alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system. ( a ) *Identification.* A total 25-hydroxyvitamin D mass spectrometry test system is a device intended for use in clinical laboratories for the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) in serum or plasma to be used in the assessment of vitamin D sufficiency.
( b ) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 862.9. The device must comply with the following special controls: ( 1 ) The device must have initial and annual standardization verification by a certifying vitamin D standardization organization deemed acceptable by FDA.
( 2 ) The 21 CFR 809.10(b) compliant labeling must include detailed descriptions of performance testing conducted to evaluate precision, accuracy, linearity, interference, including the following: ( i ) Performance testing of device precision must, at a minimum, use intended sample type with Vitamin D concentrations at medically relevant decision points. At least one sample in the precision studies must be an unmodified patient sample. This testing must evaluate repeatability and reproducibility using a protocol from an FDA-recognized standard.
( ii ) Performance testing of device accuracy must include a minimum of 115 serum or plasma samples that span the measuring interval of the device and compare results of the new device to results of a reference method or a legally marketed standardized mass spectrometry based vitamin D assay. The results must be described in the 21 CFR 809.10(b)(12) compliant labeling of the device.
( iii ) Interference from vitamin D analogs and metabolites including vitamin D2, vitamin D3, 1-hydroxyvitamin D2, 1-hydroxyvitamin D3, 3-Epi-25-Hydroxyvitamin D2, 3-Epi-25-Hydroxyvitamin D3, 1,25-Dihydroxyvitamin D2, 1,25-Dihydroxyvitamin D3, 3-Epi-1,25-Dihydroxyvitamin D2, and 3-Epi-1,25-Dihydroxyvitamin D3, 25, 26-Dihydroxyvitamin-D3, 24 (R), 25-dihydroxyvitamin-D3, 23 (R), 25-dihydroxyvitamin-D3 must be described in the 21 CFR 809.10(b)(7) compliant labeling of the device.
( 3 ) The 21 CFR 809.10(b) compliant labeling must be supported by a reference range study representative of the performance of the device. The study must be conducted using samples collected from apparently healthy male and female adults at least 21 years of age and older from at least 3 distinct climatic regions within the United States in different weather seasons. The ethnic, racial, and gender background of this study population must be representative of the U.S. population demographics.
( 4 ) The results of the device as provided in the 21 CFR 809.10(b) compliant labeling and any test report generated must be reported as only total 25-hydroxyvitamin D.
[82 FR 51559, Nov. 7, 2017, as amended at 83 FR 25914, June 5, 2018]
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
This schedule contains summary financial information extracted from Pan
International Gaming, Inc. and Subsidiary - Interim Consolidated Financial
Statements for the period ending June 30, 1999 and for the years ending Dec. 31,
1998 and Dec. 31, 1997 and is qualified in its entirety by reference to such
Form 10-QSB for 2nd Quarter, 1999 ended June 30, 1999.
</LEGEND>

<S>                             <C>
<PERIOD-TYPE>                   6-MOS
<FISCAL-YEAR-END>                          DEC-31-1999
<PERIOD-START>                             JAN-01-1999
<PERIOD-END>                               JUN-30-1999
<CASH>                                              17
<SECURITIES>                                         0
<RECEIVABLES>                                1,065,896
<ALLOWANCES>                               (1,065,896)
<INVENTORY>                                          0
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<DEPRECIATION>                                       0
<TOTAL-ASSETS>                                 802,711
<CURRENT-LIABILITIES>                          681,262
<BONDS>                                              0
<PREFERRED-MANDATORY>                                0
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<COMMON>                                         7,758
<OTHER-SE>                                   2,281,445
<TOTAL-LIABILITY-AND-EQUITY>                   802,711
<SALES>                                              0
<TOTAL-REVENUES>                                     0
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                                54,351
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                               (54,351)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                                  0
<DISCONTINUED>                                       0
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<CHANGES>                                            0
<NET-INCOME>                                  (54,351)
<EPS-BASIC>                                      (.01)
<EPS-DILUTED>                                    (.01)


</TABLE>
# C_2014135EN.01004601.xml

| 5.5.2014 | EN | Official Journal of the European Union | C 135/46 |
| --- | --- | --- | --- |

5.5.2014

EN

Official Journal of the European Union

C 135/46

---

Action brought on 4 February 2014 — EE v OHIM (Device of grey pattern)

(Case T-77/14)

2014/C 135/58

Language of the case: English

Parties

Parties

Applicant: EE Ltd (Hatfield, United Kingdom) (represented by: P. Brownlow, Solicitor)

Applicant:

Defendant: Office for Harmonisation in the Internal Market (Trade Marks and Designs)

Defendant:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | Annul the decision of the First Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 24 October 2013 given in Case R 704/2013-1. |
| --- | --- |

—

Annul the decision of the First Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 24 October 2013 given in Case R 704/2013-1.

