SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30 1000240336

1. REQUISITION NUMBER

2. CONTRACT NO. 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

SPE2DP-26-R-0002

5. SOLICITATION NUMBER

2026 SEP 28

6. SOLICITATION ISSUE

DATE

Rosbert Jones DRJ0048

a. NAME

Phone: (445)737-1254

b. TELEPHONE NUMBER (No Collect calls)

2026 OCT 14

8. OFFER DUE DATE/

LOCAL TIME

9. ISSUED BY CODE SPE2DP

DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN PHARM FSA

700 ROBBINS AVENUE

PHILADELPHIA PA 19111

USA

10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

8 (A)

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

339112NAICS:

SIZE STANDARD:

11. DELIVERYFOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/ CODE

OFFEROR

FACILITY

CODE

TELEPHONE NO.

18a. PAYMENT WILL BE MADE BY CODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

BELOW IS CHECKED

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

See Schedule

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

29. AWARD OF CONTRACT: REF. OFFER

DATED . YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (Type or Print) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or Print) 31c. DATE SIGNED

SEE SCHEDULE

7. FOR SOLICITATION

INFORMATION CALL:

SEE SCHEDULE

03:00 PM

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE ADDENDUM

EDWOSB

32a. QUANTITY IN COLUMN 21 HAS BEEN

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:RECEIVED INSPECTED

COMPLETE PARTIAL FINAL

STANDARD FORM 1449 (REV. 2/2012) BACK

36. PAYMENT

PARTIAL FINAL

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER 34. VOUCHER NUMBER 35. AMOUNT VERIFIED

CORRECT FOR

37. CHECK NUMBER

38. S/R ACCOUNT NO. 39. S/R VOUCHER NUMBER 40. PAID BY

42a. RECEIVED BY (Print)

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42b. RECEIVED AT (Location)

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 3 OF 48 PAGES

CONTINUED ON NEXT PAGE

SPE2DP-26-R-0002

Form

REFERENCE PAGE 1 OF THE STANDARD FORM 1449:

1. Block 9

Submission of Offers:

Refer to Addendum to 52.212-1, Instructions to Offerors - Commercial Products and Commercial Services and Addendum to 52.212-2, Evaluation - Commercial Products and Commercial Services for details regarding proposals that are required to be submitted in response to this solicitation. Partial proposals may not be evaluated and may not be eligible for award. Failure to submit a complete proposal before the Offer Due Date/Time (reference block 8 of SF 1449) will result in an offeror's proposal being rejected as untimely. It is the offeror's responsibility to ensure that its complete proposal is received at the designated Government office before the closing date and time specified in this solicitation.

For information on late submissions, modifications, and withdrawals please see applicable FAR provisions FAR 52.214-7 or 52.215-1, or FAR clause 52.212-1.

Offerors are responsible for submitting proposals, and any revisions, and modifications, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. Offerors may use any transmission method authorized by the solicitation.

The only method of proposal submission authorized under this solicitation is submission through the DLA Internet Bid Board System (DIBBS). Hand delivery of proposals is prohibited.

DLA Internet Bid Board System (DIBBS): An offeror must be registered in DIBBS, and able to log in, to submit an electronic proposal. Therefore, if not already registered, offerors are encouraged to register in DIBBS immediately.

Offerors who are already registered in DIBBS are encouraged at this time to ensure they can log into their DIBBS account.

An offeror's failure to register or be able to log in, or who experiences an inability to upload or submit a proposal on DIBBS for any reason other than a DIBBS system issue that has been confirmed by the DIBBS Help Desk, will not constitute an acceptable reason for a late submission.

NOTE: Proposal submissions using DIBBS are subject to electronic interface latency which can result in transmission delays. Offerors must consider transmission delays in the DIBBS system when submitting proposals for consideration and assume the risk of late transmission/submission. Offerors are encouraged to submit electronic proposals in DIBBS as early as possible to account for possible transmission delays.

Attached to this solicitation is a “How to Guide” for uploading and submitting a completed proposal and all associated documents to DIBBS.

2. Block 17a

Offeror's assigned Unique Entity Identifier Number: _________________________

Offeror's assigned Contractor and Government Entity (CAGE) Code: _________________________

3. Block 17b

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

4. Blocks 19-22 (Item No., Schedule of Supplies, Quantity and Unit)

See Section B for Item No., Schedule of Supplies, Quantity, and Unit of Issue

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 4 OF 48 PAGES

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Form (CONTINUED)

CAUTION NOTICES:

OTHER THAN FULL AND OPEN COMPETITION

The subject solicitation is being solicited on an Other Than Full and Open Competition basis. The applicable statutory authority permitting Other Than Full and Open Competition is 10 U.S.C. § 3204(a)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, as implemented by FAR 6.302-1.

