Dimethyl Fumarate Solicitation SPE2D2-21-R-0102.docx

SOLICITATION NO. SPE2D2-21-R-0102 Page 34 of 95

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

ESTIMATED QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

0001AA

0001AB

0001AC

0001AD

0001AE

0002AA

0002AB

0002AC

0002AD

0002AE

Dimethyl Fumarate DR 120 MG – 14 Count* National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Dimethyl Fumarate DR 240 MG – 60 Count* National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

*Package size is unit of use and is subject to Statement of Work - “Preparation for Delivery” requirement.

**BT = One Bottle

-The quantities specified in the Schedule are estimates only. Reference FAR 52.216-21 Requirements for details.

14,011

14,011

BT**

BT

BT

BT

Table of Contents

FAR 52.212-5 Contract Terms and Conditions Reuired to Implement Statues or Executive Orders - Commercial Items (JAN 2021)…………………………………………………………………………………………….………….……7

FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (AUG 2020) 15

Clauses Incorporated by Reference ……………………………………………………………………………………………………17

Manufacturing Facilities …………………………………………………………………………………………………………….………24 Recalls 26 Solicitation Provisions……………………………………………………………………………………………………………………………28 FAR 52.212-1 Instructions to Offerors - Commercial Items …………………………………………………………………28 Addendum to 52.212-1………………………………………………………………………………………………………………………32

PROCUREMENT NOTES………………………………………………………………………………………………………………………38

L06 Agency Protests ……………………………………………………………………………………………………………………… L09 Reverse Auction ………………………………………………………………………………………………………………….………38

FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (OCT 2020)……………………………………………………………….………………………………..….59 FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (AUG 2020)………………………………………………………………………………………………….62 FAR 52.204-26 Covered Telecommmunications Equipment or Services-Representation (OCT 2020)…………….………………………………………………………………………………………………….……………………….65 FAR 52.216-1 -- Type of Contract (APR 1984) 70 FAR 52.229-11 Tax on Certain Foreign Procurements - Notice and Representation (JUN 2020) ………..…70 FAR 52.229-12 Tax on Certain Foreign Procurements (JUN 2020)……………………………………………………..72 FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998) ……………………………………...74

DFARS 252.225-7013 Duty-Free Entry (Deviation 2020-O0019)…………………………………………………………..78 DFARS 252.225-7020 Trade Agreements Certificate (NOV 2014) 82 DFARS 252.225-7021 Trade Agreements (Deviation 2020-O0019) (JUL 2020)………………………………………..83 Additional Clauses as Applicable ……………………………………………………………………………….………………………17

CONTINUATION OF SF 1449

Block 9: Submission Instructions › Submit offers “electronically” at the Defense Logistics Agency Internet Bid Board System (DIBBS) https://www.dibbs.bsm.dla.mil/ › Instructions

· Vendors are required to register for DIBBS prior to submission of any offer.

· Registration assistance and guidelines may be found at: https://www.dibbs.bsm.dla.mil/refs/help/Registration/RegistrationGuidelines.aspx

· When registered, the vendor may submit an offer in response to a solicitation found on the RFP search screen by selecting the “Offer” icon. The button will only be selectable for vendors who are logged onto DIBBS. If not logged in yet, DIBBS will take you to the log in screen.

· Solicitation Number: SPE2D2-21-R-0102

· Opening/Closing Date and Time: August 16, 2021 to September 20, 2021 3:00PM EDT

· Upload a completed offer and all associated documents. The SF 1449 must be signed and the offer completed in its entirety in accordance with the solicitation requirements. Do not select “submit” until all associated documents are added. No data will be saved unless the offer is submitted. Once submitted, documents may be added, but not removed. No documents may be submitted after the closing date on September 20, 2021 3:00PM EDT.

· If the ability to upload proposals is unavailable for any reason, this does not constitute an acceptable reason for a late offer.

· CAUTION – LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.212-1 paragraph f (Page 29 of the solicitation).

