE 11252 Short Form Consent Order(08/19/19) EXHBIT C PAGE 3 OF 9 action for the violations described in the NOV, as long as Respondent complies with this Consent Order. Respondent agrees that all factual and legal claims providing the basis for this Consent Order, including all terms, provisions, and matters referred to in the Findings of Fact and Conclusions of Law, shall not be contested in any subsequent legal proceeding that may be brought to enforce the terms of this Consent Order. CONCLUSIONS OF LAW 11. As provided in Rule 62-330.020, Florida Administrative Code, and Sections 373.413 and 373.416, Florida Statutes, the District requires permits for the construction, and operation of stormwater management systems or works, including activities that impact wetlands. Activities must not harm the water resources of the District. 12. Respondent violated Chapter 373, Florida Statutes, and corresponding rules, by not meeting the conditions of the Permit. 13. The District may initiate and maintain legal action to enforce its rules, permits and orders, or to protect and preserve the water resources of the state in accordance with Section 373.129, Florida Statutes. The District may recover a civil penalty for each offense in an amount not to exceed $10,000.00 per offense. Each additional day in which a violation occurs will constitute a separate offense. The District may further recover investigative costs, court costs, and reasonable attorney's fees. THEREFORE, having reached resolution of this matter, it is ORDERED: ORDER 14. Within 14 days of the effective date of this Consent Order, Respondent must pay the District a total of $6,400.00 in civil penalties and costs for settlement of the March 20, 2020 Page 3 of 8-COST CODE 11252 Short Form Consent Order(08/19/19) EXHBIT C PAGE 4 OF 9 violations identified in this Consent Order. This amount includes $3,900.00 in civil penalties and $2,500.00 for the District's costs and attorney's fees incurred during the investigation of this matter, and the preparation and tracking of this Consent Order. Payment shall be made by cashier's check or money order. The instrument must be made payable to the "South Florida Water Management District" and must be delivered via U.S. Mail or hand delivery at the following address: South Florida Water Management District, MSC9210, Environmental Resource Bureau, 3301 Gun Club Road, West Palm Beach, Florida 33406. Respondent agrees that these amounts are reasonable and shall not contest them in any subsequent action regarding this Consent Order. GENERAL PROVISIONS 15. District representatives may enter the Property during reasonable times to verify compliance with this Consent Order. Respondent's failure to comply with this Consent Order shall constitute a violation of Chapter 373, Florida Statutes. 16. Should Respondent fail to meet the requirements set forth in this Consent Order, the District reserves the right to petition for judicial or administrative enforcement. In such event, Respondent shall not contest or deny any fact, legal conclusion, or any other matter or fact set forth in this Consent Order, including the Findings of Fact, Conclusions of Law, penalties, fees, or costs. In exchange for the District not initiating legal proceedings and by signing below, Respondent waives all rights set forth in the Notice of Rights, attached as Exhibit C. 17. If the District successfully petitions or sues for enforcement of this Consent Order, Respondent agrees to and must pay all attorneys' fees, including, but not limited March 20, 2020 Page 4 of 8—COST CODE 11252 Short Form Consent Order(08/19/19) EXHBIT C PAGE 5 OF 9 to, the fair market value of in-house counsel fees as if performed by outside or private counsel, court costs, and any other damages. 18. The District expressly reserves the right to initiate appropriate legal action to prevent or prohibit the future violation of applicable statutes or the corresponding rules, or to alleviate an immediate serious danger to the public health, safety, or welfare. If Respondent's non-compliance with this Consent Order leads to the District bringing an enforcement action, Respondent consents to receive of service of process by registered mail with no signature required and delivered to the Respondent's address. 19. This Consent Order shall take effect upon the Respondent and the District's execution and shall remain in full force and effect until its terms and conditions are completed to the District's satisfaction. 20. Entry of this Consent Order does not relieve the Respondent of the need to comply with all applicable federal, state and local laws, regulations or ordinances, including any District permitting requirements. This Consent Order does not give Respondent the authority to conduct any activities on the Property that are under District jurisdiction without first obtaining District authorization. 21. In the event it is necessary for the District to initiate legal action regarding this Consent Order, such action may be initiated in the Fifteenth Judicial Circuit in Palm Beach County, Florida. The District also reserves the right to seek administrative enforcement by issuing an Administrative Complaint and Order for Corrective Action. If the District pursues administrative enforcement, any final hearing shall be located at the closest District facility to the subject Property, unless the District agrees otherwise. March 20, 2020 Page 5 of 8—COST CODE 11252 Short Form Consent Order(08/19/19) EXHBIT C PAGE 6 OF 9 DONE AND SO ORDERED in West Palm Beach, Palm Beach County, Florida, this day of , 202_. March 20, 2020 Page 6 of 8-COST CODE 11252 Short Form Consent Order(08/19/19) EXHBIT C PAGE 7 OF 9 SOUTH FLORIDA WATER MANAGEMENT DISTRICT Regulation Division Jill S. Creech, P.E., Director Date STATE OF FLORIDA ) COUNTY OF ) The foregoing instrument was acknowledged before me by means of ❑ physical presence or ❑ online notarization, this by Signature of Notary Public—State of Florida Print, Type, or Stamp Commissioned Name of Notary Public Personally Known OR Produced Identification Type of Identification Produced General Counsel Concurrence Paula L. Cobb Date March 20, 2020 Page 7 of 8—COST CODE 11252 Short Form Consent Order(08/19/19) EXHBIT C PAGE 8 OF 9 HIGHLAND PROPERTIES OF LEE AND COLLIER, LIMITED BY: Signature DATE: PRINT NAME: TITLE: STATE OF FLORIDA ) COUNTY OF ) The foregoing instrument was acknowledged before me by means of ❑ physical presence or ❑ online notarization, this by Signature of Notary Public—State of Florida Print, Type, or Stamp Commissioned Name of Notary Public Personally Known OR Produced Identification Type of Identification Produced (name of acknowledging partner or agent) Highland Properties of Lee and Collier Limited, a Florida Limited Partnership, on behalf of the partnership. March 20, 2020 Page 8 of 8—COST CODE 11252 Short Form Consent Order(08/19/19) EXHBIT C PAGE 9 OF 9 SOUTH FLORIDA WATER MANAGEMENT DISTRICT Pre-Application Meeting Request TO: FROM: Date ERPREAPP@SFWMD.GOV Name Phone Number Email Address GENERAL INFORMATION (A location map and aerial photo.raph with geographic references should be brought to the meeting or submitted with the request.) ❑ New Project Project Name ❑ Permit Modification Permit Number Project Location Address City County South Florida Water Management District Basin Section Township Range Special Drainage District Parcel Identification(if available) PROJECT DESCRIPTION (including project acreage) Please describe the proposed land use,surface water management system and receiving system,and wetland impacts. SPECIFIC CONCERNS/ISSUES This information will help to make the meeting more productive and will assist in determining whether other District units should participate(i.e.Comprehensive Everglades Restoration Plan,right-of-way,water use,land stewardship). ADDITIONAL INFORMATION ❑ YES ❑ N• O Are there historic basin storage/floodplain issues? ❑ YES ❑ NO Does this project discharge into or is it in close proximity to an Outstanding Florida Water Aquatic Preserve? If YES,please name: ❑ YES ❑ N• O Does the site contain wetlands or other surface waters? ❑ YES ❑ NO Has District staff performed a wetland determination? If YES,please provide name of staff person: and Date: ❑ YES _ NO If NO,would you like to request one now? ❑ YES NO Does the site contain or is it adjacent to,state-owned,sovereign,submerged lands? To help us reserve the appropriate size conference room,list all persons and/or the total number who plan to attend the meeting and their affiliation. Name/Quantity Affiliation Name/Quantity Affiliation CONSENT ORDER Sf�l it1.pov Form 1274(05/2017) EXHIBIT D PAGE 1 OF 2 Exhibit I,Page 1 of 2 SOUTH FLORIDA WATER MANAGEMENT DISTRICT Pre-Application Meeting Request ENVIRONMENTAL RESOURCE BUREAU CONTACTS & LOCATIONS (CLICK ABOVE LINK AND SCROLL DOWN FOR FULL LIST) Pre-Application Meeting Request erpre ppAsfwmd.gov Upon receipt of your request it will be forwarded to the appropriate Service Center Staff. You will be contacted by Staff to set a specific date and time for the meeting. Feel free to provide your preferred date and time range in your email to the address above. Surface Water/Engineering & Variances • Broward, Miami-Dade, Monroe and Palm Beach counties Dustin Wood, P.E. duwood(a�sfwmd.gov - (561) 682-2624 • Charlotte, Collier, Hendry and Lee counties Angelica Hoffert, P.E. ahoffert a(�sfwmd.dov (239) 338-2929 x7731 • Glades, Highlands, Martin, Okeechobee and St. Lucie counties Gary Priest, P.E. gpriest c(Dsfwmd.gov- (863) 462-5260 x3016 • Orange, Osceola and Polk counties Debra Laisure, P.E. dlaisurea,sfwmd.gov - (407) 858-6100 x3805 Wetlands & State Lands • Broward, Martin, Miami-Dade, Monroe, Palm Beach, St. Lucie Barb Conmy bconmvCu sfwmd.gov- (561) 682-6937 • Charlotte, Collier, Hendry, Lee Laura Layman Ilayman(c�sfwmd.gov - (239) 338-2929 x7725 • Glades, Highlands, Okeechobee Stephanie Raymond sraymonsfwmd.gov - (863) 462-5260 x3007 • Orange, Osceola, Polk Marc Ady mady@sfwmd.gov - (407) 858-6100 x3803 CONSENT ORDER Form 1274 EXHIBIT D (07/2020r) Page 2 of 2 PAGE 2 OF 2 Exhibit I,Page 2 of 2 NOTICE OF RIGHTS As required by Chapter 120, Florida Statutes, the following provides notice of the opportunities which may be available for administrative hearing pursuant to Sections 120.569 and 120.57, Florida Statutes, or judicial review pursuant to Section 120.68, Florida Statutes, when the substantial interests of a party are determined by an agency. Please note that this Notice of Rights is not intended to provide legal advice. Some of the legal proceedings detailed below may not be applicable or appropriate for your situation. You may wish to consult an attorney regarding your legal rights. RIGHT TO REQUEST ADMINISTRATIVE HEARING A person whose substantial interests are or may be affected by the South Florida Water Management District's (District) action has the right to request an administrative hearing on that action pursuant to Sections 120.569 and 120.57, Florida Statutes. Persons seeking a hearing on a District decision which affects or may affect their substantial interests shall file a petition for hearing in accordance with the filing instructions set forth herein within 21 days of receipt of written notice of the decision unless one of the following shorter time periods apply: (1) within 14 days of the notice of consolidated intent to grant or deny concurrently reviewed applications for environmental resource permits and use of sovereign submerged lands pursuant to Section 373.427, Florida Statutes; or (2) within 14 days of service of an Administrative Order pursuant to Section 373.119(1), Florida Statutes. "Receipt of written notice of agency decision" means receipt of written notice through mail, electronic mail, posting, or publication that the District has taken or intends to take final agency action. Any person who receives written notice of a District decision and fails to file a written request for hearing within the timeframe described above waives the right to request a hearing on that decision. If the District takes final agency action that materially differs from the noticed intended agency decision, persons who may be substantially affected shall, unless otherwise provided by law, have an additional point of entry pursuant to Rule 28-106.111, Florida Administrative Code. Any person to whom an emergency order is directed pursuant to Section 373.119(2), Florida Statutes, shall comply therewith immediately, but on petition to the board shall be afforded a hearing as soon as possible. A person may file a request for an extension of time for filing a petition. The District may grant the request for good cause. Requests for extension of time must be filed with the District prior to the deadline for filing a petition for hearing. Such requests for extension shall contain a certificate that the moving party has consulted with all other parties concerning the extension and whether the District and any other parties agree to or oppose the extension. A timely request for an extension of time shall toll the running of the time period for filing a petition until the request is acted upon. FILING INSTRUCTIONS A petition for administrative hearing must be filed with the Office of the District Clerk. Filings with the Office of the District Clerk may be made by mail, hand-delivery, or e-mail. Filings by facsimile will not be accepted. A petition for administrative hearing or other document is deemed filed upon receipt during normal business hours by the Office of the District Clerk at the District's headquarters in West Palm Beach, Florida. The District's normal business hours are 8:00 a.m. — 5:00 p.m., excluding weekends and District holidays. Any document received by the Office of the District Clerk after 5:00 p.m. shall be deemed filed as of 8:00 a.m. on the next regular business day. Additional filing instructions are as follows: • Filings by mail must be addressed to the Office of the District Clerk, 3301 Gun Club Road, West Palm Beach, Florida 33406. Rev. 1/16/20 1 EXHIBIT E Page 1 of 2 • Filings by hand-delivery must be delivered to the Office of the District Clerk. Delivery of a petition to the District's security desk does not constitute filing. It will be necessary to request that the District's security officer contact the Office of the District Clerk. An employee of the District's Clerk's office will receive and process the petition. • Filings by e-mail must be transmitted to the Office of the District Clerk at clerk@sfwmd.gov. The filing date for a document transmitted by electronic mail shall be the date the Office of the District Clerk receives the complete document. INITIATION OF AN ADMINISTRATIVE HEARING Pursuant to Sections 120.54(5)(b)4. and 120.569(2)(c), Florida Statutes, and Rules 28-106.201 and 28- 106.301, Florida Administrative Code, initiation of an administrative hearing shall be made by written petition to the District in legible form and on 81/2 by 11 inch white paper. All petitions shall contain: 1. Identification of the action being contested, including the permit number, application number, District file number or any other District identification number, if known. 2. The name, address, any email address, any facsimile number, and telephone number of the petitioner, petitioner's attorney or qualified representative, if any. 3. An explanation of how the petitioner's substantial interests will be affected by the agency determination. 4. A statement of when and how the petitioner received notice of the District's decision. 5. A statement of all disputed issues of material fact. If there are none,the petition must so indicate. 6. A concise statement of the ultimate facts alleged, including the specific facts the petitioner contends warrant reversal or modification of the District's proposed action. 7. A statement of the specific rules or statutes the petitioner contends require reversal or modification of the District's proposed action. 8. If disputed issues of material fact exist, the statement must also include an explanation of how the alleged facts relate to the specific rules or statutes. 9. A statement of the relief sought by the petitioner, stating precisely the action the petitioner wishes the District to take with respect to the District's proposed action. MEDIATION The procedures for pursuing mediation are set forth in Section 120.573, Florida Statutes, and Rules 28- 106.111 and 28-106.401—.405, Florida Administrative Code. The District is not proposing mediation for this agency action under Section 120.573, Florida Statutes, at this time. RIGHT TO SEEK JUDICIAL REVIEW Pursuant to Section 120.68, Florida Statutes, and in accordance with Florida Rule of Appellate Procedure 9.110,a party who is adversely affected by final District action may seek judicial review of the District's final decision by filing a notice of appeal with the Office of the District Clerk in accordance with the filing instructions set forth herein within 30 days of rendition of the order to be reviewed,and by filing a copy of the notice with the appropriate district court of appeals via the Florida Courts E-Filing Portal. EXHIBIT E Page 2 of 2 Rev. 1/16/20 ti'` SOUTH FLORIDA WATER MANAGEMENT DISTRICT I s ..�ifi Notice of Consent Order Document Prepared By: South Florida Water Management District Return Recorded Document To: Regulation Division South Florida Water Management District 3301 Gun Club Road West Palm Beach, FL 33406 MSC 2430 RE: Respondent: HIGHLAND PROPERTIES OF LEE AND COLLIER, LIMITED Parcels: 00407360000, 00407320008, 00408160005, 00408400008, 00408440000, and 00406720007 County: COLLIER A Consent Order between HIGHLAND PROPERTIES OF LEE AND COLLIER, LIMITED, and the South Florida Water Management District ("SFWMD") Regulation Division, District Order Number SFWMD 2022- -CO-ERP. Notice The SFWMD hereby gives notice that a Consent Order has been entered into between HIGHLAND PROPERTIES OF LEE AND COLLIER, LIMITED, ("Respondent") and the SFWMD pertaining to the real property described on Exhibit 1, attached hereto and made a part hereof ("Property"). This Property is subject to the requirements and restrictions set forth in Chapter 373, Florida Statutes (FS), Title 40E, Florida Administrative Code (FAC), and the provisions of the Consent Order. Within thirty (30) days of any transfer of interest or control of any portion of the property described in the attached Consent Order, the Respondent must notify the SFWMD in writing of the property transfer. The Property identified in the Consent Order is subject to restoration plans or other requirements such as obtaining a permit. Purchasers are put on notice that such restoration plans or permit requirements exist. The purchasers are subject to compliance with all permitting and other requirements under Chapter 373, FS, Chapter 62.330, FAC, and Title 40E, FAC, for activities occurring on the Property. EXHIBIT F PAGE 1 OF 4 Conflict Between Notice and Consent Order This Notice of Consent Order may not include all of the information contained in the file of record. The entire Consent Order is available online at: www.sfwmd.gov/epermittinq, select the Enforcement tab, then enter Cost Code: 11252. A paper copy can be obtained by contacting: Matt Brosious — Environmental Analyst 3, South Florida Water Management District, 2301 McGregor Blvd. Fort Myers, Fl 33901, or by phone at: (239) 338-2929 x7713. Provisions in this Notice of Consent Order shall not be used in interpreting the Consent Order provisions. In the event of conflict between this Notice of Consent Order and the Order itself, the Consent Order shall control. EXHIBIT F PAGE 2 OF 4 Release This Notice may not be released or removed from the public records without the prior written consent of the South Florida Water Management District. The contact for this release is the Director of the Environmental Resource Bureau, 3301 Gun Club Road, West Palm Beach, FL 33406. The terms, conditions, covenants, and provisions of the Consent Order encumber the real property described on Exhibit 1, attached hereto and incorporated herein ("Property"), shall run with the Property, and shall be binding upon and inure to the benefit of the parties hereto, their heirs, successors, and assigns, and all subsequent owners of the Property. This Notice is executed on this day of , 20 . South Florida Water Management District District Clerk STATE OF COUNTY OF The foregoing instrument was acknowledged before me this day of , 20 by , as District Clerk of the South Florida Water Management District a public corporation, on behalf of the public corporation. He/She is personally known to me or has produced as identification. Notary Public (seal) Print My Commission Expires: EXHIBIT F PAGE 3 OF 4 Exhibit 1 LEGAL DESCRIPTIONS(Parcel Number) 00407360000 SEC 9 TWP 50 RNG 26 W1/2 OF NW1/4 OF NW1/4 LESS N 75FT FOR RAN, LESS OR BOOK 4075 PG 572 FOR RAN, LESS OR BOOK 4353 PG 1085 FOR RAN 00407320008 SEC 9 TWP 50 RNG 26NW1/4 OF SW1/4 OF NW1/4 10 AC AS DESC IN OR BOOK 1087 PG 841, LESS OR BOOK 4353 PG 1085 FOR SANTA BARBARA EXT 00408160005 SEC 9 TWP 50 RNG 26 N1/2 OF NE1/4 OF SW1/4 OF NW1/4 5 AC OR BOOK 1186 PG 2060 00408400008 SEC 9 TWP 50 RNG 26 S1/2 OF NE1/4 OF SW1/4 OF NW1/4 00408440000 SEC 9 TWP 50 RNG 26 N1/2 OF SE1/4 OF SW1/4 OF NW1/4 00406720007 SEC 9 TWP 50 RNG 26SE1/4 OF NW1/4 40 AC OR BOOK 1116 PG 333 EXHIBIT F PAGE 4 OF 4 E110 8 —I Po C n Z r-pp • • • • m N v n 0')o � • • • • X O N C c 00 .9 CI ll oPq CD 0 N = ' . (i) LLO N cm = rr+ IV t J + m cu CD 0 — r-r 0_ fD _ NI _, 0 v c� "0 N = p N r�-r V■ 0" O 0 CD fD CD 0 .