amendment_0004.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO.

See Block 14

4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

6. ISSUED BY CODE SPE2D2 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

CODE FACILITY CODE

SPE2D217R0023

X

2017 APR 28

10A. MODIFICATION OF CONTRACT/ORDER NO.

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 OffersX X is extended, is not extended.

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.

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

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:

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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:

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

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

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)

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

16B. UNITED STATES OF AMERICA15B. CONTRACTOR/OFFEROR

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

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

(a) By completing Items 8 and 15, and returning

DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN FSGB

700 ROBBINS AVENUE

PHILADELPHIA PA 19111

15C. DATE SIGNED 16C. DATE SIGNED

D. OTHER (Specify type of modification and authority)

6/1/2017

3. EFFECTIVE DATE

See Attached Continuation Sheet(s).

(X)

CHECK ONE

PAGE OF PAGES

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

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

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

CONTINUED ON NEXT PAGE

A. The subject solicitation closing date is hereby extended until June 13, 2017 3PM EST.

B. The Hydrochlorothiazide 25MG 5000 count requirement has been removed from the schedule of supplies.

Please note the change to the Hydrochlorothiazide 25MG 1000 count quantities. See attached for updated schedule of supplies and related charts.

C. All other terms and conditions remain the same.

PAGE 2 OF 3 PAGESCONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED:

SPE2D217R0023-0004

SECTION J - LIST OF ATTACHMENTS

List of Attachments

Description File Name

PAGE 3 OF 3 PAGESCONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED:

SPE2D217R0023-0004

SOLICITATION NO. SPE2D2-17-R-0023 Page 2 of 70

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT

PRICE

24.

AMOUNT

0001AA

0001AB

0001AC

0001AD

0001AE

0002AA

0002AB

0002AC

0002AD

0002AE

0003AA

0003AB

0003AC

0003AD

0003AE

0004AA

0004AB

0004AC

0004AD

0004AE

0005AA

0005AB

0005AC

0005AD

0005AE

0006AA

0006AB

0006AC

0006AD

0006AE

Hydrochlorothiazide 25MG Tablet 90 Count**

National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Hydrochlorothiazide 25MG Tablet 100 Count

National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Hydrochlorothiazide 25MG Tablet 1000 Count

National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Hydrochlorothiazide 50MG Tablet 90 Count**

National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Hydrochlorothiazide 50MG Tablet 100 Count

National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Hydrochlorothiazide 50MG Tablet 1000 Count

National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

688,419

688,419

17,833

17,833

110,641

110,641

23,349

23,349

2,802

2,802

8,104

8,104

*BT

BT

BT

* BT

BT

BT

BT

BT

BT

SOLICITATION NO. SPE2D2-17-R-0023 Page 3 of 70

0007AA

0007AB

0007AC

0007AD

0007AE

Hydrochlorothiazide 12.5MG Tablet 100 Count

National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

*BT = Bottle

** Package size is unit of use and is subject to Statement of Work

- “Preparation for Delivery” requirement.

-The quantities specified in the Schedule are estimates only.

Reference FAR 52.216-21 Requirements for additional details.

115,988 115,988 115,988 115,988 115,988

*BT

BT

BT

SOLICITATION NO. SPE2D2-17-R-0023 Page 56 of 70

___ Asian-Pacific American (persons with origins from Burma, Thailand, Malaysia, Indonesia, Singapore, Brunei, Japan, China, Taiwan, Laos, Cambodia (Kampuchea), Vietnam, Korea, The Philippines, Republic of Palau, Republic of the Marshall Islands, Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, Guam, Samoa, Macao, Hong Kong, Fiji, Tonga, Kiribati, Tuvalu, or Nauru).

___ Subcontinent Asian (Asian-Indian) American (persons with origins from India, Pakistan, Bangladesh, Sri Lanka, Bhutan, the Maldives Islands, or Nepal).

___ Individual/concern, other than one of the preceding.

Attachment(s) for FAR 52.212-3

FAR 52.215-20 Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data. (Alternate IV) (OCT 2010)

(a) Submission of certified cost or pricing data is not required.