· The instructions to upload a solicitation and associated documents can be found at: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.dla.mil%2FPortals%2F104%2FDocuments%2FInformationOperations%2FEBS%2520Supplier%2520Information%2FUpload%2520Proposal%2520DIBBS%2520Help.docx (Please contact Kevin.rafferty@dla.mil with any questions or technical issues related to DIBBS submission of offers for this solicitation. Secondary POC is Denise.Taubman@dla.mil) Block 17a: DUNS & CAGE › Offeror’s assigned Unique Entity Identifier Number:_______________ (If you do not have a Unique Entity Identifier number, contact the individual identified in Block 7a of the SF 1449 or see 52.212-1, Instructions to Offerors—Commercial Items (paragraph j) for information on establishing a unique entity identifier) › Offeror’s assigned Contractor and Government Entity (CAGE) Code:__________________

Block 17b: Remittance Address (if different from Contractor/Offeror address in block 17a of the SF 1449.)

CAUTION NOTICE

1. Offerors are required to submit offers via Defense Logistics Agency Internet Bid Board System (DIBBS).

See page 5 Block 9: Submission Instructions for link to DIBBS. Upload of offer to DIBBS is the only authorized method of proposal submittal. Offers submitted by email, postal mail, or physical delivery ARE NOT AUTHORIZED.

2. Reverse Auction Notification This solicitation contains Procurement Note L09 for reverse auction (RA). The Government may activate this provision after timely offers have been received and evaluated. Prior to doing so, the contracting officer will establish a competitive range, decide whether or not an RA will be conducted, and determine which offerors will participate in this event. Firms removed from the competitive range will be notified in writing prior to the Government conducting the RA.

The reverse auction vendor provides the tool/software that allows for the reverse auction. By submitting an offer, the offeror consents that the reverse auction vendor may have access to its submitted data for the purpose of the reverse auction. Reverse auction vendors are bound by confidentiality agreements.

3. Subcontracting Plan Pursuant to the requirements of Public Law 95-507, all large business offerors must submit a subcontracting plan with their offer. All large business concerns are required to have an approved subcontracting plan for contracts valued over $750,000 before the Government can award a contract (see FAR 52.219-9 for details). Offerors must submit a currently approved commercial plan or a new plan for review and approval.

Instructions for submitting the subcontracting plan are included in FAR 52.212-1. Contractors are required to report progress on subcontracting goals to the electronic Subcontracting Reporting System (eSRS) twice a year. eSRS is an internet-based tool that streamlines the process of reporting on subcontracting plans and provides agencies with access to analytical data on subcontracting performance

4. Assessments/Reports As prescribed in FAR Part 42.15, DLA evaluates contractor performance on all contracts that exceed $250,000, and shares those evaluations with other federal government agencies. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement, DLA will be using an online database, the Contractor Performance Assessment Reporting System (CPARS). Annual reporting of past performance will be completed at http://www.cpars.gov and uploaded to PPIRS (Past Performance Information Retrieval System).

5. Contractor Code of Business Ethics FAR Part 3.1002(a) requires all government contractors to conduct themselves with the highest degree of integrity and honesty. Contractors should have a written code of business ethics and conduct within thirty days of award. To promote compliance with such code of business ethics and conduct, contractors should have an employee business ethics and compliance training program that facilitates timely discovery and disclosure of improper conduct in connection with government contracts and ensures corrective measures are promptly instituted and carried out. A contractor may be suspended and/or debarred for knowing failure by a principal to timely disclose to the government, in connection with the award, performance, or closeout of a government contract performed by the contractor or a subcontract awarded there under, credible evidence of a violation of federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations found in title 18 of the United States Code or a violation of the False Claims Act. (31 U.S.C. 3729-3733)

If this solicitation or contract includes FAR clause 52.203-13 - CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT; the contractor shall comply with the terms of the clause and have a written code of business ethics and conduct; exercise due diligence to prevent and detect criminal conduct; promote ethical conduct and a commitment to compliance with the law within their organization; and timely report any violations of federal criminal law involving fraud, conflict of interest, bribery or gratuity violations found in title 18 of the United States Code or any violations of the False Claims Act. (31 U.S.C. 3729-3733). When FAR 52.203-13 is included in the contract, contractors must provide a copy of its written code of business ethics and conduct to the contracting officer upon request by the contracting officer.

