Solicitation Amendment W81K0026QA0640001 SF 30 Approved.pdf

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

1. This amendment adds the FAR Block 14 (Description of Amendment/Modification):

Clause 52.244-2. Subcontracts and adds the following language:

Prime Contractor as Single Point of Responsibility: Pursuant to the principles outlined in FAR 52.244-2, Subcontracts, the Prime Contractor is and shall remain fully responsible for the performance of this entire contract. The Prime Contractor is liable for the acts and omissions of its subcontractors at any tier as if they were the acts and omissions of the Prime Contractor itself.

All requirements must be met by a single entity, either the Prime Contractor or a single subcontractor. A combination of capabilities between the Prime Contractor and a subcontractor to collectively meet a single requirement is not permissible. The Government's approval of any subcontract does not relieve the Prime Contractor of any responsibility for performing this contract.

2. This amendment also adds the following to the Addendum 52.212-1, Instructions to Offerors- Commercial Products and Commercial Services and Addendum 52.212-2 Evaluation- Commercial Products and Commercial Services:

Amendment Section: Prime Contractor and Subcontractor Requirements

Overall Responsibility for Performance: The Prime Contractor shall be fully responsible for all work performed under this contract, whether performed by the Prime Contractor's own forces or by subcontractors. The use of subcontractors shall not relieve the Prime Contractor of its responsibility to meet all requirements of the solicitation and the resulting contract. The Government will hold the Prime Contractor solely responsible for the complete and satisfactory performance of all work.

Submission of Teaming Agreement(s): All offerors proposing to use one or more subcontractors to perform substantive work under this contract must submit a copy of their executed Teaming Agreement(s) as part of their proposal package. The agreement(s) must clearly delineate the roles, responsibilities, and planned work allocation between the Prime Contractor and each respective subcontractor. The agreement must be signed by authorized representatives of all parties. Failure to provide a signed Teaming Agreement for any proposed subcontractor may render the proposal non-responsive and ineligible for award.

3. This amendment also removes the language " Subject to Availability of Funds" from CLIN 0001.

Continuation of Supplies or Services and Prices/Costs

The following CLIN(s) / SLIN(s) / ELIN(s) were modified:

INFORMATION FROM TO CHANGED

BY

Description Compound Compound

W81K0026QA0640001

Pharmaceuticals Period of Performance 1 April 2026 to 30 September Subject to Availability of Funds.

Pharmaceuticals Period of Performance 1 April 2026 to 30 September

Addendum to Contract Clauses

Additional Information/Notes

The following clauses were added:

FAR Clauses Incorporated by Full Text

52.244-2 Subcontracts. (Jun 2020)

Subcontracts (Jun 2020)

(a) . As used in this clause-Definitions

"Approved purchasing system" means a Contractor's purchasing system that has been reviewed and approved in accordance with part 44 of the Federal Acquisition Regulation (FAR).

"Consent to subcontract" means the Contracting Officer's written consent for the Contractor to enter into a particular subcontract.

Subcontract means any contract, as defined in FAR subpart 2.1, entered into by a subcontractor to furnish supplies or services for performance of the prime contract or a subcontract. It includes, but is not limited to, purchase orders, and changes and modifications to purchase orders.

(b) When this clause is included in a fixed-price type contract, consent to subcontract is required only on unpriced contract actions (including unpriced modifications or unpriced delivery orders), and only if required in accordance with paragraph (c) or (d) of this clause.

(c) If the Contractor does not have an approved purchasing system, consent to subcontract is required for any subcontract that-

(1) Is of the cost-reimbursement, time-and-materials, or labor-hour type; or

(2) Is fixed-price and exceeds-

(i) For a contract awarded by the Department of Defense, the Coast Guard, or the National Aeronautics and Space Administration, the greater of the simplified acquisition threshold, as defined in FAR 2.101 on the date of subcontract award, or 5 percent of the total estimated cost of the contract; or

(ii) For a contract awarded by a civilian agency other than the Coast Guard and the National Aeronautics and Space Administration, either the simplified acquisition threshold, as defined in FAR 2.101 on the date of subcontract award, or 5 percent of the total estimated cost of the contract.

