36C77019Q0169_2.docx

36C77019Q0169

OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL

BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SI

GN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGN

ATURE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR

LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

NCO 15 Contracting Ofc - CMOP 770-19-1-801-0045 36C77019Q0169 01-07-2019

NICHOLS FELLOWS, LORI

913-684-0154 01-25-2019

2:00PM CT

36C770 Department of Veterans Affairs National CMOP Contracting Office 3450 S. 4th Street Trafficway Leavenworth KS 66048 X 325412 1250 Employees N/A N/A X 36C770

DELIVERY

ADDRESSES TO BE SPECIFIED

ON INDIVIDUAL DELIVERY ORDERS

36C770 Department of Veterans Affairs National CMOP Contracting Office 3450 S. 4th St. Trafficway Leavenworth KS 66048-5581

Department of Veterans Affairs

FSC

PO Box 149971 Austin TX 78714-8971 877-353-9791 See CONTINUATION Page Description of Requirement:

Indefinite Delivery Indefinite Quantity (IDIQ) Single Award Contract for Theophylline as specified B.2 (Statement of Requirements).

**THIS IS AN UNRESTRICTED SOLICITATION.**

Offerors shall be registered at System for Award Management (SAM) at time of quote submittal to the Government.

Please submit technical questions in writing only to Lori Nichols Fellows, Contracting Officer, at lori.nicholsfellows@va.gov by 1-14-2019 Please submit quotes and subcontracting plan (if large business) to Ms. Nichols Fellows no later than due date and time specified in Block 8 of Standard Form (SF) 1449 of solicitation.

This acquistion is subject to the Drug Supply Chain Security Act as specified in Section B.2 (Statement of Requirements).

See CONTINUATION Page 770-3690160-801-822400-2580 0100224G3 X X X Lori J. Nichols Fellows Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C770 Lori.NicholsFellows@va.gov Department of Veterans Affairs National CMOP Contracting Office 3450 S. 4th Street Trafficway

Leavenworth KS 66048

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

FSC

PO Box 149971 Austin TX 78714-8971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

36C77019Q0169

Page 1 of Page 1 of

B.2 STATEMENT OF REQUIREMENTS

1. PRODUCT SERVICE CODE/NAICS INFORMATION

Product Service Code: 6505 (Drugs and Biologicals) NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing)

2. DESCRIPTION OF REQUIREMENT

Theophylline, for a single award Indefinite Delivery, Indefinite Quantity (IDIQ) for Consolidated Mail Outpatient Pharmacy (CMOP) Nationwide.

3. ROLES AND RESPONSIBILITIES

Contracting Officer Representative (COR) A COR will be designated on authority of the Contracting Officer (CO) to monitor all technical aspects and assist in administering the IDIQ and related delivery orders. The types of actions within the purview of the COR’s authority are to assure that the vendor perform the technical requirements of the contract; to perform or cause to be performed inspections necessary in connection with performance of the contract; to maintain both written and oral communications with the vendor concerning the aspects of the contract within his/her purview; to issue written interpretations of technical requirements of Government specifications; and to monitor the performance of the vendor under the contract and notify the vendor and CO of any deficiencies observed. A memorandum of delegation will be issued to the COR with a copy supplied to the vendor, stating the responsibilities and limitations of the COR.

At no time may the scope, work, price, delivery dates, or other mutually agreed upon terms or provisions of the contract be changed without being executed in writing by the CO authorizing such changes.

The COR may be changed at any time by the Government without prior notice to the vendor, but notification of the change, including the name and address of the successor COR, will be promptly provided to the vendor by the CO in writing.

Contracting Officer (CO) Name: Lori Nichols Fellows Phone: 913-684-0154 E-mail: Lori.NicholsFellows@va.gov All contract administration will be effected by the CO. Communications pertaining to contract administration matters will be addressed to the Contacting Officer. No changes in or deviation from the scope of work shall be effected without a Standard Form 30 (Modification of Contract) executed by the CO authorizing such changes.

The CO is the only person authorized to make or approve any changes in any of the requirements of the contract and related delivery orders; and notwithstanding any provisions contained elsewhere, the said authority remains solely with the CO. In the event the vendor makes any changes at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

4. PERIOD OF PERFORMANCE

This is a single award IDIQ contract with delivery orders.

Period of performance (one six (6) month base period and nine (9) six (6) month option periods) for an IDIQ contract is as follows:

Option periods are at the Government’s discretion and will be exercised on the basis of continued need for products, vendor performance, and availability of funds on delivery orders issued against this IDIQ.

