PHARM MANUF/DISTR DIV - FSA

; and any readily available information about mitigation actions undertaken or recommended.
(ii) Within 30 business days of submitting the information in paragraph (d)(2)(i) of this clause: any further available information about mitigation actions undertaken or recommended. In addition, the Contractor shall describe the efforts it undertook to prevent use or submission of a covered defense telecommunications equipment or services, and any additional efforts that will be incorporated to prevent future use or submission of covered telecommunications equipment or services.
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(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e), in all subcontracts and other contractual instruments, including subcontracts for the acquisition of commercial products or commercial services.
FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):
- FAR: https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52
- DFARS https://www.ecfr.gov/cgi-bin/text idx?SID=2a65ee6d124e0949d61d01c7d637b675&mc=true&tpl=/ ecfrbrowse/Title48/48tab02.tpl · DLAD: http://www.dla.mil/HQ/Acquisition/Offers/DLAD.aspx http://www.dla.mil/HQ/Acquisition/Offers/DLAD.aspx
The following additional clauses are incorporated by reference:
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STATEMENT OF WORK
1. Background The Defense Logistics Agency (DLA) Troop Support, Directorate of Medical Materiel provides pharmaceutical products for the Department of Defense (DoD) to its customers through its Pharmaceutical Prime Vendor (PPV) program. The Department of Veterans Affairs (VA) provides pharmaceutical products to its customers as well as the Indian Health Service (IHS) and the Bureau of Prisons (BoP) through the VA Pharmaceutical Prime Vendor Program. Hereafter these programs are collectively referred to as the “PPV.” A prime vendor is an independent business concern that functions as a purchaser's primary source for specified classes of products and is responsible for the delivery of goods produced by various suppliers. As a part of the Pharmaceutical Prime Vendor Program, this solicitation will establish a national contract for the items listed in the schedule. The PPV Programs consist of separate contracts which establish the fees for the distribution of pharmaceutical products that are distributed through the PPV Programs on Federal Government (i.e., Federal Supply Schedules, DLA National Contracts) contracts. The awardee consents to allow VA and DLA Troop Support Prime Vendors to distribute the listed products in the schedule.
2. Purpose and Objective A contract resulting from this solicitation will establish a national supply source, in accordance with FAR 52.216-21 Requirements, to provide the drugs listed in the schedule for purchase by DLA and VA customers through the PPV. The annual usage for DLA, VA, BoP and IHS customers served through the Prime Vendor Programs is estimated in the Schedule of Supplies. The objective of the contract is to ensure availability and consistency of product and to obtain volume-based, committed use pricing.
3. Purchase Compliance Ordering activities will purchase the selected contractor's product for the items listed in the Schedule of Supplies section of this Solicitation through the DLA or VA PPV contractors except when: (1) the contracted items is/are unavailable to meet the needs of the Government or (2) an alternate is requested by the prescribing healthcare provider, or (3) the contract holder does not participate in third party reimbursement programs, such as the Medicaid Rebate Program (#3 applies to IHS requirements only).
4. Extent of Obligation The contractor shall provide the products specified in the schedule to all DLA and VA PPV contractors in order to facilitate the products' availability for all eligible DoD, VA, BoP and IHS ordering activities.
5. Contract Price Effective Date The Contract Price Effective Date shall be no more than 60 calendar days after award.
6. Contract Performance Date The contract performance date shall be 45 calendar days (or sooner upon mutual agreement) after the date of contract award. This is the date the contractor shall be ready to fill orders from the PPV contractors.
