alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
acad-ex101_8.htm



Exhibit 10.1

 

ACADIA Pharmaceuticals Inc.

 

Description of Outside Director Compensation Program

 

The Board of Directors (the “Board”) of ACADIA Pharmaceuticals Inc. (“ACADIA”) has approved the following fees that are payable to the non-management directors who are members of the Board, effective June 1, 2017:

 


		
	
Annual Retainer
	
$50,000

	
Additional Retainer for Board Chair
	
$30,000

	
Additional Retainer for Audit Chair 
	
$20,000

	
Additional Retainer for Audit Member (non-Chair)
	
$10,000

	
Additional Retainer for Compensation Chair
	
$20,000

	
Additional Retainer for Compensation Member (non-Chair)
	
$10,000

	
Additional Retainer for Nominating and Corporate Governance Chair
	
$10,000

	
Additional Retainer for Nominating and Corporate Governance Member (non-Chair)
	
$ 5,000

	
 
	
 

	
 
	
 

	
Options
	
15,000 upon joining Board

	
 
	
15,000 annual grant thereafter




 

The Annual Retainer amounts are payable following the first meeting of the Board that follows the annual meeting of ACADIA’s stockholders. Annual option grants to directors are made at the Board meeting following the annual meeting of stockholders in accordance with the provisions of stock option plans that have been approved by ACADIA’s stockholders.  The annual retainer amount may be pro- rated for a director that joins the Board other than at the first meeting of the Board following the annual meeting of stockholders.
§ 814.1 Scope. ( a ) This section implements sections 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended for human use.
( b ) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
( c ) This part applies to any class III medical device, unless exempt under section 520(g) of the act, that: ( 1 ) Was not on the market (introduced or delivered for introduction into commerce for commercial distribution) before May 28, 1976, and is not substantially equivalent to a device on the market before May 28, 1976, or to a device first marketed on, or after that date, which has been classified into class I or class II; or
( 2 ) Is required to have an approved premarket approval application (PMA) or a declared completed product development protocol under a regulation issued under section 515(b) of the act; or
( 3 ) Was regulated by FDA as a new drug or antibiotic drug before May 28, 1976, and therefore is governed by section 520(1) of the act.
( d ) This part amends the conditions to approval for any PMA approved before the effective date of this part. Any condition to approval for an approved PMA that is inconsistent with this part is revoked. Any condition to approval for an approved PMA that is consistent with this part remains in effect.
[51 FR 26364, July 22, 1986, as amended at 79 FR 1740, Jan. 10, 2014]
§ 660.40 Hepatitis B Surface Antigen. ( a ) *Proper name and definition.* The proper name of this product shall be Hepatitis B Surface Antigen (HBsAg), which shall consist of a serum or tissue preparation containing one or more subtypes of the Hepatitis B Surface Antigen.
( b ) *Source.* The source of the product shall be blood, plasma, serum, or tissue, obtained aseptically from nonhuman primates that have met the applicable requirements of § 600.11 of this chapter, or from human donors whose blood is positive for the Hepatitis B Surface Antigen.
§ 820.90 Nonconforming product. ( a ) *Control of nonconforming product.* Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.
( b ) *Nonconformity review and disposition.* ( 1 ) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use.
( 2 ) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.
Exhibit
31.1




I, Mary
G. Merritt, certify that:




1. I have
reviewed this annual report on Form 10-KSB of Preferred Voice,
Inc.;




2. Based
on my knowledge, this annual 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 annual
report;




3. Based
on my knowledge, the financial statements, and other financial information
included in this annual report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as
of, and for, the periods presented in this annual report.




4. I am
responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and I
have:




a.
designed such disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to me by others within those entities, particularly during the
period in which this annual report is being prepared;




b.
evaluated the effectiveness of the registrant’s disclosure controls and
procedures as of a date within 90 days prior to the filing date of this annual
report (the “Evaluation Date”); and




c.
presented in this annual report my conclusions about the effectiveness of the
disclosure controls and procedures based on my evaluation as of the Evaluation
Date;




5. I have
disclosed, based on our most recent evaluation, to the registrant’s auditors and
the board of directors (or persons performing the equivalent
function):




a. all
significant deficiencies in the design or operation of internal controls which
could adversely affect the registrant’s ability to record, process, summarize
and report financial data and have identified for the registrant’s auditors any
material weaknesses in internal controls; and




b. any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant’s internal controls; and




6. I have
indicated in this annual report whether or not there were significant changes in
internal controls or in other factors that could significantly affect internal
controls subsequent to the date of our most recent evaluation, including any
corrective actions with regard to significant deficiencies and material
weaknesses.




