Gene synthesis/cloning, peptide synthesis, and QC analysis
National Cancer Institute (NCI) Surgery Branch plans to procure brand name or equal services from Genscript USA Inc of 860 Centennial Ave Piscataway, New Jersey 08854. This is a combined synopsis/soli... National Cancer Institute (NCI) Surgery Branch plans to procure brand name or equal services from Genscript USA Inc of 860 Centennial Ave Piscataway, New Jersey 08854. This is a combined synopsis/solicitation for commercial items, prepared in accordance with the 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, 75N91021Q00179, is issued as a request for quotation (RFQ) and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2020-04 (January 15, 2020), simplified procedures for commercial items. The North American Industry Classification System code is 621511 and the business size standard is $35,000,000. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type purchase order. The National Cancer Institute (NCI), Surgery Branch (SB) is developing immune-based therapies to treat patients with metastatic cancer. One of the branch’s current major therapeutic strategies is to use tumor mutation-reactive T cells to treat patients with cancer. This is based on data from the SB clinical trials demonstrating that the curative responses seen in patients with melanoma treated with T cells are likely mediated by mutation-reactive T cells. Moreover, the NCI treated a patient with metastatic bile duct cancer with a highly pure population of mutation-reactive T cells and are observing ongoing tumor regression at 16+ months after therapy. The SB is thus attempting to treat more patients with mutation-reactive T cells. In order to do this, the SB first has to identify mutation- reactive T cells from patients. The reagents that the branch requires to identify mutation-reactive T cells are custom genes and custom peptides that encode for tumor mutations. Since the SB is using these reagents in “real time” to develop therapies to treat patients with late-stage cancer, the branch requires that these reagents be synthesized quickly, be error-free and that the product sequences are of high quality. OBJECTIVE The patients being treated at the SB are late-stage patients with no other therapeutic options, thus the NCI requires that all these reagents be synthesized in an expeditious manner as time is of the essence. This process is required for every single patient on the SB protocol (i.e., this is highly personalized medicine/therapy). SCOPE Independently, and not as an agent of the Government, the Contractor shall furnish all necessary supplies, equipment, labor, and services to perform gene synthesis/cloning, peptide synthesis, and QC analysis of peptides and mammalian expression constructs for the Government's use in the conduct of cancer-related clinical research/trials. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS Contractor shall conduct gene synthesis/cloning, peptide synthesis, and QC analysis of peptides and mammalian expression constructs for 125 cases. Detailed requirements for each of these services are as follows: 1 - Gene Synthesis/Cloning and Peptide Synthesis: The contractor shall produce crude or HPLC purified peptides or peptide pools that encode normal endogenous protein sequences and those with tumor mutations embedded. They will use the sequence file that researchers provide to them from the NGS sequencing done on clinical trial patient tumor samples associated with one of many trials under The National Cancer Institute (NCI), Surgery Branch (SB). Additionally, the contractor shall provide tandem minigene fragments that encode normal endogenous gene sequences and those with tumor mutations embedded in tandem. Gene fragments will be cloned into mammalian expression vectors provided by the researcher. The contractor shall provide purified TMG constructs at varying concentrations dependent upon what the researcher requestors. The contractor shall provide retroviral mammalian expression vectors containing antigen specific T-cell receptor (TCR) inserts for the TCR-alpha/beta chains (TCRa/b). Constructs shall be purified at varying concentrations dependent upon what the researcher requestors. Importantly, the contractor shall provide advice on the codon optimization of mammalian expression inserts to ensure that all constructs will have a good chance of working in vitro and in vivo. 2 - QC Analysis of peptides and mammalian expression constructs: The contractor shall perform QC analysis of crude or HPLC purified peptides or peptide pools that encode normal endogenous protein sequences and those with tumor mutations embedded using Mass Spectrometry (MS) to determine the amino acid composition of said peptides. Documentation shall be sent with the peptides or via email to the specific researcher. Additionally, the contractor shall Sanger sequence every construct that the researchers request to determine that either the TMG insert is correct in sequence or that the TCRa/b molecule is correct in sequence. The sequencing file for all constructs shall be made available via mail or email. TYPE OF ORDER This will be issued as a firm fixed price purchase order for severable services. PERIOD OF PERFORMANCE The period of performance is for twelve (12) months with two (2) twelve (12) month option periods. PLACE OF PERFORMANCE All work shall be performed at the Contractor’s facility. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The Contractor shall provide the following: Sequence data of the constructs. The constructs shall be DNA sequenced for verification, and electronic files that describe the generated product shall contain electropherograms showing the DNA sequence of the constructs. These shall show the cloning site as well as the full length insert. Lyophilized crude peptides containing the specific amino acid sequence. Peptides shall be delivered within 2-4 weeks of order. (Delivery address to be provided by the NCI Technical Point of Contact (TPC)). Lead times exceeding 4 weeks may be authorized by the NCI TPC depending on complexity of sequence and length of peptide. Genetic constructs encoding the mutations cloned into an expression plasmid. Genetic constructs shall be made and delivered within 3 weeks of order. (Delivery address to be provided by the TPC). The aforementioned deliverables and any ancillary