5. ORDERING PROCEDURES

The IDIQ contract does not obligate any funding. Funding will be obligated via issuance of delivery orders against this IDIQ contract. Vendor is expected to be able to perform all aspects of the work specified in B.2 (Statement of Requirements).

All delivery orders issued by the Government will specify at a minimum:

· Period of performance of delivery orders

· CMOP locations to be serviced by delivery orders

· Quantities/descriptions of items for delivery orders

· National Drug Code (NDC) accepted by CMOP, as well as any acceptable NDC proposed by the vendor

Delivery orders may be issued by any warranted Contracting Officer (CO) within Network Contracting Office (NCO) 15, CMOP Division or Ordering Officer, as designated by the CO.

All delivery orders against this IDIQ contract shall also adhere to the following:

6. TRADE AGREEMENTS ACT (TAA) – DESIGNATED COUNTRIES

Products offered under this solicitation that are end products of countries other than the United States or “Designated Countries” will not be considered for award, unless there are no acceptable offers from the vendor for TAA-designated end products. “Designated Countries” means a World Trade Organization Government Procurement Agreement (WTO GPA) country, a Free Trade Agreement (FTA) country, a Least Developed Country, or a Caribbean Basin Country. Further information about the Trade Agreements Act can be found in Federal Acquisition Regulations (FAR) clause 52.225-5 (Trade Agreements).

7. DELIVERY TERMS

0. Vendor shall deliver entire purchased amounts of items within date specified on delivery orders awarded against this IDIQ.

0. The Government reserves the right to cancel any quantities not delivered on or before date specified on delivery order awarded against this IDIQ.

0. All products supplied under this contract and related delivery orders must be shippable by the United States Postal Service (USPS), unless specifically identified otherwise by the offeror and accepted by the Contracting Officer. Failure of the offeror to notify the contracting officer of the non-shippable status of a product (usually due to flammability) will result in cancellation or return of the product at the offeror’s expense. “Shippable” means the product must be able to be shipped by the USPS when the Consolidated Mail Order Pharmacy (CMOP) issues it to a patient. It DOES NOT mean that the product supplier must ship the product to the CMOP via USPS. The most cost effective method of shipping should be used for initial delivery to the CMOP.

0. Vendor shall deliver purchased product to multiple delivery points as specified on delivery orders against this IDIQ contract.

0. Vendor shall include pedigree requirements in accordance with Title II (Drug Supply Chain Security Act) of the Drug Quality and Security Act (http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm)

0. Vendor shall e-mail tracking information to VA-designated CMOP receiving points of contact on delivery orders issued against IDIQ, upon shipment of items.

8. ADDITIONAL TERMS PROPOSED BY THE VENDOR

Any alternate National Drug Codes (NDCs) the vendor wishes to propose shall be listed on Solicitation Attachment 1 (Quote Spreadsheet) if applicable for this solicitation and on delivery orders competed against IDIQ.

1. Other than alternate NDCs, the vendor shall list any proposed alternate terms or conditions to this solicitation (e.g. delivery terms, bottle counts, etc) in its quote in order for the vendor to successfully fulfill the terms of the resultant IDIQ and related delivery orders.

1. The proposed alternate terms or conditions shall be reviewed by the CO and, if accepted, shall be included in the contract terms upon signatures from both parties. Once the proposed terms or conditions are approved by both parties, they shall become a binding part of the contract and the vendor shall be responsible for all requirements set forth in the resultant contract. Alternate terms and conditions proposed elsewhere will not be considered and will not be included in any resultant contract and may result in the offer being removed from further consideration.

9. AS508 BAR CODING (MAY 2012)

All pharmaceutical products provided under this contract shall include bar code labeling at the unit-of-use package level. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC) Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GSI or HIBCC parameters including, but not limited to: symbology type or encoded pattern, bar and space dimensions and tolerances, and allowable ratio of wide to narrow elements.

The bar code may be any linear bar code symbology such as GS1-128 (formerly EAN.UCC), GS1 Data Bar (formerly RSS), or Universal Product Code (if the UPC contains the National Drug Code or NDC). The bar code must encode the NDC, either alone or within the GS1 data structure (Global Trade Item Number (GTIN)).

The bar code printing must be American National Standards Institute (ANSI)/International Organization for Standardization (ISO)/IEC Quality Grade C or better. Manufacturers and packagers must ensure that production runs include an initial verification check, as well as routine audits to ensure the bar code is printed clearly and consistently to meet the quality standard of Grade C or better. Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this clause prior to shipping pharmaceutical products to any Government Prime Vendor or authorized ordering activity under this contract.

