alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 880
Editorial Note: Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.

§ 880.5950 Umbilical occlusion device. ( a ) *Identification.* An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
( 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 the limitations in § 880.9.
[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]
#### § 812.64 IRB's continuing review.

The IRB shall conduct its continuing review of an investigation in accordance with part 56.

[46 FR 8957, Jan. 27, 1981]
EX-10.3 Certification of CFO



 




Exhibit 10.3




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 IONA
Technologies PLC (the “Company”) on Form 20-F for
the period ending December 31, 2002 as filed with the
Securities and Exchange Commission on the date hereof (the
“Report”), I, Daniel Demmer, Chief Financial
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 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.
    




     
A signed original of this written statement
required by Section 906 has been provided to the Company
and will be retained by the Company and furnished to the
Securities and Exchange Commission or its staff upon request.




		
	 	
    /s/ DANIEL DEMMER
    
	 	
    

	 	
    Daniel Demmer
	 	
    Chief Financial Officer





Date: April 4, 2003
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.4475 Spring-powered jet injector. ( a ) *Identification.* A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.
( b ) *Classification.* Class II.
Exhibit 10 (V)

               LANDLORD'S CONSENT TO ASSIGNMENT OF LEASE AGREEMENT

         Whereas, this Landlord's Consent to Assignment of Lease Agreement (the
"Consent") is entered this 1 day of APRIL , 2003, by Russell Acree, M.D.,
pursuant to the provision in Article VII, Section 8.l, Assignment and
Subletting, in that certain Lease Agreement, dated February 1, 1988, also
including all Extensions and Amendments thereto, by and between Russell Acree,
M.D. and Gambro Healthcare Renal Care, Inc., formerly known as Cominunity
Dialysis Centers, Inc. (hereinafter "Gambro") (the "Assigned Agreement").

         Whereas, referenre is hereby made to that certain Asset Sale Agreement
to be executed between Gambro Healthcare Renal Care, Inc. (the "Seller") and
Dialysis Corporation of America (the "Buyer") (the "Sale Agreement"), pursuant
to which the Seller proposes to sell to the Buyer substantially all of the
assets and going business of the Seller relating to the outpatient dialysis
center located in and around Adel, Georgia (the "Transaction").

         Whereas, the undersigned party (the "Contract Party") to the Assigned
Agreement hereby consents to the following assignment and assumption, pursuant
to the Sale Agreement, and the Contract Party does hereby irrevocably release
Gambro from any and all liability of any form or nature whatsoever under the
Assigned Agreement, from and after the Effective Date of the Assignment of
Contracts for this Transaction between the Seller and the Buyer, which shall
become effective as of the date of the closing of the Transaction (the "Closing
Date"):

         (a) the assignment by the Seller to the ]Buyer of all of the rights,
interests and benefits of the Seller in and under the Assigned Contract arising
from and after the Closing Date; and
         (b) the assumption by the Buyer of all of the obligations of the Seller
under the Assigned Contract arising from and after the Closing Date, and the
agreement of the Buyer to comply with and be bound by the provisions of the
Assigned Contract from and after the Closing Date.

         IN WITNESS WHEREOF, the Contract Party has caused this Consent to be
executed on the date set forth above by its duly authorized officer or other
signatory.

                                                     /s/ Russell Acree, M.D.

                                                     ------------------------
                                                     RUSSELL ACREE, M.D.
Editorial Note on Part 880
Editorial Note: Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.

