alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
# C_2023338EN.01002602.xml

| 25.9.2023 | EN | Official Journal of the European Union | C 338/26 |
| --- | --- | --- | --- |

25.9.2023

EN

Official Journal of the European Union

C 338/26

---

Order of the President of the General Court of 24 July 2023 — Mylan Ireland v Commission

(Case T-256/23 R)

(Interim relief - Medicinal products for human use - Marketing authorisation - Application for interim measures - Application for injunction - Lack of urgency)

(2023/C 338/35)

Language of the case: English

Parties

Applicant: Mylan Ireland Ltd (Dublin, Ireland) (represented by: K. Roox, T. De Meese, J. Stuyck and C. Dumont, lawyers)

Defendant: European Commission (represented by: E. Mathieu, L. Haasbeek and A. Spina, acting as Agents)

Re:

By its application based on Articles 278 and 279 TFEU, the applicant seeks, in essence, first, suspension of operation of Commission Implementing Decision C(2023) 3067 final of 2 May 2023 amending Commission Implementing Decision C(2014) 601 final of 30 January 2014 granting marketing authorisation (‘MA’) for the medicinal product for human use Tecfidera — Dimethyl fumarate under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), as amended, and any subsequent decision or act extending or replacing the contested decision in so far as they concern it, and, second, an injunction requiring the European Commission to refrain from taking any other measures which would amount to a withdrawal of the MA enjoyed by it or a prohibition on placing generic Dimethyl fumarate products on the market.

Operative part of the order

| 1. | The application for interim measures is dismissed. |
| --- | --- |

1.

The application for interim measures is dismissed.

| 2. | There is no longer any need to rule on the application to intervene submitted by Biogen Netherlands BV or on the application for confidential treatment submitted by Mylan Ireland Ltd. |
| --- | --- |

2.

There is no longer any need to rule on the application to intervene submitted by Biogen Netherlands BV or on the application for confidential treatment submitted by Mylan Ireland Ltd.

| 3. | The costs relating to the proceedings for interim relief are reserved. |
| --- | --- |

3.

The costs relating to the proceedings for interim relief are reserved.

| 4. | Each party shall bear its own costs relating to the application to intervene submitted by Biogen Netherlands. |
| --- | --- |

4.

Each party shall bear its own costs relating to the application to intervene submitted by Biogen Netherlands.

---
STATE v. GRAHAM.

No. COA08-334.

Court of Appeals of North Carolina.

Filed December 2, 2008.

Certification Date December 22, 2008.

Appeal from Forsyth (06CRS56614, 06CRS20438).

Case reported without published opinion. No error.
# Community Charge Debt (Scotland) Act 2015

        - Previous
        - Next

S

# Community Charge Debt (Scotland) Act 2015

# 2015 asp 3                     

The Bill for this Act of the Scottish Parliament was passed by the Parliament on 19th February 2015 and received Royal Assent                        on 25th March 2015                     

An Act of the Scottish Parliament to extinguish various liabilities arising by virtue of the Abolition of Domestic Rates Etc.                        (Scotland) Act 1987.                     

## 1Debt extinguishedS

(1)On 1 February 2015, all—                  

(a)community charge liabilities, and                  

(b)associated liabilities,                  

are extinguished.

(2)Accordingly, on that day—                  

(a)summary warrants, and                  

(b)decrees,                  

become unenforceable in so far as they relate to liabilities extinguished by subsection (1).

## 2InterpretationS

(1)The following definitions apply for the purposes of section 1.                  

(2)A community charge liability is a liability to pay any—                  

(a)charge imposed under section 7 of the Abolition of Domestic Rates Etc. (Scotland) Act 1987 (“the 1987 Act”),                  

(b)charge imposed under paragraph 6 of Schedule 5 to that Act.                  

(3)An associated liability is a liability to pay any—                  

(a)civil penalty imposed under section 17 of the 1987 Act (including one imposed by virtue of section 18A of that Act),                  

(b)sum by way of interest arising under section 18(3)(a) of that Act,                  

(c)surcharge arising under section 18(3)(b) of that Act,                  

(d)surcharge arising under paragraph 7(2) of Schedule 2 to that Act,                  

(e)expense which—                  

(i)was incurred in the course of, or in relation to, the execution of a summary warrant or decree that section 1(2) makes wholly                        unenforceable, and                  

(ii)an enactment makes chargeable against the person who was the debtor under the summary warrant or decree.                  

(4)For the avoidance of doubt, a reference in subsection (3) to a provision of the 1987 Act includes the provision as it applies                        by virtue of paragraph 11 of Schedule 5 to that Act.                  