CONTRACT CLAUSES

FAR 52.212-4 Contract Terms and Conditions—Commercial Items (OCT 2018) Incorporated in this solicitation by reference. Its full text may be accessed electronically at https://www.ecfr.gov/cgi-bin/ECFR?SID=efef3c52b917f6248e7b50687672ed94&mc=true&page=browse.

Text is available for viewing in Subpart 52.2 Text of Provisions and Clauses, through either the HTML or PDF Format links.

FAR 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items. (JAN 2021)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.]

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved]

__ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).

_X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41 U.S.C. 2313).

__ (10) [Reserved]

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole Source Award (MAR 2020) (15 U.S.C. 657a)

__ (ii) Alternate I (MAR 2020) of 52.219-3.

_X_ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Class Deviation 2020-O0008) (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (MAR 2020) of 52.219-4.

__ (13) [Reserved]

__ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Class Deviation 2020-O0008) (NOV 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Class Deviation 2020-O0008) (MAR 2020) of 52.219-6.

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (Class Deviation 2020-O0008) (NOV 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Class Deviation 2020-O0008) (MAR 2020) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).

_X_ (17)(i) 52.219-9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (NOV 2016) of 52.219-9.

_X_ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (JUN 2020) of 52.219-9.

__ (18)(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

__ (ii) Alternate I (MAR 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (Class Deviation 2020-O0008) (MAR 2020) (15 U.S.C. 637(a)(14)).

_X_ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (JAN 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Class Deviation 2020-O0008) (MAR 2020) (15 U.S.C. 657f).

_X_ (22)(i) 52.219-28, Post-Award Small Business Program Rerepresentation (NOV 2020) (15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Class Deviation 2020-O0008) (MAR 2020) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Class Deviation 2020-O0008) (MAR 2020) (15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (Class Deviation 2020-O0008) (MAR 2020) (15 U.S.C. 637(a)(17)).

_X_ (27) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

_X_ (28) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Class Deviation 2020-O0008) (JAN 2020) (E.O. 13126)

_X_ (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

_X_ (30)(i) 52.222-26, Equal Opportunity (SEPT 2016) (E.O. 11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

_X_ (31)(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

__ (ii) Alternate I (July 2014) of 52.222-35.

_X_ (32)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

__ (ii) Alternate I (July 2014) of 52.222-36.

_X_ (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

_X_ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

_X_ (35)(i) 52.222-50, Combating Trafficking in Persons (OCT 2020) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (MAY 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (40)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (OCT 2015) of 52.223-13.

__ (41)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

__ (43)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (JUN 2016) (E.O. 13693).

__ (47)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

__ (48) 52.225-1, Buy American—Supplies (JAN 2021) (41 U.S.C. chapter 83).

__ (49)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (JAN 2021) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (JAN 2021) of 52.225-3.

__ (iii) Alternate II (JAN 2021) of 52.225-3.

__ (iv) Alternate III (JAN 2021) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (OCT 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (JUNE 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV 2007) (42 U.S.C. 5150).

_X_ (55) 52.229-12, Tax on Certain Foreign Procurements (FEB 2021) __ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C.4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (OCT 2018) (31 U.S.C. 3332).

__ (59) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (JUL 2013) (31 U.S.C. 3332).

_X_ (60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

__ (61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

_X_ (62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

_X_ (63)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

__ (iii) Alternate II (Feb 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).

__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

__ (7) 52.222-55, Minimum Wages Under Executive Order 13658 (NOV 2020).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) of this paragraph in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(vii) 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246).

(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (AUG 2018)(41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (OCT 2020) (22 U.S.C. chapter 78 and E.O. 13627).

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (NOV 2020).

(xviii) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xix)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor May include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (AUG 2020)

(a) Definition. As used in this clause–“Commercial and Government Entity (CAGE) code” means–

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

(b) Contractors shall ensure that the CAGE code is maintained throughout the life of the contract. For contractors registered in the System for Award Management (SAM), the DLA Commercial and Government Entity (CAGE) Branch shall only modify data received from SAM in the CAGE master file if the contractor initiates those changes via update of its SAM registration. Contractors undergoing a novation or change-of-name agreement shall notify the contracting officer in accordance with subpart 42.12. The contractor shall communicate any change to the CAGE code to the contracting officer within 30 days after the change, so that a modification can be issued to update the CAGE code on the contract.