/s/
Mary G. Merritt




Mary G.
Merritt Chief
Financial Officer (Principal
Executive Officer and
Principal Financial Officer) June 16,
2009
# LI2019316DE.01000401.xml

| 6.12.2019 | DE | Amtsblatt der Europäischen Union | LI 316/4 |
| --- | --- | --- | --- |

6.12.2019

DE

Amtsblatt der Europäischen Union

LI 316/4

---

Berichtigung der Verordnung (EU) 2018/1862 des Europäischen Parlaments und des Rates vom 28. November 2018 über die Einrichtung, den Betrieb und die Nutzung des Schengener Informationssystems (SIS) im Bereich der polizeilichen Zusammenarbeit und der justiziellen Zusammenarbeit in Strafsachen, zur Änderung und Aufhebung des Beschlusses 2007/533/JI des Rates und zur Aufhebung der Verordnung (EG) Nr. 1986/2006 des Europäischen Parlaments und des Rates und des Beschlusses 2010/261/EU der Kommission

(
  Amtsblatt der Europäischen Union L 312 vom 7. Dezember 2018
  )

Auf Seite 81, Artikel 36 Absatz 1:

Anstatt:

„(1)   Personenausschreibungen und Sachfahndungsausschreibungen in Bezug auf die in Artikel 38 Absatz 2 Buchstaben a, b, c, e, g, h, i, k und l genannten Sachen sowie ...“

muss es heißen:

„(1)   Personenausschreibungen und Sachfahndungsausschreibungen in Bezug auf die in Artikel 38 Absatz 2 Buchstaben a, b, c, e, g, h, j, k und l genannten Sachen sowie ...“.

---
# C_2014395EN.01006802.xml

| 10.11.2014 | EN | Official Journal of the European Union | C 395/68 |
| --- | --- | --- | --- |

10.11.2014

EN

Official Journal of the European Union

C 395/68

---

Action brought on 7 August 2014 — ZZ v Council

(Case F-77/14)

(2014/C 395/84)

Language of the case: French

Parties

Applicant: ZZ (represented by: S. Pappas, lawyer)

Defendant: Council of the European Union

Subject-matter and description of the proceedings

Declaration of the inapplicability of Article 8 of Annex VII to the Staff Regulations of Officials, as amended by Article 1(67)(d) of Regulation No 1023/2013, in that it establishes a link between the grant of the benefits provided for in that article and expatriate status, and the annulment of the General Implementing Provisions relating to the travel expenses between the place of employment and the place of origin adopted by the Council on 1 January 2014 applying the same link.

Form of order sought

| — | Declare that, by virtue of Article 277 TFEU, Article 1(67)(d) of Regulation No 1023/2013 must be disapplied in that it links the reimbursement of annual travel expenses provided for in Article 7 of Annex VII to the Staff Regulations to expatriate status; |
| --- | --- |

—

Declare that, by virtue of Article 277 TFEU, Article 1(67)(d) of Regulation No 1023/2013 must be disapplied in that it links the reimbursement of annual travel expenses provided for in Article 7 of Annex VII to the Staff Regulations to expatriate status;

| — | Annul Article 1 of the GIPs of 1 January 2014 in that it links the reimbursement of annual travel expenses provided for in Article 7 of Annex VII to the Staff Regulations to expatriate status; |
| --- | --- |

—

Annul Article 1 of the GIPs of 1 January 2014 in that it links the reimbursement of annual travel expenses provided for in Article 7 of Annex VII to the Staff Regulations to expatriate status;

| — | Order the Council to pay the costs. |
| --- | --- |

—

Order the Council to pay the costs.

---
###### Editorial Note on Part 312

#### Editorial Note:

Nomenclature changes to part 312 appear at 69 FR 13717, Mar. 24, 2004.