SYSTEM FOR AWARD MANAGEMENT (SAM)

All offerors must register on the SAM website: https://www.sam.gov/portal/public/SAM/ in order to be considered for award. All offerors shall maintain an active SAM registration from proposal submission through award. The awardee shall maintain an active SAM registration for the duration of the contract.

Offerors are reminded to complete all applicable representations and certifications appearing in this solicitation. Failure to complete all representations and certifications may result in the offer being removed from award consideration for failure to comply with all terms and conditions of the solicitation.

52.219-28 POST AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (FEB 2024) FAR

FAR clause 52.219-28 is not being used as an evaluation factor but will apply to the subsequent award.

CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT

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. 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)

This solicitation or contract includes FAR clause 52.203-13, CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT;

contained elsewhere in the solicitation or contract, 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.

SECTION B: SUPPLIES/SERVICES AND PRICES/COSTS

ITEM: INFLUENZA VIRUS VACCINE, SOUTHERN HEMISPHERE - 2027 FORMULA FOR AGE 6 MONTHS AND OLDER, .5 ML

DOSE (SYRINGE) - 10 SYRINGES PER PACKAGE

NSN: TBD

UNIT OF ISSUE: Packages (PG) ANNUAL ESTIMATED QUANTITY: 3,000 Packages (or 30,000 doses)

PRICE PER EACH: $ __________/EA

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SPE2DP-26-R-0002

Form (CONTINUED)

TOTAL UNIT PRICE: $ __________/PG (Price shall be F.O.B. destination and exclusive of federal excise tax)

The contract awarded under this solicitation will result in firm-fixed price, indefinite delivery, indefinite quantity type contract. The contract will be for one twelve-month contract.

IMPORTANT NOTES REGARDING PROPOSAL SUBMISSION:

1. Offerors shall mark each page of their proposals with “Source Selection Information - See FAR 2.101 & 3.104.”

2. Offerors shall provide a unit price per PG below. Offerors are permitted to provide price breaks based on quantity.

Failure to provide a unit price may be deemed as non-acceptance of the terms and conditions and may result in the rejection of the offeror's entire proposal.

NOTES REGARDING SUBMISSION OF UNIT PRICES:

1. The Guaranteed Minimum Quantity of 2,250 PG as described in the chart above, is 75% of the Annual Estimated Quantity. e Government guarantees that during the duration of the contract, at least 2,250 PG, or the Guaranteed Minimum Dollar Value associated with the cost of 2,250 PG, will be ordered during the contract.

2. The Guaranteed Minimum Dollar Value is calculated by multiplying the minimum quantity described above by the offeror's unit price at the time of award and will be obligated by the Government at the time of award. The Government may fulfill the guaranteed minimum dollar value by issuing a single delivery order or any number of delivery orders.

3. The Annual Estimated Quantity refers to the Government's good faith estimate of the requirements during a specified contract term. The estimated quantity does not obligate the government to order a specific quantity; it is provided for informational purposes only. The government is only required to order the Guaranteed Minimum Quantity.

4. The Maximum Quantity of 4,500 PG as described in the chart above, is 150% of the Annual Estimated Quantity. The Government reserves the right to place orders up to the maximum quantity, but not to exceed the order limitation of FAR clause 52.216-19. The Government is not obligated to order the maximum quantity; however, the Government has the legal right to order up to this quantity prior to the final contract expiration date.

5. The Federal Excise Tax (FET) of $0.75 per dose, or $7.50 per package, will be included on the subsequent award as separate line item, and therefore the price offered on the Flu Vaccine lines shall not include the FET.

6. The Unit Price offered to the Government should include all costs (components, manufacturing, transportation, etc.)

with delivery to:

DODAAC: SV3100

DLA Distribution Susquehanna U Avenue, Bldg. 89, Door 6 New Cumberland, PA 17070 Attn: Jim Earp 717-770-3128

7. Unit Price shall be based on F.O.B. DESTINATION only.

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SPE2DP-26-R-0002

Form (CONTINUED)

8. Inspection and Acceptance: DESTINATION.

9. All quantities shall be delivered to the Defense Distribution Center, Susquehanna, PA. The contractor shall be capable of delivering 100% of the quantities by March 31, 2027. Accelerated deliveries are permitted at any time at no extra cost to the Government. Early delivery will be provided if the product is available for delivery prior to this date at no extra cost to the Government.

