alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.3560 OTC denture reliner. ( a ) *Identification.* An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.
( b ) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's: ( 1 ) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
( 2 ) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996; 65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019]
<PAGE>

                                                                    EXHIBIT 4.11





                                                       August 8, 2002


Mr. Steven Fisch
78 Highland Avenue
Newton, Massachusetts 02460

Re:   SEVERANCE

Dear Steven,

In the event that your employment is involuntarily terminated by IONA other than
for cause and you satisfy the conditions described below, IONA will pay you
severance as follows:

(i)   if you are terminated during your first year of employment by IONA, you
      will be paid cash severance equal to the total annualized cash
      compensation set forth in the first paragraph of the "Compensation"
      section of the offer letter dated August 8, 2002 from IONA to you ("Total
      Annualized Cash Compensation") less the amount of all cash paid to you by
      IONA through the date of your termination; or

(ii)  if you are terminated during your second or any subsequent year of
      employment by IONA you will be paid cash severance equal to your Total
      Annualized Cash Compensation.

In order to receive any severance, you must, within the period specified by
IONA, sign and deliver to IONA a Separation Agreement and Release in a form
satisfactory to IONA and you must return all of IONA's property.

For purposes of this letter, "cause" shall mean conduct involving one or more of
the following: (i) your substantial and continuing failure, after notice
thereof, to render services to the Company in accordance with the terms or
requirements of your employment; (ii) disloyalty, gross negligence, willful
misconduct, dishonesty or breach of fiduciary duty to the Company; (iii) the
commission of an act of embezzlement or fraud; (iv) deliberate disregard of the
rules or policies of the Company which results in direct or indirect loss,
damage or injury to the Company; (v) the unauthorized disclosure of any trade
secret or confidential information of the Company; or (vi) the commission of an
act which constitutes unfair competition with the Company or which induces any
customer or supplier to breach a contract with the Company.

Sincerely,


/s/ Nancy E. Fleming
-------------------------------------------
Nancy E. Fleming
Senior Director, Human Resources - Americas


AGREED & ACCEPTED:

SIGNED:     /s/ Steven Fisch
        -----------------------------------

PRINTED NAME: Steven Fisch
              -----------------------------

DATE:   August 8, 2002
        -----------------------------------
| (logo) WELLS

           FARGO | Commercial Mortgage Servicing

D1086-120, 12th Floor

550 South Tryon Street 

Charlotte, NC 28202

1-800-326-1334 |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|

 

ANNUAL STATEMENT OF COMPLIANCE

 

 

Reference is hereby made to that certain Pooling and Servicing Agreement dated as of April 1, 2015, by and among WELLS FARGO COMMERCIAL MORTGAGE SECURITIES, INC., as Depositor, WELLS FARGO BANK, NATIONAL ASSOCIATION, as Master Servicer, RIALTO CAPITAL ADVISORS, LLC, as Special Servicer, TRIMONT REAL ESTATE ADVISORS, INC, as Trust Advisor, WELLS FARGO BANK, NATIONAL ASSOCIATION, as Certificate Administrator, as Tax Administrator and as Custodian and WILMINGTON TRUST, NATIONAL ASSOCIATION, as Trustee, with respect to Commercial Mortgage Pass-Through Certificates Series 2015-NXS1 (the "Agreement"). Capitalized terms used herein not otherwise defined shall have the meanings assigned in the Agreement.

 

Pursuant to Section 11.12 of this Agreement, I, Daniel Bober, Executive Vice President of Commercial Mortgage Services do hereby certify that:

 

1. A review of the activities of the Master Servicer during the period from April 1, 2015 through December 31, 2015 (the “Reporting Period”), and of its performance per the Agreement during such period has been made under my supervision, and 

 

2. To the best of my knowledge, based on such review, the Master Servicer, has fulfilled all of its obligations under this Agreement in all material respects throughout the Reporting Period.

 

 

IN WITNESS WHEREOF, the undersigned has executed this Certificate as of the 4th day of March 2016.

 

 

/s/ Daniel Bober

Daniel Bober

Executive Vice President

Wells Fargo Bank

 

 

|  Wells Fargo Bank, N.A. | (logo) Together we’ll go far |
|------------------------------|------------------------------------|
Editorial Note on Part 878
Editorial Note: Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.

§ 878.3925 Plastic surgery kit and accessories. ( a ) *Identification.* A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.
( 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 § 878.9.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000]
§ 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss. ( a ) *Identification.* This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.
( 2 ) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows: ( i ) Performance bench testing in a simulated use model must evaluate device disintegration and device hydration state throughout the gastrointestinal tract;
( ii ) Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and
( iii ) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.
( 3 ) Clinical performance testing must demonstrate the device performs as intended and evaluate the following: ( i ) Weight change;
( ii ) All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and
( iii ) Interaction with representative medications.
( 4 ) Physician and patient device labeling must state: ( i ) The clinical benefit of the device as assessed by using percent total body weight loss;
( ii ) Treatment must be offered in combination with diet and exercise;
( iii ) Instructions on how to use the device as intended including how to avoid interaction with medication; and
( iv ) The shelf life of the device.
[86 FR 70372, Dec. 10, 2021]
exh43tos8april2003.htm



EXHIBIT 4.3

PHOTOWORKS,
INC.

