alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 520.905b Fenbendazole granules. ( a ) *Specifications.* Each gram of granules contains 222 milligrams (mg) fenbendazole.
( b ) *Sponsor.* See No. 000061 in § 510.600(c) of this chapter.
( c ) *Special considerations.* See § 500.25 of this chapter.
( d ) *Conditions of use* — ( 1 ) *Horses* — ( i ) *Amount.* 5 mg/kilogram (kg) for large strongyles, small strongyles, and pinworms; 10 mg/kg for ascarids.
( ii ) *Indications for use.* For the control of infections of large strongyles (*Strongylus edentatus, S. equinus, S. vulgaris*), small strongyles, pinworms (*Oxyuris equi*), and ascarids (*Parascaris equorum*).
( iii ) *Limitations.* Sprinkle the appropriate amount of drug on a small amount of the usual grain ration. Prepare for each horse individually. Withholding feed or water is not necessary. Retreat in 6 to 8 weeks if required. Do not use in horses intended for food.
( 2 ) *Dogs* — ( i ) *Amount.* 50 mg/kg daily for 3 consecutive days.
( ii ) *Indications for use.* For the treatment and control of ascarids (*Toxocara canis, Toxascaris leonina*), hookworms (*Ancylostoma caninum, Uncinaria stenocephala*), whipworms (*Trichuris vulpis*), and tapeworms (*Taenia pisiformis*).
( iii ) *Limitations.* Mix the appropriate amount of drug with a small amount of the usual food; dry dog food may require slight moistening to facilitate mixing. Medicated food must be fully consumed.
( 3 ) *Zoo and wildlife animals* — ( i ) *Amount.* 10 mg/kg per day for 3 days.
( ii ) *Indications for use.* For control of internal parasites of *Felidae* and *Ursidae* as follows: ( A ) Lion (*Panthera leo*) and Tiger (*Panthera tigris*): Ascarid (*Toxocara cati, Toxascaris leonina*), Hookworm (*Ancylostoma* spp.).
( B ) Cheetah (*Acinonyx jubatus*): Ascarid (*Toxocara cati, Toxascaris leonina*).
( C ) Puma (*Felis concolor*), Panther (*Panthera* spp.), Leopard (*Panthera pardus*), Jaguar (*Panthera onca*): Ascarid (*Toxocara cati, Toxascaris leonina*), Hookworm (*Ancylostoma* spp.), Tapeworm (*Taenia hydatigena, T. krabbei, T. taeniaeformis*).
( D ) Black Bear (*Ursus americanus*): Ascarid (*Baylisascaris transfuga, Toxascaris leonina*), Hookworm (*Ancylostoma caninum*), Tapeworm (*Taenia hydatigena, T. krabbei*).
( E ) Polar Bear (*Ursus maritimus*) and Grizzly Bear (*Ursus horribilis*): Ascarid (*Baylisascaris transfuga, Toxascaris leonina*).
( iii ) *Limitations.* Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season.
[44 FR 1375, Jan. 5, 1979, as amended at 47 FR 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009]
UNPUBLISHED

UNITED STATES COURT OF APPEALS 

FOR THE FOURTH CIRCUIT 

No. 08-6447

GREGORY RICE, 

 Plaintiff - Appellant, 

 v. 

STATE OF MARYLAND, in and for Washington County; FRED C. 

WRIGHT, III; DONALD EUGENE BEACHLEY; DON MCDOWELL; CHARLES 

STRONG; DANA MAYLAN, Ethics Commission; JOHN BARR, 

President, Commissioner, 

 Defendants - Appellees. 

Appeal from the United States District Court for the District of 

Maryland, at Baltimore. Peter J. Messitte, Senior District 

Judge. (8:08-cv-00590-PJM) 

Submitted: September 28, 2009 Decided: October 22, 2009 

Before MOTZ and DUNCAN, Circuit Judges, and HAMILTON, Senior 

Circuit Judge. 