10. The Government intends to award based on initial offers without conducting discussions. However, the Government reserves the right to conduct negotiations/discussions if deemed necessary.

AUTHORIZED NEGOTIATORS

Offeror shall list the name(s), title(s), e-mail address(es), and telephone number(s) for each person(s) authorized to negotiate on its behalf with the Government in connection with this request for proposal.

NOTE: The contact information listed above will only be used during negotiations (provided the contracting officer determines it is necessary to conduct negotiations/discussions).

SECTION C: DESCRIPTION/SPECIFICATION/STATEMENT OF WORK

I. SPECIFICATIONS

A. ITEM: INFLUENZA VIRUS VACCINE, SOUTHERN HEMISPHERE - 2027 FORMULA FOR AGE 6 MONTHS AND OLDER, .5 ML

DOSE (SYRINGE) - 10 SYRINGES PER PACKAGE

B. SCOPE: A contract resulting from this solicitation will establish a source of supply for This specification covers the requirement of an Influenza Virus Vaccine, Southern Hemisphere with variety of virus strains. This product is an annual vaccination using a vaccine specific for a given year and recommended by the CDC Advisory Committee on Immunization Practices (ACIP) to protect against the highly variable influenza virus.

C. CONTRACT DURATION

The contract resulting herein will be for a twelve (12) month term.

D. EXTENT OF OBLIGATION

Offerors must comply with the terms of PUBLIC LAW 113 -54 --NOV. 27, 2013 DRUG SUPPLY CHAIN SECURITY ACT

(DSCSA).

E. SALIENT CHARACTERISTICS

Indication and Usage: Shall be Influenza Virus Vaccine, Southern Hemisphere in accordance with the requirements of the USP.

Shall be a Quadrivalent or Trivalent Vaccine, suitable for intramuscular administration. The vaccine formula shall meet the minimum formula for the 2027 Influenza Vaccine season as determined by the FDA's Vaccines and Related Biological Products Advisory Committee.

Shall be FDA approved and ACIP recommended for immunizing patients six months of age and older.

Dose Presentations, Size and Age Indication: Shall be presented in a single-dose, pre-filled syringe (PFS) presentation; as indicated in the each line item in the Schedule of Supplies. Each, single dose, pre-filled syringe presentation shall include one dose suitable for 6 months of age and older. The vaccine presented in single-dose, CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 7 OF 48 PAGES

SPE2DP-26-R-0002

Form (CONTINUED) pre-filled syringe presentations shall be free of thimerosal or other preservatives.

Perishable Medical Material: Perishable medical material includes both cold chain management and routine temperature-sensitive items. Perishable items requiring chill or freeze temperatures shall be properly packaged in accordance with DLAI 4145.21/TB MED 284/ NAVSUPINST 4610.31A/AFJI 41-208, or, as an alternate, in accordance with acceptable commercial practice. When specified in the contract/purchase order and/or SOW, perishable items requiring constant refrigeration shall be properly packaged and marked in accordance with cold chain management protocols. In addition to all applicable regulatory requirements and markings specified in the contract/purchase order and/or SOW, perishable medical material shall be marked as specified in Medical Marking Standard No. 1D.

Packaging and Storage: Keep temperature sensitive products requiring refrigeration temperatures between 2° C to 8° C (36o F- 46o F) within these temperature ranges during transportation, for up to 72 hours. No EXCURSIONS are acceptable. Protect from light. DO NOT FREEZE.

The contractor shall provide the Government with either product stability information to be used as part of the Government's disposition decision, or provide a point of contact who will review each excursion forwarded to them by the Government, and provide the Government disposition. Disposition will then be provided to the end customer by the Government. If end customers contact the contractor directly with temperature questions regarding the product (i.e. temperature monitoring device questions, refrigerator malfunctions, etc.), the contractor will provide the Government documentation of the call and outcome.

The minimum acceptable stability allowance is 48 hours.

For information regarding cold chain management protocols, including availability of updated requirements, contact DLA Troop Support via email at DSCPcoldchain@dla.mil.

Expiration Date: Shall not be later than 18 months after date of issue from manufacturer's cold storage (5o, 1 year).

Labeling: The label on each unit of Influenza Virus Vaccine shall bear the full prescribing information.

Workmanship: The Influenza Virus Vaccine shall be free from defect that detract from its appearance or impair its serviceability.

Unit: Package (PG). One package containing 10 single-dose presentations, as specified, constitutes one (1) unit.

F. REGULATORY REQUIREMENTS

Federal Food, Drug, and Cosmetic Act: If the product covered by this document has been determined by the U.S.