 AMENDMENT
NO. 2 TO 

1999 STOCK INCENTIVE COMPENSATION
PLAN

    WHEREAS, the Board
of Directors of PhotoWorks, Inc. (the "Corporation") has approved
certain changes to the Corporation's 1999 Stock Incentive Compensation Plan (the
"Plan"), as amended, to increase the number of shares of Common Stock
available for issuance under the Plan;

    THEREFORE, Section
4.1 of the Plan is hereby amended to read in its entirety as follows:

	 	    
               Subject to adjustment from time to time as provided in Section
               14.1, a maximum of 1,800,000 shares of Common Stock shall be
               available for issuance under the Plan.  Shares issued under
               the Plan shall be drawn from authorized and unissued shares.


    IN WITNESS WHEREOF,
this Amendment No. 2 has been executed as of the 5th day of February, 2003.

	 	PHOTOWORKS,
               INC.
		
	 	
	
               By:
	/s/
               L. Cashmore Bond
		
               

          
	 	Name: 
               Loran Cashmore Bond
	 	Title: 
               Vice President
**Exhibit 31.1**

 

**CERTIFICATION**

 

I, Robin Raina, certify that:

 

1. I have reviewed thisquarterly report on Form 10-Q of Ebix, Inc.;

 

2. Based on my knowledge, thisreport does not contain any untrue statement of a material fact or omit tostate a material fact necessary to make the statements made, in light of thecircumstances under which such statements were made, not misleading withrespect to the period covered by this report;

 

3. Based on my knowledge, thefinancial statements, and other financial information included in this report,fairly present in all material respects the financial condition, results ofoperations and cash flows of the registrant as of, and for, the periodspresented in this report;

 

4. The registrant’s othercertifying officer and I are responsible for establishing and maintainingdisclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)and 15d-15(e)) for the registrant and have:

 

(a) Designed such disclosurecontrols and procedures, or caused such disclosure controls and procedures tobe designed under our supervision, to ensure that material information relatingto the registrant, including its consolidated subsidiaries, is made known to usby others within those entities, particularly during the period in which thisreport is being prepared;

 

(b) Evaluated the effectivenessof the registrant’s disclosure controls and procedures and presented in thisreport our conclusions about the effectiveness of the disclosure controls andprocedures, as of the end of the period covered by this report based on suchevaluation; and

 

(c) Disclosed in this reportany change in the registrant’s internal control over financial reporting thatoccurred during the registrant’s most recent fiscal quarter (the registrant’sfourth fiscal quarter in the case of an annual report) that has materiallyaffected, or is reasonably likely to materially affect, the registrant’sinternal control over financial reporting; and

 

5. The registrant’s othercertifying officer and I have disclosed, based on our most recent evaluation ofinternal control over financial reporting, to the registrant’s auditors and theaudit committee of the registrant’s board of directors (or persons performingthe equivalent functions):

 

(a) All significantdeficiencies and material weaknesses in the design or operation of internalcontrol over financial reporting which are reasonably likely to adverselyaffect the registrant’s ability to record, process, summarize and reportfinancial information; and

 

(b) Any fraud, whether or notmaterial, that involves management or other employees who have a significantrole in the registrant’s internal control over financial reporting.

 

 
| Date:  | August 16, 2004         | /s/ Robin Raina |   |
|--------|-------------------------|-----------------|--------|
|   | Robin Raina             |
|   | Chief Executive Officer |

 

1

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

<ARTICLE> 5
<MULTIPLIER> 1,000
<CURRENCY> U.S. DOLLARS

<S>                             <C>
<PERIOD-TYPE>                   YEAR
<FISCAL-YEAR-END>                          DEC-31-1996
<PERIOD-START>                             JAN-01-1996
<PERIOD-END>                               DEC-31-1996
<EXCHANGE-RATE>                                      1
<CASH>                                      26,017,000
<SECURITIES>                                 6,853,000
<RECEIVABLES>                               14,555,000
<ALLOWANCES>                                   780,000
<INVENTORY>                                          0
<CURRENT-ASSETS>                            51,137,000
<PP&E>                                       9,149,000
<DEPRECIATION>                               2,385,000
<TOTAL-ASSETS>                              58,364,000
<CURRENT-LIABILITIES>                       18,178,000
<BONDS>                                              0
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                        24,000
<OTHER-SE>                                           0
<TOTAL-LIABILITY-AND-EQUITY>                58,364,000
<SALES>                                     41,513,000
<TOTAL-REVENUES>                            64,274,000
<CGS>                                          392,000
<TOTAL-COSTS>                               12,655,000
<OTHER-EXPENSES>                                     0
<LOSS-PROVISION>                               455,000
<INTEREST-EXPENSE>                             159,000
<INCOME-PRETAX>                             15,579,000
<INCOME-TAX>                                 4,674,000
<INCOME-CONTINUING>                         10,905,000
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                10,905,000
<EPS-PRIMARY>                                     0.42
<EPS-DILUTED>                                     0.42


