VA770-17-R-0417-008.docx

VA770-17-R-0417

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

National CMOP

VA770-17-R-0417

12-27-2017

HALLIBURTON-SHANNON, EVELYN

972-228-6263 01-29-2018

4PM CST

36C770 Department of Veterans Affairs National CMOP 3450 S. 4th St. Trafficway Leavenworth KS 66048-5581 X 561910 $11 Million X N/A X 36C770

TO BE DETERMINED

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

Department of Veterans Affairs

FSC

PO Box 149971 Austin TX 78714-8971 Repacker Services for Consolidated Mail Outpatient Pharmacy (CMOP) As specified in the Statement of Work.

Vendors shall be registered active in System for Award Management (SAM ) at the time of offer.

$0.00 X X X Linda Bayer Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR: ____________________________

b. GOVERNMENT: Contracting Officer – Evelyn Halliburton-Shannon- 0770 Network Contracting Office (NCO) 15 2962 S. Longhorn Drive Lancaster, TX 75134

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:

c. Other [X]The contractor shall provide an itemized invoice on a monthly basis that reflects the quantity of each product, by strength and package size, shipped to VA facilities during the month.

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

PO BOX 149971

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

B.2 STATEMENT OF WORK

A. BACKGROUND

1. The Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP) program serves over 7 million enrolled Veterans, dispensing more than 120 million prescriptions per year for Department of Veterans Affairs Medical Centers (VAMC’s) and Community Based Outpatient Clinics (CBOC’s) throughout the United States. Currently there are a total of eight nationally located CMOP facilities that use repacked pharmaceuticals in their automated and semi-automated pharmacy systems in order to fulfill the prescription orders. CMOP has identified the continued need to receive repacked pharmaceuticals from a Food and Drug Administration (FDA) licensed repacker/distributor (contractor) of oral, solid pharmaceuticals.

2. Repackaged pharmaceuticals play a vital role in the fulfillment process by improving the efficiency of CMOP operations creating faster delivery times to our veteran patients. Fluctuations in the need for pharmaceuticals make it is difficult to determine the exact quantities that will be required during the contract term(s) however based off on historic data from the previous contract the government anticipates a need for approximately 17 million repackaged bottles per year.

B. SCOPE

The contractor shall be registered with the FDA and Drug Enforcement Agency (DEA) and licensed in order to repack oral, solid pharmaceuticals. In addition, the contractor shall hold a valid, current certificate from DEA for Class III (narcotic and non-narcotic), Class IV, and Class V controlled substances. The contractor shall have a minimum of two years proven past experience, as a repacker, with a repacking volume of at least 17 Million bottles of oral solid pharmaceuticals per year. The contractor shall accept shipments of Government-owned pharmaceutical drugs from an authorized CMOP or its prime vendor contractor or alternative source, repack into individual bottles per the Statement of Work (SOW), and all repacked product shall be shipped to the CMOP designated on the order. All repacking work shall be accomplished based on information provided within the task orders issued from each CMOP.

1. The contractor shall serve as a unit-of-use repacker for pharmaceuticals. Under this program, CMOP will purchase the pharmaceuticals separately from this contract, and arrange delivery of such products to the contractor for processing. The Contracting Officer (CO) or a delegated Ordering Officer (OO) within the CMOP will provide instructions to the contractor for repacking of the product into various bottle sizes. The product list may vary through the life of the contract as the CO or OO adds product and package sizes to the program. In addition to repacking of pharmaceuticals, the contractor shall be required to receive, process, and provide short-term warehousing. Government-Owned pharmaceuticals must be physically segregated from non-government product. CMOP orders shall not be co-mingled with other government or non-government orders. The contractor shall ship product FOB Destination to the ordering CMOP(s). All actions by the contractor under the awarded contract shall be in accordance with applicable FDA, DEA, EPA, Federal, State, and local codes and laws or regulations.

2. Only a warranted CO within the CMOP or a delegated OO are authorized to order repacking services under this contract. There are eight CMOP facilities and a CMOP National Office that may have delegated Ordering Officers.

3. The contractor will be required to deliver all articles that are properly ordered during the contract performance period, in accordance with the terms and conditions of the contract.

C. CONTRACT PERIOD

1. The contract performance period is for a one-year base period plus four one-year option periods.

2. Implementation/Transition Period is defined as the amount of time after contract award and before the contract effective date to ensure sufficient administrative time has been allowed for continuity of service in support of the CMOP program, and the change of contractors from the incumbent contractor to the newly awarded contractor. The implementation/transition period shall be no more than thirty (30) calendar days from date of contract award.