� rat Q Q 5•ot) v -a v 0 O v) 1 1 OMN C Q a) � .- aD N• fD 0 imi 3 X' O n CO n 0 o O -i 0. 0_ 3 O 3 7+. 3 DI PP a 3 —1, 1.■ c clitn _ c 0 c a e=1: `< 3 N rt a) m O -, (!) s .) O n' O c) G) . 3 .< N •V i I le !0 1m ic cn ■ --•■ U] ••9%13)NIS sm■ Z Rai :11:W J 21 Q N a c L O 4.1 col w _ tV a w w Q 'Q fV JQ = a z t ww z t!f CC a) . .. . w ul -10 = ,.l , 1113 I ' I I: ....,_ U ' an s vavdave VINVS (� P�� oa) x ., f \ o P • o�ri __ QVO8 N8Y9 ,LLN(O3 J // = - c7 U (/) a W 41.1 N cc a D Z O .. V m a O y W J N. ¢ N a W> z y. N U < w O z :� O U La a O W > J Z m Z W = K La Z O a a W 4 Cl, s = Z ¢ U N 0 U U\ 3 E Q U W U_ ti a v Y O N o \ La!Z W O < ON cc 0 m j O Z W O J Q CI CI 0 >D J O O zZ 111 W W I a K O mN W a a -N 'O NK / — K ¢ Q lr� CO Ct K 11-D O Z =1,2 `v, Z Z N K a W J = N N O U U O a a a > ' 7 J V Cr Z iW K N „Luca Z m m a az Oa O oz O Dx (7W - U CC ce • I 7 ce O I Z•-_. U 1< Z U a Z Q O 2 N �i [�;= • I I • ri ❑ a + lG Z V o O ~ LOP - z /�/ W Z J W D o I E.I'.;-:. rill. n O ztili = rn z r o P1 -E-, 0 -■ Or1 O 3 -o n --„, . r'll. ......, ,..,.<0-----...... . o COLLIER BLVD C.R.951L _ - m �� .�� 11 - - • - _ - I ii..'.1 1 t • 17PIIV' 77.----- .7' 1 E a 0. , 1., x .�I - o. > co_ v .,-� m �- Ilv - J.. s - _1• a 'f_ entn. t .• •J m I. �. fD FY1 V) " - 5 .414, . . 1 t' ' O R. , 46 1 .str " . p re r. �ygv�i� cn i" .....,....''''. 1111101 70 :. N L ti i I IC k R_2 g O I 1N ■ SINCE 1966 a■ ■■996137NI4 no2 z1 S3NYI VON310V14 Ofl Vd ONINOZ iw OE S 1IP 2 2 J ZII I'W wR17sa a z ij U ^/ I r n Q LLo � i 3 m O I � U (� Z wa Zya LL --- .. ' LL hi N ma� Q F; ° L O N� / = F~ 7 w p n G _ aoy N fa p i 3a U1\ I Z Z - s 1 0 0 6 U `3 111 om Yg-g M w b2�1 Q — �� °Q, 72 n s 0 x a e,�1,, a,,991O`d2J1 U ��'„��wn >• n >y <�t!' 4U 3 ¢ 0 r F-r s3 ... f Q rrrl-r o (a0 mw- w '¢wo °g J !ai < Z V 'oSI NZ O >N< W2��w�uu J �LLX V m ZW ��w M 0 LLp`<W y CO x N¢ N 2 Fm W w 2' W r w° o wqg 6i _, Ciw w0 � 0 o w � �nwww 0 D o Q 0 2' U 7 ugF H - ii0`�'* L. .O 9_r 4w0, W " W njo S<_WO aTip V 5 N v 0 r z r L”A W d S r i < r K U, it fU I— / o_ NQ0 W E'di, C3 Z g- QN r >/ LPL b (I p WO 6L r0 0 <�mUO4f'J N LL oSf w _ rUrU rrrr L-p r ? < p i -_ QKK] rr Z_ Luv w o ZQ �IIN< 'ng iPP rii 1 < 6 5 w 2s of I qpi is o wo �2 ;IF , / \ 6;2.4 — U w w,46 y� a[ "oid i a LB6'ITO rW> �'° poi 0 s L U L _— U CU vR fa = o0 E ra ro /� — W J W � o � z Ill p 11 E.1.0 n --I • • 1-1 rJ c � • • D- p • • • • Lp o —I m- n J O O N i cQ Ql n D- -0 O 0 0 L, Pc 3 2- 5. CD C > c (7 a cur' rT � Q n v v D Li) fl NQ � 3m— C T n T70 .< p < -0 73 ,. p mg v) c 0 ,� N.) Ds< —S rt 0 `r■ •v cu = —N p — CD -m Q * n N N . O O r-r n -• — O O O MEo n' N• fD 9u el co r+ I a. r�-F e"t• IIIM■ o p 0 OO ri M.y D : -I — - a- 0 3 O in ' 11C fl. C. O (D4 cm Cl c -s O -5 tD V) U) CO a• �+ Q O c 0. (D - fq " N D -1 (D 0 00 I--r, (D < o C) 0 - (D -5 n a -3 N r (D O i=2 _, !O CU 1m c) 3 a ;z a-I 5m Rcn 3■ , "o ■I.9%1 MIS ■ N z1 a) c 3 w n3 0 O U a in aA a) ,_ f o c - >- c7 o +1 biD 4 o a) aA aA 0 N c c +0 0 iy C 0 'C 0 in n csi O C13 > = a / E 0 C6 til >4 co -i-' 4-- N O y-- K L n3 O +-+ g v Ov a, o a) .o ea O s_ > o 3 Isla csIA 0 o i — N 0.0 N N U ■■— co c v 7:30 > iL75 - N m O c a-+ 4...1 S..'O OD (� O O N �o ,TD C c -a O • v V 0 an . . CU Noy CD CL) 4_, c O L „ U o a) 73 C LE N O O ^ a--+ U = E 0 CU Q. c c a) O o —. ,Cf3 , DOU) U) a.) o --- . aA ci- o " E E o L •— C ON 2 _ _. „ moo CO — 4-- 4- >-- (13 0 0 0 I- v .- ca .— aJ v a) zi a. o_ U E C6 N � v z %V U 4_, >- (-0 +, v O O F C _ _, v C co C m > >` > 0 v c13 c c E c O c ICZ CC CDcvn can _0 c E < cvn O Lio I O N -a i "3N Co NO O 0 Ol 73 -0 0 -0 J o C �imc c Ln cc < Q0_ Qc ZO —on rz- O • • • . • • O • • • • • W 5' N N cc o I� v 8 —I 7:, crn •zpp • • • • GI r rn N -5 Li) l a) CS • • • • X O 00 • o � NJ O -0 � rD � rD 0' rD LID rn 3 rD rD z fl r+ � v rD fD P — r-+ 0- CD MO l ) VI 7 3. 0 SD_ Cm 00 a.) r) -0 N = o 0_ N - O °- `■1 II rD o a) (= -5 CL) n) n _• .•D 0 r (1) am+ Q • _•5 -h r) —h SD Ca— Cli 0 rim rD Imi T. (p (/)� A (n - (IF <.' 0 3 Fi W r ' -�Li 0. c O CO u; 3 3 0_ * E o 3 . 3 0) FP a 3 —h NM. m n = 0 cn iq. ''< 3 a — N rt CD m O (n 0.) rt O cu v, a 0' i 1 le !0 or gm aO m MCI)S. ••9%199NIS •ENO WI Zl g 3 IlJ J Os =r a in a III E IA c7 0 vi u 0 n L 0 0 N col a - W W Q`... -0 N CK W • < a al CU to n A '' • ' ‘-, , 113 tA ilirl 1 I MI C ,,,,,,_ o MI y o m Y s rit; L J . - an ie vadeave v1Nvs = w ce•_-._._ CI) x s \� >N. CIVOtJ NEWEL A1Nf10D U tx U Vl < K W a m w < N sz MIMI1- Wm (/) Q Z = e U J O W a �� g Z w cc N_ W U < 1-W w O N 4 ib= OW VUM < U W U < u W W < V1 ee O]m J O p UW'O (Z < Q N a < Q K j m N W < <• c W j 0 W U _ N y- K a' 1 UO t O^ ce,- m C �`O J< 7� WH = F W J O2 VI zO Z (n < J N O U U O < < 5 I F-K J V d' 7 Z Q.X KF, Xm W a ce 0 z.Z. co.7W Z ? OU ¢Z <O Z VI 0, ] F1 ■ u II ■ ❑ ■ ❑ ■ 2 V O ~ V0 0 J `^ o m z J NJ n CC o I--- 8 r 0 n zril crn z DJ o n '"f mil II Pq0 -i 3 > _z_ (--, -< . . . ___,„k ) i‘gatiiiiis • - • % .r It , ��� COLLIER BLVD(C.R. 951 _ - - ° �� ai I •rs '1i �i i.1 . it:� , E +. � di i 41 i -;NV . 9' }AI ' "401"m' :"'""'• -•--.4 fD It N co fat c r _Jr O. Co -1 1. L___ 53 a. . ...‘, • mar ti i v, rr, 1 J tn. rn ..4 ii t PqiiV li. k . ' H. a ICi•, , N • 1.i 3 wT. e Ail ` i r tri a �,!I N . • ,...'Att- -.‘' . :-.. I ;! -.N . m • E iZ im AN ■ SINCE 1966■■ LU ■■9%t 3]NIS'A pp • 0# >z_ Ili .9 Z O� S3NVl VON310VN.Of1dW.ONINOZ — Y o„may I iIu `w 01 :� IL row.4 �wniM. / rc wII w ��2 a w (9 W _tcl, N a to b I- 3 1-1 .. . z .Q._LO 2il J a� ° _ r+ z w;LL 5 V P U„P g o O O ULL.m I N� r U MP F W U O J mo /,li I—on o .5 N zl b ‘ w Z 5 rc 10 nil ,) ,.3.,,,4 Z cn Z _ r tan w O VHl UQ \ om�Q24MZs / fi o R ".g 'O Q cc . a7 \i. a\. 2Ns W U� per'm� 2 a �� � : .9..LOVH1 . 2` . A VO W j avl fF - rr� _.... / yggg g m Q _ .___ .—_ _ __. ��41R d° 2 Y Y,nl to =3 ( - .-, x cn wce ° 'O O) ¢ w 0 W o i -3R $nz Eg 2 o a a ao > J 3 RR zw it J O o gg 4�' as a zw 1 2_2 IF, gw WW QO V J UQ w :iw O nLi p7 zw On F 6 m co W wO / _ K w 5 2_ Q /J hi ZZ o aO 2 o �� F- p '-, iaaw<� O • a� - 0 z P,�0 5<W 3a'g U U, m _ 1 - ii r i"LL Z> m rL z v❑-iwii!n>1 (0 P 0 L/L g. v I w rcF,2 c°,3wrci O g g r rp I y: ,,.60iui�t9 N wF F.- 1 3 rL-....- -i_ a f- <f 1 zD i z 0 Nz g L OU PMC 9 I ' Z o $Ceq . v J¢ I'll ��n^a w m - f FW nhZ y NW Mil a LS6'8'0 Fr: wz oz0 ❑ �Lw < z❑f❑ L. a) .11.• in v 0 al _ o o -3 V 0 E (C5 ......1 N u CO J Cl. W z o i- _ n a n —I • • crn • • = O • • • • lD 1� NJ N C u i .p -A N o r 1 lD O n s I O O N lD c p Ql n 0.) =` r-r 0._ O 3 NJ �rt �N Tf�D rD �' CDzll _1 Q 71 fDQ o 7 DO =•< o _ - < -0 MO n O m c 0- '' N =- - --, r-I- 0 V■ E. co c o 0- — 0 0,,,, F) 0 0 M <_. � r+ n . O -h 0 n O O elm m Lii n •fD V, �. _ - - CC CD - p fm ` Ol O x 0 C o _- 0. —. o �• Co V) ` ' CO rt o a - MD - c N (D 00 �; CD < i-io c) 0 Cl..)0 et N -5 n a -0 0 r�-t- (D O o __N -t, 1m n �p Im ig (D 3cn ■ CO ••9961MIS ■E(p g Ili i Z1 0E C -0 21 cu c Z W 0 c aP-J (B D N ON U Q III 4A aJ L— x O C - >.. (7 co +-' aA u 0 a) tD by O Q 3 a U E tn fB in >14 co -O C O 4-- 13 I- coO +-+ g @ O v " E o v Q /�MIMI -C Op L 0 N .� Yl — c� ° t�A N cu ,cn U J ■� C - 'S I L. _ co -o O a_., .I., 1- L. 0 °' CLO � � O O N ,o C C -0 O v V O OD CU . . N o w m —a CU 713 C N a--+ c a) L i O CL) CU 0 DC) O 'onC— O ° E E ° -- o L � ,� � '> +J +J y U = - - O v N ON 2 0 O ' —0 C = Ua)QJ z�} j ' ' U a) U D >45 > D CC C) can) can _0 n E < con c6 a) c6 0 V p. o O i • 0 N O O O Ql N -a O _0-0 v J o °or (NJ mcvmcv '-' 1 o' QQ0- Qo' /� Z W J O • • • • • • O • • • • • W m N N CC o I-- 8 n o .77 Z crn Z G) N n 0 C) o Pq ma r) O n 3 is:)) CD X f. N 0 O. fp ED cp O > O 3 0 O O _ CD ri- —1 3 tA M o n r"r CD < � � c Ro (/) 01_, r' O al � N si, -.< C � O N.) �. N N0" r O co n w —' mor O n CA -I 3 iii rok Oph n wi i-L u•F-L rp .4 . = < fa. DI 3 %< CD A O rill ' m i0 3-4 1m Mtn ■ SINLF 1966 111 a f.1 ■•9%I1�NIs'^ • N, W ,... Z, (:) 21 ZIC3)! Q d. II a) o) a a-.) C c5 o 2 Q o • aL+ N ( c .0 ta N p in d U a) J U 13 p .> U 0 0co„ L; u x oc3 — >. 0 a) yl H(ic F---I(.,;-- ... O J I- N C ,— N p LU E C C L o6 ril p p a� U C o 4� p IE J a) °' U ■^ _I & = _ O. 0 5 W 0, C. U L U U < am Ln . i—i ,_, CO > • — M 0 a) u. LU E > pJ Q ZU C C C ~ L� a--) Q �C Z L V o .0 C 00 (1 5 � ftoo ° oC c a z cn m F W • a. • • • • GC © H v • • • • C) 8 —I n 1— —I -1 D O > n70 -, 73 0 O rD • _ -1, O rD O 'T' 3 aCD 3 - n � o = n Z °° 3 �` n v o (D * rD' v ,-.f. oO D -) a) C 3 D CD rD 8- P'1 cn C a) 0 ri. � pq a v v • -1 Q C � K � = cum � eL (DCD = o -0o' -. 3 .< K:u - < z r-r 0 -0 rD -.< , a. O= a. Cr CD n -. -, _ -. 3 Bt. c rD r=-r — r- �' C) < D- 0 N r•+ N W O-, -1 (D 7 n• n v) (D n co rD CD CD `° E (D0_ 5 � - r-t N E o ED gin' — 0_ L rD "' rD � pi 0_ • O — MI n D Q N c 01:1 x rD 3 • c r1- O N N n (0 X rD rD O 5 N D O v v = N N rD• Q rD (/) coX n) N O cp = - f-t• N N -s r-h C < 0o N O0 Cr r-t a rD 0_ O CD 7 r--r O (A o -h C r N n -• PP va,' N 0 -• (OD :- m - �+ Q C Q O O Li) D 3 n v v k r-ICD . rD n. r--F C T n rD 2 cu o �, rt' -• H N — CD • -H W: r=-r - •< r" rD CAD CDD a M V) NI la, O Cr 0_Ort13 C q . Or CD rD N < n O_ I-. 12 ( a rD D• n tyi D Q N -o ram+ le D .< O CU O CD rD D- &C a) a. rD k:0 im itn ■ SINCE 1966■■ LC) r_> { E;•9%,„ws N cii �I w i i-n a (a - ' ca 0 E a) 00 � Ca >' en a.) cZ W 1 0 ID I CD w = O 4-, v) 4-, a) 0_ •+� CO N N a in C � "I O 0 C o O OCa LN O OE U • - — CO N cn 4-1 la) ca a) 5, Q CU v) 0 = a E -a u a) a) Q o 0 c a) O .4-' co - ' O L •c O C cn E n 'a o Q (I) a) Ca C •0 i c L _C L co .:: - CD o +� >a -Q & Ca D a) L N OCa E CO -o -O -o C Li— yi a in N u) _ C 0 J • N L Ca O m Ca 4 �� O .> a--, co a) 'a N U _Ia) N-1 O a Ca CO D CQ • 4', � U4 Ca) OU G - 11) CD "i O co a) _ N O La c CeN v) 0O � C o C a) N (/) N = bfl d2 co D -0 Q N < S- Ca CCU tD a) }' cn O v�i •> — CO C C O D 0 L N = ai -O EL-L- L CO }, •N }' la) N '5 a) a_ -CDa L -0 0 a2a) a-' Q — L C v) o Q O I— C (A N a) m 3 •C E o o � -� v) C _ -0 0 C +' `Id _C 2O Q o 0 c) a) C CO 4., C Q I U Q ate--+ : w R6 a) C V +- ) 0 }' D Lc) a�QQ CoCo� � J cu }' O O Q) O m 4-) E LI o Q t)0 0 Ottnco m a) D a) .0 v J E -ov 5 is m Lus J D _c , a) -0 U O 4- a--� +' CC Z U 2 cc < E 4— O cc .� Q i•__ g • • • • • • rl CCCI z r r O 0 n z I T�^ C C CD 0 0 fD' rim CO 0 a o a (1) x' 0 a c CP o a o O rt O 3 f+ u o r m Ii 5NC[1%6 h-' rn ■ ,,,, 73 COQj ■I H1 U co E 3 ri U Q O ii U Qi 47J a IA r4 O ,_ ; o 0 -U a) H U OJD J •1--) a c Q k U) — v 0 Q p •.... •Q QCL -0 UE71 Z ° 44- 4-) Q J O co C (' Q 0 ai (a c (i) Q p 4� U ■ ■ a -7) _ 2 (0 0 .0 (� '4-, d' O ■ ■ (!) >< (5 o o ma E = O U UO VE o C N-oo E Q N 1 cu oiz O 4- ja 0 cn '-' z V N a__, = v o a) a) 0 O OC TO E NE Eri u_4m 0> E = c Q V) Q LIJ 51 (5 Q O L co 1- C) C 0- r f‘"--' '--- e , . Q , Q D Z 2 ® a > %< -h n ,� > 0 0 N �'} O fD W C ' - 0 -, 0 -I co -' v n -1 in I Q =. m - ' n C7 tu f < �_ hu 10 z ..0 = A a 0 ,,z n E; co ...7.- ci-- ',Z t / mem F) , D 0 c -: a- 2 CD > 74- _ n - -- ,� co m _ cr a1 CD 15 -. w o C '-i-" M E D = A 0. CD - Col �0 CT C CD ca, cn rim c oar. �, cva rim 13) ra to - 6 o cu i. p0' coel cr ^10 c co 0 na' "". c CD ( ' c —■ O - � tea. �, c Pi' 0. a CD II 3 r a O = = o a * fd 0 acr. _ w 0 C92_ 3 = - 3 2 wi-3 p a, al to — CI) C] , ' ..y. vy W 0. R 0 c � F a 0 (D a so 5. C X wort D 0 - .per CD 0 Z (p 3 fl7 0 co -, c �. tl) '�' C7 3 c� = (D C 0 NCD Cl CD rifr ^ rt 0- —■ A ,Jw) o "� O G.) c 3 a] (-) o --1 r `sso tioCD 1-6 13CZC ( 3 "mtu, a v En a ° �._ a, 0 a,s a a �5 0 i"F aZ 0 1Em 3Mtn ■ SfNC!1%6■■ ■ al w1 CU 4A H '0 n a) Z w 0 O o1 4A a r4 C = c� o EL *' elO }' " 0 E 0J `� a O c co U a coVI u •Q m _ 2 O Q `0 4_ C CO x • 4.0 0 N w O 0 o E C C E c0 E_ c E ' O M EMI �' o 0 ki co E -0 -0 0 E i o ,w w E O U s -0 a) N C ca • C 0 n 0) c6 Q Om O N o o W , >- r—I N C)_ E t10 C...) 0 O C co = aJ 0- .4-1 co c O o C E 0 a) V o aU. 0) U 0 0 -� ES E 0 13 W m U 4-/ CO CD m cc o N U N• f— > LO F- CO 1- < c) Q Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make amp thing but gold and silver Coin a Tender in Payment of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Ther ,for, We the People, lawfully andrmally petition our State Legislators, ON e F va rk c)pe r errc , and 5.zo .kcti44ke, Pc 51&.4"a6 to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to impliment a Gold and Silver backed U.S. Dollar immediately. Date Printed Name Autograph County 9-at- aoa.a Di°tne_ r c4ctfe_ l'' 4 le Law- (--oli ice 4 / . 2 UM-,J-L 40 . vi ( (btb y/u ,� De-) /E= Uo& A L_c;- C o !l . -L - l t a► a IIrts ej4244 II /1S 41- ,..-/ ,..:',2 ,,e/t 7.4/ lz2/-zee) ,--i: - e/ . e , .2). SJSec„, 04-0, G ,i /2/1 zz Arma Z36-AAvAr/ fdd-p-d_ /,Iv_/pi V Mick,/ gLt I ii,.. _ ca://bn.„---' . 5,,,/,,,___ 6 L ( 11,...a) ,00....‘„,, _ ,______ t �4► �.Z ��'� � � w_Axi,,,t-Zezi- ttw( .iv Cal < Q g/L z thg ��Y1�Ga DliY�X i lw /% cog1ef1/ Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make any thing but gold and silver Coin a Tender in Payment of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor, We the People, lawfully and formally petition our State Legislators, ,,.. n,\.e QV' �4 c,Ab , cJvc. Kc>min l �CL Q-fkri .M2k , , and fl cxv\-A R oc Q c C•c. to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to impliment a Gold and Silver backed U.S. Dollar immediately. Date Printed Name Autograph County I , 1 • . .. ks . .Y"\ . ' A SI WriOir/ . L z 0 - 1A • M . , ' t... GILWArifreallIE ii:ds 5 a MEW iht=,11Nrall,„A iii ffirilM„_ MIMINE: ! ,_ . S — —2 a Air, , aismiiir_ ,, .., ,i _t,, ,, ,ar• i / C-0 i 0 c . ez:zc-)4 Gt. . ice /1 r /� � W. .. s v G/y... 4.t4:, /c AMMO gzE' Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make am/ thing but gold and silver Coin a Tender in Payment of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor, We the People, lawfully and formally petition our St4e Legiplators, La,yeetk AA, do , \e e A ChAtp (�CA) o nnwv�\ , and f)Qrr c (3 d f g 4-r 0 to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to impliment a Gold and Silver backed U.S. Dollar immediately. Date Printed Name rr Autograph County 4-i-n- 1401 \IOAN‘ / iiii- ,LA____ t( cf- -i (i 7 A tit/ . -e Z`i- r e_• Zz :1—o11,-Q YYJ,, C LL„ej; 9 2z- /� /1/q Z;- ' f7 (- Ong G'ai`P` t `4 2`�- k ao C9.�s CP G 11. ---- -Aikt) - , °�.. ,)) 7 Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make anti thing but gold and silver Coin a Tender in Payment of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor, We the,eople, lawfully and formally g�eetitio our State Legislators, �,AA.V2ev\ �ct�;cb�1a. , and I, 4_0r-e.►� Ak cO �to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to impliment a Gold and Silver backed U.S. Dollar immediately. Date 3 Printed Name Autograph County S3// Z.Z ZI 22e-4-e Amay . oS � lF ca - 1J7L 6.'c' / / it 'rY v I , v /r �1 ( i vi , -y2/ -040c'�i? 4 C, I (17 r c�lc -'-' d-d- b/5/01-7eid.-°r(-4-) Al- . ae-2.-h?----- 313d2,� /1 At�y ,Mash ,e, __ lr>.C�-.4 �� /3fJzz V la)c .ech s l:;iT l,II"V�ie r FL , .? /iiis ,,I/ Cr 1 Ir•i� �! (3( iz-z_ Ao grr`t�, e?c ,„,G ___:f:' 7,.7 ?/ 3 /1 � -e G,,�� [1 e ( fc)\ M �I /_i_i . 0 A ,. t -4P' �- �f/ rr Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make any thing but gold and silver Coin a Tender in Paument of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefo , Wet Peo le, lawfully and formally pe ion our State Legislators 1�- h A�ct59 i acxmc 15 c) c3rntnv_( g , C-tkvt Q� -Mk(o , and J i`.c. (>a Cr2rc. to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to impliment a Gold and Silver backed U.S. Dollar immediately. Date Printed Name Autograph, County 3222 eJcj') Cock. (A( r 242-Li 2- _ ,��jc„�, O5eri ,,,., ii-�, -0'' C-o 1'‘ t r D41 C: . CP( (__ 5 -30~a � DcT( C j ft 3 1- -L- 4,1..1' -,c a Lit. --.' a aAcA (Mior i , 3 3f A I foil'a no� AG a ral i-e ►.2 3 ,...1 ,.? ,,, /3 A ,,c , ( 0, ///.6-1 2 3 3(f Z2 mar"( C,6A, . vj aasv� cc,c(ir ?f 3 t C -z-Z A ut vt Ance .1` ( 1 Ca, /6 C�a,�C�' T� 1 ,< 31511 l L_ -.\--cose Va2,lh\ Oi. Col (, c r- 11 o12 Z Viimk\t. o 17Gt l� F2A - clULA CSA 11 fr-Al2-e_411 r_ ten)_ r., Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas,Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make any thing but gold and silver Coin a Tender in Payment of Debts....;"and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor, We the People, lawfully and formally petition our State Legislators, Representative Bob Rommel, Representative Lauren Melo and State Senator Kathleen Passidomo to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to implement a Gold and Silver backed U.S. Dollar immediately. Date Printed Name Auto rah Coun 14kfti NHS c -) q M A(Lit c 04--64.3 c o,.4-4 3----g 1.,,,,4,,, 1.,,,:,4 in 5)( 1 Zi3citT 59 LaL, '' ''71 *-3----:.,) 0.3(- et9e1A-le, 1 qint- PIA 1-eihthe .4-"Ie-i. 'ma. , 14 , ' OW 411/1A---• il 1,1 gif15 /9 ,,1,i/ 6 .„vi - a f„. _ fI/ZZ PeY LFX „` oe /fc,c_, ri it.1-t-v L o t i t. c Ati,MAY• at 101 1 . 1 R, 4vltity 'er I I .r / 7, ..._ tjrArteonv 1"-Zn t, t/ )lc( L ,-►-i2IS p►-\-a 110 1 &7 1 I C ,,-.. Petition to the Florida State Legislature to restore Gold as Silver backed Currency Whereas,Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make any thing but gold and silver Coin a Tender in Payment of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations,poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central hank). Therefor, We the People, lawfully and formally petition our State Legislators, Representative Bob Rommel, Representative Lauren Melo and State Senator Kathleen Passidomo to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to implement a Gold and Silver backed U.S. Dollar immediately. Date Printed Name Autograph County - ViitAa..; L9/4 ik.,:r 13 /2 At,,rA I., /- ( r. { ,n x 5 ((Lit t_ 2— Askittakt a 0.41M4 a--4ZY ,1,1.. 66142.1 ,-a- 'Z€yttsv �a I Yt2t .c CA ,t..- t. ..it. .• .J /.. 5 . la - 0 /d (a G rce.6 "91-'4 -. g 1 'ICI i.- 1 g," 22" Alet)..,ki -k--;11 1 f._.672 . Dd om gi y6 h 1 f , , •-•\ (,---: :7 0 diS. 7/1 ,,, i i 7 2_2___ lk.(P,2 604e- ---j X‘U-terN_ iN4 \,..k..k.:)--"e===,— 110.-t•L,:- 4-x.2-q . fit.1,1- NAL Nt Wow- , ;, ?iv;-- S' -;'i L- M Oki ills 7 L,) l , LC/l. z-. i t l c n % iki _ 6bir-e4--- i4 Petition to the Florida State Legislature to restore Gold as Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make any thing but gold and silver Coin a Tender in Payment of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor, We the People, lawfully and formally petition our State Legislators, , , and to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S.Treasury and to impliment a Gold and Silver backed U.S. Dollar immediately. Dat Printed Name Auto p, County f:ii4 2 rcv p C /," e- V177 lbst,"14 voulds:v --0-10.,- Q.e; LQ►nt,.. ,..a.C.nay.t e_ 1,.1 ,c�wv gc�►. y /� -L t— . \ - v2 c, - L.;r'n ��c,1 Cot c' 'r Se"--ct: - ik =- -- Zc-R_____ _T k ii � T f> : G r )7 (L 5I t&/TY- f . CePo 6 iMN I> ALA Cd LL/L ie. -tt -1--4 1-0 ,., lac. - , c 0tl - -= /-c,, �L ��-- A pie fp,c ci - ' . �--s' L.e.Q i I I/).-).- x"�o 'k. LE; /: iz� c.�/lie/- Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make any thing but gold and silver Coin a Tender in Paument of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations,poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor,We the People, lawfully and formally petition our State Legislators, Representative Bob Rommel, Representative Lauren Melo and State Senator Kathleen Passidomo to pass a resolutioncalling for the L.T.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to implement a Gold and Silver backed U.S. Dollar immediately. Date - -7_ Name Autograph County ..1: c 11 tlry . hi.zelc . Le i •• _ „,,A/:, - .- __--v: ...