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Contract Terms and Instructions

269-A2-VACCINES AND BIOLOGICALS

Start Date: 01/2007

End Date: 03/2013


ALL APPLICABLE FEDERAL EXCISE TAXES NOTED BELOW ARE PER DOSE PER VACCINE COMPONENT

Section 1: 1.1 DESCRIPTION OF CONTRACT: 269-A2 Vaccines and Biologicals. Flu Vaccine is contained in contract 269-A3. 1.2 TYPE: Automated Discount-From-List. 1.3 INITIAL TERM OF CONTRACT: January 26, 2007 through November 30, 2009. RENEWAL TERM OF CONTRACT: December 1, 2009 through November 30, 2010. EXTENDED: December 1, 2010 through May 31, 2011 EXTENDED: June 1, 2011 through August 31, 2011 EXTENDED: September 01, 2011 through November 30, 2011 EXTENDED: November 30, 2011 to February 29, 2012 EXTENDED: February 29, 2012 to June 30, 2012 EXTENDED: July 1, 2012 to September 30, 2012 EXTENDED: September 01, 2012 through December 31, 2012 EXTENDED: January 01, 2013 through January 31, 2013 EXTENDED: February 01, 2013 through February 28, 2013 EXTENDED: March 1, 2013 through March 31, 2013 1.4 DELIVERY: 14 days after receipt of order (ARO) unless otherwise specified (see section 2.3 "Fast Ship). Vaccines are subject to availability. 1.5 MINIMUM ORDER: A combined total of 20 doses of any product or $150, whichever is less. 1.6 SPOT PURCHASE OPTION: Not applicable 1.7 ZONE: This is a statewide contract. 1.8 SHIPPING INFORMATION: F.O.B. destination, freight prepaid and allowed on orders totaling $150.00 or more shipped to a single destination. Orders totaling less than $150.00 will be shipped freight prepaid and added as a separate item on invoice. Qualified ordering entities must not be charged freight for partial shipments of any order with a net total of $150.00. GlaxoSmithKline does not charge freight on any order, regardless of size. 1.9 WARRANTY: Manufacturer's standard warranty applies. 1.10 CASH DISCOUNT: Applicable cash discounts, if available, are identified in line item descriptions. 1.11 EDUCATIONAL DISCOUNT: None 1.12 QUANTITY OR LARGE ORDER DISCOUNT: Voluntary one-time price reduction should be indicated on the invoice. 1.13 PRICE CHANGES: Price changes are to be in accordance with Section II.B. of the "General Instructions, Terms and Conditions." As an exception, prices may be increased at any time. If a vendor offers a decrease in its catalog prices and such revised catalog prices are lower than the then-current discounted prices available to Texas, the vendor shall also offer the same discount to the state of Texas for the term of the contract. If the bid prices are affected by statute, regulation, administrative or judicial order only, vendor may not include additional costs in billings to the end user. Vendor must first provide written justification for the increase to the Texas Comptroller of Public Accounts (CPA). The CPA will make a determination of the applicability of the increase to the contract. 1.14 RECYCLED PRODUCTS: Efforts have been made to identify any product meeting the criteria definitions of recycled. If you have questions regarding recycled products, please contact the Recycling Coordinator at (512) 463-3034. 1.15 FUNDING OUT: Any blanket purchase order (an order calling for multiple deliveries over a specified period of time) is contingent upon the continued availability of appropriations. Vendor(s) will be notified should this occur. 1.16 POINT OF CONTACT: Vendor contacts are listed at the end of the contract. 1.17 HUB VENDORS: HUB vendors are identified in the Contract Vendor List as "HUB." 1.18 CPA CONTRACT MANAGER: Questions concerning terms and conditions and technical specifications should be directed to: Yvette Marietta, CTPM Purchaser C Texas Comptroller of Public Accounts (512) 463-6988 FAX (512) 475-0851 E-mail: yvette.marietta@cpa.state.tx.us 1.19 Enter requisition(s) into the TxSmartBuy on-line ordering system. Only purchase orders issued through TxSmartBuy are eligible for contract pricing. For State Agencies: PCC A NIGP Code(s): 269-04 269-24 269-40 269-68 269-08 269-28 269-52 269-84 269-12 269-32 269-56 269-88 Section 2 - Specific Contract Instructions: 2.1 NEW ACCOUNTS: We request that a vendor expedite the process to set up an account for a qualified ordering entity that is purchasing for the first time. NOTE: IF YOU KNOW YOU ARE PLACING AN ORDER WITH A VENDOR FOR THE FIRST TIME, IT WILL GREATLY EXPEDITE THE PROCESS IF YOU CALL THE VENDOR FIRST AND ADVISE THEM THAT YOU WILL NEED AN ACCOUNT SET UP. 2.2 FAST SHIP: State of Texas ordering entities must contact the vendor if expedited shipping is needed. Freight charges incurred will be billed to ordering entity as a separate line item on the invoice. 