D. GENERAL REQUIREMENTS

1. The contractor shall receive a bulk shipment of medications to be repackaged into smaller quantities of various sizes. The repacking contractor shall not procure the drugs to be repacked. The government shall provide the medications to be repackaged and shall be shipped directly to the contractor’s site.

2. Due to the anticipated high dollar value of the inventory’s total dollar amount, a spot inventory may be conducted on-site at the contractor’s facility by CMOP representatives and/or an independent audit firm, paid for by the government.

3. Pharmaceuticals are typically repacked into various sizes that may include, but not limited to 15 count, 30 count, 45 count, 60 count, 90 count, 120 count, 135 count, 180 count, 270 count, and 360 count. Repacked bulk sizes may include, but are not limited to 1 liter, 2 liter, 3 liter and 4 liter bottles.

4. Additional products and package sizes may be added, by modification, to the contract by mutual agreement of the contractor and the government.

5. Quantities are based on estimates and past usage; however, this does not guarantee future volume. There is no expressed or implied guarantee that the estimated quantities shall be purchased under this contract. Actual quantities may exceed or be less than those represented.

6. Historical data shows an average of 12 pallets of controlled bulk product is sent to the repacker each week equating to an average of 30 pallets of finished product that is shipped to CMOP.

7. Historical data for the past year shows that there was an average of thirty (30) shipments per month, from the repacker to the CMOP facilities.

8. The government may place one or more employees in the contractor’s facility to observe contractor’s accountability and repacking practices on behalf of the CMOP. The contractor shall provide office space for the employee(s), along with desks and chairs. Other office needs for this employee(s), e.g., IT equipment, file cabinets, telephone, office supplies, etc.), shall be the responsibility of the Government.

E. FEDERAL GOVERNMENT HOLIDAYS

F. DEFINITIONS AND ACRONYMS

1. Batch – The production of a product that has the same drug name, strength, expiration date and lot number.

2. Barcode 128 – One-dimensional ("1D") barcode symbol used throughout the ID, inventory, shipping and distribution chain. Code 128 barcodes are alphanumeric machine-readable symbols. They can be printed with or without human-readable characters.

3. Business day - Monday through Friday of each week, not including Federal Holidays.

4. Consolidated Mail Outpatient Pharmacy (CMOP) – Division of the United States Department of Veterans Affairs; provides mail order prescriptions to veterans. (8 CMOP locations are: two at Leavenworth, KS; Tucson, AZ; Chelmsford, MA; Dallas, TX; Murfreesboro (or designated facility), TN; Hines, IL; and Charleston, SC.

5. Contracting Officer (CO) – Government employee with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

6. Contracting Officer’s Representative (COR) – Representative from the requiring activity delegated by the contracting officer to perform surveillance and to act as liaison between the contractor and the Contracting Officer. This individual has no authority to change the terms or conditions of the contract. The contracting officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract.

7. Contractor – Vendor/Company authorized to provide services awarded under this contract.

8. Disasters – As declared by the Federal/State/Local government for a specific situation. Also, when contractor facilities are unable to provide the requirements of this contract resulting from perils of nature, mechanical or electrical failure, medical epidemic, etc

9. Drug Supply Chain Security Act (DSCSA) - Enacted by Congress on November 27, 2013. Title II of Drug Quality and Security Act (DQSA) outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

10. Emergency - An unforeseen combination of circumstances or the resulting state that calls for immediate action.

11. Freight on Board Destination (FOB). - The repacker takes delivery of goods being shipped to it by a supplier once the goods arrive at the repacker's receiving dock.

12. First Databank (FDB) - Part of the Hearst Health network, is the leading provider of drug knowledge that helps healthcare professionals to make precise medication-related decisions worldwide.

13. Immediately – when used in conjunction with a notification requirement, is defined as written notification to the COR or contracting officer within one business day of occurrence.

14. Medi-Span - Master Drug Data Base provides pricing and descriptive drug information on name brand, generic, prescription and OTC medications, and herbal products. It includes industry standard identifiers for all brand and generic drugs on the market including National Drug Code (NDC), Universal Product Code (UPC) and Health Related Item (HRI) numbers.

15. Normal Business Hours – For the purposes of this contract normal business hours will be defined as 8:00AM to 5:00PM CST Monday through Friday excluding Federal holidays.

