SF33_SPE2DP25R0001.PDF

10. FOR

INFORMATION

CALL:

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

2. CONTRACT No.

SPE2DP-25-R-0001

3. SOLICITATION No. 4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)X

2025 AUG 25

5. DATE ISSUED

1000197843

6. REQUISITION/PURCHASE No.

7. ISSUED BY 8. ADDRESS OFFER TO

NOTE : In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in local time

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

11. TABLE OF CONTENTS

DESCRIPTION

25. PAYMENT WILL BE MADE BY

CODE

SOLICITATION

until (Hour) (Date)

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION NOT USABLE

STANDARD FORM 33 (Rev.9-97) Prescribed by GSA FAR (48 CFR) 53.214 (c)

OFFER (Must be fully completed by offeror ) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

AWARD (To be completed by Government)

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER

(Type or print)

14. ACKNOWLEDGMENT OF AMEND-

MENTS (The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

CONTRACT ADMINISTRATION DATA L INSTRS., CONDS., AND NOTICES TO OFFERORS

SPECIAL CONTRACT REQUIREMENTS M EVALUATION FACTORS FOR AWARD

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

(X) PAGE(S) SEC. DESCRIPTION PAGE(S)

SUPPLIES OR SERVICES AND PRICES/COSTS PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

I CONTRACT CLAUSESSOLICITATION/CONTRACT FORM

DESCRIPTION/SPECS./WORK STATEMENT J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING PART IV - REPRESENTATIONS AND INSTRUCTIONS

DELIVERIES OR PERFORMANCE

K REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

AMENDMENT NO. DATEAMENDMENT NO. DATE

G

H

SEC.

B

A

C

E

D

F

(X)

FACILITY

CODE

15C. CHECK IF REMITTANCE ADDRESS IS

DIFFERENT FROM ABOVE - ENTER SUCH

ADDRESS IN SCHEDULE

17. SIGNATURE

19. ACCEPTED AS TO ITEMS NUMBERED

23. SUBMIT INVOICES TO ADDRESS SHOWN IN22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

24. ADMINISTERED BY (If other than item 7) CODE CODE

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer )

26. NAME OF CONTRACTING OFFICER (Type or print) calendar days (60 calendar days unless a different

15A. NAME AND

ADDRESS

OF OFFER-

OR

10 U.S.C. 2304 (c) ( 41 U.S.C. 253 (c) () )

DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN PHARM FSA

700 ROBBINS AVENUE

PHILADELPHIA PA 19111

USA

See Continuation Sheet

Not Applicable 3:00PM 2025-Sep-24

Yu Chen DYC0004

A. NAME

Phone: 445-737-7606

FAX:

B. PHONE/FAX (NO COLLECT CALLS)

YU.CHEN@dla.mil

C. EMAIL ADDRESS

X 1

X 4

X 5

X 14

X 16

X 16

X 17

X 51

X 63

X 65

15B. TELEPHONE NUMBER 18. OFFER DATE

28. AWARD DATE

20. AMOUNT

10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) CALENDAR DAYS (%)30 CALENDAR DAYS (%)

21. ACCOUNTING AND APPROPRIATION

ITEM

SPE2DP

EXT.NUMBERAREA CODE

(4 copies unless otherwise specified)

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CONTINUED ON NEXT PAGE

SPE2DP-25-R-0001

SECTION A - SOLICITATION/CONTRACT FORM

Reference page 1 of the Standard Form 33:

1. Block 9.

Offer Due Date/Local Time: September 24,2025 3:00PM/EDT

2. Block 9.

At this time and until further notice, proposals shall be submitted electronically via DLA Internet Bid Board System

(DIBBS).

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.

For any questions or concerns on how to upload proposals to DIBBS please contact the contracting officer (yu.

chen@dla.mil) or contract specialist (rosbert.jones@dla.mil).