Food and Drug Administration to be under its jurisdiction, the offeror/ contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.

Recovered Materials: The offeror/contractor is encouraged to use recovered materials in accordance with the Federal Acquisition Regulation (FAR) Subpart 23.403 to the maximum extent practical.

G. QUALITY ASSURANCE PROVISIONS

Contractor Certification: The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Medical Procurement Item Description, and that the product conforms to the producers' own drawings, specifications, standards, and quality assurance practices, and is the same product offered for sale in the commercial market-place. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.

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Responsibility for Inspection: Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.

Records: Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government upon the Government's request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate.

Inspection: Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item.

Examination and Testing: Examination and testing shall be conducted on the product in accordance with commercial practice. The sampling for examination and testing shall be in accordance with commercial practice.

Metric Products.: Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units. Dimensions and tolerances specified shall be converted using conversion tables contained in the latest revision of ASTM E 380.

Other Quality Assurance Provision: Shall be as indicated in the contract/purchase order and/or SOW.

H. PREPARATION FOR DELIVERY

Delivery appointments are required: Your truckers/dispatchers/brokers/etc. should have the above information readily available when calling to schedule delivery appointments as follows:

DLA Distribution Susquehanna (New Cumberland, PA)

Carriers must email a copy of the Commercial Bill(s) of Lading CBL(s) to prelodge@dla.mil when requesting a delivery appointment or can call 1-800-307-8496.

INSTRUCTIONS FOR DELIVERY (For New Cumberland, PA only):

Commercial carriers such as UPS/FedEx (other than FedEx Custom Critical and product shipped on skids) are generally not subject to prelodge requirements. For all other freight carriers, delivery appointments must be made through prelodge ahead of shipment. If utilizing a carrier other than the aforementioned commercial carriers, please email PRELODGE@DLA.MIL with shipment details, quantities and carrier information to confirm whether a prelodge appointment will be necessary.

If an appointment is necessary, the New Cumberland depot requires an EMAIL to be sent to PRELODGE@DLA.MIL requesting an appointment form. This form must then be completed by the carrier and sent back to DLA at which time (within 24-48 hours) an appointment is made. Please email the appointment requests as soon as possible BEFORE the desired appointment time, as appointment schedule may be based on warehouse coordination/availability.

Once an appointment is scheduled, please provide the scheduled date/time, along with the confirmation number (if applicable), to Melissa Rios Thomas at melissa.riosthomas@dla.mil and Rosbert Jones at rosbert.

jones@dla.mil. Delivery Drivers must comply with the Real ID Act. Drivers without Alternate forms or Identification may be denied access to the installation.

Hours of operation generally are from 6:00am to 10:30pm Monday through Friday and 6:00 am to 4:30pm Saturday, those these hours are subject to change. The access road is off PA Route 114 (Old York Road) 1 mile off

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SPE2DP-26-R-0002

Form (CONTINUED) the PA Turnpike and Interstate 83, Exit 39. Call 1-800-307-8496 for directions or weather related base closures.

Shipper to load; Consignee to Unload. Does not apply to tow-away shipments.

See above SALIENT CHARACTERISTICS, Section D: PACKAGING AND MARKING and Section F: DELIVERIES OR PERFORMANCE for additional packaging, marking, preparation and delivery information.

NOTES: The following documents are available from the following link:

- Medical Marking Standard No. 1D.

- DLA Troop Support Requirements for Temperature Monitoring Devices.

o https://www.dla.mil/HQ/LogisticsOperations/Packaging/MedicalPack1/

- Packing Protocols for Temperature Sensitive Medical Products requiring Storage and Transportation Temperatures between 2°C - 8°C (36°F - 46°F).

o Content Inquiries: DSCPcoldchain@dla.mil

I. NON-ACCEPTABILITY OF GOVERNMENT SURPLUS MATERIAL

(a) Definition. “Surplus material,” as used in this clause, means new, unused material that was purchased and accepted by the U.S. Government and subsequently sold by the DLA Disposition Services, by Contractors authorized by DLA Disposition Services, or through another Federal Government surplus program. The terms “surplus” and “Government surplus” are used interchangeably in this clause.

(b) The Government has determined that offers of surplus material will not be considered for this acquisition. (End of Text)

J. FOR NON-MANUFACTURERS SUCH AS DEALERS AND AUTHORIZED DISTRIBUTORS: If other than the manufacturer, the offeror shall submit with its proposal a letter of commitment from the manufacturer which shall state the offeror will be able to source the items offered for the maximum quantity listed in this solicitation. In addition, the letter shall provide assurance that offered pricing will be fixed for the life of the contract.