-.1.4 ee,s1 .4eizz,7,44-e__1- r-- 0 ..... . -:,Y.." .---',.,,,," a- maim', ,... '14--- ,& _FORIWIS 4 4 - 4 ..-. ' " ' CSN44- . . RUESD Z. c . Llr� - . -, p.,,,,,ift,,. -Tit)/4."- _zew,,,,(,<,„..e...... vt,_ Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make any thing but gold and silver Coin a Tender in Payment of Debts....;"and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor, We the People, lawfully and formally petition our State Legislators, Representative Bob Rommel, Representative Lauren Melo and State Senator Kathleen Passidomo to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to implement a Gold and Silver backed U.S. Dollar immediately. Date Printed Name Aut County 6/7#/2-7- att4104 v p J z-7/2tz. OW. 5/a7/ lQ.. A• gra la N P t +-���,� �r/�.�-<`.�- Co/ Itr G'-;ty - fad, MfSi r /`ram, 5 2,1 7-1/17 c52>tP...i I 1---evo 'Ai. 07 Nei -- 2 /27/77 Aid rfi: :p € 1 sI fri 4/2/ /� f/47 ' � l►)� bpi S/ k. .t ,irJ S: ) 1 1 L.�j P �r CG C k(....✓ Z.f 1 Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make anu thing but gold and silver Coin a Tender in Payment of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and, Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor, We the People, lawfully and formally petition our State Legislators, Representative Bob Rommel, Representative Lauren Melo and State Senator Kathleen Passidomo to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to implement a Gold and Silver backed U.S. Dollar immediately. Date Printed Name Autograph County} , =7. LIth iVigvi 15 ' /"f �z, radJ , _„, c ii , -2s'- 22 A + (. perk( ';` e S`,2c.,79- Jettn P n-e 3 tit-PCud1t 444 1-,4Cs e 0 ,i i tet-S c44/'F jt 7l l �1 72-4 L/Lf Y ,�.�r1 r av,�/�V ��//~1 `. % i / j C �- 1� -,--'e .f.......„-2 ezi ke? `7 ,/'�jU ' 45 ,a,00.4.,2, i/.�; ,,.., . , wets a, 7 ,., .:` -z-z- _at4M All&7 1. 4 4 !"/'. ' - CA .-V-14,'t "Pr -' ' , '-eems >i 7:1. k a€tf1 Mc r�1 z. J . I p a e Z oc _ 0, i C d e1" � 5-- - , 4.,z ..A i L If y174-,,, 1/ 7 (,�i/e,r4. ;- -0(1- 10--.:1 lam) i .� ' 0,-J..- L,1 Ccit L Petition to the Florida State Legislature to restore Gold 8a Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make ana thing but gold and silver Coin a Tender in Paument of Debts 'and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. Dollar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and. Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not backed by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor, We the People, lawfully and formally petition our State Legislators, Representative Bob Rommel, Representative Lauren Melo and State Senator Kathleen Passidomo to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to implement a Gold and Silver backed U.S. Dollar immediately. Date Printed Name Autograph County •')/. 172 C ekti j �b1J C( 0, _e e,J ,' / r a _ r 1 t `R `' ; `'v 4' / ' 11° cL-Str -- ,';-Iti/c) -- leintl C ' 'eSSeZ-- Le-2-... IAS Cr) I, 1—17 i :4 r6314 Zlitkocca. dt--...:0--er--- „......,---- t?3) ZZ , W . I A 1_..L- ", /off 1.),4-- 7 1 ff- L . , (;_osidi. I/ j q 04- A • -0 iwo c,,,, 5 (0 (( '( I1;._ Petition to the Florida State Legislature to restore Gold & Silver backed Currency Whereas, Article I, Section 10, clause 1 of the Constitution for the United States of America states in part, "No State shall make anm thing but gold and silver Coin a Tender in pantrnent of Debts....;" and, Whereas, the devaluation of the U.S. Dollar through inflation and the removal of the U.S. .7;llar as the world's reserve currency by several other nations, poses a threat to the American people and the American economy; and. Whereas, the American people are opposed to the Great Reset promoted by Klause Shwab and the World Economic Forum and are against a digital dollar or digital currency that is not :lacked by gold or silver; and, Whereas, the American people seek the restoration of a gold and silver backed Constitutional Currency operating out of the U.S. Treasury (and not a private central bank). Therefor, We the People, lawfully and formally petition our State Legislators, Representative Bob Rommel, Representative Lauren Melo and State Senator Kathleen Passidomo to pass a resolution calling for the U.S. Congress to reject a digital dollar, to abolish the Federal Reserve private banking system, and to return the authority to coin money to the U.S. Treasury and to implement a Gold and Silver backed U.S. Dollar immediately. Date -`l:ed Name Autogr County f 7 - s Wegt- - 64- f Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to .9 faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Pri Name Autograph County !I--- LUaa.9_ Cnifoo L >");;;1._7:i C- Oille i— zr 22_ ig2YA ✓A,. S / .17 - 4257a Z 4,fil 42 5f Lvc/ e si -2--"/- 2--2--- .L,,c e Ave-kr-3o, _ LE F ii/7(-1/1 2 �,4 Y s z ��.-e it /...94-1/-- Oho Y iiiti193 ix-srA- -2k:L- _ _9- -Z 2z 19 - dig,/ , Liia, (2 -1 , . kip, irc lilt' kze_nxiii g1/4/(;:(Awi 'aD- L l2 —CI +-,aVka IZ \< ,, ,-. c��-elde cr )4, 412_4 (2-2, jutcoviiitoi-fft Au! Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Nam Aut graph County 1-1 -a� 2/ ,;-euto.kaClein 4) 2,w /n/ 2 P.44(_ 4,-14 ' 2 ! 2 G � ` : (� y) '/-.Z -ZZ, 1 ardi‘)e-yReed (2("' ke-,--( CGLLLCX, Y Z '/ L uric S.0�e /dL/ f � �y J —7 // f/c - - v & ,. i' '! 7c-e 'a e?-2— ellel,k_ ,,e6,‘.e_ 0r--- -iii-e-/-4-z- fzi-72t Scott- r7s 0 1 J4fft Z. -ee nr- �c d? i{:t3reii-isa-n(e- /iEGG te(6 -042 4 kati i f-Al k 4 vilicivt;401A7r-re-- / J-1Izz a12146 = v Co�Liex c1-)- r /U�.ci e'l� c ti c tr-A__ Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Name Autograph County /25/)-Z 4i.t34Ai *05kIA14 - (ate' P.-/ ...." A ,s.11 P!.ti- i'. [ or, .geptill .ife.4..--... Cc, I rig, t-AY . AT- 1/:8 Arvic. ,,.„,. :4 5 7' --1 • ro 4-6/a-re_ 4 2 Z ` l lt?.ei-n arr Co I let 79- • 122_ 0-ae any In f/,'P12 rs vir(/ t. 2( /ZZ ,6O C•5-Rvc56 ,� Cx (U 7/),C0 aZ)" '). Q3'.\ C) \-Y\Y\krj______a___a___C/Vk'`. (),1-\1V-Ar)04,-/ c r 11 a ' A (Lip,....e.Lic_*_ {v O(144 (VIP 1 . _. Jf4% 6/(VC GO r►b C'b 11/:v/Z-- Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. D.to Printed Name Aut.• a.h Count iii— /It al, 44,44 '',...411 .,_ ,/ (79 . . (2el Lehi ei fit" ," .0I go g WerefilliffirOMMIllr! i _ `-/ -- ' U AT ii • r / _0 FLA.-41W... - ,_ // ; ■i' WI MIIIIAJMM.....c(- C/� �'- 2 C/� / / a 1 411L r g17Lei , 1 - ,€ ha �� s ' M.' ' prir 1 z 7 z'L ilia. 51^ v vs.ql fr i f PP .41ROLIMEMI, W MIBIRESSEINK" — .Le_ AMEIIIMMINIVEIrl. ..iik Cod/ ‘1111111Mre. A ' �`��C.'1 MYL - ) , 0 ' Pol0 .111111L-„All 1 ellik ....,A*\'' _ , - 1 Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. / Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Name Autogra County 77/7 Li ID) 22 ef-1-:-4_kko f. ,A.V C__, II I cl.-v— / ?/ 2 -G N , th m w,lk,`h #71,, I,2 -e_ ie,e - Lf T1 gy2 131?it-the, ildWq ts ' )1/ (- 4/- --r C t ( ."--- 00i/it.-- 114202- ekAg. nierpitn7- a2-7A4ift,z- epz_,e&- ._ Iz /ZZ ` NA V-,,LLu2n,,, z7 4f IL 2-a2-- Ft Gtit- 0 f l 01 An t 7cn G-IM . �, 1 S � & ti � ifeL U/ /a71 a ona ct y ,' ./ q ' 2 r 2 2 0.1ICr lvIIIC CyclC ti t� �'If l Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Name A u t Fa- County i - i v �.-t- Ce.3 1/i /z C'c,r5z, 4. Li:2-Q_ If Z. • Li 01„ J ./✓ek,f,� -- if,e-t�_' 94 17/. -- ad41-- AO Cetot)54(4 fdA A••& A .�_/ I i nJtir rillAt/i., s�,� ;if� L91_At:4J Tr V--A /22 6 116f c_luc ����' / Go/ it -, - . 7-tea V UCtn ,--,.t Lo G n CA, a -it, ,,,... CO/A { f- `�-e - _ ter. i��c . : ,� \ HOT 1-zi.. V) y.44_,--c_ tifrovv-‘ \ C(.5 I( i4 `/ 11-/.2z &,p, aE= PoS MA L�6-- LAI 27 Ill' A\ )(w,t\,U () ,12� Lee ) fi/za l N ' 3i;Dw� , Lit)7) ,--2- ' z- ►i-rkiCiri TiitAu &occiey_II: 1'72 Z Vi VI L ,, :401 1? a-u )c vvi/LUE& Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Da P inted Name utograph County en lilts& b 4ififak (0-i.b;(-- . aa r rat/ 4 Mer _Th , _ .,,, . , e ,<.Q._ '--1 ) (-(-1-7/- - IA- 1 _ ---7 /2-__ NV fivalt, 4d1,JJ-1,4.4- Cgm«h.^ S-2-2Z K r1--rt+rc-Y� t uEsc 1 ei 1_ U 4D C/it u v; r7 ! _ ,L til l c, ! l r I 3—; S c I , , .7 ape _A-- ,_. -Z_ L-i- p w 1 C2- aI2-- .�'ol • .42 tftT,6c�E' c.JleZ Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Name Autograph County 5\*/ d-lAl\i 0°IV)QPNO _...___O C-----------‘- , ;ik)A A.{) <1) Z7 )2 ✓u ':16:t,ice/ 1� —. _ ,- CO 9Z Z A NE TM- I5( z J7 —P Co L'-64E'i"( 5 ),;g T7 V f 1UMc-, 54UL2I e re„ 5 ,3' - -- ]xt rbcc,r-a1 ut It_ 4 -ef-445 6 l I,'e r s- -k4-0._a 5'1,........-..A. i 4_,,,....._4,-,0 t 1.„..t e_. / 1,, '' ) R t'1 r.G�/L "1/ co-a-ems .1-- ee Aid C.,?.&11-1— t.._,, - 5-/V7_ --(--0--e--ta40,,,/./ „ 42,c?e_.7, 5%`1/ 2 z 1L-4 1 r+- G-n-z-z_o (_16,40-a- aiiR„,c, 5/ / z Oho-t-a k<- -� '-'(_.))_ mb-kr ,. v\A(iju-t-t cd ' e Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Name Auto•ra.h Count j Lott. -'L'L- 3 a - _ IMINNEllretWOMIEra 3 •-, 7 c- •sic r _ _ � � U Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date P inted Name ., tograa County 4e as .►_lla f � r-- &h� , , Niii-L � . ‘14e_ ///, it?g,4./E ,Tif*-- ,,, ."--?.,_ 1 jo,„47(1,4, aooTekou (-41-44 4,1 1,9-1-- Aiii&o,0 --abkvi4i oArwrAriel- c-ti_2_1_ 1.) , 4.---131mLatet_ ,t0; CoJL /2C2Z S It ' anaitrt)-- k.04-1- _, / kw 6 (Li faGL c --ep tAkA7t- IA.,49\4 -ottee--( E �f/ Z`Z A.✓ia Jr)(S( ,, C �!�E✓~ bWS st - Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Print d Name I t h Count S-1# ///k-Bai/#2, S- /$22- ,I•a4. l i__, 2 , I '►l (S P --S Mt ►)P \ 6 . -,A..„ . `:: ' .,r,1.. � *' `Q. 5-; 1 g.. LO to ree r -',/-_. fi ,�r'-�i <- ..47/1"Z'l-- . , ,-. --fL_ --v& 116° 5/1 c-/( d2 Pii611WO 1 6"* ‘‘ % `/ : Z-e--- ("41(.. c-tv2/4.- litAttr L d'kA \S.... Lute', S-Ia-.21 RAY [kmt e 1 C°a6/e eE-- S-/$".?1 ti lecn Von--Zse 1 S : I ,a YY14h_ Le- ,e R. c„iiirr • L 1 C) i r ,,,,, �---7c ram-,,,, e 'rr t,.., Cc) ( (I e c� 5. \ - , C��� ' C ; I 1 , ' Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump. have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights. and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Nate Printed Name Au graph County 5 1 _ .:-;‘4.-),-, 1, 141AP \VgL__ "op r,, ii.,----- -., i. ,...__' , "ir , - (0,), hu t km , 0 AO -5:-/. /;+1-- 2111PC/4' - i 4 4,,.' .f, -4.-., _ 4-6,..do," . - pc4,va r ?ter c'3— wolf —" Lock? ii cian o ` //)7yy- /et- qiCjtitil— --4Ae'4;e4,14/C' ' Agd-'"?1,1--- -- 6L,t)il It,/ . - r jl 6a-i -ici/� �d.r�-�' �•Z- Jot-./1 3 - — i'ere �3; r \;. co( 'er Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Name Autograph County e-ft--77/7 h N. 7,,c)G / V s- G,. . ErDeJiô 6Q , PAL Ai 6-e:, j, � „ (1c 479 - DLivA pt Cora/ -' 44-711 '., Li 7? -). Ser) Co7^1,- I Co l - ,f,i- z-I ,V \-5 il t I'rtik/iAC''-7-'2 i .f it �, Cr•,C/ r s< s--- -2� <--k-vim._ -.s , ,, _ .-- cl) 1' ( S-A - P s \CZ CA, • U3 U. ricA„ Lem q')102 Ems.,btif So I; ,,a i , t,, Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Name Autograph County Vi b -12-2kil,y A/ /14 r 'x vr— I/r , y /ro/ --- 1 1 -. i-(.-1JJ L G -'L-_ 1 1/le/7-t-__ - ti frf p J .- --). - dol/.. 51 lb r .2 l' e, i-t,d.e-/t. 5 , J / t...-2.- AV..-lei L, f:v AL— {/'f i/-�.X�._ d?t'ur '( '✓ l ..1 ti4,a. y" IC, C-z 1--. fZt2 ,49z T Glt'7 f1 a,+'D / - .� ,s22� '�. .� c'OZ cr�-- 5 l !p .The- ` .,ti,.) - " , L e�- .5 110 7,,,i_ )..),(_:. b .-1--, ?(- 6eirrejt ;\---/r ";74441,44 1 . OU '\scV A.,y ! —it '� - QV'•, KZGAna i• Cu ‘ +s•e,r- / k( r r •A C7(rbQJC7 —39 ei----As v—,Ls vt, J , Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Name Autograph County /f— 'D--- Yh Lk-( F4 Lc o fr;-‘e,---- / e z___ 1 Cell er fi-- ? 9 D/I/ , 0 1? 7ie i(L e,� //; /_L .4 - ,i/i% ia_ thi'IAikt Liciu,cliQ C. Vic.- i, �.. 61'/i f dc.. VIZ 1.2‘2-- T-ingif -t-Z,- e, ,1/44--- 5liL(21 A 1114.(((L41010 ci_lco- p 0 ,A-it �er r\.-( Co /li _ C%--.1 2, )--Acic 80-7,-ek_ je4/4-A---e-- tc_e_- AZ 0E6()P4/4 AaVE i rtAtiyaeAtic 0(_,2L-' rZ TAr zip u IIW :3 , ra ,7,4aad va,/. gi e al o//ice. Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Printed Name Auto ra County 'MM------ 22—:--Al/'Vl(...st --3-(II 1\ Cf)///e ,,. ) 7 7_ I/46e ji)//i/ "4 — (..o 5 ) r L/ z z ,S\ln n.ncr1-•. s .41o,_-- c M Gantt. S r 2-/1-Z- icii ,tie( C l&r-k_ lam frto.4t-bak._ 5717 / 2 is a,Cot- . C _,e,‘ ID. ID: ei -.e.\e. \-\e,o\e-v) C..-a t. ,,f, E"!t a I .0. A -1e AIt,17 (%i !;LA— Y/f 13 2z.. P1it row C"a tt t .et--. ,51/2 22 11-c,44-4C arc"C> t( ' 71J420 ry Si/3/2R 6 isec 4i 9 /1cz 6 . TL ;, , /3/ a_ C'_a.-,wiL ' ,rGLA6 C .a.e_ /3 .. e i i_ f i '° '.' II)) -�' ,rr owl W' 1. -et.., Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall ...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42. and the actions of past Administrations prior to President Trump. have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. 2.`E Printed Name Auto aph County E ,r�L7.� 1- - PR?j 044 c i d I 2:1 12.22__ A_\ mc.1,i,, _ , 17Z- 4 6,1A /Y eyrfiZ, ,lie5r---' ,. , 1 zi kyiyy( ,&-bortsz/ i-,-;:aLN r,s,k,o_ i , L,2_g_ ‘ .2-- /I. -.- ,14-A1-4?pis--e-.s._ "di-- , W tLeA ! —y 1 ' , b f '� „5-c-Dit K/L;e--/ Co_ez..4,..., - _ _ 1-3 14./ a 4,414,&/4 r t-- A-'1 /.>--- (I. I I-ZA-1 4 - 4 - -,.... . , 7 K / _ =-�- r - --- � `� OAS Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump. have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. Date Print,{ed Name Autogra �cç County ,„...,——!c 4 7/1-, d,:'' ,..c,ii cr,vtar_s h..,vt_z_fs ,.._ t . , _ _...,..--A,....Q r - s' _--)- /j'1i f fi - /30 c the ,!0 ` CAI,../re f e 6, c- 1 TimRuG5peLL "2�;7 � ‹. o cc_/f{ re', r . ._C hdt a t et_ I G. .. '� 1+ e-Y .. 1-- , A:i g 1 66 , '1_, Lail.7Z ti i_,. c - -v1J74 14 / - 01-1)Sfil t �i,tev Iti oh ley Slr ) 9\3 ---- vt you Auvimi„ Q0 1 I,�'V Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights. and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. ;Lots Printed Name Autograph-- County fzi:---7 '-- 1 A apict) trifig-tAA-f: C ty I.—s..._k't.'iil 4.'5- --- -• .r /14 cs/),t-v -7- 464.4.' nils-ii - ., s,-,, , ,,.2 k„#„,,,,t,...;k4. ..„/ \s‘. ,Lz,.. , .. _. . _ . 0: -,,— if , t/ 1,eint,t) ' e- �-" — r6 csf e- - - ..�-_ 1 a sue' , _ - ill I (� %fir` V..';R--. ‘ $sa - _----. KK... ra-m---. C%. Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump. have resulted in an unsecure southern border by failing to fa:'-'-gully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor DeSantis, to exercise our rights under the Constitution and of the if Rights, and in the spirit of the Declaration of Independence, to .:a.it Florida's State Guard to stop the invasion of illegal immigration. Printed Name Autograph county - — 1-a-1/\ Ovi SS() vt_ /Li r 0 /-614.,\ -,- Z1'-1 3 Q r-,I efd Tiu,2i k 4 q) I r f/t., Ufa/ )0 a. Joe Lci OI . . £ ( I J&� 7:gio ej That.f-[) Pr.[' t L. - Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. ;ItPrinted Name Autograph ' C ntv 41hcrlr (I.14 74 4.re,4 t.. /62--r kriak\-ej Q"r (ate r�/�" ,4. ( � 0 ...,,,,,. 6l `5-C 4+a1--t u3 \. 1-t7 ) , w v.- ----,-). i 27-- --1ZIM p Jr q -. 3, Gct ti! ;.: ‘; A 1 t � :.>C} yroz, * .2 )(244_.z..e.,... ___,...„...26,...1 ,,iyAr i - t ,5 f c ''1 " vier G ; .. y jX 9 tti c,,,,k; j.G l r<._cS�.....� Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in his Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, to commit Florida's State Guard to stop the invasion of illegal immigration. r A. Dat Printed Name ca }• \ County . .a.Afacikv<ta 1Z -j fier V - 41 P/4Ichf1rJvA � "/iR2 Acit. th(4,/,/- `« ( I'er �tfln.-t i 1SZ ' = .emu►,,. 31�t. ter= /Z/ L (" 14 LfC- trot:LP' t Petition to Governor Ron DeSantis to send Florida State Guard to help Secure the Southern Border Whereas, Article II, Section 3, clause 4 of the Constitution for the united States of America states that the President shall "...take Care that the Laws be faithfully executed..." and, Whereas, Article IV, Section 4 of the Constitution for the united States of America states that "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion " and, Whereas, the actions of the Biden Administration, particularly removing Title 42, and the actions of past Administrations prior to President Trump, have resulted in an unsecure southern border by failing to faithfully execute the laws of the Constitution. Therefor, We the People, lawfully and formally petition Florida Governor Ron DeSantis, to exercise our rights under the Constitution and of the Bill of Rights, and in the spirit of the Declaration of Independence, commit Florida's State Guard to stop the invasion of illegal immigration. 5/221,22_ dory 52b" CO if Date Printed Name Auto raph County 7/Z i jZZ utt�[1 S iiLrd5 ta_1c• a rot kr- 4fr( dQ5 R.~hie.ir.eurd5 ., � ©!(i/er ,,�1)-2( L2_ �ti � C Z1 ( � rY ��t �ti l t xitt, /,sA,t Q G � d ( t e 51Zi/Z2 o.nn At. J 6e/1,- J a rnit'6rz-/ g9i a 'r /-7) l a P.04) pl-st (6404%Q. S 122 22. 4_,. u. YPufA /11 et' Iz 2 2-, ry Y ( c4 51Z2)22 rod-n . so C 14 6-- v-a Lic 51a1 a Nicole Cct, tcr ,er �f 1 fro �� Case 4:21-cv-01058-P Document 35 Filed 01/06/22 Page 1 of 4 PagelD 1715 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, v. No. 4:21-cv-1058-P FOOD AND DRUG ADMINISTRATION, Defendant. ORDER This case involves the Freedom of Information Act ("FOIA"). Specifically, at issue is Plaintiff's FOIA request seeking "[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Events Reporting System" from the Food and Drug Administration ("FDA"). See ECF No. 1. As has become standard, the Parties failed to agree to a mutually acceptable production schedule; instead, they submitted dueling production schedules for this Court's consideration. Accordingly, the Court held a conference with the Parties to determine an appropriate production schedule.' See ECF Nos. 21, 34. "Open government is fundamentally an American issue"—it is neither a Republican nor a Democrat issue.2 As James Madison wrote, "[a] popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be their own Governors, must arm themselves with the power which 'Surprisingly, the FDA did not send an agency representative to the scheduling conference. 2151 CONG.REC. S1521 (daily ed. Feb. 16, 2005) (statement of Sen.John Cornyn). Case 4:21-cv-01058-P Document 35 Filed 01/06/22 Page 2 of 4 PagelD 1716 knowledge gives."3 John F. Kennedy likewise recognized that "a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people."4 And, particularly appropriate in this case, John McCain (correctly) noted that"[e]xcessive administrative secrecy . . . feeds conspiracy theories and reduces the public's confidence in the government."5 Echoing these sentiments, "[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society." NLRB v. Robbins Tire &Rubber Co., 437 U.S. 214, 242 (1977). "FOIA was [therefore] enacted to `pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny."'Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep't of the Air Force v. Rose, 425 U.S. 352, 361 (1976)). And "Congress has long recognized that `information is often useful only if it is timely' and that, therefore `excessive delay by the agency in its response is often tantamount to denial."' Open Soc'y Just. Initiative v. CIA, 399 F. Supp. 3d 161, 165 (S.D.N.Y. 2019) (quoting H.R. REP. No. 93-876, at 6271 (1974)). When needed, a court "may use its equitable powers to require an agency to process documents according to a court-imposed timeline." Clemente v. FBI, 71 F. Supp. 3d 262, 269 (D.D.C. 2014). Here, the Court recognizes the"unduly burdensome" challenges that this FOIA request may present to the FDA. See generally ECF Nos. 23, 30, 34. But, as expressed at the scheduling conference, there may not be a "more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not 0 rush[ed] on behalf of the United States . . . ." ECF No. 34 at 46. 3Letter from James Madison to W.T. Barry(August 4, 1822), in 9 WRITINGS OF JAMES MADISON 103 (S. Hunt ed., 1910). 4John F.Kennedy,Remarks on the 20th Anniversary of the Voice of America(Feb. 26, 1962). 5America After 9/11:Freedom Preserved or Freedom Lost?:Hearing Before the S. Comm. on the Judiciary, 108th Cong. 302(2003). 2 Case 4:21-cv-01058-P Document 35 Filed 01/06/22 Page 3 of 4 PagelD 1717 Accordingly,the Court concludes that this FOIA request is of paramount public importance. "[S]tale information is of little value." Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). The Court, agreeing with this truism,therefore concludes that the expeditious completion of Plaintiffs request is not only practicable, but necessary. See Bloomberg, L.P. v. FDA, 500 F. Supp. 2d 371, 378 (S.D.N.Y. Aug. 15, 2007) ("[I]t is the compelling need for such public understanding that drives the urgency of the request."). To that end, the Court further concludes that the production rate, as detailed below, appropriately balances the need for unprecedented urgency in processing this request with the FDA's concerns regarding the burdens of production. See Halpern v. FBI, 181 F.3d 279, 284-85 (2nd Cir. 1991) ("[FOIA] emphasizes a preference for the fullest possible agency disclosure of such information consistent with a responsible balancing of competing concerns . . . ."). Accordingly, having considered the Parties' arguments, filings in support, and the applicable law, the Court ORDERS that: 1. The FDA shall produce the "more than 12,000 pages" articulated in its own proposal, see ECF No. 29 at 24, on or before January 31, 2022. 