3. Block 12.

In compliance with the above, the undersigned agrees, if this offer is accepted within 180 calendar days from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

4. Block 15a.:

a. Offeror's assigned Unique Entity ID:__________________

b. Offeror's assigned Contractor and Government Entity (CAGE) Code: _____________

5. Block 15c.: Remittance Address (if different form Contractor/Offeror address in Block 15a

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. This acquisition is not set

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SPE2DP-25-R-0001

SECTION A - SOLICITATION/CONTRACT FORM (CONTINUED)

aside for small business.

AUTHORIZED NEGOTIATORS

The Government intends to evaluate proposals and award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). However, the Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary. Please 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, if negotiations are deemed necessary by the Contracting Officer.

Please list names, titles, e-mail addresses, and telephone numbers for each authorized negotiator:

SYSTEM FOR AWARD MANAGEMENT (SAM)

All Contractors must register on the SAM website: https://www.sam.gov in order to be considered for award.

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.

NOTES REGARDING PROPOSAL SUBMISSION:

The successful offeror shall have FDA approval to sell Adeno before award decision.

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

OTHER COMPLIANCES

The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

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

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SECTION A - SOLICITATION/CONTRACT FORM (CONTINUED)

ethics and conduct to the contracting officer upon request by the contracting officer.

SECTION B - SUPPLIES OR SERVICES AND PRICES OR COSTS

Item: Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, Enteric Coated Tablets for Oral Administration, one (1) package.

(Adeno)

NSN: 6505-01-642-0106

Adeno shall be made in accordance with SECTION C - SPECIFICATIONS/SOW/SOO/ORD (Page 5)

The contract awarded under this solicitation will result in firm-fixed price, indefinite delivery, indefinite quantity type contract. The contract will have a one-year base term and four one-year option terms with a maximum five (5) year ordering period. Offerors shall provide a unit price for each CLIN. Failure to provide a unit price for each CLIN below may be deemed as non-acceptance of the terms and conditions and may result in the rejection of the offeror's entire proposal.

Unit. Package (PG). Two (2) bottles of 100 tablets each of Type 4 and 100 tablets each of Type 7 Adenovirus Vaccine, Live, Oral, shall constitute the "UNIT”

CLIN 0001 Base Year Annual Estimated Quantity - 2,000 Packages Unit Price - $__________________/PG Total - $__________________

CLIN 0002 Option Year 1 Annual Estimated Quantity - 2,000 Packages Unit Price - $__________________/PG Total - $__________________

CLIN 0003 Option Year 2 Annual Estimated Quantity - 2,000 Packages Unit Price - $__________________/PG Total - $__________________

CLIN 0004 Option Year 3 Annual Estimated Quantity - 2,000 Packages Unit Price - $__________________/PG Total - $__________________

CLIN 0005 Option Year 4 Annual Estimated Quantity - 2,000 Packages Unit Price - $__________________/PG Total - $__________________

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SECTION B - SUPPLIES OR SERVICES AND PRICES OR COSTS (CONTINUED)

NOTES REGARDING SUBMISSION OF UNIT PRICES:

1. Each CLIN listed above represents a one-year period.

2. The Government is only bound to order the Guaranteed Minimum Quantity stated here: The Government will guarantee a minimum annual purchase of 1,500 packages, or the dollar value associated with the price of 1,500 packages, for the base contract period (CLIN 0001) and a minimum purchase of 1,500 packages, or the dollar value associated with the price of 1,500 packages, for each contract option period that is exercised (CLIN 0002 - CLIN 0005). The guaranteed minimum dollar value for the base year only will be obligated at the time of award. If it is in the Government's best interests to invoke an option term, then the guaranteed minimum dollar value of that option term will be obligated with the release/issuance of the contract modification invoking the option term.

3. The resultant contract will also have an annual maximum quantity of 2,300 packages, which will allow the Government to order that amount within each year of the base period and each option period that is exercised. The Government reserves the right to place orders up to the Maximum Contract 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 expiration.

4. The Unit Price offered to the Government should include all costs (manufacturing, transportation, etc.) to Destinations stated on Statement of Work Section V.