K. INTERMEDIATE PACKAGE: Intermediate package marked as specified in Medical Marking Standard No. 1D. is preferred. Alternative commercial marking for intermediate package may be considered. If commercial marking for intermediate package is proposed, please provide the sample of commercial marking.

L. SHIPMENT

Stop shipment delays and rejections!

For deliveries to DLA Distribution Susquehanna or the 3PL-Third Party Logistics locations, ensure your Government or Commercial Bills of Lading are correctly annotated with the following information in the description of articles:

* Weight

* Pieces

* National Stock Number(s) (NSNs)

* Contract Number

* Shipment Number

SHIPPING AND MARKING INSTRUCTIONS FOR FROZEN, REFRIGERATED, AND LIMITED UNREFRIGERATED

MEDICAL MATERIAL SHIPMENTS

(a) Shipping instructions:

(1) Commercial refrigerated containers, chill or freeze, shall be used as applicable, to ship material requiring refrigeration or frozen items.

(2) Scheduling of shipments: Shipments will be scheduled to arrive at destination during normal business days and working hours. Advance notice of the shipment and estimated time of arrival will be https://www.dla.mil/HQ/LogisticsOperations/Packaging/MedicalPack1/ file:///DSCPcoldchain@dla.mil

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Form (CONTINUED) forwarded expeditiously to the consignee.

(3) Perishable items which do not require constant refrigeration shall be transported by a mode of transportation which will ensure receipt by the consignee within allowable shipping time for unrefrigerated shipments specified in the solicitation. When shipping time will exceed the maximum allowable time, such shipments shall be forwarded in refrigerated containers which will maintain the required temperature range of 2 degrees - 8 degrees Celsius (or 36 degrees - 46 degrees Fahrenheit) while enroute to the consignee. When refrigerated transportation is available from the consignor to the consignee, such transportation may be used in lieu of refrigerated containers.

(4) Perishable items requiring constant refrigeration shall be shipped by refrigerated transportation or in refrigerated containers which will maintain the required temperature while enroute to consignee.

(5) Perishable items required to be frozen shall be shipped by freezer transportation or in freeze containers which will maintain the required temperature range of -25 degrees and -10 degrees Celsius (-13 degrees and 14 degrees Fahrenheit) when enroute to the consignee.

(b) Special labeling:

(1) For refrigerated, chilled or frozen shipment: Each exterior container shall be marked as indicated in military standard military standard (MIL-STD) -129 for chilled or frozen material, as applicable. When refrigerated or freezer transportation is utilized, in lieu of chilled or freeze exterior containers, the chilled or frozen shipment markings of MIL-STD-129 are not required.

(2) For limited unrefrigerated shipment: Each limited unrefrigerated exterior container shall be marked as indicated in MIL-STD-129.

(3) Notices: The contractor shall place one copy of the applicable notice (indicated below) inside of the shipping container, under the inner flaps, before sealing. The following forms may be obtained upon request to the contracting officer, DLA Troop Support:

(i) DLA Troop Support Form 2770, Notice for Frozen Shipments;

(ii) DLA Troop Support Form 2770-1, Notice for Chilled Medical Material Shipments; and

(iii) DLA Troop Support Form 2270-2, Notice for Limited Unrefrigerated Medical Shipments.

REPORT OF SHIPMENT (REPSHIP) OF PERISHABLE MEDICAL ITEMS - DLA TROOP SUPPORT - MEDICAL

(a) Unless otherwise directed by the Contracting Officer, the Contractor shall send a prepaid notice of shipment to the consignee Transportation Officer (T.O.) for all shipments of perishable medical items when given to a commercial carrier (common, contract or private) for shipment within the United States (U.S.). The notice shall be transmitted by rapid means (telephone or teletype) to be received by the consignee transportation officer at least 24 hours prior to the arrival of the shipment. It shall contain all information listed below and be prominently identified as being a "Report of Shipment of Perishable Medical Items" or, "Repship for T.O. perishable medical items".

(b) Refrigerated items which are restricted as to length of time during which they can be without temperature control shall not be entered into the postal system, even though they otherwise qualify for this service.

(c) The following information will be included in the Repship:

(1) Repship for T.O. perishable medical items (and date of message).

(2) Transportation Officer.

(3) Consignee name and address.

(4) Bill of Lading (BL) number.

(5) Document identification, requisition number, and contract or purchase order number.

(6) Item identification and protective requirements.

(7) Route (all participating carriers).

