alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
TPOXX (tecovirimat)

If you have monkeypox symptoms, talk to your healthcare provider even if you haven’t had contact with someone who has 

monkeypox. 

What you need to know:

• TPOXX is an antiviral drug 

• There are no FDA-approved treatments for monkeypox virus infections, and no data establishing the safety or

effectiveness of using TPOXX to treat monkeypox in humans.

• TPOXX

weakened immune systems.

approved by the FDA in 2018 to treat smallpox in adults and children. 

may be used for people with severe disease or who are more likely to get severely ill, like patients with 

About the drug:

• The FDA approved TPOXX for smallpox under the FDA’s Animal Rule regulations, which allows for approval of

certain drugs and biological products when human efficacy studies are not ethical and field trials to study the

effectiveness of drugs or biological products are not feasible.

• Human efficacy studies of smallpox disease are not feasible because smallpox has been eradicated globally and

exposing people to smallpox virus for the purpose of a clinical trial is not ethical. Due to scientific and logistical

limitations with the use of smallpox virus in animal models, the efficacy of TPOXX was established in animal models

using related viruses, specifically non-human primates infected with monkeypox virus and rabbits infected with

rabbitpox virus. These studies demonstrated improved survival in animals that received TPOXX compared to

animals that received placebo.

• There are currently no data demonstrating the effectiveness of TPOXX for the treatment of smallpox or

monkeypox in humans. TPOXX has only been tested in healthy human volunteers, without smallpox or monkeypox

infection, to assess safety.

• Drugs that are effective in animal studies are not always effective in humans. Conducting randomized, controlled

trials to assess TPOXX’s safety and efficacy in humans with monkeypox infections is essential.

• As monkeypox was endemic in other parts of the world (e.g., the Democratic Republic of Congo), it was not eligible

for approval for the treatment of monkeypox disease under the FDA’s Animal Rule regulations because it was both

ethical and feasible to conduct clinical trials in humans.

• The prescribing information contains more information about the drug.

Additional information: 

• The CDC holds an expanded access Investigational New Drug protocol, sometimes referred to as “compassionate

use”, that allows for the use of TPOXX for treatment of monkeypox, and the product is only available from the

Strategic National Stockpile. The FDA worked closely with the CDC to streamline the protocol to reduce data

collection and reporting requirements. The revised protocol is now available for use.

• Information for healthcare professionals on treatment of monkeypox can be found on the CDC’s page: 

Information for Healthcare Professionals.

Treatment 

Monkeypox Fast Facts
##### 



Exhibit 12
  TEXTRON
    FINANCIAL CORPORATION
    COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES
    (Dollars in millions)
  Three Months EndedMarch 31, 2007Income before income taxes

$
52FIXED CHARGES:Interest on debt


100Estimated interest portion of rents


1Total fixed charges


101Adjusted income

$
153Ratio of earnings to fixed
    charges(1)


1.51x     (1)
    
    The ratio of earnings to fixed charges has been computed by
    dividing income before income taxes and fixed charges by fixed
    charges. Fixed charges consist of interest on debt and one-third
    rental expense as representative of interest portion of rentals.
**EXHIBIT 31**
**CERTIFICATIONS**
I, Ron Hooper, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Sabine Royalty Trust,for which Bank of America, N.A. acts as Trustee;
2. Based on my knowledge, this quarterly report does not contain any untruestatement of a material fact or omit to state a material fact necessary to makethe statements made, in light of the circumstances under which such statementswere made, not misleading with respect to the period covered by this quarterlyreport;
3. Based on my knowledge, the financial statements, and other financialinformation included in this quarterly report, fairly present in all materialrespects the financial condition, distributable income and changes in trustcorpus of the registrant as of, and for, the periods presented in this quarterlyreport;
4. I am responsible for establishing and maintaining disclosure controls andprocedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) andinternal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), or forcausing such controls and procedures to be established and maintained, for theregistrant and I have:
 a) Designed such disclosure controls and procedures, or causedsuch disclosure controls and procedures to be designed undermy supervision, to ensure that material information relatingto the registrant, including its consolidated subsidiaries, ismade known to me by others within those entities, particularlyduring the period in which this report is beingprepared;  b) Designed such internal control over financial reporting, or causedsuch internal control over financial reporting to be designed undermy supervision, to provide reasonable assurance regarding the reliability offinancial reporting and the of financial statements for external purposes;  c) Evaluated the effectiveness of the registrant’s disclosurecontrols and procedures and presented in this reportmy conclusions about the effectiveness of the disclosurecontrols and procedures, as of the end of the period covered bythis report based on such evaluation; and  d) Disclosed in this report any change in theregistrant’s internal control over financial reporting thatoccurred during the registrant’s most recent fiscal quarter(the registrant’s fourth fiscal quarter in the case of anannual report) that has materially affected, or is reasonablylikely to materially affect, the registrant’s internal controlover financial reporting; and
5. I have disclosed, based on my most recent evaluation of internal controlover financial reporting, to the registrant’s auditors:
 a) All significant deficiencies and material weaknesses in thedesign or operation of internal control over financialreporting which are reasonably likely to adversely affect theregistrant’s ability to record, process, summarize and reportfinancial information; and  b) Any fraud, whether or not material, that involves managementor other employees whohave a significant role in the registrant’s internal controlover financial reporting.        Date: November 4, 2005By:  /s/ Ron Hooper    Ron Hooper    Senior Vice President andTrust AdministratorBank of America, N.A.
OPTIONABLE