5. The offeror's proposed prices are to be expressed in US dollars, using only two decimal places, and to include both an Offered Unit Price and Total Offered Price for each CLIN of the Schedule of Supplies.

6. Unit Price shall be based on F.O.B. DESTINATION only. Destinations are stated on Statement of Work Section V. ALL DELIVERIES ARE TO BE FOB DESTINATION AND DELIVERED ON A MONTLY BASIS. DELIVERY DESTINATIONS WILL BE

DESIGNATED ON EACH INDIVIDUAL DELIVERY ORDER.

7. Inspection and Acceptance: DESTINATION.

8. The Total Dollar Value for each CLIN is calculated by multiplying each CLIN's unit price by the Annual Estimated Quantity.

9. The Maximum Contract Dollar Value will be utilized for evaluation purposes and is calculated in the following manner:

the Unit Price for each CLIN is multiplied by the annual maximum quantity of 2,300 packages for each CLIN to arrive at a Total Maximum Dollar Value for each CLIN. Then the Total Maximum Dollar Value for each CLIN is added together to arrive at a Maximum Contract Dollar Value, which will be used for the price evaluation.

SECTION C - SPECIFICATIONS/SOW/SOO/ORD

Statement of Work

I. Specifications

Except as stated in this Statement of Work, the Adenovirus Vaccine shall be in accordance with the SPECIFICATION SHEET DATED April 1, 2025 on page 11.

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SECTION C - SPECIFICATIONS/SOW/SOO/ORD (CONTINUED)

II. Ordering Quantities

The annual estimated quantity is 2,000 packages. The Government will guarantee a minimum annual purchase of 1,500 packages, or the dollar value associated with the price of 1,500 packages, for the base contract period and a minimum purchase of 1,500 packages, or the dollar value associated with the price of 1,500 packages, for each contract option period that is exercised. The resultant contract will also have an annual maximum quantity of 2,300 packages, which will allow the Government to order that amount within the base period and each option period if such additional or unplanned demand exists.

III. Logistics

1. The logistics for the Adenovirus Vaccine shall be coordinated by the Defense Health Agency (DHA) Operational Medicine (OPMED), the United States Army Medical Materiel Agency Distribution Operations Center (USAMMA-DOC), and the Defense Logistics Agency Troop Support (DLA Troop Support).

2. DHA OPMED is the Department of Defense agency responsible for developing and implementing all policies and procedures associated with the distribution of adenovirus vaccine. DHA OPMED will be responsible for the following actions:

• Initiate and schedule all vaccine shipments through direct coordination with DLA Troop Support and USAMMA-

DOC.

• Determine annual vaccine shipping requirements through coordination with receiving installations, develop a monthly shipping projection, and submit that projection to DLA Troop Support.

3. USAMMA-DOC will assist DHA OPMED by having distribution oversight for this vaccine. It is anticipated that DHA OPMED will authorize direct coordination between USAMMA-DOC and DLA Troop Support to confirm and adjust shipping destinations and quantities prior to executing shipments, and to resolve any discrepancy with the shipments in accordance with the awarded contract. It is envisioned that the USAMMA-DOC will maintain total asset visibility over the shipments and maintain the related records. USAMMA-DOC will be responsible for the following actions:

• Monitor all vaccine shipments after departure from Contractor facility.

• Instruct each receiving activity on proper procedures for opening and processing each vaccine shipment.

• Review all temperature monitoring devices proposed for use by Contractor.

• Review the transportation carriers proposed by Contractor.

• Collect and review all certificates of validation and qualification of packing materials and protocols as submitted by Contractor.

• Provide instructions to each receiving activity on proper handling, storage and processing procedures of vaccine.

• Designate a point of contact for coordination and resolution of all logistics actions as documented in this statement of work.

4. The Contractor shall be responsible for the following:

• Designate a logistics representative to serve as a point of contact for coordination and resolution of all logistics actions to include all actions and responsibilities as prescribed in this Statement of Work.