Affirmed by unpublished per curiam opinion. 

Gregory Rice, Appellant Pro Se.

Unpublished opinions are not binding precedent in this circuit. 
2 

PER CURIAM: 

Gregory Rice appeals the district court’s order 

construing his 42 U.S.C. § 1983 (2006) complaint as a petition 

for writ of mandamus and dismissing it without prejudice.∗

 We 

have reviewed the record and find no reversible error. Although 

the district court did not specifically address Rice’s claim of 

the denial of access to courts, we find that the claim fails 

because the defendants are immune from suit. Stump v. Sparkman, 

435 U.S. 349, 356-57 (1978); King v. Myers, 973 F.2d 354, 356-57 

(4th Cir. 1992). Accordingly, we affirm. We dispense with oral 

argument because the facts and legal contentions are adequately 

presented in the materials before the court and argument would 

not aid the decisional process. 

AFFIRMED

 ∗

 Generally, dismissals without prejudice are interlocutory 

and not appealable. Domino Sugar Corp. v. Sugar Workers Local 

Union 392, 10 F.3d 1064, 1066 (4th Cir. 1993). However, a 

dismissal without prejudice could be final if no amendment to 

the complaint could cure the defects in the plaintiff’s case. 

Id. at 1066-67. We conclude that the defects in this case 

cannot be cured by an amendment to the complaint and that the 

order is therefore appealable.
§ 26.60 Definitions. ( a ) The following terms and definitions shall apply to this subpart only: ( 1 ) *Designating Authority* means a body with power to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies as specified under this part.
( 2 ) *Designation* means the identification by a designating authority of a conformity assessment body to perform conformity assessment procedures under this part.
( 3 ) *Regulatory Authority* means a government agency or entity that exercises a legal right to control the use or sale of products within a party's jurisdiction and may take enforcement action to ensure that products marketed within its jurisdiction comply with legal requirements.
( b ) Other terms concerning conformity assessment used in this part shall have the meaning given elsewhere in this part or in the definitions contained in “Guide 2: Standardization and Related Activities—General Vocabulary of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC)” (ISO/IEC Guide 2) (1996 edition), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the International Organization for Standardization, 1, rue de Varembé, Case postale 56, CH-1211 Genève 20, Switzerland, or on the Internet at *http://www.iso.ch* or may be examined at the Food and Drug Administration's Medical Library, 5600 Fishers Lane, rm. 11B-40, Rockville, MD 20857, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html .* In the event of an inconsistency between the ISO/IEC Guide 2 and definitions in this part, the definitions in this part shall prevail.
§ 26.4 Product coverage. ( a ) The provisions of this subpart will apply to medicinal products for human or animal use, intermediates and starting materials (as referred to in the European Community (EC)) and to drugs for human or animal use, biological products for human use, and active pharmaceutical ingredients (as referred to in the United States), only to the extent they are regulated by the authorities of both parties as listed in appendix B of this subpart.
( b ) Human blood, human plasma, human tissues and organs, and veterinary immunologicals (under 9 CFR 101.2, “veterinary immunologicals” are referred to as “veterinary biologicals”) are excluded from the scope of this subpart. Human plasma derivatives (such as immunoglobulins and albumin), investigational medicinal products/new drugs, human radiopharmaceuticals, and medicinal gases are also excluded during the transition phase; their situation will be reconsidered at the end of the transition period. Products regulated by the Food and Drug Administration's Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research as devices are not covered under this subpart.
( c ) Appendix C of this subpart contains an indicative list of products covered by this subpart.
[63 FR 60141, Nov. 6, 1998, as amended at 70 FR 14980, Mar. 24, 2005]
Exhibit








Exhibit 10.1
Amendment No. 3
to the Edwards Lifesciences Corporation 401(k)
Savings and Investment Plan
(Effective January 1, 2016)




The Edwards Lifesciences Corporation 401(k) Savings and Investment Plan ("Plan") as amended and restated as of January 1, 2016 is amended effective January 1, 2017, unless specified otherwise:


1.     The first paragraph of Section 2.16 is amended by the addition of subsection (g) to read as follows:


“2.16  “Eligible Employee” means an Employee on the payroll of an Employer incorporated in the United States whose Compensation constitutes wages from employment within the meaning of Sections 3121(a) and (b) of the Federal Insurance Contribution Act on and after the effective date of the adoption of the Plan by the Employer, but excluding:
(a)An Employee who is a member of a group of Employees represented by a collective bargaining representative, with respect to which the Plan has not been extended by a currently effective collective bargaining agreement between his Employer and the collective bargaining representative of the group of Employees of which he is a member after good faith bargaining on the subject of employee benefits;


(b)An Employee who is otherwise excluded from all of the groups of Employees to whom the Plan is extended by the Employers;


(c)A leased employee who is considered an Employee under Section 2.17; and


(d)Any other individual who performs services for an Employer pursuant to an agreement (written or oral) that classifies such individual as an independent contractor or as an employee of another entity, or that otherwise contains a waiver of participation in this Plan, regardless of such individual’s employment status under common law


(e)any employee who is classified as a “proctor” who is hired in conjunction with the launch of the THV product.


(f)individuals employed by an Employer whose entire amount of non-imputed U.S. source income is  paid to a U.S. taxing authority.


(g)Employees who are classified as interns, unless they are credited with 1,000 Hours of Service within a consecutive 12 month period.”


IN WITNESS WHEREOF, a duly authorized officer of the Company and a member of the Administrative and Investment Committee has caused this Plan to be executed on the 24th day of February, 2017.


EDWARDS LIFESCIENCES
CORPORATION ADMINISTRATIVE
AND INVESTMENT COMMITTEE






By:     /s/ Christine Z. McCauley
Christine Z. McCauley
Chairperson, Administrative and Investment Committee
§ 514.12 Confidentiality of data and information in an investigational new animal drug notice. ( a ) The existence of an INAD notice will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged.
( b ) The availability for public disclosure of all data and information in an INAD file shall be handled in accordance with provisions established in § 514.11.
**Exhibit 31.1**

 

**CERTIFICATION AS REQUIRED BY RULE 13a-14(a),**

**AS ADOPTED PURSUANT TO SECTION 302 OF THE**

**SARBANES-OXLEY ACT OF 2002**

 

I, Arthur L. Freeman, certify that: 

 

1. I have reviewed this report on Form 10-KSB of 1st Independence Financial Group, 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 thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 

 

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

 

4. The small business issuer’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (asdefined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the small business issuer and have: 

 

(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the small business issuer, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is beingprepared; 

 

(b) [omitted in accordance with SECRelease Nos. 33-8238 and 34-47986]; 

 

(c)evaluated the effectiveness of the small business issuer’s disclosure controls and procedures and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of theperiod covered by this report based on such evaluation; and****

 

(d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the small business issuer’s fourthfiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and ****

 

5. The small business issuer’s other certifying officer and I havedisclosed, based on our most recent evaluation of internal control, to the small business issuer’s auditors and the audit committee of the small business issuer’s board of directors (or persons performing the equivalent functions):

 

(a) all significant deficiencies and materialweaknesses in the design or operation of internal control which are reasonably likely to adversely affect the small business issuer’s ability to record, process summarize and report financial information; and 

(b) any fraud, whether or not material, that involves management or other employees whohave a significant role in the small business issuer’s internal controls over financial reporting. 

 
Date: March 29, 2005
/s/ Arthur L. Freeman
Arthur L. FreemanChairman and Chief Executive Officer
#### § 520.1720 Phenylbutazone oral dosage forms.
#### § 1304.01 Scope of part 1304.

Inventory and other records and reports required under section 307, section 311, or section 1008(e) of the Act (21 U.S.C. 827, 831, and 958(e)) shall be in accordance with, and contain the information required by, those sections and by the sections of this part.