16. Ordering Officer (OO) - Government employee with the authority to place and administer funded orders against the contract.

17. Product - is defined as the end item produced and suppled to the government.

18. Promptly – when used in conjunction with a notification requirement, is defined as written notification to the COR or Contracting Officer within two business days of occurrence.

19. Quality Control – Actions taken by a contractor to control the performance of services so that they meet the requirements of the SOW.

20. Stock - is the pharmaceutical provided by the government to the contractor for repacking,

21. United States Pharmacopeia (USP) - A scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than one-hundred forty (140) countries.

G. APPLICABLE CREDENTIALS, CERTIFICATIONS, REGULATIONS AND STANDARDS

1. Contractor shall be FDA registered to repack oral, solid pharmaceuticals and certified with the Drug Enforcement Agency (DEA) for Class III (narcotic and non-narcotic), Class IV, and Class V controlled substances.

2. Contractor control, accounting and repacking of pharmaceuticals shall be done using FDA and DEA guidance, regulations and approved procedures, and in accordance with current Good Manufacturing Practices (cGMPs). https://www.fda.gov/cosmetics/guidanceregulation/guidancedocuments/ucm2005190.htm

3. Contractor shall warehouse pharmaceuticals on a short-term basis in accordance with FDA and USP Standards for both security and environmental requirements.

a. The contractor shall submit to FDB and Medi-Span product information pertaining to the products repacked under this contract, including the contractor’s unique National Drug Code(s), during the period of contract performance. A New Product Submission Form can be completed by contacting.

b. First Databank:

Email:Editorial_Services@fdbhealth.com;

c. Medi-Span:

Email: mfgdata@wolterskluwer.com

4. The contractor shall supply a weekly report to the OO new NDC’s registered with either First Databank or Media-Span.

5. The contractor shall follow all appropriate requirements as implemented in the DSCSA.

H. CONTRACTOR RESPONSIBILITY

1. The contractor shall schedule work based on the delivery or orders placed in accordance with the terms and conditions of the contract.

2. The contractor shall be responsible for full control and accounting of all products that are delivered for repacking in accordance with the Government Property Clause.

3. The contractor shall establish processes acceptable to CMOP for performing the receiving inventory function, to include but not be limited to accurate counting of product being received. The contractor shall also be responsible for recording all DSCSA information (such as lot number and quantity of each) and forwarding that information immediately to the ordering office. The CO, OO and the COR shall be immediately notified of any discrepancies. The contractor shall have processes which include, but are not limited to, auditable receiving processes and document trails for all products being received.

4. The contractor shall have adequate resources, to include sufficient space for controlling inventory and segregation of stock. Government-Owned pharmaceuticals must be physically segregated from non-government product. Government orders shall not be co-mingled with government or non-government orders.

5. Controlled pharmaceuticals must be received and stored in a separate secured location in accordance with FDA, DEA, and EPA regulations.

6. Any excess product in the repacking process shall not be added to the FDA-mandated retention samples. Destruction of these stored amounts shall be in accordance with all FDA, DEA, and EPA regulations. Reports of stored samples and subsequent destruction shall be submitted to CMOP. Damaged stock received prior to the repacking process shall be returned to the ordering CMOP.

7. Contractor shall have a policy in place for initial hiring drug tests, random drug testing, and for drug testing when there is reasonable suspicion of impairment.

8. Contractor shall have a plan for contingency operations for disasters, which identifies the ability to provide uninterrupted support under unprecedented situations that cannot be reasonably mitigated and/or contingency conditions.

I. GOVERNMENT RESPONSIBILITY

1. A warranted CO or delegated OO, with a warrant or delegation which allows placing task orders against existing contracts, shall be the delegated authority to place task orders to the contractor citing the terms and conditions of the contract resulting from this solicitation.

2. The task order shall:

a. Identify the total number of bottles to be repacked, to include the “mix” required (i.e., 50mg, 30 per bottle; 100mg, 90 per bottle; etc.).

b. Provide a required delivery date for the task order to be completed.

c. Identify a point of contact at CMOP for the contractor. Generally this shall be the OO.

d. Identify the exact task information for the CMOP(s) where the repacked products are to be delivered.