2.3 ALTERNATE SOURCES: For some items in this contract, it may not be possible to guarantee product availability for the term of the contract. In some cases, multiple awards were made for like items to circumvent problems caused by shortages. If a purchase order is accepted by a vendor, the order must be filled as written. 2.4 CONTRACT RENEWAL: This contract may be renewed for three (3) additional one-year periods. This will be done with the mutual consent of both parties. Any renewal will be processed upon mutual agreement of the awarded contractor and the State of Texas with 30 days written notice. The CPA will inform contract vendors, by letter, of our desire to renew the contract. If the vendor agrees to the renewal, he will indicate this on the letter and return it to the CPA. 2.5 ADDITIONAL ITEMS: If new package sizes or strengths of a drug become available during the term of the contract, the vendor may request that they be added to the award. This must be done in writing and accompanied by the most recent dated manufacturer's price list. The pricing for the new items must be based upon the same percentage of discount (or add-on) to the list price as the items originally awarded. 2.6 PACKAGING AND LABELING: All pharmaceuticals must be placed in the original packages of the manufacturer and labeled according to the Federal Food, Drug and Cosmetic Act. Each bottle, vial, package, etc. must bear the manufacturers lot number or control number. The product shall be labeled with labels that contain the following information: brand name and generic name, formulation, potency and/or volume, name of business, address of the original manufacturer and distributor of the finished dosage form (if applicable), lot identification number and expiration date (if applicable). NOTE: We prefer that all pharmaceuticals be supplied in tamper resistant containers, when applicable. 2.7 INTENDED USE: For the purpose of this provision, "Purchaser" is defined as the "qualified ordering entity. Product sold under this contract to the state of Texas shall be for Purchasers "own use" only and shall not be subject to resale. Therefore, the following clause is part of this contract. "Purchaser hereby certifies and represents to seller that it is a non-profit institution purchasing the products described herein for its own use as defined in Portland Retail Druggists Association vs. Abbott Laboratories, et.al. and that the products are not for dispensation to persons who are not patient, physicians or employees of the buyer or for other nonexempt dispensation. Purchaser further certifies that, in the event of any nonexempt use of these products, purchaser will submit to seller an accounting of such use, to be followed by an appropriate price adjustment. Additionally, violations of this policy, if proven, shall be treated as a breach of the Agreement of sales between an individual member or authorized purchaser and vendor(s). In the event vendor identifies a misuse of this contract, they have a right to require an appropriate price adjustment. 2.8 PRODUCT INFORMATION: Following award, the State may request descriptive product information if such is available. This information would include a description of the physical appearance of a drug including the imprinted identification. 2.9 QUALITY CONTROL PROGRAM: All ingredients used in the preparation of all products must be chemically assayed and/or biologically and/or physiologically tested. The manufacturer or manufacturers jobbers must show proof, upon request by the CPA, that the manufacturer maintains a quality assurance program as to quality and manufacture control to include: production procedure, assay of raw materials, assay of finished products (to assure every batch is of appropriate potency, purity and quantity of active ingredients), shelf life control, proper packaging (to eliminate contaminations and loss of potency), and a control numbering system that will insure that the drugs purchased will meet all standards set forth by the FDA, CBER (formerly the Bureau of Biologicals) and the state of Texas. A complete record of control in the manufacture of all products must be properly kept with records of chemical and/or biological and/or physiological assays of all finished products. All ingredients must comply with the New Drug Application (NDA). Not withstanding the foregoing, contractor shall comply solely with current good manufacturing practices as set forth in 21 C.F.R. ' 1 et seq., including without limitation, testing, recordkeeping and compliance with applicable standards. 