2. The FDA shall produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete. 3. To the extent the FDA asserts any privilege, exemption, or exclusion as to any responsive record or portion thereof, FDA shall, concurrent with each production required by this Order, produce a redacted version of the record, redacting only those portions as to which privilege, exemption, or exclusion is asserted. 3 Case 4:21-cv-01058-P Document 35 Filed 01/06/22 Page 4 of 4 PagelD 1718 4. The Parties shall submit a Joint Status Report detailing the progress of the rolling production by April 1, 2022, and every 90 days thereafter.6 SO ORDERED on this 6th day of January, 2022. /ilaA --- 7___ ? _ p.,____ Mark T. Pittman UNITED STATES DISTRICT JUDGE 6Although the Court does not decide whether the FDA correctly denied Plaintiff's request for expedited processing, the issue is not moot. Should the Parties seek to file motions for summary judgment,the Court will take up the issue then. 4 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048(BNT162B2) RECEIVED THROUGH 28-FEB-2021 I 2 0 Report Prepared by: 0 c`. Worldwide Safety Pfizer The information contained in this document is proprietary and confidential.Any disclosure,reproduction, distribution,or other dissemination of this information outside of Pfizer,its Affiliates,its Licensees,or Regulatory Agencies is strictly prohibited.Except as may be otherwise agreed to in writing,by accepting or co reviewing these materials,you agree to hold such information in confidence and not to disclose it to others O (except where required by applicable law),nor to use it for unauthorized purposes. N O L Q c. -0 O L QO. 0 0 co cri a) CO O7 r a) N- 0 Q) 0 CONFIDENTIAL Page 1 FDA-CBER-2021-5683-0000054 BNT I 62b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports TABLE OF CONTENTS LIST OF TABLES 3 LIST OF FIGURES 3 APPENDICES 3 LIST OF ABBREVIATIONS 4 1. INTRODUCTION 5 2. METHODOLOGY 5 3. RESULTS 6 3.1. Safety Database 6 3.1.1. General Overview 6 3.1.2. Summary of Safety Concerns in the US Pharmacovigilance Plan 9 3.1.3. Review of Adverse Events of Special Interest(AESIs) 16 3.1.4. Medication error 26 4. DISCUSSION 28 5. SUMMARY AND CONCLUSION 29 2 0 co N O O 1 N O N CI Q O c) C 0 O > O L C. C. % 0 > O L a a 5 O O co T Cu a) C) r U) N- N- O O) O CONFIDENTIAL Page 2 F DA-C B E R-2021-5683-0000055 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports LIST OF TABLES Table 1. General Overview: Selected Characteristics of All Cases Received During the Reporting Interval 7 Table 2. Events Reported in>2% Cases 8 Table 3. Safety concerns 9 Table 4. Important Identified Risk 10 Table 5. Important Potential Risk 11 Table 6. Description of Missing Information 12 Table 7. AESIs Evaluation for BNT162b2 16 Table 8. ME PTs by seriousness with or without harm co-association (Through 28 February 2021) 27 LIST OF FIGURES Figure 1. Total Number of 13vPnC AEs by System Organ Classes and Event Seriousness 8 H 2 0 APPENDICES N o APPENDIX 1 LIST OF ADVERSE EVENTS OF SPECIAL INTEREST 30 N 0 0 N O 5 a) 0 5 0 0 o co rn a; ti ti rn CONFIDENTIAL Page 3 FDA-CBER-2021-5683-0000056 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports LIST OF ABBREVIATIONS Acronym Term AE adverse event AESI adverse event of special interest BC Brighton Collaboration CDC Centers for Disease Control and Prevention COVID-19 coronavirus disease 2019 DLP data lock point EUA emergency use authorisation HLGT (MedDRA) High Group Level Term HLT (MedDRA)High Level Term MAH marketing authorisation holder MedDRA medical dictionary for regulatory activities MHRA Medicines and Healthcare products Regulatory Agency PCR Polymerase Chain Reaction PT (MedDRA)Preferred Term PVP pharmacovigilance plan RT-PCR Reverse Transcription-Polymerase Chain Reaction RSI reference safety information THE targeted medically event 2 SARS-CoV-2 severe acute respiratory syndrome coronavirus 2 SMQ standardised MedDRA query N SOC (MedDRA) System Organ Class UK United Kingdom N US United States VAED vaccine-associated enhanced disease VAERD vaccine-associated enhanced respiratory disease VAERS vaccine adverse event reporting system 0 • C 0 O L 0 Qa V a) O L ca. 0 co ca a) co rn a) ti ti V! 0 CONFIDENTIAL Page 4 FDA-CBER-2021-5683-0000057 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports 1. INTRODUCTION Reference is made to the Request for Comments and Advice submitted 04 February 2021 regarding Pfizer/BioNTech's proposal for the clinical and post-authorization safety data package for the Biologics License Application(BLA)for our investigational COVID-19 Vaccine(BNT162b2). Further reference is made to the Agency's 09 March 2021 response to this request,and specifically,the following request from the Agency. "Monthly safety reports primarily focus on events that occurred during the reporting interval and include information not relevant to a BLA submission such as line lists of adverse events by country. We are most interested in a cumulative analysis of post-authorization safety data to support your future BLA submission. Please submit an integrated analysis of your cumulative post-authorization safety data, including U.S. and foreign post-authorization experience, in your upcoming BLA submission. Please include a cumulative analysis of the Important Identified Risks, Important Potential Risks, and areas of Important Missing Information identified in your Pharmacovigilance Plan, as well as adverse events of special interest and vaccine administration errors(whether or not associated with an adverse event). Please also include distribution data and an analysis of the most common adverse events. In addition,please submit your updated Pharmacovigilance Plan with your BLA submission." This document provides an integrated analysis of the cumulative post-authorization safety data, including U.S. and foreign post-authorization adverse event reports received through 28 2 February 2021. N 2. METHODOLOGY Pfizer is responsible for the management post-authorization safety data on behalf of the N MAH BioNTech according to the Pharmacovigilance Agreement in place.Data from BioNTech are included in the report when applicable. Pfizer's safety database contains cases of AEs reported spontaneously to Pfizer, cases reported by the health authorities,cases published in the medical literature,cases from Pfizer-sponsored marketing programs,non-interventional studies,and cases of serious AEs O reported from clinical studies regardless of causality assessment. a> oThe limitations of post-marketing adverse drug event reporting should be considered when interpreting these data: 5 • Reports are submitted voluntarily, and the magnitude of underreporting is unknown. oSome of the factors that may influence whether an event is reported include: length of time since marketing,market share of the drug,publicity about a drug or an AE, 5 seriousness of the reaction,regulatory actions,awareness by health professionals and consumers of adverse drug event reporting,and litigation. co - a�i • Because many external factors influence whether or not an AE is reported,the rn spontaneous reporting system yields reporting proportions not incidence rates. As a m result,it is generally not appropriate to make between-drug comparisons using these r- rn CONFIDENTIAL Page 5 FDA-CBER-2021-5683-0000058 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports proportions;the spontaneous reporting system should be used for signal detection rather than hypothesis testing. • In some reports,clinical information(such as medical history,validation of diagnosis, time from drug use to onset of illness,dose,and use of concomitant drugs)is missing or incomplete,and follow-up information may not be available. • An accumulation of adverse event reports(AERs)does not necessarily indicate that a particular AE was caused by the drug;rather,the event may be due to an underlying disease or some other factor(s) such as past medical history or concomitant medication. • Among adverse event reports received into the Pfizer safety database during the cumulative period,only those having a complete workflow cycle in the safety database (meaning they progressed to Distribution or Closed workflow status)are included in the monthly SMSR. This approach prevents the inclusion of cases that are not fully processed hence not accurately reflecting final information. Due to the large numbers of spontaneous adverse event reports received for the product,the MAH has prioritised the processing of serious cases,in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity. The increased volume of reports has not impacted case processing for serious reports,and 2 compliance metrics continue to be monitored weekly with prompt action taken as needed 0 to maintain compliance with expedited reporting obligations.Non-serious cases are co entered into the safety database no later than 4 calendar days from receipt. Entrance into the database includes the coding of all adverse events; this allow for a manual review of events being received but may not include immediate case processing to completion. o Non-serious cases are processed as soon as possible and no later than 90 days from cL receipt. Pfizer has also taken a multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process o and workflow solutions,as well as increasing the number of data entry and case co processing colleagues. To date,Pfizer has onboarded approximately 600 additional full- O time employees(FTEs).More are joining each month with an expected total of more than -10 1,800 additional resources by the end of June 2021. a 3. RESULTS 5 3.1. Safety Database D a' 3.1.1. General Overview 0 a It is estimated that approximately 126,212,580 doses of BNT162b2 were shipped worldwide 5 from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021. co co Cumulatively,through 28 February 2021,there was a total of 42,086 case reports(25,379 a) rn medically confirmed and 16,707 non-medically confirmed)containing 158,893 events. Most cases(34,762)were received from United States(13,739),United Kingdom(13,404)Italy ti (2,578),Germany(1913),France(1506),Portugal(866)and Spain(756);the remaining 7,324 were distributed among 56 other countries. rn 0 CONFIDENTIAL Page 6 FDA-CBER-2021-5683-0000059 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 1 below presents the main characteristics of the overall cases. Table 1. General Overview: Selected Characteristics of All Cases Received During the Reporting Interval Characteristics Relevant cases(N=42086) Gender: Female 29914 Male 9182 No Data 2990 Age range(years): < 17 175' 0.01 -107 years 18-30 4953 Mean=50.9 years 31-50 13886 n=34952 51-64 7884 65-74 3098 >75 5214 Unknown 6876 Case outcome: Recovered/Recovering 19582 Recovered with sequelae 520 Not recovered at the time of report 11361 Fatal 1223 Unknown 9400 a. in 46 cases reported age was<16-year-old and in 34 cases<12-year-old. 2 As shown in Figure I,the System Organ Classes(SOCs)that contained the greatest number (>2%) of events, in the overall dataset, were General disorders and administration site C°y conditions (51,335 AEs), Nervous system disorders (25,957),Musculoskeletal and connective tissue disorders(17,283), Gastrointestinal disorders(14,096), Skin and subcutaneous tissue disorders(8,476), Respiratory,thoracic and mediastinal disorders (8,848), Infections and infestations(4,610),Injury,poisoning and procedural complications (5,590), and Investigations(3,693). 0 0 V m 0 L Q 0 5 a) 0 L a. 0_ 5 0 0 co Cu a) CD a) ti t` 0 a) 0 CONFIDENTIAL Page 7 F DA-C B E R-2021-5683-0000060 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Figure 1. Total Number of BNT162b2 AEs by System Organ Classes and Event Seriousness ❑ _. n _--- f— _ _ r - - 2 e .2 2 _ Z _ 2 ' i — _ z 3 0 — CO N = O 0 Table 2 shows the most commonly(>2%)reported MedDRA(v. 23.1)PTs in the overall dataset(through 28 February 2021), co OTable 2. Events Reported in>2% Cases Cumulatively Through 28 February 2021 0 0_ MedDRA SOC MedDRA PT AEs(AERP%) 0_ N=42086 5 Blood and lymphatic system disorders O Lymphadenopathy 1972(4.7%) Q Cardiac disorders C. Tachycardia 1098(2.6%) 5 Gastrointestinal disorders Nausea 5182(12.3%) 00 Diarrhoea 1880(4.5%) N Vomiting 1698(4.0%) General disorders and administration site conditions Pyrexia 7666(18.2%) Fatigue 7338(17.4%) Chills 5514(13.1%) Vaccination site pain 5181 (12.3%) O O CONFIDENTIAL Page 8 FDA-CBER-2021-5683-0000061 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 2. Events Reported in a.2% Cases Cumulatively Through 28 February 2021 MedDRA SOC MedDRA PT AEs(AERP%) N=42086 Pain 3691(8.8%) Malaise 2897(6.9%) Asthenia 2285(5.4%) Drug ineffective 2201 (5.2%) Vaccination site erythema 930(2.2%) Vaccination site swelling 913(2.2%) Influenza like illness 835(2%) Infections and infestations COVID-19 1927(4.6%) Injury,poisoning and procedural complications Off label use 880(2.1%) Product use issue 828(2.0%) Musculoskeletal and connective tissue disorders Myalgia 4915(11.7%) Pain in extremity 3959(9.4%) Arthralgia 3525(8.4%) Nervous system disorders Headache 10131 (24.1%) Dizziness 3720(8.8%) Paraesthesia 1500(3.6%) 2 Hypoaesthesia 999(2.4%) (7 Respiratory,thoracic and mediastinal disorders Dyspnoea 2057(4.9%) N Cough 1146(2.7%) Oropharyngeal pain 948(2.3%) O Skin and subcutaneous tissue disorders N Pruritus 1447(3.4%) N Rash 1404(3.3%) Erythema 1044(2.5%) Hyperhidrosis 900(2.1%) Urticaria 862(2.1%) M Total number of events 93473 0 a) 3.1.2. Summary of Safety Concerns in the US Pharmacovigilance Plan 0 Table 3. Safety concerns 5 Important identified risks Anaphylaxis N O Important potential risks Vaccine-Associated Enhanced Disease(VAED),Including Vaccine-associated O. Enhanced Respiratory Disease(VAERD) Missing information Use in Pregnancy and lactation O Use in Paediatric Individuals<12 Years of Age Vaccine Effectiveness CO CO N Co ti ti O CONFIDENTIAL Page 9 FDA-CBER-2021-5683-0000062 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 4. Important Identified Risk Topic Description Important Post Authorization Cases Evaluation(cumulative to 28 Feb 2021) Identified Total Number of Cases in the Reporting Period(N=42086) Risk Anaphylaxis Since the first temporary authorization for emergency supply under Regulation 174 in the UK (01 December 2020)and through 28 February 2021,1833 potentially relevant cases were retrieved from the Anaphylactic reaction SMQ(Narrow and Broad)search strategy,applying the MedDRA algorithm. These cases were individually reviewed and assessed according to Brighton Collaboration(BC) definition and level of diagnostic certainty as shown in the Table below: Brighton Collaboration Level Number of cases BC I 290 BC 2 311 BC 3 10 BC 4 391 BC 5 831 Total 1833 Level 1 indicates a case with the highest level of diagnostic certainty of anaphylaxis, whereas the diagnostic certainty is lowest for Level 3.Level 4 is defined as"reported event of anaphylaxis with insufficient evidence to meet the case definition"and Level 5 as not a case of anaphylaxis. There were 1002 cases(54.0%of the potentially relevant cases retrieved),2958 potentially relevant events,from the Anaphylactic reaction SMQ(Broad and Narrow)search strategy,meeting BC Level 1 to 2 4: (9 Country of incidence:UK(261),US(184),Mexico(99),Italy(82),Germany(67),Spain(38),France co CV (36),Portugal(22),Denmark(20),Finland,Greece(19 each),Sweden(17),Czech Republic, ONetherlands(16 each),Belgium,Ireland(13 each),Poland(12),Austria(11);the remaining 57 cases originated from 15 different countries. j Relevant event seriousness:Serious(2341),Non-Serious(617); Gender:Females(876),Males(106),Unknown(20); Age(n=961)ranged from 16 to 98 years(mean=54.8 years,median=42.5 years); Relevant even outcome: fatal(9)t,resolved/resolving(1922),not resolved(229),resolved with sequelae (48),unknown(754); Most frequently reported relevant PTs(>2%),from the Anaphylactic reaction SMQ(Broad and Narrow) search strategy:Anaphylactic reaction(435),Dyspnoea(356),Rash(190),Pruritus(175), Erythema (159),Urticaria(133),Cough(115),Respiratory distress,Throat tightness(97 each),Swollen tongue 0 (93),Anaphylactic shock(80),Hypotension(72),Chest discomfort(71),Swelling face(70),Pharyngeal a) swelling(68),and Lip swelling(64). QConclusion:Evaluation of BC cases Level 1-4 did not reveal any significant new safety information. Anaphylaxis is appropriately described in the product labeling as are non-anaphylactic hypersensitivity 5 events.Surveillance will continue. a Different clinical outcome may be reported for an event that occurred more than once to the same individual. > b There were 4 individuals in the anaphylaxis evaluation who died on the same day they were vaccinated. 2 Although these patients experienced adverse events(9)that are potential symptoms of anaphylaxis,they all had serious underlying medical conditions,and one individual appeared to also have COVID-19 pneumonia,that likely contributed to 5 their deaths O O O (t3 4) co O N r- r- O O O CONFIDENTIAL Page 10 FDA-CBER-2021-5683-0000063 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 5. Important Potential Risk Topic Description Important Post Authorization Cases Evaluation(cumulative to 28 Feb 2021) Potential Total Number of Cases in the Reporting Period(N=42086) Risk Vaccine- No post-authorized AE reports have been identified as cases of VAEDNAERD,therefore,there is no Associated observed data at this time. An expected rate of VAED is difficult to establish so a meaningful Enhanced observed/expected analysis cannot be conducted at this point based on available data. The feasibility of Disease conducting such an analysis will be re-evaluated on an ongoing basis as data on the virus grows and the (VAED), vaccine safety data continues to accrue. including Vaccine- The search criteria utilised to identify potential cases of VAED for this report includes PTs indicating a Associated lack of effect of the vaccine and PTs potentially indicative of severe or atypical COVID-19a. Enhanced Respiratory Since the first temporary authorization for emergency supply under Regulation 174 in the UK(01 Disease December 2020)and through 28 February 2021,138 cases[0.33%of the total PM dataset],reporting 317 (VAERD) potentially relevant events were retrieved: Country of incidence:UK(71),US(25),Germany(14),France,Italy,Mexico,Spain,(4 each),Denmark (3);the remaining 9 cases originated from 9 different countries; Cases Seriousness: 138; Seriousness criteria for the total 138 cases:Medically significant(71,of which 8 also serious for disability),Hospitalization required(non-fatal/non-life threatening)(16,of which 1 also serious for disability),Life threatening(13,of which 7 were also serious for hospitalization),Death(38). Gender:Females(73),Males(57),Unknown(8); Age(n=132)ranged from 21 to 100 years(mean=57.2 years,median=59.5); Ur Case outcome:fatal(38),resolved/resolving(26),not resolved(65),resolved with sequelae(1),unknown (8); NOf the 317 relevant events,the most frequently reported PTs(>_2%)were:Drug ineffective(135), Dyspnoea(53),Diarrhoea(30),COVID-19 pneumonia(23),Vomiting(20),Respiratory failure(8),and Seizure(7). CV Conclusion:VAED may present as severe or unusual clinical manifestations of COVID-19.Overall,there N were 37 subjects with suspected COVID-19 and 101 subjects with confirmed COVID-19 following one Q or both doses of the vaccine;75 of the 101 cases were severe,resulting in hospitalisation,disability, life-threatening consequences or death.None of the 75 cases could be definitively considered as o VAEDNAERD. cr) In this review of subjects with COVID-19 following vaccination,based on the current evidence, VAEDNAERD remains a theoretical risk for the vaccine.Surveillance will continue. 