alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
# C_2015228EN.01002701.xml

| 13.7.2015 | EN | Official Journal of the European Union | C 228/27 |
| --- | --- | --- | --- |

13.7.2015

EN

Official Journal of the European Union

C 228/27

---

Judgment of the Civil Service Tribunal (Third Chamber) of 3 June 2015 — Gross v EEAS

(Case F-78/14) (1)

1

((Civil Service - Staff of the EEAS - Officials - Promotion - Articles 43 and 45(1) of the Staff Regulations - Comparative examination of the merits of all officials eligible for promotion - Officials put forward by the services of the EEAS and those not put forward - Taking into account of the staff reports - Exclusively literal assessments))

(2015/C 228/39)

Language of the case: French

Parties

Parties

Applicant: Philipp Oliver Gross (Brussels, Belgium) (represented initially by: D. de Abreu Caldas, M. de Abreu Caldas and J.-N. Louis, lawyers, and subsequently by: J.-N. Louis, laywer)

Applicant:

Defendant: European External Action Service (EEAS) (represented by: S. Marquardt and M. Silva, acting as Agents)

Defendant:

Re:

Re:

Annulment of the decisions not to promote the applicant to the next grade in the 2013 promotion procedure of the European External Action Service (EEAS).

Operative part of the judgment

Operative part of the judgment

The Tribunal:

| 1. | Annuls the decision of the Appointing Authority of the European External Action Service of 9 October 2013 establishing the list of officials promoted under promotion year 2013 in so far as the name of Mr Gross is not included; |
| --- | --- |

1.

Annuls the decision of the Appointing Authority of the European External Action Service of 9 October 2013 establishing the list of officials promoted under promotion year 2013 in so far as the name of Mr Gross is not included;

| 2. | Orders the European External Action Service to bear its own costs and to pay the costs incurred by Mr Gross. |
| --- | --- |

2.

Orders the European External Action Service to bear its own costs and to pay the costs incurred by Mr Gross.

---

(1)  OJ C 388, 3.11.2014, p. 31.

1

---
§ 810.13 Mandatory recall order. ( a ) If the person named in a cease distribution and notification order does not request a regulatory hearing or submit a request for agency review of the order, or, if the Commissioner of Food and Drugs or the presiding officer denies a request for a hearing, or, if after conducting a regulatory hearing under § 810.11 or completing agency review of a cease distribution and notification order under § 810.12, FDA determines that the order should be amended to require a recall of the device with respect to which the order was issued, FDA shall amend the order to require such a recall. FDA shall amend the order to require such a recall within 15 working days of issuance of a cease distribution and notification order if a regulatory hearing or agency review of the order is not requested, or within 15 working days of denying a request for a hearing, or within 15 working days of completing a regulatory hearing under § 810.11, or within 15 working days of receipt of a written request for review of a cease distribution and notification order under § 810.12.
( b ) In a mandatory recall order, FDA may: ( 1 ) Specify that the recall is to extend to the wholesale, retail, or user level;
( 2 ) Specify a timetable in accordance with which the recall is to begin and be completed;
( 3 ) Require the person named in the order to submit to the agency a proposed recall strategy, as described in § 810.14, and periodic reports describing the progress of the mandatory recall, as described in § 810.16; and
( 4 ) Provide the person named in the order with a model recall notification letter that includes the key elements of information that FDA has determined are necessary to inform health professionals and device user facilities.
( c ) FDA will not include in a mandatory recall order a requirement for: ( 1 ) Recall of a device from individuals; or
( 2 ) Recall of a device from device user facilities, if FDA determines that the risk of recalling the device from the facilities presents a greater health risk than the health risk of not recalling the device from use, unless the device can be replaced immediately with an equivalent device.
( d ) FDA will include in a mandatory recall order provisions for notification to individuals subject to the risks associated with use of the device. If a significant number of such individuals cannot be identified, FDA may notify such individuals under section 705(b) of the act.
# C_2019325EN.01000101.xml

| 30.9.2019 | EN | Official Journal of the European Union | C 325/1 |
| --- | --- | --- | --- |

