Ephinephrine Injector Solicitation_updated9.30.26.docx

SOLICITATION NO. SPE2D2-26-R-0009

Table of Contents

Page

Caution Notices

Contract Clauses

Statement of Work

Solicitation Provisions

Procurement Notes

Appendixes

CONTINUATION OF SF 1449

Block 9, Issued By: Submission Instructions › Submit offers “electronically” at the Defense Logistics Agency Internet Bid Board System (DIBBS) https://www.dibbs.bsm.dla.mil/ › Instructions

· Vendors are required to register for DIBBS prior to submission of any offer.

· Registration assistance and guidelines may be found at: https://www.dibbs.bsm.dla.mil/refs/help/Registration/RegistrationGuidelines.aspx

· When registered, the vendor may submit an offer in response to a solicitation found on the RFP search screen by selecting the “Offer” icon. The button will only be selectable for vendors who are logged onto DIBBS. If not logged in yet, DIBBS will take you to the log in screen.

· Solicitation Number: SPE2D2-26-R-0009

· Opening/Closing Date and Time: October 1, 2026 to November 2, 3:00PM ET.

· Upload a completed offer and all associated documents. The SF 1449 must be signed and the offer completed in its entirety in accordance with the solicitation requirements. Do not select “submit” until all associated documents are added. No data will be saved unless the offer is submitted. Once submitted, documents may be added, but not removed. No documents may be submitted after the closing date on November 2, 2026 3:00PM ET.

· If the ability to upload proposals is unavailable for any reason, this does not constitute an acceptable reason for a late offer.

· CAUTION – Late submissions, modifications, revisions, and withdrawals of offers: See Section L, Provision No. 52.212-1(c) (Page 30 of the solicitation).

· The instructions to upload a solicitation and associated documents can be found at: https://www.dla.mil/Portals/104/Documents/InformationOperations/EBS%20Supplier%20Information/Upload%20Proposal%20DIBBS%20Help_1.docx?ver=2020-04-23-150759-460

(Please contact Jeremy.Brown@dla.mil with any questions or technical issues related to DIBBS submission of offers for this solicitation.)

Block 17a: Contractor/Offeror › Offeror’s assigned Unique Entity Identifier Number:_______________ (If you do not have a Unique Entity Identifier number, contact the individual identified in Block 7a of the SF 1449 or see FAR 52.204-7(b)(1)(i) for information on establishing a unique entity identifier) › Offeror’s assigned Contractor and Government Entity (CAGE) Code:__________________

Block 17b: Remittance Address (if different from Contractor/Offeror address in block 17a of the SF 1449.)

Blocks 19-22:

Item No., Schedule of Supplies/Services, Quantity, Unit:

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

ESTIMATED QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

0001AA

0001AB

0001AC

0001AD

0001AE

Epinephrine 0.3 MG/0.3 ML Injection, Auto – Injector 2S – 2 count box*

National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

* Package size is unit of use and is subject to Statement of Work – “Preparation for Delivery” requirement.

**BX=Box -The quantities specified in the Schedule are estimates only. Reference FAR 52.216-21 Requirements for details.

473,905

473,905

BX**

BX

BX

CAUTION NOTICE

1. Offerors are required to submit offers via the Defense Logistics Agency Internet Bid Board System (DIBBS).

See page 4: Submission Instructions for link to DIBBS. Upload of offer to DIBBS is the only authorized method of proposal submittal. Offers submitted by email, postal mail, or physical delivery ARE NOT AUTHORIZED.

2. Reverse Auction Notification This solicitation contains DLAD Procurement Note L09 for Reverse Auction (RA). The Government may activate this provision after timely offers have been received and evaluated. Prior to doing so, the Contracting Officer will establish a competitive range, decide whether an RA will be conducted, and determine which offerors will participate in this event. Firms removed from the competitive range will be notified in writing prior to the Government conducting the RA.

The RA vendor provides the tool/software that allows for the reverse auction. By submitting an offer, the offeror consents that the reverse auction vendor may have access to its submitted data for the purpose of the reverse auction. RA vendors are bound by confidentiality agreement. Offeror will also agree to terms and conditions of the entire solicitation and the commercial reverse auction service, and training will be required to participate.

3. Subcontracting Plan Pursuant to the requirements of Public Law 95-507, all large business offerors must submit a subcontracting plan with their offer. All large business concerns are required to have an approved subcontracting plan for contracts expected to exceed $900,000 before the Government can award a contract (see FAR 52.219-9 for details). Offerors must submit a currently approved commercial plan or a new plan for review and approval.

Instructions for submitting the subcontracting plan are included in FAR 52.212-1 Addendum 2. Contractors are required to report progress on subcontracting goals in SAM.gov.