0 a. Search criteria:Standard Decreased Therapeutic Response Search AND PTs Dyspnoea;Tachypnoea;Hypoxia; COVID 19 pneumonia;Respiratory Failure;Acute Respiratory Distress Syndrome;Cardiac Failure;Cardiogenic shock; Acute myocardial infarction;Arrhythmia;Myocarditis;Vomiting;Diarrhoea;Abdominal pain;Jaundice; 2 Acute hepatic failure;Deep vein thrombosis;Pulmonary embolism;Peripheral Ischaemia;Vasculitis;Shock; Acute kidney injury;Renal failure;Altered state of consciousness;Seizure;Encephalopathy;Meningitis; Q Cerebrovascular accident;Thrombocytopenia;Disseminated intravascular coagulation;Chilblains; Erythema multiforme;Multiple organ dysfunction syndrome;Multisystem inflammatory syndrome in children. a) O L Q Q 5 0 0 0 a) 0 rn a) t` r— o rn 0 CONFIDENTIAL Page 11 FDA-CBER-2021-5683-0000064 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 6. Description of Missing Information Topic Description Missing Post Authorization Cases Evaluation(cumulative to 28 Feb 2021) Information Total Number of Cases in the Reporting Period(N=42086) Use in Pregnancy • Number of cases:413'(0.98%of the total PM datacrt);84 serious and 329 non-serious; and lactation • Country of incidence:US(205),UK(64),Canada(31),Germany(30),Poland(13),Israel (11);Italy(9),Portugal(8),Mexico(6),Estonia,Hungary and Ireland,(5 each),Romania(4), Spain(3),Czech Republic and France(2 each),the remaining 10 cases were distributed among 10 other countries. Pregnancy cases:274 cases including: • 270 mother cases and 4 foetus/baby cases representing 270 unique pregnancies(the 4 foetus/baby cases were linked to 3 mother cases;1 mother case involved twins). • Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion(23), outcome pending(5),premature birth with neonatal death,spontaneous abortion with intrauterine death(2 each),spontaneous abortion with neonatal death,and normal outcome(1 each).No outcome was provided for 238 pregnancies(note that 2 different outcomes were reported for each twin,and both were counted). • 146 non-serious mother cases reported exposure to vaccine in utero without the occurrence of any clinical adverse event.The exposure PTs coded to the PTs Maternal exposure during pregnancy(111),Exposure during pregnancy(29)and Maternal exposure timing unspecified 2 (6).Trimester of exposure was reported in 21 of these cases: 1st trimester(15 cases),2nd (� trimester(7),and 3rd trimester(2). • 124 mother cases,49 non-serious and 75 serious,reported clinical events,which occurred in to CV the vaccinated mothers.Pregnancy related events reported in these cases coded to the PTs Abortion spontaneous(25),Uterine contraction during pregnancy,Premature rupture of membranes,Abortion,Abortion missed,and Foetal death(1 each).Other clinical events which CVO occurred in more than 5 cases coded to the PTs Headache(33),Vaccination site pain(24), Pain in extremity and Fatigue(22 each),Myalgia and Pyrexia(16 each),Chills(13)Nausea (12),Pain(11),Arthralgia(9),Lymphadenopathy and Drug ineffective(7 each),Chest pain, Dizziness and Asthenia(6 each),Malaise and COVID-I9(5 each).Trimester of exposure was O reported in 22 of these cases: 1st trimester(19 cases),2nd trimester(1 case),3rd trimester(2 ch cases). O • 4 serious foetus/baby cases reported the PTs Exposure during pregnancy,Foetal growth 0 restriction,Maternal exposure during pregnancy,Premature baby(2 each),and Death neonatal (1).Trimester of exposure was reported for 2 cases(twins)as occurring during the 1st trimester. Breast feeding baby cases: 133,of which: 5 • 116 cases reported exposure to vaccine during breastfeeding(PT Exposure via breast milk) without the occurrence of any clinical adverse events; O • 17 cases,3 serious and 14 non-serious,reported the following clinical events that occurred in the infant/child exposed to vaccine via breastfeeding:Pyrexia(5),Rash(4),Infant irritability 5 (3),Infantile vomiting,Diarrhoea,Insomnia,and Illness(2 each),Poor feeding infant, O Lethargy,Abdominal discomfort,Vomiting,Allergy to vaccine,Increased appetite,Anxiety, Crying,Poor quality sleep,Eructation,Agitation,Pain and Urticaria(1 each). co Breast feeding mother cases(6): a) • 1 serious case reported 3 clinical events that occurred in a mother during breast feeding(PT Maternal exposure during breast feeding);these events coded to the PTs Chills,Malaise,and Pyrexia ti • 1 non-serious case reported with very limited information and without associated AEs. Q Q CONFIDENTIAL Page 12 FDA-CBE R-2021-5683-0000065 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 6. Description of Missing Information Topic Description Missing Post Authorization Cases Evaluation(cumulative to 28 Feb 2021) Information Total Number of Cases in the Reporting Period(N=42086) • In 4 cases(3 non-serious;1 serious)Suppressed lactation occurred in a breast feeding women with the following co-reported events:Pyrexia(2),Paresis,Headache,Chills,Vomiting,Pain in extremity,Arthralgia,Breast pain,Scar pain,Nausea,Migraine,Myalgia,Fatigue and Breast milk discolouration(1 each). Conclusion:There were no safety signals that emerged from the review of these cases of use in pregnancy and while breast feeding. Use in Paediatric Paediatric individuals<12 years of age Individuals • Number of cases:34`'(0.1%of the total PM dataset),indicative of administration in paediatric <12 Years of subjects<12 years of age; Age • Country of incidence:UK(29),US(3),Germany and Andorra(1 each); • Cases Seriousness:Serious(24),Non-Serious(10); • Gender:Females(25),Males(7),Unknown(2); • Age(n=34)ranged from 2 months to 9 years,mean=3.7 years,median=4.0; • Case outcome:resolved/resolving(16),not resolved(13),and unknown(5). • Of the 132 reported events,those reported more than once were as follows:Product administered to patient of inappropriate age(27,see Medication Error),Off label use(11), Pyrexia(6),Product use issue(5),Fatigue,Headache and Nausea(4 each),Vaccination site pain(3),Abdominal pain upper,COVID-19,Facial paralysis,Lymphadenopathy,Malaise, Pruritus and Swelling(2 each). 2 0 Conclusion:No new significant safety information was identified based on a review of these cases compared with the non-paediatric population. N d) Vaccine Company conventions for coding cases indicative of lack of efficacy: O Effectiveness N The coding conventions for lack of efficacy in the context of administration of the COVID-19 vaccine O were revised on 15 February 2021,as shown below: • PT"Vaccination failure"is coded when ALL of the following criteria are met: Q o The subject has received the series of two doses per the dosing regimen in local Q labeling. Mo At least 7 days have elapsed since the second dose of vaccine has been administered. o The subject experiences SARS-CoV-2 infection(confirmed laboratory tests). O • PT"Drug ineffective"is coded when either of the following applies: o The infection is not confirmed as SARS-CoV-2 through laboratory tests (irrespective of the vaccination schedule).This includes scenarios where LOE is CD stated or implied,e.g.,"the vaccine did not work","I got COVID-19". o It is unknown: Q • Whether the subject has received the series of two doses per the dosing regimen in local labeling; • How many days have passed since the first dose(including unspecified number of days like"a few days","some days",etc.); 2 • If 7 days have passed since the second dose; Q o The subject experiences a vaccine preventable illness 14 days after receiving the 0. g first dose up to and through 6 days after receipt of the second dose. Note:after the immune system as had sufficient time(14 days)to respond to the vaccine,a report of OD COVID-19 is considered a potential lack of efficacy even if the vaccination course is not complete. Cu CO Summary of the coding conventions for onset of vaccine preventable disease versus the vaccination date: a) N - N- O c) O CONFIDENTIAL Page 13 FDA-CBER-2021-5683-0000066 ENT l 62b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 6. Description of Missing Information Topic Description Missing Post Authorization Cases Evaluation(cumulative to 28 Feb 2021) Information Total Number of Cases in the Reporting Period(N=42086) 1st dose(day 1-13) From day 14 post 1st dose to Day 7 post 2nd dose day 6 post 2nd dose Code only the events Code"Drug ineffective" Code"Vaccination failure" describing the SARS-CoV-2 infection Scenario Not considered Scenario considered LOE as Scenario considered LOE as LOE "Drug ineffective" "Vaccination failure" Lack of efficacy cases • Number of cases: 1665b(3.9%of the total PM dataset)of which 1100 were medically confirmed and 565 non medically confirmed; • Number of lack of efficacy events: 1665[PT:Drug ineffective(1646)and Vaccination failure (19)11 • Country of incidence:US(665),UK(405),Germany(181),France(85),Italy(58),Romania (47),Belgium(33),Israel(30),Poland(28),Spain(21),Austria(18),Portugal(17),Greece (15),Mexico(13),Denmark(8),Canada(7),Hungary,Sweden and United Arab Emirates(5 each),Czech Republic(4),Switzerland(3);the remaining 12 cases originated from 9 different countries. • COVID-19 infection was suspected in 155 cases,confirmed in 228 cases,in 1 case it was reported that the first dose was not effective(no other information). • COVID-I9 infection(suspected or confirmed)outcome was reported as resolved/resolving rfl (165),not resolved(205)or unknown(1230)at the time of the reporting;there were 65 cases N where a fatal outcome was reported. O N Drug ineffective cases(1649) O • Drug ineffective event seriousness:serious(1625),non-serious 21 • Lack of efficacy term was reported: o after the 1st dose in 788 cases O o after the 2nd dose in 139 cases o in 722 cases it was unknown after which dose the lack of efficacy occurred. • Latency of lack of efficacy term reported after the first dose was known for 176 cases: o Within 9 days:2 subjects; 2 o Within 14 and 21 days: 154 subjects; O. o Within 22 and 50 days:20 subjects; 5 • Latency of lack of efficacy term reported after the second dose was known for 69 cases: o Within 0 and 7 days:42 subjects; 2 Within 8 and 21 days:22 subjects; o Within 23 and 36 days:5 subjects. Q g • Latency of lack of efficacy term reported in cases where the number of doses administered was O not provided,was known in 409 cases: O CO o Within 0 and 7 days after vaccination:281 subjects. o Within 8 and 14 days after vaccination:89 subjects. a) O o Within 15 and 44 days after vaccination:39 subjects. a) ti According to the RSI,individuals may not be fully protected until 7 days after their second dose of vaccine,therefore for the above 1649 cases where lack of efficacy was reported after the 1st dose or the O a) O CONFIDENTIAL Page 14 FDA-CBER-2021-5683-0000067 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 6. Description of Missing Information Topic Description Missing Post Authorization Cases Evaluation(cumulative to 28 Feb 2021) Information Total Number of Cases in the Reporting Period(N=42086) 2nd dose,the reported events may represent signs and symptoms of intercurrent or undiagnosed COVID- 19 infection or infection in an individual who was not fully vaccinated,rather than vaccine ineffectiveness. Vaccination failure cases(16) • Vaccination failure seriousness:all serious; • Lack of efficacy term was reported in all cases after the 2nd dose: • Latency of lack of efficacy was known for 14 cases: o Within 7 and 13 days:8 subjects; o Within 15 and 29 days:6 subjects. COVID-19(10)and Asymptomatic COVID-19(6)were the reported vaccine preventable infections that occurred in these 16 cases. Conclusion:No new safety signals of vaccine lack of efficacy have emerged based on a review of these cases. a. From a total of 417 cases,4 cases were excluded from the analysis.In 3 cases,the MAH was informed that a 33-year-old and two unspecified age pregnant female patients were scheduled to receive bnt162b2(PT reported Off label use and Product use issue in 2 cases;Circumstance or information capable of leading to 0 medication error in one case).One case reported the PT Morning sickness;however,pregnancy was not confirmed in this case. N b. 558 additional cases retrieved in this dataset were excluded from the analysis;upon review,546 cases cannot be considered true lack of efficacy cases because the PT Drug ineffective was coded but the subjects developed SARS-CoV-2 infection during the early days from the first dose(days 1—13);the vaccine has not had sufficient time to stimulate the immune system and,consequently,the development of a vaccine preventable disease during this time is not considered a potential lack of effect of the vaccine;in 5 cases the PT Drug ineffective was removed after data lock point(DLP)because the subjects did not develop COVID- 19 infection;in 1 case,reporting Treatment failure and Transient ischaemic attack,the Lack of efficacy PT did not refer to BNT162b2 vaccine;5 cases have been invalidated in the safety database after DLP; 1 case has been deleted from the discussion because the PTs reported Pathogen resistance and Product preparation O issue were not indicative of a lack of efficacy.to be eliminated. c. Upon review,31 additional cases were excluded from the analysis as the data reported(e.g.clinical 13 aa) details,height,weight,etc.)were not consistent with paediatric subjects 0 d. Upon review,28 additional cases were excluded from the analysis as the data reported(e.g.clinical details,height,weight,etc.)were not consistent with paediatric subjects. e. Different clinical outcomes may be reported for an event that occurred more than once to the same 5 individual f. In 2 cases the PT Vaccination failure was replaced with Drug ineffective after DLP. Another case was p not included in the discussion of the Vaccination failure cases because correct scheduling(21 days apart between the first and second dose)cannot be confirmed. 5 0 0 CO c0 a) 0 rn r a) r- N- 0 rn 0 CONFIDENTIAL Page 15 FDA-C BER-2021-5683-0000068 _ v BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports 3.1.3.Review of Adverse Events of Special Interest(AESIs) Please refer to Appendix 1 for the list of the company's AESIs for BNT162b2. The company's AESI list takes into consideration the lists of AESIs from the following expert groups and regulatory authorities: Brighton Collaboration(SPEAC),ACCESS protocol, US CDC(preliminary list of AESI for VAERS surveillance),MHRA(unpublished guideline). The AESI terms are incorporated into a THE list and include events of interest due to their association with severe COVID-19 and events of interest for vaccines in general. The AESI list is comprised of MedDRA PTs,HLTs, HLGTs or MedDRA SMQs and can be changed as appropriate based on the evolving safety profile of the vaccine. Table 7 provides a summary review of cumulative cases within AESI categories in the Pfizer safety database. This is distinct from safety signal evaluations which are conducted and included,as appropriate,in the Summary Monthly Safety Reports submitted regularly to the FDA and other Health Authorities. Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluationb 2 0 Category Total Number of Cases(N=42086) N Anaphylactic Reactions Please refer to the Risk`Anaphylaxis'included above in Table 4. Search criteria:Anaphylactic o reaction SMQ(Narrow and Broad, with the algorithm applied), ( 1selecting relevant cases according to BC criteria Cardiovascular AESIs • Number of cases: 1403(3.3%of the total PM dataset),of which Search criteria:PTs Acute 241 are medically confirmed and 1162 are non-medically myocardial infarction; confirmed; Arrhythmia;Cardiac failure; • Country of incidence:UK(268),US(233),Mexico(196),Italy O Cardiac failure acute; (141),France(128),Germany(102),Spain(46),Greece(45), Cardiogenic shock;Coronary Portugal(37),Sweden(20),Ireland(17),Poland(16),Israel(13), 0 artery disease;Myocardial Austria,Romania and Finland(12 each),Netherlands(11), Q infarction;Postural orthostatic Belgium and Norway(10 each),Czech Republic(9),Hungary and cot. tachycardia syndrome;Stress Canada(8 each),Croatia and Denmark(7 each),Iceland(5);the 5 cardiomyopathy;Tachycardia remaining 30 cases were distributed among 13 other countries; • Subjects'gender:female(1076),male(291)and unknown(36); p • Subjects'age group(n=1346):Adulte(1078),Elderlyd(266) Child and Adolescent'(1 each); • Number of relevant events: 1441,of which 946 serious,495 o non-serious;in the cases reporting relevant serious events; oo • Reported relevant PTs:Tachycardia(1098),Arrhythmia(102), Myocardial infarction(89),Cardiac failure(80),Acute myocardial cu infarction(41),Cardiac failure acute(11),Cardiogenic shock and Postural orthostatic tachycardia syndrome(7 each)and Coronary artery disease(6); • Relevant event onset latency(n=1209):Range from<24 hours to 0 21 days,median<24 hours; rn 0 CONFIDENTIAL Page 16 FDA-CBER-2021-5683-0000069 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluation' Category Total Number of Cases(N=42086) • Relevant event outcomes:fatal(136),resolved/resolving(767), resolved with sequelae(21),not resolved(140)and unknown (380); Conclusion:This cumulative case review does not raise new safety issues.Surveillance will continue COVID-19 AESIs • Number of cases:3067(7.3%of the total PM dataset),of which Search criteria:Covid-19 SMQ 1013 are medically confirmed and 2054 are non-medically (Narrow and Broad)OR PTs confirmed; Ageusia;Anosmia • Country of incidence:US(1272),UK(609),Germany(360), France(161),Italy(94),Spain(69),Romania(62),Portugal(51), Poland(50),Mexico(43),Belgium(42),Israel(41),Sweden(30), Austria(27),Greece(24),Denmark(18),Czech Republic and Hungary(17 each),Canada(12),Ireland(11),Slovakia(9),Latvia and United Arab Emirates(6 each);the remaining 36 cases were distributed among 16 other different countries; • Subjects'gender:female(1650),male(844)and unknown(573); • Subjects'age group(n=1880):Adult(1315),Elderly(560), Infant'and Adolescent(2 each),Child(1); 0 • Number of relevant events:3359,of which 2585 serious,774 non-serious; co N • Most frequently reported relevant PTs(>1 occurrence):COVID- a 19(1927),SARS-CoV-2 test positive(415),Suspected COVID-19 (270),Ageusia(228),Anosmia(194),SARS-CoV-2 antibody test c\l negative(83),Exposure to SARS-CoV-2(62),SARS-CoV-2 antibody test positive(53),COVID-19 pneumonia(51), Q Asymptomatic COVID-19(31),Coronavirus infection(13), Occupational exposure to SARS-CoV-2(11),SARS-CoV-2 test false positive(7),Coronavirus test positive(6),SARS-CoV-2 test negative(3)SARS-CoV-2 antibody test(2); • Relevant event onset latency(n=2070):Range from<24 hours to O 374 days,median 5 days; a) • Relevant event outcome:fatal(136),not resolved(547), 2 resolved/resolving(558),resolved with sequelae(9)and unknown a (2110). a 5 Conclusion:This cumulative case review does not raise new safety > issues.Surveillance will continue 0 a Dermatological AESIs • Number of cases:20 cases(0.05%of the total PM dataset),of Search criteria:PT Chillblains; which 15 are medically confirmed and 5 are non-medically o Erythema mullforme confirmed; cg • Country of incidence:UK(8),France and Poland(2 each),and the remaining 8 cases were distributed among 8 other different Qom) countries; rn • Subjects'gender:female(17)male and unknown(1 each); • Subjects'age group(n=19):Adult(18),Elderly(1); • Number of relevant events:20 events, 16 serious,4 non-serious rn a CONFIDENTIAL Page 17 FDA-C BER-2021-5683-0000070 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluation' Category Total Number of Cases(N=42086) • Reported relevant PTs:Erythema multiforme(13)and Chillblains (7) • Relevant event onset latency(n=18):Range from<24 hours to 17 days,median 3 days; • Relevant event outcome:resolved/resolving(7),not resolved(8) and unknown(6). Conclusion:This cumulative case review does not raise new safety issues.Surveillance will continue. Haematological AESIs • Number of cases:932(2.2%of the total PM dataset),of which Search criteria:Leukopenias NEC 524 medically confirmed and 408 non-medically confirmed; (HLT)(Primary Path)OR • Country of incidence:UK(343),US(308),France(50),Germany Neutropenias(HLT)(Primary (43),Italy(37),Spain(27),Mexico and Poland(13 each), Path)OR PTs Immune Sweden(10),Israel(9),Netherlands(8),Denmark,Finland, thrombocytopenia, Portugal and Ireland(7 each),Austria and Norway(6 each), Thrombocytopenia OR SMQ Croatia(4),Greece,Belgium,Hungary and Switzerland(3 each), Haemorrhage terms(excl Cyprus,Latvia and Serbia(2 each);the remaining 9 cases laboratory terms originated from 9 different countries; • Subjects'gender(n=898):female(676)and male(222); 2 • Subjects'age group(n=837):Adult(543),Elderly(293),Infant 0 (1); • Number of relevant events: 1080,of which 681 serious,399 N non-serious; o • Most frequently reported relevant PTs(>15 occurrences)include: Epistaxis(127),Contusion(112),Vaccination site bruising(96), N Vaccination site haemorrhage(51),Petechiae(50),Haemorrhage o (42),Haematochezia(34),Thrombocytopenia(33),Vaccination site haematoma(32),Conjunctival haemorrhage and Vaginal haemorrhage(29 each),Haematoma, Haemoptysis and (o Menorrhagia(27 each),Haematemesis(25),Eye haemorrhage (23),Rectal haemorrhage(22),Immune thrombocytopenia(20), Blood urine present(19),Haematuria,Neutropenia and Purpura (16 each)Diarrhoea haemorrhagic(15); • Relevant event onset latency(n=787):Range from<24 hours to 2 33 days,median= 1 day; a • Relevant event outcome:fatal(34),resolved/resolving(393), 5 resolved with sequelae(17),not resolved(267)and unknown (371). 