alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
www.fda.gov Interchangeable Biological Products | 1

Interchangeable Biological Products

An interchangeable biological product is a biosimilar that meets additional requirements and 

may be substituted for the reference product at the pharmacy, depending on state pharmacy 

laws. Interchangeable biological products (also called interchangeable biosimilars or 

interchangeable products) may help increase patient access to biologics.

Interchangeable Biosimilars

• An interchangeable biosimilar may be substituted at 

the pharmacy for the reference product without the 

intervention of the prescribing health care provider — 

much like how generic drugs are routinely substituted 

for brand-name drugs.

• Not all biosimilars are interchangeable. Companies 

must submit an application with adequate information 

to support an interchangeability determination for their

product to be approved as an interchangeable biosimilar.

Pharmacy-Level Substitution

Pharmacist substitutes the interchangeable 

biosimilar for the reference product

Script goes to the pharmacy Patient receives the 

interchangeable biosimilar

Doctor prescribes the 

reference product

Interchangeable Biosimilar Approval Process

• Unlike a reference product, which is approved 

in a standalone application, all biosimilar and 

interchangeable biosimilars are approved through

an abbreviated pathway that compares the product

to the reference product to show biosimilarity. 

• For approval as an interchangeable biosimilar, 

manufacturers must provide additional data that

reflect how the interchangeable biosimilar may be

used in the marketplace with patients. Like generic 

drugs, patients receiving their medications through 

their pharmacies may switch between a brand-name 

biologic and an interchangeable biosimilar. 

• To assess the safety of switching, manufacturers 

generally conduct studies in which patients alternate 

between the reference product and the interchangeable 

biosimilar and compare those patients to patients who 

are just being treated with the reference product. The 

results must show no decrease in effectiveness or 

increase in safety risk associated with switching.

• While this additional information helps FDA to 

determine the safety of pharmacy-level substitution, 

this does not mean that an interchangeable biosimilar

is safer or more effective than other biosimilars.

All biological products are approved only after they meet FDA’s rigorous approval standards, so health care professionals 

and patients can be confident in the safety and effectiveness of a biosimilar product, whether or not it has also been 

approved as an interchangeable biosimilar, just as they would be for a reference product.

Explore FDA’s biosimilar resources for health care professionals at www.fda.gov/biosimilars.
Gerald C. &aa **AUEIXN BP.**  **TEXAS**

Mr. Quincy Hawkins County Auditor Henderson

County Athens, Texas Dear Sirt OpinionDo. O-719 Rer Liability

of the CountyComaissioaers~

Court for interest

on generel.fmd sorip. Your requestfor ea opinionon the followiag question: "IS the countyliableto holdersof general sarip for six per cent laterest on saum?" has bsea received

by this offioe.

us quote from ea opinion Do. O-505,writtenby the Hoa. Richard E. Coake,

Assistant

Attorney Generals

as followsr *A countygeneralfund wemeat, casmoaly oalled generalfund scrip, is not a negotiable iastruemsat. h-t. 5932, Sea. 1, B.C.S. of Texas. It ia only evidence of indebtedness shmlng that the claimpresented wee allowed. It is not a contract to pay oa demead. The scrip is sa orderto the Couaty Treasurer .to issue a vouoherto the payee for the amount thereofo 55 Tex. 49, Aske v. Herris Cow&y." Prior to this holding by this department, it has been trios held by the department

that a mmnrissioaers ' Court is withoutauthority to allow or pay the iaterest upon ordinary

muvents or sorip issued in payment of current

expenses, It is, therefore,

our opinionthat a county is not legallyliable to pay interestoa soripwarrantsissued to pay monthly acoouats. Yours very truly FCC:ob:egw APPROVED Gerald C. %na ATTOFGIEX

G- OF TBXAS ATTORNEYGWERAI,OF TFiXAS By s/Fred C. Chandler Fred C. Chandler Assistant

### vr. ;uincy Hawkins, thy 2, 1959, Page 2

that a Coxiissionere* Court is without authority to allow or pay the intereet upon ordfnary countywarrnnt6 or norlp issued in payneat 0r 

### current ex~3enses.



### It Is, therefore, our opinion that a county is not legally liable to pay interest on scrip warrants issued to pay monthly acaounts.

