Attachment_4_Task_Order_1_SOW.pdf

Attachment 4

RFQ 75N94024Q00094

TASK ORDER 1 (Non-Severable)

STATEMENT OF WORK

1.0 TASK ORDER TITLE

Intravenous Stable Isotopes (6,6 Deuterated Glucose & D5 Glycerol)

2.0 BACKGROUND

Stable isotopes have been used safely in clinical research for decades and have contributed seminal insights into human metabolism. In many cases, stable isotopes allow a generation of knowledge that may not be possible by any other method. Under the directive of the NIH Sterile Products for Human Administration (SPHA) Executive Committee and the NIH Office of Research Support and Compliance (approved 10/2021), stable isotopes used in clinical human metabolic studies must meet certain specified minimum requirements. Pine pharmaceuticals was initially approved by the NIH Office of Deputy Director of Clinical Care in August 2016 and the decision re-affirmed by the NIH Sterile Products for Human Research Committee (SPHA) on July 24th, 2018. The decision to continue using Pine Pharmaceuticals, LLC followed extensive year-long vetting and an external audit commissioned by the NIH CC Office of Research Support and Compliance (ORSC). A quality agreement was implemented in February 2019 and is in place between Pine Pharmaceuticals, LLC and NIH Pharmacy and NIDDK.

This Statement of Work (SOW), initiated on behalf of principal investigators of NIDDK, is for the procurement of oral stable isotopes for metabolic research. The Contractor shall be responsible for sourcing the raw material, packaging and/ or manufacturing the isotope product, and submitting and releasing the product to the NIH Clinical Center Pharmacy after microbial and analytical testing.

3.0 SCOPE

The objective of this requirement is for the procurement of additional stability testing for the intravenous stable isotopes (6,6 deuterated Glucose and D5 Glycerol). Stability testing is needed to ensure isotopes are effective past manufacturer expiration date to prevent waste and disruption of services/research.

There will be two (2) timepoints at eighteen (18) months and twenty-four (24) months past the expiration date.

4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The following isotopes will be needed, which include the following specifications and packaging. The certificate of analysis and/or the enhanced technical data package should meet the following requirements for the most recently manufactured lot with date.

1. Additional stability testing for 6,6 deuterated Glucose at timepoints 18 months and 24 months.

2. Additional stability testing for D5 Glycerol at timepoints 18 months and 24 months.

Important Notes:

The raw material and finished product requirements are outlined in Appendix A. Minimum requirements for stable isotopes used in clinical (human) metabolic studies, V1.7.

The raw material 6,6 deuterated Glucose and D5 glycerol must be obtained from Cambridge Isotope Laboratories.

These stable isotopes are needed for metabolic research protocols that are Internal Review Board (IRB) approved to meet NIDDK mission and goals. The requirements stated above are based on the minimum specifications for stable isotopes used in clinical (human) metabolic studies by the NIH SPHA Executive Committee and Office of Research Support and Compliance.

Table 1 describes the Stability testing and timeline

Base Period

T=0

Stability Storage

3 mth 6 mth 9mth 12 mth 18 mth 24 mth

Identification

HPLC

Conforms X

Potency

HPLC:

90-110% X X X X X X X

Appearance:

Clear, colorless solution with no visible particulates

X X X X X X X

Odor No odor X X X X X X X

Sterility Test

USP<71>

Sterile/Negative X

Endotoxin

USP<85>

<1.00 EU/mL X pH Report X X X X X X X

Particulate Matter

USP <788>

Conforms

X X X X X X X

5.0 TECHNICAL REPORTING REQUIREMENTS AND DELIVERABLES

Trackable Deliverables:

Number Description Send to Due Date

1 Isotopes Proof of delivery / packing slip CO and COR via Merlin

Specified in each task order

2 Sterility testing results email CO and COR via Merlin

Provided prior to isotope delivery

Non-Trackable Deliverables:

Number Description Send to Due Date

1 Notification of events that impact isotope production or delivery

CO and COR via email

Within 48 hours of the event

2 Maintain requirements for certifications CO and COR via email As needed

All reports required herein shall be submitted in electronic format, via the NICHD Merlin Contract Management System. All electronic contract deliverables shall be submitted via the NICHD Merlin Contracts Contract Management System available at the following website:

Merlin Contract Management System (nih.gov). All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at http://www.hhs.gov/web/508/index.html under "Making Files Accessible." The Contractor must provide to the CO/CS the name of the person(s) submitting electronic reports via the NICHD Merlin Contract Management System in order to initiate access.

6.0 TASK AREAS

6.1 Task Area 1 – Delivery Timelines

Contractor shall deliver the described testing approximately no later than January 2026 (see Table 1 for delivery timelines).

6.2 Task Area 2 – Shipping

Contractor shall arrange shipment to the below specified location referenced in Section 9.0.

7.0 ORDER TYPE

This is a Nonseverable Firm-Fixed Price Task Order.

https://merlin.nichd.nih.gov/Home.aspx http://www.hhs.gov/web/508/index.html

8.0 PERIOD OF PERFORMANCE

The anticipated period of performance for this requirement is:

Base Period: September 30, 2024 – September 29, 2026

9.0 INSPECTION AND ACCEPTANCE

The Project Officer/Project Officer Supervisor or the Contracting Officer Representative (COR) will perform inspection and acceptance of materials and services to be provided. The batch records will be reviewed by NIDDK prior to shipment of final formulated and vialed product.

The final product will not be accepted if it fails a sterility test performed by a third party independent product testing lab. Receiving will occur in Investigational Drug Unit (IDCU).

Inspection and acceptance will be performed in NIH Clinical Center Pharmacy by:

To be named at time of award

10.0 PROJECT OFFICER

The following Project Officer(s) will represent the Government for the purpose of this Task Order:

Project Officer: TBD Alternate Project Officer: TBD

The Project Officer is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this Task Order; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this Task Order. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this Task Order; or (5) otherwise change any terms and conditions of this Task Order.

3.0 SCOPE