(c) Contractors located in the United States or its outlying areas that are not registered in SAM shall submit written change requests to the DLA Commercial and Government Entity (CAGE) Branch. Requests for changes shall be provided at https://cage.dla.mil. Change requests to the CAGE master file are accepted from the entity identified by the code.

(d) Contractors located outside the United States and its outlying areas that are not registered in SAM shall contact the appropriate National Codification Bureau (points of contact available at http://www.nato.int/structur/AC/135/main/links/contacts.htm) or NSPA at https://eportal.nspa.nato.int/AC135Public/scage/CageList.aspx.

(e) Additional guidance for maintaining CAGE codes is available at https://cage.dla.mil.

FAR 52.204-19 Incorporation by Reference of Representations and Certifications (DEC 2014) 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) FAR 52.232-39 Unenforceability of Unauthorized Obligations (JUN 2013)

(a) Except as stated in paragraph (b) 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:

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

(2) 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.

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

(b) Paragraph (a) 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.

(End of clause) FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

· FAR: https://www.ecfr.gov/cgi-bin/text-idx?SID=2a65ee6d124e0949d61d01c7d637b675&mc=true&tpl=/ecfrbrowse/Title48/48tab_02.tpl

· DFARS https://www.ecfr.gov/cgi-bin/text idx?SID=2a65ee6d124e0949d61d01c7d637b675&mc=true&tpl=/ecfrbrowse/Title48/48tab_02.tpl

· DLAD: http://www.dla.mil/HQ/Acquisition/Offers/DLAD.aspx

The following additional clauses are incorporated by reference:

CLAUSE NUMBER

FAR

DFARS

FAR 52.216-21 Requirements (OCT 1995)

(a) This is a requirements contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies or services specified in the Schedule are estimates only and are not purchased by this contract. Except as this contract may otherwise provide, if the Government’s requirements do not result in orders in the quantities described as “estimated” or “maximum” in the Schedule, that fact shall not constitute the basis for an equitable price adjustment.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. Subject to any limitations in the Order Limitations clause or elsewhere in this contract, the Contractor shall furnish to the Government all supplies or services specified in the Schedule and called for by orders issued in accordance with the Ordering clause. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(c) Except as this contract otherwise provides, the Government shall order from the Contractor all the supplies or services specified in the Schedule that are required to be purchased by the Government activity or activities specified in the Schedule.

(d) The Government is not required to purchase from the Contractor requirements in excess of any limit on total orders under this contract.

(e) If the Government urgently requires delivery of any quantity of an item before the earliest date that delivery may be specified under this contract, and if the Contractor will not accept an order providing for the accelerated delivery, the Government may acquire the urgently required goods or services from another source.

(f) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after the last outstanding delivery is received for orders placed by the expiration date of the contract.

FAR 52.217-5 Evaluation of Options (JUL 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

FAR 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor at any time during the term of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years.

FAR 52.247-34 F.o.B. Destination (JAN 1991)

(a) The term “f.o.b. destination,” as used in this clause, means --(1) Free of expense to the Government, on board the carrier’s conveyance, at a specified delivery point where the consignee’s facility (plant, warehouse, store, lot, or other location to which shipment can be made) is located; and (2) Supplies shall be delivered to the destination consignee’s wharf (if destination is a port city and supplies are for export), warehouse unloading platform, or receiving dock, at the expense of the Contractor. The Government shall not be liable for any delivery, storage, demurrage, accessorial, or other charges involved before the actual delivery (or “constructive placement” as defined in carrier tariffs) of the supplies to the destination, unless such charges are caused by an act or order of the Government acting in its contractual capacity. If rail carrier is used, supplies shall be delivered to the specified unloading platform of the consignee. If motor carrier (including “piggyback”) is used, supplies shall be delivered to truck tailgate at the unloading platform of the consignee, except when the supplies delivered meet the requirements of Item 568 of the National Motor Freight ClassificatioFn for “heavy or bulky freight.” When supplies meeting the requirements of the referenced Item 568 are delivered, unloading (including movement to the tailgate) shall be performed by the consignee, with assistance from the truck driver, if requested. If the contractor uses rail carrier or freight forwarded for less than carload shipments, the contractor shall ensure that the carrier will furnish tailgate delivery, when required, if transfer to truck is required to complete delivery to consignee.

