NIHCC CPL_SON_GentleMacsOcto.docx

STATEMENT OF NEED (SON)

Instructions: This document should be used for the acquisition of PRODUCTS. Instructions for completion are in red, and should be excluded in the completed document.

1.0 TITLE

Purchase of Miltenyi Biotec GentleMACS Octo Dissociator with Heaters

2.0 BACKGROUND

This Statement of Need (SON) supports the purchase of a Miltenyi Biotec GentleMACS Octo Dissociator with Heater to be located in the Clinical Pharmacology Laboratory (CPL) at the National Institutes of Health (NIH). The instrument is essential for the automated dissociation and homogenization of preclinical and clinical tissue samples prior to liquid chromatography-mass spectrometry (LC-MS) analysis. These procedures are required for the accurate quantification of therapeutic agents and their metabolites in tissues for pharmacokinetic (PK) and tissue distribution studies.

This equipment is integral to the CPL’s role in supporting translational pharmacology, biomarker discovery, and pharmacokinetic/pharmacodynamic (PK/PD) profiling across multiple NIH protocols and collaborations.

3.0 TYPE OF ORDER

This is a Firm Fixed-Price Quote.

4.0 SPECIAL ORDER REQUIREMENTS

This purchase will be paid in full upon acceptance.

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The gentleMACS Octo Dissociator with Heaters (Generation 3) provides automated, standardized dissociation, homogenization, and tissue processing for up to eight samples simultaneously. Key features include:

· Automated dissociation, homogenization, and perfusion of tissue samples with minimal hands-on time

· Simultaneous processing of up to eight samples to increase throughput and laboratory efficiency

· Integrated heating units that enable temperature-controlled tissue dissociation and enzymatic digestion workflows

· Standardized processing protocols that improve reproducibility across operators and experiments

· Compatibility with a wide range of preclinical and clinical tissue types

· Closed-system sample processing that minimizes contamination risk and sample loss

· Benchtop design suitable for routine use in translational and pharmacology laboratories This instrument is essential for the preparation of preclinical and clinical tissue samples for downstream LC-MS analyses used in pharmacokinetic (PK), pharmacodynamic (PD), tissue distribution, and biomarker studies. Automated and standardized tissue processing will improve sample quality, increase throughput, reduce operator variability, and support ongoing translational research activities across multiple NIH-supported projects and collaborations.

4.2 DELIVERY / INSTALLATION

Delivery of the gentleMACS Octo Dissociator with Heaters is included in the quoted price. No installation services are required, as the instrument is designed for benchtop operation and can be placed into service by laboratory personnel following manufacturer instructions.

4.3 TRAINING

No additional training is required. Support includes access to online resources and application specialists.

5.0 PAYMENT

Payment shall be made in full upon receipt of invoice and in accordance with NIH prompt payment terms.

Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JUL 2013) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I INVOICE REQUIREMENTS

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

* NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

C. Mail an original and 1 copy of the itemized invoice to:

National Institutes of Health Office of Financial Management, Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

For inquiries regarding payment call: (301) 496-6088

In order to facilitate the prompt payment of invoices, it is recommended that the vendor submit a photocopy of the invoice to the “Consignee” designated for the acquisition in blocks 6A – 6E of the face page of the Order/Award document.

II. INVOICE PAYMENT

A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. INTEREST PENALTIES

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (DEC 2013)

1. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

1. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.