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2 DEPARTMENT OF VETERANS AFFAIRS BLANKET PURCHASE AGREEMENT Omeprazole 20mg capsules RFQ NO.: 36E79719Q0009 ISSUE DATE: 22 May 2019 DUE DATE: 29 May 2019 8:00 a.m. Central Time BPA NO.: (For Gov t Use... 2 DEPARTMENT OF VETERANS AFFAIRS BLANKET PURCHASE AGREEMENT Omeprazole 20mg capsules RFQ NO.: 36E79719Q0009 ISSUE DATE: 22 May 2019 DUE DATE: 29 May 2019 8:00 a.m. Central Time BPA NO.: (For Gov t Use Only) BPA AWARD DATE: (For Gov t Use Only) BPA EFFECTIVE PERIOD: (Offeror to Complete) FSS CONTRACT NO.: (Offeror to Complete) FSS CONTRACT EFFECTIVE PERIOD: QUOTATIONS SHOULD BE SUBMITTED TO: ATTN: Bonita Smith, Contracting Officer Telephone: (708) 786-5175 e-mail: Bonita.Smith@va.gov OFFEROR INFORMATION (please complete): Company Name: Address: City, State & Zip Code: Offeror Point of Contact: Telephone: FAX:__________________ E-mail Address: Typed Name & Title: Authorized signature: ________________________________________ Completed BPA information and signature (below) establishes the BPA (Gov t to complete) Contracting officer name: Contracting Officer Signature & Date signed: NOTE. Offerors are required to submit a copy of their FSS Price List with their Request for Quotation. Omeprazole 20mg capsules minimum 500 count must be included on FSS contract prior to establishment of a Blanket Purchase Agreement. DUE DATE OF QUOTES. This procurement will be advertised at www.FedBizOps and will be emailed to current FSS contractors of Omeprazole. Quotations are to be submitted via email to the Contracting Officer no later than 8:00 a.m. (CT), 29 May 2019. Quotations may be submitted in Microsoft Word or PDF form via e-mail to Bonita Smith at Bonita.Smith@va.gov with a signed, scanned (pdf) copy of page one. Please note that faxed quotations are not acceptable and will be rejected. ESTIMATED ANNUAL REQUIREMENTS: Based on VA s historical purchases, the estimated annual requirements are indicated below. Only one BPA will be established for Omeprazole 20mg capsules. To be considered for this BPA, offerors must submit pricing for the strength listed below. The total aggregate price will be computed by multiplying the estimated quantity for each strength by the offered price per tablet and summing the total of all strengths. ESTIMATED ANNUAL DESCRIPTION STRENGTH REQUIREMENTS Omeprazole 20mg See chart below OFFEROR - PLEASE SUBMIT YOUR OFFER BY PROVIDING THE FOLLOWING INFORMATION: Product Description Estimated Annual Quantity (in capsules) *** National Drug Code (NDC) Number Proposed Price Per Tablet or Capsule Offered Package Size * Proposed Price for Offered Package Size for period of performance**** Current FSS Price per Package Size Expiration Dating at time of shipment ** Omeprazole 20mg capsules Minimum 500 count bottles 66,000,000 Omeprazole 20mg capsules BULK 280,000,000 *Must be in package size of a minimum of 500 capsules (see paragraph 6) **Must not be less than 18 months (see paragraph 6) *** The estimated annual usage cited above is the Government s total estimated usage for the strength listed. There is no expressed or implied guarantee that the estimated quantities will be purchased under this BPA. Actual quantities purchased may exceed or be less than those represented. **** This price per tablet must be fixed for the entire period of performance, including option years. SCOPE: This is a request for a Blanket Purchase Agreement (BPA) quotation for Omeprazole capsules, pursuant to Clause I-FSS-646 of your Federal Supply Schedule (FSS) contract. The Department of Veterans Affairs, National Acquisition Center (NAC) intends to establish a BPA for Omeprazole capsules for use by Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacies (CMOP) and VA Medical Centers under VA s Pharmaceutical Repackaging Program. The purpose of this BPA is to obtain the product in large package sizes (see paragraph 6) and have it repackaged by the current repackaging contractor, Aphena Pharma Solutions, into unit of use package sizes under VA s Pharmaceutical Repackaging Program. Aphena Pharma Solutions will deliver the repackaged product directly to VA CMOPs and VA Medical Centers. This will result in a continuous supply source of Omeprazole capsules in the required sizes to the Government. Aphena Pharma Solutions serves as a unit-of-use repackager and distributor for generic pharmaceuticals under a separate contract on VA s Pharmaceutical Repackaging Program. The VA National Acquisition Center, Pharmaceutical Repackaging Program Contracting Officer intends to order this product from the successful offeror of this BPA once or several times a month for direct delivery F.O.B. Destination by the BPA contractor to Aphena Pharma Solutions, Cookeville, Tennessee. The following provides an overview of the terms and conditions of the resultant BPA: Each offered package size must