Pleas in law and main arguments

Pleas in law and main arguments

Community trade mark concerned: The figurative trade mark representing a device of grey pattern for goods and services in Classes 7, 9, 16, 25, 35-39, 41, 42 and 45 — Community trade mark application No 11 388 386

Community trade mark concerned:

Decision of the Examiner: Found the mark applied for not eligible for registration

Decision of the Examiner:

Decision of the Board of Appeal: Dismissed the appeal

Decision of the Board of Appeal:

Pleas in law: Infringement of Article 7(1)(b) CTMR.

Pleas in law:

---
NOT FINAL UNTIL TIME EXPIRES TO FILE REHEARING MOTION AND, IF FILED, DETERMINED

IN THE DISTRICT COURT OF APPEAL OF FLORIDA SECOND DISTRICT THEODORE DAVIS, JR., ) ) Appellant, ) ) v. ) Case No. 2D17-4009 ) STATE OF FLORIDA, ) ) Appellee. ) ___________________________________) Opinion filed March 7, 2018. Appeal pursuant to Fla. R. App. P. 9.141(b)(2) from the Circuit Court for Hillsborough County; Tom Barber, Judge. Theodore Davis, Jr., pro se.

PER CURIAM.

Affirmed. See Johnson v. State, 60 So. 3d 1045 (Fla. 2011); Dale v. State, 703 So. 2d 1045 (Fla. 1997); Hughes v. State, 22 So. 3d 132 (Fla. 2d DCA 2009); Steward v. State, 931 So. 2d 133 (Fla. 2d DCA 2006); Shortridge v. State, 884 So. 2d 321 (Fla. 2d DCA 2004); Brown v. State, 827 So. 2d 1054 (Fla. 2d DCA 2002); Walls v. State, 730 So. 2d 294 (Fla. 1st DCA 1999).

NORTHCUTT, LUCAS, and SALARIO, JJ., Concur.
_________________________________________ 

 

 

 

 

Order Supreme Court 

Lansing, Michigan 

September 23, 2005 Clifford W. Taylor,

 Chief Justice 

Michael F. Cavanagh 128340 Elizabeth A. Weaver 

Marilyn Kelly 

Maura D. Corrigan 

Robert P. Young, Jr. 

PEOPLE OF THE STATE OF MICHIGAN, Stephen J. Markman,

Plaintiff-Appellee, Justices 

v SC: 128340 

 COA: 256534 

Kent CC: 01-002731-FC 

KENNETH JAY HOULIHAN,

Defendant-Appellant. 

_________________________________________/ 

On order of the Court, the application for leave to appeal the February 10, 2005 

order of the Court of Appeals is considered and, pursuant to MCR 7.302(G)(l), we direct 

the Clerk to schedule oral argument on whether to grant the application or take other 

peremptory action permitted by MCR 7.302(G)(l). The parties are directed to file 

supplemental briefs by October 24, 2005, addressing whether the holding in Halbert v 

Michigan, 545 US ___; 125 S Ct 2582; 162 L Ed 2d 552 (2005), retroactively applies to 

defendant’s motion for relief from judgment from his plea-based conviction where the 

trial court denied his request for the appointment of appellate counsel to assist him in 

pursuing a direct appeal. In addressing this issue, the parties may benefit from 

considering Teague v Lane, 489 US 288, 356; 109 S Ct 1060; 103 L Ed 2d 334 (1989), 

Beard v Banks, 542 US 406; 124 S Ct 2504; 159 L Ed 2d 494 (2004), and Howard v 

United States, 374 F3d 1068 (CA 11, 2004). 

We further order the Kent Circuit Court to appoint the State Appellate Defender 

Office to represent the defendant in this Court. 

