Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E226, Bethesda, MD 20892, UNITED STATES. Non-USPS mail such as Fedex, UPS and other private carriers please use Rockville, MD 20850. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. N02RC62631-24 includes all applicable provisions and clauses in effect through FAR FAC 2005-89 (August 2016) simplified procedures for commercial items. The North American Industry Classification System code is 541380 and the business size standard is $15.0 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Description of Requirement The Laboratory of Molecular Biology, Molecular Biology Section, has developed an immunotoxin drug targeting mesothelin. This recombinant immunotoxin (RIT) composed of an antibody Fv targeting moiety and a Pseudomonas exotoxin cytotoxic moiety has been used in clinical trials for mesothelioma, pancreatic and ovarian cancers. Immunotoxins elicit antibodies that limit their use in immunocompetent patients so we have modified the RIT by genetic engineering to reduce its immunogenicity. De-immunized RITs are smaller and result in a faster clearance and shorter half-life in mice and humans. The NCI therefore needs to extend the half-life of our newest genetically engineered RIT, huSS1svFc-T20, by conjugating a polyethylene glycol (PEG) residue to the protein drug to increase its half-life in the blood. Tasks: 1. Preparation of a suitable PEG-reagent Based on a Y-shaped PEG-NHS ester (40 kDa) a corresponding Y-shaped PEG containing a Maleimido terminal group will be synthesized, purified and characterized by 1H-NMR and HPLC, respectively. 2. PEGylation of huSS1svFc-T20 2.1 Set-up Initial analytics of the protein starting material (reducing/non-reducing SDS-PAGE, SEC, UV-absorbance, determination of thiol content). Selection of suitable PEGylation strategy and planning of screening program. 2.2 Reaction screening - Performance of reaction screening in 25-50?L scale - Investigation of maleimide chemistry for PEGylation at extra cysteine. - Development of suitable reaction conditions. 2.3 Sample preparation - Development of one-step purification protocol. - Preparation of 5-10 mg PEGylated protein. - Release analytics comprising: - Purity by SDS-PAGE - MW by MALDI-MS - Homogeneity and aggregates by SEC-HPLC - Concentration by UV-absorbance Deliverables: 1. 5-10 mg of PEG-protein including Certificate of Analysis 2. A hard copy of a report showing the results 3. A data CD that contains all of the figures, graphs, and data in the report Period of performance: 4 months from date of award Place of Performance: Service shall be performed at the Contractor's site. Payment: Payment shall be made after delivery and acceptance of the product. Payment authorization requires submission and approval of invoice to the NCI COR and NIH Commercial Accounts. Questions are Due: August 24, 2016 The purchase order will be awarded to the Lowest Price Technically Acceptable (LPTA). The award will be made on the basis of the lowest evaluated price of quotations meeting or exceeding the acceptability standards for the requirements/technical specifications stated above. The technical evaluation will be a determination based on information furnished by the vendor. The Government is not responsible for locating or securing any information which is not identified in the quote. The Government reserves the right to make an award without discussions. PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition: FAR clause 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (October 2015); FAR clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS- (April 2016) WITH DUNS NUMBER ADDENDUM {52.204-6 (July 2013)}; FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (May 2015); FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (June 2016). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition; FAR Clause 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment FAR Clause 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns FAR Clause 52.222-21 Prohibition of Segregated Facilities FAR Clause 52.222-26 Equal Opportunity FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases FAR Clause 52.232-33 Payment by Electronic Funds Transfer-System for Awards Management (SAM) Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI website at http://ncioa.cancer.gov/oa-internet/ or from Kimesha Leake, Contract Specialist at
contact@example.gov OFFERORS: Offers must be submitted on an SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror OR provide valid certification showing that the offeror is registered in the System for Award Management (SAM) through www.sam.gov Quotations must be received in the NCI-OA contracting office by August 29, 2016 at 4:00 pm. Please refer to solicitation number N02RC62631-24 on all correspondence. No collect calls or faxed quotations will not be accepted. Electronic quotations will be accepted at
contact@example.gov All questions shall be in writing and may be addressed to the aforementioned individual noted above. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management through sam.gov.