The bar code must be on the outside container or wrapper of the medication as well as on the immediate container, unless the bar code is readily visible and machine-readable through the outside container or wrapper. When the bar code is not easily machine-readable through the over wrap, the over wrap should contain the bar code.

The bar code must go on each cell of a blister pack. Furthermore, the bar code must remain intact under normal conditions of use; thus it should not be printed across the perforations of a blister pack.

When applicable to the symbology used, bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly. Bar code placement shall minimize curvature of the bar code. For example, bar codes should be placed in “ladder orientation” on vials or bottles to minimize curvature of the bar code. Bar code labeling shall not be placed solely on outer packaging.

It is recommended that bar code labeling also include the lot number and expiration date. If two separate distinctive bar codes are used, one for NDC and the other for lot number/expiration date, the lot number and expiration date bar code must not be in close proximity to the NDC barcode or in a format that may be confused with the NDC bar code. When applicable, all Healthcare Distribution Management Association (HDMA) guidelines shall be followed.

10. AS1335 THERAPEUTIC EQUIVALENCE (FEB 2007)

Only products that have received under the Federal Food, Drug and Cosmetic Act a therapeutic equivalence code of “A” by the Food and Drug Administration will be considered, unless all drugs in the family group are “B” rated. In that case, no award will be made other than to the innovator unless the non-innovator vendor submits acceptable data demonstrating bioequivalence.

11. AS1344 RECALLS (NOV 2013)

If a drug recall is initiated for any drug provided under this contract, regardless of whether it is a voluntary recall by the manufacturer or a recall required by the U.S. Food and Drug Administration (FDA); or, if FDA withdraws their approval to manufacture any drug that is included on this contract, the following action shall immediately be taken by the contractor:

Forward two copies of the recall notification along with any pertinent information to:

1) Director, CMOP Acquisitions Veterans Health Administration Network Contracting Office (NCO15) 3450 South 4th Street Leavenworth, KS 66048-5012 Fax Number (913) 758-4732

2) Deputy Chief Consultant (M/S119D) VHA Pharmacy Benefits Management Services 1st Ave., 1 Block North of Cermak Rd., Bldg. 37, Rm 139 Hines, IL 60141 Fax Number (708) 786-7894

3) Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 VHANCPSRecallsNotification@va.gov Phone Number: (734) 930-5865

4) CMOP address shown in Block 15 of the SF 1449.

12. AS1527 NATIONAL DRUG CODES (MAY 2009)

Vendor shall provide a separate and distinct eleven-digit National Drug Code (NDC) number unique to the offeror (e.g., 00012-3456-78) for each product proposed, in the space provided following each item in Attachment 1, Quote Spreadsheet, of the solicitation. The first five numbers of the eleven-digit NDC number for each product proposed shall identify the offeror. Offers that fail to provide the information required by this clause by the solicitation closing date shall be rejected and shall receive no further consideration.

13. LETTER OF COMMITMENT OR DOCUMENTATION OF PRODUCT AVAILABILITY (APPLIES TO REQUESTS FOR QUOTES AGAINST IDIQS AND DELIVERY ORDERS AWARDED AGAINST IDIQS)

(a) If other than the manufacturer, the vendor shall submit either: (1) A letter of commitment from the manufacturer to the vendor which will assure the vendor of a source of supply sufficient to satisfy the Government's requirements for the contract period, OR (2) Documentation of Product Availability showing that the vendor will have an uninterrupted source of supply from which to satisfy the Government's requirements for the contract period. Quotes that fail to meet this requirement before contract award may be rejected and may receive no further consideration.

(1) To be considered acceptable, the letter of commitment:

a) Shall be on the manufacturer’s letterhead.

b) Shall be dated.

c) Shall reference the solicitation number and the product committed to manufacture.

d) Shall state that the manufacturer assures the vendor of an uninterrupted source of supply sufficient to satisfy the Government’s requirements for the contract period, and that the manufacturer is currently manufacturing the product.

e) Shall be signed by an officer of the manufacturer’s company (include printed name, title and telephone number).

f) Shall indicate source of product to include country of origin.

(2) To be considered acceptable, Documentation of Product Availability

a) Shall be on the source company’s letterhead or be clearly identifiable as coming from the source (for example, source company e-mail with company officials name and position identified).

b) Shall be dated.

c) Shall reference the solicitation number and the product committed to the company making the offer to the government.

d) Shall state that the source assures the offeror of an uninterrupted source of supply sufficient to satisfy the Government’s requirements for the contract period, and that the source currently has the product available.

e) Shall indicate source of product to include country of origin.

The vendor shall also notify Government within 24 hours after award whether or not they can ensure delivery of items on delivery order. The Government reserves the right to award to the next best value vendor absent this notification.