The Criminal Defense Attorneys of Michigan and the Prosecuting Attorneys 

Association of Michigan are invited to file briefs amicus curiae by November 1, 2005. 

s0919 

I, CORBIN R. DAVIS, Clerk of the Michigan Supreme Court, certify that the 

foregoing is a true and complete copy of the order entered at the direction of the Court. 

September 23, 2005
 

Clerk
<TABLE> <S> <C>

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<CASH>                                           2,475
<INT-BEARING-DEPOSITS>                               0
<FED-FUNDS-SOLD>                                 9,402
<TRADING-ASSETS>                                     0
<INVESTMENTS-HELD-FOR-SALE>                     16,234
<INVESTMENTS-CARRYING>                           3,278
<INVESTMENTS-MARKET>                            16,193
<LOANS>                                         48,095
<ALLOWANCE>                                      2,999
<TOTAL-ASSETS>                                  82,483
<DEPOSITS>                                      72,205
<SHORT-TERM>                                         0
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<OTHER-SE>                                           0
<TOTAL-LIABILITIES-AND-EQUITY>                  82,483
<INTEREST-LOAN>                                  1,169
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<INTEREST-OTHER>                                    64
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</TABLE>
<PAGE>


                                                                   EXHIBIT 10.40

            DESCRIPTION OF RETIREMENT ACCOUNT MATCHING CONTRIBUTIONS

         Microtel International, Inc. matches up to the lesser of $2,000 and 20%
of Randolph Foote's contributions to his 401(k) account. During 2002, those
matching contribution amounted to $1,604. This matching arrangement was
generally made available to all employees of MicroTel International, Inc. and
provides for the same method of allocation of benefits between management and
non-management participants.

         Also, XCEL Power Systems, Ltd. makes matching contributions of up to 6%
of Graham Jefferies' salary to an executives' defined contribution plan. Other
employees of XCEL Power Systems, Ltd. may receive matching contributions to a
defined contribution plan of up to 4% of their salary. Amounts contributed to
the defined contribution plans are intended to used to purchase annuities upon
retirement. During 2002, 2001 and 2000, Mr. Jefferies received matching
contributions of $9,000, $7,697 and $6,869, respectively.
**Exhibit32.1**

 

**CERTIFICATIONPURSUANT TO**

 

**18U.S.C. SECTION 1350,**

 

**ASADOPTED PURSUANT TO**

 

**SECTION906 OF THE SARBANES-OXLEY ACT OF 2002**

 

In connectionwith the Quarterly Report of ebix.com, Inc. (the “Company”) on Form 10-Q forthe period that ended September 30, 2003, as filed with the Securities andExchange Commission on the date hereof (the “Report”), I, Robin Raina, ChiefExecutive Officer of the Company, certify, pursuant to 18 U.S.C.  1350, as adopted pursuant to 906 of theSarbanes-Oxley Act of 2002, that:

 

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

 

2.  The information contained in the Reportfairly presents, in all material respects, the financial condition and resultof operations of the Company.

 

 
| Date:  | November 10, 2003 | /s/ Robin Raina         |   |
|--------|-------------------|-------------------------|--------|
|   |              | Robin Raina             |
|   |              | Chief Executive Officer |

 

1

----
**Exhibit32.2**

**CERTIFICATIONPURSUANT TO**

**18 U.S.C.SECTION 1350,**

**ASADOPTED PURSUANT TO**

**SECTION 906OF THE SARBANES-OXLEY ACT OF 2002**

In connection with theQuarterly Report on Form 10-Q of Ebix, Inc. (the “Company”) for the periodended September 30, 2006, as filed with the Securities and Exchange Commissionon the date hereof (the “Report”), I, Richard J. Baum, Chief Financial Officerof the Company, certify, pursuant to 18 U.S.C. 1350, as adopted pursuant to 906of the Sarbanes-Oxley Act of 2002, that:

1. The Report fullycomplies with the requirements of section 13(a) or 15(d) of the SecuritiesExchange 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.
| By:                     | /s/ Richard J. Baum |   |
|-------------------------|---------------------|--------|
|                    |                |   |
| Name:                   | Richard J. Baum     |   |
|                    |                |   |
| Chief Financial Officer |                |
|                    |                |   |
| November 20, 2006       |                |

 

----
<PAGE>
                                                                   EXHIBIT 10(m)


                         CORE MOLDING TECHNOLOGIES, INC.
                        INFORMAL CASH PROFIT SHARING PLAN

         Core Molding has an informal cash profit sharing plan for its
management and salaried employees which is calculated as follows:

         A profit sharing pool is created after a reasonable return is provided
to stockholders.