J. PRODUCT CHARACTERISTIC REQUIREMENTS

1. The contractor shall provide bottles, caps, and labels to repackage all medications.

2. The pharmaceutical bottles shall have the following characteristics:

a. White pharmacy grade high-density polyethylene.

b. Round with no ridges, bowing or protrusions that would prevent them from being horizontally or vertically stacked. (Convex shaped bottles are unacceptable).

c. Must have a flat surface with minimum dimensions of 2.5’’ W x 5.5’’ L sufficient for applying a label without overlap.

d. Bottle sizes repacked into are 120cc, 200cc, 300cc, 400cc, 625cc, 1Liter, 2Liter, 3Liter and 4Liter.

e. Bottles shall be recycled.

f. A tamper evident seal shall be applied to each bottle. This seal must not be above/over the cap.

g. Must be capable of being dispensed from the automated labeling and automated dispensing systems installed at each CMOP facility, including but not limited to: A-Frames, Flex-Pick systems, Automated Dispensing Unit (ADU) systems, Checking and Labeling Systems (CLS), and Package Dispensing and Labeling Automation (PDLA).

h. The prospective contractor must supply testing data / certification showing that the cap bottle assembly / unit is in compliance with the Consumer Product Safety Commissions (CPSC) current protocol and standards for child resistant effectiveness as per Code of Federal Regulations (C.F.R.) Title 16, Part 1700. (This paragraph does not apply to the bulk up sized bottles, i.e. liter size bottles).

3. The bottle caps shall have the follow characteristics:

a. Shall not exceed the diameter of the bottle.

b. Shall be of convertible design to allow user to convert it from child-resistant to non-child resistant with hand applied pressure to outer ring of the cap when cap is on the bottle. Five-hundred forty (540) count bottles or less shall be required to have a child-resistant cap.

c. Shall be imprinted with the MyHealtheVet logo or other logos that shall be alternated at the discretion of the CO in accordance with the attached logo specifications. See Section D Attachment 4. No more than four logos shall be required.

d. The imprint must be high quality resolution, visible under the cap surface, and be approved for use by the CO.

e. All bottle and cap combinations shall meet or exceed the USP standards for moisture permeability and light resistance.

4. The product labels shall have the following characteristics:

a. Shall not exceed 3.5 mils thickness (for affixed labels).

b. Directly printed labels may be used, but shall be machine readable and non-smudging.

c. Labels must not peel off or be damaged in automated machinery.

d. Centered in bottle label area to ensure barcode readability.

5. The product labels shall include the following:

a. The product label must be of a material that shall allow a patient label to adhere to it.

b. Fill size and strength for quick recognition. The generic name shall be bold font and larger font than other printed label information.

c. Drug name positioned such that after applying the patient label the product can still be identified. The product name, strength and package size shall be printed twice on the label: once in the middle of the label and once on the extreme left hand side vertically. Font size for both label locations is to be the same.

d. At the time of solicitation Bar Code 128 is required. The government requirement for bar code shall change during the base year of the contract. The implementation of the 2D (Q/R) type automated information data carrier shall be incorporated by the contractor on the date required by the DSCSA.

e. Bar codes shall be clear and defined with no break in the bar code graphics. A sufficient amount of clear white space needs to be around the bar code so numbers and/or letters do not interfere with the bar code.(see attachment 2, Label Sample)

f. The government requires identical vertical bar codes to appear on the left and right sides of the label. The Manufacturer Lot Number, Repacked Batch Number, Expiration Date, and NDC number shall appear as human readable language adjacent to the bar code.

g. State storage conditions.

h. Indicate the “Manufactured By” name and “Packaged By” name and address.

i. The statement "Warning: May be habit forming" where applicable, the controlled drug substances symbol required by DEA, and the name and quantity or proportion of any substance as required.

j. Boxes or cases shall be clearly marked with a product label as described in (J)(4)(d), above. Case quantity shall be stamped on the outside of each case if it contains less than the standard container capacity (e.g.: 40 bottles in a box or case that holds 100) than would be expected.

k. Upcoming DSCSA requirements such as, but not limited to, serialization must be incorporated by the contractor on the dates required by the DSCSA.

K. PLACEMENT OF TASK ORDERS

1. The CMOP’s are supported by the contracting office located in Leavenworth KS. A warranted CO or a delegated OO are authorized to place task orders against existing terms and conditions of the contract resulting from this solicitation. All orders shall be written and may be provided to the contractor via facsimile, email with attachments or by use of the contractor secure web-based ordering system should the Government decide to implement that method for placing orders. (See Section L. Ordering System.)

2. Individual CMOPs shall be responsible for providing repacking instructions to the contractor and are responsible for administration of their repacking orders.