30.9.2019

EN

Official Journal of the European Union

C 325/1

---

COUNCIL DECISION

of 26 September 2019

appointing the Deputy Executive Director of the European Union Intellectual Property Office

(2019/C 325/01)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (1), and in particular Article 158(6) thereof,

Whereas on 4 June 2019 a list of candidates for the post of Deputy Executive Director of the European Union Intellectual Property Office (‘the Office’) was submitted to the Council by the Management Board of the Office,

HAS ADOPTED THIS DECISION:

Article 1

1.   Mr Andrea DI CARLO, born in Rome (Italy) on 9 September 1970, is hereby appointed as Deputy Executive Director of the European Union Intellectual Property Office (‘the Office’) for a term of five years.

2.   The date on which the five-year term referred to in paragraph 1 commences shall be determined by the Management Board of the Office.

Article 2

This Decision shall enter into force on the date of its publication in the Official Journal of the European Union.

Done at Brussels, 26 September 2019.

For the Council

The President

T. HARAKKA

---

(1)  OJ L 154, 16.6.2017, p. 1.

1

---
Exhibit
32.1







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 of Preferred Voice, Inc. (the "Company") on
Form 10-KSB for the period ending March 31, 2008 as filed with the Securities
and Exchange Commission on the date hereof (the "Report"), I, Mary G. Merritt,
Principal Executive Officer and Principal Financial Officer of the Company,
certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to § 906 of the
Sarbanes-Oxley Act of 2002, that:






(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
respects, the financial condition and result of operations of the
Company.










/s/ Mary G.
Merritt




Mary G.
Merritt


Principal
Executive Officer


Principal
Financial Officer


July 11,
2008
§ 820.80 Receiving, in-process, and finished device acceptance. ( a ) *General.* Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.
( b ) *Receiving acceptance activities.* Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.
( c ) *In-process acceptance activities.* Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.
( d ) *Final acceptance activities.* Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until: ( 1 ) The activities required in the DMR are completed;
( 2 ) the associated data and documentation is reviewed;
( 3 ) the release is authorized by the signature of a designated individual(s); and
( 4 ) the authorization is dated.
( e ) *Acceptance records.* Each manufacturer shall document acceptance activities required by this part. These records shall include: ( 1 ) The acceptance activities performed;
( 2 ) the dates acceptance activities are performed;
( 3 ) the results;
( 4 ) the signature of the individual(s) conducting the acceptance activities; and
( 5 ) where appropriate the equipment used. These records shall be part of the DHR.
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.3590 Meprobamate test system. ( a ) *Identification.* A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Design verification and validation must include: ( i ) Robust data demonstrating the accuracy of the device when used in the intended specimen matrix. The accuracy data must include a comparison between the meprobamate test system results and meprobamate results that are measured on an FDA-accepted measurement method that is specific and accurate (e.g., gas or liquid chromatography combined with tandem mass spectrometry).
( ii ) Robust analytical data demonstrating the performance characteristics of the device, including, but not limited to, specificity, cross-reactivity to relevant endogenous and exogenous substances, and the reproducibility of analyte detection around the cutoff(s).
( 2 ) The intended use of the device must not include an indication for use in monitoring therapeutic drug concentrations or informing dosing adjustment decisions.
( 3 ) Your 21 CFR 809.10 labeling must include the following: ( i ) If indicated for use as a screening test to identify preliminary results for further confirmation, the intended use must state “This assay provides only a preliminary analytical result. A more specific alternative chemical confirmatory method (e.g., gas or liquid chromatography and mass spectrometry) must be used to obtain a confirmed analytical result. Clinical consideration and professional judgment must be exercised with any drug of abuse test, particularly when the preliminary test result is positive.”
( ii ) A limiting statement that reads as follows: “This test should not be used to monitor therapeutic drug concentrations or to inform dosing adjustment decisions.”
[83 FR 54876, Nov. 1, 2018]
# C_2016106EN.01003402.xml

| 21.3.2016 | EN | Official Journal of the European Union | C 106/34 |
| --- | --- | --- | --- |