4. Assessments/Reports DLA Troop Support evaluates contractor performance on all contracts that exceed $350,000.00 and shares those evaluations with other federal government agencies. The FAR requires that the contractor be provided with an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement, DLA Troop Support will be using an online database, the Contractor Performance Assessment Reporting System (CPARS). Annual reporting of past performance will be completed at https://www.cpars.gov.

5. Contractor Code of Business Ethics FAR Part 3.1002(a) requires all Government contractors to conduct themselves with the highest degree of integrity and honesty. Contractors should have a written code of business ethics and conduct within thirty days of award. To promote compliance with such code of business ethics and conduct, contractors should have an employee business ethics and compliance training program that facilitates timely discovery and disclosure of improper conduct in connection with Government contracts and ensures corrective measures are promptly instituted and carried out. A contractor may be suspended and/or debarred for knowing failure by a principal to timely disclose to the Government, in connection with the award, performance, or closeout of a Government contract performed by the contractor or a subcontract awarded there under, credible evidence of a violation of federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations found in title 18 of the United States Code or a violation of the False Claims Act. (31 U.S.C. 3729-3733)

If this solicitation or contract includes FAR clause 52.203-13 - CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT; the contractor shall comply with the terms of the clause and have a written code of business ethics and conduct; exercise due diligence to prevent and detect criminal conduct; promote ethical conduct and a commitment to compliance with the law within their organization; and timely report any violations of federal criminal law involving fraud, conflict of interest, bribery or gratuity violations found in title 18 of the United States Code or any violations of the False Claims Act. (31 U.S.C. 3729-3733). When FAR 52.203-13 is included in the contract, contractors must provide a copy of its written code of business ethics and conduct to the contracting officer upon request by the contracting officer.

CONTRACT CLAUSES

FAR 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014)

The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

FAR 52.216-21 Requirements (DEVIATION 2026-O0038) (FEB 2026)

(a) This is a requirements contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies or services specified in the Schedule are estimates only and are not purchased by this contract. Except as this contract may otherwise provide, if the Government’s requirements do not result in orders in the quantities described as "estimated" or "maximum" in the Schedule, that fact shall not constitute the basis for an equitable price adjustment.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. Subject to any limitations in the Order Limitations clause or elsewhere in this contract, the Contractor shall furnish to the Government all supplies or services specified in the Schedule and called for by orders issued in accordance with the Ordering clause. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(c) Except as this contract otherwise provides, the Government shall order from the Contractor all the supplies or services specified in the Schedule that are required to be purchased by the Government activity or activities specified in the Schedule.

(d) The Government is not required to purchase from the Contractor requirements in excess of any limit on total orders under this contract.

(e) If the Government urgently requires delivery of any quantity of an item before the earliest date that delivery may be specified under this contract, and if the Contractor will not accept an order providing for the accelerated delivery, the Government may acquire the urgently required goods or services from another source.

(f) Any order issued during the ordering period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s ordering period; provided, that the Contractor shall not be required to make any deliveries under this contract after the last outstanding delivery is received for orders placed by the expiration date of the contract.

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 60 day of expiration provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years.

FAR 52.219-28 Postaward Small Business Program Representation (DEVIATION 2026-O0038) (FEB 2026)

(a) Definitions. As used in this clause— Long-term contract means a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority.

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of this clause.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

(b) If the Contractor represented that it was a small business concern, a small disadvantaged business concern, or a joint venture that was any of the small business concerns identified in 19.000(a)(3) prior to award of this contract, the Contractor shall represent its size and socioeconomic status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon occurrence of any of the following:

(1) Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.

(2) Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.

(3) For long-term contracts-

(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and

(ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.

(c) The Contractor shall represent its size status in accordance with the size standard in effect at the time of this representation that corresponds to the North American Industry Classification System (NAICS) code(s) assigned to this contract. The small business size standard corresponding to this NAICS code(s) can be found at https://www.sba.gov/document/support--table-size-standards.

(d) The small business size standard for a Contractor providing an end item that it does not manufacture, process, or produce itself, for a contract other than a construction or service contract, is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition—

(1) Was set aside for small business and has a value above the simplified acquisition threshold;

(2) Used the HUBZone price evaluation preference regardless of dollar value, unless the Contractor waived the price evaluation preference; or

(3) Was an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(e) Except as provided in paragraph (g) of this clause, the Contractor shall make the representation(s) required by paragraph (b) of this clause by validating or updating all its representations in the Representations and Certifications section of the System for Award Management (SAM) and its other data in SAM, as necessary, to ensure that they reflect the Contractor's current status. The Contractor shall notify the contracting officer in writing within the timeframes specified in paragraph (b) of this clause, that the data have been validated or updated, and provide the date of the validation or update.

(f) If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs (e) or (g) of this clause.