(8) Carrier identification number if other than BL number, such as air bill or air express receipt number.

(9) Flight number (when appropriate).

(10) Departure time (date/hour).

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(11) Estimated delivery time, indicated on the BL as DDD.

(12) Deadline delivery time (date/hour, a.m. or p.m., that item must be returned to refrigerator/freezer or re-iced).

(13) A request for the consignee to contact the local carrier to trace and expedite delivery if not received by the estimated delivery time (11) above).

(14) Name and address of Contractor.

M. DLA TROOP SUPPORT TECHNICAL AND QUALITY REQUIREMENTS

RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS (IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB AT: http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx.

FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE

AMENDMENT DATE CONTROLS.

RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT

RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES

RQ018: CONTRACTOR RETENTION OF SUPPLY CHAIN TRACEABILITY DOCUMENTATION (JAN 2020)

This item requires supply chain traceability documentation in accordance with DLA Directive (DLAD) Procurement Notes #C03 Contractor Retention of Supply Chain Traceability Documentation (AUG 2016)#. The full text of C03 can be found in the DLAD Procurement Notes on the Web at: http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.

aspx.

FOR AGES 6 MONTHS AND OLDER. LATEX AND PRESERVATIVE FREE.

This device or drug is regulated by the FDA.

N. NON-ACCEPTABILITY OF GOVERNMENT SURPLUS MATERIAL

(a) Definition.

“Surplus material,” means new, unused material that was purchased and accepted by the U.S. Government and subsequently sold by the DLA Disposition Services, by Contractors authorized by DLA Disposition Services, or through another Federal Government surplus program. The terms “surplus” and “Government surplus” are used interchangeably in this clause.

(b) The Government has determined that offers of surplus material will not be considered for this acquisition.

O. FOOD AND DRUG ADMINISTRATION (FDA) COMPLIANCE - DLA TROOP SUPPORT MEDICAL AND SUBSISTENCE

If any supplies acquired hereunder are recalled under the provisions of the Federal Food, Drug and Cosmetic Act, and regulations there under, the Contractor shall, at the Government's option, either reimburse the Government or repair/replace the recalled supplies. Additionally, the Contractor shall notify the Contracting Officer immediately when a firm decides to voluntarily recall or withdraw any product from the marketplace. Upon notification by the Contracting Officer that supplies acquired hereunder have been recalled, the Contractor shall either (a) accept certificates of destruction from the Government after the supplies have been properly disposed of, (b) request return of the supplies, or (c) if supplies may be repaired on site without transporting them from their location, furnish all materials necessary to effect repairs. Replacement or reimbursement will be accomplished by the Contractor immediately on receipt of Certificates of Destruction or returned supplies. The costs of replacement or repair of supplies, and transportation and handling costs for movement of returned, replaced or repaired supplies within the http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx

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Form (CONTINUED) contiguous United States shall be paid by the Contractor. The provisions of this clause are applicable only when the value of the recalled supplies in the possession of the Government amounts to $100 or more. The rights and remedies of the Government provided in this clause are in addition to, and do not limit, any rights afforded to the Government by any other clause in the contract.

DLAD PROCUREMENT NOTE C02 MANUFACTURING PHASE OUT OR DISCONTINUATION OF PRODUCTION, DIMINISHING SOURCES, AND OBSOLETE MATERIALS OR COMPONENTS (DEC 2016)

DLAD PROCUREMENT NOTE C03 CONTRACTOR RETENTION OF SUPPLY CHAIN TRACEABILITY DOCUMENTATION (JUN 2023)

DLAD PROCUREMENT NOTE C14 CORRECTION OF NONCONFORMING PACKAGING OR MARKING (MAY 2020)

DLAD PROCUREMENT NOTE C20 VENDOR SHIPMENT MODULE (VSM) (MAY 2026)

SECTION D: PACKAGING AND MARKING

PREPARATION FOR DELIVERY

Preservation: Preservation shall be commercial, as specified in the contract or purchase order.

Unit. Each unit, as specified in this specification; shall be supplied in a suitable sealed commercial container.

Packing: Packing shall be commercial, as specified in the contract or purchase order.

Commercial. Exterior (shipping) container shall contain one unit.

Unitization. Material shall be unitized on 4-way entry pallets as specified in the contract or purchase order.

Packing list. Packing list shall be supplied as specified in Medical Marking Standard No. 1D.