Trustln~thatthlrr anmara your inw.rY. we are Youra Yerp truly Kl ’TORNEF GENERAL OF 

### TlSAB
Calvin Mortimer BRAME, Jr., aka C-Baby, petitioner, v. UNITED STATES.

No. 12-9315.

Supreme Court of the United States

April 15, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Fourth Circuit denied.
Panagiotis ARMATAS, petitioner, v. Elena MAROULLETI, et al.

No. 12-939.

Supreme Court of the United States

April 1, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Second Circuit denied.
[Wells Fargo Logo] **Wells Fargo Bank, NA****Document Custody**1015 - 10th Ave SE Minneapolis, MN 55014**ASSESSMENT OF COMPLIANCE WITH APPLICABLE SERVICING CRITERIA**Corporate Trust Services division of Wells Fargo Bank, National Association (the "Company") is responsible for assessing compliance with the servicing criteria set forth in Item 1122(d) of Regulation AB promulgated by the Securities and Exchange Commission. The Company has determined that the servicing criteria are applicable in regards to the servicing platform as of and for the period as follows: Platform: Publicly-issued (i.e., transaction level reporting required under the Securities Exchange Act of 1934, as amended) residential mortgage-backed securities and commercial mortgage-backed securities issued on or after January 1, 2006 for which the company provides document custody services, excluding any publicly issued transactions issued by any government sponsored entity (the "Platform").  Applicable Servicing Criteria: The servicing criteria set fo rth in Item 1122(d)( 1)(iv), 1122(d)(4)(i) and 1122(d)(4)(ii), in regard to the activities performed by the Company with respect to the Platform (the "Applicable Servicing Criteria"). Management of the Company has determined that all other servicing criteria set forth in item 1122(d) are not applicable to the Platform. Period: As of and fo r the twelve months ended December 31, 2007 (the "Period").  With respect to the Platform and the Period, the Company provides the following assessment of compliance with respect to the Applicable Servicing Criteria: 1.The Company is responsible for assessing its compliance with the Applicable Servicing Criteria. 2.The Company has assessed compliance with the Applicable Servicing Criteria. In performing this assessment , the Company used the criteria set forth by the Securities and Exchange Commission in paragraph (d) of Item 1122 of Regulation AB. 3.Based on such assessment, as of and for the Period, the Company has complied, in all material respects with the Applicable Servicing Criteria. KPMG LLP, a registered public accounting firm, has issued an attestation report with respect to the Company's assessment of compliance as of and for the Period.  WELLS FARGO BANK, NATIONAL ASSOCIATION By: /s/ Shari Gillund Its: Senior Vice Presiden t Dated: February 29, 2008
* Pursuant to 5TH CIR. 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 5TH CIR.

R. 47.5.4.

United States Court of Appeals

Fifth Circuit

FILED

June 13, 2003

Charles R. Fulbruge III

Clerk

UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

____________________

02-20733

Summary Calendar

____________________

UNITED STATES OF AMERICA,

Plaintiff-Appellee,

versus

ALFRED CHARLES HABELMAN,

Defendant-Appellant.

_________________________________________________________________

Appeal from the United States District Court

for the Southern District of Texas

(H-02-CV-1328)

_________________________________________________________________

Before BARKSDALE, DeMOSS, and BENAVIDES, Circuit Judges.

PER CURIAM:*

Alfred Habelman, pro se, appeals the 90-day confiscation of

his pilot’s certificate in 2002, pursuant to an enforcement action

brought by the Government. Habelman contested the suspension of

his pilot’s certificate in earlier proceedings; the suspension was

affirmed. Habelman v. Garvey, No. 98-60710 (5th Cir. 19 July 1999)

(unpublished). Once the Government sued to enforce that judgment,

Habelman complied voluntarily and the district court entered final
2

judgment. Habelman’s contentions belong to the original litigation

and cannot be heard by this court when considering the enforcement

at issue. E.g., In re Gibraltar Resources, Inc., 210 F.3d 573, 576

(5th Cir. 2000).

AFFIRMED
Văn Phòng Sức Khỏe của Nhóm Thiểu Số và Bình Đẳng Y Tế

Để biết thêm thông tin về bình đẳng y tế, hãy truy cập

www.fda.gov/healthequity.