be included in the offeror s FSS contract prior to responding to this RFQ. Tablets must be compatible with automated dispensing units (Baxter ATC Canister, OptiFill, etc.) C. If the offeror is not the manufacturer, the offeror shall submit with its quotation 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 period of this agreement, OR (2) evidence that the offeror will have an uninterrupted source of supply from which to satisfy the Government s requirements for the term of this agreement. If the offeror and its manufacturer are affiliates, the letter of commitment or evidence as required herein is required of the manufacturing facility, regardless of the relationship with the offeror. Offerors that fail to provide this information before establishment of the BPA shall be rejected and will receive no further consideration. All sales under the resultant BPA must be included in the total quarterly sales reported under the BPA holder s current FSS contract and are subject to the Industrial Funding Fee (IFF). Sales under this agreement must also be reported separately in accordance with Section 22 of this BPA entitled, Reports . The BPA holder shall provide written notice to the VA National Acquisition Center, Pharmaceutical Repackaging Program Contracting Officer, of any changes to its FSS contract, specifically to any items on the resultant BPA. Changes include, but are not limited to, price decreases, product deletions, and/or change in contractor company information, including contract administrator, company name, address and phone number. PERIOD OF AGREEMENT. This BPA is effective the date it is signed by the Government; however, delivery of the initial order will not be required sooner than 10 days ARO in accordance with paragraph 4. The BPA will have a period of agreement of one year, with two one-year option periods or until expiration of the contractor s FSS contract period (including extensions), whichever is earlier. In accordance with FAR 8.405-3(e), the Government shall conduct an annual review of the established BPA. Upon completion of the annual review, a determination will be made whether or not it is in the best interest of the Government to exercise an option period and continue with performance of the BPA. Technical Requirements. This BPA will be established with the responsible offeror that submits the lowest price per tablet and meets the following technical requirements for the request for quotation. The technical requirements include: 1) The offered items must fully meet the product description, to include, the drug name, strength(s), and package size(s), as stated in the chart above; 2) The National Drug Code (NDC) number of the offered product must be unique to the offeror; 3) All offered pharmaceuticals must be Food and Drug Administration (FDA) approved and will be verified on the FDA website; and 4) The Manufacturing Facility/Place of Performance must be FDA cGMP acceptable. UNINTERRUPTED SOURCE OF SUPPLY. By submission of a quotation, the offeror guarantees to provide an uninterrupted source of supply of the product from which to satisfy the Government's requirement for the performance period of the resultant BPA. If the contractor anticipates terminating production of a product under this BPA, and contemplates replacement with an alternative product, VA reserves the right to evaluate the potential replacement product. There is no guarantee that VA will evaluate any replacement product favorably. BACKORDERS. This BPA will be VA s primary source of supply. VA s ability to provide quality healthcare to its patient population is severely impaired when a BPA product is not available due to backorders. The purpose of this paragraph is to provide guidance to the successful offeror regarding a temporary solution to BPA backorders that may be implemented in lieu of the Government exercising the cancellation provision of this BPA. For purposes of this BPA, a backorder occurs when VA issues an order with the established contractor for the product in this BPA, and the complete order quantity is not delivered to Aphena within 10 days after receipt of order. The established contractor shall inform the Pharmaceutical Repackaging Program Contracting Officer within 4 calendar days of order receipt if a product is backordered and will not be delivered on time. In addition to informing the contracting officer of the backorder, the contractor shall provide an estimated date when the backorder will be delivered. If this delivery date is in excess of the 10 calendar days allowed in paragraph 18. Delivery and Ordering Requirements, the Government may order product from an alternate source until the backorder is resolved and bill the contractor for any excess procurement costs. In other words, if the government must purchase product from another vendor because of a BPA backorder, the contractor