(b) Provide information described below:

For a commercial item, the offeror shall submit, at minimum, information on prices at which the same item or similar items have previously been sold in the commercial market that is adequate for evaluating the reasonableness of the price for this acquisition. Such information may include –

(A) For catalog items, a copy of or identification of the catalog and its date, or the appropriate pages for the offered items, or a statement that the catalog is on file in the buying office to which the proposal is being submitted. Provide a copy or describe current discount policies and price lists (published or unpublished), e.g., wholesale, original equipment manufacturer, or reseller. Also explain the basis of each offered price and its relationship to the established catalog price, including how the proposed price relates to the price of recent sales in quantities similar to the proposed quantities;

(B) For market-priced items, the source and date or period of the market quotation or other basis for market price, the base amount, and applicable discounts. In addition, describe the nature of the market.

Pursuant to the clause above, please provide the following information:

LINE ITEM 0001: HYDROCHLOROTHIAZIDE 25MG TAB 90 COUNT

All prices exclusive of Federal Excise Tax:

Current (2017) Commercial List Price: ___________

Previous (2016) Commercial List Price: ___________

2017 Federal Supply Schedule Price: ___________

2016 Federal Supply Schedule Price: ___________

2017 Federal Ceiling Price ___________

2016 Federal Ceiling Price ___________

SOLICITATION NO. SPE2D2-17-R-0023 Page 57 of 70

LINE ITEM 0002: HYDROCHLOROTHIAZIDE 25MG TAB 100 COUNT

All prices exclusive of Federal Excise Tax:

Current (2017) Commercial List Price: ___________

Previous (2016) Commercial List Price: ___________

2017 Federal Supply Schedule Price: ___________

2016 Federal Supply Schedule Price: ___________

2017 Federal Ceiling Price ___________

2016 Federal Ceiling Price ___________

LINE ITEM 0003: HYDROCHLOROTHIAZIDE 25MG TAB 1000 COUNT

All prices exclusive of Federal Excise Tax:

Current (2017) Commercial List Price: ___________

Previous (2016) Commercial List Price: ___________

2017 Federal Supply Schedule Price: ___________

2016 Federal Supply Schedule Price: ___________

2017 Federal Ceiling Price ___________

2016 Federal Ceiling Price ___________

LINE ITEM 0004: HYDROCHLOROTHIAZIDE 50MG TAB 90 COUNT

All prices exclusive of Federal Excise Tax:

Current (2017) Commercial List Price: ___________

Previous (2016) Commercial List Price: ___________

2017 Federal Supply Schedule Price: ___________

2016 Federal Supply Schedule Price: ___________

2017 Federal Ceiling Price ___________

2016 Federal Ceiling Price ___________

LINE ITEM 0005: HYDROCHLOROTHIAZIDE 50MG TAB 100 COUNT

All prices exclusive of Federal Excise Tax:

Current (2017) Commercial List Price: ___________

Previous (2016) Commercial List Price: ___________

2017 Federal Supply Schedule Price: ___________

SOLICITATION NO. SPE2D2-17-R-0023 Page 58 of 70

2016 Federal Supply Schedule Price: ___________

2016 Federal Ceiling Price ___________

LINE ITEM 0006: HYDROCHLOROTHIAZIDE 50MG TAB 1000 COUNT

All prices exclusive of Federal Excise Tax:

Current (2017) Commercial List Price: ___________

Previous (2016) Commercial List Price: ___________

2017 Federal Supply Schedule Price: ___________

2016 Federal Supply Schedule Price: ___________

2017 Federal Ceiling Price ___________

2016 Federal Ceiling Price ___________

LINE ITEM 0007: HYDROCHLOROTHIAZIDE 12.5MG TAB 100 COUNT

All prices exclusive of Federal Excise Tax:

Current (2017) Commercial List Price: ___________

Previous (2016) Commercial List Price: ___________

2017 Federal Supply Schedule Price: ___________

2016 Federal Supply Schedule Price: ___________

2016 Federal Ceiling Price ___________

FAR 52.215-6 Place of Performance (OCT 1997)

(a) The offeror or respondent, in the performance of any contract resulting from this solicitation, intends, does not intend [check applicable block] to use one or more plants or facilities located at a different address from the address of the offeror or respondent as indicated in this proposal or response to request for information.

Pursuant to the clause above, please review and provide the required information:

1. The U.S. Food and Drug Administration (FDA) is the Government agency responsible for providing and enforcing pharmaceutical current Good Manufacturing Practices (cGMP) standards for pharmaceutical products included in this solicitation. Only offers from companies that have an acceptable cGMP status on record with the FDA for the facilities identified by the offeror in Paragraph 7 below will be considered for award. The FDA will evaluate a prospective

SOLICITATION NO. SPE2D2-17-R-0023 Page 59 of 70 offeror for DLA procurements only if the offeror has had a qualifying cGMP inspection within the previous two years. Before a contract can be awarded, any successful offeror’s manufacturing facilities shall have a current acceptable cGMP status with FDA, or shall have had an acceptable report from the last FDA facility inspection on record. In the absence of a current cGMP evaluation, an offeror is required to include with its proposal documentation on the acceptable outcome of a FDA facility inspection that occurred more than two years prior to submission of the offer.

2. If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility.

Subcontractors (i.e., packagers, labelers, etc.) that participate in the production of the products offered on this solicitation shall also be listed along with their addresses. All facilities described in this paragraph and listed below shall be substantially in compliance with applicable FDA cGMP standards prior to contract award.

3. Offeror shall identify below or by attachment (if additional space is needed), the products offered on this solicitation (products shall be identified by product name and by solicitation item number); whether the offeror manufactures the products; and/or whether the offeror is a distributor of the products offered.

4. If the finished products to be offered are of foreign manufacture, the complete name and address of the manufacturer shall be provided below. The offeror is also required to check the box below that is applicable to its offer. Please note that the information required below must be the name and address of the manufacturing facility, rather than the address of the foreign headquarters, distributor or agent.

☐OFFEROR IS THE MANUFACTURER (AT THE FOLLOWING LOCATIONS) OF THE PRODUCTS OFFERED

ON THIS SOLICITATION.

☐OFFEROR IS A DISTRIBUTOR OF THE PRODUCTS OFFERED ON THIS SOLICITATION. THE PRODUCTS

WILL BE MANUFACTURED BY THE FOLLOWING COMPANY AT THE FOLLOWING LOCATIONS:

(Name of Manufacturing Company)

(Street Address) (Post Office Address Not Acceptable)

(U.S.A. Point of Contact, e-Mail Address and U.S.A Telephone Number)

TABLETS, CAPSULES AND PILLS

Item Complete Address of Facility Where Ingredients are

Measured, Weighed, Mixed and Compounded

Point of Contact Including Phone Number

0001 – Hydrochlorothiazide 25MG TAB 90 Count Bottle

SOLICITATION NO. SPE2D2-17-R-0023 Page 60 of 70

0002 – Hydrochlorothiazide 25MG TAB 100 Count Bottle

0003 – Hydrochlorothiazide 25MG TAB 1000 Count Bottle

0004 – Hydrochlorothiazide 50MG TAB

0005 – Hydrochlorothiazide 50MG TAB

0006 – Hydrochlorothiazide 50MG TAB

0007 – Hydrochlorothiazide 12.5MG

TAB

PACKAGING

Item Complete Address of Facilities Where Intermediate Containers will be Filled and Labeled

Point of Contact Including Phone Number

SOLICITATION NO. SPE2D2-17-R-0023 Page 61 of 70

PACKING

Item Complete Address of Facilities Where Products will be Packed and Prepared for Shipment

Point of Contact Including Phone Number

SOLICITATION NO. SPE2D2-17-R-0023 Page 62 of 70

New Drug Applications (NDA)

Offerors shall represent below information pertaining to FDA approval of New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA), when such approval is a prerequisite to marketing, and container/closure system information relative to product stability. (If additional space is needed, the required information may be provided in an attachment to the offer.)

(a) NDA/ANDA.

Item ___________________________, FDA Approval File Number _______________________, Date of FDA approval _________________________.

(b) CONTAINER/CLOSURE SYSTEM MATERIALS.

(describe)

DFARS 252.225-7020 Trade Agreements Certificate.

TRADE AGREEMENTS CERTIFICATE—BASIC (NOV 2014)

(a) Definitions. “Designated country end product,” “nondesignated country end product,” “qualifying country end product,” and “U.S.-made end product” as used in this provision have the meanings given in the Trade Agreements—Basic clause of this solicitation.

(b) Evaluation. The Government—

(1) Will evaluate offers in accordance with the policies and procedures of Part 225 of the Defense Federal Acquisition Regulation Supplement; and

0004 ATTACH.SPE2D2-17-R-0023