reports containing relevant data items, per above, will be scrutinized and subsequently accepted within thirty (30) calendar days of receipt, The Government’s Technical Point of Contact (TPC), who will be named upon award, will be responsible for reviewing the work done by the Contractor, making sure that it is consistent with the terms of the Contract, and approving the reports/deliverables provided by the contractor. The TPC is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Government may unilaterally change its TPC designation. All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible." Payment: Payment shall be made after delivery, installation, and successful operation of equipment. Payment authorization requires submission and approval of invoice to the NCI COR and NIH Commercial Accounts. Clauses and Provisions: FAR 52.211-6 BRAND NAME OR EQUAL (AUG 1999) (a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation. (b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must: (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation. (2) Clearly identify the item by— (i) Brand name, if any; and (ii) Make or model number. (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. (c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation. FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/. 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/reference.jsp or from Miguel Diaz, Contracting Officer at miguel.diaz@nih.gov. Clause No. Title FAR 52.212-1 INSTRUCTION TO OFFERORS COMMERCIAL ITEMS (OCT 2018) FAR 52.212-2 EVALUATION COMMERCIAL ITEMS (OCT 2014) FAR 52.212-3 OFFERORS REPRESENTATIONS AND CERTIFICATIONS -COMMERCIAL ITEMS (DEC 2019) FAR 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (OCT 2018) HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS (DEC 2015) HHSAR 352.224–71 CONFIDENTIAL INFORMATION (DEC 2015) FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS---COMMERCIAL ITEMS (JAN 2020). The following additional far clauses cited in this clause are applicable: (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: 52.203-6 Restrictions on Subcontractor Sales to the Government (SEP 2006), with Alternate I (OCT 1995) (41 U.S.C. 253g and 10 U.S.C. 2402) 52.203-13 Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509) 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards (OCT 2015) (Pub.L. 109-282) (31 U.S.C. 6101 note). 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment. (DEC 2019) 52.209-6 Protecting the Government' Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015) (31 U.S.C. 6101 note). 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). 52.219-28 Post Award Small Business Program Representation (JUL 2013) (15 U.S.C. 632(a) (2)). 52.222-3 Convict Labor (JUN 2003) (E.O. 11755). 52.222-19 Child Labor Cooperation with Authorities and Remedies (FEB 2016) (E.O. 13126). 52.222-21 Prohibition of Segregated Facilities (APR 2015) 52.222-26 Equal Opportunity (APR 2015) (E.O. 11246). 52.222-35 Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212). 52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793). 52.222-37 Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212). 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (AUG 2011) (E.O. 13513). 52.225-3 Buy American—Free Trade Agreements-Israeli Trade Act. (MAY 2014) 52.225-5 Trade Agreements (FEB 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). 52.225-13 Restrictions on Certain Foreign Purchase (JUN 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). 52.232-33 Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) (31 U.S.C. 3332). Submission Information: Quotes must be submitted by returning completed copies of the attached SF-1449 and FAR 52.204-26 Certification - (OCT 2020) form 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 a copy of valid certification in the System for Award Management (SAM) at www.sam.gov. Quote must contain all information necessary to allow for a comprehensive evaluation of the prices quoted. Specifically, quotes must include the following: Federal Tax Identification Number (TIN); Data Universal Numbering System (DUNS) Number; Business Size (e.g., small or large) Questions must be submitted electronically (via email) to Contracting Officer, Miguel Diaz, at miguel.diaz@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 12:00 PM EST, on Thursday, August 5, 2021. Proposals must be submitted electronically (via email) to Contracting Officer, Miguel Diaz, at miguel.diaz@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 12:00 PM EST, on Monday, August 09, 2021. All responses must be received by the specified due date and time in order to be considered. PROPOSALS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls will be accepted. Please refer to solicitation no: 75N91021Q00179 on all correspondence. Basis for Award: Award will be made to the responsible firm submitting the offer meeting or exceeding the acceptability standards for the requirements/technical specifications stated above. Award will be made on all or none basis. A technically acceptable offer is one in which the Offeror complies with the requirements/technical specifications stated above, and does not take exception, nor object to any of the terms contained in this request. Offers that are not technically acceptable will not be considered further. The technical evaluation will be a determination based on information furnished by the Contractor. The Government is not responsible for locating or securing any information which is not identified in the proposal. The Government reserves the right to make an award without discussions. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received. If you are providing an “equal” product, you must submit additional documentation that highlights and describes how your offering is equal in accordance with FAR 52.211-6. Price: Price will be evaluated for reasonableness in accordance with FAR 13.106-3. For a price to be reasonable, it must represent a price to the Government that a prudent person would pay when consideration is given to prices in the market. Normally price reasonableness is established through adequate price competition but may also be determined through price and/or cost analysis techniques as described in FAR 15.404.
Data sourced from SAM.gov.
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