    


    


    January
15, 2009

    


    


    Mr.
Andrew Samaan

    


    


    


    Dear Mr.
Samaan:

    


    As you are aware, you have been elected
to the Board of Directors (the “Board”) of Optionable, Inc. (“Optionable”)
effective as of the date on which you agree to and accept the terms
hereof.  We welcome you to the Board and believe that the extensive
experience, knowledge and insights which you will bring to the Board will
greatly benefit Optionable and its stockholders.

    


    Your
annual compensation for serving on the Board will be $25,000 paid in 12 equal
monthly installments. In the event that you resign from the Board, you are
removed from the Board for any reason, you are not re-elected as a director or
you otherwise cease to be a director, effective on such date, the Company will
have no further payment obligation to you other than amounts that may be owed to
you for your service on the Board prior to such date. In return for such
consideration you will be expected to fulfill your duties as a member of the
Board, to attend in person (or if unavailable, by telephone) regularly scheduled
meetings and special meetings of the Board, and to participate in committees of
the Board to which you may be appointed.

    


    Thank you for joining Optionable and we
look forward to your valuable services as a director.

    
      	 
      	 
      
	 
      	
              Very
      truly yours,

            
	 
      	 
      
	 
      	
              OPTIONABLE,
      INC.

            
	 
      	 
      
	 
      	 
      
	 
      	
              /s/
      Edward
      O’Connor                  
      

            
	 
      	
              Name:
      Edward O’Connor

            
	 
      	
              Title:
      President

            
	 
      	 
      
	
              AGREED
      AND ACCEPTED,

            	 
      
	
              As
      of January 15, 2009

            	 
      
	 
      	 
      
	
              /s/
      Andrew
      Samaan                    
      

            	 
      
	
              Name:
      Andrew Samaan
Watmind USA: Speedy Swab Rapid COVID-19 Antigen Self-Test

6-month to 21-month shelf-life extension granted by the FDA on February 21, 2023

Lot Number

Tests with this printed

expiration date

(Year-Month-Day)

Now have this extended

expiration date

(Year-Month-Day)

22090100 2023-03-06 2024-06-06

22090200 2023-03-06 2024-06-06

22090300 2023-03-06 2024-06-06

22090400 2023-03-06 2024-06-06

22120200 2023-06-12 2024-09-12
Troy James POWELL, petitioner, v. UNITED STATES.

No. 12-9918.

Supreme Court of the United States

May 28, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Fourth Circuit denied.
----

----

| (1) | The      Report fully complies with the requirements of Section 13(a) or 15(d) of      the Securities Exchange Act of 1934;and |
|-----|--------------------------------------------------------------------------------------------------------------------------------|

| (2) | The      information contained in the Report fully presents, in all material      respects, the financial condition and results of operations or the      Company. |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|                     |                         |                       |
|--------------------------|------------------------------|----------------------------|
| Date:      July 24, 2008 | By:                          | /s/ Ross    Bernstein |
|                     | Ross      Bernstein          |
|                     | Chief      Executive Officer |
|                     |                         |

----

----
Exhibit 31.2

                                 CERTIFICATION
                                 -------------

I, Joseph E. Sutaris, certify that:

1. I have reviewed this quarterly report on Form  10-Q of The Wilber
Corporation;

2.  Based on my knowledge,  this quarterly report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by
this quarterly report.

3. Based on my knowledge,  the financial statements, and other financial
information included in this quarterly report,  fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this quarterly report.

4. The registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures  (as defined
in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and we have:

      a)   Designed such disclosure controls and procedures, or caused such
      disclosure controls and procedures to be designed under our supervision,
      to ensure that material information relating to the registrant,
      including its consolidated subsidiaries, is made known to us by others
      within those entities,  particularly during the period in which this
      quarterly report is being prepared;

      b)  Evaluated the effectiveness of the registrant's disclosure controls
      and procedures as of the end of the period covered by this report based
      on such evaluation ( the "Evaluation Date"); and

      c)   Disclosed in this quarterly report any change in the registrant's
      internal control over financial reporting that occurred during the
      registrant's first fiscal quarter that has materially affected,  or is
      reasonably likely to affect the registrant's internal control over
      financial reporting.

