PHARM MANUF/DISTR DIV - FSA

The Defense Logistics Agency awarded Contract SPE2D226D0012 to EXELAN PHARMACEUTICALS INC for the supply of Sertraline tablets in multiple strengths and bottle configurations under a firm-fixed-price, requirements-type contract with a base year and four optional years, spanning up to five years of performance. The total contract value is $22,510,720.70, with delivery terms governed by F.O.B. Destination, meaning the contractor assumes all costs and risks until goods are received at designated government or Pharmaceutical Prime Vendor facilities. The contract is governed by a comprehensive set of Federal Acquisition Regulation and Defense Federal Acquisition Regulation Supplement clauses, including mandatory requirements for cybersecurity, commercial item acquisition, whistleblower protections, small business subcontractor payment acceleration, prohibitions on telecommunications equipment from covered foreign entities, and supply chain transparency under the Federal Acquisition Supply Chain Act. Packaging and labeling must comply with strict industry standards such as GS1-128 and HIBC for barcoding, require child-proof closures, prohibit glass containers, and mandate clear visibility of NDC, lot number, and expiration data with specific dimensional and positioning guidelines to ensure compatibility with automated dispensing systems. The award follows a Lowest Price Technically Acceptable (LPTA) evaluation process, where offerors must meet all technical and past performance criteria to be eligible for award consideration, with price being the sole differentiating factor among technically acceptable bids. Contract administration is handled through commercial invoicing channels via Pharmaceutical Prime Vendors including AmerisourceBergen, Cardinal Health, DMS Pharmaceutical Group, and McKesson Corp, with no direct invoicing to the government. The contractor must ensure full compliance with FDA current Good Manufacturing Practices, maintain active NDA, ANDA, or BLA approvals for all products, report any FDA warning letters or inspection failures immediately, and provide quarterly sales reports and facility disclosures. All manufacturing sites must be disclosed, and the product's country of origin must adhere to DFARS trade agreement requirements. The contract includes provisions for accelerated payments to small business subcontractors, restrictions on inverted domestic corporations, and compliance with the American Recovery and Reinvestment Act whistleblower protections. Point of contact for contract execution is Christopher Newman, with Jason Wray designated for recall coordination. Subcontractors must be vetted under FAR 52.209-6, and the contractor is obligated to maintain up-to-date representations and certifications in SAM.gov, including disclosure of ownership structure and exclusion status.