Signed SPE2D220D0092 P00006 Lamotrigine ER.pdf

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Attached to
Lamotrigine Extended Release Tablets Federal contract opportunity
Solicitation number
SPE2D220R0059
Issued by
Defense Logistics Agency Troop Support Medical

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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1

1. CONTRACT I� CODE

I

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. I

5. PROJECT NO. (If applicable)

P00006 See Blk. 16C See Block 14

6. ISSUED BY CODE SPE2D2 7. ADMINISTERED BY (/father than Item 6) CODE I SPE2D2

DLA TROOP SUPPORT DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN FSGB

MEDICAL SUPPLY CHAIN FSGB 700 ROBBINS AVENUE

PHILADELPHIA PA 19111 700 ROBBINS AVENUE

USA PHILADELPHIA PA 19111

Initiator: Kyle Lewicki

USA DKL0040 Tel: 215-737-3696 Email: Kyle.Lewicki@dla.mil

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

AVKARE, LLC

615 N 1ST ST

PULASKI TN 38478-2403 10A. MODIFICATION OF CONTRACT/ORDER NO.

USA

SPE2D2-20-D-0092

10B. DATED (SEE ITEM 13)

2020 MAY 13

CODE 4QGW8 FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

0 The above numbered solicitation Is amended as set forth in Item 14. The hour and date specified for receipt of Offers D Is extended, 0 is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning _____ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicllatlon and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. lf by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES ( such as changes in paying office, appropriation dale, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103 (b).

C. T HIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

X FAR 52.212-4(c)

D. OTHER (Specify type of modification and authority)

E. IMPORT ANT: Contractor D is not, 0 is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

See Continuation Sheet

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect 15A NAME AND TITLE OF SIGNER (Type or print) 16A. NAME ANO TITLE OF CONTRACTING OFFICER(Type or print)

NSN 7540-01-152-8070

Previous edition unusable

VYl)

JASON WRAY

16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of Contracting Officer)

ST AN DARO FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

8-7-2023

2 AMENDMENTMODIFICATION NO P00006:
9B DATED SEE ITEM 11:
CODE 4QGW8 FACILITY CODE:
or c By separate letter or telegram which includes a reference to the solicllatlon and amendment numbers FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE:
12 ACCOUNTING AND APPROPRIATION DATA If required:
13 THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTSORDERS:
A THIS CHANGE ORDER IS ISSUED PURSUANT TO Specify authority THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO IN ITEM 10A:
CHECK ONERow1:
C THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF FAR 522124c:
XRow1:
D OTHER Specify type of modification and authority:
0 is required to sign this document and return:
14 DESCRIPTION OF AMENDMENTMODIFICATION Organized by UCF section headings including solicitationcontract subject matter where feasible:
2023-08-07T12:48:00-0400
WRAY.JASON.CHRISTOPHER.1238740742
CONTINUATION SHEET:
REFERENCE NO OF DOCUMENT BEING CONTINUED SPE2D220D0092 P00006:
PAGE 2 OF 2 PAGES:
1 his modification hereby revises Solicitation page number 29 paragraph 15 Labeling within the Statemen of Work to nclude Drug Supply Chain Security Act language as referenced below 15 Labeling All pharmaceutcal procucts proviced under this contrac shall include bar cede labeling at the unitofuse package level The bar code labeling must be in a linear format that conforms tc all GSl128 formerly EAKUCC or Health Industry Business Communication Council HIBCC Heath Industry Bar Code HIBC supplier abeling standards The bar cede symbology must comply with all GSl or HIBCC parameers inclucing but not limited o symbology type or encoded pattern bar and space dimensions and tolerances and allowable ratio of wde to narrow elements The bar code may be any linear bar code symbology such as GSl28 formery EANUCC GSl DataBar formery RSS or Universal Product Code if the UPC contains the Natonal Drug Code or NOC The bar code must encode the NOC either alone or within the GSl data structure Global Trade Item Nurrber GTIN The bar code prnting must be American Natonal Standards nstitute ANSI Internatonal Organization for Standardization ISO IEC cuality grace C or better Manufacturers and packagers mus ensure that production runs include an initial verificaticn check as well as rcutine audis to ensure the bar code is printed clearly and consistently to meet he quaity standard cf grade C or better Contractors shall be responsible for ensuring that bar coce labels meet the quality requirements specified in this clause pror to shipping pharmaceuical products to any Government prime vencor or authorizeci ordering activiy under this contract The bar code must be on the cutsicie conainer or wrapper of the medication as well as on the immeciiate container unless the bar code is readily visible and machine readable through the outside container or wrapper When the bar cede is not easily machine readable through the overwrap the overwrap should contain the bar code The bar code must go on each eel of a blister pack Furthermore the bar code must remain ntact under normal conditions of use thus it should not be printed across the perforations of a blister pack When applicable tc the symbology used bar cedes shall be surrounced by sufficent quie zone so that the bar code can be scanned correctly Bar code placemen shall minimize curvature of the bar code For example bar codes should be placed in ladder orienation on vials or bottles to minimize curvature of the bar code Bar code labeling shall not be placed soley en outer packaging It s required that bar code labelinq also incude the lot number and expration ciate If two separate distinctive bar cedes are used one for NOC and the other for ot numberexpiration date the ot number and expiration date bar code must not be in clcse proximiy to the KOC barcode or in a format that may be confused with the NOC bar code When appicablc al Hcathcarc Distribution Management Association HOMA guidelines shall be followcci Drug Supply Chain Security Act DCSA The contractor shall folow all approprate requirements as implemented in he Drug Supply Chain Security Act DCSA including al applicable traceabilty and licensing requirerrents 2 All other terms and condiions remain unchangec:

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