(b) The Contractor shall --

(1) (i) Pack and mark the shipment to comply with contract specifications; or (ii) In the absence of specifications, prepare the shipment in conformance with carrier requirements;

(2) Prepare and distribute commercial bills of lading;

(3) Deliver the shipment in good order and condition to the point of delivery specified in the contract;

(4) Be responsible for any loss of and/or damage to the goods occurring before receipt of the shipment by the consignee at the delivery point specified in the contract;

(5) Furnish a delivery schedule and designate the mode of delivering carrier; and

(6) Pay and bear all charges to the specified point of delivery.

STATEMENT OF WORK

1. Background The Defense Logistics Agency (DLA), Directorate of Medical Materiel provides pharmaceutical products for the Department of Defense (DoD) to its customers through its Pharmaceutical Prime Vendor program. Hereafter this program is referred to as the “PPV.” A prime vendor is an independent business concern that functions as a purchaser's primary source for specified classes of products and is responsible for the delivery of goods produced by various suppliers. As a part of the Pharmaceutical Prime Vendor Program, this solicitation will establish a national contract for the items listed in the schedule. The PPV Program consist of separate contracts which establish the fees for the distribution of pharmaceutical products that are distributed through the PPV Program on Federal Government (i.e., Federal Supply Schedules, DLA National Contracts) contracts. The awardee consents to allow DLA prime vendors to distribute the listed products in the schedule.

2. Purpose and Objective A contract resulting from this solicitation will establish a national supply source, in accordance with FAR 52.216-21 Requirements, to provide the drugs listed in the schedule for purchase by DLA customers through the PPV. The annual usage for DLA customers served through the Prime Vendor Program is estimated in the Schedule of Supplies. The objective of the contract is to ensure availability and consistency of product and to obtain volume-based, committed use pricing.

3. Purchase Compliance Ordering activities will purchase the selected contractor’s product for the items listed in the Schedule of Supplies section of this Solicitation through the DLA PPV contractors except when: (1) the contracted items is/are unavailable to meet the needs of the Government or (2) an alternate is requested by the prescribing healthcare provider.

4. Extent of Obligation The contractor shall provide the products specified in the schedule to all DLA PPV contractors in order to facilitate the products’ availability for all eligible DoD ordering activities.

5. Contract Price Effective Date The Contract Price Effective Date shall be no more than 60 days after award.

6. Contract Performance Date The contract performance date shall be 45 days (or sooner upon mutual agreement) after the date of contract award. This is the date the contractor shall be ready to fill orders from the PPV contractors.

The contract prices shall be effective 15 days after the contract performance date. Before the contract performance date, the PPVs will begin placing orders with the contractor for delivery to multiple PPV distribution centers for distribution to the participants under this contract. See Appendix A for the current list of PPVs. The current PPV contractors may change and the contractor will be notified of any changes in PPV contractors during the term of the contract resulting from this solicitation. The contractor shall ensure that sufficient inventory of contract items awarded under this solicitation is available to ensure delivery to the PPV distribution centers within 15 days of the contract performance date. In order to facilitate the sale of the awardee’s product to government ordering activities through the DLA PPV contractors, the awardee shall enter into business-to-business agreements with each of the DLA PPV contractors. Payment terms, time and place of delivery to PPV distribution centers, and other relevant terms shall be agreed upon between the PPV contractors and the contractor awarded a contract from this solicitation in these agreements. The Government is not obligated to become involved in or assume any responsibility for financial or other disputes involving these agreements. Offerors may approach the PPV contractors regarding establishing business-to-business agreements prior to submitting an offer in response to this solicitation. Within 15 days of award, the Contracting Officer shall be notified by the contractor if any business-to-business-agreements cannot be reached with the PPV contractors.

7. Chargeback Agreements Chargeback arrangements shall be coordinated between the prime vendors and the successful contractor.