3. Currently CMOP is using both a consolidated ordering function and an individual site level ordering function. The consolidated order is a high-volume repacking order being placed from the CMOP National Office with delivery to multiple CMOP facilities. Orders may also be placed by one CMOP with delivery directly to that CMOP.

L. ORDERING SYSTEM

1. The contractor must have the ability to provide CMOP with a secure web-based ordering system should the Government decide to implement that method for placing orders. Only CO’s or OO’s may be granted logins, unique for each individual. Passwords must adhere to the standards established by CMOP.

2. The ordering system shall be able to provide real-time confirmation within the system when an order is placed. The system shall cancel items that cannot be filled. The confirmation shall indicate the cancelled items.

3. When the order has shipped from the repacker, an email shall be sent to the individual placing the order unless otherwise indicated identifying the complete shipment, projected delivery date, and tracking number. This email shall also include a comma separated variable (CSV) file as an attachment, which shall include the following minimum data fields:

4. Manual ordering methods may include facsimile (fax), email, or in writing delivered by standard delivery methods (e.g.: USPS, UPS, etc.). Every task order shall be in writing and electronically signed by the OO. ORAL ORDERS ARE

NOT AUTHORIZED.

5. The repacking contractor shall not procure the drugs to be repacked. Each CMOP shall provide the contractor with the drug to be repacked. The shipment of the product to be repacked by the contractor shall be arranged and underwritten by the CMOP, and shall be by a conveyance deemed appropriate by the CMOP that meets all FDA and/or USP requirements for safe and secure transit of the material. (See N. Product Handling below for information on the responsibilities toward return shipment to the CMOP.)

6. The products shall be purchased in the most economical count size. CMOP will not necessarily purchase the stock to be repacked in the largest count package available if a smaller count package is more economical. When the Pharmaceutical Prime Vendor (PPV) contract is used by the CMOP for ordering, the PPV contractor may ship the product to the repacking contractor and shall bill the CMOP for the product.

M. PRODUCT HANDLING

1. Pharmaceuticals shall be received by the contractor directly from a CMOP, a prime Vendor contractor, or alternative source pharmaceutical supplier. These pharmaceuticals are Government-Owned property. Immediately upon receipt of Government-Owned property, the contractor shall log and reconcile the packing list for all products received and report any damages or discrepancies to ordering facility as well as verifying DSCSA transaction information.

2. The contractor shall be responsible for reporting to the ordering CMOP when an excess of three lot numbers for a single drug are received.

3. The contractor is responsible for product damaged while the product is in the contractor’s care.

4. Pharmaceuticals received under this contract shall be repacked into unit of use sizes by written direction of the CO, OO or as defined by the task order.

5. Pharmaceutical product retention shall be handled as defined in CFR Title 21, Section 211.

6. Any excess product in the repacking process shall not be added to the FDA-mandated retention samples.

7. Product shall be processed and repacked and delivered into unit of use sizes in accordance with the instructions provided by the CO or OO no later than ten (10) calendar days after receipt of pharmaceuticals, or, as agreed upon between the repacker and the CO or OO. Shipments to the requesting CMOP are to be sent FOB Destination.

8. Finished product that is shipped on pallets shall be shrink-wrapped. All pallets shall be wrapped using black shrink wrap to encapsulate the pallet and containers.

9. Pallets shall contain a packing slip identifying contents as well as an itemized invoice alphabetized line by line.

10. Controlled substances shall be wrapped separately from other portions of a shipment.

11. No more than 100 bottles per box or case.

12. A maximum weight of 25 pounds per box or case.

13. No “mix” of fill sizes, strengths, or drugs in any one box or case.

14. All partially-filled boxes, as well as partial deliveries, must be clearly marked and placed at the top of each shipping pallet used.

15. Destruction of retained samples, excess and/or damaged product shall be done in accordance with applicable regulations, including but not limited to any required by the DEA, FDA, and EPA. Within fourteen (14) calendar days after destruction the contractor shall provide the government with a Certificate of Destruction.

16. The repacking contractor shall be accountable for, and shall reimburse the ordering CMOP for, any government property spilled or damaged during the repack process. CMOP shall be reimbursed for the price paid for the unusable product.

17. Finished products that are received at the CMOP that are damaged, including missing or damaged caps, damaged bottles, missing or damaged labels that cannot be barcode scanned or are otherwise illegible, shall be returned to the repacking contractor for identification of the drug content and proper disposal. The damaged product shall be credited back to CMOP for the cost of the product plus repacking fee. If 10% or more of a batch is received damaged, the contractor must also pay for expedited shipment of replacement product.

