Sol_75N94024Q00094_Amd_0001.pdf

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 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.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

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

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

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.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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)

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Kimesha Leake, Contracting Officer

The purpose of Amendment 1 is to provide the responses to Offerors' questions and to update page 2 of the RFQ.

NICHD Office of Acquisition 6710 Rockledge Drive Bethesda, MD 20892

To All Offerors 75N94024Q00094

1 3

8/26/2024

8/15/2024

Kimesha M. Leake -S Digitally signed by Kimesha M. Leake - S Date: 2024.08.26 10:43:13 -04'00'

COMBINED SYNOPSIS / SOLICITATION

CONTRACT CLAUSES

The following Federal Acquisition Regulation (FAR) and Health & Human Services Acquisition Regulation (HHSAR) Provisions/Clauses apply to this acquisition:

FAR 52.216-18 Ordering (AUG 2020)

(a) Any supplies to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be from September 30, 2024 through September 29, 2029.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered “issued” when–

1. If sent by mail (includes transmittal by U.S. mail or private delivery service), the

Government deposits the order in the mail;

2. If sent by fax, the Government transmits the order to the Contractor’s fax number; or

3. If sent electronically, the Government either–

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of clause)

FAR 52.216-19 Order Limitation (OCT 1995)

(a) Minimum Order. When the Government requires supplies or services covered by this contract in an amount of less $1,000 the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum Order. The Contractor is not obligated to honor –

1. Any order for a single item in excess of $1,000,000.00

2. Any order for a combination of items in excess of the total contract value of $7,272,048.50; or

3. A series of orders from the same ordering office within thirty (30) calendar days that together call for quantities exceeding the limitation in subparagraph (1) or (2) above.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) above.

75N94024Q00094 – Metabolic Isotopes

# Question/Comments Government Response

So, we can offer these items for sure for solicitation # 75N94024Q00094. The only thing would be the stability testing for these products.

We do not offer stability testing on most of the requested items. The thing we would need to know is how much of each item they would need and if they would need the stability on each product?

It is very difficult to determine exactly how much of each isotope is needed as it is dependent on the need and activity of our clinical protocols. Each order would be custom and therefore a custom amount. Stability testing is a requirement for our intravenous products and a non-negotiable.

I have a question on how I should be providing the cost quotation for this project. Since this is an indefinite delivery / indefinite quantity, we don't have an exact cost. Everything will depend on how many orders and products the NIH requests over the next 5 years.

The ceiling amount for the 5 year ordering period is valued at $7,272,048.50. Page 2 of the RFQ has been updated to reflect this change.