• Pack and ship all vaccines in accordance with approved packing protocols

• Obtain approval of the shipping carrier from the USAMMA-DOC Cold Chain Manager prior to commencement of any shipments under this contract. (Note: this requirement is only applicable to any proposed change to the

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SECTION C - SPECIFICATIONS/SOW/SOO/ORD (CONTINUED)

currently approved DHA OPMED shipping carriers as of January 1, 2019).

• Obtain approval for use of the selected temperature-monitoring device from USAMMA- DOC prior to commencement of any shipments under this contract. (Note: this requirement is only applicable to any proposed change to the currently approved DHA OPMED shipping carriers as of January 1, 2019).

• Deliver copies of regulatory submissions made to Biologics License Application (BLA) for adenovirus vaccine, BLA number 125-296, from October 1, 2026 through end of performance of this contract to DHA OPMED.

• Deliver copies of all communications with the Food and Drug Administration regarding the above referenced BLA from October 1, 2026 through end of performance of this contract to DHA OPMED.

5.DLA Troop Support is the DLA contracting activity and is responsible for issuing and administering the contract for adenovirus vaccine in accordance with the terms and conditions herein.

IV. Packaging, Storage, and Shipping

The Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Enteric Coated Tablets is packaged in a carton of two bottles of 100 tablets of each component of the vaccine. The vaccine is supplied as a single carton containing 1 x 100 tablets Adenovirus Type 4 Component and 1 x 100 tablets Adenovirus Type 7 Component.

No less than twelve (12) months expiration dating shall remain at time of delivery to Government receiving activities.

The Government may consider accepting cartons with a shelf life of less than twelve (12) months at the time of delivery;

however, the Contractor must request and receive Government approval in writing prior to delivering vaccine with less than 12 months shelf-life. If acceptable, the Government will issue a delivery order indicating the specific delivery site for the respective short shelf-life vaccine packages. For CLIN 0001, the unit price for approved packages with less than six (6) months shelf life at the time of delivery shall be reduced by 1/9 for each month of shelf life remaining below six (6) months. For CLINs 0002-0005, the unit price for approved packages with less than nine (9) months shelf life at time of delivery shall be reduced by 1/9 for each month of shelf life remaining below nine (9) months. Tablet bottles will be labeled with the FDA approved label. The carton containing the Tablet bottles will be labeled with the FDA approved label. The shipping containers for transportation will ensure acceptance by common carrier for safe overnight delivery to destination while maintaining temperature controls and as specified by the validated and accepted packing protocol.

1. When distributing adenovirus vaccine, the Contractor should assess using a first released/first distributed basis to maximize product use based on shelf life. The Government understands though, that matching Type 4 and Type 7 adenovirus vaccine batches in common packages presents a challenge to the Contractor given that the number of tablets in each manufactured batch can vary, sometimes significantly.

As a result, solely distributing on a first release/first distributed basis may result in the waste of a significant number of tablets over the course of a production cycle which increase the overall cost of manufacturing. Accordingly, the Contractor may exercise reasonable discretion in packaging the tablet on the basis of avoiding wasted tablets, even if this results in a shortened shelf life. In such instances, the Contractor will ensure that the contractual or agreed upon shelf-life requirement is met. All Contractor storage sites, and shipping containers will maintain the vaccines at the proper temperature range of 2-8 degrees Celsius and ensure proper cold chain management including monitoring and documentation throughout the distribution.

2. Each shipping container shall contain 900 doses, or 9 packages of 100 doses (1 bottle of 100 tablets of ADVV Type 4 and 1 bottle of 100 tablets of ADVV Type 7). Shipping containers shall be capable of supporting cold chain management at 2-8 degrees Celsius (i.e., capable of maintaining that temperature range) for at least 48 hours duration. “Duration” is defined as the time elapsed from completion of packing at the Contractor's facility until delivery to the installation/ receiving activity. The shipping containers will be marked showing the contract number and the destination address.