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The contract prices shall be effective 15 calendar days after the contract performance date. Before the contract performance date, the PPVs will begin placing orders with the contractor for delivery to multiple PPV distribution centers for distribution to the participants under this contract. See Appendix A for the current list of PPVs. The current PPV contractors may change and the contractor will be notified of any changes in PPV contractors during the term of the contract resulting from this solicitation. The contractor shall ensure that sufficient inventory of contract items awarded under this solicitation is available to ensure delivery to the PPV distribution centers within 15 days of the contract performance date. In order to facilitate the sale of the awardee's product to Government ordering activities through the DLA and VA PPV contractors, the awardee shall enter into business-to-business agreements with each of the DLA and VA PPV contractors. Payment terms, time and place of delivery to PPV distribution centers, and other relevant terms shall be agreed upon between the PPV contractors and the contractor awarded a contract from this solicitation in these agreements. The Government is not obligated to become involved in or assume any responsibility for financial or other disputes involving these agreements. Offerors may approach the PPV contractors regarding establishing business-to-business agreements prior to submitting an offer in response to this solicitation. Within 15 days from receipt of award, the Contracting Officer shall be notified by the contractor if any business-to-business-agreements cannot be reached with the PPV contractors.
7. Chargeback Agreements Chargeback arrangements shall be coordinated between the prime vendors and the successful contractor.
8. Special Contract Considerations As discussed in Section 2, this solicitation establishes a supply source to provide the drugs listed in the schedule for purchase through the PPV programs. Additionally, as outlined in Section 6, the awarded contractor under this solicitation must reach a business-to-business agreement with each of the DLA and VA PPV contractors. Because the PPV contractors distribute the supplies sourced from this solicitation, special contract considerations apply.
Under this resulting contract, the contractor will be receiving payments from the PPV contractors instead of directly from the Government. Due to this unique payment structure, the contractor cannot assign its rights to receive payment under this contract. Additionally, disputes arising between the awardee and the PPV contractors do not give rise to a “claim” under the Disputes Clause. Finally, no invoices will be provided from the contractor to the Government ordering facilities. Instead, the contractor shall submit invoices in accordance with the business-to-business agreements reached with the PPV contractors.
9. Delivery The complete order quantity shall be delivered to the PPV contractors within 15 calendar days after receipt of order.
Other delivery requirements including but not limited to product quantities, time and place of delivery and method of delivery for products awarded as a result of this procurement action will be determined by the contract awardee and the prime vendors.
10. Transition Period After the effective date a short phase-in period may be needed to convert patients and medical centers to the awarded products. Every effort will be made to begin transitioning as many patients as possible by the contract performance date.
11. Contract Duration The contract resulting herein will be for a one year base period and include four option years for a maximum possible term of five years. The contract will not exceed five years.
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12. Ordering and Acceptance of Orders The contractor agrees to accept orders that are placed by, and provide items to, the prime vendors for use by medical treatment facilities, formularies, eligible beneficiaries and other ordering activities served by the DLA and VA PPV contractors. The Government reserves the right to delete ordering sites/activities which are current prime vendor customers during the effective period of this contract. In addition, the Government reserves the right to add Government pharmacies and ordering activities, including the pharmacies and ordering activities of agencies, which are not current PPV customers, during the effective period of this contract. There is no expressed or implied guarantee that the estimated quantity will be purchased under this contract. Actual quantities purchased may exceed or be less than those represented.
The Government also reserves the right to add other federally funded customers, including those that are not served by the DLA PPV contractors, during the life of the awarded contract. However, the estimated quantities in Appendix B: Agency Annual Demand Projections are based on DoD, Department of VA, IHS, and BoP demand. Offeror's proposals should be based on the estimated quantities in Appendix B.
The price the Government pays a PPV contractor for the awardee's product will be adjusted by the distribution fees established by the terms of that PPV contractor's separate contract with the Government. All of the DLA PPV contractors' contracts with the Government currently contain negative distribution fees. This means that the price paid by the Government to a PPV contractor for the awardee's product may be less than the unit price established by a contract awarded from this Solicitation.
13. Initial Orders Ordering activities (DoD, VA, IHS, and BoP) may place initial orders with the PPV contractors totaling up to 30% of each agency's stated estimated annual contract quantities, located in Appendix B: Agency Annual Demand Projections, immediately upon the contract effective date. The Contract Price Effective Date shall be no more than 60 days after award. Initial orders totaling up to 30% of each agency's stated estimated annual contract quantities may be placed by the PPV contractors with the national contract awardee of this solicitation to fulfill the initial order requirements.
