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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 22, 2014 FBO #4654
DOCUMENT

65 -- Donepezil HCL 10MG TAB 1000ct bottles - Attachment

Notice Date

8/20/2014
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office (NCO) 15;3450 S 4th Street;Leavenworth KS 66048
 

ZIP Code

66048
 

Solicitation Number

VA25514Q1735
 

Response Due

8/20/2014
 

Archive Date

10/19/2014
 

Point of Contact

Jennifer Arellano
 

E-Mail Address

8-4761<br
 

Small Business Set-Aside

N/A
 

Description

CHARLESTON SC CMOP Pharmaceutical(s) DESCRIPTION DONEPEZIL HCL 10MG TAB, 1000CT PREFERRED NDC: 43547-0276-11 320 BOTTLES 1000S DELIVERED ON/BEFORE AUGUST 27, 2014 320 BOTTLES 1000S DELIVERED ON/BEFORE SEPT 10, 2014 320 BOTTLES 1000S DELIVERED ON/BEFORE SEPT 30, 2014 PLEASE SEE LETTER OF COMMITMENT BELOW. MUST BE RECEIVED BY RFQ CLOSING DATE AND TIME. CONTRACT DELIVERY TERMS The Government reserves the right to cancel any quantities NOT delivered on or before 5 days after award of the contract. All products supplied under this contract must be shippable by the United States Postal Service unless specifically identified otherwise by the offeror and accepted by the contracting officer. Failure of the offeror to notify the contracting officer of the non-shippable status of a product (usually due to flammability) will result in cancellation or return of the product at the offeror's expense. Shippable means the product must able to be shipped by the USPS when the CMOP issues it to a patient. It DOES NOT mean that the product supplier must ship the product to the CMOP via USPS. The most cost effective method of shipping should be used for initial delivery to the CMOP. Deliver by means of multiple deliveries. Delivery must be made between the hours of M-Th 630am-3pm EST and Friday 630am-230pm EST. The contractor is to email tracking information to rachel.maccumbee@va.gov upon shipment of the product. ADDITIONAL TERMS PROPOSED BY CONTRACTOR: Any alternate NDCs the offerors wish to propose shall be listed on the attached spreadsheet (where applicable). Other than alternate NDCs, offerors shall list below any proposed alternate terms or conditions to this solicitation (e.g. delivery terms, bottle counts, etc ¦) in order for Offeror to successfully fulfill the terms of the resultant contract. The proposed alternate terms or conditions shall be reviewed by the Contracting Officer and, if accepted, shall be included in the contract terms upon signatures from both parties. Once the proposed terms or conditions are approved by both parties, they shall become a binding part of the contract and Offeror shall be responsible for all requirements set forth in the resultant contract. Alternate terms and conditions proposed elsewhere will not be considered and will not be included in any resultant contract and may result in the offer being removed from further consideration. _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ AS508 BAR CODING (MAY 2012) All pharmaceutical products provided under this contract shall include bar code labeling at the unit-of-use package level. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC) Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GSI or HIBCC 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 GS1-128 (formerly EAN.UCC), GS1 Data Bar (formerly RSS), or Universal Product Code (if the UPC contains the National Drug Code or NDC). The bar code must encode the NDC, either alone or within the GS1 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 over wrap, the over wrap 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 recommended 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 number/expiration 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. AS1335 THERAPEUTIC EQUIVALENCE (FEB 2007) Only products that have received under the Federal Food, Drug and Cosmetic Act a therapeutic equivalence code of "A" by the Food and Drug Administration will be considered, unless all drugs in the family group are "B" rated. In that case, no award will be made other than to the innovator unless the non-innovator vendor submits acceptable data demonstrating bioequivalence. AS1527 NATIONAL DRUG CODES (MAY 2009) Offerors shall provide a separate and distinct eleven-digit National Drug Code (NDC) number unique to the offeror (e.g., 00012-3456-78) for each product proposed, in the space provided following each item in Part I, "Schedule of Supplies and Prices" of the solicitation. The first five numbers of the eleven-digit NDC number for each product proposed shall identify the offeror. Offers that fail to provide the information required by this clause by the solicitation closing date shall be rejected and shall receive no further consideration. Letter of Commitment or Documentation of Product Availability Include: (a) If other than the manufacturer, the offeror shall submit either: (1) A letter of commitment from the manufacturer to the offeror which will assure the offeror of a source of supply sufficient to satisfy the Government's requirements for the contract period, OR (2) Documentation of Product Availability showing that the offeror will have an uninterrupted source of supply from which to satisfy the Government's