[74 FR 15623, Apr. 6, 2009]
Exhibit 4.3

Terms & Conditions of the MTIP 2004 of Deutsche Telekom AG and participating companies

Sec. 1 Subject matter and duration of the plan

Sec. 2 Performance targets

---







Sec. 3 Payment

Sec. 4 Expiry of rights

---









Sec. 5 Limitations of liability

DTAG
and the participating companies, as well as their legal representatives, employees and agents shall not be liable for slight negligence, consequential damage, interest on arrears or lost profit.

Sec. 6 Optional performance

Sec. 7 Obligation to secrecy

The plan participant is obliged to maintain secrecy regarding the content of the MTIP 2004 and the content of the reward certificate
vis-à-vis third parties.

Sec. 8 Applicable law, place of performance and place of jurisdiction

---



Sec. 9 Miscellaneous

This
translation is for courtesy purposes only. The German version shall prevail.

---



QuickLinks
<PAGE>   1
                                                                    Exhibit 10.5




Corixa Corporation
1124 Columbia Street
Suite 200
Seattle, WA  98104 USA
(206) 754-5711 Voice
(206) 754-5715 Fax

VIA FACSIMILE AND COURIER

May 22, 1998

Jane Smith, Ph.D.
Technology Acquisitions Manager
D-9RK AP6C2
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL   60064-3500

RE:    LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT, DATED AS OF JULY 24, 1997,
BETWEEN ABBOTT LABORATORIES AND CORIXA CORPORATION (THE "LICENSE AGREEMENT").

Dear Jane:

In connection with a recent review of the License Agreement, we have determined
that it would be in Corixa's best interest to modify the notice provision in
Section 13.5 from sixty (60) days to forty five (45) days. If this modification
is acceptable, please have this letter countersigned by a duly authorized
representative of Abbott and returned to my attention by facsimile with original
to follow.


<PAGE>   2
We appreciate your cooperation in this matter.

Best regards,

Mark McDade

/s/ Mark McDade
Chief Operating Officer

ACKNOWLEDGED AND AGREED

ABBOTT LABORATORIES

By:  /s/ Jay B. Johnson
Its: Vice President
§ 522.150 Azaperone. ( a ) *Specifications.* Each milliliter of solution contains 40 milligrams (mg) azaperone.
( b ) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.
( c ) *Related tolerances.* See § 556.68 of this chapter.
( d ) *Conditions of use* — ( 1 ) *Indications for use.* For control of aggressiveness when mixing or regrouping weanling or feeder pigs weighing up to 80 pounds.
( 2 ) *Dosage.* 2.2 mg per kilogram (1 mg per pound) by deep intramuscular injection.
( 3 ) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[74 FR 65689, Dec. 11, 2009, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48702, July 26, 2016; 84 FR 32992, July 11, 2019]
<PAGE>   1
                                                                    EXHIBIT 23.1

               Consent of Ernst & Young LLP, Independent Auditors



We consent to the incorporation by reference in the Registration Statement (Form
S-8 No. 33-92034) pertaining to the Ride Snowboard Company 1994 Stock Option
Plan and Ride Snowboard Company 1994 Directors Nonqualified Stock Option Plan
and in the Registration Statement (Form S-8 No. 33-81029) pertaining to the
Ride, Inc. 1995 Employee Stock Purchase Plan and Ride, Inc. foreign Subsidiary
1995 Employee Stock Purchase Plan of our report dated March 3, 1998, with
respect to the consolidated financial statements and schedule of Ride, Inc.
included in its Annual Report (Form 10-K) for the year ended December 31, 1997
filed with the Securities and Exchange Commission.

