SPE2D219D0077 Mod P00002 NDC Change with attachment signed.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

J

2. AMENDMENT/MODIFICATION NO.

P00002

3. EFFECTIVE DATE

See Blk. 16C

4. REQUISITION/PURCHASE REQ. NO.

See Block 14

5. PROJECT NO. (If applicable)

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

DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN FSGB

700 ROBBINS AVENUE

PHILADELPHIA PA 19111

USA

Initiator: Catherine Hunt DCH0046 Tel: 215-737-4778 Email: Catherine.Gilbert@dla.mil

DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN FSGB

700 ROBBINS AVENUE

PHILADELPHIA PA 19111

USA

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

Harvard Drug Group L.L.C., The DBA Major Pharmaceuticals 17177 N Laurel Park Dr Ste 233

LIVONIA MI 48152-3951

USA

(X) 9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

X

10A. MODIFICATION OF CONTRACT/ORDER NO.

SPE2D2-19-D-0077

10B. DATED (SEE ITEM 13)

2019 SEP 05

CODE 1LEZ0 FACILITY CODE

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 Offers is extended, is not extended.

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:

(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 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.

CHECK ONE 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

date, etc. ) SET FORTH IN

CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE

ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103 (b).

CHANGES such as changes in paying office, appropriation

X

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

Mutual Agreement by both parties

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return 1 copies to the issuing office.

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

See Continuation Sheet

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

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV.

10-83) Prescribed by GSA FAR (48 CFR)

X mailto:Catherine.Gilbert@dla.mil julie.freeman Typewritten Text Stephen Karavitch, GVP Government Sales & Ops.

julie.freeman Typewritten Text 02.18.2020

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED:

SPE2D2-19-D-0077 / P00002

PAGE 2 OF 3 PAGES

1. The NDC and the supplier of Fexofenadine 180MG 100 and 500 count bottles is changed per Schedule B and FAR 52.215-6. Changes are effective March 11th, 2020. See attachment for details.

2. All other terms and conditions of the contract remain the same.

CONTINUED ON NEXT PAGE

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED:

SPE2D2-19-D-0077 / P00002

PAGE 3 OF 3 PAGES

Attachments

List of Attachments

File Name Description

ATTACH_ATTACHMENT MOD 00

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

Fexofenadine HCL 60MG 100 count bottle National Drug Code (NDC) 00904-6979-60 Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Fexofenadine HCL 60MG 500 count bottle National Drug Code (NDC) 00904-6979-40 Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Fexofenadine HCL 180MG 100 count bottle National Drug Code (NDC) 00904-7050-60 Base Year Option Year 1 Option Year 2

Fexofenadine HCL 180MG 500 count bottle National Drug Code (NDC) 00904-7050-40 Base Year Option Year 1 Option Year 2

* BT = Bottle

-The quantities specified in the Schedule are estimates only.

Reference FAR 52.216-21 Requirements for additional details.

12,758

12,758

2,820

2,820

84,458

84,458

44,297

44,297

*BT

BT

BT

BT

BT

BT

$11.37

$11.37

$58.07

$58.07

$11.60

$11.60

$67.38

$67.38

$145,058.46

$145,058.46

$163,757.40

$163,757.40

$979,712.80

$979,712.80

$2,984,731.86

$2,984,731.86

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 _00904-7050-60 and 00904-7050-40, FDA Approval File Number ___A204507_, Date of FDA approval __09/16/25015__.

(b) CONTAINER/CLOSURE SYSTEM MATERIALS.

(describe)

DFARS 252.225-7020 Trade Agreements Certificate (NOV 2014)

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

(2) Will consider only offers of end products that are U.S.-made, qualifying country, or designated country end products unless—

(i) There are no offers of such end products;

(ii) The offers of such end products are insufficient to fulfill the Government’s requirements; or

(iii) A national interest waiver has been granted.

(c) Certification and identification of country of origin.

(1) For all line items subject to the Trade Agreements—Basic clause of this solicitation, the offeror certifies that each end product to be delivered under this contract, except those listed in paragraph (c)(2) of this provision, is a U.S.-made, qualifying country, or designated country end product.

(2) The following supplies are other non designated country end products:

(Line Item Number) (Country of Origin)

DFARS 252.247-7022 Representation of Extent of Transportation by Sea (AUG 1992).

(a) The Offeror shall indicate by checking the appropriate blank in paragraph (b) of this provision whether transportation of supplies by sea is anticipated under the resultant contract. The term “supplies” is defined in the Transportation of Supplies by Sea clause of this solicitation.

(b) Representation. The Offeror represents that it—

_____ Does anticipate that supplies will be transported by sea in the performance of any contract or subcontract resulting from this solicitation.

___x__ Does not anticipate that supplies will be transported by sea in the performance of any contract or subcontract resulting from this solicitation.

(c) Any contract resulting from this solicitation will include the Transportation of Supplies by Sea clause. If the Offeror represents that it will not use ocean transportation, the resulting contract will also include the Defense FAR Supplement clause at 252.247-7024, Notification of Transportation of Supplies by Sea.

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 4 below will be considered for award. The FDA will evaluate a prospective offeror for DLA procurements only if the source has had a qualifying cGMP inspection within the previous two years. Before a contract can be awarded, any successful offeror’s (or its source’s) manufacturing facilities shall have a current acceptable cGMP status with FDA, or shall have had an acceptable report from the last FDA facility http://www.acq.osd.mil/dpap/dars/dfars/html/current/252247.htm 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 less 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:

Line Items 0001AA-0002AE

Perrigo

(Name of Manufacturing Company)

515 Eastern Ave Allegan, MI 49010 (Street Address) (Post Office Address Not Acceptable)

Clara Maten, clara.maten@perrigo.com, 800-527-2296 (U.S.A. Point of Contact, e-Mail Address and U.S.A Telephone Number)

Line Items 0003AA-0004AE

_PL Development/Sciegen Pharmaceuticals_____________________________ (Name of Manufacturing Company)

__89 Arkay Dr, Hauppauge, NY 11788, USA________________________ (Street Address) (Post Office Address Not Acceptable)

_Frank Culotta/ fculotta@pldevelopment.com___________________________ (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- Fexofenadine HCL 60MG 100 count bottle

Perrigo/Teva 20 Hiryat HaMada Street Har Hozvim Industrial Zone Jerusalem, Israel

Clara Maten Clara.maten@perrigo.com 800-527-2296

0002- Fexofenadine HCL 60MG 500 count bottle

Perrigo/Teva 20 Hiryat HaMada Street Har Hozvim Industrial Zone Jerusalem, Israel

Clara Maten Clara.maten@perrigo.com 800-527-2296

0003- Fexofenadine HCL 180MG 100 count bottle

PL Development/Sciegen Pharmaceutical, 89 Arkay Dr, Hauppauge, NY 11788, USA

Frank Culotta email:

fculotta@pldevelopment.com

0004- Fexofenadine HCL 180MG 500 count bottle

PL Development/Sciegen Pharmaceutical, 89 Arkay Dr, Hauppauge, NY 11788, USA

Frank Culotta email:

fculotta@pldevelopment.com

PACKAGING

Item Complete Address of Facilities

Where Intermediate Containers will be Filled and Labeled

Point of Contact Including Phone Number

0001- Fexofenadine HCL 60MG 100 count bottle

Perrigo 515 Eastern Avenue Allegan, MI 49010

Clara Maten Clara.maten@perrigo.com 800-527-2296

0002- Fexofenadine HCL 60MG 500 count bottle

Perrigo

800-527-2296

0003- Fexofenadine HCL 180MG 100 count bottle

PL Development/Sciegen Pharmaceutical, 89 Arkay Dr, Hauppauge, NY 11788, USA

Frank Culotta email:

fculotta@pldevelopment.com

0004- Fexofenadine HCL 180MG 500 count bottle

PL Development/Sciegen Pharmaceutical, 89 Arkay Dr, Hauppauge, NY 11788, USA mailto:Clara.maten@perrigo.com mailto:fculotta@pldevelopment.com mailto:fculotta@pldevelopment.com mailto:Clara.maten@perrigo.com mailto:Clara.maten@perrigo.com mailto:fculotta@pldevelopment.com mailto:fculotta@pldevelopment.com

PACKING

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

Point of Contact Including Phone Number

0001- Fexofenadine HCL 60MG 100 count bottle

Perrigo

800-527-2296

0002- Fexofenadine HCL 60MG 500 count bottle

Perrigo

800-527-2296

0003- Fexofenadine HCL 180MG 100 count bottle

PL Development/Sciegen Pharmaceutical, 89 Arkay Dr, Hauppauge, NY 11788, USA

Frank Culotta email:

fculotta@pldevelopment.com

0004- Fexofenadine HCL 180MG 500 count bottle

PL Development/Sciegen Pharmaceutical, 89 Arkay Dr, Hauppauge, NY 11788, USA mailto:fculotta@pldevelopment.com mailto:fculotta@pldevelopment.com