(d) If the Contractor has an approved purchasing system, the Contractor nevertheless shall obtain the Contracting Officer's written consent before placing the following subcontracts:

Subcontracts for compound pharmaceuticals________

(e)

(1) The Contractor shall notify the Contracting Officer reasonably in advance of placing any subcontract or modification thereof for which consent is required under paragraph (b), (c), or (d) of this clause, including the following information:

(i) A description of the supplies or services to be subcontracted.

(ii) Identification of the type of subcontract to be used.

(iii) Identification of the proposed subcontractor.

(iv) The proposed subcontract price.

(v) The subcontractor's current, complete, and accurate certified cost or pricing data and Certificate of Current Cost or Pricing Data, if required by other contract provisions.

(vi) The subcontractor's Disclosure Statement or Certificate relating to Cost Accounting Standards when such data are required by other provisions of this contract.

(vii) A negotiation memorandum reflecting-

(A) The principal elements of the subcontract price negotiations;

(B) The most significant considerations controlling establishment of initial or revised prices;

(C) The reason certified cost or pricing data were or were not required;

(D) The extent, if any, to which the Contractor did not rely on the subcontractor's certified cost or pricing data in determining the price objective and in negotiating the final price;

(E) The extent to which it was recognized in the negotiation that the subcontractor's certified cost or pricing data were not accurate, complete, or current; the action taken by the Contractor and the subcontractor; and the effect of any such defective data on the total price negotiated;

(F) The reasons for any significant difference between the Contractor's price objective and the price negotiated; and

(G) A complete explanation of the incentive fee or profit plan when incentives are used. The explanation shall identify each critical performance element, management decisions used to quantify each incentive element, reasons for the incentives, and a summary of all trade-off possibilities considered.

(2) The Contractor is not required to notify the Contracting Officer in advance of entering into any subcontract for which consent is not required under paragraph (b), (c), or (d) of this clause.

(f) Unless the consent or approval specifically provides otherwise, neither consent by the Contracting Officer to any subcontract nor approval of the Contractor's purchasing system shall constitute a determination-

(1) Of the acceptability of any subcontract terms or conditions;

(2) Of the allowability of any cost under this contract; or

(3) To relieve the Contractor of any responsibility for performing this contract.

(g) No subcontract or modification thereof placed under this contract shall provide for payment on a cost-plus-a-percentage-of-cost basis, and any fee payable under cost-reimbursement type subcontracts shall not exceed the fee limitations in FAR 15.404-4(c)(4)(i).

(h) The Contractor shall give the Contracting Officer immediate written notice of any action or suit filed and prompt notice of any claim made against the Contractor by any subcontractor or vendor that, in the opinion of the Contractor, may result in litigation related in any way to this contract, with respect to which the Contractor may be entitled to reimbursement from the Government.

(i) The Government reserves the right to review the Contractor's purchasing system as set forth in FAR subpart 44.3.

(j) Paragraphs (c) and (e) of this clause do not apply to the following subcontracts, which were evaluated during negotiations:

(End of clause)

Addendum to 52.212-1, Instructions to Offerors - Commercial Products and Commercial Services

Miscellaneous text in this section has been modified to:

Addendum to 52.212-1, Instructions to Offerors - Commercial Products and Commercial Services

The Government will award one Purchase Order resulting from this solicitation to the responsible offeror whose quote conforms to the instructions of this solicitation and is the most advantageous to the Government, price and other factors considered. Factors being utilized to evaluate quotes are:

Award shall be made on a Lowest Price Technically Acceptable (LPTA) basis in accordance with the evaluation criteria stated in Addendum to FAR Provision 52.212-2, which could result in awarding to other than the lowest offer. An Offeror's proposed quote will be evaluated to determine if it is acceptable or unacceptable as stated in Addendum to FAR Provision 52.212-2.

