Fingolimod Capsules

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SPE2D2-26-R-0007 Page 2 of 62 Table of Contents Page Continuation of Blocks from the Standard Form 1449 4 Block 9, Issued By 4 Block 17a, Contractor/Offeror 4 Block 17b, Remittance Address 4 Block 19-22, Item No., Schedule of Supplies/Services, Quantity, Unit 5 Caution Notices DIBBS, RA Notification, Subcontracting Plan, Reports, and Contractor Code of Ethics 5 Contract Clauses FAR 52.204-19 Incorporation by Reference of Representations and Certifications (DEC 2014) 6 FAR 52.216-21 Requirements (DEVIATION 2026-O0038) (FEB 2026) 6 FAR 52.217-9 Option to Extend the Term of the Contract (MAR 2000) 7 FAR 52.219-28 Postaward Small Business Program Representation (DEVIATION 2026-O0038) (FEB 2026) 7 FAR 52.252-6 Authorized Deviations in Clauses (NOV 2020) 10 DFARS 252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services (DEVIATION 2026- O0025) (FEB 2026) 10 FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998) 13 Statement of Work 1. Background 16 2. Purpose and Objective 17 3. Purchase Compliance 17 4. Extent of Obligation 17 5. Contract Price Effective Date 17 6. Contract Performance Date 17 7. Chargeback Agreements 18 8. Special Contract Considerations 18 9. Delivery 18 10. Transition Period 18 11. Contract Duration 18 12. Ordering and Acceptance of Orders 18 13. Initial Orders 19 14. National Contract Backorders 19 15. Product Registration 20 16. Preparation for Delivery 20 17. Labeling 21 18. Therapeutic Equivalence 22 19. Drug Application 22 20. Manufacturing Facilities 22 -- 2 of 62 -- SOLICITATION NO. SPE2D2-26-R-0007 Page 3 of 62 21. Recalls 24 22. Cost Recovery Fee and Submission of Quarterly Sales Reports 25 Solicitation Provisions FAR 52.209-5 Certification Regarding Responsibility Matters (DEVIATION 2026-O0038) (FEB 2026) 27 FAR 52.209-7 Information Regarding Responsibility Matters (DEVIATION 2026- O0038) (FEB 2026) 28 FAR 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (DEVIATION 2026-O0038) (FEB 2026) 30 FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (DEVIATION 2026-O0038) (FEB 2026) 30 Addendum 1 to 52.212-1 – Paragraph Modifications 32 Addendum 2 to 52.212-1 – Preparation & Organization of Proposals 32 Addendum 3 to 52.212-1 – Volume 2 – Price Proposal 38 Addendum 4 to 52.212-1 – Caution Statements and Notifications 38 FAR 52.212-2 Evaluation—Commercial Products and Commercial Services (DEVIATION 2026-O0038) (FEB 2026) 39 FAR 52.215-6 Place of Performance (DEVIATION 2026-O0038) (FEB 2026) 44 FAR 52.215-20 Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data (DEVIATION 2026-O0038) (FEB 2026) 46 FAR 52.216-1 Type of Contract (DEVIATION 2026-O0038) (FEB 2026) 47 FAR 52.219-1 Small Business Program Representations (DEVIATION 2026- O0038) (FEB 2026) 47 DFARS 252.204-7016 Covered Defense Telecommunications Equipment or Services – Representation (DEVIATION 2026-O0025) (FEB 2026) 49 DFARS 252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services – Representation (DEVIATION 2026-O0025) (FEB 2026) 50 DFARS 252.204-7998 Alternate A Annual Representations and Certifications (DEVIATION 2026- O0043) (FEB 2026) 51 DFARS 252.215-7994 Requirements for Certified Cost of Pricing Data and Data Other Than Certified Cost or Pricing Data. (DEVIATION 2026-O0048) (MAR 2026) 53 FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) 58 DLAD 5452.233-9001 Disputes - Agreement to Use Alternative Dispute Resolution (JUN 2020) 59 Procurement Notes L02 Electronic Order Transmission (JUN 2020) 60 L06 Agency Protests (DEC 2016) 60 Appendixes Appendix A: Pharmaceutical Prime Vendors 61 Appendix B: Agency Annual Demand Projections 62 -- 3 of 62 -- SOLICITATION NO. SPE2D2-26-R-0007 Page 4 of 62 CONTINUATION OF SF 1449 Block 9, Issued By: 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. o Solicitation Number: SPE2D2-26-R-0007 o Opening/Closing Date and Time: June 09, 2026, to July 09, 2026, 3:00PM EST. • 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 June 09, 2026, to July 09, 2026, 3:00PM EST. • If the ability to upload proposals is unavailable for any reason, this does not constitute an acceptable reason for a late offer. o CAUTION – Late submissions, modifications, revisions, and withdrawals of offers: See Section L, Provision No. 52.212-1(c) (Page 31 of the solicitation). • The instructions to upload a solicitation and associated documents can be found at: https://www.dla.mil/Portals/104/Documents/InformationOperations/EBS%20Supplier %20Information/Upload%20Proposal%20DIBBS%20Help_1.docx?ver=2020-04-23- 150759-460 (Please contact Henry.Shelly@dla.mil with any questions or technical issues related to DIBBS submission of offers for this solicitation.) Block 17a: Contract…