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following representation and submit it to the contracting office, along with the contract number and the date on which the representation was completed:

(1) The Contractor represents that it □ is, □ is not a small business concern under NAICS Code _____ assigned to contract number _____.

(2) [Complete only if the Contractor represented itself as a small business concern in paragraph (g)(1) of this clause.] The Contractor represents that it □ is, □ is not, a small disadvantaged business concern as defined in 13 CFR 124.1001.

(3) Women-owned small business (WOSB) joint venture eligible under the WOSB Program. The Contractor represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The Contractor shall enter the name and unique entity identifier of each party to the joint venture: __.]

(4) Economically disadvantaged women-owned small business (EDWOSB) joint venture. The Contractor represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The Contractor shall enter the name and unique entity identifier of each party to the joint venture: __ .]

(5) Service-disabled veteran-owned small business (SDVOSB) joint venture eligible under the SDVOSB Program. The Contractor represents that it □ is, □ is not an SDVOSB joint venture eligible under the SDVOSB Program that complies with the requirements of 13 CFR 128.402. [ The Contractor shall enter the name and unique entity identifier of each party to the joint venture: __.]

(6) HUBZone joint venture eligible under the HUBZone Program.[ Complete only if the offeror is a HUBZone small business concern. ] The offeror represents, as part of its offer, that It □ is, □ is not a HUBZone joint venture that complies with the requirements of 13 CFR 126.616(a) through (c). [ The Contractor shall enter the name and unique entity identifier of each party to the joint venture: _____. ] Each HUBZone small business concern participating in the HUBZone joint venture must be certified as a HUBZone concern. [ Contractor to sign and date and insert authorized signer's name and title.]

FAR 52.252-6 Authorized Deviations in Clauses (NOV 2020)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of (DEVIATION) after the date of the clause.

(b) The use in this solicitation or contract of any Defense Acquisition Regulations System, Department of Defense (48 CFR Chapter 2) clause with an authorized deviation is indicated by the addition of (DEVIATION) after the name of the regulation.

DFARS 252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services (DEVIATION 2026-O0025) (FEB 2026)

(a) Definitions. As used in this clause— “Covered defense telecommunications equipment or services” means—

(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation, or any subsidiary or affiliate of such entities;

(2) Telecommunications services provided by such entities or using such equipment; or

(3) Telecommunications equipment or services produced or provided by an entity that the Secretary of Defense reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.

“Covered foreign country” means—

(1) The People’s Republic of China; or

(2) The Russian Federation.

“Covered missions” means—

(1) The nuclear deterrence mission of DoD, including with respect to nuclear command, control, and communications, integrated tactical warning and attack assessment, and continuity of Government; or

(2) The homeland defense mission of DoD, including with respect to ballistic missile defense.

“Critical technology” means—

(1) Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;

(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled—

(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or

(ii) For reasons relating to regional stability or surreptitious listening;

(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);

(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);

(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or

(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).

“Substantial or essential component” means any component necessary for the proper function or performance of a piece of equipment, system, or service.

(b) Prohibition. In accordance with section 1656 of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91), the contractor shall not provide to the Government any equipment, system, or service to carry out covered missions that uses covered defense telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless the covered defense telecommunication equipment or services are covered by a waiver described in Defense Federal Acquisition Regulation Supplement 204.2104 .

(c) Procedures. The Contractor shall review the list of excluded parties in the System for Award Management (SAM) at https://www.sam.gov for entities that are excluded when providing any equipment, system, or service, to carry out covered missions, that uses covered defense telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless a waiver is granted.

(d) Reporting.

(1) In the event the Contractor identifies covered defense telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system, during contract performance, the Contractor shall report at https://dibnet.dod.mil the information in paragraph (d)(2) of this clause.

(2) The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause:

(i) Within 3 business days from the date of such identification or notification: the contract number; the order number(s), if applicable; supplier name; brand; model number (original equipment manufacturer number, manufacturer part number, or wholesaler number); item description; 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.

(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/Title48/48tab_02.tpl

· DLAD: http://www.dla.mil/HQ/Acquisition/Offers/DLAD.aspx

The following additional clauses are incorporated by reference:

CLAUSE NUMBER

FAR

DFARS

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 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.

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.

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 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.medispan.com/manufacturers-exchange.aspx http://www.fdbhealth.com/solutions/manufacturer-relations/ MultumSupport@Cerner.com

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 (800) 633-3453, extension 566, or information can be obtained l at http://www.fdbhealth.com/solutions/manufacturer-relations/. Medispan information can be obtained at http://www.medispan.com/drug-information-products/. 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.

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:

Glass bottles are not acceptable.

Tablets/capsules must be compatible with automated dispensing units (Baxter ATC Canisters, OptiFill, etc.).

17. 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…