requirements for the contract period. Offers that fail to meet this requirement before contract award may be rejected and may receive no further consideration. (1) To be considered acceptable, the letter of commitment: a) Shall be on the manufacturer's letterhead. b) Shall be dated. c) Shall reference the solicitation number and the product committed to manufacture. d) Shall state that the manufacturer assures the offeror of an uninterrupted source of supply sufficient to satisfy the Government's requirements for the contract period, and that the manufacturer is currently manufacturing the product. e) Shall be signed by an officer of the manufacturer's company (include printed name, title and telephone number). f) Shall indicate source of product to include country of origin. (2) To be considered acceptable, Documentation of Product Availability a) Shall be on the source company's letterhead or be clearly identifiable as coming from the source (for example, source company e-mail with company officials name and position identified). b) Shall be dated. c) Shall reference the solicitation number and the product committed to the company making the offer to the government. d) Shall state that the source assures the offeror of an uninterrupted source of supply sufficient to satisfy the Government's requirements for the contract period, and that the source currently has the product available. e) Shall indicate source of product to include country of origin. OTHER REQUIREMENTS The expiration dates of the pharmaceutical(s) are to be no less than 12 months from date of delivery. Any substitution of packaging sizes must be approved in writing by the Contracting Officer. Any change that deviates from the specific item requested must be approved by the Contracting Officer in writing. For example, the replacement of capsules for tablets or suspended action for extended release items will require approval beforehand. Partial deliveries of product will need to be approved in writing by the Contracting Officer. It is incumbent upon the offeror /contractor to initiate any actions requiring the approval of the contracting officer. Failure to obtain contracting officer approvals may result in rejection of offers or cancellation of award. Acceptance of any vendor-proposed NDC or UPC shall be contingent on CMOP approval. If a line item indicates more than one NDC/UPC, Vendor MUST specify which NDC/UPC is used when quoting. If offering an alternate, Vendor MUST indicate proposed alternate on the spreadsheet, in the column titled "VENDOR PROPOSED ALTERNATE NDC (PKG SZ)" and indicate bottle size in parentheses. ALL OFFERS SHOULD BE PRESENTED IN EXCEL FORMAT NOT A PDF. If the pre-approved alternate NDC is provided by the Vendor, and if the unit size is different from the original unit requested, then the Vendor must also adjust the final quantity accordingly, e.g.: 1 bottle @1000 to 10 bottles @ 100, noting the change. For reconciliation purposes, all shipments shall reference the original VA obligation/order number even if purchased product is from another partnered company. All shipments shall come with a packing slip identifying Vendor awarded the contract, VA Purchase order number/ Obligation Number, NDC, PRODUCTS, and LINE ITEM NUMBERS from the purchase order. Documentation shall include Vendor's point of contact for reporting noted discrepancies, damages, or incorrect product. Invoice price must match purchase order price VA Purchase order number/ Obligation Number must be included as part of the ship to address on all shipping boxes and clearly printed on the packing slip. Failure to supply this information may cause a delay with payment or rejection of the product if the order information is not readily apparent. All like product shall be packaged and shipped together. Vendor shall provide a return authorization and pickup for any damaged products or incorrect products received within one week of request. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. The Government's rights after a termination for cause shall include all the remedies available to any buyer in the marketplace. The Government's preferred remedy will be to acquire similar items from another contractor and to charge the defaulted contractor with any excess re-procurement costs together with any incidental or consequential damages incurred because of the termination. Other terms: Vendor shall submit information concerning Product Status if delivery within 5 days ARO cannot be met; e.g. MFR Backorders, Product Allocations, MFR Recalls, API/Raw Material Shortages or Discontinued NDCs to determine best course
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/VA25514Q1735/listing.html)
 

Document(s)

Attachment
 

File Name: VA255-14-Q-1735 VA255-14-Q-1735_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1585224&FileName=VA255-14-Q-1735-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1585224&FileName=VA255-14-Q-1735-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: CHARLESTON CMOP;3725 RIVERS AVE;SUITE 2;NORTH CHARLESTON

Zip Code: 29405-7038
 

Record

SN03472900-W 20140822/140821000046-e14498b8d2c003e35127a900dddd24ed (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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