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SECTION C - SPECIFICATIONS/SOW/SOO/ORD (CONTINUED)

The Contractor shall include the following label on all shipping containers: “Temperature Sensitive Product --DO NOT

FREEZE”.

3. Each shipping container shall include a temperature monitoring device that shall be capable of being calibrated at the following settings:

• 20-Minute Delay

• 10-Minute Intervals between Readings

• Low-Alarm Setting of 2 degrees Centigrade

• High-Alarm Setting of 8 degrees Centigrade

Documentation supporting the type of monitoring device the Contractor uses shall be reviewed by USAMMA-DOC and approved by DLA Troop Support Cold Chain Program Manager. (Note: this requirement is only applicable to any proposed change to the currently approved DHA OPMED shipping carriers as of January 1, 2019).

4. Each shipment shall be accompanied with instructions (provided by USAMMA-DOC) for the receiving activity on how to process the temperature device, to include any requirement to return the device to USAMMA-DOC, and what actions to take if the device indicates that the required temperature range has been exceeded. At a minimum, the instructions will include the following information:

• Procedures for unpacking and immediately storing a vaccine shipment

• Instructions for how to read the temperature monitoring device

• What actions to take if the required temperature range has been exceeded during shipment.

• Instructions for returning/shipping used temperature monitoring devices to USAMMA- DOC

5. Each shipment shall include a pre-paid pre-addressed envelope and label (such as a FedEx AirBill) that can be used by the receiving activity to return temperature monitoring devices to USAMMA-DOC. USAMMA-DOC will supply the Contractor with the pre-paid envelopes and labels and provide an account number for the Contractor to reference on the label.

6. Unless otherwise advised by the contractor, the distribution of this vaccine will have no impact on current receiving activity facilities. There are no unusual storage requirements that would require construction or modification of any facilities. The adenovirus vaccine will be stored in refrigerators already in place and will be stored with other vaccines requiring refrigeration.

V. Delivery

1. Destinations. When indicated on the Delivery Order, the Contractor shall deliver F.O.B. Destination to the following addresses:

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SECTION C - SPECIFICATIONS/SOW/SOO/ORD (CONTINUED)

Additional, current contact information shall be provided on each Delivery Order.

Additional destinations within CONUS may be added at no extra cost to the Government and shall be provided on Delivery Order.

2. Shipping Frequency. It is anticipated that Delivery Orders will be issued on a monthly basis. In most cases, each address will receive between 9 and 63 packages of vaccine. Some addresses may not require vaccine every month.

Delivery Orders may be issued three (3) months (or sooner upon mutual agreement) after the date of contract award.

The complete delivery order quantity shall be delivered to the specified destination within seven (7) days after order receipt. This requirement may be modified beyond the seven (7) day requirement upon mutual consent between the Government and the Contractor for special extenuating circumstances such as weather conditions, planned shutdown of a Government destination facility (for a Tuesday, Wednesday, or Thursday) or other similar circumstance.

The Contractor shall assure that all vaccine shipments arrive not later than the following day after pick-up from Contractor's facility. The carrier's tracking number for each shipment shall be made available to USAMMA-DOC and DLA Troop Support.

The Contractor shall arrange for shipments to arrive at the receiving activities on Tuesdays, Wednesdays, and Thursdays

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SECTION C - SPECIFICATIONS/SOW/SOO/ORD (CONTINUED)

only. No weekend deliveries shall be scheduled unless clearance is obtained from USAMMA-DOC and DLA Troop Support Contracting Officer.