will issue credit or reimburse the Government for the difference between the purchase price and the established BPA price within 30 calendar days after receipt of notification. INITIAL ORDER. The resultant BPA contractor may be required to fill an initial order for a 60-day supply that will be placed by the Government for shipment to the designated repackager. Delivery to the designated repackager must be made no later than 10 days after issuance of the initial order or sooner upon mutual agreement between the Government and the BPA contractor. Subsequent orders will be placed in accordance with paragraph 18. EXPIRATION DATING. A BPA will be established with the offeror whose offer provides product with a minimum expiration dating of 18 months, and which provides the lowest price per tablet to the VA. The minimum dating of 18 months shall start from the date of shipment by the BPA contractor to the Pharmaceutical Repackager. MINIMUM PACKAGE SIZE. The minimum package size for the bottles is 500 count. The 500 count will be accepted for the bulk but a larger package size is desired for the bulk. Regardless of offered size, evaluation will be based on price per tablet. Any size quoted shall be on the offerors FSS contract. NATIONAL DRUG CODE (NDC) NUMBER. The resultant BPA contractor shall utilize NDC numbers that are unique to the offeror as product identifiers. The resultant BPA contractor shall also provide UPN bar code compliant labels on all packaging sizes down to the unit of measure. LABELER CODE. Dealers must provide their own labeler code to be used in the National Drug Code (NDC) number for the offered item. Dealers must be approved with the U.S. Food & Drug Administration (FDA) for its own labeler code prior to submitting a quotation. Offerors that do not have an FDA approved labeler code by the RFQ closing date will be rejected and will receive no further consideration. NEW DRUG APPLICATION. By submitting a quotation, the offeror certifies that it has on file (if any of the following are required by FDA for the stated drugs) a FDA approved New Drug Application (NDA), or approved Abbreviated NDA (ANDA), or a Biological License approval, as appropriate for the item offered. THERAPEUTIC EQUIVALENCE. 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 the drugs in the family group are B rated. In that case, no BPA will be established other than to the innovator unless the non-innovator contractor submits acceptable data demonstrating bioequivalence. 12. PRODUCT REGISTRATION. Product information pertaining to all items offered under this Request for Quotation, including the offeror s unique National Drug Code(s) (NDC), must be submitted to First Data Bank, Medispan and Multum prior to the effective date of contract performance. A New Product Submission Form can be obtained by emailing MultumSupport@Cerner.com. All new products and product updates should be sent to Cerner Multum at mfgproducts@cerner.com MANUFACTURING LOCATION. Only quotes from companies that have an acceptable cGMP status on record with the FDA will be considered for award. Please complete the information required in paragraph 25 for the product offered under this RFQ. ESTABLISHMENT OF BPA. A single BPA will be established under an FSS contract in accordance with the procedures of FAR 8.405-3. VA may elect to establish the BPA based on an initial quote; therefore, offerors are encouraged to provide their best price in their initial offer. The Government reserves the right to conduct negotiations if determined by the Contracting Officer to be necessary. Establishment of a BPA will be made based on the lowest price per tablet to the offeror that meets all requirements of this RFQ/BPA. This price per tablet must be fixed for the entire period of performance, including option years. EXTENT OF OBLIGATION. The Government is obligated only to the extent of authorized purchases actually made under the resultant BPA. This BPA does not obligate any funds. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE RESULTANT BPA. VA National Acquisition Center, National Contracts Service, Pharmaceutical Division Contracting Officers are the only authorized individuals who may place delivery orders under a resultant BPA. ORDERING METHOD. Orders will be placed once or several times a month against this BPA electronically via email by the VA National Acquisition Center, Pharmaceutical Repackaging Program Contracting Officer. FOB DESTINATION. Prices offered and established under the resultant BPA shall be F.O.B Destination to Aphena Pharma Solutions, Cookeville, TN or any subsequent awarded repackager. DELIVERY AND ORDERING REQUIREMENTS. The delivery time offered for all orders placed by the VA National Acquisition Center, Pharmaceutical Repackaging Program Contracting Officer, against the resultant BPA, shall not exceed 10 calendar days after receipt of