14. National Contract Backorders The ability of the DoD, VA, IHS, and BoP to provide quality healthcare to its patient population is severely impaired when a national contract product is not available due to backorders. The purpose of this paragraph is to provide guidance to the awarded contractor regarding a temporary solution to national contract item backorders that may be implemented in lieu of the Government terminating the contract for cause. However, nothing in this section will waive any of the Government's rights to terminate the contract for cause in accordance with FAR 52.212-4(m). For purposes of this contract, a backorder occurs when a Pharma Prime Vendor issues an order with the awardee of this National Contract, for the products in this solicitation, and the complete order quantity is not delivered to the PPV contractor within 15 calendar days after receipt of order. This includes initial Consolidated Mail Order Pharmacy (CMOP) orders. If a national contract item is backordered by a PPV contractor, the contracting officer will review the backorder to determine the cause of the backorder. The awarded contractor shall inform the contracting officer within 4 calendar days after a backorder occurs or is foreseen. In addition to informing the contracting officer of the backorder, the awardee shall provide an estimated date when the backorder will be shipped, and may propose a solution to satisfy the Government's needs for the contract items until the backorder is resolved. The Government reserves the right to accept or reject any possible solutions that the awardee may propose to alleviate a national contract backorder situation. In the event of a back order, the Government may authorize the PPV contractors to acquire the same or similar items from another source. If the contracting officer
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determines that the backorder is awardee-caused, the contracting officer will bill the awardee for any excess procurement costs. In other words, if the government purchases product from another vendor because of an awardee-caused backorder, the awardee will issue credit or reimburse the Government for the difference between the purchase price and the contract price within 30 calendar days after receipt of notification. The awardee shall also provide written verification to the Contracting Officer when credits or reimbursement have been made within 30 calendar days from date of reimbursement. After an awardee-caused backorder, the Government's decision to implement the process described above will not deprive the Government of its right under FAR 52.212-4 (m) to terminate the contract.
15. Product Registration Product information pertaining to all items offered under this solicitation must be registered with RXNorm, First Data Bank and Medi-Span prior to the effective date of contract performance. Details on submitting this information can be found at the following links: http://www.nlm.nih.gov/research/umls/rxnorm/ http://www.nlm.nih.gov/research/umls/rxnorm/ http://www.medispan.com/manufacturers-exchange.aspx http://www.medispan.com/manufacturers-exchange.aspx http://www.fdbhealth.com/solutions/manufacturer-relations/ http://www.fdbhealth.com/solutions/manufacturer-relations/ contact@example.gov
Product Registration Product information pertaining to all items offered under this solicitation, including the offeror's unique National Drug Code(s) (NDC), must be submitted to First Data Bank, Medispan and Multum 5 DAYS after award. A New Product Submission Form can be obtained by contacting First Data Bank at +1 (555) 000-0000, extension 566, or information can be obtained l at http://www.fdbhealth.com/solutions/manufacturerrelations/. Medispan information can be obtained at http://www.medispan.com/drug-information-products/. A New Product Submission Form can be obtained by emailing contact@example.gov. All new products and product updates should be sent to Cerner Multum at contact@example.gov.
16. Preparation for Delivery Preservation and packaging shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc., involving shipment from the supply source to and from the receiving activity and shall conform to the applicable carrier's rules and regulations. Tablets/capsules must be compatible with automated dispensing units (Baxter ATC Canisters, OptiFill, etc.).