3. Period of Performance. The Government contemplates establishing an indefinite quantity type contract for a one-year base period with options for four (4) additional one-year periods. The resultant contract will have the following periods of performance during which the monthly deliveries will occur:

Contract Period Period of Performance

Base period October 1, 2026 to September 30, 2027 Option 1 October 1, 2027 to September 30, 2028 Option 2 October 1, 2028 to September 30, 2029 Option 3 October 1, 2029 to September 30, 2030 Option 4 October 1, 2030 to September 30, 2031

VI. Inspection and Acceptance/Invoicing

1. The Contractor shall include with each shipment a completed Material Inspection and Receiving Report (DD Form 250). In addition to the required information, the DD 250 shall include in block 16:

• Vaccine expiration date(s)

• Vaccine lot number(s)

• Serial number of temperature monitoring devices by shipping container number

2. Inspection and acceptance shall occur at the receiving activity. USAMMA-DOC will provide instruction to the receiving activity regarding the correct procedures for opening the container, checking on the status of the shipment, and reading the accompanying temperature-monitoring device and storing the adenovirus vaccine until acceptance.

Any temperature excursion shall be referred by the receiving activity to USAMMA-DOC for resolution with the Contractor. USAMMA-DOC shall notify Contractor of the temperature excursion within three (3) business days that USAMMA-DOC is being notified of the temperature excursion by the receiving activity. The receiving activity shall accept or reject the supplies based on instructions from USAMMA-DOC and in accordance with the terms of this contract. The receiving activity shall immediately forward the signed DD 250, indicating acceptance of supplies or any exceptions thereto, to USAMMA-DOC. USAMMA-DOC will coordinate the receipt of all DD 250 forms submitted by the receiving activities and forward them to the Contractor. Except in cases involving temperature excursions, the Government will accept or reject supplies within 24 hours of delivery. All other terms of FAR clause 52.246-2 remain unchanged.

3. The Contractor shall invoice using Wide Area Workflow (WAWF) and attach a signed DD250 for each invoiced shipment.

VII. In-Process Reviews

DLA Troop Support reserves the option to conduct in-process reviews (IPRs) at the Contractor's facility. The review shall be limited to not more than once per year and scheduled by DLA Troop Support not less than thirty (30) days in advance of the IPR at a time which shall be mutually determined by the parties. Requests for IPRs by any other personnel will be referred to DLA Troop Support. If the Contractor requires Confidential Disclosure Agreements (CDAs) from Government personnel, such CDAs shall be submitted to the Government at least fourteen (14) days prior to the scheduled IPR.

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 11 OF 65 PAGES

SPECIFICATION SHEET

DATE: April 1, 2025

NSN: 6505-01-642-0106

ITEM IDENTIFICATION: Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, Enteric Coated Tablets for Oral Administration, one (1) package.

SALIENT CHARACTERISTICS

Shall be a live, bi-valent, enteric-coated orally administered vaccine intended for active immunization for the prevention of respiratory infections caused by the adenovirus types 4 and 7.

Each dose shall be formulated to provide immunization against respiratory adenovirus infection and disease by inducing asymptomatic infection of the intestinal tract in individuals with low or no pre-existing neutralizing antibodies. The enteric- coated tablets shall be designed to release the virus into the intestinal tract after completion of passage through the stomach.

Shall be indicated for active immunization of military populations in which epidemic respiratory disease due to adenovirus type 4 and type 7 have been shown likely to occur (basic training facilities).

Shall be suitable for oral administration only; tablets are to be swallowed whole, without chewing.

Shall be supplied in a commercially available container considered acceptable to the FDA.

Expiration date shall be not less than 31 months from the date of manufacture.

Material shall be shipped and stored refrigerated between 2° and 8° C (35° and 46° F) and protected from moisture and freezing. No EXCURSIONS are acceptable.

Unit. Package (PG). Two (2) bottles of 100 tablets each of Type 4 and 100 tablets each of Type 7 Adenovirus Vaccine, Live, Oral, shall constitute the "UNIT”.

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.

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 marketplace. The government reserves the right to require proof of such conformance

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SECTION C - SPECIFICATIONS/SOW/SOO/ORD (CONTINUED)

prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.

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 Provisions. Shall be as indicated in the contract/purchase order and/or SOW.

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. 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.