N. REPORTS

1. Quarterly Container Report Under the awarded task order the contractor shall be required to provide a container report for the CMOP facilities under this contract for the preceding calendar quarter. The overall dollar value shall be rounded to the nearest whole dollar, of all sales. For the purpose of this requirement, the calendar quarters are Jan – Mar, Apr – Jun, Jul – Sep, and Oct - Dec. The report for the first month (first month begins October 1, or first day of January, April, or July, if that is that month that is immediately following contract award notice to proceed), and subsequent reports shall be due within 10 calendar days from the end of the immediate preceding defined calendar quarter. The report may be prepared and submitted in a format of the contractor’s choosing as long as it contains the minimum required data and clearly identifies the period of time reported. The report may be prepared and submitted in a format of the contractor’s choosing as long as it contains the minimum of dollars by bottle size by CMOP facility based on facility orders, and dollars by bottle size by CMOP facility based on centralized orders.

2. Monthly Container Reports: Under the awarded task order the contractor shall be required to provide a container report for the CMOP facilities under this contract for the preceding month. The report for the first month (first month begins October 1, or first day of month immediately following contract award notice to proceed), and subsequent months shall be due within 10 calendar days from the end of the immediate preceding month. The report may be prepared and submitted in a format of the contractor’s choosing as long as it contains the minimum of dollars by bottle size by CMOP facility based on facility orders, and dollars by bottle size by CMOP facility based on centralized orders.

3. Monthly Retention Reports: Under the awarded task order the contractor shall be required to provide a report identifying: retention samples and their consequent destruction. This report shall reflect total count and associated identifying data for all product held as retention samples, and shall reflect if and when any consequent destruction has occurred. The report for the first month (first month begins October 1, or first day of month immediately following contract award notice to proceed), and subsequent months shall be due within 10 calendar days from the end of the immediate preceding month. The report may be prepared and submitted in a format of the contractor’s choosing as long as it contains the minimum required data and clearly identifies the period of time reported.

4. Weekly Yield Report – Under the awarded task order the contractor shall be required provide a weekly actual yield report in Microsoft Excel format. This report shall be provided by product and lot number reflecting at a minimum: the date received, quantity received, lot numbers, repacking start and completion date, total yield (including samples and partials), quantity turned in for sale, samples not turned in, and process status (if in process, finished, etc.) Standard acceptance criteria for total unit doses packaged shall be + 1% variation; however reasonable variations may be permitted based on historic data by individual drug product. This report shall include distribution-only product as well to reflect shipment receipt. The CO shall be consulted to establish any variation other than the 1% stated. For purposes of reporting, the week shall begin on Thursday and end at close of business Wednesday with reports due by close of business the following day.

O. ESTIMATED QUANTITIES

NOTE: It is not always possible for CMOP to obtain a single lot number for the stock to be repacked, and, small production repacking runs which can be less than 100 bottles

1. The government anticipates a total of approximately 17 million repacked bottles per year, consisting of oral, solid pharmaceutical tablets and/or capsules. This estimate is based on historic data from the previous repacking contract. The anticipated use shall include, but not be limited to, bottle counts previously stated. Estimated quantities are anticipated to remain stable for the base year.

2. During option years there is likelihood that the volume may change, upward or downward, although total change cannot be estimated due to the size of the served patient population being in constant flux and other variable factors, including but not limited to fluctuations in need for repacking certain oral solid pharmaceuticals which could be based on alternative availability. Therefore, it is impossible to determine the exact quantities that shall be required during the contract term, nor the quantities that may be required by each CMOP.

3. The following is an estimated volume, based on historic data, for each bottle size been used in prior repacking activity. Past use does not guarantee future volume, although it shall show an approximate relative pattern of the usage per size. The volume below is based on usage averages and will not total 100%.

120cc Bottles: > 70%, estimated at > approximately 11,250,000 – 13,500,000 bottles 200cc Bottles: < 15%, estimated at < approximately 2,250,000 – 2,700,000 bottles 300cc Bottles: < 7%, estimated at < approximately 1,050,000 – 1,260,000 bottles 400cc Bottles: < 5%, estimated at < approximately 750,000 – 900,000 bottles 625cc Bottles: < 2%, estimated at < approximately 450,000 – 540,000 bottles 1,000cc Bottles: <1%, estimated at < approximately 150,000 – 180,000 bottles 2,000cc Bottles: <1%, estimated at < approximately 150,000 – 180,000 bottles 3,000cc Bottles: <1%, estimated at < approximately 150,000 – 180,000 bottles 4,000cc Bottles: <2%, estimated at < approximately 450,000 – 540,000 bottles

4. The contractor shall be required to deliver all articles that are properly ordered during the contract term, in accordance with the terms and conditions of the contract.