0 a Conclusion:This cumulative case review does not raise new safety issues.Surveillance will continue pHepatic AESIs • Number of cases:70 cases(0.2%of the total PM dataset),of 0o Search criteria:Liver related which 54 medically confirmed and 16 non-medically confirmed; investigations,signs and symptoms • Country of incidence:UK(19),US(14),France(7),Italy(5), (SMQ)(Narrow and Broad)OR Germany(4),Belgium,Mexico and Spain(3 each),Austria,and co PT Liver injury Iceland(2 each);the remaining 8 cases originated from 8 different a) countries; • Subjects'gender:female(43),male(26)and unknown(1); • Subjects'age group(n=64):Adult(37),Elderly(27); rn 0 CONFIDENTIAL Page 18 FDA-CBER-2021-5683-0000071 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluation' Category Total Number of Cases(N=42086) • Number of relevant events:94,of which 53 serious,41 non-serious; • Most frequently reported relevant PTs(>3 occurrences)include: Alanine aminotransferase increased(16),Transaminases increased and Hepatic pain(9 each),Liver function test increased(8), Aspartate aminotransferase increased and Liver function test abnormal(7 each),Ganuna-glutamyltransferase increased and Hepatic enzyme increased(6 each),Blood alkaline phosphatase increased and Liver injury(5 each),Ascites,Blood bilirubin increased and Hypertransaminasaemia(3 each); • Relevant event onset latency(n=57):Range from<24 hours to 20 days,median 3 days; • Relevant event outcome:fatal(5),resolved/resolving(27), resolved with sequelae(1),not resolved(14)and unknown(47). Conclusion:This cumulative case review does not raise new safety issues.Surveillance will continue Facial Paralysis • Number of cases:449'(1.07%of the total PM dataset),314 Search criteria:PTs Facial medically confirmed and 135 non-medically confirmed; paralysis,Facial paresis • Country of incidence:US(124),UK(119),Italy(40),France(27), 0 Israel(20),Spain(18),Germany(13),Sweden(11),Ireland(9), Cyprus(8),Austria(7),Finland and Portugal(6 each),Hungary N and Romania(5 each),Croatia and Mexico(4 each),Canada (3),Czech Republic,Malta,Netherlands,Norway,Poland and Puerto Rico(2 each);the remaining 8 cases originated from 8 c different countries; N • Subjects'gender:female(295),male(133),unknown(21); • Subjects'age group(n=411):Adult(313),Elderly(96),Infant and Child(1 each); • Number of relevant events':453,of which 399 serious,54 non-serious; •O • Reported relevant PTs:Facial paralysis(401),Facial paresis(64); -0 • Relevant event onset latency(n=404):Range from<24 hours to 46 days,median 2 days; 2 • Relevant event outcome:resolved/resolving(184),resolved with a sequelae(3),not resolved(183)and unknown(97); 5 a) Overall Conclusion:This cumulative case review does not raise new 0 safety issues.Surveillance will continue.Causality assessment will be C. further evaluated following availability of additional unblinded data go from the clinical study C4591001,which will be unblinded for fmal analysis approximately mid-April 2021.Additionally,non- interventional post-authorisation safety studies,C4591011 and C4591012 are expected to capture data on a sufficiently large a) 0 vaccinated population to detect an increased risk of Bell's palsy in vaccinated individuals.The timeline for conducting these analyses will ti be established based on the size of the vaccinated population captured ti in the study data sources by the first interim reports(due 30 June 0 cn 0 CONFIDENTIAL Page 19 FDA-CBER-2021-5683-0000072 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluationb Category Total Number of Cases(N=42086) 2021).Study C4591021,pending protocol endorsement by EMA,is also intended to inform this risk. Immune-Mediated/Autoimmune • Number of cases: 1050(2.5%of the total PM dataset),of which AESIs 760 medically confirmed and 290 non-medically confirmed; Search criteria:Immune- • Country of incidence(>10 cases):UK(267),US(257),Italy(70), mediated/autoimmune disorders France and Germany(69 each),Mexico(36),Sweden(35),Spain (SMQ)(Broad and Narrow)OR (32),Greece(31),Israel(21),Denmark(18),Portugal(17), Autoimmune disorders HLGT Austria and Czech Republic(16 each),Canada(12),Finland(10). (Primary Path)OR PTs Cytokine The remaining 74 cases were from 24 different countries. release syndrome;Cytokine storm; • Subjects'gender(n=682):female(526),male(156). Hypersensitivity • Subjects'age group(n=944):Adult(746),Elderly(196), Adolescent(2). • Number of relevant events: 1077,of which 780 serious,297 non-serious. • Most frequently reported relevant PTs(>10 occurrences): Hypersensitivity(596),Neuropathy peripheral(49),Pericarditis (32),Myocarditis(25),Dermatitis(24),Diabetes mellitus and Encephalitis(16 each),Psoriasis(14),Dermatitis Bullous(13), Autoimmune disorder and Raynaud's phenomenon(11 each); • Relevant event onset latency(n=807):Range from<24 hours to CD30 days,median<24 hours. • Relevant event outcome:resolved/resolving(517),not resolved co (215),fatal(12),resolved with sequelae(22)and unknown(312). N C) O Conclusion:This cumulative case review does not raise new safety issues.Surveillance will continue a Musculoskeletal AESIs • Number of cases:3600(8.5%of the total PM dataset),of which Search criteria:PTs Arthralgia; 2045 medically confirmed and 1555 non-medically confirmed; Arthritis;Arthritis bacterial"; • Country of incidence:UK(1406),US(1004),Italy(285),Mexico Chronic fatigue syndrome; (236),Germany(72),Portugal(70),France(48),Greece and O Polyarthritis;Polyneuropathy; Poland(46),Latvia(33),Czech Republic(32),Israel and Spain Post viral fatigue syndrome; (26), Sweden(25),Romania(24),Denmark(23),Finland and > Rheumatoid arthritis Ireland(19 each),Austria and Belgium(18 each),Canada(16), 2 Netherlands(14),Bulgaria(12), Croatia and Serbia(9 each), a Cyprus and Hungary(8 each),Norway(7),Estonia and Puerto 5 Rico(6 each),Iceland and Lithuania(4 each);the remaining 21 cases originated from 11 a) different countries; o • Subjects'gender(n=3471):female(2760),male(711); • Subjects'age group(n=3372):Adult(2850),Elderly(515),Child Q- (4),Adolescent(2),Infant(1); 5 • Number of relevant events:3640,of which 1614 serious,2026 non-serious; co • Reported relevant PTs:Arthralgia(3525),Arthritis(70), ai Rheumatoid arthritis(26),Polyarthritis(5),Polyneuropathy,Post co viral fatigue syndrome,Chronic fatigue syndrome(4 each), rn Arthritis bacterial(1); N- • Relevant event onset latency(n=2968):Range from<24 hours to r 32 days,median 1 day; 0 rn 0 CONFIDENTIAL Page 20 FDA-C B E R-2021-5683-0000073 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluations' Category Total Number of Cases(N=42086) • Relevant event outcome:resolved/resolving(1801),not resolved (959),resolved with sequelae(49),and unknown(853). Conclusion:This cumulative case review does not raise new safety issues.Surveillance will continue. Neurological AESIs(including • Number of cases:501 (1.2%of the total PM dataset),of which dmyelination) 365 medically confirmed and 136 non-medically confirmed. Search criteria:Convulsions • Country of incidence(>9 cases):UK(157),US(68),Germany (SMQ)(Broad and Narrow)OR (49),Mexico(35),Italy(31),France(25),Spain(18),Poland(17), Demyelination(SMQ)(Broad and Netherlands and Israel(15 each),Sweden(9).The remaining 71 Narrow)OR PTs Ataxia; cases were from 22 different countries. Cataplexy;Encephalopathy; • Subjects'gender(n=478):female(328),male(150). Fibromyalgia;Intracranial • Subjects'age group(n78):Adult(329),Elderly(149); pressure increased;Meningitis; • Number of relevant events:542,of which 515 serious,27 Meningitis aseptic;Narcolepsy non-serious. • Most frequently reported relevant PTs(>2 occurrences)included: Seizure(204),Epilepsy(83),Generalised tonic-clonic seizure (33),Guillain-Barre syndrome(24),Fibromyalgia and Trigeminal neuralgia(17 each),Febrile convulsion,(15),Status epilepticus 2 (12),Aura and Myelitis transverse(11 each),Multiple sclerosis O relapse and Optic neuritis(10 each),Petit mal epilepsy and Tonic convulsion(9 each),Ataxia(8),Encephalopathy and Tonic clonic cv movements(7 each),Foaming at mouth(5),Multiple sclerosis, oNarcolepsy and Partial seizures(4 each),Bad sensation, Demyelination,Meningitis,Postictal state,Seizure like cv phenomena and Tongue biting(3 each); • Relevant event onset latency(n=423):Range from<24 hours to 48 days,median 1 day; • Relevant events outcome:fatal(16),resolved/resolving(265), o resolved with sequelae(13),not resolved(89)and unknown(161); 0 Conclusion:This cumulative case review does not raise new safety issues.Surveillance will continue o Other AESIs • Number of cases:8152(19.4%of the total PM dataset),of which Q C Search criteria:Herpes viral 4977 were medically confirmed and 3175 non-medically infections(HLT)(Primary Path) confirmed; > OR PTs Adverse event following • Country of incidence(>20 occurrences):UK(2715),US(2421), 2 immunisation;Inflammation; Italy(710),Mexico(223),Portugal(210),Germany(207),France Q- Manufacturing laboratory (186),Spain(183),Sweden(133),Denmark(127),Poland(120), Greece 95 ,Israel 79 ,Czech Republic 76,Romania 57 analytical testing issue; ( ) ( ) eP ( ) ( ), o Manufacturing materials issue; Hungary(53),Finland(52),Norway(51),Latvia(49),Austria Manufacturing production issue; (47),Croatia(42),Belgium(41),Canada(39),Ireland(34),Serbia MERS-CoV test;MERS-CoV test (28),Iceland(25),Netherlands(22).The remaining 127 cases aa) negative;MERS-CoV test positive; were from 21 different countries; co Middle East respiratory syndrome; • Subjects'gender(n=7829):female(5969),male(1860); j Multiple organ dysfunction • Subjects'age group(n=7479):Adult(6330),Elderly(1125), syndrome;Occupational exposure Adolescent,Child(9 each),Infant(6); 0 to communicable disease;Patient rn 0 CONFIDENTIAL Page 21 FDA-C BER-2021-5683-0000074 BNTI 62b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluation'' Category Total Number of Cases(N=42086) isolation;Product availability • Number of relevant events:8241,of which 3674 serious,4568 issue;Product distribution issue; non-serious; Product supply issue;Pyrexia; • Most frequently reported relevant PTs(>6 occurrences)included: Quarantine;SARS-CoV-1 test; Pyrexia(7666),Herpes zoster(259),Inflammation(132),Oral SARS-CoV-1 test negative;SARS- herpes(80),Multiple organ dysfunction syndrome(18),Herpes CoV-1 test positive virus infection(17),Herpes simplex(13),Ophthalmic herpes zoster(10),Herpes ophthalmic and Herpes zoster reactivation(6 each); • Relevant event onset latency(n=6836):Range from<24 hours to 61 days,median 1 day; • Relevant events outcome:fatal(96),resolved/resolving(5008), resolved with sequelae(84),not resolved(1429)and unknown (1685). Conclusion:This cumulative case review does not raise new safety issues.Surveillance will continue Pregnancy Related AESIs For relevant cases,please refer to Table 6,Description of Missing Search criteria:PTs Amniotic Information,Use in Pregnancy and While Breast Feeding cavity infection;Caesarean 2 section;Congenital anomaly; O Death neonatal;Eclampsia; Foetal distress syndrome;Low N birth weight baby;Maternal rn exposure during pregnancy; Placenta praevia;Pre-eclampsia; 0 Premature labour;Stillbirth; N Uterine rupture; Vasa praevia Renal AESIs • Number of cases:69 cases(0.17%of the total PM dataset),of Search criteria:PTs Acute kidney which 57 medically confirmed, 12 non-medically confirmed; oM injury;Renal failure. • Country of incidence:Germany(17),France and UK(13 each), US(6),Belgium,Italy and Spain(4 each),Sweden(2),Austria, O Canada,Denmark,Finland,Luxembourg and Norway(1 each); :3 • Subjects'gender:female(46),male(23); o • Subjects'age group(n=68):Adult(7),Elderly(60),Infant(1); a • Number of relevant events:70,all serious; a • Reported relevant PTs:Acute kidney injury(40)and Renal failure 5 (30); a) • Relevant event onset latency(n=42):Range from<24 hours to 15 p days,median 4 days; a • Relevant event outcome:fatal(23),resolved/resolving(10),not 5 resolved(15)and unknown(22). 0 0 Conclusion:This cumulative case review does not raise new safety a) issues.Surveillance will continue. rn Respiratory AESIs • Number of cases: 130 cases(0.3%of the total PM dataset),of tiSearch criteria:Lower respiratory which 107 medically confirmed; tract infections NEC(HLT) 0 rn 0 CONFIDENTIAL Page 22 FDA-CBER-2021-5683-0000075 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluation' Category Total Number of Cases(N=42086) (Primary Path)OR Respiratory • Countries of incidence:United Kingdom(20),France(18),United failures(excl neonatal)(HLT) States(16),Germany(14),Spain(13),Belgium and Italy(9), (Primary Path)OR Viral lower Denmark(8),Norway(5),Czech Republic,Iceland(3 each);the respiratory tract infections(HL7) remaining 12 cases originated from 8 different countries. (Primary Path)OR PTs:Acute • Subjects'gender(n=130):female(72),male(58). respiratory distress syndrome; • Subjects's age group(n=126):Elderly(78),Adult(47), Endotracheal intubation;Hypoxia; Adolescent(1). Pulmonary haemorrhage; • Number of relevant events: 137,of which 126 serious, 11 Respiratory disorder;Severe acute non-serious; respiratory syndrome • Reported relevant PTs:Respiratory failure(44),Hypoxia(42), Respiratory disorder(36),Acute respiratory distress syndrome (10),Chronic respiratory syndrome(3),Severe acute respiratory syndrome(2). • Relevant event onset latency(n=102):range from<24 hours to 18 days,median 1 day; • Relevant events outcome:fatal(41),Resolved/resolving(47),not recovered(18)and unknown(31). Conclusion:This cumulative case review does not raise new safety 2 issues.Surveillance will continue. Thromboembolic Events • Number of cases: 151 (0.3%of the total PM dataset),of which CO N Search criteria:Embolism and 111 medically confirmed and 40 non-medically confirmed; o thrombosis(HLGT)(Primary • Country of incidence:UK(34),US(31),France(20),Germany Path),excluding PTs reviewed as (15),Italy and Spain(6 each),Denmark and Sweden(5 each), o Stroke AESIs, OR PTs Deep vein Austria,Belgium and Israel(3 each),Canada,Cyprus,Netherlands cV thrombosis;Disseminated and Portugal(2 each);the remaining 12 cases originated from 12 Q intravascular coagulation; different countries; Q Embolism;Embolism venous; • Subjects'gender(n=144):female(89),male(55); Pulmonary embolism • Subjects'age group(n=136):Adult(66),Elderly(70); cY) • Number of relevant events: 168,of which 165 serious,3 O non-serious; • Most frequently reported relevant PTs(>1 occurrence)included: a) Pulmonary embolism(60),Thrombosis(39),Deep vein o thrombosis(35),Thrombophlebitis superficial(6),Venous Q thrombosis limb(4),Embolism,Microembolism, 5 Thrombophlebitis and Venous thrombosis(3 each)Blue toe syndrome(2); a) • Relevant event onset latency(n=124):Range from<24 hours to a 28 days,median 4 days; g • Relevant event outcome:fatal(18),resolved/resolving(54), 0 resolved with sequelae(6),not resolved(49)and unknown(42). 0 co Conclusion:This cumulative case review does not raise new safety co a� issues.Surveillance will continue. rn Stroke • Number of cases:275(0.6%of the total PM dataset),of which r Search criteria:HLT Central 180 medically confirmed and 95 non-medically confirmed; nervous system haemorrhages and • Country of incidence:UK(81),US(66),France(32),Germany p cerebrovascular accidents (21),Norway(14),Netherlands and Spain(11 each),Sweden(9), a.) 0 CONFIDENTIAL Page 23 FDA-CBER-20 2 1-56 83-0000076 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluation' Category Total Number of Cases(N=42086) (Primary Path)OR HLT Israel(6),Italy(5),Belgium(3),Denmark,Finland,Poland and Cerebrovascular venous and sinus Switzerland(2 each);the remaining 8 cases originated from 8 thrombosis(Primary Path) different countries; • Subjects'gender(n=273):female(182),male(91); • Subjects'age group(n=265):Adult(59),Elderly(205),Child"' (1); • Number of relevant events:300,all serious; • Most frequently reported relevant PTs(>1 occurrence)included: o PTs indicative of Ischaemic stroke:Cerebrovascular accident(160),Ischaemic stroke(41),Cerebral infarction (15),Cerebral ischaemia,Cerebral thrombosis,Cerebral venous sinus thrombosis,Ischaemic cerebral infarction and Lacunal infarction(3 each)Basal ganglia stroke, Cerebellar infarction and Thrombotic stroke(2 each); o PTs indicative of Haemorrhagic stroke:Cerebral haemorrhage(26),Haemorrhagic stroke(11), Haemorrhage intracranical and Subarachnoid haemorrhage(5 each),Cerebral haematoma(4),Basal ganglia haemorrhage and Cerebellar haemorrhage(2 each); 2 • Relevant event onset latency(n=241):Range from<24 hours to 0 41 days,median 2 days; 0 • Relevant event outcome:fatal and resolved/resolving(61 each), resolved with sequelae(10),not resolved(85)and unknown(83). rn N NConclusion:This cumulative case review does not raise new safety issues.Surveillance will continue. Vasculitic Events • Number of cases:32 cases(0.08%of the total PM dataset),of o Search criteria: Vasculitides HLT which 26 medically confirmed and 6 non-medically confirmed; ch • Country of incidence:UK(13),France(4),Portugal,US and Spain(3 each),Cyprus,Germany,Hungary,Italy and Slovakia O and Costa rica(1 each); • Subjects'gender:female(26),male(6); 2 • Subjects'age group(n=31):Adult(15),Elderly(16); 0. • Number of relevant events:34,of which 25 serious,9 non-serious; 5 • Reported relevant PTs:Vasculitis(14),Cutaneous vasculitis and Vasculitic rash(4 each),(3),Giant cell arteritis and Peripheral ischaemia(3 each),Behcet's syndrome and Hypersensitivity 2 vasculitis(2 each)Palpable purpura,and Takayasu's arteritis(1 a each); 5 • Relevant event onset latency(n=25):Range from<24 hours to 19 o days,median 3 days; co • Relevant event outcome:fatal(1),resolved/resolving(13),not resolved(12)and unknown(8). 