#### § 312.80 Purpose.

The purpose of this section is to establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely-debilitating illnesses, especially where no satisfactory alternative therapy exists. As stated § 314.105(c) of this chapter, while the statutory standards of safety and effectiveness apply to all drugs, the many kinds of drugs that are subject to them, and the wide range of uses for those drugs, demand flexibility in applying the standards. The Food and Drug Administration (FDA) has determined that it is appropriate to exercise the broadest flexibility in applying the statutory standards, while preserving appropriate guarantees for safety and effectiveness. These procedures reflect the recognition that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening and severely-debilitating illnesses, than they would accept from products that treat less serious illnesses. These procedures also reflect the recognition that the benefits of the drug need to be evaluated in light of the severity of the disease being treated. The procedure outlined in this section should be interpreted consistent with that purpose.
#### William T. Hunt *v.*Bernard Shapiro, Welfare Commissioner

*William T. Hunt,*pro se, in support of the petition.

*Edmwnd C. Walsh,*assistant attorney general, in opposition.

Submitted July 28

decided September 24, 1969

The petition by the plaintiff for certification for appeal from the Appellate Division of the Circuit Court is denied.
Editorial Note on Part 201
Editorial Note: Nomenclature changes to part 201 appear at 69 FR 13717, Mar. 24, 2004.

§ 201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil. ( a ) In the past few years research studies have altered medical opinion as to the usefulness and harmfulness of mineral oil in the human body. These studies have indicated that when mineral oil is used orally near mealtime it interferes with absorption from the digestive tract of provitamin A and the fat-soluble vitamins A, D, and K, and consequently interferes with the utilization of calcium and phosphorus, with the result that the user is left liable to deficiency diseases. When so used in pregnancy it predisposes to hemorrhagic disease of the newborn.
( b ) There is accumulated evidence that the indiscriminate administration of mineral oil to infants may be followed by aspiration of the mineral oil and subsequent “lipoid pneumonia.”
( c ) In view of these facts, the Department of Health and Human Services will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act a drug for oral administration consisting in whole or in part of mineral oil, the labeling of which encourages its use in pregnancy or indicates or implies that such drug is for administration to infants.
( d ) It is also this Department's view that the act requires the labelings of such drugs to bear a warning against consumption other than at bedtime and against administration to infants. The following form of warning is suggested: “Caution: To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.”
( e ) This statement of interpretation does not in any way exempt mineral oil or preparations containing mineral oil from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act.
Exhibit 31.1

 

**CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER**

 

I, Thomas J. Shaw, certify that:

 

1. I have reviewed this annual report on Form 10-K/A of Retractable Technologies, Inc.;

 

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; and

 

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

 

Date:       June 9, 2011

 
| /S/   THOMAS J. SHAW       |   |
|----------------------------|--------|
| THOMAS   J. SHAW           |   |
| PRESIDENT,   CHAIRMAN, AND |   |
| CHIEF   EXECUTIVE OFFICER  |   |

 