P. SCHEDULE OF SUPPLIES/SERVICES AND PRICE/COSTS.

1. Offeror’s prices are a repacking fee that is quoted per bottle, and as such must include all the offeror’s costs. These costs include, but are not limited to: labor, G&A costs, supplies (e.g. bottles, labels, shipping cartons, etc.), and shipping costs to the CMOP.

2. Offeror shall specify any additional charges (if applicable) per delivery trip, for emergency orders which exceed the two per month shipment limitation.

3. Request for payment of any amount due under this contract shall be submitted in writing to the CO within 30 days after the end of the contract period.

4. The guaranteed minimum does not apply if the contract is terminated for convenience or cause.

Q. DELIVERY

1. Delivery is required within ten (10) calendar days of receipt of a task order and the product to be repacked, although voluntary earlier deliveries are generally acceptable. If the tenth calendar day falls on a weekend or Federal Holiday, then delivery shall be made on the next normal business day for the CMOP.

2. Emergency, expedited deliveries of repacked drugs may be required before the next scheduled delivery day. The contractor shall provide a minimum of two monthly emergency deliveries for each delivery location at no additional charge. Emergency deliveries shall be made within 48 hours after receipt of order. Emergency deliveries will not exceed twenty (20) cases of product. The COR will be responsible for tracking all emergency order for each delivery location and notification when the two are reached.

3. Offeror shall specify additional charges (if applicable) per delivery trip, for emergency orders which exceed the two per month shipment limitation in the cost proposal. Additional emergency order delivery charges in excess of the two no charge deliveries shall be charged at a flat rate per delivery trip.

4. Partial Deliveries, delivery of shipment by the scheduled date shown on each task order shall be complete except as authorized by the OO.

R. INVOICES

1. Contractor shall submit invoices for payment to the office shown on each individual task order. Any partial deliveries, when approved by the OO, shall be separately invoiced to each delivery made from the over-arching order, not invoiced as a single delivery.

a. A detailed version of the invoice containing the following information shall be submitted to a designated CMOP contact on the same date the electronic version is submitted to the FSC.

· Vendor name, invoice number, and date

· Complete purchase order number assigned by CMOP for services. To ensure prompt payment, please contact the VA facility to ensure that the assigned purchase order number is current and correct.

· Itemized description of product, quantity, and unit price.

· Discount or net terms

2. Each invoice must be able to be reconciled to the line item level. Invoices shall be separated into three areas as follows:

a. Total product price

b. Total handling fee

c. Invoice grand total

S. SUPPORTED FACILITIES

1. The following facilities are eligible to order from the resultant contract.

CMOP National Office (770) 5049 S. 13th Street Leavenworth, KS 66048-5580

2. This list may be changed by modification, after award, to include new facilities or delete existing facilities.

T. MINIMUM – MAXIMUM GUARANTEE

1. The guaranteed minimum award amount for this contract is $100,000.00. The maximum aggregate value of orders that can be placed under this contract is $143,000,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

VA770-17-R-0417

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B.3 PRICE/COST SCHEDULE

*estimated quantities*

0001 Pharmaceutical Repacking, Base Year

0001A 120cc Bottles 13,500,000 BT $_________

0001B 200cc Bottles 2,700,000 BT $_________

0001C 300cc Bottles 1,260,000 BT $_________

0001D 400cc Bottles 900,000 BT $_________

0001E 625cc Bottles 540,000 BT $_________

0001F 1,000cc (1 L) Bottles 180,000 BT $_________

0001G 2,000cc (1 L) Bottles 180,000 BT $_________

0001H 3,000cc (1 L) Bottles 180,000 BT $_________

0001I 4,000cc (1 L) Bottles 540,000 BT $_________

0002 Lot/Volume Discounts The offeror may insert a percentage, or price, which can be applied, as a discount or deduction to the above unit pricing, when a volume level or action, identified below, is achieved per individual task order. This additional discount will not be cumulative; each order stands alone. The discount or deduction offered when single lot numbers can be provided for repacking shall also indicate if the value may be calculated before or after volume discounts or deductions are calculated.