## 3CommencementS

This Act comes into force on the day after Royal Assent.

## 4Short titleS

The short title of this Act is the Community Charge Debt (Scotland) Act 2015.
Exhibit



Exhibit 10.6


Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2


Change Order Form # 32





Change order under Agreement dated: Fifth Amendment to Development and Clinical Supplies Agreement dated December 14, 2012


Between:  Radius Health, Inc and 3M


Project Name: For the development of Radius’ Abaloparatide compound delivered via 3M’s Microstructured Transdermal Delivery System




Change requested by: Radius
Name: Michele Gehrt
Company:  3M
Date:  22July2016


Description of change: 
Radius has requested that 3M complete pH testing in support of the Phase I clinical supplies of the sMTS abaloparatide (ABL) product. A method will be developed to test the Ready to Coat (RTC). The activities and deliverables in this Workplan are intended to support the further development of an optimized, sMTS abaloparatide product that demonstrates comparability (including pharmacokinetic bioequivalence or bioavailability) to the abaloparatide-SC injection product. The total estimated costs are $[*].
Scope:
3M will conduct the tasks necessary to complete the development of a pH method for the RTC.


Assumptions:
		
	•
	RTC pH method development


		
	◦
	A probe will need to be purchased to test smaller volumes of formulation


Deliverables:
		
	•
	pH method for RTC


		
	•
	Presentations at JTT meetings outlining work as progressed.


Timing:
The required effort in hours, duration of the study in months, and estimated costs for the work plan are summarized in the table below.


	
				
	Task
	Estimated Effort (hours)
	Estimated
Duration (month)
	Estimated Direct Costs 
($)

	RTC pH Method Development
	55
	2
	$[*]










[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2


Change Order Form # 32





Total Estimated Costs:  $[*]




In all other respects, the terms and conditions of the Agreement remain in full force and effect.


Requested task, dates and costs are approved by:


		
	Company: Radius Health, Inc
	Company:  3M


		
	Name: Ehab Hamed
	Name:  Michele Gehrt


		
	Signature: /s/ Ehab Hamed
	Signature: /s/ Michele Gehrt


		
	Position: Director
	Position:  Commercialization Mgr


		
	Date (dd/mm/yy): 22 Jul 2016
	Date (dd/mm/yy): 22/07/2016




2
[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
<PAGE>
                                                                      EXHIBIT 32

                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 John Q. Hammons Hotels, Inc. on Form
10-Q for the period ended October 3, 2003, as filed with the Securities and
Exchange Commission, we, John Q. Hammons, Chief Executive Officer, and Paul E.
Muellner, Chief Financial Officer, 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 Quarterly Report fully complies with the requirements of Section
            13(a) of the Securities Exchange Act of 1934; and

      2.    The information contained in the Quarterly Report fairly presents,
            in all material respects, the financial condition and results of
            operation of John Q. Hammons Hotels, Inc.

A signed original of this written statement required by Section 906 has been
provided to John Q. Hammons Hotels, Inc. and will be retained by John Q. Hammons
Hotels, Inc. and furnished to the Securities and Exchange Commission or its
Staff upon request.



Dated:  November 14, 2003

                                           /s/ John Q. Hammons
                                           -----------------------------------
                                           John Q. Hammons


                                           /s/ Paul E. Muellner
                                           -----------------------------------
                                           Paul E. Muellner


                                       28
SANTONI v. SUNDOWN COVE, LLC.

No. COA08-715.

Court of Appeals of North Carolina.

Filed January 20, 2009.

Certification Date February 9, 2009.

Appeal from LLC Iredell (06CVS3118).

Case reported without published opinion. Affirmed.
# Commission Implementing Regulation (EU) No 954/2014Show full title

Commission Implementing Regulation (EU) No 954/2014 of 4 September 2014 approving non-minor amendments to the specification            for a name entered in the register of protected designations of origin and protected geographical indications (Livarot (PDO))         

        - Previous
        - Next

U.K.

# Commission Implementing Regulation (EU) No 954/2014                     

# of 4 September 2014

# approving non-minor amendments to the specification for a name entered in the register of protected designations of origin                        and protected geographical indications (Livarot (PDO))                     

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality                           schemes for agricultural products and foodstuffs(1), and in particular Article 52(2) thereof,                        

Whereas:

(1)By virtue of the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined France's                              application for the approval of amendments to the specification for the protected designation of origin ‘Livarot’, registered                              under Commission Regulation (EC) No 1107/96(2).