0 rn tiConclusion:This cumulative case review does not raise new safety issues.Surveillance will continue rn 0 CONFIDENTIAL Page 24 FDA-CBER-2021-5683-0000077 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 7. AESIs Evaluation for BNT162b2 AESIsa Post-Marketing Cases Evaluationb Category Total Number of Cases(N=42086) a. For the complete list of the AESIs,please refer to Appendix 5; b. Please note that this corresponds to evidence from post-EUA/conditional marketing authorisation approval data sources; c. Subjects with age ranged between 18 and 64 years; d. Subjects with age equal to or above 65 years; e. Subjects with age ranged between 2 and 11 years; f. Subjects with age ranged between 12 and less than 18 years; g. Multiple episodes of the same PT event were reported with a different clinical outcome within some cases hence the sum of the events outcome exceeds the total number of PT events; h. Subjects with age ranged between 1 (28 days)and 23 months; i. Twenty-four additional cases were excluded from the analysis as they were not cases of peripheral facial nerve palsy because they described other disorders(stroke,cerebral haemorrhage or transient ischaemic attack); 1 case was excluded from the analysis because it was invalid due to an unidentifiable reporter; j. This UK case report received from the UK MHRA described a 1-year-old subject who received the vaccine,and had left postauricular ear pain that progressed to left-sided Bell's palsy 1 day following vaccination that had not resolved at the time of the report; k. If a case included both PT Facial paresis and PT Facial paralysis,only the PT Facial paralysis was considered in the descriptions of the events as it is most clinically important; 1. Multiple episodes of the same PT event were reported with a different clinical outcome within some cases hence the sum of the events outcome exceeds the total number of PT events m. This UK case report received from the UK MHRA described a 7-year-old female subject who received the vaccine and had stroke(unknown outcome);no follow-up possible for clarification. ) is n. This PT not included in the AESIs/TME list was included in the review as relevant for ACCESS CO protocol criteria; 0) CD N N L 5. O M C 0 a) O L 0. Q 5 a) O L Q Q. 5 CD O CO Cu a) CO a) r- ti O CD CONFIDENTIAL Page 25 FDA-CBER-2021-5683-0000078 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports 3.1.4. Medication error Cases potentially indicative of medication errors' that cumulatively occurred are summarized below. • Number of relevant medication error cases: 20562(4.9%)of which 1569(3.7%)are medically confirmed. • Number of relevant events: 2792 • Top 10 countries of incidence: — US(1201),France(171),UK(138),Germany(88),Czech Republic(87),Sweden (49), Israel(45), Italy(42), Canada(35),Romania(33),Finland(21),Portugal(20), Norway(14),Puerto Rico(13),Poland(12),Austria and Spain(10 each). Medication error case outcomes: • Fatal(7)3, • Recovered/recovering(354,of which 4 are serious), 2 • Recovered with sequelae(8,of which 3 serious) 0 c0 N O) O N N 'MedDRA(version 23.1)Higher Level Terms:Accidental exposures to product;Product administration Lcerrors and issues;Product confusion errors and issues;Product dispensing errors and issues;Product label issues;Product monitoring errors and issues;Product preparation errors and issues;Product selection errors and p issues;Product storage errors and issues in the product use system;Product transcribing errors and ch communication issues,OR Preferred Terms:Accidental poisoning;Circumstance or information capable of leading to device use error;Circumstance or information capable of leading to medication error; O Contraindicated device used;Deprescribing error;Device use error;Dose calculation error;Drug titration error; Expired device used;Exposure via direct contact;Exposure via eye contact;Exposure via mucosa;Exposure via p skin contact;Failure of child resistant product closure;Inadequate aseptic technique in use of product;Incorrect disposal of product;Intercepted medication error;Intercepted product prescribing error;Medication error; Multiple use of single-use product;Product advertising issue;Product distribution issue;Product prescribing 5 error;Product prescribing issue;Product substitution error;Product temperature excursion issue;Product use in N unapproved therapeutic environment;Radiation underdose;Underdose;Unintentional medical device removal; 2 Unintentional use for unapproved indication;Vaccination error;Wrong device used;Wrong dosage form; Wrong dosage formulation;Wrong dose;Wrong drug;Wrong patient;Wrong product procured;Wrong product stored;Wrongrate;Wrongroute;Wrongschedule;Wrongstrength;Wrongtechnique in device usage process; Q q g P , o Wrong technique in product usage process. CO 2 Thirty-five(35)cases were exclude from the analysis because describing medication errors occurring in an unspecified number of individuals or describing medication errors occurring with co suspects were codetermined to be non-contributory. a) 3 All the medication errors reported in these cases were assessed as non-serious occurrences with an unknown outcome;based on the available information including the causes of death,the relationship between 0 the medication error and the death is weak.. rn 0 CONFIDENTIAL Page 26 FDA-CBER-2021-5683-0000079 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports • Not recovered(189,of which 84 are serious), • Unknown(1498, of which 33 are serious). 1371 cases reported only MEs without any associated clinical adverse event. The PTs most frequently reported(>12 occurrences)were: Poor quality product administered(539), Product temperature excursion issue (253), Inappropriate schedule of product administration (225),Product preparation error(206), Underdose(202), Circumstance or information capable of leading to medication error(120), Product preparation issue(119), Wrong technique in product usage process (76), Incorrect route of product administration(66), Accidental overdose(33),Product administered at inappropriate site(27), Incorrect dose administered and Accidental exposure to the product(25 each), Exposure via skin contact (22),Wrong product administered(17), Incomplete course of vaccination, and Product administration error(14 each)Product administered to patient of inappropriate age(12). In 685 cases, there were co-reported AEs. The most frequently co- associated AEs (>40 occurrences)were: Headache(187),Pyrexia(161),Fatigue(135), Chills(127),Pain(107), Vaccination site pain(100), Nausea(89), Myalgia(88),Pain in extremity(85)Arthralgia (68), Off label use(57), Dizziness(52),Lymphadenopathy(47), Asthenia(46)and Malaise (41). These cases are summarized in Table 8. I- 2 Table 8. ME PTs by seriousness with or without harm co-association(Through 28 0 February 2021) 0 Serious Non-Serious rn O ME PTs With Harm Without Harm With Harm Without Harm N O Accidental exposure to 0 0 0 5 Q product Accidental overdose 4 1 9 6 O Booster dose missed 0 0 0 1 Circumstance or information 0 0 5 11 2 capable of leading to medication error tZ 5 N Contraindicated product 1 0 0 2 administered O L QExpired product administered 0 0 0 2 5 00 Exposure via skin contact 0 0 0 5 co Inappropriate schedule of 0 2 8 264 a) product administration CT) N Incorrect dose administered 1 1 0 0 I` O c) O CONFIDENTIAL Page 27 FDA-CBER-2021-5683-0000080 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Table 8. ME PTs by seriousness with or without harm co-association (Through 28 February 2021) Serious Non-Serious ME PTs With Harm Without Harm With Harm Without Harm Incorrect route of product 2 6 16 127 administration Lack of vaccination site 1 0 0 0 rotation Medication error 0 0 0 1 Poor quality product 1 0 0 34 administered Product administered at 2 1 13 29 inappropriate site Product administered to 0 4 0 40 patient of inappropriate age Product administration error 1 0 0 3 2 (� Product dose omission issue 0 1 0 3 O Product preparation error 1 0 4 11 0) O Product preparation issue 1 1 0 14 N O N Overall,there were 68 cases with co-reported AEs reporting Harm and 599 cases with co- o cf) reported AEs without harm. Additionally, Intercepted medication errors was reported in 1 O case(PTs Malaise,clinical outcome unknow)and Potential medication errors were reported -a in 17 cases. a) 4. DISCUSSION Pfizer performs frequent and rigorous signal detection on BNT 162b2 cases. The findings of these signal detection analyses are consistent with the known safety profilea) of the vaccine. o This cumulative analysis to support the Biologics License Application for BNT162b2,is an 0_ integrated analysis of post-authorization safety data, from U.S. and foreign experience, 5 focused on Important Identified Risks, Important Potential Risks,and areas of Important 0o Missing Information identified in the Pharmacovigilance Plan, as well as adverse events of 00 special interest and vaccine administration errors (whether or not associated with an adverse event). The data do not reveal any novel safety concerns or risks requiring label changes and co support a favorable benefit risk profile of to the BNT162b2 vaccine. .7D rn CONFIDENTIAL Page 28 F DA-C B E R-2021-5683-0000081 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports 5. SUMMARY AND CONCLUSION Review of the available data for this cumulative PM experience,confirms a favorable benefit: risk balance for BNT 162b2. Pfizer will continue routine pharmacovigilance activities on behalf of BioNTech according to the Pharmacovigilance Agreement in place,in order to assure patient safety and will inform the Agency if an evaluation of the safety data yields significant new information for BNT 162b2. H 2 0 co N 6 O N 0 ( 1 a Q 0 () C 0 .a a) > O L 0. a % 13 a) > O L a a % 0 0 co (13 a) (0 rn a) r- N- 0 rn 0 CONFIDENTIAL Page 29 FDA-C BER-2021-5683-0000082 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports APPENDIX 1.LIST OF ADVERSE EVENTS OF SPECIAL INTEREST 1p36 deletion syndrome;2-Hydroxyglutaric aciduria;5'nucleotidase increased;Acoustic neuritis;Acquired Cl inhibitor deficiency;Acquired epidermolysis bullosa;Acquired epileptic aphasia;Acute cutaneous lupus erythematosus;Acute disseminated encephalomyelitis;Acute encephalitis with refractory,repetitive partial seizures;Acute febrile neutrophilic dermatosis;Acute flaccid myelitis;Acute haemorrhagic leukoencephalitis;Acute haemorrhagic oedema of infancy;Acute kidney injury;Acute macular outer retinopathy;Acute motor axonal neuropathy;Acute motor-sensory axonal neuropathy;Acute myocardial infarction;Acute respiratory distress syndrome;Acute respiratory failure;Addison's disease;Administration site thrombosis;Administration site vasculitis;Adrenal thrombosis;Adverse event following immunisation;Ageusia;Agranulocytosis;Air embolism;Alanine aminotransferase abnormal;Alanine aminotransferase increased;Alcoholic seizure;Allergic bronchopulmonary mycosis;Allergic oedema;Alloimmune hepatitis;Alopecia areata;Alpers disease;Alveolar proteinosis;Ammonia abnormal;Amrnonia increased;Amniotic cavity infection;Amygdalohippocampectomy;Amyloid arthropathy;Amyloidosis;Amyloidosis senile;Anaphylactic reaction;Anaphylactic shock;Anaphylactic transfusion reaction;Anaphylactoid reaction;Anaphylactoid shock;Anaphylactoid syndrome of pregnancy;Angioedema;Angiopathic neuropathy;Ankylosing spondylitis;Anosmia;Antiacetylcholine receptor antibody positive;Anti-actin antibody positive;Anti-aquaporin-4 antibody positive;Anti-basal ganglia 2 antibody positive;Anti-cyclic citrullinated peptide antibody positive;Anti-epithelial antibody 0 positive;Anti-erythrocyte antibody positive;Anti-exosome complex antibody positive;Anti- N GAD antibody negative;Anti-GAD antibody positive;Anti-ganglioside antibody o positive;Antigliadin antibody positive;Anti-glomerular basement membrane antibody positive;Anti-glomerular basement membrane disease;Anti-glycyl-tRNA synthetase antibody o positive;Anti-HLA antibody test positive;Anti-IA2 antibody positive;Anti-insulin antibody cL increased;Anti-insulin antibody positive;Anti-insulin receptor antibody increased;Anti- insulin receptor antibody positive;Anti-interferon antibody negative;Anti-interferon antibody o positive;Anti-islet cell antibody positive;Antimitochondrial antibody positive;Anti-muscle specific kinase antibody positive;Anti-myelin-associated glycoprotein antibodies p positive;Anti-myelin-associated glycoprotein associated polyneuropathy;Antimyocardial antibody positive;Anti-neuronal antibody positive;Antineutrophil cytoplasmic antibody o increased;Antineutrophil cytoplasmic antibody positive;Anti-neutrophil cytoplasmic a antibody positive vasculitis;Anti-NMDA antibody positive;Antinuclear antibody a increased;Antinuclear antibody positive;Antiphospholipid antibodies positive;Antiphospholipid syndrome;Anti-platelet antibody positive;Anti-prothrombin o antibody positive;Antiribosomal P antibody positive;Anti-RNA polymerase III antibody apositive;Anti-saccharomyces cerevisiae antibody test positive;Anti-sperm antibody 5 positive;Anti-SRP antibody positive;Antisynthetase syndrome;Anti-thyroid antibody positive;Anti-transglutaminase antibody increased;Anti-VGCC antibody positive;Anti- 0 co VGKC antibody positive;Anti-vimentin antibody positive;Antiviral prophylaxis;Antiviral a`oi treatment;Anti-zinc transporter 8 antibody positive;Aortic embolus;Aortic co thrombosis;Aortitis;Aplasia pure red cell;Aplastic anaemia;Application site m thrombosis;Application site vasculitis;Arrhythmia;Arterial bypass occlusion;Arterial bypass ti thrombosis;Arterial thrombosis;Arteriovenous fistula thrombosis;Arteriovenous graft site stenosis;Arteriovenous graft thrombosis;Arteritis;Arteritis rn 0 CONFIDENTIAL Page 1 FDA-CBER-2021-5683-0000083 I) Page 30 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports coronary;Arthralgia;Arthritis;Arthritis enteropathic;Ascites;Aseptic cavernous sinus thrombosis;Aspartate aminotransferase abnormal;Aspartate aminotransferase increased;Aspartate-glutamate-transporter deficiency;AST to platelet ratio index increased;AST/ALT ratio abnormal;Asthma;Asymptomatic COVID- 19;Ataxia;Atheroembolism;Atonic seizures;Atrial thrombosis;Atrophic thyroiditis;Atypical benign partial epilepsy;Atypical pneumonia;Aura;Autoantibody positive;Autoimmune anaemia;Autoimmune aplastic anaemia;Autoimmune arthritis;Autoimmune blistering disease;Autoimmune cholangitis;Autoimmune colitis;Autoimmune demyelinating disease;Autoimmune dermatitis;Autoimmune disorder;Autoimmune encephalopathy;Autoimmune endocrine disorder;Autoimmune enteropathy;Autoimmune eye disorder;Autoimmune haemolytic anaemia;Autoimmune heparin-induced thrombocytopenia;Autoimmune hepatitis;Autoimmune hyperlipidaemia;Autoimmune hypothyroidism;Autoimmune inner ear disease;Autoimmune lung disease;Autoimmune lymphoproliferative syndrome;Autoimmune myocarditis;Autoimmune myositis;Autoimmune nephritis;Autoimmune neuropathy;Autoimmune neutropenia;Autoimmune pancreatitis;Autoimmune pancytopenia;Autoimmune pericarditis;Autoimmune retinopathy;Autoimmune thyroid disorder;Autoimmune thyroiditis;Autoimmune uveitis;Autoinflammation with infantile enterocolitis;Autoinflammatory disease;Automatism epileptic;Autonomic nervous system imbalance;Autonomic seizure;Axial spondyloarthritis;Axillary vein thrombosis;Axonal and demyelinating polyneuropathy;Axonal neuropathy;Bacterascites;Baltic myoclonic epilepsy;Band 2 sensation;Basedow's disease;Basilar artery thrombosis;Basophilopenia;B-cell aplasia;Behcet's syndrome;Benign ethnic neutropenia;Benign familial neonatal N convulsions;Benign familial pemphigus;Benign rolandic epilepsy;Beta-2 glycoprotein ai antibody positive;Bickerstaffs encephalitis;Bile output abnormal;Bile output decreased;Biliary ascites;Bilirubin conjugated abnormal;Bilirubin conjugated Nincreased;Bilirubin urine present;Biopsy liver abnormal;Biotinidase deficiency;Birdshot chorioretinopathy;Blood alkaline phosphatase abnormal;Blood alkaline phosphatase increased;Blood bilirubin abnormal;Blood bilirubin increased;Blood bilirubin unconjugated o increased;Blood cholinesterase abnormal;Blood cholinesterase decreased;Blood pressure co decreased;Blood pressure diastolic decreased;Blood pressure systolic decreased;Blue toe 0 syndrome;Brachiocephalic vein thrombosis;Brain stem embolism;Brain stem thrombosis;Bromosulphthalein test abnormal;Bronchial oedema;Bronchitis;Bronchitis o mycoplasmal;Bronchitis viral;Bronchopulmonary aspergillosis allergic;Bronchospasm;Budd- a Chiari syndrome;Bulbar palsy;Butterfly rash;Clq nephropathy;Caesarean section;Calcium g embolism;Capillaritis;Caplan's syndrome;Cardiac amyloidosis;Cardiac arrest;Cardiac failure;Cardiac failure acute;Cardiac sarcoidosis;Cardiac ventricular thrombosis;Cardiogenic o shock;Cardiolipin antibody positive;Cardiopulmonary failure;Cardio-respiratory a arrest;Cardio-respiratory distress;Cardiovascular insufficiency;Carotid arterial 5 embolus;Carotid artery thrombosis;Cataplexy;Catheter site thrombosis;Catheter site covasculitis;Cavernous sinus thrombosis;CDKLS deficiency disorder;CEC syndrome;Cement co embolism;Central nervous system lupus;Central nervous system vasculitis;Cerebellar artery a) thrombosis;Cerebellar embolism;Cerebral amyloid angiopathy;Cerebral arteritis;Cerebral co artery embolism;Cerebral artery thrombosis;Cerebral gas embolism;Cerebral microembolism;Cerebral septic infarct;Cerebral thrombosis;Cerebral venous sinus thrombosis;Cerebral venous thrombosis;Cerebrospinal thrombotic rn CONFIDENTIAL Page 2 FDA-CBER-2021-5683-0000084 Page 31 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports tamponade;Cerebrovascular accident;Change in seizure presentation;Chest discomfort;Child- Pugh-Turcotte score abnormal;Child-Pugh-Turcotte score increased;Chillblains;Choking;Choking sensation;Cholangitis sclerosing;Chronic autoimmune glomerulonephritis;Chronic cutaneous lupus erythematosus;Chronic fatigue syndrome;Chronic gastritis;Chronic inflammatory demyelinating polyradiculoneuropathy;Chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids;Chronic recurrent multifocal osteomyelitis;Chronic respiratory failure;Chronic spontaneous urticaria;Circulatory collapse;Circumoral oedema;Circumoral swelling;Clinically isolated syndrome;Clonic convulsion;Coeliac disease;Cogan's syndrome;Cold agglutinins positive;Cold type haemolytic anaemia;Colitis;Colitis erosive;Colitis herpes;Colitis microscopic;Colitis ulcerative;Collagen disorder;Collagen-vascular disease;Complement factor abnormal;Complement factor Cl decreased;Complement factor C2 decreased;Complement factor C3 decreased;Complement factor C4 decreased;Complement factor decreased;Computerised tomogram liver abnormal;Concentric sclerosis;Congenital anomaly;Congenital bilateral perisylvian syndrome;Congenital herpes simplex infection;Congenital myasthenic syndrome;Congenital varicella infection;Congestive hepatopathy;Convulsion in childhood;Convulsions local;Convulsive threshold lowered;Coombs positive haemolytic anaemia;Coronary artery disease;Coronary artery embolism;Coronary artery thrombosis;Coronary bypass thrombosis;Coronavirus infection;Coronavirus test;Coronavirus test negative;Coronavirus test positive;Corpus callosotomy;Cough;Cough variant asthma;COVID-19;COVID-19 2 immunisation;COVID-19 pneumonia;COVID-19 prophylaxis;COVID-19 treatment;Cranial nerve disorder;Cranial nerve palsies multiple;Cranial nerve paralysis;CREST co syndrome;Crohn's disease;Cryofibrinogenaemia;Cryoglobulinaemia;CSF oligoclonal band present;CSWS syndrome;Cutaneous amyloidosis;Cutaneous lupus erythematosus;Cutaneous sarcoidosis;Cutaneous vasculitis;Cyanosis;Cyclic neutropenia;Cystitis interstitial;Cytokine N release syndrome;Cytokine storm;De novo purine synthesis inhibitors associated acute inflammatory syndrome;Death neonatal;Deep vein thrombosis;Deep vein thrombosis postoperative;Deficiency of bile secretion;Deja vu;Demyelinating polyneuropathy;Demyelination;Dermatitis;Dermatitis bullous;Dermatitis herpetiformis;Dermatomyositis;Device embolisation;Device related thrombosis;Diabetes O mellitus;Diabetic ketoacidosis;Diabetic mastopathy;Dialysis amyloidosis;Dialysis membrane -o reaction;Diastolic hypotension;Diffuse vasculitis;Digital pitting scar;Disseminated a) o intravascular coagulation;Disseminated intravascular coagulation in newbom;Disseminated a neonatal herpes simplex;Disseminated varicella;Disseminated varicella zoster vaccine virus 5 infection;Disseminated varicella zoster virus infection;DNA antibody positive;Double cortex syndrome;Double stranded DNA antibody positive;Dreamy state;Dressler's syndrome;Drop o attacks;Drug withdrawal convulsions;Dyspnoea;Early infantile epileptic encephalopathy with burst-suppression;Eclampsia;Eczema herpeticum;Embolia cutis medicamentosa;Embolic 5 cerebellar infarction;Embolic cerebral infarction;Embolic pneumonia;Embolic 0o stroke;Embolism;Embolism arterial;Embolism venous;Encephalitis;Encephalitis co allergic;Encephalitis autoimmune;Encephalitis brain stem;Encephalitis ai haemorrhagic;Encephalitis periaxialis diffusa;Encephalitis post rn immunisation;Encephalomyelitis;Encephalopathy;Endocrine disorder;Endocrine ophthalmopathy;Endotracheal intubation;Enteritis;Enteritis leukopenic;Enterobacter pneumonia;Enterocolitis;Enteropathic spondylitis;Eosinopenia;Eosinophilic rn CONFIDENTIAL Page 3 FDA-C BER-2021-5683-0000085 Page 32 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports fasciitis;Eosinophilic granulomatosis with polyangiitis;Eosinophilic oesophagitis;Epidermolysis;Epilepsy;Epilepsy surgery;Epilepsy with myoclonic-atonic seizures;Epileptic aura;Epileptic psychosis;Erythema;Erythema induratum;Erythema multiforme;Erythema nodosum;Evans syndrome;Exanthema subitum;Expanded disability status scale score decreased;Expanded disability status scale score increased;Exposure to communicable disease;Exposure to SARS-CoV-2;Eye oedema;Eye pruritus;Eye swelling;Eyelid oedema;Face oedema;Facial paralysis;Facial paresis;Faciobrachial dystonic seizure;Fat embolism;Febrile convulsion;Febrile infection-related epilepsy syndrome;Febrile neutropenia;Felty's syndrome;Femoral artery embolism;Fibrillary glomerulonephritis;Fibromyalgia;Flushing;Foaming at mouth;Focal cortical resection;Focal dyscognitive seizures;Foetal distress syndrome;Foetal placental thrombosis;Foetor hepaticus;Foreign body embolism;Frontal lobe epilepsy;Fulminant type 1 diabetes mellitus;Galactose elimination capacity test abnormal;Galactose elimination capacity test decreased;Gamma-glutamyltransferase abnormal;Gamma-glutamyltransferase increased;Gastritis herpes;Gastrointestinal amyloidosis;Gelastic seizure;Generalised onset non-motor seizure;Generalised tonic-clonic seizure;Genital herpes;Genital herpes