0002A Single lot # ______________% or price: __________________ Before ___ After

0002B 2,500 Bottles ______________% or price: _______________

0002C 5,000 Bottles ______________% or price: _______________

0002D 10,000 Bottles ______________% or price: _______________

0002E 15,000 Bottles ______________% or price: _______________

0002F 20,000 Bottles ______________% or price: _______________

0002G 25,000 Bottles ______________% or price: _______________

0002H 35,000 Bottles ______________% or price: _______________

0002J 50,000 Bottles ______________% or price: _______________

0003 Expedite 1 EA _________ Offeror may indicate a cost, or a percentage to be applied to an individual task order price, expedited delivery is required.

ITEM DESCRIPTION OF EST QTY* UNIT TOTAL NUMBER SUPPLIES/SERVICES PRICE

1001 Pharmaceutical Repacking, Option Year 1

1001A 120cc Bottles 13,500,000 BT $_________

1001B 200cc Bottles 2,700,000 BT $_________

1001C 300cc Bottles 1,260,000 BT $_________

1001D 400cc Bottles 900,000 BT $_________

1001E 625cc Bottles 540,000 BT $_________

1001F 1,000cc (1 L) Bottles 180,000 BT $_________

1001G 2,000cc (1 L) Bottles 180,000 BT $_________

1001H 3,000cc (1 L) Bottles 180,000 BT $_________

1001I 4,000cc (1 L) Bottles 540,000 BT $_________

* NOTE: for QTY information, the largest estimated volume.

1002 Lot/Volume Discounts The offeror may insert a percentage, or price, which can be applied, as a discount or deduction to the above unit pricing, when a volume level or action, identified below, is achieved per individual task order. This additional discount will not be cumulative; each order stands alone. The discount or deduction offered when single lot numbers can be provided for repacking shall also indicate if the value may be calculated before or after volume discounts or deductions are calculated.

1002A Single lot # ______________% or price: _______________ ___ Before ___ After

1002B 2,500 Bottles ______________% or price: _______________

1002C 5,000 Bottles ______________% or price: _______________

1002D 10,000 Bottles ______________% or price: _______________

1002E 15,000 Bottles ______________% or price: _______________

1002F 20,000 Bottles ______________% or price: _______________

1002G 25,000 Bottles ______________% or price: _______________

1002H 35,000 Bottles ______________% or price: _______________

1002J 50,000 Bottles ______________% or price: _______________

1003 Expedite 1 EA _________ Offeror may indicate a cost, or a percentage to be applied to an individual task order price, expedited delivery is required.

ITEM DESCRIPTION OF EST QTY* UNIT TOTAL NUMBER SUPPLIES/SERVICES PRICE

2001 Pharmaceutical Repacking, Option Year 2

2001A 120cc Bottles 13,500,000 BT $_________

2001B 200cc Bottles 2,700,000 BT $_________

2001C 300cc Bottles 1,260,000 BT $_________

2001D 400cc Bottles 900,000 BT $_________

2001E 625cc Bottles 540,000 BT $_________

2001F 1,000cc (1 L) Bottles 180,000 BT $_________

2001G 2,000cc (1 L) Bottles 180,000 BT $_________

2001H 3,000cc (1 L) Bottles 180,000 BT $_________

2001I 4,000cc (1 L) Bottles 540,000 BT $_________

* NOTE: for QTY information, the largest estimated volume.

2002 Lot/Volume Discounts The offeror may insert a percentage, or price, which can be applied, as a discount or deduction to the above unit pricing, when a volume level or action, identified below, is achieved per individual task order. This additional discount will not be cumulative; each order stands alone. The discount or deduction offered when single lot numbers can be provided for repacking should also indicate if the value may be calculated before or after volume discounts or deductions are calculated.

2002A Single lot # ______________% or price: _______________ ___ Before ___ After

2002B 2,500 Bottles ______________% or price: _______________

2002C 5,000 Bottles ______________% or price: _______________

2002D 10,000 Bottles ______________% or price: _______________

2002E 15,000 Bottles ______________% or price: _______________

2002F 20,000 Bottles ______________% or price: _______________

2002G 25,000 Bottles ______________% or price: _______________

2002H 35,000 Bottles ______________% or price: _______________

2002J 50,000 Bottles ______________% or price: _______________

2003 Expedite 1 EA _________ Offeror may indicate a cost, or a…