(2)Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission                              published the amendment application in the *Official Journal of the European Union* (3) as required by Article 50(2)(a) of that Regulation.

(3)As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments                              should be approved,

HAS ADOPTED THIS REGULATION:

# Article 1U.K.

The amendments to the specification published in the *Official Journal of the European Union* regarding the name ‘Livarot’ (PDO) are hereby approved.                  

# Article 2U.K.

This Regulation shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union*.                  

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 4 September 2014.

*For the Commission,*                            

*On behalf of the President,*                            

Dacian Cioloș                            

*Member of the Commission*                            

1

OJ L 343, 14.12.2012, p. 1.                           

2

Commission Regulation (EC) No 1107/96 of 12 June 1996 on the registration of geographical indications and designations of                              origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/92 (OJ L 148, 21.6.1996, p. 1).                           

3

OJ C 125, 26.4.2014, p. 8.
STATE of North Carolina v. Sabas IBARRA.

No. 227P08-2.

Supreme Court of North Carolina.

December 3, 2008.

Sabas Ibarra, Pro Se.

Joseph Finarelli, Assistant Attorney General, Garry W. Frank, District Attorney, for State of NC.

*ORDER*

Upon consideration of the application filed by Defendant on the 6th day of November 2008 in this matter for Writ of Habeas Corpus, the following order was entered and is hereby certified to the Superior Court, Davidson County:

"Denied by order of the Court in conference, this the 3rd day of December 2008."
# CE2004065EN.01006802.xml

| 13.3.2004 | EN | Official Journal of the European Union | CE 65/68 |
| --- | --- | --- | --- |

13.3.2004

EN

Official Journal of the European Union

CE 65/68

---

(2004/C 65 E/077)

WRITTEN QUESTION E-1221/03

by Roberta Angelilli (UEN) to the Commission

(2 April 2003)

Subject:   Use of funds under the Framework for action on sustainable urban development in the European Union by the municipality of Siena

Subject:

In September 2002, the monitoring committee of the Italian Ministry for Economic Affairs issued a report on the spending of EU funds.

The report reveals the alarming slowness and inefficiency with which EU funds are allocated to projects by some regional authorities.

The grave concerns about the inadequate use of European funds by local authorities have frequently been echoed by the Commission.

Bearing in mind that some local authorities, such as the municipality of Siena, urgently need to use European funds to promote sustainable urban development,

can the Commission state:

| 1. | whether the municipality of Siena has submitted projects for the Framework for action on sustainable urban development in the European Union? |
| --- | --- |

1.

whether the municipality of Siena has submitted projects for the Framework for action on sustainable urban development in the European Union?

| 2. | whether the municipality of Siena has secured funding for these projects? |
| --- | --- |

2.

whether the municipality of Siena has secured funding for these projects?

| 3. | whether this funding has been used? |
| --- | --- |

3.

whether this funding has been used?

---
MCMILLAN v. SWIFT.

No. COA07-238.

Court of Appeals of North Carolina.

Filed September 4, 2007.

Certification Date September 24, 2007.

Appeal from Wake (05CVS9881).

Case reported without published opinion Dismissed.
MAJORS v. MAJORS.

No. COA07-392.

Court of Appeals of North Carolina.

Filed March 4, 2008.

Certification Date March 24, 2008.

Appeal from Rowan (05CVS2954).

Case reported without published opinion. Affirmed.
STATE v. VILLARREAL.

No. COA08-244.

Court of Appeals of North Carolina.

Filed December 16, 2008.

Certification Date January 5, 2009.

Appeal from Forsyth (07CRS52285).

Case reported without published opinion. No Error.
UNPUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 11-6543

JAMES LEWIS COLE, 

Petitioner – Appellant, 

v. 

KEITH W. DAVIS, Warden, 

Respondent – Appellee. 

Appeal from the United States District Court for the Eastern 

District of Virginia, at Alexandria. Anthony John Trenga, 

District Judge. (1:11-cv-00119-AJT-JFA) 

Submitted: June 16, 2011 Decided: June 21, 2011

Before NIEMEYER and GREGORY, Circuit Judges, and HAMILTON, 

Senior Circuit Judge. 

Dismissed by unpublished per curiam opinion. 

James Lewis Cole, Appellant Pro Se. 

Unpublished opinions are not binding precedent in this circuit. 
2

PER CURIAM: 

James Lewis Cole seeks to appeal the district court’s 

order denying relief on his 28 U.S.C. § 2254 (2006) petition. 

The order is not appealable unless a circuit justice or judge 

issues a certificate of appealability. See 28 U.S.C. 