14. OTHER REQUIREMENTS

1. Offerors must state the exact name of the drug being supplied as it will appear on the label. Offerors shall also provide a unique 11-digit NDC number for all items offered; the NDC number must be specific to the offering company and to the drug being supplied. Any package size ordered below 500 count will be considered to be for Unit of Use issue and will require a Safety/Child Proof cap. Glass bottles are not acceptable.

1. The expiration dates of the pharmaceutical(s) are to be no less than 12 months from date of delivery.

1. Any substitution of packaging sizes must be approved in writing by the Contracting Officer.

1. Any change that deviates from the specific item requested must be approved by the Contracting Officer in writing. For example, the replacement of capsules for tablets or suspended action for extended release items will require approval beforehand.

1. Partial deliveries of product will need to be approved in writing by the Contracting Officer.

1. Minimal lot numbers of three (3) of product is required. More than three (3) lot numbers of product must be approved by the Contracting Officer in writing.

1. Vendor shall provide if possible items in original manufacturer cases; if not, alternate cases must be approved by CO in writing.

1. A minimum bottle size will be 100cc with a child safety type cap that does not exceed the diameter of the bottle. It must also have a cylindrical body and minimum of 5.75 inches circumference. Items packaged in a bottle smaller than 100cc will be considered, but a positive cost adjustment per bottle of $0.6165 will be applied during price evaluation to each bottle to compensate for the cost to repackage in an adequately sized bottle to allow labeling.

1. It is incumbent upon the offeror to initiate any actions requiring the approval of the Contracting Officer. Failure to obtain Contracting Officer approvals may result in rejection of offers or cancellation of award.

1. Acceptance of any vendor-proposed NDC shall be contingent on CMOP approval.

1. If a line item indicates more than one NDC, offeror MUST specify which NDC is used when quoting. If offering an alternate, offeror MUST indicate proposed alternate on Solicitation Attachment 1 (Quote Spreadsheet), in the column titled “VENDOR COMMENTS” and indicate bottle size in parentheses. ALL QUOTES SHOULD BE PRESENTED IN EXCEL FORMAT NOT A PDF.

1. If the pre-approved alternate NDC is provided by the offeror, and if the unit size is different from the original unit requested, then the offeror must also adjust the final quantity accordingly, e.g.: 1 bottle @1000 to 10 bottles @ 100, noting the change.

1. For reconciliation purposes, all shipments shall reference the original VA purchase order number/delivery order number even if purchased product is from another partnered company.

1. All shipments shall come with a packing slip identifying the Vendor awarded the contract, VA purchase order number/delivery order number, NDC, Products, and Line Item Numbers from the purchase order. Documentation shall include the Vendor’s point of contact for reporting noted discrepancies, damages, or incorrect product. Invoice price must match purchase order price.

1. VA purchase order number/delivery order number must be included as part of the ship to address on all shipping boxes and clearly printed on the packing slip. Failure to supply this information may cause a delay with payment or rejection of the product if the order information is not readily apparent.

1. All like product shall be packaged and shipped together.

1. Breakable items shall be packaged appropriately with blister pack or bubble wrap.

1. Vendor shall provide a return authorization and pickup for any damaged products or incorrect products received within one week of request.

1. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Vendor, or if the Vendor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Vendor for any amount for supplies or services not accepted, and the Vendor shall be liable to the Government for any and all rights and remedies provided by law. The Government’s rights after a termination for cause shall include all the remedies available to any buyer in the marketplace.

1. The Government’s preferred remedy will be to acquire similar items from another contractor and to charge the defaulted contractor with any excess re-procurement costs together with any incidental or consequential damages incurred because of the termination.

15. VENDOR PERFORMANCE

Vendor’s performance under this contract shall be assessed annually in accordance with the requirements of FAR Subpart 42.15 (Contractor Performance Information). The Government will also utilize the Contractor Performance Assessment Reporting System (CPARS) evaluation on delivery orders issued against IDIQs as applicable to report performance. The Government reserves the right to utilize other methodologies to assess performance including surveys.

16. ADMINISTRATIVE REQUIREMENTS

Vendor shall be available to meet with the CO, COR, and other Government personnel upon request to discuss progress on deliverables, exchange information, and resolve emergent technical problems and issues.

The Vendor shall notify the CO and COR immediately of all problems that impact or potentially impact the deliverables schedule, costs, and performance. Such notifications shall be made verbally to COR and then in writing to COR with cc to CO within 24 hours after the identification of the problem. Resolution to problem/issue identified shall be within 24 hours, unless longer deadline is mutually agreed to in writing by CO, COR, and the Vendor.