Date:  August 5, 2004
       --------------

By:
    ------------------------------
Treasurer and Chief Financial Officer
1

In The

Court of Appeals

Ninth District of Texas at Beaumont

__________________

NO. 09-19-00281-CV

__________________

RENA HILLIARD, Appellant

V.

BEAUMONT HOUSING AUTHORITY AND RASHAD BOWMAN, 

Appellees

__________________________________________________________________

On Appeal from the County Court at Law No. 1

Jefferson County, Texas

Trial Cause No. 133658

__________________________________________________________________

MEMORANDUM OPINION

The appellant, Rena Hilliard, and the appellees, Beaumont Housing Authority 

and Rashad Bowman, filed a joint motion to dismiss this appeal. The motion states 

the parties settled the dispute, which moots the appeal. The parties filed the motion

voluntarily and before the Court issued any decision. We grant the motion to dismiss. 
2

See Tex. R. App. P. 42.1(a)(2). No other party filed a notice of appeal. We dismiss 

the appeal.

APPEAL DISMISSED.

______________________________

 HOLLIS HORTON

 Justice

Submitted on October 23, 2019

Opinion Delivered October 24, 2019

Before Kreger, Horton, and Johnson, JJ.
Peter Paul MITRANO, petitioner, v. Helen M. MORRIS, Trustee.

No. 12-1314.

Supreme Court of the United States

June 10, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Fourth Circuit denied.
REGULATORY COUNSEL 

Description of Duties 

Develops policies and programs that affect tobacco product regulation. Drafts and critically 

reviews policies and program proposals and decisions on tobacco product regulation and 

compliance and enforcement activities. In developing regulations, compliance strategies, and 

other written statements of agency policies, the regulatory counsel consults with staff at all levels 

of FDA to identify issues and areas of concern. 

Qualifications 

 The experience requirement for the GS-9 level may be met by a master's or equivalent 

graduate degree or two (2) full years of academic graduate level education leading to 

such a degree or LL.B. or J.D., which is directly related to the duties of the position. A 

combination of education (coursework equivalent to a major) and experience may be 

considered. 

 U.S. citizenship is required. 

Education 

An official transcript, unofficial transcript, or a list including courses, grades earned, completion 

dates, and quarter and semester hours earned may be required. If you are using education 

completed in foreign colleges or universities to meet the qualification requirements, you must 

show that the education credentials have been evaluated by a private organization that specializes 

in interpretation of foreign education programs and such education has been deemed equivalent 

to that gained in an accredited U.S. education program; or full credit has been given for the 

courses at a U.S. accredited college or university. For further information, click on: foreign 

education. 

Note: Please review each grade announcement for the specific qualifications and specialized 

experience. 

Grade (Salary) Level 

Federal General Schedule (GS) grade levels at which Regulatory Counsels are commonly filled 

are: 

 GS-09 through GS-13 ($54,972.00 to $123,234.00 / Per Year) 
Geographic Locations 

Regulatory Counsels are located at FDA Headquarters in Silver Spring, MD
Certification Pursuant to


18 U.S.C Section 1350,


As added by


Section 906 of the Sarbanes-Oxley Act of 2002





In connection with the annual report of Seven Arts Pictures PLC (“the Company”) on Form 20-F for the Fiscal Year ended June 30, 2009 as filed with the Securities and Exchange Commission on the date hereof (“the Report”) I, Michael E Garstin, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §
1350 as added by § 906 of the Sarbanes-Oxley Act of 2002, that, based on my knowledge:





1.            The report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and





2.            The information contained in the Report fairly presents, in all material aspects the financial condition and results of operations of the Company.








March 22, 2010





/s/ Michael E. Garstin


Michael E. Garstin












SEVEN ARTS PICTURES PLC


38 Hertford Street ~ London W1J 7SG


Tel: + 44 20 3006 8222 ~ Fax: +44 20 3006 8220


Registered Address: One America Square, London EC4A 4HJ


Company No. 5160597
Donald DESTIN, Appellant, v. STATE of Florida, Appellee.

Case No. 5D18-3359

District Court of Appeal of Florida, Fifth District.

Decision filed June 25, 2019

**DECISION WITHOUT PUBLISHED OPINION**

AFFIRMED.
Gary LEE, petitioner, v. UNITED STATES.

No. 12-10113.

