Signed P00004 SPE2D2-22-D-0145.pdf

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Attached to
SPE2D2-22-D-0145 Estradiol Patch 24 Contract Federal contract opportunity
Solicitation number
SPE2D221R0115
Issued by
Defense Logistics Agency Troop Support Medical

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SPE2D222D0145 P00007.PDF PDF
SPE2D222D0145 P00005.PDF PDF
SPE2D222D0145 P00006.PDF PDF
SPE2D222D0145 P00008 SIGNED.pdf PDF
SF30_SPE2D222D0145P00002.PDF PDF
Signed Modification P00001 SPE2D2-22-D-0145.pdf PDF
Modification P00003 SPE2D222D0145 Option Year 1.pdf PDF
Signed Estradiol 24HR Patch Award SPE2D2-22-D-0145.pdf PDF

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11 CONTRACT I CODE:

PAGE 1 OF 2:
AMENDMENT OF SOLICITATIONMODIFICATION OF CONTRACT:
3 EFFECTIVE DATE See Blk 16C:
SPE2D2Row1:
PHPHAC7 Tel 2157377941 FAX 2157375226 Email PHYLLISDARAIODLAMIL:
USA:
9B DATED SEE ITEM 11:
X 8 NAME AND ADDRESS OF CONTRACTOR No street county State and ZIP Code MYLAN PHARMACEUTICALS INC 3711 COLLINS FERRY RD MORGANTOWN WV 265052362 USA:
10A MODIFICATION OF CONTRACTORDER NO:
CODE 3KJG9 FACILITY CODE:
X:
or c By separate letter or telegram which includes a reference to the solicitation and amendment numbers FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE:
12 ACCOUNTING AND APPROPRIATION DA TA If required:
13 THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTSORDERS:
IN ITEM 10A:
Row1:
date etc SET FORTH IN ITEM 14 PURSUANT TO THE AUTHORITY OF FAR 43103 b:
XRow1:
D OTHER Specify type of modification and authority:
E IMPORTANT Contractor D is not 0 is required to sign this document and return:
15B CONTRACTOROFFEROR:
JASON WRAY:
2023-08-22T10:14:44-0400
WRAY.JASON.CHRISTOPHER.1238740742
CONTINUATION SHEET:
REFERENCE NO OF DOCUMENT BEING CONTINUED SPE2D222D0145 I P00004:
PAGE 2 OF 2 PAGES:
1 This modification hereby revises Solicitation page number 24 paragraph 17 Labeling within the Statement of Work to include prug Supply Chain Security Act language as referenced below 1 7 Labeling All pharmaceutical products provided under this contract shall include bar code labeling at the unitofuse package level The bar code labeling must be in a linear format that conforms to all GSl128 formerly EANUCC or Health Industry Business Communication Council HIBCC Health Industry Bar Code HIBC supplier labeling standards The bar code symbology must comply with all GSl or HJBCC parameters including but not limited to symbology type or encoded pattern bar and space dimensions and tolerances and allowable ratio of wide to narrow elements The bar code may be any linear bar code symbology such as GSl128 formerly EANUCC GSl DataBar formerly RSS or Universal Product Code if the UPC contains the National Drug Code orNDC The bar code must encode the NDC either alone or within the GSl data structure Global Trade Item Number GTIN The bar code printing must be American National Standards Institute ANSI International Organization for Standardization ISO IEC quality grade C or better Manufacturers and packagers must ensure that production runs include an initial verification check as well as routine audits to ensure the bar code is printed clearly and consistently to meet the quality standard of grade C or better Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this clause prior to shipping pharmaceutical products to any Government prime vendor or authorized ordering activity under this contract The bar code must be on the outside container or wrapper of the medication as well as on the immediate container unless the bar code is readily visible and machine readable through the outside container or wrapper When the bar code is not easily machine readable through the overwrap the overwrap should contain the bar code The bar code must go on each cell of a blister pack Furthermore the bar code must remain intact under normal conditions of use thus it should not be printed across the perforations of a blister pack When applicable to the symbology used bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly Bar code placement shall minimize curvature of the bar code For example bar codes should be placed in ladder orientation on vials or bottles to minimize curvature of the bar code Bar code labeling shall not be placed solely on outer packaging It is required that bar code labeling also include the lot number and expiration date If two separate distinctive bar codes are used one for NDC and the other for lot numberexpiration date the lot number and expiration date bar code must not be in close proximity to the NDC barcode or in a format that may be confused with the NDC bar code When applicable all Healthcare Distribution Management Association HDMA guidelines shall be followed Drug Supply Chain Security Act DCSA The contractor shall follow all appropriate requirements as implemented in the Drug Supply Chain Security Act DCSA including all applicable traceability and licensing requirements 2 All other terms and conditions remain unchanged:

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