   
Seattle, Washington
March 24, 1998                            ERNST & YOUNG LLP
KIDEO PRODUCTIONS, INC.
                 STATEMENT OF COMPUTATION OF EARNINGS PER SHARE
                                  EXHIBIT 11.1


<TABLE>
<S>                                             <C>        <C>        <C>        <C>     
PROFORMA NET LOSS:

Net Loss ....................................   $(3,059)   $(1,579)   $(1,471)   $  (427)
Interest expense on convertible debt
  assumed to be converted for purposes
  of this calculation .......................        91         65         22         15
Proforma effect of executive employment
  contracts, if such contracts were in effect
  at the beginning of each period presented .       (74)      (338)      --          (81)
                                                -------    -------    -------    -------
Proforma net loss used for the calculation
  of loss per share .........................   $(3,042)   $(1,852)   $(1,449)   $  (493)
                                                           =======    =======    ======= 
  Apportionment of loss for 1996:
    First 3 quarters (Pre-IPO) ..............    (1,593)
    Fourth quarter ..........................    (1,449)
                                                ------- 
  Full year loss accounted for ..............   $(3,042)
                                                ======= 

SHARES

Shares outstanding at the beginning of
  each respective period ....................   See below      617        915        617

Adjusted beginning balance, after giving
  effect to pre-IPO issuances and
  conversion rights at less than                           -------    -------    -------
  the IPO price .............................   See below    1,571      1,259      1,571
                                                           =======               =======
Stock issued in the IPO
  (1,400 x 37 days/90 days) .................                             576

Conversion of debentures
  (280 x 37 days/90 days) ...................                             115

Weighted average shares outstanding:                                  -------
  For the Quarter ended 7/31/96 .............                           1,950
                                                                      =======

PROFORMA LOSS PER SHARE:

Proforma loss per share for the nine
  months ended 4/30/96 ($1,593/1.571 shs) ...   $  (1.01)
Proforma loss per share for the year
  ended 7/31/95 .............................              $ (1.18)
Proforma loss per share for the quarter
  ended 7/31/96 ($1,449/1,950 shs) ..........   $  (0.74)             $ (0.74)
Proforma loss per share for the quarter
  ended 7/31/95 .............................                                    $ (0.31)
                                                --------   -------    -------    ------- 
Proforma loss per share, each period ........   $  (1.75)  $ (1.18)   $ (0.74)   $ (0.31)
                                                ========   =======    =======    ======= 
</TABLE>
Editorial Note on Part 314
Editorial Note: Nomenclature changes to part 314 appear at 69 FR 13717, Mar. 24, 2004; 81 FR 69639, Oct. 6, 2016.

§ 314.162 Removal of a drug product from the list. ( a ) FDA will remove a previously approved new drug product from the list for the period stated when: ( 1 ) The agency withdraws or suspends approval of a new drug application or an abbreviated new drug application under § 314.150(a) or § 314.151 or under the imminent hazard authority of section 505(e) of the act, for the same period as the withdrawal or suspension of the application; or
( 2 ) The agency, in accordance with the procedures in § 314.153(b) or § 314.161, issues a final decision stating that the listed drug was withdrawn from sale for safety or effectiveness reasons, or suspended under § 314.153(b), until the agency determines that the withdrawal from the market has ceased or is not for safety or effectiveness reasons.
( b ) FDA will publish in the Federal Register a notice announcing the removal of a drug from the list.
( c ) At the end of the period specified in paragraph (a)(1) or (a)(2) of this section, FDA will relist a drug that has been removed from the list. The agency will publish in the Federal Register a notice announcing the relisting of the drug.
[57 FR 17996, Apr. 28, 1992]
EXHIBIT 32



SECTION 906 CERTIFICATIONS



Each of the undersigned hereby certifies, in accordance with 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, in his capacity as an
officer of Provena Foods Inc. (the Company), that, to his knowledge, the Quarterly Report of the Company on Form 10-Q for the period ended March 31, 2005, fully complies with the requirements of Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 and that the information contained in such report fairly presents, in all material respects, the financial condition and results of operation of the Company.



Date: May 13, 2005



/s/    THEODORE L. ARENATheodore L. Arena, Chief Executive Officer/s/    THOMAS J.
MULRONEYThomas J. Mulroney, Chief Financial Officer