36C24E21Q0104 0001.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

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:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(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 is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, 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.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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.

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

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 00240E US Department of Veterans Affairs Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh

PA

15212-5319 00240E US Department of Veterans Affairs Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh

PA

15212-5319 To all Offerors/Bidders

36C24E21Q0104

X

THIS AMENDMENT IS TO ANSWER ALL VENDOR QUESTIONS. NO FURTHER QUESTIONS WILL BE ACCEPTED. ALL FORMAL QUOTES DUE ON 6/15

AND MUST FOLLOW INSTRUCITONS IN ORIGINAL RFQ POSTING. 100% VOSB SET ASIDE.

Lynn Portman

CONTINUATION PAGE

CUSTOMS BROKER VENDOR QUESTIONS & ANSWERS ***NO FURTHER QUESTIONS WILL BE ACCEPTED*** FORMAL RESPONSED ARE DUE BY 6/15 AND MUST SUBMITTED ON THE ORIGINAL RFQ DOCUMENT. 100% SET ASIDE FOR VETERAN OWNED SMALL BUSINESS (VOSB)

1. Will the freight arrive to the Albuquerque International Airport? If not, do you know where the shipments will arrive? DFW, LAX, Houston?

ANSWER: See answer to Question #10

2. Would it be possible to open this contract to include all the local export services and air freight? This will then be a EX Works shipment and the contractor would have better control to support the user with the entire process from origin to delivery.

ANSWER: Suppliers are handling shipment to the point of Port of Entry and this cannot be changed.

3. In regards to the price/schedule are you looking for a per lbs or per kgs rate? The shipment cost will be determined on a few factors that are unknown at this time.

ANSWER: Weights in Question #4 are in KG

4. Is there an idea of the estimated weight and dimensions of the pallets at this time?

ANSWER: Details below MetFormin and placebo (data is per shipment) Shipment weight = 3,720,600 KG Volume = 19,372 cubic meter Pallets = 31 to 32

N-Acetyl Cysteine (NAC) effervescent and Placebo

Nabiximols and Placebo – NOTE: This is expected to replace the AFQ056 (Mavoglurant) and placebo

5. The SOW mentions transport for drugs, devices or other related products. Do you know if any of the devices are classified as Dangerous Goods or contain any items that might be classified as hazardous materials? Is there a possible that the devices contain Lithium batteries?

ANSWER: Specific products are listed in the SOW as the expected imports. No devices are currently planned.

6. Will the shipment pallets be stackable to maximize the loading in the truck?

ANSWER: No stacking

7. Customs Bond: bond is an insurance, and it is secured to protect interest of the U.S. Government, when comes to duty. The cost depends on the amount of “coverage” the importer is required. Same as when you purchase auto insurance, you tell the insurance carrier how much your car worth, to determine the premium. Minimum value for Continuous Bond is $50,000 and cost of that bond is +/-$500. However, if merchandise imported is of a high value and regulated (by FDA or any other agency), bond amount may need to be higher. We will gladly provide the price for annual continuous bond but need to know the amount of the bond VA will be looking to secure. If you can advise the maximum value of the shipment VA will be bringing in, we will help to determine bond amount VA will be required to carry to meet CBP requirements.

ANSWER: Details below

- MetFormin valued at $40,068 per shipment

- MetFormin Placebo valued at $56,142 per shipment

- N-Acetyl Cysteine (NAC) effervescent and Placebo (NOTE: this pricing is only an estimate)

Nabiximols and Placebo – NOTE: This is expected to replace the AFQ056 (Mavoglurant) and placebo

8. Import Fees: this is rather vague. Are you looking for us to provide one all-in service charge, which will cover clearance of the merchandise, or you would like us to break it down by specific service task, e.g. import entry, FDA filing, payments of 3rd party fees (if any), CBP/FDA inspection oversight, etc

ANSWER: All-in-one for Import Fees is sufficient

9. Insurance: are we only insuring the freight for the land portion in the U.S. or from origin? Is VA looking for individual policy for each shipment, or an umbrella policy covering all shipments within specified period? What is the value of the merchandise to be insured?

ANSWER:

Shipment values are in a previous answer Individual policies Insure freight from Port-of-Entry to Albuquerque

10. Transportation: understand everything will be going to Albuquerque, NM, but what would be the entry point? Cost of moving a pallet to Albuquerque from JFK is very different from LAX. See tentative schedule on pages 6-7, but would need to know weight and dimensions for those pallets. For example 31 pallets can be 2 truckloads, or, if they are short and stackable, might be able to load one full truck double stack. Understand there are temp and recording requirements, but not sure if they are for all or just some shipments. Also, item H on page 5 states cost estimate must be provided prior to formalizing of the transportation.

ANSWER:

Metformin/placebo – planning on LAX

- Per shipment: 32 pallets 2 trucks, temperature monitors and recording requirements are required

N-Acetyl Cysteine (NAC) effervescent/placebo – planning on LAX

- No temperature monitoring and approximate shipment size

Year 1 Cubic feet per Shipment Year 3 Cubic feet per Shipment Year 5 Cubic feet per Shipment

Nabiximols – planning on ABQ Sunport

Cubic feet per Shipment Year 3 Cubic feet per Shipment Year 5 Cubic feet per Shipment