All unit of use packaging (identified in schedule of supplies beginning on Page 5) must contain a child proof closure (safety cap) and a bottle with a minimum required size of 100cc volume. The safety cap must not exceed the diameter of the bottle. The bottle must have a cylindrical body and minimum of 5.75” circumference. The bottle must fit a label with dimensions of 5.25” x 2”. The 0.5” additional space is required to keep the bar code exposed and/or allow for the display of the expiration date and lot number. Sample pictures (bar code exposed) of how the label must fit the offered bottle are below:
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1. Labeling 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 GS1 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 DataBar (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 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 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
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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. Therapeutic Equivalence Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. Only Federal Drug Administration (FDA) approved products with therapeutic equivalence evaluations that resulted in a FDA Therapeutic Equivalence Code (TE Code) of “A” will be considered, unless all drugs in the family group are “B” rated. If all products in a family group have a “B” TE Code, no award will be made to other than the innovator unless the non-innovator vendor submits acceptable data demonstrating bioequivalence.
19. Drug Application By signing this solicitation, the offeror certifies that it has on file (if any of the following are required by FDA for the offered drugs) an FDA approved New Drug Application (NDA), an approved abbreviated NDA (ANDA), or a Biologic License approval, as appropriate for the items offered in response to the solicitation. The NDA, ANDA, or Biologic License must be approved no later than the time of the solicitation's closing. An offeror utilizing an NDA, ANDA, or Biologic License that is pending approval with the FDA at the time of the solicitation's closing, but has not yet been approved, is technically unacceptable and will not be considered for award. Such an offeror will remain technically unacceptable even if the NDA, ANDA, or Biologic License receives approval from the FDA after the solicitation's closing, but prior to the award of a contract.
20. Manufacturing Facilities If at any time during the term of the contract, the contractor's facility or the source from which the contractor obtains any of the products supplied by this contract is informed in a FDA “warning letter” that it fails to meet FDA current Good Manufacturing Practices (cGMP) (21 CFR Part 210 and 211), the contractor shall immediately communicate to the Contracting Officer the facility or source's cGMP violation(s) or failed inspection status as outlined in a FDA warning letter. Once the Contracting Officer is aware that the contractor's facility or the source from which the contractor obtains any of the products provided fails to meet FDA cGMP, the procedures outlined in the paragraph below will apply. These procedures will apply regardless of whether the cGMP violation(s) or failed inspection status of the contractor's facility or the source from which the contractor obtains the products was brought to the Contracting Officer's attention by the contractor or by other means.
The DLA Troop Support Contracting officer will review the contractor's (or its source's) cGMP violation(s) or failed inspection status unacceptable cGMP status with appropriate DLA clinical staff and will either:
- Instruct the contractor to stop the shipment of products listed on this contract that were manufactured, packaged, and/or packed in a facility with cGMP violation(s) or failed inspection status , or
- Authorize the contractor to continue to supply such contract products for 90 days from the date when the cGMP violation(s) or failed inspection status was brought to the Contracting Officer's attention, provided that the products have not been subjected to a consumer-level recall. Additional periods of 90 days may be authorized at the discretion of the DLA Contracting Officer.
Contractors are cautioned that products that were manufactured, packaged, and/or packed in a facility with cGMP violation(s) or failed inspection status and then shipped without written authorization from the DLA Contracting Officer shall be returned to the contractor at the contractor's risk and expense, regardless of whether the contractor
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was aware of the facility's cGMP violation(s) or failed inspection status at the time the products were shipped. The contractor (or its source) shall have corrected all significant cGMP deficiencies or have an acceptable plan with the FDA for the correction of such deficiencies which led to cGMP violation(s) or failed inspection status by the end of the 90-day authorization period as evidenced by a Corrective Action Plan submitted to the FDA and/or issuance of a “close-out letter” by the FDA and any extensions of such period granted by the DLA Contracting Officer. Additionally, the contractor is responsible for keeping the DLA Contracting Officer informed of all corrections made and shall provide the DLA Contracting Officer with: 1) written documentation of the correction plan, 2) notification from FDA of acceptance of the plan, and 3) a copy of any re-inspection requests and subsequent reports, when they are available. If the FDA's NSN/Part Number: 3RFQ3SEESOW