8. Special Contract Considerations As discussed in Section 2, this solicitation establishes a supply source to provide the drugs listed in the schedule for purchase through the PPV program. Additionally, as outlined in Section 6, the awarded contractor under this solicitation must reach a business-to-business agreement with each of the DLA PPV contractors. Because the PPV contractors distribute the supplies sourced from this solicitation, special contract considerations apply.

Under this resulting contract, the contractor will be receiving payments from the PPV contractors instead of directly from the Government. Due to this unique payment structure, the contractor cannot assign its rights to receive payment under this contract. Additionally, disputes arising between the awardee and the PPV contractors do not give rise to a “claim” under the Disputes Clause. Finally, no invoices will be provided from the contractor to the Government. Instead, the contractor shall submit invoices in accordance with the business-to-business agreements reached with the PPV contractors.

9. Delivery The complete order quantity shall be delivered to the PPV contractors within 15 days after receipt of order.

Other delivery requirements including but not limited to product quantities, time and place of delivery and method of delivery for products awarded as a result of this procurement action will be determined by the contract awardee and the prime vendors.

10. Transition Period After the effective date a short phase-in period may be needed to convert patients and medical centers to the awarded products. Every effort will be made to begin transitioning as many patients as possible by the contract performance date.

11. Contract Duration The contract resulting herein will be for a one year base and include four option years for a maximum possible term of five years. The contract will not exceed five years.

12. Ordering and Acceptance of Orders The contractor agrees to accept orders that are placed by, and provide items to, the prime vendors for use by medical treatment facilities, formularies, eligible beneficiaries and other ordering activities served by the DLA PPV contractors. The Government reserves the right to delete ordering sites/activities which are current prime vendor customers during the effective period of this contract. In addition, the Government reserves the right to add Government pharmacies and ordering activities of agencies, which are not current PPV customers, during the effective period of this contract. There is no expressed or implied guarantee that the estimated quantity will be purchased under this contract. Actual quantities purchased may exceed or be less than those represented.

The Government also reserves the right to add other federally funded customers, including those that are not served by the DLA PPV contractors, during the life of the awarded contract. However, the estimated quantities in Appendix B: Agency Annual Demand Projections are based on DoD demand. Offeror’s proposals should be based on the estimated quantities in Appendix B.

The price the Government pays a PPV contractor for the awardee’s product will be adjusted by the distribution fees established by the terms of that PPV contractor’s separate contract with the Government. All of the DLA PPV contractors’ contracts with the government currently contain negative distribution fees. This means that the price paid by the Government to a PPV contractor for the awardee’s product may be less than the unit price established by a contract awarded from this Solicitation.

13. Initial Orders DoD ordering activities may place initial orders with the PPV contractors totaling up to 30% of the DoD's stated estimated annual contract quantities, located in Appendix B: Agency Annual Demand Projections, immediately upon the contract effective date. Initial orders totaling up to 30% of the DoD's stated estimated annual contract quantities may be placed by the PPV contractors with the national contract awardee of this solicitation to fulfill the initial order requirements.

14. National Contract Backorders The ability of the Department of Defense (DoD) to provide quality healthcare to its patient population is severely impaired when a national contract product is not available due to backorders. The purpose of this paragraph is to provide guidance to the awarded contractor regarding a temporary solution to national contract item backorders that may be implemented in lieu of the Government terminating the contract for cause. However, nothing in this section will waive any of the Government’s rights to terminate the contract for cause in accordance with FAR 52.212-4(m).

For purposes of this contract, a backorder occurs when a PPV contractor issues an order with the contractor awarded a contract for the products in this solicitation, and the complete order quantity is not delivered to the PPV contractor within 15 days after receipt of order. This includes initial Consolidated Mail Order Pharmacy (CMOP) orders. If a national contract item is backordered by a PPV contractor, the contracting officer will review the backorder to determine the cause of the backorder. The awarded contractor shall inform the contracting officer within 4 calendar days after a backorder occurs or is foreseen. In addition to informing the contracting officer of the backorder, the awardee shall provide an estimated date when the backorder will be shipped, and may propose a solution to satisfy the Government’s needs for the contract items until the backorder is resolved. The Government reserves the right to accept or reject any possible solutions that the awardee may propose to alleviate a national contract backorder situation.