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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 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 stringent old chain management and routine temperature- sensitive items. Perishable items requiring chill or freeze temperatures shall be properly packaged in accordance with DLAR (JP) 4145.21, 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:

Stringent Cold chain management items.

(a) Marking requirements. Shipments of FSC 6505 Vaccines and other designated items requiring compliance with stringent 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 DLAR (JP) 4145.21. 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 USAMMA-DOC at 301-619-4318.

Temperature Monitors. Temperature monitoring devices will be provided by the contractor. In order to monitor the temperature ranges during transit for bulk shipments, if/when required, the contractor is required to place one temperature monitor into 5 randomly chosen boxes for each full truckload shipment to each requested destination (2 monitors will be required for less than a full truckload). 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 the 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.

HTTP://WWW.DLA.MIL/LANDANDMARITIME/OFFERS/SERVICES/TECHNICALSUP PORT/LOGISTICS/PACKAGING/

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SECTION C - SPECIFICATIONS/SOW/SOO/ORD (CONTINUED)

MEDICALPACK1.ASPX

- DLA Troop Support Temperature Monitoring Device Specification.

- DLAR(JP)4145.21, Preparation of Medical Temperature Sensitive Products Requiring Cold Chain Management for

Shipment.

https://www.medical.dla.mil/Portal/Pharmaceutical/ColdChainPackaging

Content Inquiries: DSCPcoldchain@dla.mil

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)

SECTION D - PACKAGING AND MARKING

COMMERCIAL SHIPPING DOCUMENTS

(a) Commercial shipping documents are authorized. Packing lists, invoices, and bills of lading must contain the complete shipping address and markings exactly as specified in the Schedule including the Transportation Control Number (TCN), National Stock Number (NSN), Contract Line Item Number (CLIN), Quantity and Unit of Issue, contract/order number, and Shipment Number with a request for the carrier to perpetuate the complete information when delivery is to a port. One copy of the shipping document and one copy of the order, Department of Defense (DD) Form 1155, shall accompany or be included in each shipment.

(b) In addition, for all direct shipments to overseas and domestic consignees, including shipments to consolidation and containerization points, the documentation with complete mark for information is to be placed in a water-resistant envelope securely attached to the outside of the shipping container/exterior pack. (This paragraph is not applicable to shipments to a Government Packing Facility).

(End of Text)

SPECIAL HANDLING AND STORAGE INSTRUCTIONS

(a) To assure that all receiving activities can properly identify items requiring special handling and storage, the contractor shall annotate all copies of the Department of Defense (DD) form 250, Material Inspection and Receiving Report, with the storage and handling instructions required on the exterior shipping containers. The statement(s) shall be in capital letters and entered in block 16 of the DD form 250. The envelope containing the shipping documents accompanying the shipment shall be marked in capital letters with the notation: "contains special handling and storage instructions."

(b) Special handling and storage statements include the following:

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SECTION D - PACKAGING AND MARKING (CONTINUED)

"Store between 2 degrees - 8 degrees c (36 degrees - 46 degrees f)" "Store at controlled room temperature 15 degrees - 30 degrees c (59 degrees - 86 degrees f)" “Store between 20 degrees - 25 degrees c (68 degrees - 77 degrees f)”"do not freeze" "Keep frozen" "Keep from heat" "Flammable" "Store in a cool place" "Fragile"

(c) For unrefrigerated medical material shipments, the DD form 250 will be annotated in block 16 to state the maximum unrefrigerated shipping time, as designated in the procurement document. If refrigerated transport is used, the following shall appear "refrigerated transport utilized". For drugs, chemicals, and sterile items, the contractor shall also annotate the DD Form 250 to show the quantity shipped, the expiration date or date of manufacture whichever is applicable, for each lot, batch or control number.

(End of Text)

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 forwarded expeditiously to the consignee.

(3) Perishable items which do not require constant refrigeration shall be transported by a mode of transportation which will assure 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.

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SECTION D - PACKAGING AND MARKING (CONTINUED)

(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.