CHẨN ĐOÁN MỨC A1C

Bình thường

Tiền tiểu đường

Bệnh tiểu đường

Dưới 5.7%

5.7% tới 6.4%

6.5% trở lên

Xét nghiệm A1C có thể được sử dụng để chẩn đoán 

hoặc quản lý bệnh tiểu đường bằng cách đo lượng 

đường huyết trung bình (mức đường huyết) của bạn 

trong 3 tháng qua.

Đối với hầu hết những người sống với bệnh tiểu 

đường, A1C từ 7% trở xuống là lý tưởng. Mức A1C cao 

hơn khiến bạn có nguy cơ bị các biến chứng tiểu 

đường.

Nói chuyện với nhà cung cấp dịch vụ chăm sóc sức 

khỏe của bạn về việc làm xét nghiệm A1C và tần suất 

phù hợp với bạn.

KIỂM TRA A1C CHO BỆNH TIỂU ĐƯỜNG
KIỂM TRA A1C CHO BỆNH TIỂU ĐƯỜNG

Văn Phòng Sức Khỏe của Nhóm Thiểu Số và Bình Đẳng Y Tế

Để biết thêm thông tin về bình đẳng y tế, hãy truy cập

www.fda.gov/healthequity.

CHẨN ĐOÁN MỨC A1C

Bình thường

Tiền tiểu đường

Bệnh tiểu đường

Dưới 5.7%

5.7% tới 6.4%

6.5% trở lên

Xét nghiệm A1C có thể được sử dụng để chẩn đoán 

hoặc quản lý bệnh tiểu đường bằng cách đo lượng 

đường huyết trung bình (mức đường huyết) của bạn 

trong 3 tháng qua.

Đối với hầu hết những người sống với bệnh tiểu 

đường, A1C từ 7% trở xuống là lý tưởng. Mức A1C cao 

hơn khiến bạn có nguy cơ bị các biến chứng tiểu 

đường.

Nói chuyện với nhà cung cấp dịch vụ chăm sóc sức 

khỏe của bạn về việc làm xét nghiệm A1C và tần suất 

phù hợp với bạn.
KIỂM TRA A1C CHO BỆNH TIỂU ĐƯỜNG

Văn Phòng Sức Khỏe của Nhóm Thiểu Số và Bình Đẳng Y Tế

Để biết thêm thông tin về bình đẳng y tế, hãy truy cập

www.fda.gov/healthequity.

CHẨN ĐOÁN MỨC A1C

Bình thường

Tiền tiểu đường

Bệnh tiểu đường

Dưới 5.7%

5.7% tới 6.4%

6.5% trở lên

Xét nghiệm A1C có thể được sử dụng để chẩn đoán 

hoặc quản lý bệnh tiểu đường bằng cách đo lượng 

đường huyết trung bình (mức đường huyết) của bạn 

trong 3 tháng qua.

Đối với hầu hết những người sống với bệnh tiểu 

đường, A1C từ 7% trở xuống là lý tưởng. Mức A1C cao 

hơn khiến bạn có nguy cơ bị các biến chứng tiểu 

đường.

Nói chuyện với nhà cung cấp dịch vụ chăm sóc sức 

khỏe của bạn về việc làm xét nghiệm A1C và tần suất 

phù hợp với bạn.
Jonathan DAVIS, petitioner, v. Dwight BARBEE, Warden.

No. 12-9701.

Supreme Court of the United States

June 10, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Sixth Circuit denied.
**E-filed 9/15/05**

IT IS SO ORDERED. 9/15/05 Judge Jeremy Fogel/s/electronic signature authorized

United States District Court

Case 5:05-cv-01952-JF Document 6 Filed 09/15/05 Page 1 of 1
Willie Terion WASHINGTON, petitioner, v. Rick THALER, Director, Texas Department of Criminal Justice, Correctional Institutions Division.

No. 11-10870.

Supreme Court of the United States

June 3, 2013.