Supreme Court of the United States

June 3, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Third Circuit denied.
Ronald KOEKOEK, Appellant/Petitioner(s), v. BANK OF NEW YORK MELLON, Appellee/Respondent(s).

CASE NO.: 2D19-2339

District Court of Appeal of Florida, Second District.

July 11, 2019

**DECISION WITHOUT PUBLISHED OPINION**

Accepted. Mandamus is dismissed.
# m8509.docx

EUROPEAN COMMISSION Brussels, 27.7.2017 C(2017) 5439 final To the notifying part ies : Subject : Case M. 8509 – LVMH / MARCOLIN / JV Commission decision pursuant to Article 6(1)(b) of Council Regulation (EC) No 139/2 004 1 and Article 57 of the Agreement on the European Economic Area 2 Dear Sir or Madam, 1. On 30 June 2017 , the European Commission received notification of a proposed conc entration pursuant to Article 4 of the Merger Regulation by which the undertakings LVMH-Moët Hennessy Louis Vuitton SE ('LVMH', France) controlled by Groupe Arnault SEDCS and Marcolin S.p.A . (' Marcolin ', Italy) controlled by PAI Partners S.A.S., acquire within the meaning of Article 3( 4 ) of the Merger Regulation joint control of Newco by way of purchase of shares in a newly created company constituting a full-function joint venture . 3 2. The business activities of the undertakings concerned are: - for LVMH: production and sale of luxury goods through a portfolio of over 60 luxury brands and over thousands points of sale worldwide, - for Marcolin : manufacturing and wholesale distribution of eyewear, notably eyeglass frames and sunglasses, - for NewCo : design, development, and manufacturing of eyewear products worldwide . 3. After examination of the notification, the European Commission has concluded that the notified operation falls within the scope of the Merger Regulation and of paragraph 5 ( a ) and 5 ( c ) of the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 . 4 4. For the reasons set out in the Notice on a simplified procedure, the European Commission has decided not to oppose the notified operation and to declare it compatible with the internal market and with the EEA Agreement. This decision is adopted in application of Article 6(1)(b) of the Merger Regulation and Article 57 of the EEA Agreement . For the Commission
( S igned)
Johannes LAITENBERGER Director - General
(1)
OJ L 24, 29.1.2004, p. 1 ( the ' Merger Regulation ' ). With effect from 1 December 2009, the Treaty on the Functioning of the European Union ( ' TFEU ' ) has introduced certain changes, such as the replacement of ' Community ' by ' Union ' and ' common market ' by ' internal market ' . The terminology of the TFEU will be used throughout this decision.
(2) OJ L 1, 3.1.1994, p. 3 ( the ' EEA Agreement ' ).
(3) Publication in the Official Journal of the European Union No C 222 , 11 . 7 . 2017 , p. 7 .
(4)
OJ C 366, 14.12.2013, p. 5 .
In re Leroy STERLING, petitioner.

No. 12-9665.

Supreme Court of the United States

June 10, 2013.

Petition for writ of mandamus and/or prohibition denied.
Charles E. HILL, petitioner, v. SUPERIOR COURT OF CALIFORNIA, LOS ANGELES COUNTY.

No. 12-672.

Supreme Court of the United States

April 1, 2013.

Petition for rehearing denied.
Michael Danotus YOUNG, petitioner, v. UNITED STATES.

No. 12-10248.

Supreme Court of the United States

June 10, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Sixth Circuit denied.

Justice KAGAN took no part in the consideration or decision of this petition.
Exhibit 32.2

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO
SECTION 906

OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report on Form 10-K of DuPont Fabros Technology, L.P. (the Company) for the year ended
December 31, 2010 as filed with the Securities and Exchange Commission on the date hereof (the Report), we, Hossein Fateh and Mark L. Wetzel, President and Chief Executive Officer and Executive Vice President, Chief Financial
Officer and Treasurer, respectively, of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to our knowledge:



| | 1. | The Report fully complies with the requirements of Sections 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
| | -- | ----------------------------------------------------------------------------------------------------------------------------------



| | 2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------



|                        |  |  |  |        |  |                                                                |  | 
|----------------------- |  |  |  | ------ |  | -------------------------------------------------------------- |  | 
|Date: February 24, 2011 |  |  |  | By:    |  | /s/    Hossein
Fateh                                          
|                        |  |  |  | Name:  |  | Hossein Fateh                                                 
|                        |  |  |  | Title: |  | President and Chief Executive Officer                         
|                        |  |  | 
|                        |  |  |  | By:    |  | /s/    Mark L.
Wetzel                                         
|                        |  |  |  | Name:  |  | Mark L. Wetzel                                                
|                        |  |  |  | Title: |  | Executive Vice President, Chief Financial Officer andTreasurer