21.3.2016

EN

Official Journal of the European Union

C 106/34

---

Order of the General Court of 28 December 2015 — Skype v OHIM — Sky International (SKYPE)

(Case T-797/14) (1)

1

((Community trade mark - Opposition proceedings - Withdrawal of the opposition - No need to adjudicate))

(2016/C 106/39)

Language of the case: English

Parties

Parties

Applicant: Skype Ultd (Dublin, Ireland) (represented by: A. Carboni and M. Browne, solicitors)

Applicant:

Defendant: Office for Harmonisation in the Internal Market (Trade Marks and Designs) (represented by: P. Bullock, acting as Agent)

Defendant:

Other party to the proceedings before the Board of Appeal of OHIM intervening before the General Court: Sky International AG (Zug, Switzerland) (represented by: D. Rose and J. Curry, lawyers)

Other party to the proceedings before the Board of Appeal of OHIM intervening before the General Court:

Re:

Re:

Action brought against the decision of the Fourth Board of Appeal of OHIM of 29 September 2014 (Case R 1075/2013-4), relating to opposition proceedings between Sky International AG and Skype.

Operative part of the order

Operative part of the order

| 1. | There is no longer any need to adjudicate on the action. |
| --- | --- |

1.

There is no longer any need to adjudicate on the action.

| 2. | Skype Ultd and Sky International AG are ordered to bear their own costs and to each pay half of the costs incurred by the Office for Harmonisation in the Internal Market (trade marks and designs) (OHIM). |
| --- | --- |

2.

Skype Ultd and Sky International AG are ordered to bear their own costs and to each pay half of the costs incurred by the Office for Harmonisation in the Internal Market (trade marks and designs) (OHIM).

---

(1)  OJ C 46, 9.2.2015.

1

---
<TABLE> <S> <C>



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<OTHER-INCOME>                                 104
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<UNDERWRITING-OTHER>                           486
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<RESERVE-OPEN>                                 9,458
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<PAYMENTS-PRIOR>                               1,949
<RESERVE-CLOSE>                                9,114
<CUMULATIVE-DEFICIENCY>                        60
        

</TABLE>
Exhibit 32.1



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-KSB ("Form 10-KSB") of Smart-tek

Solutions, Inc. (the "Company") for the annual period ended June 30,2005 as filed with

the Securities and Exchange Commission on the date hereof, I, Donald Gee, Chief Executive

Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant

to Section 906 of the Sarbanes-Oxley Act of 2002, that:



(1)   The Form 10-KSB 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 Form 10-KSB fairly presents, in all

material respects, the financial condition and results of operations

of the Company.



/s/ Donald Gee

---------------------------

Donald Gee

Chief Executive Officer

October xx, 2005
Editorial Note on Part 866
Editorial Note: Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.

§ 866.3355 *Listeria* spp. serological reagents. ( a ) *Identification. Listeria* spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify *Listeria* spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of *Listeria* spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify *Listeria* spp. directly from clinical specimens. The identification aids in the diagnosis of listeriosis, a disease caused by bacteria belonging to the genus *Listeria,* and provides epidemiological information on diseases caused by these microorganisms. *Listeria monocytogenes,* the most common human pathogen of this genus, causes meningitis (inflammation of the brain membranes) and meningoencephalitis (inflammation of the brain and brain membranes) and is often fatal if untreated. A second form of human listeriosis is an intrauterine infection in pregnant women that results in a high mortality rate for infants before or after birth.
( b ) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]
EXHIBIT 31.4

SECTION 302
CERTIFICATION

I, Michael l-Hillow, certify that:

1. I have reviewed this Annual
Report on Form 10-K/A of Evergreen Solar, Inc; and

2. Based on
my knowledge, this 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 report.

|/s/ MICHAELEL-HILLOW         
|-----------------------------
|Michael
      El-Hillow      
|Chief Financial
      Officer
|April 29,
      2008         

---
<PAGE>
                                                                    Exhibit 23.1


            CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We hereby consent to the incorporation by reference in the Registration
Statements on Form S-8 (File Nos. 333-53374, 333-105963 and 333-127025) and Form
S-3 (File Nos. 333-106126, 333-117264, 333-119864, 333-128074 and 333-138748) of
Evergreen Solar, Inc. of our report dated February 27, 2007 relating to the
financial statements, financial statement schedule, management's assessment of
the effectiveness of internal control over financial reporting and the
effectiveness of internal control over financial reporting, which appears in
this Form 10-K.