§ 880.5180 Burn sheet. ( a ) *Identification.* A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants.
( 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 the limitations in § 880.9.
[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001]
# C_2016016EN.01003101.xml

| 18.1.2016 | EN | Official Journal of the European Union | C 16/31 |
| --- | --- | --- | --- |

18.1.2016

EN

Official Journal of the European Union

C 16/31

---

Judgment of the General Court of 25 November 2015 — Ewald Dörken v OHIM — Schürmann (VENT ROLL)

(Case T-223/14) (1)

1

((Community trade mark - Invalidity proceedings - Community word mark VENT ROLL - Absolute grounds for refusal - Descriptive character - Lack of distinctive character - Article 52(1) and Article 7(1)(b) and (c) of Regulation (EC) No 207/2009))

(2016/C 016/37)

Language of the case: German

Parties

Parties

Applicant: Ewald Dörken AG (Herdecke, Germany) (represented by: N. Grüger, lawyer)

Applicant:

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

Defendant:

Other party to the proceedings before the Board of Appeal of OHIM, intervening before the General Court: Wolfram Schürmann (Neuhausen, Switzerland) (represented by: M. Wesle, lawyer)

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 30 January 2014 (Case R2156/2012-4) relating to invalidity proceedings between Mr Wolfram Schürmann and Ewald Dörken AG.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Dismisses the action; |
| --- | --- |

1.

Dismisses the action;

| 2. | Orders Ewald Dörken AG to pay the costs. |
| --- | --- |

2.

Orders Ewald Dörken AG to pay the costs.

---

(1)  OJ C 184, 16.6.2014.

1

---
Editorial Note on Part 880
Editorial Note: Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.

§ 880.5510 Non-AC-powered patient lift. ( a ) *Identification.* A non-AC-powered patient lift is a hydraulic, battery, or mechanically powered device, either fixed or mobile, used to lift and transport a patient in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and a sling to support the patient.
( 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 the limitations in § 880.9.
[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38804, July 25, 2001]
# C_2014292EN.01004601.xml

| 1.9.2014 | EN | Official Journal of the European Union | C 292/46 |
| --- | --- | --- | --- |

1.9.2014

EN

Official Journal of the European Union

C 292/46

---

Action brought on 3 June 2014 — Universal Music v OHIM — Yello Strom (Yellow Lounge)

(Case T-379/14)

2014/C 292/56

Language in which the application was lodged: German

Parties

Parties

Applicant: Universal Music GmbH (Berlin, Germany) (represented by: M. Viefhues, lawyer)

Applicant:

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

Defendant:

Other party to the proceedings before the Board of Appeal: Yello Strom GmbH (Cologne, Germany)

Other party to the proceedings before the Board of Appeal:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | annul the decision of the Fourth Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 20 March 2014 in Case R 274/2013-4; and |
| --- | --- |

—

annul the decision of the Fourth Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 20 March 2014 in Case R 274/2013-4; and

| — | order the defendant, and where appropriate the other party to the proceedings, to pay the costs of the proceedings. |
| --- | --- |

—

order the defendant, and where appropriate the other party to the proceedings, to pay the costs of the proceedings.

Pleas in law and main arguments

Pleas in law and main arguments

Applicant for a Community trade mark: Universal Music GmbH

Applicant for a Community trade mark:

Community trade mark concerned: Word mark ‘Yellow Lounge’ for goods and services in Classes 9, 16, 35, 38, 41, 42 and 45 — Community trade mark application No 1 0 0 33  421

Community trade mark concerned:

Proprietor of the mark or sign cited in the opposition proceedings: Yello Strom GmbH

Proprietor of the mark or sign cited in the opposition proceedings:

Mark or sign cited in opposition: National word mark ‘Yello’ for goods and services in Classes 4, 7, 9, 16, 35, 38, 41, 42 and 45

Mark or sign cited in opposition:

Decision of the Opposition Division: The opposition was upheld

Decision of the Opposition Division:

Decision of the Board of Appeal: The appeal was dismissed

Decision of the Board of Appeal:

Pleas in law: Infringement of Article 8(1)(b) of Regulation No 207/2009

Pleas in law:

---
<PAGE>

                                                                    Exhibit 10-f

Excerpts from an agreement between Professor Dr. h.c. Bernd-Artin Wessels,
Holthorster Weg 59, 27721 Ritterhude (referred to as "BAW") and Chiquita Brands
International, Inc., Cincinnati, Ohio, USA (referred to as "Chiquita")

                                    Preamble

BAW is Chairman of the Supervisory Board of Atlanta AG, Breitenweg 29-33,
D-28195 Bremen (hereinafter referred to as "Atlanta"). BAW holds a limited
partnership interest of 1.021 Mio. (euro) in Scipio & Co. KG, Breitenweg 29-33,
28195 Bremen (hereinafter referred to as "Scipio"). BAW is sole shareholder and
general manager of Benedict & Co. GmbH, Breitenweg 29-33, 28195 Bremen
(hereinafter referred to as "Benedict"), which is the general partner of Scipio.
Scipio is the sole shareholder of Atlanta. ...