QUESTIONS: Offerors shall submit all questions regarding this solicitation via email to sheryl.j.

egans.civ@health.mil by 3 February 2026, 8AM Central Standard Time (CST). The Government shall publish all responses questions through https://www.sam.gov. no later than end of business day 5 February 2026, CST. The identity of the firm submitting the question shall not be disclosed. The Government will accept all questions until the date specified in the solicitation. Questions submitted after the due date and time for questions shall not be accepted or considered.

QUOTE DUE DATE: Offerors shall submit signed and dated via email no later than the date and time specified in the portal. Offers submitted outside the listed email address shall not be accepted. Untimely offers shall not be considered. All quotes submitted after the deadline reflected in this solicitation will be considered untimely and ineligible for award. Hardcopies of quotes shall not be accepted.

QUOTE PREPARATION INSTRUCTIONS: Offeror shall provide one (1) electronic quote copy to email address: sheryl.j.egans.civ@health.mil The response/quote shall be clear, concise and include sufficient detail for effective evaluation. Responses to this solicitation shall strictly adhere to the requirements/instructions set forth in the solicitation. Submissions that do not adhere to format and content requirements of this solicitation will be considered non-compliant.

A compliant quote is one that meets all of the terms, conditions, and specifications, provides all required documents and complies with all quote instruction to this solicitation. A non-compliant quote shall be eliminated from the competition. Only compliant quotes will be evaluated for award. The quote shall not contain any extraneous information such as advertisements, or marketing information.

Award may be made without discussions with Offerors (except limited exchanges conducted for the purpose of minor clarification). Therefore, Offerors are encouraged to present their best quote and price in the initial quote submission. However, IAW FAR Part 15.306, should discussions become necessary, the Government reserves the right to hold them. If this occurs, a competitive range will be established and offerors notified. The competitive range may be limited for purposes of efficiency IAW FAR Part 15.306(c)(2).

Your quote shall be submitted in three (3) sections: Administrative, Technical, and Pricing, as outlined in the following paragraphs.

SECTION I - ADMINISTRATIVE: Within the Administrative section, the Offeror shall ensure that the quote reflects Offeror's name, address, and telephone number CAGE code and UEI number; the full address, phone, and facsimile numbers of the Offeror; points of contact (POCs) authorized to negotiate with the Government on the Offeror's behalf; the solicitation number; a statement confirming the Offeror is willing to hold its prices firm for at least 120 days from the date specified for receipt of offers.

The Offeror shall be registered in the System for Award Management (SAM) with the appropriate NAICS Code and shall not have any Active Exclusions listed within SAM. lf the Offeror is currently registered in SAM with up to date/completed representations and certifications, provide an affirmation on the title page (or second page) that these representations and certificates are current, complete, and accurate as of the due date of this solicitation. Otherwise, the Offeror shall include one (1) copy of the following provisions located within this solicitation. The provisions shall be completed and included with the quote: FAR Provision 52.212-3, Offeror Representations and Certifications, Alternate I; FAR Provision 52.209-7, Information Regarding Responsibility Matters.

1. Prime Contractor and Subcontractor Requirements

Overall Responsibility for Performance: The Prime Contractor shall be fully responsible for all work performed under this contract, whether performed by the Prime Contractor's own forces or by subcontractors. The use of subcontractors shall not relieve the Prime Contractor of its responsibility to meet all requirements of the solicitation and the resulting contract. The Government will hold the Prime Contractor solely responsible for the complete and satisfactory performance of all work.

Submission of Teaming Agreement(s): All offerors proposing to use one or more subcontractors to perform substantive work under this contract must submit a copy of their executed Teaming Agreement(s) as part of their quote package. The agreement(s) must clearly delineate the roles, responsibilities, and planned work allocation between the Prime Contractor and each respective subcontractor. The agreement must be signed by authorized representatives of all parties. Failure to provide a signed Teaming Agreement for any proposed subcontractor may render the proposal non-responsive and ineligible for award.

SECTION II- TECHNICAL:

a. The technical quote shall be written in detail for the Government to determine if the offeror's product(s) adequately meets the specific requirement as stated in 52.212-2.

b. The offeror MUST be able to provide the ENTIRETY of the requested compound pharmaceuticals. If not able the provide the entirety of the items the offeror is ineligible for award.