Labeling and Marking: Marking requirements, Medical material shall be marked in English as specified herein and in the applicable contract or purchase order. Required markings may include identification data, bar codes, destination address, shelf life, lot (control) number, storage legends, markings for items requiring special handling (i.e., perishable items, controlled items, hazardous items, etc.) and shall be supplied as applicable. Markings include, but are not limited to, the following”:

Unit Pack: Each unit pack shall be marked in accordance with commercial practice. In addition to the requirements specified in the latest revision of Medical Marking Standard No. 1D (MMS 1D), mark each unit pack with lot number, contractor cage code, manufacturer's cage code and part number. Markings may be supplied by any suitable means, i.e., printed directly on the bag, printed on a pressure sensitive label permanently affixed to the bag, or printed on a sheet of paper inserted into the bag prior to closing.

Intermediate Package: Each intermediate package shall be marked as specified in Medical Marking Standard No. 1D.

Exterior (shipping) Container. Each exterior (shipping) container shall be marked as specified in Medical Marking Standard No. 1D.

Unitized Load: Each unitized load shall be marked as specified in Medical Marking Standard No. 1D.

Other Required Markings: Other required markings shall be as specified in Medical Marking Standard No. 1D. They shall be supplied as applicable. Markings include, but are not limited to, the following:

Shelf Life Markings: Shelf-life markings shall be supplied as specified in the contract or purchase order. Shelf life

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Form (CONTINUED) markings may include the expiration date, date of manufacture, inspection/test date, etc., as applicable.

Material requiring special handling marking and/or storage legends: In addition to applicable commercial markings, and all markings as specified in the contract/purchase order and/or SOW, special handling and/or storage legends shall be supplied on the unit, intermediate package, exterior (shipping) container and unitized load, as applicable, and may consist of printed legends and/or pictorial markings. Placement shall not interfere with or obscure any other markings.

Perishable medical material: Perishable medical material includes both cold chain management and routine temperature-sensitive items. Perishable items requiring chill or freeze temperatures shall be properly packaged in accordance with DLAI 4145.21/TB MED 284/ NAVSUPINST 4610.31A/AFJI 41-208, or, as an alternate, in accordance with acceptable commercial practice. When specified in the contract/purchase order and/or SOW, perishable items requiring constant refrigeration shall be properly packaged and marked in accordance with cold chain management protocols. In addition to all applicable regulatory requirements and markings specified in the contract/purchase order and/or SOW, perishable medical material shall be marked as follows:

Cold chain management items:

(a) Marking requirements. Shipments of FSC 6505 Vaccines and other designated items requiring compliance with specialized cold chain management protocols shall be marked in accordance with regulatory requirements and as specified in the applicable protocol. Markings shall include “ARROW” and “FRAGILE” markings, as applicable. Protocols are available in DLAI 4145.21/TB MED 284/ NAVSUPINST 4610.31A/AFJI 41-208. Protocols may also be available in the contract/purchase order and/or SOW. Protocols are subject to change periodically. For information regarding protocols, including availability of updated requirements, contact DLA Troop Support via email at DSCPcoldchain@dla.mil.

(b) Temperature Monitors. In order to monitor the temperature ranges during transit, the contractor is required to place one DLA-compatible temperature monitor (that shall be pre-approved by the government) into 5 randomly chosen boxes for each full truck-load shipment to each requested destination (2 monitors will be required for less than a full truck-load). The contractor shall place an “X” or some other identifying mark on the boxes containing the monitors to alert the receiving depot to their location. When small parcel carriers are used (e.g. FedEx), 1 temperature monitor per box will be required. Any shipment of any size that is delivered to the Government without temperature monitors will be rejected and returned to the contractor at contractor's expense, or disposed of at the direction of the contractor.

NOTES: The following documents are available from the following link:

- Medical Marking Standard No. 1D.

- DLA Troop Support Requirements for Temperature Monitoring Devices.

o https://www.dla.mil/HQ/LogisticsOperations/Packaging/MedicalPack1/

- Packing Protocols for Temperature Sensitive Medical Products requiring Storage and Transportation Temperatures between 2°C - 8°C (36°F - 46°F).

o Content Inquiries: DSCPcoldchain@dla.mil

SECTION E: INSPECTION AND ACCEPTANCE

PRODUCT RETURNS: Product is acceptable on a non-returnable basis; however, the Government shall retain all rights with mailto:DSCPcoldchain@dla.mil https://www.dla.mil/HQ/LogisticsOperations/Packaging/MedicalPack1/ file:///DSCPcoldchain@dla.mil

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Form (CONTINUED) regard to non-conforming vaccine, which shall be returned or replaced at contractor's expense

FAR 52.246-2 INSPECTION OF SUPPLIES FIXED PRICE (AUG 1996)

FAR 52.246-16 RESPONSIBILITY FOR SUPPLIES (APR 1984)

DLAD Procurement Note E05 PRODUCT VERIFICATION TESTING (MAY 2020)

(1) Product verification testing (PVT) under this procurement note will only apply when the contracting officer specifically invokes it in writing. The contracting officer may invoke PVT at or after contract award. If the contracting officer invokes PVT at contract award, the contract will explicitly state this testing requirement. If the contracting officer invokes PVT after contract award, the contracting officer shall notify the contractor and the cognizant DCMA ACO. The Government will perform PVT testing at a Government-designated testing laboratory.