§ 2253(c)(1) (2006). A certificate of appealability will not 

issue absent “a substantial showing of the denial of a 

constitutional right.” 28 U.S.C. § 2253(c)(2). When the 

district court denies relief on the merits, a prisoner satisfies 

this standard by demonstrating that reasonable jurists would 

find that the district court’s assessment of the constitutional 

claims is debatable or wrong. Slack v. McDaniel, 529 U.S. 473, 

484 (2000); see Miller-El v. Cockrell, 537 U.S. 322, 336-38 

(2003). When the district court denies relief on procedural 

grounds, the prisoner must demonstrate both that the dispositive 

procedural ruling is debatable, and that the petition states a 

debatable claim of the denial of a constitutional right. Slack, 

529 U.S. at 484-85. We have independently reviewed the record 

and conclude that Cole has not made the requisite showing. 

Accordingly, we deny a certificate of appealability and dismiss 

the appeal. We dispense with oral argument because the facts 

and legal contentions are adequately presented in the
3

materials before the court and argument would not aid the 

decisional process. 

DISMISSED
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
SEPTEMBER 30, 1997 FORM 10-Q OF JOHNS MANVILLE INTERNATIONAL GROUP, INC. AND IS
QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1997
<PERIOD-START>                             JAN-01-1997
<PERIOD-END>                               SEP-30-1997
<CASH>                                         110,100
<SECURITIES>                                     1,658
<RECEIVABLES>                                  294,689
<ALLOWANCES>                                     8,324
<INVENTORY>                                    117,449
<CURRENT-ASSETS>                               560,171
<PP&E>                                       1,429,271
<DEPRECIATION>                                 631,685
<TOTAL-ASSETS>                               1,805,351
<CURRENT-LIABILITIES>                          310,510
<BONDS>                                        456,596
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                             0
<OTHER-SE>                                     393,980
<TOTAL-LIABILITY-AND-EQUITY>                 1,805,351
<SALES>                                      1,245,168
<TOTAL-REVENUES>                             1,245,168
<CGS>                                          913,702
<TOTAL-COSTS>                                  913,702
<OTHER-EXPENSES>                                     0
<LOSS-PROVISION>                                   706
<INTEREST-EXPENSE>                              41,510
<INCOME-PRETAX>                                142,284
<INCOME-TAX>                                    58,335
<INCOME-CONTINUING>                             83,949
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                    83,949
<EPS-PRIMARY>                                        0
<EPS-DILUTED>                                        0
        

</TABLE>
James Eddie WILSON, Jr. v. Barbara Waters WILSON. appealed by Aylward at Fenton Place (AFP).

No. 253P07.

Supreme Court of North Carolina.

December 6, 2007.

Ilonka Aylward, for AFP.

Annette R. Heim, for Wilson.

Prior report: ___ N.C.App. ___, 644 S.E.2d 379.

*ORDER*

Upon consideration of the notice of appeal from the North Carolina Court of Appeals, filed by Appellant (Aylward at Fenton Place) on the 30th day of May 2007 in this matter pursuant to G.S. 7A-30 (substantial constitutional question), the following order was entered and is hereby certified to the North Carolina Court of Appeals: the notice of appeal is

"Dismissed ex mero motu by order of the Court in conference, this the 6th day of December 2007."

Upon consideration of the petition filed on the 30th day of May 2007 by Appellant (Aylward at Fenton Place) in this matter for discretionary review of the decision of the North Carolina Court of Appeals pursuant to G.S. 7A-31, the following order was entered and is hereby certified to the North Carolina Court of Appeals:

"Denied by order of the Court in conference, this the 6th day of December 2007."
EXHIBIT 32


                    CERTIFICATION OF CHIEF EXECUTIVE OFFICER
                        AND PRINCIPAL FINANCIAL OFFICER
                          ALL-AMERICAN SPORTPARK, INC.
                      PURSUANT TO 18 U.S.C. SECTION 1350


     I hereby certify that, to the best of my knowledge, the Annual Report on
Form 10-QSB of All-American SportPark, Inc. for the quarter ending March 31,
2005:

     (1) 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
All-American SportPark, Inc.


Dated:  May 12, 2005




/s/ Ron Boreta
Ron Boreta
Chief Executive Officer
(Principal Executive Officer) and
Principal Financial Officer



A signed original of this written statement required by Section 906 of the
Sarbanes-Oxley Act of 2002 has been provided to All-American SportPark, Inc.
and will be retained by All-American SportPark, Inc. and furnished to the
Securities and Exchange Commission upon request.