Chiquita intends to acquire the general partnership interest and all limited
partnership interests of Scipio and thereby control of the Scipio/Atlanta Group,
on a date most likely before the end of March 2003 ("Closing date"). ...

                                      (S) 1
                                     Scipio

1.   On the closing date BAW shall sell and assign his limited partnership
     interest in Scipio in the amount of 1.021 Mio. (euro) to Chiquita or an
     entity designated by Chiquita which accepts such sale and assignment. The
     purchase price shall be the nominal amount of the partnership interest. The
     purchase price shall be set off against a loan owed by Benedict to Atlanta
     in the capital amount of 765.750,00 (euro), so that the net amount to be
     paid to BAW shall be 1.021 Mio (euro) minus 765.750,00 (euro) and
     applicable interest.

2.   At the request of Chiquita BAW shall cause Benedict to sell and assign
     without undue delay its general partnership interest in Scipio to Hameico
     Fruit Tade GmbH for no consideration.
Alternative modeling (Donovan NO2/NOx stack ratio)

Steve Hill to: Gerardo Rios, Cleveland Holladay, Roger Kohn, 

Shirley Rivera

05/23/2012 01:51 PM

Cc:

"W. David Jenkins (djenkins@apexpowergroup.com)" , Gary 

Rubenstein , "McKinsey, John A.", Maggie Fitzgerald, "Foster, 

Melissa A. (mafoster@stoel.com)", "Moore, Steve", "Hellwig, 

Attached are the results of the alternative analysis requested by EPA. 

Data files are being transmitted physically.

Please let me know if you have any questions.

--Steve Hill Alternative Donovan NO2-NOx Modeling 0512.pdf
§ 884.1700 Hysteroscopic insufflator. ( a ) *Identification.* A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.
( b ) *Classification.* ( 1 ) Class II (performance standards).
( 2 ) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, 2001]
# C_2015198EN.01001601.xml

| 15.6.2015 | EN | Official Journal of the European Union | C 198/16 |
| --- | --- | --- | --- |

15.6.2015

EN

Official Journal of the European Union

C 198/16

---

Appeal brought on 2 September 2014 by Fundação Calouste Gulbenkian against the judgment of the General Court (Sixth Chamber) delivered on 26 June 2014 in Case T-541/11: Fundação Calouste Gulbenkian v Office for Harmonisation in the Internal Market (Trade Marks and Designs)

(Case C-414/14 P)

(2015/C 198/21)

Language of the case: English

Parties

Parties

Appellant: Fundação Calouste Gulbenkian (represented by: G. Macias Bonilla, G. Marín Raigal, P. López Ronda, lawyers)

Appellant:

Other parties to the proceedings: Office for Harmonisation in the Internal Market (Trade Marks and Designs), Micael Gulbenkian

Other parties to the proceedings:

By order of 26 February 2015 the Court of Justice (Eighth Chamber) has dismissed the appeal and ordered Fundação Calouste Gulbenkian to bear its own costs.