(2) The contractor shall not ship or deliver any material until it receives notification of the acceptable PVT results, unless the contracting officer directs it to do so in writing The Government will provide the PVT results to the contractor within 20 business days after receipt at the Government testing facility, unless the Government specifies otherwise in writing.

(3) The contractor shall provide and maintain an inspection system acceptable to the Government in accordance with FAR Clause 52.246-2 or 52.246-3; and maintain and make available all records evidencing those details if requested by the Government. When the Government finds evidence of risk associated with the contractor's sampling process, the Government may witness and evaluate the contractors sampling process. The contractor shall randomly select samples from the production lot(s), unless the contracting officer specifies otherwise in writing. The contractor shall ship the selected PVT samples with a copy of the system of record receiving report (i.e., WAWF, DD Form 250, or commercial shipping document) and the contractor's signed DD Form 1222. The contractor shall prepare the shipping container(s) by marking the external packages in bold letters, “Product Verification Test Samples - Do Not Post to Stock," Contract Number [ ] and Lot/Item Number [ ]” adjacent to the MIL-STD-129 (latest revision) identification markings. The contractor shall use a hard copy of the system of record receiving report as a packing list, in accordance with DFARS Appendix F.

The contractor shall mark the exterior of the shipping container in accordance with MIL-STD129 (latest revision), paragraph 5.11. The contractor shall send samples by traceable means (e.g., certified or registered mail, United Parcel Service, Federal Express). The contractor shall include the following in the interior package:

(a) Hard copies of the contract;

(b) Material certifications/process operation sheets; and

(c) Drawings used to manufacture the units and return shipping information.

(4) The Government will return samples that pass testing and are not destroyed during evaluation to the contractor at the Government's expense for the contractor to include as part of the total contract quantity to be delivered under the contract. The contractor and Government may agree to dispose of samples not destroyed when the cost of the item does not justify the shipping expense. If the Government does not return approved samples that pass testing to the contractor, the Government will consider those samples as part of the contract quantity for payment and delivery.

(5) If samples fail testing, the Government may reject the entire contract lot from which the contractor took the samples. The Government may, at its discretion, retain samples that fail testing without obligation to the contractor.

DLAD PROCUREMENT NOTE E07 EVALUATION FACTOR FOR ORIGIN INSPECTION (JAN 2018)

SECTION F: DELIVERIES OR PERFORMANCE

FAR 52.247-34 F.O.B. DESTINATION (JAN 1991)

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Form (CONTINUED)

SECTION G: CONTRACT ADMINISTRATION DATA

DFARS 252.232-7003, ELECTRONIC SUBMISSION OF PAYMENT REQUESTS AND RECEIVING REPORTS (DEC 2018)

DFARS 252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (JAN 2023)

(a) Definitions. As used in this clause - Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization. Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF). Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system. Payment request and receiving report are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation System (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall -

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher. (ii) For fixed price line items -

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

Invoice (stand-alone) and Receiving Report (stand-alone) or Invoice and Receiving Report (combination)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial financing, submit a commercial financing request.

https://www.sam.gov https://wawf.eb.mil/ https://wawf.eb.mil/

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Form (CONTINUED)

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table *

Field Name in WAWF Data to be entered in WAWF Guidance

Pay Official DoDAAC See Block 12 (SF26), 15 (DD 1155), or 18a (SF1449) (If blank, see resulting award)

Issue By DoDAAC See Block 5 (SF26), 6 (DD 1155), or 9 (SF1449) (If blank, see resulting award)

Admin DoDAAC See Block 6 (SF26), 7 (DD 1155), or 16 (SF1449) (If blank, see resulting award)

Inspect By DoDAAC SEE SECTION B (If blank, see resulting award)

Ship To Code SEE SECTION B (If blank, see resulting award)

Ship From Code SEE SECTION B (If blank, see resulting award)

Mark For Code SEE SECTION B (If blank, see resulting award)

Service Approver (DoDAAC) (If blank, see…