</TABLE>
Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### National Institutes of Health

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

*Name of Committee:*                         National Institute of Child Health and Human Development Special Emphasis Panel, The Role of Human-Animal Interaction in Child Health and Development.                    

*Date:*                         March 23-24, 2010.                    

*Time:*                         9 a.m. to 5 p.m.                     

*Agenda:*                         To review and evaluate grant applications and/or proposals.                    

*Place:*                         St. Gregory Hotel, 2033 M Street, NW., Washington, DC 20036.                    

*Contact Person:*                         Marita R. Hopmann, PhD, Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Building, Room 5B01, Bethesda, MD 20892. (301) 435-6911.                         *hopmannm@mail.nih.gov.*

(Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)

Dated: February 25, 2010.

Jennifer Spaeth,

Director, Office of Federal Advisory Committee Policy.

[FR Doc. 2010-4479 Filed 3-3-10; 8:45 am]

BILLING CODE 4140-01-P
# C_2014261EN.01002401.xml

| 11.8.2014 | EN | Official Journal of the European Union | C 261/24 |
| --- | --- | --- | --- |

11.8.2014

EN

Official Journal of the European Union

C 261/24

---

Action brought on 29 April 2014 — Borde and Carbonium v Commission

(Case T-314/14)

2014/C 261/46

Language of the case: English

Parties

Parties

Applicants: Alexandre Borde (Paris, France) and Carbonium (Paris) (represented by: A. Herzberg, lawyer)

Applicants:

Defendant: European Commission

Defendant:

Form of order sought

Form of order sought

The applicants claim that the Court should:

| — | annul respondent’s decisions dated 19 and 20 February 2014 to terminate applicant No 1’s assignment in relation to the global GCCA and the Intra-ACP GCCA evaluation programmes; |
| --- | --- |

—

annul respondent’s decisions dated 19 and 20 February 2014 to terminate applicant No 1’s assignment in relation to the global GCCA and the Intra-ACP GCCA evaluation programmes;

| — | order respondent to pay the costs. |
| --- | --- |

—

order respondent to pay the costs.

Pleas in law and main arguments

Pleas in law and main arguments

In support of the action, the applicants rely on three pleas in law.

| 1. | First plea in law, alleging infringement of essential procedural requirements, including the applicants’ right to be heard and the obligation to give reasons for decisions. |
| --- | --- |

1.

First plea in law, alleging infringement of essential procedural requirements, including the applicants’ right to be heard and the obligation to give reasons for decisions.

| 2. | Second plea in law, alleging infringement of the Treaty on European Union, the Charter of Fundamental Rights of the European Union and the European Convention for the Protection of Human Rights and Fundamental Freedoms, the defendant having violated the applicants’ rights to be treated in a fair, equitable and non-arbitrary manner and the applicants’ right to protection of their reputation. |
| --- | --- |

2.

Second plea in law, alleging infringement of the Treaty on European Union, the Charter of Fundamental Rights of the European Union and the European Convention for the Protection of Human Rights and Fundamental Freedoms, the defendant having violated the applicants’ rights to be treated in a fair, equitable and non-arbitrary manner and the applicants’ right to protection of their reputation.

| 3. | Third plea in law, alleging that the attacked decisions constitute a misuse of the defendant’s powers. |
| --- | --- |

3.

Third plea in law, alleging that the attacked decisions constitute a misuse of the defendant’s powers.

---
Exhibit 32.1

Certification Pursuant to 18 U.S.C. § 1350 as Adopted

Pursuant to § 906 of the
Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, in
connection with the filing of the Form 10-Q of STERIS Corporation (the Company) for the quarter ended December 31, 2006, as filed with the Securities and Exchange Commission on the date hereof (the Report), each of the
undersigned officers of the Company certifies, that, to such officers 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 respects, the financial condition and results of operations of the Company as of the dates and for the
periods expressed in the Report.
| | --- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



/s/    LES C. VINNEYName:

Les C. VinneyTitle:

President and Chief Executive Officer/s/    MICHAEL J. TOKICHName:

Michael J. TokichTitle:

Vice President and Corporate Controller


Dated: February 7, 2007