---
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.6866 Radiofrequency toothbrush. ( a ) *Identification.* A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested, and detailed protocols must be provided for each test conducted: ( i ) Validation of the radiofrequency performance specifications including output power, voltage output, radiofrequency, pulse cycle, waveform, and pulse duration;
( ii ) Temperature performance testing to evaluate the temperature change of the device, structures of the oral cavity (including skin, tissue, and dental restorations), and toothpaste under worst-case conditions;
( iii ) An assessment of mechanical output specifications and physical properties including vibration frequency, tuft retention, brush head strength, and battery voltage; and
( iv ) Use life and durability testing.
( 2 ) A label comprehension and self-selection study must demonstrate that the intended user population can understand the package labeling and correctly choose the device for the indicated use.
( 3 ) Usability performance evaluation must demonstrate that the user can safely and correctly use the device, based solely on reading the directions for use.
( 4 ) The patient-contacting components of the device must be demonstrated to be biocompatible.
( 5 ) Electrical safety, thermal safety, mechanical safety, battery safety, and electromagnetic compatibility (EMC) testing must be performed.
( 6 ) Software verification, validation, and hazard analysis must be performed.
( 7 ) Labeling must include: ( i ) Information on how the device operates, including images or illustrations;
( ii ) A detailed summary of the device technical specifications;
( iii ) A warning which states that the use of this device is not a substitute for regular visits to a dentist for routine clinical care;
( iv ) Instructions on how to clean and maintain the device; and
( v ) The use life and disposal of the components of the device.
[89 FR 72321, Sept. 5, 2024]
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.3650 Opiate test system. ( a ) *Identification.* An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
( b ) *Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]
EXHIBIT 32.a



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 Quarterly Report of American Affordable Housing II Limited Partnership (the "Partnership") on Form 10-Q for the period ended September 30, 2005 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, John P. Manning, Principal Executive Officer of the general partner of the general partner of the Partnership's general partner, C&M Management Inc., certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge, after due inquiry:



|(1) | The Report fully complies with the requirements of section 13(a)-15 or 15(d)-15 of the Securities and 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 Partnership.



|                  |     |                            
|----------------- | --- | ---------------------------
|Date:             |     |                            
|November 21, 2005 | By: | /s/ John P. Manning        
|                  |     |                            
|                  |     | John P. Manning            
|                  |     | Principal Executive Officer

A signed original of this written statement required by Section 906, or other

document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Fund and will be retained by the Fund and furnished to the Securities and Exchange Commission or its staff upon request.
| (logo) WELLS 

           FARGO | **Commercial  Mortgage Servicing**D1050-084,  8th Floor  401 South Tryon St.  Charlotte, NC 28202  1-800-326-1334

 

  |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|

**ANNUAL STATEMENT OFCOMPLIANCE**

 

 

Reference is hereby made to that certainPooling and Servicing Agreement dated as of August 1, 2015, by and among WELLSFARGO COMMERCIAL MORTGAGE SECURITIES, INC., as Depositor, WELLS FARGO BANK,NATIONAL ASSOCIATION, as Master Servicer, RIALTO CAPITAL ADVISORS, LLC, asSpecial Servicer, TRIMONT REAL ESTATE ADVISORS, INC, as Trust Advisor, WELLSFARGO BANK, NATIONAL ASSOCIATION, as Certificate Administrator, as TaxAdministrator and as Custodian and WILMINGTON TRUST, NATIONAL ASSOCIATION, asTrustee, with respect to Commercial Mortgage Pass-Through Certificates Series2015-SG1(the "Agreement"). Capitalized terms used herein nototherwise defined shall have the meanings assigned in the Agreement.

 

Pursuant to Section 11.12 of thisAgreement, I, Leslie Hayton, Managing Director of Commercial Mortgage Servicesdo hereby certify that:

 

1.       Areview of the activities of the Master Servicer during the period from January1, 2018 through December 31, 2018 (the “Reporting Period”), and of itsperformance per the Agreement during such period has been made under mysupervision, and

 

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

 

 

IN WITNESS WHEREOF, the undersigned hasexecuted this Certificate as of the 28th day of February 2019.

 

 

/s/Leslie Hayton

LeslieHayton

ManagingDirector

WellsFargo Bank

 

 

| Wells  Fargo Bank, N.A. | (logo) Together  we’ll go far |
|-------------------------|-------------------------------------|