         The Company's Board of Directors established thresholds for Earnings
Before Taxes ("EBT") to provide such return to the stockholders for each fiscal
year ended December 31.

         A profit sharing pool will be created based upon percentages of EBT for
each fiscal year ended December 31, above the thresholds which will be shared
with the permanent salaried employees in the form of profit sharing.

         A total profit sharing pool is limited to a maximum percentage of EBT
as established by the Board of Directors.

         The salaried profit sharing pool is split into two groups, an
"executive" group and a "salary" group. The executive group consists of the
Chief Executive Officer, the Chief Financial Officer, the Vice President of
Sales and Marketing, the Vice President of Operations - Columbus, and each
locations' plant manager.

         The executive group shares in 20% of the pool while the remaining
salary group shares in 80% of the pool.

         Employees must have been employed as of December 31 of each year to be
eligible to participate. There is no pro-rating for terminated employees.

         The Board of Directors reserves the right to change the plan as deemed
necessary.
§ 876.4350 Fluid jet system for prostate tissue removal. ( a ) *Identification.* A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Clinical performance testing must evaluate the following: ( i ) All adverse events associated with the device, and
( ii ) Improvement in lower urinary tract symptoms (LUTS).
( 2 ) Physician training must be provided that includes: ( i ) Information on key aspects and use of the device, and
( ii ) Information on how to override or stop resection.
( 3 ) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.
( 4 ) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: ( i ) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and
( ii ) High pressure fluid jet verification testing at target and non-target tissues.
( 5 ) Software verification, validation, and hazard analysis must be performed.
( 6 ) The patient-contacting elements of the device must be demonstrated to be biocompatible.
( 7 ) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.
( 8 ) Performance data must demonstrate the sterility of the patient-contacting components of the device.
( 9 ) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
( 10 ) Performance data must validate the instructions for reprocessing and reliability of reusable components.
( 11 ) Labeling must include the following: ( i ) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;
( ii ) A shelf life for single use components;
( iii ) A use life for reusable components; and
( iv ) Reprocessing instructions for reusable components.
[83 FR 27897, June 15, 2018]
#### [231] D. JOHNSON *against*J. A. JOHNSON.

ON CEETIOBAEI.

Proceedings void, execution without judgment, costs uncertain.

It appeared by the return made to the writ by the justice, that no state of demand or copy of account, had been delivered to the justice; but that the parties instituted, [*] as the justice states it, an *amicable suit*in trover, and then referred the cause generally. The referees reported in favor of the plaintiff, fifty-five dollars, and add, *and all the costs of a former trial,*to abide the event of the suit. Without ■entering any judgment, the justice issued execution, which execution recited a judgment for $55 debt and 53 cents ■costs; and then commands the constable to levy, &c., as much as to pay tire debt and all legal costs. On the back of the execution is indorsed, debt $55, costs $11.62 — on which the constable collects for debt, interest and costs, $11.89.

It was moved by the counsel for the plaintiff in *certiorari,*who was the defendant below, to set aside the proceedings of the justice, for that it did not appear that the costs of a former trial was any way submitted to the referees — nor couj.d it, from the nature of the action, be a controversy in the suit; and even had it been submitted, yet that the report •of referees was defective, and wholly uncertain, in not ascertaining the amount of the costs; that no judgment had been entered by the justice, yet he had issued execution-- and that for an uncertain sum.1

*L. H. Stockton,*att’y for plaintiff.

1

*Ante 156-7*

The court being of opinion, that the proceeding of the justice was in various respects erroneous, and especially in the particulars pointed out by the counsel for the plaintiff’, ordered the proceedings to be set aside.

Cited in *Krumeick*v. *Krumeick, 3 Gr. 39.*
###### Editorial Note on Part 60

#### Editorial Note:

Nomenclature changes to part 60 appear at 68 FR 24879, May 9, 2003, and at 88 FR 45065, July 14, 2023.

#### § 60.46 Administrative decision.

Within 30 days after the completion of the due diligence hearing, the Commissioner will affirm or revise the determination made under § 60.34(a) and will publish the due diligence redetermination in the Federal Register, notify PTO of the redetermination, and send copies of the notice to PTO and to the requesting party, the applicant, and the petitioner.