simplex;Genital herpes zoster;Giant cell arteritis;Glomerulonephritis;Glomerulonephritis membranoproliferative;Glomerulonephritis membranous;Glomerulonephritis rapidly progressive;Glossopharyngeal nerve paralysis;Glucose transporter type 1 deficiency syndrome;Glutamate dehydrogenase increased;Glycocholic acid increased;GM2 gangliosidosis;Goodpasture's syndrome;Graft 2 thrombosis;Granulocytopenia;Granulocytopenia neonatal;Granulomatosis with polyangiitis;Granulomatous dermatitis;Grey matter heterotopia;Guanase increased;Guillain- co N Barre syndrome;Haemolytic anaemia;Haemophagocytic lymphohistiocytosis;Haemorrhage;Haemorrhagic ascites;Haemorrhagic disorder;Haemorrhagic pneumonia;Haemorrhagic varicella syndrome;Haemorrhagic o vasculitis;Hantavirus pulmonary infection;Hashimoto's ci encephalopathy;Hashitoxicosis;Hemimegalencephaly;Henoch-Schonlein purpura;Henoch- Q Schonlein purpura nephritis;Hepaplastin abnormal;Hepaplastin decreased;Heparin-induced o thrombocytopenia;Hepatic amyloidosis;Hepatic artery embolism;Hepatic artery flow co decreased;Hepatic artery thrombosis;Hepatic enzyme abnormal;Hepatic enzyme 0 decreased;Hepatic enzyme increased;Hepatic fibrosis marker abnormal;Hepatic fibrosis marker increased;Hepatic function abnormal;Hepatic hydrothorax;Hepatic o hypertrophy;Hepatic hypoperfusion;Hepatic lymphocytic infiltration;Hepatic mass;Hepatic apain;Hepatic sequestration;Hepatic vascular resistance increased;Hepatic vascular 5 thrombosis;Hepatic vein embolism;Hepatic vein thrombosis;Hepatic venous pressure gradient abnormal;Hepatic venous pressure gradient increased;Hepatitis;Hepatobiliary scan o abnormal;Hepatomegaly;Hepatosplenomegaly;Hereditary angioedema with Cl esterase ainhibitor deficiency;Herpes dermatitis;Herpes gestationis;Herpes oesophagitis;Herpes 5 ophthalmic;Herpes pharyngitis;Herpes sepsis;Herpes simplex;Herpes simplex cervicitis;Herpes simplex colitis;Herpes simplex encephalitis;Herpes simplex gastritis;Herpes co simplex hepatitis;Herpes simplex meningitis;Herpes simplex meningoencephalitis;Herpes a) simplex meningomyelitis;Herpes simplex necrotising retinopathy;Herpes simplex rn oesophagitis;Herpes simplex otitis extema;Herpes simplex pharyngitis;Herpes simplex pneumonia;Herpes simplex reactivation;Herpes simplex sepsis;Herpes simplex ti viraemia;Herpes simplex virus conjunctivitis neonatal;Herpes simplex visceral;Herpes virus rn CONFIDENTIAL Page 4 FDA-CBER-2021-5683-0000086 Page 33 BNT 162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports infection;Herpes zoster;Herpes zoster cutaneous disseminated;Herpes zoster infection neurological;Herpes zoster meningitis;Herpes zoster meningoencephalitis;Herpes zoster meningomyelitis;Herpes zoster meningoradiculitis;Herpes zoster necrotising retinopathy;Herpes zoster oticus;Herpes zoster pharyngitis;Herpes zoster reactivation;Herpetic radiculopathy;Histone antibody positive;Hoigne's syndrome;Human herpesvirus 6 encephalitis;Human herpesvirus 6 infection;Human herpesvirus 6 infection reactivation;Human herpesvirus 7 infection;Human herpesvirus 8 infection;Hyperammonaemia;Hyperbilirubinaemia;Hypercholia;Hypergammaglobulinaemia benign monoclonal;Hyperglycaemic seizure;Hypersensitivity;Hypersensitivity vasculitis;Hyperthyroidism;Hypertransaminasaemia;Hyperventilation;Hypoalbuminaemia;H ypocalcaemic seizure;Hypogammaglobulinaemia;Hypoglossal nerve paralysis;Hypoglossal nerve paresis;Hypoglycaemic seizure;Hyponatraemic seizure;Hypotension;Hypotensive crisis;Hypothenar hammer syndrome;Hypothyroidism;Hypoxia;Idiopathic CD4 lymphocytopenia;Idiopathic generalised epilepsy;Idiopathic interstitial pneumonia;Idiopathic neutropenia;Idiopathic pulmonary fibrosis;IgA nephropathy;IgM nephropathy;IIIrd nerve paralysis;IIlyd nerve paresis;Iliac artery embolism;Immune thrombocytopenia;Immune- mediated adverse reaction;Immune-mediated cholangitis;Immune-mediated cholestasis;Immune-mediated cytopenia;Immune-mediated encephalitis;Immune-mediated encephalopathy;Immune-mediated endocrinopathy;Immune-mediated enterocolitis;Immune- mediated gastritis;Immune-mediated hepatic disorder;Immune-mediated hepatitis;Immune- P mediated hyperthyroidism;Immune-mediated hypothyroidism;Immune-mediated 2 myocarditis;Immune-mediated myositis;Immune-mediated nephritis;Immune-mediated neuropathy;Immune-mediated pancreatitis;Immune-mediated pneumonitis;Immune-mediated N renal disorder;Immune-mediated thyroiditis;Immune-mediated uveitis;Immunoglobulin G4 related disease;Immunoglobulins abnormal;Implant site thrombosis;lnclusion body myositis;Infantile genetic agranulocytosis;Infantile spasms;Infected vasculitis;Infective thrombosis;Inflammation;Inflammatory bowel disease;Infusion site thrombosis;Infusion site vasculitis;Injection site thrombosis;Injection site urticaria;Injection site vasculitis;Instillation site thrombosis;Insulin autoimmune syndrome;Interstitial granulomatous o dermatitis;Interstitial lung disease;Intracardiac mass;Intracardiac thrombus;Intracranial co pressure increased;lntrapericardial thrombosis;Intrinsic factor antibody abnormal;Intrinsic 0 factor antibody positive;IPEX syndrome;Irregular breathing;IRVAN syndrome;IVth nerve a�i paralysis;IVth nerve paresis;JC polyomavirus test positive;JC virus CSF test positive;Jeavons o syndrome;Jugular vein embolism;Jugular vein thrombosis;Juvenile idiopathic aarthritis;Juvenile myoclonic epilepsy;Juvenile polymyositis;Juvenile psoriatic 5 arthritis;Juvenile spondyloarthritis;Kaposi sarcoma inflammatory cytokine syndrome;Kawasaki's disease;Kayser-Fleischer ring;Keratoderma blenorrhagica;Ketosis- o prone diabetes mellitus;Kounis syndrome;Lafora's myoclonic epilepsy;Lambl's excrescences;Laryngeal dyspnoea;Laryngeal oedema;Laryngeal rheumatoid 5 arthritis;Laryngospasm;Laryngotracheal oedema;Latent autoimmune diabetes in adults;LE 0o cells present;Lemierre syndrome;Lennox-Gastaut syndrome;Leucine aminopeptidase co increased;Leukoencephalomyelitis;Leukoencephalopathy;Leukopenia;Leukopenia a`) neonatal;Lewis-Sumner syndrome;Lhermitte's sign;Lichen planopilaris;Lichen planus;Lichen sclerosus;Limbic encephalitis;Linear IgA disease;Lip oedema;Lip swelling;Liver function test abnormal;Liver function test decreased;Liver function test increased;Liver ti induration;Liver injury;Liver iron concentration abnormal;Liver iron concentration rn CONFIDENTIAL Page 5 FDA-C BER-2021-5683-0000087 Page 34 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports increased;Liver opacity;Liver palpable;Liver sarcoidosis;Liver scan abnormal;Liver tenderness;Low birth weight baby;Lower respiratory tract herpes infection;Lower respiratory tract infection;Lower respiratory tract infection viral;Lung abscess;Lupoid hepatic cirrhosis;Lupus cystitis;Lupus encephalitis;Lupus endocarditis;Lupus enteritis;Lupus hepatitis;Lupus myocarditis;Lupus myositis;Lupus nephritis;Lupus pancreatitis;Lupus pleurisy;Lupus pneumonitis;Lupus vasculitis;Lupus-like syndrome;Lymphocytic hypophysitis;Lymphocytopenia neonatal;Lymphopenia;MAGIC syndrome;Magnetic resonance imaging liver abnormal;Magnetic resonance proton density fat fraction measurement;Mahler sign;Manufacturing laboratory analytical testing issue;Manufacturing materials issue;Manufacturing production issue;Marburg's variant multiple sclerosis;Marchiafava-Bignami disease;Marine Lenhart syndrome;Mastocytic enterocolitis;Matemal exposure during pregnancy;Medical device site thrombosis;Medical device site vasculitis;MELAS syndrome;Meningitis;Meningitis aseptic;Meningitis herpes;Meningoencephalitis herpes simplex neonatal;Meningoencephalitis herpetic;Meningomyelitis herpes;MERS-CoV test;MERS-CoV test negative;MERS-CoV test positive;Mesangioproliferative glomerulonephritis;Mesenteric artery embolism;Mesenteric artery thrombosis;Mesenteric vein thrombosis;Metapneumovirus infection;Metastatic cutaneous Crohn's disease;Metastatic pulmonary embolism;Microangiopathy;Microembolism;Microscopic polyangiitis;Middle East respiratory syndrome;Migraine-triggered seizure;Miliary pneumonia;Miller Fisher syndrome;Mitochondrial aspartate aminotransferase increased;Mixed connective tissue 2 disease;Model for end stage liver disease score abnormal;Model for end stage liver disease score increased;Molar ratio of total branched-chain amino acid to tyrosine;Molybdenum N cofactor deficiency;Monocytopenia;Mononeuritis;Mononeuropathy CDmultiplex;Morphoea;Morvan syndrome;Mouth swelling;Moyamoya disease;Multifocal motor neuropathy;Multiple organ dysfunction syndrome;Multiple sclerosis;Multiple sclerosis Nrelapse;Multiple sclerosis relapse prophylaxis;Multiple subpial transection;Multisystem inflammatory syndrome in children;Muscular sarcoidosis;Myasthenia gravis;Myasthenia gravis crisis;Myasthenia gravis neonatal;Myasthenic syndrome;Myelitis;Myelitis transverse;Myocardial infarction;Myocarditis;Myocarditis post infection;Myoclonic co epilepsy;Myoclonic epilepsy and ragged-red fibres;Myokymia;Myositis;Narcolepsy;Nasal 0 herpes;Nasal obstruction;Necrotising herpetic retinopathy;Neonatal Crohn's disease;Neonatal epileptic seizure;Neonatal lupus erythematosus;Neonatal mucocutaneous herpes o simplex;Neonatal pneumonia;Neonatal seizure;Nephritis;Nephrogenic systemic a fibrosis;Neuralgic amyotrophy;Neuritis;Neuritis cranial;Neuromyelitis optica pseudo 5 relapse;Neuromyelitis optica spectrum disorder;Neuromyotonia;Neuronal neuropathy;Neuropathy peripheral;Neuropathy, ataxia,retinitis pigmentosa o syndrome;Neuropsychiatric lupus;Neurosarcoidosis;Neutropenia;Neutropenia Qa_ neonatal;Neutropenic colitis;Neutropenic infection;Neutropenic sepsis;Nodular rash;Nodular g vasculitis;Noninfectious myelitis;Noninfective encephalitis;Noninfective 0o encephalomyelitis;Noninfective oophoritis;Obstetrical pulmonary embolism;Occupational co exposure to communicable disease;Occupational exposure to SARS-CoV-2;Ocular m hyperaemia;Ocular myasthenia;Ocular pemphigoid;Ocular sarcoidosis;Ocular co vasculitis;Oculofacial paralysis;Oedema;Oedema blister;Oedema due to hepatic m disease;Oedema mouth;Oesophageal achalasia;Ophthalmic artery thrombosis;Ophthalmic r~. herpes simplex;Ophthalmic herpes zoster;Ophthalmic vein thrombosis;Optic neuritis;Optic rn CONFIDENTIAL Page 6 FDA-CBER-2021-5683-0000088 Page 35 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports neuropathy;Optic perineuritis;Oral herpes;Oral lichen planus;Oropharyngeal oedema;Oropharyngeal spasm;Oropharyngeal swelling;Osmotic demyelination syndrome;Ovarian vein thrombosis;Overlap syndrome;Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection;Paget-Schroetter syndrome;Palindromic rheumatism;Palisaded neutrophilic granulomatous dermatitis;Palmoplantar keratoderma;Palpable purpura;Pancreatitis;Panencephalitis;Papillophlebitis;Paracancerous pneumonia;Paradoxical embolism;Parainfluenzae viral laryngotracheobronchitis;Paraneoplastic dermatomyositis;Paraneoplastic pemphigus;Paraneoplastic thrombosis;Paresis cranial nerve;Parietal cell antibody positive;Paroxysmal nocturnal haemoglobinuria;Partial seizures;Partial seizures with secondary generalisation;Patient isolation;Pelvic venous thrombosis;Pemphigoid;Pemphigus;Penile vein thrombosis;Pericarditis;Pericarditis lupus;Perihepatic discomfort;Periorbital oedema;Periorbital swelling;Peripheral artery thrombosis;Peripheral embolism;Peripheral ischaemia;Peripheral vein thrombus extension;Periportal oedema;Peritoneal fluid protein abnormal;Peritoneal fluid protein decreased;Peritoneal fluid protein increased;Peritonitis lupus;Pemicious anaemia;Petit mal epilepsy;Pharyngeal oedema;Pharyngeal swelling;Pityriasis lichenoides et varioliformis acuta;Placenta praevia;Pleuroparenchymal fibroelastosis;Pneumobilia;Pneumonia;Pneumonia adenoviral;Pneumonia cytomegaloviral;Pneumonia herpes viral;Pneumonia influenzal;Pneumonia measles;Pneumonia mycoplasmal;Pneumonia necrotising;Pneumonia parainfluenzae viral;Pneumonia respiratory syncytial viral;Pneumonia viral;POEMS 2 syndrome;Polyarteritis nodosa;Polyarthritis;Polychondritis;Polyglandular autoimmune syndrome type I;Polyglandular autoimmune syndrome type II;Polyglandular autoimmune N syndrome type III;Polyglandular disorder;Polymicrogyria;Polymyalgia rheumatica;Polymyositis;Polyneuropathy;Polyneuropathy idiopathic progressive;Portal pyaemia;Portal vein embolism;Portal vein flow decreased;Portal vein pressure Nincreased;Portal vein thrombosis;Portosplenomesenteric venous thrombosis;Post procedural hypotension;Post procedural pneumonia;Post procedural pulmonary embolism;Post stroke epilepsy;Post stroke seizure;Post thrombotic retinopathy;Post thrombotic syndrome;Post viral o fatigue syndrome;Postictal headache;Postictal paralysis;Postictal psychosis;Postictal state;Postoperative respiratory distress;Postoperative respiratory failure;Postoperative 0 thrombosis;Postpartum thrombosis;Postpartum venous thrombosis;Postpericardiotomy m syndrome;Post-traumatic epilepsy;Postural orthostatic tachycardia syndrome;Precerebral o artery thrombosis;Pre-eclampsia;Preictal state;Premature labour;Premature menopause;Primary amyloidosis;Primary biliary cholangitis;Primary progressive multiple 5 sclerosis;Procedural shock;Proctitis herpes;Proctitis ulcerative;Product availability issue;Product distribution issue;Product supply issue;Progressive facial o hemiatrophy;Progressive multifocal leukoencephalopathy;Progressive multiple sclerosis;Progressive relapsing multiple sclerosis;Prosthetic cardiac valve 5 thrombosis;Pruritus;Pruritus allergic;Pseudovasculitis;Psoriasis;Psoriatic o arthropathy;Pulmonary amyloidosis;Pulmonary artery thrombosis;Pulmonary co embolism;Pulmonary fibrosis;Pulmonary haemorrhage;Pulmonary microemboli;Pulmonary aa) oil microembolism;Pulmonary renal syndrome;Pulmonary sarcoidosis;Pulmonary co sepsis;Pulmonary thrombosis;Pulmonary tumour thrombotic microangiopathy;Pulmonary m vasculitis;Pulmonary veno-occlusive disease;Pulmonary venous thrombosis;Pyoderma ti gangrenosum;Pyostomatitis vegetans;Pyrexia;Quarantine;Radiation leukopenia;Radiculitis C7 CONFIDENTIAL Page 7 FDA-CBER-2021-5683-0000089 Page 36 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports brachial;Radiologically isolated syndrome;Rash;Rash erythematous;Rash pruritic;Rasmussen encephalitis;Raynaud's phenomenon;Reactive capillary endothelial proliferation;Relapsing multiple sclerosis;Relapsing-remitting multiple sclerosis;Renal amyloidosis;Renal arteritis;Renal artery thrombosis;Renal embolism;Renal failure;Renal vascular thrombosis;Renal vasculitis;Renal vein embolism;Renal vein thrombosis;Respiratory arrest;Respiratory disorder;Respiratory distress;Respiratory failure;Respiratory paralysis;Respiratory syncytial virus bronchiolitis;Respiratory syncytial virus bronchitis;Retinal artery embolism;Retinal artery occlusion;Retinal artery thrombosis;Retinal vascular thrombosis;Retinal vasculitis;Retinal vein occlusion;Retinal vein thrombosis;Retinol binding protein decreased;Retinopathy;Retrograde portal vein flow;Retroperitoneal fibrosis;Reversible airways obstruction;Reynold's syndrome;Rheumatic brain disease;Rheumatic disorder;Rheumatoid arthritis;Rheumatoid factor increased;Rheumatoid factor positive;Rheumatoid factor quantitative increased;Rheumatoid lung;Rheumatoid neutrophilic dermatosis;Rheumatoid nodule;Rheumatoid nodule removal;Rheumatoid scleritis;Rheumatoid vasculitis;Saccadic eye movement;SAPHO syndrome;Sarcoidosis;SARS-CoV-1 test;SARS-CoV-1 test negative;SARS-CoV-1 test positive;SARS-CoV-2 antibody test;SARS-CoV-2 antibody test negative;SARS-CoV-2 antibody test positive;SARS-CoV-2 carrier;SARS-CoV-2 sepsis;SARS-CoV-2 test;SARS- CoV-2 test false negative;SARS-CoV-2 test false positive;SARS-CoV-2 test negative;SARS- CoV-2 test positive;SARS-CoV-2 viraemia;Satoyoshi syndrome;Schizencephaly;Scleritis;Sclerodactylia;Scleroderma;Scleroderma associated 2 digital ulcer;Scleroderma renal crisis;Scleroderma-like reaction;Secondary amyloidosis;Secondary cerebellar degeneration;Secondary progressive multiple N sclerosis;Segmented hyalinising vasculitis;Seizure;Seizure anoxic;Seizure cluster;Seizure like phenomena;Seizure prophylaxis;Sensation of foreign body;Septic embolus;Septic pulmonary embolism;Severe acute respiratory syndrome;Severe myoclonic epilepsy of o infancy;Shock;Shock symptom;Shrinking lung syndrome;Shunt thrombosis;Silent cL thyroiditis;Simple partial seizures;Sjogren's syndrome;Skin swelling;SLE arthritis;Smooth muscle antibody positive;Sneezing;Spinal artery embolism;Spinal artery thrombosis;Splenic artery thrombosis;Splenic embolism;Splenic thrombosis;Splenic vein co thrombosis;Spondylitis;Spondyloarthropathy;Spontaneous heparin-induced O thrombocytopenia syndrome;Status epilepticus;Stevens-Johnson syndrome;Stiff leg syndrome;Stiff person syndrome;Stillbirth;Still's disease;Stoma site thrombosis;Stoma site o vasculitis;Stress cardiomyopathy;Stridor;Subacute cutaneous lupus erythematosus;Subacute aendocarditis;Subacute inflammatory demyelinating polyneuropathy;Subclavian artery 5 embolism;Subclavian artery thrombosis;Subclavian vein thrombosis;Sudden unexplained death in epilepsy;Superior sagittal sinus thrombosis;Susac's syndrome;Suspected COVID- 0 19;Swelling;Swelling face;Swelling of eyelid;Swollen tongue;Sympathetic aophthalmia;Systemic lupus erythematosus;Systemic lupus erythematosus disease activity 5 index abnonnal;Systemic lupus erythematosus disease activity index decreased;Systemic lupus erythematosus disease activity index increased;Systemic lupus erythematosus oo rash;Systemic scleroderma;Systemic sclerosis ai pulmonary;Tachycardia;Tachypnoea;Takayasu's arteritis;Temporal lobe epilepsy;Terminal rn ileitis;Testicular autoimmunity;Throat tightness;Thromboangiitis obliterans;Thrombocytopenia;Thrombocytopenic ti purpura;Thrombophlebitis;Thrombophlebitis migrans;Thrombophlebitis QT V/ CONFIDENTIAL Page 8 FDA-CBER-2021-5683-0000090 Page 37 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports neonatal;Thrombophlebitis septic;Thrombophlebitis superficial;Thromboplastin antibody positive;Thrombosis;Thrombosis corpora cavernosa;Thrombosis in device;Thrombosis mesenteric vessel;Thrombotic cerebral infarction;Thrombotic microangiopathy;Thrombotic stroke;Thrombotic thrombocytopenic purpura;Thyroid disorder;Thyroid stimulating immunoglobulin increased;Thyroiditis;Tongue amyloidosis;Tongue biting;Tongue oedema;Tonic clonic movements;Tonic convulsion;Tonic posturing;Topectomy;Total bile acids increased;Toxic epidermal necrolysis;Toxic leukoencephalopathy;Toxic oil syndrome;Tracheal obstruction;Tracheal oedema;Tracheobronchitis;Tracheobronchitis mycoplasmal;Tracheobronchitis viral;Transaminases abnormal;Transaminases increased;Transfusion-related alloimmune neutropenia;Transient epileptic amnesia;Transverse sinus thrombosis;Trigeminal nerve paresis;Trigeminal neuralgia;Trigeminal palsy;Truncus coeliacus thrombosis;Tuberous sclerosis complex;Tubulointerstitial nephritis and uveitis syndrome;Tumefactive multiple sclerosis;Tumour embolism;Tumour thrombosis;Type 1 diabetes mellitus;Type I hypersensitivity;Type III immune complex mediated reaction;Uhthoffs phenomenon;Ulcerative keratitis;Ultrasound liver abnormal;Umbilical cord thrombosis;Uncinate fits;Undifferentiated connective tissue disease;Upper airway obstruction;Urine bilirubin increased;Urobilinogen urine decreased;Urobilinogen urine increased;Urticaria;Urticaria papular;Urticarial vasculitis;Uterine rupture;Uveitis;Vaccination site thrombosis;Vaccination site vasculitis;Vagus nerve paralysis;Varicella;Varicella keratitis;Varicella post vaccine;Varicella zoster 2 gastritis;Varicella zoster oesophagitis;Varicella zoster pneumonia;Varicella zoster sepsis;Varicella zoster virus infection;Vasa praevia;Vascular graft thrombosis;Vascular CO pseudoaneurysm thrombosis;Vascular purpura;Vascular stent thrombosis;Vasculitic rash;Vasculitic ulcer;Vasculitis;Vasculitis gastrointestinal;Vasculitis necrotising;Vena cava N embolism;Vena cava thrombosis;Venous intravasation;Venous recanalisation;Venous thrombosis;Venous thrombosis in pregnancy;Venous thrombosis limb;Venous thrombosis neonatal;Vertebral artery thrombosis;Vessel puncture site thrombosis;Visceral venous thrombosis;VIth nerve paralysis;VIth nerve paresis;Vitiligo;Vocal cord paralysis;Vocal cord paresis;Vogt-Koyanagi-Harada disease;Warm type haemolytic anaemia;Wheezing;White nipple sign;XIth nerve paralysis;X-ray hepatobiliary abnormal;Young's syndrome;Zika virus O associated Guillain Barre syndrome. a aD 0 L Q Q 5 a) 0 L Q 3 0 0 CO c0 a) 0 rn a) 0 rn 0 CONFIDENTIAL Page 9 FDA-CBER-2021-5683-0000091 Page 38