N0018320Q0157 Amendment 0001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to extend the closing date to 25 Sept. 2020 and to clarify that this is a sole sourse for INOtherapy Servies.

All other Terms and conditions remain the same POC: Paula Poe at paula.m.poe.civ@mail.mil

1. CONTRACT ID CODE PAGE OF PAGES

J 1 4

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

16C. DATE SIGNED

BY 21-Sep-2020

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X N0018320Q0157

X 9B. DATED (SEE ITEM 11)

24-Aug-2020

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

Offer 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 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram 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 telegram or letter, provided each telegram or letter 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 NO. AS DESCRIBED IN ITEM 14.

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

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, 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.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

21-Sep-2020

CODE

NAVAL MEDICAL CENTER

MMD/CONTRACTING DIVISION

ATTN: PAULA POE

54 LEWIS MINOR STREET

PORTSMOUTH VA 23708-2297

N00183 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

N0018320Q0157

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN description has changed from INO Therapy (Nitric Oxide) to INO Therapy Services.

The CLIN extended description has changed from:

Naval Medical Center Portsmouth - Respiratory Therapy Department has arequirement for INO Therapy (Nitric Oxide) Services for inhalation portablealuminum cylinders.Name: INOMAX 800PPM GAS (NITRIC OXIDE 800PPM GAS)NDC With Dashes: 64693-0002-01Size: DPackage Description: 353 LitersVA Class: CN201Name:

INOMAX 800PPM GAS (NITRIC OXIDE 800PPM GAS)NDC With Dashes: 64693-0002-02Size: 88Package Description: 1963 LitersVA Class: CN201Vendor shall provide NMCP with use of INOtherapy Services, which consists of:--The pharmaceutical drug INOmax® (nitric oxide) for inhalation (“INOmax”)--Delivery device meeting the criteria for the administration of INOmax set forth in the product label for INOmax (the “Delivery Device”)-- Various maintenance and calibration items, accessories, and disposables--Training, support, maintenance, pick-up and delivery, and other services, all as described in further detail in Exhibit A

To:

Naval Medical Center Portsmouth - Respiratory Therapy Department has arequirement for INO Therapy Services for inhalation portablealuminum cylinders. Please see Section CName: INOMAX 800PPM GAS (NITRIC OXIDE 800PPM GAS)NDC With Dashes: 64693-0002-01Size: DPackage Description: 353 LitersVA Class: CN201Name:

INOMAX 800PPM GAS (NITRIC OXIDE 800PPM GAS)NDC With Dashes: 64693-0002-02Size: 88Package Description: 1963 LitersVA Class: CN201Vendor shall provide NMCP with use of INOtherapy Services, which consists of:--The pharmaceutical drug INOmax® (nitric oxide) for inhalation (“INOmax”)--Delivery device meeting the criteria for the administration of INOmax set forth in the product label for INOmax (the “Delivery Device”)-- Various maintenance and calibration items, accessories, and disposables--Training, support, maintenance, pick-up and delivery, and other services, all as described in further detail in Exhibit A

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

SOO

STATEMENT OF OBJECTIVES (SOO)

Naval Medical Center Portsmouth - Respiratory Therapy Department has a requirement for INO Therapy Services for inhalation portable aluminum cylinders Vendor to provide INO Therapy Respiratory services. A minimum of 2 systems are requested:

1. Vendor shall provide Customer with use of INOtherapy Services, which consists of:

a. The pharmaceutical drug INOmax® (nitric oxide) for inhalation (“INOmax”)

b. Delivery device meeting the criteria for the administration of INOmax set forth in the product label for

INOmax (the “Delivery Device”)

c. Various maintenance and calibration items, accessories, and disposables

d. Training, support, maintenance, pick-up and delivery, and other services, all as described in further detail in Exhibit A

2. Contractor warrants that the INOtherapy System(s) delivered to Customer’s facilities shall be in good working order.

3. Contractor shall provide periodic and as needed maintenance thereof as further described in Exhibit A.

a. Customer shall promptly notify Contractor in the event of any malfunction of any INOtherapy System(s) in NMCP’s possession or control.

b. All services provided by Contractor hereunder shall be performed in a professional and workmanlike manner.

4. INOtherapy System(s). Customer’s requests two (2) systems for 2,215 hours (volume of use during the Term)

a. Including, without limitation, the appropriate number of cylinders of INOmax to be held in inventory at

NMCP facility.

5. Maintain the proper operation of the INOtherapy System(s) at NMCP facilities and to maximize patient safety,

a. NMCP shall

i. Use the INOtherapy System(s) only with equipment, devices, software, or other items with which they have been validated as reflected in the documentation for the INOtherapy System(s),

ii. Permit only qualified personnel who have received adequate training to administer INOtherapy,

iii. Comply with such instructions, warnings, documentation, guidance, or other recommendations as may be provided by Ikaria,

iv. Not modify any INOtherapy System without Ikaria’s prior written consent.

b. NMCP acknowledges and agrees that regular checks of INOtherapy System(s) provided to NMCP are essential to the continued proper operation of those systems.

c. Consistent with training, NMCP shall perform routine monthly system checks of the INOtherapy System(s) located at Customer’s facilities.

d. NMCP acknowledges and agrees that NMCP shall be solely responsible for:

i. Determining the quantity of INOMAX that Customer may use or purchase

ii. Determining, consistent with whatever standards or policies to which Customer’s prescribing physicians may be subject, the uses and therapies for which Customer may utilize INOmax provided hereunder.

6. Safety and Training.

a. INOtherapy is comprised of, among other things, an FDA-approved pharmaceutical drug (INOMAX) that is administered through the use of a complex, FDA-cleared electro-mechanical drug delivery system.

NMCP acknowledges and agrees that INOtherapy is typically used in a critical care context, where the proper use and administration of INOtherapy may be essential to maintain blood oxygenation in critically ill patients with pulmonary hypertension.

EXHIBIT A

SERVICE:

Vendor shall provide Customer with use of INOtherapy Services, which consists of:

a. the pharmaceutical drug INOmax® (nitric oxide) for inhalation (“INOmax”)

b. a delivery device meeting the criteria for the administration of INOmax set forth in the product label for INOmax (the “Delivery Device”)

c. various maintenance and calibration items, accessories, and disposables

d. training, support, maintenance, pick-up and delivery, and other services, all as described in further detail in Exhibit A

e. For purposes of this Agreement, an “INOtherapy System” shall include those items listed in subsections (a) through (c) of the previous sentence.

ITEMS:

INOmax (nitric oxide) for inhalation portable aluminum cylinders:

a. 64693-002-01 Size D, 353 liters @ STP of nitric oxide gas, 800ppm concentration

b. 64693-002-02 Size 88, 1963 liters @ STP of nitric oxide gas, 800ppm concentration

Use of Delivery Device meeting the criteria for the administration of INOmax set forth in the product label for INOmax

Included

INOcal purified calibration gases for calibrating the Delivery Device(s) Included Disposables, Adaptors, Parts, and Accessories Included Training & In Service Included 24/7 Technical & Customer Support Included Test Gas Program & Monthly System Check-Out Kits Included Routine Preventive Maintenance and Updates for Delivery Devices Included Replacement/Repair of Delivery Devices on an as needed basis Included Routine scheduled pick-ups and deliveries to provide Customer with appropriate levels of cylinders of INOmax and related supplies and disposable items

Included

Emergency Deliveries INOtherapy Systems (including Delivery Device(s), cylinders, calibration gas, disposables, etc.) on an as needed basis

Included

Reimbursement Support Services Included

(End of Summary of Changes)