On petition for writ of certiorari to the United States Court of Appeals for the Fifth Circuit. Motion of petitioner for leave to proceed *in forma pauperis* and petition for writ of certiorari granted. Judgment vacated, and case remanded to the United States Court of Appeals for the Fifth Circuit for further consideration in light of *Trevino v. Thaler* , 569 U.S. ----, 133 S.Ct. 1747, 185 L.Ed.2d 783 (2013).
|   | **Exhibit 21.1** |
|--------|------------------|

 

**Subsidiaries of Pioneer Southwest Energy Partners L.P. as of December 31, 2008**

 

 

|  

**Name of Subsidiary**                  |   | **State or other Jurisdiction of**

**Incorporation or Organization** |   |  

**Ownership** |
|-------------------------------------------------|--------|-----------------------------------------------------------------------|--------|-----------------------|
| Pioneer Southwest Energy Partners USA LLC       |   | Delaware                                                              |   | 100%                  |
| Pioneer Southwest Energy Partners Midstream LLC |   | Delaware                                                              |   | 100%                  |
|                                            |   |                                                                  |   |                  |
VOTER VERIFIED, INC., petitioner, v. ELECTION SYSTEMS & SOFTWARE, INC.

No. 12-1228.

Supreme Court of the United States

June 10, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Federal Circuit denied.
#### UNITED STATES of America, Plaintiff—Appellee, v. Michael Tyvon BRACEY, Defendant—Appellant.

No. 02-4677.

United States Court of Appeals, Fourth Circuit.

Submitted May 13, 2004.

Decided May 18, 2004.

Robert J. Harris, Durham, North Carolina, for Appellant. Lisa Boggs, Office of the United States Attorney, Greensboro, North Carolina, for Appellee.

Before WILKINSON, MOTZ, and DUNCAN, Circuit Judges.

Affirmed by unpublished PER CURIAM opinion.

Unpublished opinions are not binding precedent in this circuit. See Local Rule 36(c).

PER CURIAM:

Michael Tyvon Bracey pled guilty pursuant to a written plea agreement to one count of disqualified possession of ammunition, 18 U.S.C. § 922(g)(1) (2000). Bracey’s counsel has filed a brief in accordance with *Anders v. California,*386 U.S. 738, 87 S.Ct. 1396, 18 L.Ed.2d 493 (1967), raising one issue on appeal, but stating that, in his view, there are no meritorious issues for appeal. Bracey was informed of his right to file a pro se supplemental brief, but has failed to do so.

Bracey asserts his plea of guilty was involuntary because he was unaware that his failure to report to serve a sentence for a North Carolina probation violation would increase the criminal history points in the computation of his sentencing level. *See U.S. Sentencing Guidelines Manual*§ 4A1.1 (2002). The imposition of a sentence exceeding Bracey’s expectations does not render his plea involuntary. *United States v. Lambey,*974 F.2d 1389, 1394-95 (4th Cir.1992). Additionally, we find no error in the computation of Bracey’s sentence.

In accordance with *Anders,*we have reviewed the entire record in this case and have found no meritorious issues for appeal. We therefore affirm Bracey’s conviction and sentence. This court requires that counsel inform his client, in writing, of his right to petition the Supreme Court of the United States for further review. If the client requests that a petition be filed, but counsel believes that such a petition would be frivolous, then counsel may move in this court for leave to withdraw from representation. Counsel’s motion must state that a copy thereof was served on the client. 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*
Adewale Johnson ALADEKOBA, petitioner, v. UNITED STATES.

No. 12-9856.

Supreme Court of the United States

May 20, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Fourth Circuit denied.
---

Logo


FAX (303) 623-4258621 SEVENTEENTH STREET
SUITE 1550
DENVER, COLORADO 80293
TELEPHONE (303) 623-9147








Exhibit No. 23.1








CONSENT OF INDEPENDENT PETROLEUM ENGINEERS





As independent petroleum and natural gas consultants, we hereby consent to the reference of our name in the Report on Form 10-K for the year ending December 31, 2009 and December 31, 2008 of Rockies Region 2007 Limited Partnership (the "Partnership"). We have no interest of a substantial or material nature in the Partnership, or in any affiliate. We have not been employed on a contingent basis, and we are not connected with the Partnership, or any affiliate as a promoter, underwriter, voting trustee, director, officer, employee or affiliate.