SECTION III- PRICE:

a. The offeror shall submit quote pricing for all compound pharmaceuticals listed. Include the unit price and the total extended price for each subCLIN.

b. Offeror agrees to hold their prices for ninety (90) days from the quote submission.

The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

(End of Provision)

Addendum to Evaluation - Commercial Product and Commercial Services

Miscellaneous text in this section has been modified to:

ADDENDUM TO 52.212-2 Evaluation-Commercial Products and Commercial Services.

Award will be made using the lowest-price, technically-acceptable (LTPA) source selection process. The Government will initially list quotes from lowest to highest price. The Government will evaluate the lowest priced quote first. If that quote is determined technically unacceptable, the Government will evaluate the next lowest priced quote and continue in that manner until a quote is rated Technically Acceptable. If a quote is rated Technically Unacceptable, the Government will not evaluate any other factor.

USING THIS PROCEDURE, THE GOVERNMENT MIGHT NOT EVALUATE ALL QUOTES.

(a). The Government will award a Purchase Order resulting from this solicitation, to the responsible Request For Quote (RFQ) conforming to the solicitation, that is lowest price technically acceptable (LPTA). Award will be on an all or none basis. The following evaluation factors shall be used to evaluate offers:

Technical Acceptability and Price.

The following evaluation factors shall be used to evaluate offers:

1. Technical.

a. The technical quote shall be written in detail for the Government to determine if the offeror's product(s) adequately meets the specific requirement as stated in 52.212-2.

b. The offeror MUST be able to provide the ENTIRETY of the requested compound pharmaceuticals. If not able to provide the entirety of the items, the offeror is ineligible for award.

c. Provide documented proof and compliance with the following:

a) Certification/Accreditations: FDA or Pharmacy Compounding Accreditation Board (PCAB) certification. The company will have an active certification which will be maintained annually to ensure the products are conducted with strict adherence to quality standards and principles of professional compounding. Provide copy in response.

b) USP Chapter: The pharmacy must be compliant with ongoing changes and keeping up to date with requirements imposed by USP Chapter. Products made are performed under the guidance set forth by this organization.

c) Quality Control: A system of quality checks which include environmental monitoring, raw material testing, in process testing, endotoxin testing, product sterility and fungal testing as well as potency and stability testing of finished preparations. May conduct studies to verify and potentially extend stability and use-by dating on all preparations. Vendor shall provide QI/QA certification on every batch regardless of size.

d) Prime Contractor and Subcontractor Requirements: Overall Responsibility for Performance:

The Prime Contractor shall be fully responsible for all work performed under this contract, whether performed by the Prime Contractor's own forces or by subcontractors. The use of subcontractors shall not relieve the Prime Contractor of its responsibility to meet all requirements of the solicitation and the resulting contract. The Government will hold the Prime Contractor solely responsible for the complete and satisfactory performance of all work.

Submission of Teaming Agreement(s): All offerors proposing to use one or more subcontractors to perform substantive work under this contract must submit a copy of their executed Teaming Agreement(s) as part of their proposal package. The agreement(s) must clearly delineate the roles, responsibilities, and planned work allocation between the Prime Contractor and each respective subcontractor. The agreement must be signed by authorized representatives of all parties. Failure to provide a signed Teaming Agreement for any proposed subcontractor may render the proposal non-responsive and ineligible for award.

Prime Contractor as Single Point of Responsibility: Pursuant to the principles outlined in FAR 52.244-2, Subcontracts, the Prime Contractor is and shall remain fully responsible for the performance of this entire contract. The Prime Contractor is liable for the acts and omissions of its subcontractors at any tier as if they were the acts and omissions of the Prime Contractor itself.