----
Participants on call with AAPCA Member states Held 11/30 /2015

AAPC A

Clint Woods, AAPCA

AAPCA Member State Participants

Alabama

Arkansas

Florida Kentucky

Louisiana

North Carolina

North Dakota

Ohio

Tennessee

Texas

West Virginia

Wyoming

EPA Participants

Bruce Moore, OAQPS

Chris Stoneman , OAQPS Cheryl Vetter, OAQPS

Jodi Howard, OAQPS

Gerri Garwood, OAQPS

Lisa Thompson, OAQPS

Charlene Spells, OAQPS

Jameel Alsalam, OAP Jackie Ashley, OAQPSMatt Witosky, OAQPS

ECR ? Greg Nizich, OAQPS

Amy Hambrick, OAQPS
§ 510.207 Disclosure of information submitted in a request. ( a ) When a request is determined to be complete for FDA's consideration, the Commissioner will provide public notification of the request containing the name of the requester and a brief description of the request in general terms. A copy of the notification will be sent to the requester at the time the information is made available to the public.
( b ) Any notification establishing, amending, or revoking an import tolerance will be made publicly available. A summary of the basis for the decision will be publicly released in accordance with the provisions of part 20 of this chapter. If FDA determines that the new animal drug referred to in the request is a new animal drug that induces cancer when ingested by people or animals, and the requester complies with the requirements of §§ 500.80 through 500.92 of this chapter (Subpart E, Regulation of Carcinogenic Compounds Used in Food-Producing Animals), the regulatory method for ascertaining the marker residue in the target tissue will be made publicly available. All information and safety data submitted with the request, or previously submitted information incorporated in, and considered as part of, a request on the basis of specific reference to such information, shall be available for public disclosure, also in accordance with the provisions of part 20 of this chapter. Trade secrets and confidential commercial or financial information are exempted from release under § 20.61 of this chapter.
```

[115th Congress Public Law 313]
[From the U.S. Government Publishing Office]

[[Page 132 STAT. 4430]]

Public Law 115-313
115th Congress

                                 An Act

 
To designate the facility of the United States Postal Service located at 
20 Ferry Road in Saunderstown, Rhode Island, as the ``Captain Matthew J. 
       August Post Office''. <<NOTE: Dec. 13, 2018 -  [S. 3414]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
SECTION 1. CAPTAIN MATTHEW J. AUGUST POST OFFICE.

    (a) Designation.--The facility of the United States Postal Service 
located at 20 Ferry Road in Saunderstown, Rhode Island, shall be known 
and designated as the ``Captain Matthew J. August Post Office''.
    (b) References.--Any reference in a law, map, regulation, document, 
paper, or other record of the United States to the facility referred to 
in subsection (a) shall be deemed to be a reference to the ``Captain 
Matthew J. August Post Office''.

    Approved December 13, 2018.

LEGISLATIVE HISTORY--S. 3414:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 164 (2018):
            Nov. 15, considered and passed Senate.
            Nov. 29, considered and passed House.

                                  <all>
```
* Pursuant to 5 TH C IR . R. 47.5, the court has determined

that this opinion should not be published and is not precedent except under the limited circumstances set forth in 5 TH C IR . R. 47.5.4. IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT

No. 04-50053 Conference Calendar

UNITED STATES OF AMERICA, Plaintiff-Appellee,

versus NEFTALI ADALID MONTOYA-NAVA, also known as Neftali Montoya-Nava Defendant-Appellant.

-------------------- Appeal from the United States District Court for the Western District of Texas USDC No. EP-03-CR-1497-ALL-FM

-------------------- Before BARKSDALE, DeMOSS, and CLEMENT, Circuit Judges.
PER CURIAM: * Neftali Adalid Montoya-Nava appeals the sentence imposed following his guilty plea conviction of being found in the United States after deportation/removal in violation of 8 U.S.C. § 1326. Montoya-Nava contends that 8 U.S.C. § 1326(a) and 8 U.S.C. § 1326(b) define separate offenses. He argues that the prior conviction that resulted in his increased sentence is an element of a separate offense under 8 U.S.C. § 1326(b) that should have United States Court of Appeals

Fifth Circuit 

## F I L E D June 23, 2004 Charles R. Fulbruge III ClerkNo. 04-50053 -2- been alleged in his indictment. Montoya-Nava maintains that he pleaded guilty to an indictment which charged only simple reentry under 8 U.S.C. § 1326(a). He argues that his sentence exceeds the two-year maximum term of imprisonment which may be imposed for that offense.
In Almendarez-Torres v. United States , 523 U.S. 224, 235 (1998), the Supreme Court held that the enhanced penalties in 8 U.S.C. § 1326(b) are sentencing provisions, not elements of separate offenses. The Court further held that the sentencing provisions do not violate the Due Process Clause. Id. at 239-47. Montoya-Nava acknowledges that his argument is foreclosed by Almendarez-Torres , but asserts that the decision has been cast into doubt by Apprendi v. New Jersey , 530 U.S. 466, 490 (2000). He seeks to preserve his argument for further review. Apprendi did not overrule Almendarez-Torres
. See Apprendi , 530 U.S. at 489-90; United States v. Dabeit , 231 F.3d 979, 984 (5th Cir. 2000). This court must follow Almendarez-Torres “unless and until the Supreme Court itself determines to overrule it.” Dabeit , 231 F.3d at 984 (internal quotation marks and citation omitted). The judgment of the district court is
AFFIRMED. The Government has moved for a summary affirmance in lieu of filing an appellee’s brief. In its motion, the Government asks that an appellee’s brief not be required. The motion is GRANTED.
AFFIRMED; MOTION GRANTED.
Exhibit 13.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 annual report on Form 20-F of Petaquilla Minerals Ltd. for the 15-months ended April 30, 2007, as filed with the Securities and Exchange Commission, I 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 annual report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

2.  The information contained in the annual report fairly presents, in all material respects, the financial condition and results of operations of the registrant.

Date: October 1, 2007

/s/ Richard FiferRichard Fifer, President

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 registrant and will be retained by the registrant and furnished to the Securities and Exchange Commission or its staff upon request.