/s/ Ryder Scott Company, L.P.RYDER SCOTT COMPANY, LP








Denver, Colorado


March 26, 2010








1100 LOUISIANA, SUITE 3800
HOUSTON, TEXAS 77002-5218
TEL (713)651-9191
FAX (713)651-08491200, 530-8TH AVENUE, S.W.
CALGARY, ALBERTA T2P 3S8
TEL (403) 262-2799
FAX (403) 262-2790
<TABLE> <S> <C>


<ARTICLE>                                            9
<CIK>                         0000710507
<NAME>                        First Banks, Inc.
<MULTIPLIER>                                     1,000

<S>                             <C>
<PERIOD-TYPE>                   6-mos
<FISCAL-YEAR-END>                          Dec-31-2000
<PERIOD-START>                             Jan-01-2000
<PERIOD-END>                               Jun-30-2000
<CASH>                                         137,265
<INT-BEARING-DEPOSITS>                           3,424
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<TRADING-ASSETS>                                     0
<INVESTMENTS-HELD-FOR-SALE>                    414,978
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<DEPOSITS>                                   4,456,453
<SHORT-TERM>                                   150,812
<LIABILITIES-OTHER>                            123,472
<LONG-TERM>                                    127,695
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<PREFERRED>                                     13,063
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<TOTAL-LIABILITIES-AND-EQUITY>               5,180,472
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<INTEREST-INVEST>                               14,019
<INTEREST-OTHER>                                 2,033
<INTEREST-TOTAL>                               201,878
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<INTEREST-EXPENSE>                              88,058
<INTEREST-INCOME-NET>                          113,820
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<SECURITIES-GAINS>                                 379
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<INCOME-PRETAX>                                 47,943
<INCOME-PRE-EXTRAORDINARY>                      47,943
<EXTRAORDINARY>                                      0
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<NET-INCOME>                                    29,259
<EPS-BASIC>                                   1,222.71
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<LOANS-NON>                                     33,822
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<ALLOWANCE-FOREIGN>                                  0
<ALLOWANCE-UNALLOCATED>                          9,269



</TABLE>
Troy E. DONNELLY, Appellant, v. STATE of Florida, Appellee.

Case No. 2D17-2495

District Court of Appeal of Florida, Second District.

Opinion filed April 24, 2019

**DECISION WITHOUT PUBLISHED OPINION**

Affirmed.
Jon A. WOODARD, petitioner, v. John Craig TURNBULL, Superintendent, Spring Creek Correctional Center.

No. 12-8935.

Supreme Court of the United States

April 15, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Ninth Circuit denied.
Jorge Lenin Izaguirre CABRERA, petitioner, v. UNITED STATES.

No. 12-9105.

Supreme Court of the United States

April 15, 2013.

Petition for writ of certiorari to the United States Court of Appeals for the Eleventh Circuit denied.
<TABLE> <S> <C>

<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE BALANCE
SHEET AT MARCH 31, 2000 (UNAUDITED) AND THE STATEMENT OF OPERATIONS FOR THE
THREE MONTHS ENDED MARCH 31, 2000 (UNAUDITED) AND IS QUALIFIED IN ITS ENTIRETY
BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1

<S>                             <C>
<PERIOD-TYPE>                   3-MOS
<FISCAL-YEAR-END>                          DEC-31-1999
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<CASH>                                       3,384,958
<SECURITIES>                                         0
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<TOTAL-ASSETS>                              15,592,744
<CURRENT-LIABILITIES>                        3,462,644
<BONDS>                                              0
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<PREFERRED>                                 38,598,919
<COMMON>                                        33,312
<OTHER-SE>                                 (32,424,130)
<TOTAL-LIABILITY-AND-EQUITY>                15,592,744
<SALES>                                        710,644
<TOTAL-REVENUES>                               710,644
<CGS>                                          349,013
<TOTAL-COSTS>                                2,300,527
<OTHER-EXPENSES>                                     0
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<INTEREST-EXPENSE>                             284,531
<INCOME-PRETAX>                             (2,135,779)
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<DISCONTINUED>                                       0
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<CHANGES>                                            0
<NET-INCOME>                                (2,835,799)
<EPS-BASIC>                                       (.86)
<EPS-DILUTED>                                     (.86)


</TABLE>
Anthony CHICO, petitioner, v. ILLINOIS.

No. 12-9028.

Supreme Court of the United States

April 15, 2013.

Petition for writ of certiorari to the Appellate Court of Illinois, First District, denied.