17. ACCEPTANCE AND INSPECTION

In addition to Inspection clauses cited under Section C (Contract Clauses), the Government shall indicate acceptance of items via COR certifying invoices and doing a receiving report via VA’s VISTA system. The COR and technical personnel will perform inspection and acceptance of items provided under delivery orders issued against IDIQs. Items will be considered to be accepted when all discrepancies, errors, or other deficiencies have been resolved to the Government’s satisfaction. Acceptable quality is that items meet the agreed to delivery schedule, cost, and product description/quantity/costs as specified in delivery order.

In the event of rejection of any deliverable, the Vendor will be notified in writing by the COR, giving the specific reason(s) for the rejection. The Vendor will have one (1) business day to correct the rejected deliverable and return it to the CMOP location(s) specified on delivery order.

Partial deliveries will be allowed at the discretion of the Government provided the delivered items can be processed for acceptance, and non-delivered items do not cause a delay in the completion of the requirement. The Vendor will receive written notice of missed deliverables; if a deliverable is missed, the Government will consider legal remedies available to ensure deliverable is met.

It is also the Vendor’s responsibility to notify Government if a deliverable will not be met or deadline missed.

18. (For Awarded Vendor) Only to Complete on Issued Delivery Orders Against IDIQ Contract Drug Supply Chain Security Act Compliance (http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm) As of January 1, 2015, all suppliers of prescription drug products (i.e, products which have been approved and which may be dispensed only by prescription under section 503(b) of the Food, Drug, and Cosmetics Act [FD&C], must comply with the provisions of The Drug Supply Chain Security Act and all trading partners must be authorized as defined by the FD&C Act.

Additionally, CMOP has a preference for trading partners who can comply with the provisions of The Drug Supply Chain Security Act starting January 1, 2015. CMOP prefers documentation to comply with the act be received from the supplier with the product or prior to receipt. The documentation can be paper-based or electronic to meet the requirements of the Act. CMOP prefers this documentation be provided in an Electronic Data Interchange (EDI), Electronic Product Code (EPCIS) or Abstract Syntax Notation (ASN) file format. The TH (Transaction History), TI (Transaction Information), and TS (Transaction Statement) may be submitted by e-mail to the following: peter.barrett2@va.gov with cc to points of contact listed on delivery orders issued against IDIQs.

The documentation required is as follows:

Transaction History (TH) A paper or electronic statement, including the transaction information for each prior transaction for the subject product going back to the manufacturer of the product.

Transaction Information (TI) A paper or electronic document containing:

1. the proprietary or established name or names of the product;

1. the strength and dosage form of the product as stated on the manufacturer’s label

1. the National Drug Code number of the product;

1. the container size;

1. the number of containers;

1. the lot number of the product;

1. the date of the transaction;

1. the date of the shipment, if more than 24 hours after the date of the transaction;

1. the business name and address of the person from whom ownership is being transferred; and

1. the business name and address of the person to whom ownership is being transferred.

Transaction Statement (TS) A paper or electronic document stating that the entity transferring ownership in a transaction:

1. is authorized as required under the Drug Supply Chain Security Act;

1. received the product from source that is authorized as required under the Drug Supply Chain Security Act;

1. received transaction information and a transaction statement from the prior owner of the product, as required under section 582;

1. did not knowingly ship a suspect or illegitimate product;

1. had systems and processes in place to comply with verification requirements under section 582;

1. did not knowingly provide false transaction information; and

1. did not knowingly alter the transaction history.

B.3 (PRICE/COST SCHEDULE)

Item #

62332-0025-31

BT

62332-0025-31

BT

62332-0025-31

BT

62332-0025-31

BT

62332-0025-31

BT

62332-0025-31

BT

62332-0025-31

BT

62332-0025-31

BT

Theophylline – 300 MG SA TAB - 1000CT

62332-0025-31

BT

Pricing is firm fixed unit price. Offeror shall complete pricing as listed on Solicitation Attachment 1 (Quote Spreadsheet). Any pricing not submitted via this attachment will not be accepted by the Government.

Minimum order is $3,000 and maximum order is $150,000 on delivery orders. Initial pricing submitted for this IDIQ solicitation is maximum pricing under IDIQ contract.

Quantities cited on Solicitation Attachment 1 (Quote Spreadsheet) and above are estimated quantities for base and all option periods based on CMOP data. Actual quantities and CMOP facility delivery addresses will be established via delivery orders issued against the IDIQ contract. Solicitation Attachment 1 (Quote Spreadsheet) is broken by separate base period and option periods for vendor to complete pricing on.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2…