/s/ PricewaterhouseCoopers LLP

Boston, Massachusetts
February 27, 2007
Exhibit 32

 

CERTIFICATIONPURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTEDPURSUANT TO

SECTION 906OF THE SARBANES-OXLEY ACT OF 2002

 

Solely in connection with the filing of the AnnualReport of Retractable Technologies, Inc. (the “Company”) on Form 10-Kfor the period ended December 31, 2007, as filed with the United StatesSecurities and Exchange Commission on the date hereof (the “Report”), theundersigned Thomas J. Shaw, Chief Executive Officer, and Douglas W. Cowan,Chief Financial Officer, do hereby certify, pursuant to 18 U.S.C. Section 1350,as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002,that:

 

(1) The Report fullycomplies with the requirements of Section 13(a) or 15(d) of theSecurities Exchange Act of 1934; and

 

(2) The informationcontained in the Report fairly presents, in all material respects, thefinancial condition and results of operations of the Company.

 

Date:       March 31, 2008

 

 
|   |   | /s/ Thomas J. Shaw                 |   |
|--------|--------|------------------------------------|--------|
|   |   | THOMAS J. SHAW                     |   |
|   |   | PRESIDENT, CHAIRMAN, AND |   |
|   |   | CHIEF EXECUTIVE OFFICER            |   |
|   |   |                               |   |
|   |   |                               |   |
|   |   | /s/ Douglas W. Cowan               |   |
|   |   | DOUGLAS W. COWAN                   |   |
|   |   | VICE PRESIDENT AND                 |   |
|   |   | CHIEF FINANCIAL OFFICER            |   |

 

 

----
<TABLE> <S> <C>

<ARTICLE> 9
<MULTIPLIER>   1,000
       
<S>                             <C>
<PERIOD-TYPE>                   12-MOS
<FISCAL-YEAR-END>                          SEP-30-1996
<PERIOD-END>                               SEP-30-1996
<CASH>                                           1,493
<INT-BEARING-DEPOSITS>                           7,476
<FED-FUNDS-SOLD>                                     0
<TRADING-ASSETS>                                     0
<INVESTMENTS-HELD-FOR-SALE>                     73,730
<INVESTMENTS-CARRYING>                          10,376
<INVESTMENTS-MARKET>                            10,373
<LOANS>                                        275,487
<ALLOWANCE>                                      2,419
<TOTAL-ASSETS>                                 388,431
<DEPOSITS>                                     248,723
<SHORT-TERM>                                    76,354
<LIABILITIES-OTHER>                              2,100
<LONG-TERM>                                          0
<PREFERRED-MANDATORY>                              425
<PREFERRED>                                          0
<COMMON>                                             0
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<INTEREST-OTHER>                                   270
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<INTEREST-EXPENSE>                              12,426
<INTEREST-INCOME-NET>                           12,223
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<SECURITIES-GAINS>                                (29)
<EXPENSE-OTHER>                                  8,852
<INCOME-PRETAX>                                  5,213
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<EXTRAORDINARY>                                  2,623
<CHANGES>                                            0
<NET-INCOME>                                     3,058
<EPS-PRIMARY>                                      .67
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</TABLE>
#### § 660.32 Collection of source material.

Blood for Reagent Red Blood Cells from donors of peripheral blood shall be collected as prescribed under § 640.4 of this chapter, except that paragraphs (c), (d), (g), and (h) of § 640.4 shall not apply.