SECTION E - INSPECTION AND ACCEPTANCE

INSPECTION AND ACCEPTANCE WILL BE AT DESTINATION.

TESTING AT GOVERNMENT LABORATORY - DLA TROOP SUPPORT - MEDICAL

The Government reserves the right to select samples of any item at any one or more stages of production for testing. Such samples shall be forwarded by the Contractor, at its expense, to the government laboratory designated by the cognizant inspector. Thereafter, no supplies represented by the samples shall be shipped, unless otherwise directed by the inspector, until the Contractor receives notification from the designated laboratory that the samples have been approved. Provided such samples are not destroyed in testing, they shall be packed, packaged, and returned to the Contractor, at its expense, if so requested at time of their submission.

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

52.246-16 RESPONSIBILITY FOR SUPPLIES (APR 1984) FAR

SECTION F - DELIVERIES OR PERFORMANCE

F.O.B. DESTINATION.

Destinations are stated on Statement of Work Section V.

ALL DELIVERIES ARE TO BE FOB DESTINATION AND DELIVERED ON A MONTLY BASIS.

DELIVERY DESTINATIONS WILL BE DESIGNATED ON EACH INDIVIDUAL DELIVERY ORDER.

52.211-17 DELIVERY OF EXCESS QUANTITIES (SEP 1989) FAR

52.242-15 STOP-WORK ORDER (AUG 1989) FAR

52.242-17 GOVERNMENT DELAY OF WORK (APR 1984) FAR

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SECTION F - DELIVERIES OR PERFORMANCE (CONTINUED)

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

SECTION I - CONTRACT CLAUSES

52.202-1 DEFINITIONS (JUN 2020) FAR

52.203-3 GRATUITIES (APR 1984) FAR

52.203-5 COVENANT AGAINST CONTINGENT FEES (MAY 2014) FAR

52.203-6 RESTRICTIONS ON SUBCONTRACTOR SALES TO THE GOVERNMENT (JUN 2020) FAR

52.203-7 ANTI-KICKBACK PROCEDURES (JUN 2020) FAR

52.203-8 CANCELLATION, RECISSION, AND RECOVERY OF FUNDS FOR ILLEGAL OR IMPROPER ACTIVITY (MAY 2014) FAR

52.203-10 PRICE OR FEE ADJUSTMENT FOR ILLEGAL OR IMPROPER ACTIVITY (MAY 2014) FAR

52.203-12 LIMITATION ON PAYMENTS TO INFLUENCE CERTAIN FEDERAL TRANSACTIONS (JUN 2020) FAR

52.203-13 CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT (NOV 2021) FAR

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS (JAN 2017)

FAR

252.203-7000 REQUIREMENTS RELATING TO COMPENSATION OF FORMER DOD OFFICIALS (SEP 2011) DFARS

252.203-7001 PROHIBITION ON PERSONS CONVICTED OF FRAUD OR OTHER DEFENSE-CONTRACT-RELATED FELONIES (JAN

2023) DFARS

252.203-7002 REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (DEC 2022) DFARS

252.203-7003 AGENCY OFFICE OF THE INSPECTOR GENERAL (AUG 2019) DFARS

252.203-7004 DISPLAY OF HOTLINE POSTERS (JAN 2023) DFARS

52.204-10 REPORTING EXECUTIVE COMPENSATION AND FIRST-TIER SUBCONTRACT AWARDS (JUN 2020) FAR

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018) FAR

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (AUG 2020) FAR

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (AUG 2020) FAR

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND CERTIFICATIONS (DEC 2014) FAR

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (NOV 2021) FAR

52.204-22 ALTERNATE LINE ITEM PROPOSAL (JAN 2017) FAR

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SECTION I - CONTRACT CLAUSES (CONTINUED)

52.204-23 PROHIBITION ON CONTRACTING FOR HARDWARE, SOFTWARE, AND SERVICES DEVELOPED OR PROVIDED BY

KASPERSKY LAB COVERED ENTITIES (DEC 2023) FAR

52.204-27…