order (ARO). Indicate if delivery time of less than 10 calendar days can be offered: ___________________. DELIVERY TICKETS. At a minimum, delivery tickets or sales slips must contain the following information and must accompany all deliveries under this BPA, unless otherwise agreed to: Name of the contractor FSS Contract Number BPA Number National Drug Code (NDC) Purchase Order Number Date of purchase Date of shipment Quantity, unit price, and extension of each item INVOICES. The itemized invoice shall identify the ship-to-address of supplies as stated on the Delivery Order, the BPA number, and the delivery/purchase order number assigned by the NAC Pharmaceutical Repackaging Program at the time of order placement. Invoices are submitted to Hines Fiscal for payment. REPORTS. In order to track compliance under the Pharmaceutical Repackaging Program, VA requires the contractor to submit the Contractor s Report of Sales for National Contracts form (furnished at time of BPA execution). This report shall provide a quarterly report of sales, by line item, no later than 60 calendar days after the end of each calendar quarter ending December (1st quarter), March (2nd quarter), June (3rd quarter), and September (4th quarter). This report is in addition to and separate from the quarterly sales report that is submitted to the VA FSS Contracting Officer under the terms of the FSS contract. Reports shall be faxed or sent electronically to the contracting officer at Bonita.Smith@va.gov CANCELLATION. Either party may terminate this BPA at any time upon 30 days prior written notice to the other party. The cancellation will take effect 30 calendar days after the other party receives the notice of cancellation. ORDER OF PRECEDENCE. The terms and conditions of the contractor's FSS contract (including any contract modifications) apply to all Blanket Purchase Agreements (BPA) and task or delivery orders issued under the contract as a result of this RFQ. When a lower price has been established, or when the delivery terms, FOB terms, or ordering requirements have been modified by the BPA or task/delivery order, those modified terms will apply to all purchases made pursuant to it and take precedence over the FSS contract. Any unique terms and conditions of a BPA or order issued under the contract that are not a part of the applicable FSS contract will govern. In the event of an inconsistency between the terms and conditions of a BPA or task/delivery order and the Contractor's FSS terms, other than those identified above, the terms of the FSS contract will take precedence. MANUFACTURER/DISTRIBUTOR. Please provide the complete name and address of the manufacturer below. Check the box below that is applicable to this offer. Please note that the information required below must be the name and address of the manufacturing facility, rather than the address of the headquarters, distributor or agent. ( ) OFFEROR IS THE MANUFACTURER (AT THE FOLLOWING LOCATIONS) OF THE PRODUCTS OFFERED ON THIS SOLICITATION. ( ) OFFEROR IS A DISTRIBUTOR OF THE PRODUCTS OFFERED ON THIS SOLICITATION. THE PRODUCTS WILL BE MANUFACTURED BY THE FOLLOWING COMPANY AT THE FOLLOWING LOCATIONS: (Name of Manufacturing Company) (Street Address) (Post Office Address Not Acceptable) ____________________________________________________________ (U.S.A. Point of Contact, e-Mail Address and U.S.A Telephone Number) PHARMACEUTICALS PARENTERALS SOLICITATION ITEM# LOCATION AND OWNER OF FACILITY POINT OF AND PRODUCT NAME WHERE INGREDIENTS ARE MEASURED, CONTACT WEIGHED, MIXED AND COMPOUNDED INCLUDING (Facility Owner Name, Address, City PHONE # County, State and Zip Code) PHARMACEUTICALS PARENTERALS, STERLIZATION SOLICITATION ITEM# STERILIZATION AND OWNER POINT OF AND PRODUCT NAME LOCATION (Facility Owner Name, CONTACT Address, City, County, State and Zip Code) INCLUDING PHONE # TABLETS, CAPSULES AND PILLS SOLICITATION ITEM# LOCATION AND OWNER OF FACILITY POINT OF AND PRODUCT NAME WHERE INGREDIENTS ARE MEASURED, CONTACT WEIGHED, MIXED AND COMPOUNDED INCLUDING (Facility Owner Name, Address, City PHONE # County, State and Zip Code) OTHER PHARMACEUTICAL PRODUCTS (Solutions, syrups, mixtures, powders, ointments, pastes, creams, etc.) SOLICITATION ITEM# LOCATION AND OWNER OF FACILITY POINT OF AND PRODUCT NAME WHERE INGREDIENTS ARE MEASURED, WEIGHED, MIXED AND COMPOUNDED (Facility Owner Name, Address, City County, State and Zip Code) CONTACT INCLUDING PHONE # PACKAGING SOLICITATION ITEM# LOCATION OF FACILITIES WHERE POINT OF AND PRODUCT NAME INTERMEDIATE CONTAINERS WILL CONTACT BE FILLED AND LABELED (Facility Name, INCLUDING Location, City, County, State and Zip Code) PHONE PACKING SOLICITATION ITEM# LOCATION OF FACILITIES WHERE POINT OF AND PRODUCT NAME PRODUCTS WILL BE PACKED AND CONTACT PREPARED FOR SHIPMENT (Facility Name, INCLUDING Location, City, County, State and Zip Code) PHONE #