2.10 SPECIFICATION DEFICIENCIES: Should any product supplied by any vendor under this contract be proven, upon assay by an independent laboratory or by the Texas Health and Human Services Commission,to not meet FDA or CBER specifications and requirements, the contract is subject to cancellation. 2.11 PHARMACEUTICAL ELEGANCE: Not applicable to vaccines. 2.12 DATE OF EXPIRATION AND ORIGINATION (MANUFACTURE): The product/vaccine supplied shall not expire or be rendered unusable within 12 months of receipt. However, the CPA reserves the right to waive this requirement on an individual basis because of the nature or availability of the product. 2.13 RETURN OF EXPIRED PHARMACEUTICALS: Vendor agrees to accept the return of unbroken packages - for replacement of like merchandise, credit against future or past orders, or refund check - of all expired merchandise supplied under this contract, providing a request for such return is initiated by the qualified ordering entity within six months following the expiration date of the drug. 2.14 STORAGE AND ROTATION OF VACCINES: State of Texas ordering entities shall handle and store vaccines in a clean and orderly location and in a manner which will assure the proper rotation and quality of such vaccines are maintained. Entities shall comply with criteria on storing items requiring special handling as recommended by the manufacturer. 2.15 NON-CONTRACT PURCHASES WITH FEDERAL FUNDS: If Federal funds are made available to the various qualified ordering entities, we reserve the right to purchase contract items from other sources with these funds, costs being less. 2.16 BULK QUANTITY PURCHASES: Not applicable. 2.17 PHARMACEUTICAL EQUIVALENTS: This contract is based upon pharmaceutical equivalents, i.e., drug products that contain the same active ingredients, are equivalent in strength (not necessarily identical), are supplied in the same dosage form for the same route of administration, and which meet the same or comparable standards. They may differ in such characteristics as color, taste, shape, packaging, expiration time and (within limits as set by F.D.A.) labeling. 2.18 THERAPEUTIC EQUIVALENTS: Therapeutic equivalency will be considered, if established by the Food and Drug Administration under the following criteria: A. They are "pharmaceutical equivalents" (as defined above). B. They are "bioequivalents" in that: 1. They do not present a known or potential bioinequivalence problem, or 2. If they do present such a problem, they have been shown to meet the appropriate bioequivalence standard. C. They are adequately labeled, and D. They are manufactured according to current good manufacturing practice regulations. E. The manufacturer must hold new drug applications (NDA's) or abbreviated new drug applications (ANDA's) Form 5 (6 for antibiotics) for drugs determined by the F.D.A. to be therapeutically effective and posing no known or potential bioequivalency problems. If bioequivalence or bioinequivalence has not been established, "pharmaceutical equivalents" will be acceptable alternatives providing they meet compendium and/or other established standards, and the terms, conditions and descriptions contained in this contract. 2.19 THERAPEUTIC EQUIVALENCY DETERMINATIONS: Therapeutic equivalency determinations will be based on the latest information available, as documented to the Food and Drug Administration and as published by that agency in "Approved Prescription Drug Products with Therapeutic Equivalency Evaluations," 19th Ed., 1999, and its supplements. Copies of this publication may be obtained from: United States Government Printing Office Washington, D.C. 20402 2.20 "DUTY TO WARN" CLAUSE: "State of Texas ordering entities agree that it will take all appropriate steps to assure that all products supplied hereunder pursuant to the terms of this contract, shall be administered to each patient on the basis of an individualized medical judgment by a physician. All appropriate steps will be taken to provide such patient, parent or guardian meaningful warnings relating to the risks and benefits of vaccination, in form and language understandable to such patient, parent, or guardian."


ALL APPLICABLE FEDERAL EXCISE TAXES NOTED BELOW ARE PER DOSE PER VACCINE COMPONENT


  
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