All requirements must be met by a single entity, either the Prime Contractor or a single subcontractor. A combination of capabilities between the Prime Contractor and a subcontractor to collectively meet a single requirement is not permissible. The Government's approval of any subcontract does not relieve the Prime Contractor of any responsibility for performing this contract.

e) In addition to providing the entirety of the requested compound pharmaceuticals the offeror shall meet the following:

o The Contractor shall deliver orders to CRDAMC Ordering Officer within four (4) business days (Monday through Friday, not including Federal Holidays) upon receipt of order.

o The Contractor shall have a minimum of one (1) year experience in Compound Pharmaceutical manufacturing.

o The Contractor shall provide compounded pharmaceuticals meeting or exceeding the minimum shelf life listed in Pharmaceutical Drug List while stored at specified room temperature or refrigerated.

o The Contractor shall use only FDA approved drugs, containers, and diluents (e.g. ingredients supplied from authorized sources).

o The Contractor shall be in compliant with Trade Agreements Act (TAA) (ingredients supplied from authorized sources).

o The Contractor shall delivery pharmaceuticals within +/- 10% per USP standards.

o The Contractor shall be in compliant with Compounding Quality Act Title I of the Drug Quality and Security Act of 2013.

o The Contractor shall be in compliant with Current Good Manufacturing Practices (cGMP) (section 503b).

o The Contractor shall label the product with appropriate drug labeling as per NPSG.03.04.01 for labeling of all medications to follow Joint Commission.

o The Contractor shall comply with all the requirements for facilities that compound drugs (cGMPs requirement under section 503b).

o The Contractor shall provide QI/QA certification on every batch regardless of size.

o The Contractor shall provide 24/7 customer service.

o The contractor must comply with all DEA Licensing requirements for the manufacturing and distribution of controlled substances to the facility.

To meet and maintain the high-quality standard of the Carl R. Darnall Army Medical Center (CRDAMC), a list of the necessary elements of compliance has been compiled. The requirement for patient specific prescriptions such as those compounded by local pharmacies do not meet specification required for bulk compounds. Below are the items and quantities required:

*NOTE Partial quantities or partial listed items will not be technically acceptable.

ITEM QTY

Succinylcholine Chloride 100 mg (20 mg/ml) 5 ml syringe 2640

Oxytocin 30 Units added to 500 ml 0.9% Sodium Chloride solution bag 2400

L.E.T. (Lidocaine, Epinephrine, Tetracaine) Solution 3 ml in 5 ml Topical Syringe 1200

Phenylephrine HCl 1 mg (100 mcg/ml) 10 ml in 0.9% Sodium Chloride solution 10ml syringe

Minimum Shelf Life and Storage requirements

Succinylcholine Chloride 100 mg (20 mg/ml) 5 ml syringe, (minimum shelf life: 45 days, at room temperature)

Oxytocin 30 Units added to 500 ml 0.9% Sodium Chloride solution bag, (minimum shelf life: 45 days, at room temperature)

L.E.T. (Lidocaine, Epinephrine, Tetracaine) Solution 3 ml in 5 ml Topical Syringe, (minimum shelf life: 45 days, at room temperature)

Phenylephrine HCl 1 mg (100 mcg/ml) 10 ml in 0.9% Sodium Chloride solution 10ml syringe, (minimum shelf life: 45 days, at room temperature)

Technical Acceptability: Each factor must be found technically acceptable to be eligible for award.

Acceptable: Documentation provided clearly meets the minimum requirements of the solicitation.

Unacceptable: Documentation provided does not meet the minimum requirements of the solicitation.

Each factor must be found technically acceptable for each Factor to be Acceptable. To be eligible for award, each Technical Factor must be found to be "Acceptable". Any factor or subfactor receiving an "Unacceptable" will be ineligible for award.

2. Price.

a. The offeror shall submit quote pricing for all compound pharmaceuticals listed. Include the unit price and the total extended price for each subCLIN.

b. Offeror agrees to hold their prices for ninety (90) days from the quote submission.

(a) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options shall not obligate the Government to exercise the option(s).

The Government will use the following definitions/ratings when making an overall Performance Confidence Assessment (PCA).

(end of provision)

MEDICAL READINESS CONTR OFFICE WEST, 3160 MCINDOE BLDG1103

JBSA FT SAM HOUSTON, TX 78234-4504

UNITED STATES

SHERYL EGANS, EMAIL: SHERYL.J.EGANS.CIV@HEALTH.MIL TELEPHONE: 254-287-8881

AdminBy:

SCD: PAS: