eprocurement SPE2D219D0080P00004.pdf

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

J

2. AMENDMENT/MODIFICATION NO.

P00004

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: CHRISTOPHER NEWMAN DCN0010 Tel: DSN-444-2905 Email: Christopher.Newman@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) (X) 9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

Golden State Medical Supply, Inc.

5187 Camino Ruiz

CAMARILLO CA 93012-8601

USA

X

10A. MODIFICATION OF CONTRACT/ORDER NO.

SPE2D2-19-D-0080

10B. DATED (SEE ITEM 13)

2019 SEP 26

CODE 1HT23 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

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

FAR 43.103(a) Mutual Agreement of 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 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

(Signature of person authorized to sign)

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV.

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

Benjamin Hall, CEO

3/18/2021 mailto:Christopher.Newman@dla.mil

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED:

SPE2D2-19-D-0080 / P00004

PAGE 2 OF 2 PAGES

1. The purpose of this modification is to change the location of manufacturer and point of contact.

FROM:

Mylan Pharmaceuticals, Inc.

781 Chestnut Ridge Road, Morgantown, West Virginia 26505 Erik Williams, Erik.Williams@mylan.com, 304-554-6474

TO:

AlphaPharm PTY, LTD.

15 Garnet Street, Carole Park, QLD 4300, Australia (AUS) Jill Dean, Jill.Dean@viatris.com, 800-796-9526

2. See attached FAR clause 52.215-6 Place of Performance.

3. All other terms and conditions remain the same.

mailto:Erik.Williams@mylan.com mailto:Jill.Dean@viatris.com

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

2021-03-18T09:45:32-0400

TAUBMAN.DENISE.MARGARET.1029494025

Text2: Denise Taubman

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 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:

________Alphapharm PTY, Ltd.____________________________________________________ (Name of Manufacturing Company)

_ 1__________5 Garnet St. Carole Par___________k,_____________ QLD 4300, Australia (AUS)____________________________ (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 – Atenolol 25MG 90 count bottle

0002 – Atenolol 25MG 1000 count bottle

0003 – Atenolol 50MG

0004 – Atenolol 50MG

0005 – Atenolol 100MG

0006 – Atenolol 100MG

Jill Dean, jill.dean@viatris.com, 800-796-9526

15 Garnet St Carole Park QLD 4300, Australia (AUS)

Jill Dean, 800-796-9526

PACKAGING

PACKING

5187 Camino Ruiz Camarillo, CA 93012

Trudy Nickelson 805-477-9866 Ext. 135

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)

073457 3002806388

1/24/1992

STANDARD FORM 30 (REV. 10-83)

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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

6. ISSUED BY

CODE

7. ADMINISTERED BY

(If other than

Item

6)

CODE

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

ZIP

Code)

10A. MODIFICATION OF CONTRACT/ORDER NO.

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.

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.

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:

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).

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.)

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 AMERICA

15B. 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

CHECK ONE

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

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

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

PAGE

1.5 Amendment of Solicitation/Modification Contract skim Standard Form - Amend Acrobat Distiller 4.0 for Windows D:20001018094515Z D:20090422155830-04'00' FAR 43.103(a) Mutual Agreement of both parties

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